Intuniv

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

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This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 1 mg prolonged-release tablets 

Intuniv 2 mg prolonged-release tablets 

Intuniv 3 mg prolonged-release tablets 

Intuniv 4 mg prolonged-release tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Intuniv 1 mg prolonged-release tablet 

 

Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine. 

 

Excipient(s) with known effect 

Each tablet contains 22.41 mg of lactose (as monohydrate). 

 

Intuniv 2 mg prolonged-release tablet 

 

Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine. 

 

Excipient(s) with known effect 

Each tablet contains 44.82 mg of lactose (as monohydrate). 

 

Intuniv 3 mg prolonged-release tablet 

 

Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine. 

 

Excipient(s) with known effect 

Each tablet contains 37.81 mg of lactose (as monohydrate). 

 

Intuniv 4 mg prolonged-release tablet 

 

Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine. 

 

Excipient(s) with known effect 

Each 4 mg tablet contains 50.42 mg of lactose (as monohydrate). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Prolonged-release tablet 

 

Intuniv 1 mg prolonged-release tablet 

 

7.14 mm round, white to off-white tablets debossed with ‘1MG’ on one side and ‘503’ on the other 

side. 

 



 

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Intuniv 2 mg prolonged-release tablet 

 

12.34 mm x 6.10 mm oblong shaped, white to off-white tablets debossed with ‘2MG’ on one side and 

“503” on the other side. 

 

Intuniv 3 mg prolonged-release tablet 

 

7.94 mm round, green tablets debossed with ‘3MG’ on one side and ‘503’ on the other side. 

 

Intuniv 4 mg prolonged-release tablet 

 

12.34 mm x 6.10 mm oblong shaped, green tablets debossed with ‘4MG’ on one side and ‘503’ on the 

other side. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children 

and adolescents 6-17 years old for whom stimulants are not suitable, not tolerated or have been shown 

to be ineffective. 

 

Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including 

psychological, educational and social measures. 

 

4.2 Posology and method of administration 

 

Treatment must be initiated under the supervision of an appropriate specialist in childhood and/or 

adolescent behavioural disorders. 

 

Pre-treatment screening 

 

Prior to prescribing, it is necessary to conduct a baseline evaluation to identify patients at increased 

risk of somnolence and sedation, hypotension and bradycardia, QT-prolongation arrhythmia and 

weight increase/risk of obesity. This evaluation should address a patient’s cardiovascular status 

including blood pressure and heart rate, documenting comprehensive history of concomitant 

medications, past and present co-morbid medical and psychiatric disorders or symptoms, family 

history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight 

on a growth chart (see section 4.4). 

 

Posology 

 

Careful dose titration and monitoring is necessary at the start of treatment since clinical improvement 

and risks for several clinically significant adverse reactions (syncope, hypotension, bradycardia, 

somnolence and sedation) are dose- and exposure-related. Patients should be advised that somnolence 

and sedation can occur, particularly early in treatment or with dose increases. If somnolence and 

sedation are judged to be clinically concerning or persistent, a dose decrease or discontinuation should 

be considered. 

 

For all patients, the recommended starting dose is 1 mg of guanfacine, taken orally once a day. 

 

The dose may be adjusted in increments of not more than 1 mg per week. Dose should be 

individualised according to the patient’s response and tolerability. 

 

Depending on the patient’s response and tolerability for Intuniv the recommended maintenance dose 

range is 0.05-0.12 mg/kg/day. The recommended dose titration for children and adolescents is 



 

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provided below (see tables 1 and 2). Dose adjustments (increase or decrease) to a maximum tolerated 

dose within the recommended optimal weight-adjusted dose range based upon clinical judgement of 

response and tolerability may occur at any weekly interval after the initial dose. 

 

Monitoring during titration 

During dose titration, weekly monitoring for signs and symptoms of somnolence and sedation, 

hypotension and bradycardia should be performed. 

 

Ongoing monitoring 

During the first year of treatment, the patient should be assessed at least every 3 months for: 

• Signs and symptoms of: 
o somnolence and sedation 
o hypotension 
o bradycardia 

• weight increase/risk of obesity 
It is recommended clinical judgement be exercised during this period. 6 monthly monitoring should 

follow thereafter, with more frequent monitoring following any dose adjustments (see section 4.4). 

 

Table 1 

 

Dose titration schedule for children aged 6-12 years 

Weight Group  Week 1 Week 2 Week 3 Week 4 

25 kg and up  

Max 

Dose= 4 mg 

1 mg 2 mg 3 mg 4 mg 

 

Table 2 

 

Dose titration schedule for adolescents (aged 13-17 Years) 

Weight Groupa 
Week 

1 

Week 

2 

Week 

3 

Week 

4 
Week 5 Week 6 Week 7 

34-41.4 kg 

Max 

Dose= 4 mg 

1 mg 2 mg 3 mg 4 mg    

41.5-49.4 kg 

Max 

Dose= 5 mg 

1 mg 2 mg 3 mg 4 mg 5 mg   

49.5-58.4 kg 

Max 

Dose= 6 mg 

1 mg 2 mg 3 mg 4 mg 5 mg 6 mg  

58.5 kg and 

above 

Max 

Dose= 7 mg 

1 mg 2 mg 3 mg 4 mg 5 mg 6 mg 7 mgb 

a Adolescent subjects must weigh at least 34 kg. 
b Adolescents weighing 58.5 kg and above may be titrated to a 7 mg/day dose after the 

subject has completed a minimum of 1 week of therapy on a 6 mg/day dose and the 

physician has performed a thorough review of the subject’s tolerability and efficacy. 

 



 

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The physician who elects to use guanfacine for extended periods (over 12 months) should re-evaluate 

the usefulness of guanfacine every 3 months for the first year and then at least yearly based on clinical 

judgement (see section 4.4), and consider trial periods off medication to assess the patient’s 

functioning without pharmacotherapy, preferably during times of school holidays. 

 

Downward titration and discontinuation 

Patients/caregivers should be instructed not to discontinue guanfacine without consulting their 

physician. 

 

When stopping treatment, the dose must be tapered with decrements of no more than 1 mg every 3 to 

7 days, and blood pressure and pulse should be monitored in order to minimise potential withdrawal 

effects, in particular increases in blood pressure and heart rate (see section 4.4). 

 

In a maintenance of efficacy study, upon switching from guanfacine to placebo, 7/158 (4.4%) subjects 

experienced increases in blood pressure to values above 5 mmHg and also above the 95th percentile for 

age, sex and stature (see sections 4.8 and 5.1). 

 

Missed dose 

If a dose is missed, the prescribed dose can resume the next day. If two or more consecutive doses are 

missed, re-titration is recommended based on the patient’s tolerability to guanfacine. 

 

Switching from other formulations of guanfacine 

Immediate-release guanfacine tablets should not be substituted on a mg/mg basis, because of differing 

pharmacokinetic profiles. 

 

Special populations 

 

Adults and elderly 

The safety and efficacy of guanfacine in adult and the elderly with ADHD has not been established. 

Therefore, guanfacine should not be used in this group. 

 

Hepatic impairment 

Dose reduction may be required in patients with different degrees of hepatic impairment (see 

section 5.2). 

The impact of hepatic impairment on the pharmacokinetics of guanfacine in paediatric patients 

(children and adolescents 6-17 years old) was not assessed. 

