Rivastigmine Actavis

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 1.5 mg hard capsules 
Rivastigmine Actavis 3 mg hard capsules 
Rivastigmine Actavis 4.5 mg hard capsules 
Rivastigmine Actavis 6 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Rivastigmine Actavis 1.5 mg hard capsules 
Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine. 
 
Rivastigmine Actavis 3 mg hard capsules 
Each capsule contains rivastigmine hydrogen tartrate corresponding to 3 mg rivastigmine. 
 
Rivastigmine Actavis 4.5 mg hard capsules 
Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine. 
 
Rivastigmine Actavis 6 mg hard capsules 
Each capsule contains rivastigmine hydrogen tartrate corresponding to 6 mg rivastigmine. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Hard capsule (Capsule). 
 
Rivastigmine Actavis 1.5 mg hard capsules 
Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red 
imprint “RIV 1.5mg” on body. 
 
Rivastigmine Actavis 3 mg hard capsules 
Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red 
imprint “RIV 3mg” on body. 
 
Rivastigmine Actavis 4.5 mg hard capsules 
Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint 
“RIV 4.5mg” on body. 
 
Rivastigmine Actavis 6 mg hard capsules 
Off-white to slightly yellow powder in a hard capsule with red cap and orange body, with red imprint 
“RIV 6mg” on body. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. 
 
Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s 
disease.  
 



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4.2 Posology and method of administration 
 
Treatment should be initiated and supervised by a physician experienced in the diagnosis and 
treatment of Alzheimer’s dementia or dementia associated with Parkinson’s disease. Diagnosis should 
be made according to current guidelines. Therapy with rivastigmine should only be started if a 
caregiver is available who will regularly monitor intake of the medicinal product by the patient.  
 
Posology 
Rivastigmine should be administered twice a day, with morning and evening meals. The capsules 
should be swallowed whole. 
 
Initial dose  
1.5 mg twice a day.  
 
Dose titration  
The starting dose is 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of 
treatment, the dose may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and then 
6 mg twice a day should also be based on good tolerability of the current dose and may be considered 
after a minimum of two weeks of treatment at that dose level. 
 
If adverse reactions (e.g. nausea, vomiting, abdominal pain or loss of appetite), weight decrease or 
worsening of extrapyramidal symptoms (e.g. tremor) in patients with dementia associated with 
Parkinson’s disease are observed during treatment, these may respond to omitting one or more doses. 
If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-
tolerated dose or the treatment may be discontinued. 
 
Maintenance dose  
The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should 
be maintained on their highest well tolerated dose. The recommended maximum daily dose is 6 mg 
twice a day.  
 
Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. 
Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for 
patients treated at doses less than 3 mg twice a day. If after 3 months of maintenance dose treatment 
the patient’s rate of decline in dementia symptoms is not altered favourably, the treatment should be 
discontinued. Discontinuation should also be considered when evidence of a therapeutic effect is no 
longer present. 
 
Individual response to rivastigmine cannot be predicted. However, a greater treatment effect was seen 
in Parkinson’s disease patients with moderate dementia. Similarly a larger effect was observed in 
Parkinson’s disease patients with visual hallucinations (see section 5.1). 
 
Treatment effect has not been studied in placebo-controlled trials beyond 6 months. 
 
Re-initiation of therapy  
If treatment is interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily. 
Dose titration should then be carried out as described above. 
 
Renal and hepatic impairment  
No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment. 
However, due to increased exposure in these populations dosing recommendations to titrate according 
to individual tolerability should be closely followed as patients with clinically significant renal or 
hepatic impairment might experience more dose-dependent adverse reactions. Patients with severe 
hepatic impairment have not been studied, however, Rivastigmine Actavis capsules may be used in this 
patient population provided close monitoring is exercised (see section 4.4 and 5.2). 
 



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Paediatric population 
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer’s 
disease.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance, to other carbamate derivatives or to any of the excipients 
listed in section 6.1. 
 
Previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine 
patch (see section 4.4). 
 
4.4 Special warnings and precautions for use 
 
The incidence and severity of adverse reactions generally increase with higher doses. If treatment is 
interrupted for more than three days, it should be re-initiated at 1.5 mg twice daily to reduce the 
possibility of adverse reactions (e.g. vomiting). 
 
Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in 
intensity. These reactions are not in themselves an indication of sensitisation. However, use of 
rivastigmine patch may lead to allergic contact dermatitis. 
 
Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch 
size, if there is evidence of a more intense local reaction (e.g. increasing erythema, oedema, papules, 
vesicles) and if symptoms do not significantly improve within 48 hours after patch removal. In these 
cases, treatment should be discontinued (see section 4.3). 
 
Patients who develop application site reactions suggestive of allergic contact dermatitis to 
rivastigmine patch and who still require rivastigmine treatment should only be switched to oral 
rivastigmine after negative allergy testing and under close medical supervision. It is possible that 
some patients sensitised to rivastigmine by exposure to rivastigmine patch may not be able to take 
rivastigmine in any form. 
 
There have been rare post-marketing reports of patients experiencing allergic dermatitis 
(disseminated) when administered rivastigmine irrespective of the route of administration (oral, 
transdermal). In these cases, treatment should be discontinued (see section 4.3). 
 
Patients and caregivers should be instructed accordingly. 
 
Dose titration: Adverse reactions (e.g. hypertension and hallucinations in patients with Alzheimer’s 
dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia 
associated with Parkinson’s disease) have been observed shortly after dose increase. They may 
respond to a dose reduction. In other cases, rivastigmine has been discontinued (see section 4.8). 
 
Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur 
particularly when initiating treatment and/or increasing the dose (see section 4.8). These adverse 
reactions occur more commonly in women. Patients who show signs or symptoms of dehydration 
resulting from prolonged vomiting or diarrhoea can be managed with intravenous fluids and dose 
reduction or discontinuation if recognised and treated promptly. Dehydration can be associated with 
serious outcomes. 
 
Patients with Alzheimer’s disease may lose weight. Cholinesterase inhibitors, including rivastigmine, 
have been associated with weight loss in these patients. During therapy patient’s weight should be 
monitored. 
 



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In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as 
recommended in section 4.2 must be made. Some cases of severe vomiting were associated with 
oesophageal rupture (see section 4.8). Such events appeared to occur particularly after dose 
increments or high doses of rivastigmine. 
 
Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de 
pointes, predominantly in patients with risk factors. Caution is advised in patients at higher risk of 
developing torsade de pointes; for example, those with uncompensated heart failure, recent 
myocardial infarction, bradyarrhythmias, a predisposition to hypokalaemia or hypomagnesaemia, or 
concomitant use with medicinal products known to induce QT prolongation and/or torsade de pointes 
(see sections 4.5 and 4.8). 
 
Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction 
defects (sino-atrial block, atrio-ventricular block) (see section 4.8). 
 
Rivastigmine may cause increased gastric acid secretions. Care should be exercised in treating 
patients with active gastric or duodenal ulcers or patients predisposed to these conditions. 
 
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or 
obstructive pulmonary disease. 
 
Cholinomimetics may induce or exacerbate urinary obstruction and seizures. Caution is recommended 
in treating patients predisposed to such diseases. 
 
The use of rivastigmine in patients with severe dementia of Alzheimer’s disease or associated with 
Parkinson’s disease, other types of dementia or other types of memory impairment (e.g. age-related 
cognitive decline) has not been investigated and therefore use in these patient populations is not 
recommended. 
 
Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms. 
Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or 
severity of tremor have been observed in patients with dementia associated with Parkinson’s disease 
(see section 4.8). These events led to the discontinuation of rivastigmine in some cases (e.g. 
discontinuations due to tremor 1.7 % on rivastigmine vs. 0 % on placebo). Clinical monitoring is 
recommended for these adverse reactions. 
 
Special populations 
Patients with clinically significant renal or hepatic impairment might experience more adverse 
reactions (see sections 4.2 and 5.2). Dosing recommendations to titrate according to individual 
tolerability must be closely followed. Patients with severe hepatic impairment have not been studied. 
However, rivastigmine may be used in this patient population and close monitoring is necessary. 
 
Patients with body weight below 50 kg may experience more adverse reactions and may be more 
likely to discontinue due to adverse reactions. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle 
relaxants during anaesthesia. Caution is recommended when selecting anaesthetic agents. Possible 
dose adjustments or temporarily stopping treatment can be considered if needed. 
 
In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given 
concomitantly with other cholinomimetic substances. Rivastigmine might interfere with the activity of 
anticholinergic medicinal products (e.g oxybutynin, tolterodine). 
 



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Additive effects leading to bradycardia (which may result in syncope) have been reported with the 
combined use of various beta-blockers (including atenolol) and rivastigmine. Cardiovascular beta- 
blockers are expected to be associated with the greatest risk, but reports have also been received in 
patients using other beta-blockers. Therefore, caution should be exercised when rivastigmine is 
combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, 
calcium channel antagonists, digitalis glycoside, pilocarpin). 
 
Since bradycardia constitutes a risk factor in the occurrence of torsades de pointes, the combination of 
rivastigmine with torsades de pointes-inducing medicinal products such as antipsychotics i.e. some 
phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, sultopride, amisulpride, 
tiapride, veralipride), pimozide, haloperidol, droperidol, cisapride, citalopram, diphemanil, 
erythromycin IV, halofantrin, mizolastin, methadone, pentamidine and moxifloxacine should be 
observed with caution and clinical monitoring (ECG) may also be required. 
 
No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam 
or fluoxetine in studies in healthy volunteers. The increase in prothrombin time induced by warfarin is 
not affected by administration of rivastigmine. No untoward effects on cardiac conduction were 
observed following concomitant administration of digoxin and rivastigmine. 
 
According to its metabolism, metabolic interactions with other medicinal products appear unlikely, 
although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
In pregnant animals, rivastigmine and/or metabolites crossed the placenta. It is not known if this occurs 
in humans. No clinical data on exposed pregnancies are available. In peri/postnatal studies in rats, an 
increased gestation time was observed. Rivastigmine should not be used during pregnancy unless 
clearly necessary. 
 
Breast-feeding 
 
In animals, rivastigmine is excreted in milk. It is not known if rivastigmine is excreted into human 
milk. Therefore, women on rivastigmine should not breast-feed. 
 
Fertility 
 
No adverse effects of rivastigmine were observed on fertility or reproductive performance in rats (see 
section 5.3). Effects of rivastigmine on human fertility are not known. 
 
4.7 Effects on ability to drive and use machines 
 
Alzheimer’s disease may cause gradual impairment of driving performance or compromise the ability 
to use machinery. Furthermore, rivastigmine can induce dizziness and somnolence, mainly when 
initiating treatment or increasing the dose. As a consequence, rivastigmine has minor or moderate 
influence on the ability to drive and use machines. Therefore, the ability of patients with dementia on 
rivastigmine to continue driving or operating complex machines should be routinely evaluated by the 
treating physician. 
 