 

Renal impairment 

Dose reduction may be required in patients with severe renal impairment (GFR 29-15 ml/min) and an 

end stage renal disease (GFR<15 ml/min) or requiring dialysis. The impact of renal impairment on the 

pharmacokinetics of guanfacine in paediatric patients (children and adolescents 6-17 years old) was 

not assessed (see section 5.2). 

 

Children under 6 years 

The safety and efficacy of guanfacine in children aged less than 6 years have not yet been established. 

No data are available. 

 

Patients treated with CYP3A4 and CYP3A5 inhibitors/inducers 

 

CYP3A4/5 inhibitors have been shown to have a significant effect on the pharmacokinetics of 

guanfacine when co-administered. Dose adjustment is recommended with concomitant use of 

moderate/strong CYP3A4/5 inhibitors (e.g., ketoconazole, grapefruit juice), or strong CYP3A4 

inducers (e.g., carbamazepine) (see section 4.5).  

 

In case of concomitant use of strong and moderate CYP3A inhibitors, a 50% reduction of the 

guanfacine dose is recommended. Due to variability in interaction effect, further dose titration may be 

needed (see above).  



 

6 

 

If guanfacine is combined with strong enzyme inducers, a retitration to increase the dose up to a 

maximum daily dose of 7 mg may be considered if needed. If the inducing treatment is ended, 

retitration to reduce the guanfacine dose is recommended during the following weeks (see section 4.5). 

 

Method of administration 

 

Oral use. 

 

Guanfacine is taken once daily either morning or evening. Tablets should not be crushed, chewed or 

broken before swallowing because this increases the rate of guanfacine release. 

 

Treatment is recommended only for children who are able to swallow the tablet whole without 

problems. 

 

Guanfacine can be administered with or without food but should not be administered with high fat 

meals, due to increased exposure (see sections 4.5 and 5.2). 

 

Guanfacine should not be administered together with grapefruit juice (see section 4.5). 

 

4.3 Contraindications 

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

Hypotension, bradycardia and syncope 

 

Guanfacine can cause syncope, hypotension and bradycardia. Syncope may involve risks of falls or 

accidents, which could result in serious harm (see sections 4.8 and 4.7). 

 

Prior to initiation of treatment, patient’s cardiovascular status including heart rate and blood pressure 

parameters, family history of sudden cardiac death/unexplained death, should be assessed to identify 

patients at increased risk of hypotension, bradycardia, and QT-prolongation/risk of arrhythmia. 

Monitoring of heart rate and blood pressure parameters should continue on a weekly basis during dose 

titration and stabilisation and at least every 3 months for the first year, taking into consideration 

clinical judgement. 6 monthly monitoring should follow thereafter, with more frequent monitoring 

following any dose adjustment. 

 

Caution is advised when treating patients with guanfacine who have a history of hypotension, heart 

block, bradycardia, or cardiovascular disease, or who have a history of syncope or a condition that 

may predispose them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or 

dehydration. Caution is also advised when treating patients who are being treated concomitantly with 

antihypertensives or other medicinal products that can reduce blood pressure or heart rate or increase 

the risk of syncope (see section 4.5). Patients should be advised to drink plenty of fluid. 

 

Blood pressure and heart rate increase upon discontinuation 

 

Blood pressure and pulse may increase following discontinuation of guanfacine. In post-marketing 

experience, hypertensive encephalopathy has been very rarely reported upon abrupt discontinuation of 

treatment (see section 4.8). To minimise the risk of an increase in blood pressure upon discontinuation, 

the total daily dose should be tapered in decrements of no more than 1 mg every 3 to 7 days (see 

section 4.2). Blood pressure and pulse should be monitored when reducing the dose or discontinuing 

treatment. 

 



 

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QTc interval 

 

In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval 

prolongation that exceeded change from baseline greater than >60 ms Fridericia-correction and 

Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among 

guanfacine patients. The clinical relevance of this finding is uncertain. 

 

Guanfacine should be prescribed with caution in patients with a known history of QT prolongation, 

risk factors for torsade de pointes (e.g., heart block, bradycardia, hypokalaemia) or patients who are 

taking medicinal products known to prolong the QT interval (see section 4.5). These patients should 

receive further cardiac evaluation based on clinical judgement (see section 4.8). 

 

Sedation and somnolence 

 

Guanfacine may cause somnolence and sedation predominantly at the start of treatment and could 

typically last for 2-3 weeks and longer in some cases. It is therefore recommended that patients will be 

closely monitored weekly during dose titration and stabilisation (see section 4.2), and every 3 months 

during the first year, taking into consideration clinical judgement. Before guanfacine is used with any 

other centrally active depressants (such as alcohol, sedatives, phenothiazines, barbiturates, or 

benzodiazepines) the potential for additive sedative effects should be considered (see section 4.5). 

Patients should not drink alcohol whilst taking guanfacine.  

 

Patients are advised against operating heavy equipment, driving or cycling until they know how they 

respond to treatment with guanfacine (see section 4.7). 

 

Suicidal ideation 

 

Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated 

immediately by their physician. Treatment of an underlying psychiatric condition may be necessary 

and consideration should be given to a possible change in the ADHD treatment programme. 

 

Effects on height, weight and Body Mass index (BMI) 

 

Children and adolescents treated with guanfacine may show an increase in their BMI. Therefore, 

monitoring of height, weight and BMI should be done prior to initiation of therapy and then every 

3 months for the first year, taking into consideration clinical judgement. 6 monthly monitoring should 

follow thereafter, with more frequent monitoring following any dose adjustment. 

 

Excipients 

 

Intuniv contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase 

deficiency or glucose-galactose malabsorption should not take this medicinal product. 

 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-

free’. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

When guanfacine is used concomitantly with CYP3A4/5 inhibitors or inducers, plasma concentrations 

of guanfacine may be elevated or lowered, potentially affecting the efficacy and safety of guanfacine. 

Guanfacine can increase plasma concentrations of concomitantly administered medicinal products that 

are metabolised via CYP3A4/5 (see sections 4.2, 4.4 and 5.2). 

 

Guanfacine is an in vitro inhibitor of MATE1 and the clinical relevance of MATE1 inhibition cannot 

be excluded. Concomitant administration of guanfacine with MATE1 substrates may result in 

increases in the plasma concentrations of these medicinal products. Furthermore, based on in vitro 

studies, guanfacine may be an inhibitor of OCT1 at maximal portal vein concentrations. Concomitant 



 

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administration of guanfacine with OCT1 substrates with a similar Tmax (e.g., metformin) may result in 

increases in Cmax of these medicinal products. 

 

The pharmacodynamic effect of guanfacine can have an additive effect when taken with other 

products known to cause sedation, hypotension or QT prolongation (see section 4.4). 

 

Interaction studies have only been performed in adults. However, the outcome is expected to be 

similar in the indicated paediatric age range. 

 

QT prolonging medicinal products 

 

Guanfacine causes a decrease in heart rate. Given the effect of guanfacine on heart rate, the 

concomitant use of guanfacine with QT prolonging medicinal products is generally not recommended 

(see section 4.4). 

 

CYP3A4 and CYP3A5 inhibitors 

 

Caution should be used when guanfacine is administered to patients taking ketoconazole and other 

moderate and strong CYP3A4/5 inhibitors, a decrease in the dose of guanfacine within the 

recommended dose range is proposed (see section 4.2). Co-administration of guanfacine with 

moderate and strong CYP3A4/5 inhibitors elevates plasma guanfacine concentrations and increases 

the risk of adverse reactions such as hypotension, bradycardia, and sedation. There was a substantial 

increase in the rate and extent of guanfacine exposure when administered with ketoconazole; the 

guanfacine peak plasma concentrations (Cmax) and exposure (AUC) increased 2- and 3-fold, 

respectively. Other CYP3A4/5 inhibitors may have a comparable effect, see table 3 for a list of 

examples of moderate and strong CYP3A4/5 inhibitors, this list is not definitive. 

 

CYP3A4 inducers 

 

When patients are taking guanfacine concomitantly with a CYP3A4 inducer, an increase in the dose of 

guanfacine within the recommended dose range is proposed (see section 4.2). There was a significant 

decrease in the rate and extent of guanfacine exposure when co-administered with rifampicin, a 

CYP3A4 inducer. The peak plasma concentrations (Cmax) and exposure (AUC) of guanfacine 

decreased by 54% and 70% respectively. Other CYP3A4 inducers may have a comparable effect, see 

table 3 for a list of examples of CYP3A4/5 inducers, this list is not definitive. 

 

Table 3 

 

Moderate CYP3A4/5 

inhibitors 

Strong CYP3A4/5 inhibitors CYP3A4 inducers 

Aprepitant Boceprevir Bosentan 

Atazanavir Chloramphenicol Carbamazepine 

Ciprofloxacin Clarithromycin Efavirenz 

Crizotinib Indinavir Etravirine 

Diltiazem Itraconazole Modafinil 

Erythromycin Ketoconazole Nevirapine 

Fluconazole Posaconazole Oxcarbazepine 

Fosamprenavir Ritonavir Phenobarbital 

Imatinib Saquinavir Phenytoin 

Verapamil Suboxone Primidone 

Grapefruit juice Telaprevir Rifabutin 

 Telithromycin Rifampicin 

  St. John’s wort 

See section 4.2 for further dosing recommendations 

 



 

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Valproic acid 

 

Co-administration of guanfacine and valproic acid can result in increased concentrations of valproic 

acid. The mechanism of this interaction is unknown, although both guanfacine and valproic acid are 

metabolised by glucuronidation, possibly resulting in competitive inhibition. When guanfacine is 

co-administered with valproic acid, patients should be monitored for potential additive central nervous 

system (CNS) effects and consideration should be given to the monitoring of serum valproic acid 

concentrations. Adjustments in the dose of valproic acid and guanfacine may be indicated when co-

administered. 

 

Antihypertensive medicinal products 

 

Caution should be used when guanfacine is administered concomitantly with antihypertensive 

medicinal products, due to the potential for additive pharmacodynamic effects such as hypotension 

and syncope (see section 4.4). 

 

CNS depressant medicinal products 

 

Caution should be used when guanfacine is administered concomitantly with CNS depressant 

medicinal products (e.g., alcohol, sedatives, hypnotics, benzodiazepines, barbiturates, and 

antipsychotics) due to the potential for additive pharmacodynamic effects such as sedation and 

somnolence (see section 4.4). 

 

Oral methylphenidate 

 

In an interaction study, neither guanfacine nor Osmotic Release Oral System (OROS)-

methylphenidate HCl extended-release were found to affect the pharmacokinetics of the other 

medicinal products when taken in combination. 

 

Lisdexamfetamine dimesylate 

 

In a drug interaction study, administration of guanfacine in combination with lisdexamfetamine 

dimesylate induced a 19% increase in guanfacine maximum plasma concentrations, whereas exposure 

(AUC) was increased by 7%. These small changes are not expected to be clinically meaningful. In this 

study, no effect on d-amphetamine exposure was observed following combination of guanfacine and 

lisdexamfetamine dimesylate. 

 

Food interactions 

 

Guanfacine should not be administered with high fat meals due to increased exposure, as it has been 

shown that high fat meals have a significant effect on the absorption of guanfacine (see section 4.2). 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no or limited amount of data from the use of guanfacine in pregnant women. 

Studies in animals have shown reproductive toxicity (see section 5.3). 

Guanfacine is not recommended during pregnancy and in women of childbearing potential not using 

contraception. 

 

Breast-feeding 

 

It is unknown whether guanfacine and its metabolites are excreted in human milk. 

 



 

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Available pharmacodynamic and toxicological data in animals have shown excretion of guanfacine 

and its metabolites in milk (see section 5.3). Therefore, a risk on the breast-fed infant cannot be 

excluded. 

 

A decision must be made whether to discontinue breast-feeding or to discontinue and/or abstain from 

guanfacine therapy taking into account the benefit of breast feeding for the child and the benefit of 

therapy for the woman. 

 

Fertility 

 

There are no or limited amount of data regarding effect on fertility from the use of guanfacine in 

humans. 

 

Animal studies indicate an effect on male fertility (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 

 

Guanfacine may have a moderate to severe influence on the ability to drive and use machines.  

Guanfacine can cause dizziness and somnolence. These effects occur predominantly at the start of 

treatment and may occur less frequently as treatment continues. Syncope has also been observed.  

Patients should be warned of these possible effects and be advised that if affected, they should avoid 

these activities (see section 4.4). 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most frequently reported adverse reactions include somnolence (40.6%), headache (27.4%), 

fatigue (18.1%), abdominal pain upper (12.0%), and sedation (10.2%). The most serious adverse 

reactions commonly reported include hypotension (3.2%), weight increase (2.9%), bradycardia (1.5%) 

and syncope (0.7%). The adverse reactions somnolence and sedation occurred predominantly at the 

start of treatment and may typically last for 2-3 weeks and longer in some cases. 

 

Tabulated list of adverse reactions 

 

The following table presents all adverse reactions based on clinical trials and spontaneous reporting. 

All adverse reactions from post-marketing experience are italicised. 

 

The following definitions apply to the frequency terminology used hereafter: 

very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 

to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 

 

Table 4. Adverse reactions 

System/Organ Class 

Adverse reaction 

Incidence Category 

Immune system disorders 

Hypersensitivity Uncommon 

 

Metabolism and nutrition disorders 

Decreased appetite Common 

 

Psychiatric disorders 

Depression Common 

Anxiety Common 

Affect lability Common 

Insomnia Common 

Middle insomnia Common 



 

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Table 4. Adverse reactions 

System/Organ Class 

Adverse reaction 

Incidence Category 

Nightmare Common 

Agitation Uncommon 

Hallucination Uncommon 

 

Nervous system disorders  

Somnolence Very common 

Headache Very common 

Sedation Common 

Dizziness Common 

Lethargy Common 

Convulsion Uncommon 

Syncope/loss of consciousness Uncommon 

Postural dizziness  Uncommon 

Hypersomnia Rare 

 

Cardiac disorders  

Bradycardia Common 

Atrioventricular block first degree Uncommon 

Tachycardia Uncommon 

Sinus arrhythmia Uncommon 

 

Vascular disorders 

Hypotension Common 

Orthostatic hypotension Common 

Pallor Uncommon 

Hypertension Rare 

Hypertensive encephalopathy Very rare 

 

Respiratory, thoracic, and mediastinal disorders 

Asthma Uncommon 

 

Gastrointestinal disorders 

Abdominal pain Very common 

Vomiting Common 

Diarrhoea Common 

Nausea Common 

Constipation Common 

Abdominal/stomach discomfort Common 

Dry mouth Common 

Dyspepsia Uncommon 

 