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4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38 %) 
and vomiting (23 %), especially during titration. Female patients in clinical studies were found to be 
more susceptible than male patients to gastrointestinal adverse reactions and weight loss. 
 
Tabulated list of adverse reactions 
 
Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and 
frequency category. Frequency categories are defined using the following convention: 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); not known (cannot be estimated from the available data). 
 
The following adverse reactions, listed below in Table 1, have been accumulated in patients with 
Alzheimer’s dementia treated with rivastigmine. 
 
Table 1 
 
Infections and infestations   

Very rare Urinary infection  
Metabolism and nutrition disorders   

Very common  Anorexia  
Common Decreased appetite 
Not known Dehydration 

Psychiatric disorders   
Common 
Common 

Nightmares 
Agitation  

Common Confusion  
Common Anxiety 
Uncommon Insomnia  
Uncommon Depression  
Very rare Hallucinations  
Not known Aggression, restlessness 

Nervous system disorders   
Very common Dizziness  
Common Headache  
Common Somnolence  
Common Tremor  
Uncommon Syncope  
Rare Seizures  
Very rare Extrapyramidal symptoms (including worsening of  

 Parkinson’s disease)  
Cardiac disorders   

Rare Angina pectoris  
Very rare Cardiac arrhythmia (e.g. bradycardia, atrio-ventricular block,  

 atrial fibrillation and tachycardia)  
Not known Sick sinus syndrome 

Vascular disorders   
Very rare  Hypertension  

Gastrointestinal disorders   
Very common Nausea  
Very common Vomiting  



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Very common Diarrhoea  
Common  Abdominal pain and dyspepsia  
Rare  Gastric and duodenal ulcers  
Very rare  Gastrointestinal haemorrhage  
Very rare  Pancreatitis  
Not known  Some cases of severe vomiting were associated with  

 oesophageal rupture (see section 4.4).  
Hepatobiliary disorders   

Uncommon Elevated liver function tests 
Not known Hepatitis 

Skin and subcutaneous tissue 
disorders  

 

Common Hyperhydrosis  
Rare Rash 
Not known Pruritus, allergic dermatitis (disseminated) 

General disorders and 
administration  
site conditions 

 

Common Fatigue and asthenia  
Common Malaise 
Uncommon Fall 

Investigations  
Common Weight loss 

 
The following additional adverse reactions have been observed with rivastigmine transdermal patches: 
delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity 
(uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known). 
 
Table 2 shows the adverse reactions reported during clinical studies conducted in patients with 
dementia associated with Parkinson’s disease treated with rivastigmine capsules. 
 
Table 2 
 
Metabolism and nutrition disorders   

Common  Decreased appetite  
Common  Dehydration  

Psychiatric disorders   
Common  Insomnia  
Common  Anxiety  
Common  
Common 
Common 

Restlessness  
Hallucination, visual 
Depression 

Not known Aggression 
Nervous system disorders   

Very common Tremor  
Common  Dizziness  
Common  Somnolence  
Common  Headache  
Common  Parkinson’s disease (worsening) 
Common  Bradykinesia  
Common 
Common 
Common  

Dyskinesia  
Hypokinesia 
Cogwheel rigidity 

Uncommon  Dystonia  



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Cardiac disorders   
Common  Bradycardia  
Uncommon  Atrial Fibrillation  
Uncommon  Atrioventricular block  
Not known Sick sinus syndrome 

Vascular disorders  
Common 
Uncommon 

 
Hypertension 
Hypotension 

Gastrointestinal disorders   
Very common Nausea  
Very common Vomiting  
Common  Diarrhoea  
Common  Abdominal pain and dyspepsia  
Common  Salivary hypersecretion  

Hepatobiliary disorders  
Not known  Hepatitis 

Skin and subcutaneous tissue 
disorders  

 

Common  Hyperhydrosis  
Not known Allergic dermatitis (disseminated) 

General disorders and 
administrationsite conditions  

 

Very common Fall 
Common Fatigue and asthenia  
Common  Gait disturbance  
Common Parkinson gait 

 
The following additional adverse reaction has been observed in a study of patients with dementia 
associated with Parkinson’s disease treated with rivastigmine transdermal patches: agitation 
(common). 
 
Table 3 lists the number and percentage of patients from the specific 24-week clinical study 
conducted with rivastigmine in patients with dementia associated with Parkinson’s disease with pre-
defined adverse events that may reflect worsening of parkinsonian symptoms. 
 
Table 3 
 
Pre-defined adverse events that may reflect worsening  Rivastigmine Placebo 
of parkinsonian symptoms in patients with dementia  n (%) n (%) 
associated with Parkinson’s disease    
Total patients studied  362 (100) 179 (100) 
Total patients with pre-defined AE(s)  99 (27.3) 28 (15.6) 
Tremor  37 (10.2) 7 (3.9) 
Fall  21 (5.8) 11 (6.1) 
Parkinson’s disease (worsening)  12 (3.3) 2 (1.1) 
Salivary hypersecretion  5 (1.4) 0 
Dyskinesia  5 (1.4) 1 (0.6) 
Parkinsonism  8 (2.2) 1 (0.6) 
Hypokinesia  1 (0.3) 0 
Movement disorder  1 (0.3) 0 
Bradykinesia  9 (2.5) 3 (1.7) 
Dystonia  3 (0.8) 1 (0.6) 
Gait abnormality  5 (1.4) 0 
Muscle rigidity  1 (0.3) 0 



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Balance disorder  3 (0.8) 2 (1.1) 
Musculoskeletal stiffness  3 (0.8) 0 
Rigors  1 (0.3) 0 
Motor dysfunction  1 (0.3) 0 
 
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 
 
Symptoms 
 
Most cases of accidental overdose have not been associated with any clinical signs or symptoms and 
almost all of the patients concerned continued rivastigmine treatment 24 hours after the overdose. 
 