Skin and subcutaneous tissue disorders 

Rash Common 

Pruritus Uncommon 

 

Renal and urinary disorders 

Enuresis Common 

Pollakiuria Uncommon 

 

Reproductive system and breast disorders 

Erectile dysfunction Not known 



 

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Table 4. Adverse reactions 

System/Organ Class 

Adverse reaction 

Incidence Category 

 

General disorders and administration site conditions 

Fatigue Very common 

Irritability Common 

Asthenia Uncommon 

Chest pain Uncommon 

Malaise Rare 

 

Investigations 

Blood pressure decreased Common 

Weight increased Common 

Blood pressure increased Uncommon 

Heart rate decreased  Uncommon 

Alanine aminotransferase increased Uncommon 

 

Description of selected adverse reactions 

 

Somnolence/sedation, hypotension, bradycardia and syncope 

In the overall pool of guanfacine-treated patients, somnolence occurred in 40.6% and sedation in 

10.2% of guanfacine-treated patients. Bradycardia occurred in 1.5%, hypotension in 3.2% and syncope 

occurred in 0.7% of all guanfacine-treated patients. The occurrence of somnolence/sedation and 

hypotension was most prominent in the first few weeks of treatment and diminished gradually 

thereafter. 

 

Effects on height, weight and body Mass index (BMI) 

Careful follow-up for weight suggests that children and adolescents who took guanfacine in the study 

(i.e., treatment for 7 days per week throughout the year) have demonstrated by an age- and 

sex-normalised mean change from baseline in BMI percentile, 4.3 over 1 year (average percentiles at 

baseline and 12 months were 68.3 and 73.1, respectively). Consequently, as part of routine monitoring 

height, weight and BMI should be monitored at the start of treatment and every 3 months during the 

first year, then 6 monthly taking into consideration clinical judgement with maintenance of a growth 

chart. 

 

Thorough QT /QTc study 

The effect of 2 dose levels of immediate-release guanfacine (4 mg and 8 mg) on QT interval was 

evaluated in a double-blind, randomised, placebo- and active-controlled, cross-over study in healthy 

adults. An apparent increase in mean QTc was observed for both doses. This finding has no known 

clinical relevance. 

 

In phase II-III randomised double-blind monotherapy studies respective increases in QTc interval 

prolongation that exceeded change from baseline greater than 60 ms Fridericia-correction and 

Bazett-correction were 0 (0.0%) and 2 (0.3%) among placebo and 1 (0.1%) and 1 (0.1%) among 

guanfacine patients. The clinical relevance of this finding is uncertain. 

 

Blood pressure and heart rate increase upon discontinuation of guanfacine 

Blood pressure and pulse may increase following discontinuation of guanfacine. In post-marketing 

experience, hypertensive encephalopathy has been very rarely reported upon abrupt discontinuation of 

guanfacine (see section 4.4). 

 

In a maintenance of efficacy study in children and adolescents, increases in mean systolic and diastolic 

blood pressure of approximately 3 mmHg and 1 mmHg, respectively, above original baseline were 

observed upon discontinuation of guanfacine. However, individuals may have larger increases than 

reflected by the mean changes. The increases in blood pressure were observed in some individuals at 



 

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the end of the follow up period which ranged between 3 and 26 weeks post final dose (see sections 4.2 

and 5.1). 

 

Adult patients 

 

Guanfacine has not been studied in adults with ADHD. 

 

Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

Signs and symptoms of overdose may include hypotension, initial hypertension, bradycardia, lethargy, 

and respiratory depression. Haemodynamic instability has also been associated with a guanfacine 

overdose 3 times the recommended daily dose. Management of guanfacine overdose should include 

monitoring for and treatment of these signs and symptoms. 

 

Paediatric patients (children and adolescents 6-17 years old inclusive) who develop lethargy should be 

observed for the development of more serious toxicity including coma, bradycardia, and hypotension 

for up to 24 hours, due to the possibility of delayed onset of these symptoms. 

 

Treatment of overdose may include gastric lavage if it is performed soon after ingestion. Activated 

charcoal may be useful in limiting the absorption. Guanfacine is not dialysable in clinically significant 

amounts (2.4%). 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: Antihypertensives, antiadrenergic agents, centrally acting ATC code: 

C02AC02. 

 

Mechanism of action 

 

Guanfacine is a selective alpha2A-adrenergic receptor agonist in that it has 15-20 times higher affinity 

for this receptor subtype than for the alpha2B or alpha2C subtypes. Guanfacine is a non-stimulant. The 

mode of action of guanfacine in ADHD is not fully established. Preclinical research suggests 

guanfacine modulates signalling in the prefrontal cortex and basal ganglia through direct modification 

of synaptic noradrenalin transmission at the alpha2A-adrenergic receptors. 

 

Pharmacodynamic effects 

 

Guanfacine is a known antihypertensive agent. By stimulating alpha2A-adrenergic receptors, 

guanfacine reduces sympathetic nerve impulses from the vasomotor centre to the heart and blood 

vessels. This results in a decrease in peripheral vascular resistance and blood pressure, and a reduction 

in heart rate. 

 

Clinical efficacy and safety 

 

The effects of guanfacine in the treatment of ADHD has been examined in 5 controlled studies in 

children and adolescents (6 to 17 years), 3 short-term controlled trials in children and adolescents aged 

6 to 17 years, 1 short-term controlled study in adolescents aged 13 to 17 years, and 1 randomised 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

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withdrawal trial in children and adolescents aged 6-17 years, all of whom met the DSM-IV-TR criteria 
for ADHD. The majority of patients achieved an optimised dose between 0.05-0.12 mg/kg/day. 
 

Three hundred and thirty-seven patients aged 6-17 years were evaluated in the pivotal Phase 3 Study 

SPD503-316, to assess safety and efficacy of once-daily dosing (children:1-4 mg/day, adolescents: 
1-7 mg/day). In this 12-week (6-12 years) or 15-week (13-17 years), randomised, double-blind, 

parallel-group, placebo- and active-reference (atomoxetine), dose-titration study, guanfacine showed 

significantly greater efficacy than placebo on symptoms of ADHD based upon investigator ratings on 

the ADHD Rating Scale (ADHD-RS). The ADHD Rating Scale is a measure of the core symptoms of 

ADHD. The results with respect to the primary endpoint study are presented in Table 5. 

 

Table 5. Summary of primary efficacy for study SPD503-316: ADHD-RS-IV 

 

Treatment 

groups 

N Baseline 

ADHD-RS-IV 

(SD) 

Change from 

baseline (SD) 

Difference from 

placebo 

(95%CI) 

Effect size 

Responder

s 

Difference from 

placebo (95%CI) 

Guanfacine 

 

Atomoxetine 

 

Placebo 

114 

 

112 

 

111 

43.1 (5.5) 

 

43.7 (5.9) 

 

43.2 (5.6) 

-23.9 (12.4) 

 

-18.6 (11.9) 

 

-15.0 (13.1) 

-8.9 (-11.9, -5.8) 

0.8 

-3.8 (-6.8, -0.7) 

0.3 

NA 

64.3% 

 

55.4% 

 

42.3% 

21.9% (9.2; 34.7) 

 

13.0% (0.0; 26.0) 

 

NA 

 

Results of the secondary endpoints were consistent with that of the primary endpoint. The percentages 

of subjects who met response criteria (≥30% reduction from baseline in ADHD-RS-IV Total Score 

and a CGI-I value of 1 or 2) was 64.3% for guanfacine, 55.4% for atomoxetine and 42.3% for placebo. 

Guanfacine also showed significant improvement in learning, school and family functioning as 

measured with the (WFIRS-P score). 
 

In addition a 15-week, double-blind, randomised, placebo-controlled, dose-optimisation study 

(SPD503-312) conducted in adolescents aged 13-17 years (n=314) to confirm the efficacy, safety, and 

tolerability of guanfacine (1-7 mg/day) in the treatment of ADHD. Guanfacine showed a significantly 

greater improvement in the ADHD-RS-IV total score compared with subjects receiving placebo. 

Guanfacine-treated patients were in statistically significantly better conditions on the functional 

outcome as measured by the clinical global impression of severity (CGI-S) at endpoint compared to 

placebo-treated patients. Superiority (statistical significance) over placebo on the family and school, 

and learning domains of the WFIRS-P score was not established in this study. 

 

Study (SPD503-315) was a 41 week long term maintenance of efficacy study which included an 

open-label phase (up to 13 weeks) followed by double-blind, placebo-controlled, 

randomised-withdrawal phase (up to 26 weeks), conducted in paediatric patients (children and 

adolescents aged 6-17 years old inclusive) (n=526 in the open-label phase and n=315 in the 

double-blind randomised-withdrawal phase) to assess the efficacy, safety, and tolerability of 

once-daily dosing with guanfacine (children: 1-4 mg/day, adolescents:1-7 mg/day) in the treatment of 

ADHD. Guanfacine was superior to placebo in the long-term maintenance of treatment in children and 

adolescents with ADHD as measured by cumulative treatment failures (49.3% for guanfacine, and 

64.9% for placebo, p=0.006). Treatment failure was defined as a ≥50% increase in ADHD-RS-IV total 

score and a ≥2 point increase in CGI-S score compared to the respective scores at the double-blind 

baseline visit. At the end of their double-blind treatment, a significantly larger proportion of subjects 

in the guanfacine compared with placebo group were normal or borderline mentally ill as measured by 

the clinical global impression of severity (CGI-S) that includes assessment of functioning. Superiority 

(statistical significance) over placebo on the family and school, and learning domains of the WFIRS-P 

score was not consistently established in this study. 

 

Similar results for the efficacy of guanfacine in the treatment of ADHD were established in 

2 randomised, double-blind, placebo-controlled, fixed-dose (range of 1-4 mg/day) monotherapy trials 



 

15 

in paediatric patients (children and adolescents 6-17 years old inclusive). Studies SPD503-301 and 

SPD503-304 were 8 and 9 weeks in duration, respectively, both conducted in the United States. 

Guanfacine showed significantly greater improvement compared to placebo on the change from 

baseline to final on treatment assessment in the ADHD Rating Scale (ADHD-RS-IV) score in both 

studies (placebo-adjusted reduction in LS mean range from 5.4 to 10.0, p<0.02). 

 

Study SPD503-314 was conducted in children aged 6-12 years to assess the efficacy of once daily 

dosing with guanfacine (1-4 mg) administered either in the morning or the evening. This was a 

double-blind, randomised, placebo-controlled, dose-optimisation study, 9-weeks in duration conducted 

in the United States and Canada. Symptoms of ADHD were evaluated as the change from baseline to 

week 8 (final on treatment assessment) in the ADHD Rating Scale (ADHD-RS-IV) total scores. 

Guanfacine showed significantly greater improvement compared to placebo regardless of time (AM or 

PM) of administration (placebo-adjusted LS mean difference of -9.4 and -9.8 for AM and PM dosing, 

respectively, p<0.001). 

 

Co-administration with psychostimulants 

The effect of co-administration with psychostimulants was examined in an add-on study in partial 

responders to psychostimulants. The study was double-blind, randomised, placebo-controlled, 

multi-centre, dose-optimisation 9-weeks study. It was designed to evaluate the efficacy and safety of 

guanfacine (1, 2, 3, and 4 mg/day) when co-administered with long-acting psychostimulants 

(amphetamine, lisdexamfetamine, methylphenidate, dexmethylphenidate) in children and adolescents 

aged 6-17 years with a diagnosis of ADHD and a suboptimal, partial response to psychostimulants. 

Suboptimal response was defined as an ADHD-RS-IV total score of ≥24 and a CGI-S score ≥3 at 

screening and baseline. The primary efficacy assessment was the ADHD-RS-IV total score. 

The results showed that patients treated with add-on guanfacine improved more on the ADHD-RS-IV 

compared to those treated with add-on placebo (20.7 (12.6) points vs. 15.9 (11.8); difference: 4.9 

(95% CI 2.6, 7.2). No age differences were observed with respect to response to the ADHD-RS-IV. 

 

ADHD with oppositional symptoms study 

Study SPD503-307 was a 9-week, double-blind, randomised, placebo-controlled, dose-optimisation 

study with guanfacine (1-4 mg/day) conducted in children aged 6-12 years with ADHD and 

oppositional symptoms (n=217). Oppositional symptoms were evaluated as the change from baseline 

to endpoint in the Oppositional Subscale of the Conners’ Parent Rating Scale – revised Long Form 

(CPRS-R:L) score. Results show statistically significantly (p≤0.05) greater mean reductions at 

endpoint from Baseline (indicating improvement) in oppositional subscale of CPRS-R:L scores in the 

guanfacine group compared to placebo (10.9 points vs. 6.8 for guanfacine vs. placebo, respectively) 

and the effect size was 0.6 (p<0.001). These reductions represent a percentage reduction of 56% vs. 

33% for guanfacine vs. placebo, respectively. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Guanfacine is readily absorbed, with peak plasma concentrations reached approximately 5 hours after 

oral administration in paediatric patients (children and adolescents 6-17 years old inclusive). In adults, 

the mean exposure of guanfacine increased (Cmax ~75% and AUC ~40%) when guanfacine was taken 

together with a high fat meal, compared to intake in the fasted state (see section 4.2). 

 

Distribution 

 

Guanfacine is moderately bound to plasma proteins (approximately 70%), independent of active 

substance concentration. 

 



 

16 

Biotransformation 

 

Guanfacine is metabolised via CYP3A4/5-mediated oxidation, with subsequent phase II reactions of 

sulfation and glucuronidation. The major circulating metabolite is 3-OH-guanfacine sulfate which 

lacks pharmacological activity. 

 

Guanfacine is a substrate of CYP3A4 and CYP3A5, and exposure is affected by CYP3A4 and 

CYP3A5 inducers and inhibitors. In human hepatic microsomes, guanfacine did not inhibit the 

activities of the other major cytochrome P450 isoenzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, 

CYP2C19, CYP2D6, CYP3A4 or CYP3A5); guanfacine is also not expected to be an inducer of 

CYP3A, CYP1A2 and CYP2B6. 

 

Transporters 

 

Based on in vitro studies, guanfacine is a substrate of OCT1 and OCT2, but not BCRP, OATP1B1, 

OATP1B3, OAT1, OAT3, MATE1 or MATE2. Guanfacine is not an inhibitor of BSEP, MRP2, 

OATP1B1, OATP1B3, OAT1, OAT3, OCT2 or MATE2K, but it is an inhibitor of MATE1 and may 

be an inhibitor of OCT1 at maximal portal vein concentrations. 

 

Elimination 

 

Guanfacine is cleared by the kidneys via filtration and active secretion and the liver. Active renal 

secretion is mediated via OCT2 transporter. At least 50% of the clearance of guanfacine is hepatic. 