Cholinergic toxicity has been reported with muscarinic symptoms that are observed with moderate 
poisonings such as miosis, flushing, digestive disorders including abdominal pain, nausea, vomiting and 
diarrhoea, bradycardia, bronchospasm and increased bronchial secretions, hyperhidrosis, involuntary 
urination and/or defecation, lacrimation, hypotension and salivary hypersecretion. 
 
In more severe cases nicotinic effects might develop such as muscular weakness, fasciculations, seizures 
and respiratory arrest with possible fatal outcome. 
 
Additionally there have been post-marketing cases of dizziness, tremor, headache, somnolence, 
confusional state, hypertension, hallucinations and malaise. 
 
Management 
 
As rivastigmine has a plasma half-life of about 1 hour and a duration of acetylcholinesterase 
inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose no further dose 
of rivastigmine should be administered for the next 24 hours. In overdose accompanied by severe 
nausea and vomiting, the use of antiemetics should be considered. Symptomatic treatment for other 
adverse reactions should be given as necessary. 
 
In massive overdose, atropine can be used. An initial dose of 0.03 mg/kg intravenous atropine sulfate 
is recommended, with subsequent doses based on clinical response. Use of scopolamine as an antidote 
is not recommended. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03  
 
Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to 
facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by 
functionally intact cholinergic neurones. Thus, rivastigmine may have an ameliorative effect on 
cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’s disease and 
Parkinson’s disease.  
 
Rivastigmine interacts with its target enzymes by forming a covalently bound complex that 
temporarily inactivates the enzymes. In healthy young men, an oral 3 mg dose decreases 



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acetylcholinesterase (AChE) activity in CSF by approximately 40 % within the first 1.5 hours after 
administration. Activity of the enzyme returns to baseline levels about 9 hours after the maximum 
inhibitory effect has been achieved. In patients with Alzheimer’s disease, inhibition of AChE in CSF 
by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested. Inhibition 
of butyrylcholinesterase activity in CSF of 14 Alzheimer patients treated by rivastigmine was similar 
to that of AChE.  
 
Clinical studies in Alzheimer’s dementia 
The efficacy of rivastigmine has been established through the use of three independent, domain 
specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods. 
These include the ADAS-Cog (Alzheimer’s Disease Assessment Scale – Cognitive subscale, a 
performance based measure of cognition), the CIBIC-Plus (Clinician’s Interview Based Impression of 
Change-Plus, a comprehensive global assessment of the patient by the physician incorporating 
caregiver input), and the PDS (Progressive Deterioration Scale, a caregiver-rated assessment of the 
activities of daily living including personal hygiene, feeding, dressing, household chores such as 
shopping, retention of ability to orient oneself to surroundings as well as involvement in activities 
relating to finances, etc.). 
 
The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24. 
 
The results for clinically relevant responders pooled from two flexible dose studies out of the three 
pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer’s 
Dementia, are provided in Table 4 below. Clinically relevant improvement in these studies was 
defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, 
or at least a 10 % improvement on the PDS. 
 
In addition, a post-hoc definition of response is provided in the same table. The secondary definition 
of response required a 4-point or greater improvement on the ADAS-Cog, no worsening on the 
CIBIC-Plus, and no worsening on the PDS. The mean actual daily dose for responders in the 6-12 mg 
group, corresponding to this definition, was 9.3 mg. It is important to note that the scales used in this 
indication vary and direct comparisons of results for different therapeutic agents are not valid. 
 
Table 4 
 
 Patients with Clinically Significant Response (%) 
 Intent to Treat Last Observation Carried 
  Forward 
Response Measure  Rivastigmine Placebo Rivastigmine Placebo 
 6-12 mg  6-12 mg  
 N=473 N=472 N=379 N=444 
ADAS-Cog: improvement 
of at least 4 points  

21*** 12 25*** 12 

CIBIC-Plus: improvement  29*** 18 32*** 19 
PDS: improvement of at  26*** 17 30*** 18 
least 10%      
At least 4 points  10* 6 12** 6 
improvement on ADAS-     
Cog with no worsening on      
CIBIC-Plus and PDS      
*p<0.05, **p<0.01, ***p<0.001 
 
Clinical studies in dementia associated with Parkinson’s disease 
The efficacy of rivastigmine in dementia associated with Parkinson’s disease has been demonstrated 
in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label 
extension phase. Patients involved in this study had an MMSE (Mini-Mental State Examination) score 



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of 10-24. Efficacy has been established by the use of two independent scales which were assessed at 
regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a 
measure of cognition, and the global measure ADCS-CGIC (Alzheimer’s Disease Cooperative Study-
Clinician’s Global Impression of Change). 
 