Renal excretion is the major elimination pathway (80%) with parent active substance accounting for 

30% of the urinary radioactivity. The major urinary metabolites were 3-hydroxy guanfacine 

glucuronide, guanfacine dihydrodiol, 3-hydroxy guanfacine sulfate. The elimination half-life of 

guanfacine is approximately 18 hours. 

 

The pharmacokinetics of guanfacine is similar in children (aged 6 to 12) and adolescents (aged 

13 to 17) ADHD patients, and healthy adult volunteers. 

 

Special populations 

 

There have been no studies performed in children with ADHD under the age of 6 years with 

guanfacine. 

 

Systemic exposure to guanfacine is similar for men and women given the same mg/kg dose. 

 

Formal pharmacokinetic studies for race have not been conducted. There is no evidence of any impact 

of ethnicity on the pharmacokinetics of guanfacine. 

 

5.3 Preclinical safety data 

 

No carcinogenic effect of guanfacine was observed in studies of 78 weeks in mice at doses up to 

10 mg/kg/day. A significant increase in incidence of adenomas of the pancreatic islet was observed in 

male rats treated with 5 mg/kg/day guanfacine for 102 weeks but not in female rats. The clinical 

relevance is unknown. 

 

Guanfacine was not genotoxic in a variety of test models, including the Ames test and an in vitro 

chromosomal aberration test. 

 

General toxicity observed in animals (rat, dog) upon treatment with guanfacine included prolongation 

of uncorrected QT interval (heart), atrophic spleen and decreased white blood cells, affected liver – 

increased bilirubin and ALT levels included, irritated and inflamed intestines, increased creatinine and 

blood urea nitrogen levels (kidney), corneal clouding (eye) in rat and mouse only, alveolar 

macrophage infiltration & pneumonitis and reduced spermatogenesis. 

 



 

17 

No adverse effects were observed in a fertility study in female rats at doses up to 22 times the 

maximum recommended human dose on a mg/m2 basis. 

 

Male fertility was affected at 8 mg/kg/day, the lowest dose tested, equivalent of 10.8 times the 

maximum recommended human dose of 0.12 mg/kg on a mg/m2 basis. Due to lack of proper 

toxicokinetic data, comparison to human clinical exposure was not possible. 

 

Guanfacine showed embryo foetal developmental toxicity in mice and rats (NOAEL 0.5 mg/kg/day) 

and in rabbits (NOAEL 3.0 mg/kg/day) in the presence of maternal toxicity. Due to a lack of proper 

toxicokinetic data, comparison to human clinical exposure was not possible. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Hypromellose 2208 

Methacrylic acid-ethyl acrylate copolymer 

Lactose monohydrate 

Povidone 

Crospovidone Type A 

Microcrystalline cellulose 

Silica, colloidal anhydrous 

Sodium laurilsulfate 

Polysorbate 80 

Fumaric acid 

Glycerol dibehenate 

 

3 mg and 4 mg prolonged-release tablets also include: 

Indigo carmine aluminium lake (E 132) 

Iron oxide yellow (E 172) 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

4 years. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions. 

 

6.5 Nature and contents of container 

 

The blister strips comprise of 2 layers, a clear thermoformable rigid film which is laminated with 

PCTFE to a PVC backing to which a push-through aluminium foil is adhered. The blisters are 

contained in cardboard cartons. 

 

Intuniv 1 mg prolonged-release tablet 

pack sizes: 7 or 28 tablets. 

 

Intuniv 2 mg prolonged-release tablet 

pack sizes: 7, 28 or 84 tablets. 

 



 

18 

Intuniv 3 mg prolonged-release tablet 

pack sizes: 28 or 84 tablets. 

 

Intuniv 4 mg prolonged-release tablet 

pack sizes: 28 or 84 tablets. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal  

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited 

Block 2 & 3 Miesian Plaza 

50 – 58 Baggot Street Lower 

Dublin 2  

IRELAND 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

Intuniv 1 mg prolonged-release tablet 

 

EU/1/15/1040/001-002 

 

Intuniv 2 mg prolonged-release tablet 

 

EU/1/15/1040/003-005 

 

Intuniv 3 mg prolonged-release tablet 

 

EU/1/15/1040/006-007 

 

Intuniv 4 mg prolonged-release tablet 

 

EU/1/15/1040/008-009 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 17/09/2015 

Date of latest renewal:  

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


 

19 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



 

20 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

Shire Pharmaceuticals Ireland Limited 

Block 2 & 3 Miesian Plaza 

50 – 58 Baggot Street Lower 

Dublin 2 

IRELAND 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic safety update reports (PSURs) 

 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 

reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 

subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

• Risk management plan (RMP) 

 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 

and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 

authorisation and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

 

• Additional risk minimisation measures 

 

1.  Prior to launch of Intuniv in each Member State the Marketing Authorisation Holder (MAH) must 

agree about the content and format of the educational programme, including communication media, 

distribution modalities, and any other aspects of the programme, with the National Competent 

Authority. 

 

2.  The MAH shall ensure that, following discussions and agreement with the National Competent 

Authorities in each Member State where Intuniv is launched all healthcare professionals who are 

expected to prescribe Intuniv are informed through an information letter on having access to / are 

provided with the following items: 



 

21 

• Summary of Product Characteristics (SmPC) and Package Leaflet 

• Educational material (including prescriber checklist) for the healthcare professionals 

 

The Educational material and Prescriber checklist shall contain the following key messages: 

• Information on the risks associated with Intuniv: Bradycardia, Syncope, Hypotension/decreased 

blood pressure, withdrawal blood pressure increase, sedative events and weight increase 

• Checklist prior to initiating treatment with Intuniv to identify patients at risk for serious 

undesirable effects 

• Checklist for ongoing monitoring and safety management of patients including titration phase 

during treatment with Intuniv 

• Chart for ongoing monitoring (vital signs, height, weight) of patients during treatment with 

Intuniv. 

• Checklist for discontinuation of guanfacine including monitoring blood pressure and pulse of 

patients during downward titration. 

 

• Obligation to conduct post-authorisation measures 

 

The MAH shall complete, within the stated timeframe, the below measures: 

 

Description Due date 

SHP503-401: In order to investigate the long term safety (especially effects on 

neurocognitive function) of Intuniv in Children and Adolescents Aged 6-17 Years 

with ADHD, the MAH should conduct and submit the results of a comparative 

safety study according to an agreed protocol. 

 

Submission of 

final study 

Report: 

31-January-2022 

 



 

22 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



 

23 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 



 

24 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 1 mg prolonged-release tablets 

guanfacine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains lactose. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

7 prolonged-release tablets 

28 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

Oral use. 

Swallow the tablet whole. Do not chew, divide or crush. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 



 

25 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited 

Dublin 2 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/15/1040/001 7 prolonged-release tablets 

EU/1/15/1040/002 28 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Intuniv 1 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 



 

26 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blisters 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 1 mg prolonged-release tablets 

guanfacine 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited (as MA Logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 



 

27 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 2 mg prolonged-release tablets 

guanfacine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains lactose. See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

7 prolonged-release tablets 

28 prolonged-release tablets 

84 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

Oral use. 

Swallow the tablet whole. Do not chew, divide or crush. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 

 



 

28 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited 

Dublin 2 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/15/1040/003 7 prolonged-release tablets 

EU/1/15/1040/004 28 prolonged-release tablets 

EU/1/15/1040/005 84 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Intuniv 2 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 



 

29 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blisters 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 2 mg prolonged-release tablets 

 

guanfacine 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited (as MA Logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 



 

30 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 3 mg prolonged-release tablets 

guanfacine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains lactose. See leaflet for further information 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

28 prolonged-release tablets 

84 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

Oral use. 

Swallow the tablet whole. Do not chew, divide or crush. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 

 



 

31 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited 

Dublin 2 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/15/1040/006 28 prolonged-release tablets 

EU/1/15/1040/007 84 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Intuniv 3 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 



 

32 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blisters 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 3 mg prolonged-release tablets 

 

guanfacine 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited (as MA Logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 



 

33 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 4 mg prolonged-release tablets 

guanfacine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine. 

 

 

3. LIST OF EXCIPIENTS 

 

Also contains lactose, See leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

28 prolonged-release tablets 

84 prolonged-release tablets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

Oral use. 

Swallow the tablet whole. Do not chew, divide or crush. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

 

 



 

34 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited 

Dublin 2 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/15/1040/008 28 prolonged-release tablets 

EU/1/15/1040/009 84 prolonged-release tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Intuniv 4 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN 



 

35 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

Blisters 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Intuniv 4 mg prolonged-release tablets 

 

guanfacine 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Shire Pharmaceuticals Ireland Limited (as MA Logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 



 

36 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

37 

Package leaflet: Information for the patient 

 

Intuniv 1 mg prolonged-release tablets 

Intuniv 2 mg prolonged-release tablets 

Intuniv 3 mg prolonged-release tablets 

Intuniv 4 mg prolonged-release tablets 

guanfacine 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

 

• Keep this leaflet. You may need to read it again. 

• If you have any further questions, ask your doctor, pharmacist or nurse. 

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 
even if their signs of illness are the same as yours. 

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

• This leaflet has been written as though the person taking the medicine is reading it. If you are 
giving this medicine to your child, please replace “you” with “your child” throughout. 

 

What is in this leaflet: 

 

1. What Intuniv is and what it is used for 

2. What you need to know before you take Intuniv 

3. How to take Intuniv 

4. Possible side effects 

5. How to store Intuniv 

6. Contents of the pack and other information 

 

 

1. What Intuniv is and what it is used for 

 

What Intuniv is 

 

Intuniv contains the active substance guanfacine. This medicine belongs to a group of medicines 

which affects brain activity. This medicine can help improve your attention, concentration and make 

you less impulsive and hyperactive. 

 

What Intuniv is used for 

 

This medicine is used to treat ‘attention deficit hyperactivity disorder’ (ADHD) in children and 

adolescents 6-17 years old for whom current stimulant medication is not appropriate and/or current 

medication does not adequately control ADHD symptoms. 

 

The medicine is given as part of a treatment programme, which usually includes the following: 

• psychological therapy 

• educational therapy 

• social therapy 
 



 

38 

About ADHD 

 

People with ADHD find it hard to: 

• sit still 

• concentrate. 
 

ADHD can cause problems with everyday life. Children and young people with ADHD may have 

difficulty learning and doing homework. They can find it hard to behave well at home, at school or in 

other places. 

 

 

2. What you need to know before you take Intuniv 

 

Do not take Intuniv if: 

 

• you are allergic to guanfacine or any of the other ingredients of this medicine (listed in 
section 6). 

 

Warnings and precautions 

 

Talk to your doctor or pharmacist before taking this medicine if: 

• you have low or high blood pressure, heart problems or have a family history of heart problems 

• you have fainted recently 

• you have thoughts or feelings of suicide 

• you suffer from any other psychiatric conditions 
 

Intuniv may affect your weight and height if taking for long periods, your doctor will therefore 

monitor your growth. 

 

Do not stop taking Intuniv without talking to your doctor. If you suddenly stop taking Intuniv, you 

may develop withdrawal symptoms of increased heart rate and high blood pressure (see section 4). 

 

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking 

this medicine. This is because this medicine can make these problems worse. Your doctor will 

routinely monitor you to see how this medicine affects you. 

 

Children (under 6 years old) and adults (18 years and over) 

 

This medicine should not be used in children under 6 years of age and adults 18 years and over 

because it is not known if it works or is safe. 

 

Checks your doctor will do when you take Intuniv 

 

Before you start taking this medicine your doctor will check to make sure this medicine is safe for you 

and that it will help you. While you are taking this medicine your doctor will repeat these checks 

weekly during initial dosing, after dose adjustments, at least every 3 months for the first year and then 

at least twice a year. These checks may include: 

• your blood pressure and heart rate and other checks on your heart if appropriate 

• your response to treatment, in particular if it makes you sleepy or drowsy 

• your height and weight 
 

You should talk to your doctor if you do not feel better or if you feel worse and very sleepy or drowsy 

after taking this medicine for around 6 weeks. Your doctor may want to review your treatment 

 



 

39 

Other medicines and Intuniv 

 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 

medicines. This is because Intuniv and some other medicines can affect each other. 

 

In particular, tell your doctor or pharmacist if you are taking any of the following types of medicines: 

• medicines that lower your blood pressure (antihypertensives) 

• medicines for epilepsy such as valproic acid 

• medicines that make you sleepy (sedatives) 

• medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics) 

• medicines that can affect the way Intuniv is eliminated by the liver (please see table below) 
 

Medicines Used to treat 

Aprepitant Nausea and vertigo. 

Atazanavir, efavirenz, etravirine, 

fosamprenavir, indinavir, nevirapine, 

ritonavir, saquinavir 

HIV infection. 

Ciprofloxacin, chloramphenicol, 

clarithromycin, erythromycin, rifabutin, 

rifampicin, telithromycin 

Bacterial infections. 

Fluconazole, itraconazole, posaconazole, 

ketoconazole 

Fungal infections. 

Crizotinib, imatinib Cancer. 

Diltiazem, verapamil Cardiovascular conditions. 

Boceprevir, telaprevir Viral hepatitis. 

Suboxone Substance dependence. 

Bosentan Cardiovascular conditions (e.g. constriction of 

blood vessels in the lung). 

Carbamazepine, oxcarbazepine, 

phenobarbital, phenytoin, primidone 

Used to control epilepsy. 

Modafinil Is a medicine that promotes alertness and is used to 

treat sleep disorders. 

St. John’s Wort Is a herbal preparation that is used to treat 

depression. 

 

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking 

this medicine. 

 

Intuniv with food, drinks and alcohol 

 

• Do not take this medicine with fatty foods (e.g., high fat breakfast), as it may affect the way this 
medicine works. 

• Do not take grapefruit juice with this medicine as it can have an effect on the way this medicine 
works. 

• Do not drink alcohol when taking this medicine as it may make you sleepy or drowsy. 
 

Pregnancy and breast-feeding 

 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 

your doctor or pharmacist for advice before taking this medicine. 

 

• Do not take this medicine if you are pregnant or you are not using contraception. It is not known 
if Intuniv will affect your unborn baby. 

• Do not breast-feed while taking Intuniv unless told to do so by your doctor. 
 



 

40 

Driving and using machines 

 

You may feel dizzy and drowsy when taking this medicine, especially at the start of treatment and this 

may last for 2 to 3 weeks possibly longer. If this happens, do not drive, cycle, use any tools or 

machines or participate in activities that could cause injury until you know how this medicine affects 

you. Fainting has also been reported but is not a common effect. 