Table 5 
 
Dementia associated with  ADAS-Cog  

 
ADAS-Cog  
 

ADCS- CGIC 
 

ADCS-CGIC 
 Parkinson’s Disease Rivastigmine Placebo Rivastigmine Placebo 

ITT + RDO population  (n=329)  (n=161)  (n=329)  (n=165)  

Mean baseline ± SD  23.8 ± 10.2  24.3 ± 10.5  n/a  n/a  
Mean change at 24 weeks  2.1 ± 8.2  -0.7 ± 7.5  3.8 ± 1.4  4.3 ± 1.5  
± SD      
Adjusted treatment 
difference  
p-value versus placebo  

2.881  
<0.0011 

 
                         n/a 
                       0.0072 
 

ITT - LOCF population  (n=287)  (n=154)  (n=289)  (n=158)  

Mean baseline ± SD  24.0 ± 10.3  24.5 ± 10.6  n/a  n/a  
Mean change at 24 weeks  2.5 ± 8.4  -0.8 ± 7.5  3.7 ± 1.4  4.3 ± 1.5  
± SD      
Adjusted treatment 
difference  
p-value versus placebo  

3.541 
<0.0011 

 
                         n/a 
                     <0.0012 

   
1 Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate. A 
positive change indicates improvement.  
2 Mean data shown for convenience, categorical analysis performed using van Elteren test  
ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward  
 
Although a treatment effect was demonstrated in the overall study population, the data suggested that 
a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate 
dementia associated with Parkinson’s disease. Similarly a larger treatment effect was observed in 
those patients with visual hallucinations (see Table 6). 
 
Table 6 
 
Dementia associated with  ADAS-Cog  ADAS-Cog  ADAS-Cog  ADAS-Cog  
Parkinson’s Disease  Rivastigmine  Placebo  Rivastigmine  Placebo  

 Patients with visual  Patients without visual  
 hallucinations  hallucinations  

ITT + RDO population  (n=107)  (n=60)  (n=220)  (n=101)  

Mean baseline ± SD  25.4 ± 9.9  27.4 ± 10.4  23.1 ± 10.4  22.5 ± 10.1  
Mean change at 24 weeks  1.0 ± 9.2  -2.1 ± 8.3  2.6 ± 7.6  0.1 ± 6.9  
± SD    
Adjusted treatment 
difference     4.271 2.091 
p-value versus placebo     0.0021 0.0151 
 Patients with moderate  Patients with mild dementia  



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 dementia (MMSE 10-17)  (MMSE 18-24)  

ITT + RDO population  (n=87)  (n=44)  (n=237)  (n=115)  

Mean baseline ± SD  32.6 ± 10.4  33.7 ± 10.3  20.6 ± 7.9  20.7 ± 7.9  
Mean change at 24 weeks  2.6 ± 9.4  -1.8 ± 7.2  1.9 ± 7.7  -0.2 ± 7.5  
± SD    
Adjusted treatment 
difference    4.731 2.141 
p-value versus placebo    0.0021 0.0101 
1 Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate. A 
positive change indicates improvement. 
ITT: Intent-To-Treat; RDO: Retrieved Drop Outs 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer’s dementia and 
in the treatment of dementia in patients with idiopathic Parkinson’s disease (see section 4.2 for 
information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Rivastigmine is rapidly and completely absorbed. Peak plasma concentrations are reached in 
approximately 1 hour. As a consequence of rivastigmine’s interaction with its target enzyme, the 
increase in bioavailability is about 1.5-fold greater than that expected from the increase in dose. 
Absolute bioavailability after a 3 mg dose is about 36 %±13 %. Administration of rivastigmine with 
food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30 %.  
 
Distribution 
Protein binding of rivastigmine is approximately 40 %. It readily crosses the blood brain barrier and 
has an apparent volume of distribution in the range of 1.8-2.7 l/kg. 
 
Biotransformation 
Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), 
primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite. In vitro, this 
metabolite shows minimal inhibition of acetylcholinesterase (<10 %).  
 
Based on in vitro studies, no pharmacokinetic interaction is expected with medicinal products 
metabolised by the following cytochromes isoemzymes: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, 
CYP2C9, CYP2C8, CYP2C19, or CYP2B6. Based on evidence from animal studies the major 
cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism. Total plasma 
clearance of rivastigmine was approximately 130 l/h after a 0.2 mg intravenous dose and decreased to 
70 l/h after a 2.7 mg intravenous dose. 
 
Elimination 
Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route 
of elimination. Following administration of 14C-rivastigmine, renal elimination was rapid and 
essentially complete (>90 %) within 24 hours. Less than 1 % of the administered dose is excreted in 
the faeces. There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with 
Alzheimer’s disease. 
 
A population pharmacokinetic analysis showed that nicotine use increases the oral clearance of 
rivastigmine by 23% in patients with Alzheimer’s disease (n=75 smokers and 549 non-smokers) 
following rivastigmine oral capsule doses of up to 12 mg/day. 
 



14 

Elderly population 
While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in 
Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age. 
 
Hepatic impairment 
The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than 
twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects. 
 
Renal impairment 
Cmax and AUC of rivastigmine were more than twice as high in subjects with moderate renal 
impairment compared with healthy subjects; however there were no changes in Cmax and AUC of 
rivastigmine in subjects with severe renal impairment. 
 
5.3 Preclinical safety data 
 
Repeated-dose toxicity studies in rats, mice and dogs revealed only effects associated with an 
exaggerated pharmacological action. No target organ toxicity was observed. No safety margins to 
human exposure were achieved in the animal studies due to the sensitivity of the animal models used. 
 
Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a 
chromosomal aberration test in human peripheral lymphocytes at a dose 104 times the maximum 
clinical exposure. The in vivo micronucleus test was negative. The major metabolite NAP226-90 also 
did not show a genotoxic potential. 
 
No evidence of carcinogenicity was found in studies in mice and rats at the maximum tolerated dose, 
although the exposure to rivastigmine and its metabolites was lower than the human exposure. When 
normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately 
equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the 
maximum human dose, a multiple of approximately 6-fold was achieved in animals. 
 
In animals, rivastigmine crosses the placenta and is excreted into milk. Oral studies in pregnant rats 
and rabbits gave no indication of teratogenic potential on the part of rivastigmine. In oral studies with 
male and female rats, no adverse effects of rivastigmine were observed on fertility or reproductive 
performance of either the parent generation or the offspring of the parents. 
 
A mild eye/mucosal irritation potential of rivastigmine was identified in a rabbit study. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule content: 
Magnesium stearate 
Silica colloidal, anhydrous 
Hypromellose 
Microcrystalline cellulose 
 
Capsule shell: 
Rivastigmine Actavis 1.5 mg hard capsules 
Titanium dioxide (E171) 
Yellow iron oxide (E172) 
Gelatine 
 
Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules 
Red iron oxide (E172) 



15 

Titanium dioxide (E171) 
Yellow iron oxide (E172) 
Gelatine 
 
Printing ink: 
Shellac 
Propylene glycol 
Red iron oxide (E172) 
The ink may or may not contain potassium hydroxide 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
 
6.5 Nature and contents of container 
 
- Blisters (Al/PVC): 28, 56 and 112 hard capsules. 
- Capsule containers (HDPE) with LDPE caps: 250 hard capsules. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78 
220 Hafnarfjörður 
Iceland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Rivastigmine Actavis 1.5 mg hard capsules 
EU/1/11/693/001 
EU/1/11/693/002 
EU/1/11/693/003 
EU/1/11/693/004 
 
Rivastigmine Actavis 3 mg hard capsules 
EU/1/11/693/005 
EU/1/11/693/006 
EU/1/11/693/007 
EU/1/11/693/008 
 



16 

Rivastigmine Actavis 4.5 mg hard capsules 
EU/1/11/693/009 
EU/1/11/693/010 
EU/1/11/693/011 
EU/1/11/693/012 
 
Rivastigmine Actavis 6 mg hard capsules 
EU/1/11/693/013 
EU/1/11/693/014 
EU/1/11/693/015 
EU/1/11/693/016 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 June 2011 
Date of latest renewal: 15 February 2016 
 
 
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 



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER(S) 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 
 



18 

 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturers responsible for batch release 
 
Actavis ehf.  
Reykjavíkurvegur 76 - 78 
IS-220 Hafnarfjördur 
Iceland 
 
Specifar S.A 
1, 28 Octovriou str. 
123 51 Ag. Varvara 
Athens 
Greece 
 
Tjoapack Netherlands BV 
Nieuwe Donk 9 
4879 AC Etten-Leur 
The Netherlands 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristic, section 4.2). 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports 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) 
 
Not applicable. 



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



21 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 1.5 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 hard capsules 
56 hard capsules 
112 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 



22 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/001[ 28 blister] 
EU/1/11/693/002 [56 blister] 
EU/1/11/693/003 [112 blister] 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 1.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



23 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 1.5 mg capsules 
rivastigmine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Sunday 



24 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 1.5 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 



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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 1.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



26 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 1.5 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



27 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 3 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 3 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 hard capsules 
56 hard capsules 
112 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 



29 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/005[ 28 blister] 
EU/1/11/693/006 [56 blister] 
EU/1/11/693/007 [112 blister] 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 3 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



30 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 3 mg capsules 
rivastigmine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Sunday 



31 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 3 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 3 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 



32 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 3 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
 



33 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 3 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 3 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



34 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 4.5 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 hard capsules 
56 hard capsules 
112 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 



36 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/009[ 28 blister] 
EU/1/11/693/010 [56 blister] 
EU/1/11/693/011 [112 blister] 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 4.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
 



37 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 4.5 mg capsules 
rivastigmine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Sunday 



38 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 4.5 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 



39 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 4.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
 



40 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 4.5 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



41 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 6 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 6 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
28 hard capsules 
56 hard capsules 
112 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 



43 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/013[ 28 blister] 
EU/1/11/693/014 [56 blister] 
EU/1/11/693/015 [112 blister] 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 6 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



44 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 6 mg capsules 
rivastigmine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Sunday 



45 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 6 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 6 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 



46 

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 
 
Actavis Group PTC ehf. 
220 Hafnarfjörður 
Iceland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/016 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Rivastigmine Actavis 6 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



47 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
LABEL FOR CAPSULE CONTAINER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rivastigmine Actavis 6 mg hard capsules 
rivastigmine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 capsule contains 6 mg rivastigmine (as hydrogen tartrate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
250 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
To be swallowed whole without crushing or opening. 
 
 
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 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



48 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
[Actavis logo] 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/11/693/016 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



50 

Package leaflet: Information for the user 
 

Rivastigmine Actavis 1.5 mg hard capsules 
Rivastigmine Actavis 3 mg hard capsules 

Rivastigmine Actavis 4.5 mg hard capsules 
Rivastigmine Actavis 6 mg hard capsules 

 
rivastigmine 

 
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, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
1. What Rivastigmine Actavis is and what it is used for 
2. What you need to know before you take Rivastigmine Actavis 
3. How to take Rivastigmine Actavis 
4. Possible side effects 
5. How to store Rivastigmine Actavis 
6. Contents of the pack and other information 
 
 
1. What Rivastigmine Actavis is and what it is used for 
 
The active substance of Rivastigmine Actavis is rivastigmine. 
 
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with 
Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, 
resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to 
communicate with each other). Rivastigmine works by blocking the enzymes that break down 
acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, 
Rivastigmine Actavis allows levels of acetylcholine to be increased in the brain, helping to reduce the 
symptoms of Alzheimer’s disease and dementia associated with Parkinson’s disease. 
 
Rivastigmine Actavis is used for the treatment of adult patients with mild to moderately severe 
Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability 
and behaviour. The capsules and oral solution can also be used for the treatment of dementia in adult 
patients with Parkinson’s disease. 
 
 
2. What you need to know before you take Rivastigmine Actavis 
 
Do not take Rivastigmine Actavis 
• if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in 

section 6). 
• if you have a skin reaction spreading beyond the patch size, if there is a more intense local 

reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve 
within 48 hours after removal of the transdermal patch. 

 
If this applies to you, tell your doctor and do not take Rivastigmine Actavis. 
 



51 

Warnings and precautions 
Talk to your doctor before taking Rivastigmine Actavis: 
• if you have, or have ever had, irregular or slow heartbeat. 
• if you have, or have ever had, an active stomach ulcer. 
• if you have, or have ever had, difficulties in passing urine. 
• if you have, or have ever had, seizures. 
• if you have, or have ever had, asthma or severe respiratory disease. 
• if you have, or have ever had impaired kidney function. 
• if you have, or have ever had, impaired liver function. 
• if you suffer from trembling. 
• if you have a low body weight. 
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and 

diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are 
prolonged. 

 
If any of these apply to you, your doctor may need to monitor you more closely while you are on this 
medicine. 
 
If you have not taken Rivastigmine Actavis for more than three days, do not take the next dose until 
you have talked to your doctor. 
 
Children and adolescents 
There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of 
Alzheimer’s disease. 
 
Other medicines and Rivastigmine Actavis 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Rivastigmine Actavis should not be given at the same time as other medicines with similar effects to 
Rivastigmine Actavis. Rivastigmine Actavis might interfere with anticholinergic medicines 
(medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel 
sickness). 
 
Rivastigmine Actavis should not be given at the same time as metoclopramide (a medicine used to 
relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems 
such as stiff limbs and trembling hands. 
 
If you have to undergo surgery whilst taking Rivastigmine Actavis, tell your doctor before you are 
given any anaesthetics, because Rivastigmine Actavis may exaggerate the effects of some muscle 
relaxants during anaesthesia. 
 
Caution when Rivastigmine Actavis is taken together with beta-blockers (medicines such as atenolol 
used to treat hypertension, angina and other heart conditions). Taking the two medicines together 
could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of 
consciousness. 
 
Pregnancy, breast-feeding and fertility 
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. 
 
If you are pregnant, the benefits of using Rivastigmine Actavis must be assessed against the possible 
effects on your unborn child. Rivastigmine Actavis should not be used during pregnancy, unless 
clearly necessary. 
 
You should not breast-feed during treatment with Rivastigmine Actavis. 



52 

 
Driving and using machines 
Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. 
Rivastigmine Actavis may cause dizziness and somnolence, mainly at the start of treatment or when 
increasing the dose. If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that 
require your attention. 
 
 
3. How to take Rivastigmine Actavis 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 
nurse if you are not sure. 
 
How to start treatment 
Your doctor will tell you what dose of Rivastigmine Actavis to take. 
• Treatment usually starts with a low dose. 
• Your doctor will slowly increase your dose depending on how you respond to treatment. 
• The highest dose that should be taken is 6 mg twice a day. 
 
Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor 
your weight whilst you are taking this medicine. 
 
If you have not taken Rivastigmine Actavis for more than three days, do not take the next dose until 
you have talked to your doctor. 
 
Taking this medicine 
• Tell your caregiver that you are taking Rivastigmine Actavis. 
• To benefit from your medicine, take it every day. 
• Take Rivastigmine Actavis twice a day, in the morning and evening, with food. 
• Swallow the capsules whole with a drink. 
• Do not open or crush the capsules. 
 
If you take more Rivastigmine Actavis than you should 
If you accidentally take more Rivastigmine Actavis than you should, inform your doctor. You may 
require medical attention. Some people who have accidentally taken too much Rivastigmine Actavis 
have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and 
hallucinations. Slow heartbeat and fainting may also occur. 
 
If you forget to take Rivastigmine Actavis 
If you find you have forgotten to take your dose of Rivastigmine Actavis, wait and take the next dose 
at the usual time. Do not take a double dose to make up for a forgotten dose. 
 
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. 
 
You may have side effects more often when you start your medicine or when your dose is increased. 
Usually, the side effects will slowly go away as your body gets used to the medicine. 
 
Very common (may affect more than 1 in 10 people) 
• Feeling dizzy 
• Loss of appetite 
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea 



53 

 
Common (may affect up to 1 in 10 people) 
• Anxiety 
• Sweating 
• Headache 
• Heartburn 
• Weight loss 
• Stomach pain 
• Feeling agitated 
• Feeling tired or weak 
• Generally feeling unwell 
• Trembling or feeling confused 
• Decreased appetite 
• Nightmares 
 
Uncommon (may affect up to 1 in 100 people) 
• Depression 
• Difficulty in sleeping 
• Fainting or accidentally falling 
• Changes in how well your liver is working 
 
Rare (may affect up to 1 in 1,000 people) 
• Chest pain 
• Rash, itching 
• Fits (seizures) 
• Ulcers in your stomach or intestine 
 
Very rare (may affect up to 1 in 10,000 people) 
• High blood pressure 
• Urinary tract infection 
• Seeing things that are not there (hallucinations) 
• Problems with your heartbeat such as fast or slow heartbeat 
• Bleeding in the gut – shows as blood in stools or when being sick 
• Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling 

sick (nausea) or being sick (vomiting) 
• The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, 

difficulty in carrying out movements 
 
Not known (frequency cannot be estimated from the available data) 
• Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with 

your stomach (oesophagus) 
• Dehydration (losing too much fluid) 
• Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the 

urine or unexplained nausea, vomiting, tiredness and loss of appetite) 
• Aggression, feeling restless 
• Uneven heartbeat 
 
Patients with dementia and Parkinson’s disease 
These patients have some side effects more often. They also have some additional side effects: 
 
Very common (may affect more than 1 in 10 people) 
• Trembling 
• Fainting 
• Accidentally falling 
 



54 

Common (may affect up to 1 in 10 people) 
• Anxiety 
• Feeling restless 
• Slow and fast heartbeat 
• Difficulty in sleeping 
• Too much saliva and dehydration 
• Unusually slow movements or movements you cannot control 
• The signs of Parkinson’s disease get worse or getting similar signs – such as stiff muscles, 

difficulty in carrying out movements and muscle weakness 
 
Uncommon (may affect up to 1 in 100 people) 
• Uneven heartbeat and poor control of movements 
 
Other side effects seen with rivastigmine transdermal patches and which may occur with the 
hard capsules: 
 
Common (may affect up to 1 in 10 people) 
• Fever 
• Severe confusion 
• Urinary incontinence (inability to retain adequate urine) 
 
Uncommon (may affect up to 1 in 100 people) 
• Hyperactivity (high level of activity, restlessness) 
 
Not known (frequency cannot be estimated from the available data) 
• Allergic reaction where the patch was used, such as blisters or skin inflammation 
 
If you get any of these side effects, contact your doctor as you may need medical assistance. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. 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. 
 
 
5. How to store Rivastigmine Actavis 
 
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, blister or capsule 
container after EXP. The expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
 
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 Rivastigmine Actavis contains 
- The active substance is rivastigmine hydrogen tartrate. 
- The other ingredients are: 



55 

Capsule content:  Magnesium stearate, colloidal anhydrous silica, hypromellose and 
microcrystalline cellulose. 

Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow 
iron oxide (E172) and gelatine. Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg 
hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron 
oxide (E172) and gelatine. 

Printing ink: Shellac, propylene glycol, red iron oxide (E172). The ink may or may not 
contain potassium hydroxide. 

 
Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine. 
Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine. 
Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine. 
Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine. 
 
What Rivastigmine Actavis looks like and contents of the pack 
- Rivastigmine Actavis 1.5 mg hard capsules, which contain off-white to slightly yellow powder, 

have a yellow cap and yellow body, with red imprint “RIV 1.5mg” on body. 
- Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, 

have an orange cap and orange body, with red imprint “RIV 3mg” on body. 
- Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, 

have a red cap and red body, with white imprint “RIV 4.5mg” on body. 
- Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, 

have an red cap and orange body, with red imprint “RIV 6mg” on body. 
 
The capsules are packed in blisters available in three different pack sizes (28, 56 and 112 capsules) 
and capsule containers of 250 capsules, but these may not all be available in your country. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Actavis Group PTC ehf. 
Reykjavíkurvegur 76-78 
220 Hafnarfjörður 
Iceland 
 
Manufacturer 
Specifar S.A 
1, 28 Octovriou str. 
123 51 Ag. Varvara 
Athens 
Greece  
 
Actavis ehf. 
Reykjavíkurvegur 76-78 
IS-220 Hafnarfjörður 
Iceland 
 
Tjoapack Netherlands BV 
Nieuwe Donk 9 
4879 AC Etten-Leur 
The Netherlands 
 
Actavis Group PTC ehf. 
Reykjavikurvegur 76-78 
220 Hafnarfjordur 
Iceland 



56 

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Actavis Group PTC ehf. 
IJsland / Islande / Island 
 

Lietuva 
UAB "Sicor Biotech" 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл.: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
Actavis Group PTC ehf. 
Islande / Island 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 6400 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 
 

Malta 
Actavis Ltd. 
Tel: +35621693533 
 

Deutschland 
Actavis Group PTC ehf. 
Island 
 

Nederland 
Actavis Group PTC ehf. 
IJsland 
 

Eesti 
UAB "Sicor Biotech" Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 

Ελλάδα 
Specifar ABEE 
Τηλ: +30 210 5401500 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43(0)1 97007 0  

España 
Actavis Group PTC ehf. 
Islandia 
 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel: +48 22 345 93 00 
 

France 
Actavis Group PTC ehf. 
Islande 
 

Portugal 
Actavis Group PTC ehf. 
Islândia 

Hrvatska 
Pliva Hrvatska d.o.o.  
Tel: +385 1 37 20 000  
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +4021 230 65 24 
 

Ireland 
Actavis Ireland Limited 
Tel: +353 (0)21 4619040 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
Actavis Group PTC ehf. 
Sími: +354 550 3300 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o 
Tel: +421 2 57 26 79 11 
 

Italia 
Actavis Group PTC ehf. 
Islanda 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 (0)20 180 5900 
 



57 

Κύπρος 
Specifar ABEE  
Τηλ: +30 210 5401500 
Ελλάδα 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB "Sicor Biotech" filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Actavis UK Limited 
Tel: +44 1271 385257 
 

 
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/. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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