 

Intuniv contains lactose 

 

Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some 

sugars, contact your doctor before taking this medicine. 

 

Intuniv contains sodium 

 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-

free’. 

 

 

3. How to take Intuniv 

 

Your treatment will start under the supervision of an appropriate specialist in childhood and/or 

adolescent behavioural disorders. 

 

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 

or pharmacist if you are not sure. 

 

As part of your treatment your doctor will closely monitor how Intuniv is affecting you during initial 

dosing and/or dose adjustments. 

 

How much to take 

 

• Your doctor will start you on 1 mg per day. Your doctor may increase your dose based on your 
body weight and how Intuniv is working for you but not by more than 1 mg per week. 

Depending on how you respond to treatment your doctor may increase your dose more slowly. 

The recommended maintenance dose is between 0.05 up to 0.12 mg per kg of bodyweight per 

day. 

• You may not notice an immediate effect upon starting treatment, some patients may notice an 
improvement after the first week but it could take longer. 

• Your daily dose will be between 1 and 7 mg depending on your age and how you respond to 
Intuniv, but not more that 7 mg. 

 

How to take Intuniv 

 

• This medicine should be taken once a day either in the morning or evening. 

• It can be taken with or without food, but do not take it with fatty foods (e.g., high fat breakfast). 

• Swallow the tablet whole with a drink of water or other liquid (but not grapefruit juice). 

• Do not break, crush or chew the tablet; this will affect how the tablet works. Tell your doctor if 
you cannot swallow the tablet whole. 

 

Duration of treatment 

 

If you need to take Intuniv for more than a year your doctor will monitor your response to treatment 

and your doctor may stop the medicine for a short time; this may happen during a school holiday. This 

will show if you still need to take the medicine. 

 



 

41 

If you take more Intuniv than you should 

 

If you take more Intuniv than you should, talk to a doctor or go to a hospital straight away. Take the 

medicine pack with you and tell them how much you have taken. 

 

The following effects may happen: low or high blood pressure, slow heart rate, slow breathing rate, 

feeling tired or exhausted. 

 

If you forget to take Intuniv 

 

If you forget a dose, wait until the next day and take your usual dose. 

• If you have missed two or more doses talk to your doctor as you may need to restart Intuniv 
with a lower dose. 

• Do not take a double dose to make up for a forgotten dose. 
 

If you stop taking Intuniv 

 

Do not stop taking this medicine without first talking to your doctor. 

• If you stop taking this medicine your blood pressure and heart rate may increase (see section 4 
below). 

• To stop the medicine, your doctor will slowly reduce your Intuniv dose to minimise any side 
effects. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you are 

worried, speak to your doctor. 

 

If you feel unwell in any way while you are taking your medicine please tell an adult straight 

away. 

 

Serious side effects 

 

The following serious side effects have been reported: feeling drowsy (sedation), feeling dizzy 

(hypotension), slow heart beat (bradycardia), feeling faint or loss of conciousness (syncope), a serious 

withdrawal side effect of high blood pressure after suddenly stopping Intuniv; symptoms may include 

headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy). 

 

Some of these side effects are more likely to occur at the start of treatment and may disappear as you 

continue with your treatment, if you experience any of these side effects contact your doctor straight 

away. 

 

Other side effects 

 

The following side effects have been reported. 

 

Very common (may affect more than 1 in 10 people) 

• feeling sleepy (somnolence) 

• feeling tired (fatigue) 

• headache 

• tummy pain (abdominal pain). 
 



 

42 

Common (may affect up to 1 in 10 people) 

• low heart rate 

• blood pressure decreased 

• feeling restless or irritable 

• trouble sleeping (insomnia) or broken sleep (middle insomnia) or nightmares 

• feeling depressed, worried (anxiety) or having mood swings (affect lability) 

• lack of energy (lethargy) 

• weight gain 

• loss of appetite 

• have a dry mouth 

• wetting yourself (enuresis) 

• feeling (nausea) or being sick (vomiting) 

• diarrhoea, abdominal discomfort or constipation 

• low blood pressure when standing up (orthostatic hypotension) 

• rash. 
 

Uncommon (may affect up to 1 in 100 people) 

• allergic reaction (hypersensitivity) 

• chest pain 

• indigestion (dyspepsia) 

• trouble breathing (asthma) 

• feeling weak (asthenia) 

• pale skin colour (pallor) 

• fits or convulsions 

• need to urinate frequently (pollakiuria) 

• feeling agitated 

• changes in liver blood test results (increased alanine aminotransferase) 

• increase in blood pressure 

• unusual heart rhythm (sinus arrhythmia and first-degree arterioventricular block) 

• fast heart beat (tachycardia) 

• reduced heart rate 

• feeling dizzy when standing up (postural dizziness) 

• itchy skin (pruritus) 

• seeing or hearing things that are not there (hallucination). 
 

Rare (may affect up to 1 in 1,000 people) 

• sleeping more than normal (hypersomnia) 

• high blood pressure (hypertension) 

• feeling unwell (malaise). 
 

Very rare (may affect up to 1 in 10,000 people) 

• a serious withdrawal side effect of high blood pressure after suddenly stopping Intuniv; 
symptoms may include headaches, feeling confused, nervousness, agitation, and tremors 

(hypertensive encephalopathy). 

 

Not known (frequency cannot be estimated from the available data) 

• difficulty to get or keep an erection (erectile dysfunction). 
 

Reporting of side effects 

 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

43 

 

5. How to store Intuniv 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP. 

The expiry date refers to the last day of that month. 

 

This medicinal product does not require any special storage conditions. 

 

Do not use this medicine if the tablets or blister pack look damaged. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What Intuniv contains 

 

• Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine 

• Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine 

• Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine 

• Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine 

• The other ingredients are hypromellose 2208, methacrylic acid-ethyl acrylate copolymer, lactose 
monohydrate, povidone, crospovidone Type A, microcrystalline cellulose, silica colloidal 

anhydrous, sodium laurilsulfate, polysorbate 80, fumaric acid, glycerol dibehenate. 

• The 3 mg and 4 mg tablets also contain indigo carmine aluminium lake (E 132) and yellow iron 
oxide (E 172) 

 

What Intuniv looks like and contents of the pack 

 

Intuniv is a prolonged-release tablet which means that the active substance is released from the tablet 

over a period of time. The tablets come in pack sizes of 7, 28 or 84 but not all pack sizes may be 

available. 

 

• The 1 mg prolonged-release tablets are round and white, hard tablets, debossed with 1MG on 
one side and 503 on the other side. 

• The 2 mg prolonged-release tablets are oval and white, hard tablets, debossed with 2MG on one 
side and 503 on the other side. 

• The 3 mg prolonged-release tablets are round and green, hard tablets, debossed with 3MG on 
one side and 503 on the other side. 

• The 4 mg prolonged-release tablets are oval and green, hard tablets, debossed with 4MG on one 
side and 503 on the other side. 

 

Marketing Authorisation Holder and Manufacturer 

 

Shire Pharmaceuticals Ireland Limited 

Block 2 & 3 Miesian Plaza 

50 – 58 Baggot Street Lower 

Dublin 2  

Ireland 

 

Tel: +800 66838470 

 

e-mail: medinfoEMEA@shire.com 



 

44 

 

This leaflet was last revised in . 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

 

 

http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET