Slenyto

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Slenyto 1 mg prolonged-release tablets 
Slenyto 5 mg prolonged-release tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Slenyto 1 mg prolonged-release tablets 
 
Each prolonged-release tablet contains 1 mg melatonin. 
 
Excipient with known effect 
 
Each prolonged-release tablet contains lactose monohydrate equivalent to 8.32 mg lactose. 
 
Slenyto 5 mg prolonged-release tablets 
 
Each prolonged-release tablet contains 5 mg melatonin. 
 
Excipient with known effect 
 
Each prolonged-release tablet contains lactose monohydrate equivalent to 8.86 mg lactose. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Prolonged- release tablet.  
 
Slenyto 1 mg prolonged-release tablets 
 
Pink, film coated, round, biconvex, 3 mm diameter tablets with no imprint. 
 
Slenyto 5 mg prolonged-release tablets 
 
Yellow, film coated, round, biconvex, 3 mm diameter tablets with no imprint. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism 
Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have 
been insufficient. 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended starting dose is 2 mg of Slenyto. If an inadequate response has been observed, the 
dose should be increased to 5 mg, with a maximal dose of 10 mg. 
 
Slenyto should be taken once daily, 0.5-1 hour before bedtime and with or after food.   
 



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Data are available for up to 2 years’ treatment. The patient should be monitored at regular intervals (at 
least every 6 months) to check that Slenyto is still the most appropriate treatment. After at least 
3 months of treatment, the physician should evaluate the treatment effect and consider stopping 
treatment if no clinically relevant treatment effect is seen. If a lower treatment effect is seen after 
titration to a higher dose, the prescriber should first consider a down-titration to a lower dose before 
deciding on a complete discontinuation of treatment.  
 
If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, 
no other tablet should be given before the next scheduled dose.   
 
Special populations 
 
Renal impairment 
The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied. 
Caution should be used when melatonin is administered to patients with renal impairment. 
 
Hepatic impairment 
There is no experience of the use of melatonin in patients with liver impairment. Therefore, melatonin 
is not recommended for use in patients with hepatic impairment (see section 5.2). 
 
Paediatric population (under 2 years of age) 
There is no relevant use of melatonin in children aged 0 to 2 years for the treatment of insomnia. 
 
Method of administration  
 
Oral use. Tablets should be swallowed whole.  The tablet should not be broken, crushed or chewed 
because it will lose the prolonged release properties.  
 
Tablets can be put into food such as yoghurt, orange juice or ice-cream to facilitate swallowing and 
improve compliance. If the tablets are mixed with food or drink, they should be taken immediately and 
the mixture not stored. 
 
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 
 
Drowsiness 
 
Melatonin may cause drowsiness.  Therefore the medicinal product should be used with caution if the 
effects of drowsiness are likely to be associated with a risk to safety (see section 4.7). 
 
Autoimmune diseases 
 
No clinical data exist concerning the use of melatonin in individuals with autoimmune diseases.  
Therefore, melatonin is not recommended for use in patients with autoimmune diseases.  
 
Interactions with other medicines 
 
Concomitant use with fluvoxamine, alcohol, benzodiazepines/non-benzodiazepines hypnotics, 
thioridazine and imipramine is not recommended (see section 4.5).  
 
Lactose 
 
Slenyto contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase 
deficiency or glucose-galactose malabsorption should not take this medicine. 



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4.5 Interaction with other medicinal products and other forms of interaction 
 
Interaction studies have only been performed in adults. In the absence of specific studies in children, 
the drug interactions with melatonin are those known in adults. 
 
Melatonin’s metabolism is mainly mediated by CYP1A enzymes.  Therefore, interactions between 
melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible. 
 
Concomitant use not recommended 
 
Concomitant use of the following medicinal products is not recommended (see section 4.4): 
 
Fluvoxamine 
Fluvoxamine increases melatonin levels (by 17-fold higher AUC and a 12-fold higher serum Cmax) by 
inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19.  The 
combination should be avoided. 
 
Alcohol 
Alcohol should not be taken with melatonin, because it reduces the effectiveness of melatonin on 
sleep. 
 
Benzodiazepines/non-benzodiazepine hypnotics 
Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, 
such as zaleplon, zolpidem and zopiclone.  In a clinical trial, there was clear evidence for a transitory 
pharmacodynamic interaction between melatonin and zolpidem one hour following co-dosing.  
Concomitant administration resulted in increased impairment of attention, memory and co-ordination 
compared to zolpidem alone. Combination with benzodiazepines and non-benzodiazepine hypnotics 
should be avoided. 
 
Thioridazine and imipramine 
Melatonin has been co-administered in studies with thioridazine and imipramine, active substances 
which affect the central nervous system.  No clinically significant pharmacokinetic interactions were 
found in each case.  However, melatonin co-administration resulted in increased feelings of tranquility 
and difficulty in performing tasks compared to imipramine alone, and increased feelings of “muzzy-
headedness” compared to thioridazine alone.  Combination with thioridazine and imipramine should 
be avoided. 
 
Concomitant use to be considered with caution 
 
Concomitant use of the following medicinal products should be considered with caution: 
 
5- or 8-methoxypsoralen 
Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 or 8-MOP), which increases 
melatonin levels by inhibiting its metabolism. 
 
Cimetidine 
Caution should be exercised in patients on cimetidine which is a potent inhibitor of certain cytochrome 
P450 (CYP450) enzymes, mainly CYP1A2 and thereby increases plasma melatonin levels, by 
inhibiting its metabolism. 
 
Oestrogens 
Caution should be exercised in patients on oestrogens (e.g. contraceptive or hormone replacement 
therapy), which increase melatonin levels by inhibiting its metabolism by CYP1A1 and CYP1A2. 
 



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CYP1A2 inhibitors 
CYP1A2 inhibitors such as quinolones (ciprofloxacin and norfloxacin) may give rise to increased 
melatonin exposure. 
 
CYP1A2 inducers 
CYP1A2 inducers such as carbamazepine and rifampicin may reduce plasma concentrations of 
melatonin. Therefore, when CYP1A2 inducers and melatonin are both given, dose adjustment may be 
required.   
 
Smoking 
 
Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during 
treatment with melatonin, dose adjustment may be required. 
 
NSAIDs 
 
Prostaglandin synthesis inhibitors (NSAIDs) such as acetylsalicylic acid and ibuprofen, given in the 
evening may suppress endogenous melatonin levels in the early part of the night by up to 75%. If 
possible, administration of NSAIDs should be avoided in the evening. 
 
Beta-blockers 
 
Beta-blockers may supress the night-time release of endogenous melatonin and thus should be 
administered in the morning. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no data from the use of melatonin in pregnant women.  Animal studies do not indicate 
reproductive toxicity (see section 5.3).  As a precautionary measure, it is preferable to avoid the use of 
melatonin during pregnancy. 
 
Breastfeeding 
 
Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably 
secreted into human milk.  Data in animals indicate maternal transfer of melatonin to the foetus via the 
placenta or in the milk.  The effect of melatonin on newborns/infants is unknown. 
 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from 
melatonin therapy taking into account the benefit of breast feeding for the child and the benefit of 
therapy for the woman. 
 
Fertility 
 
In studies performed in both adult and juvenile animals, melatonin had no effect on male or female 
fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Melatonin has a moderate influence on the ability to drive and use machines. 
 
Melatonin may cause drowsiness, therefore melatonin should be used with caution if the effects of 
drowsiness are likely to be associated with a risk to safety.  
 



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4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse reactions with Slenyto in clinical studies were somnolence, 
fatigue, mood swings, headache, irritability, aggression and hangover occurring in 1:100-1:10 
children.  
 
Tabulated list of adverse reactions 
 
Adverse reactions 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). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
System Organ Class Common 
Psychiatric disorders Mood swings, Aggression, Irritability 
Nervous system disorders Somnolence, Headache, Sudden onset of sleep  
Respiratory, thoracic and 
mediastinal disorders 

Sinusitis 

General disorders and 
administration site conditions 

Fatigue, Hangover 

 
The following adverse reactions (frequency unknown) have been reported with off-label use of the 
adult formulation, 2 mg prolonged-release melatonin tablets: epilepsy, visual impairment, dyspnoea, 
epistaxis, constipation, decreased appetite, swelling face, skin lesion, feeling abnormal, abnormal 
behaviour and neutropenia. 
 
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 
 
If overdose occurs, drowsiness is to be expected.  Clearance of the active substance is expected within 
12 hours after ingestion.  No special treatment is required. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group:  Psycholeptics, melatonin receptor agonists, ATC code: N05CH01 
 
Mechanism of action 
 
The activity of melatonin at the melatonin receptors (MT1, MT2 and MT3) is believed to contribute to 
its sleep-promoting properties, as these receptors (mainly MT1 and MT2) are involved in the 
regulation of circadian rhythms and sleep regulation. 
 

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


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Clinical efficacy and safety in the paediatric population 
 
Efficacy and safety have been assessed in a randomised, placebo-controlled study in children 
diagnosed with ASDs and neurodevelopmental disabilities caused by Smith-Magenis syndrome who 
had not shown improvement after standard sleep behavioural intervention. Treatment was 
administered for up to two years.  
 
The study comprises 5 periods: 1) pre-study period (4 weeks), 2) baseline single-blind placebo period 
(2 weeks), 3) randomized placebo-controlled treatment period (13 weeks), 4) open label treatment 
period (91 weeks), and 5) single blind run-out period (2 weeks placebo).  
 
A total of 125 children (2-17.0 years of age, mean age 8.7 +/- 4.15; 96.8% ASD, 3.2% Smith-Magenis 
syndrome [SMS]) whose sleep failed to improve on behavioural intervention alone were randomized 
and 112 weeks’ results are available. 28.8% patients were diagnosed with ADHD before study 
initiation and 77% had abnormal SDQ hyperactivity/inattention score (>=7) at baseline. 
 
Randomized placebo-controlled treatment period results (13 weeks) 
The study met the primary endpoint, demonstrating statistically significant effects of Slenyto 2/5 mg 
versus placebo on change from baseline in mean Sleep and Nap Diary (SND)-assessed Total Sleep 
Time (TST) after 13 weeks of double-blind treatment. At baseline, mean TST was 457.2 minutes in 
the Slenyto and 459.9 minutes in the placebo group. After 13 weeks of double-blind treatment, 
participants slept on average 57.5 minutes longer at night with Slenyto compared to 9.1 minutes with 
placebo adjusted mean treatment difference Slenyto–placebo 33.1 minutes in the all Randomized Set; 
Multiple Imputation (MI) (p=0 .026).  
 
At baseline, mean Sleep Latency (SL) was 95.2 minutes in the Slenyto and 98.8 minutes in the placebo 
group. By the end of the 13-week treatment period, children fell asleep on average 39.6 minutes faster 
with Slenyto and 12.5 minutes faster with placebo adjusted mean treatment difference -25.3 minutes in 
the all Randomized Set; MI( p=0.012) without causing earlier wakeup time. The rate of participants 
attaining clinically meaningful responses in TST (increase of 45 minutes from baseline) and/or SL 
(decrease of 15 minutes from baseline) was significantly higher with Slenyto than with placebo 
(68.9% versus 39.3% respectively; p=0 .001). 
 
Besides shortening of SL, increase in the longest sleep episode (LSE) = uninterrupted sleep duration 
compared to placebo was observed. By the end of the 13-week double-blind period, the mean LSE 
increased on average by 77.9 minutes in the Slenyto treated group, compared to 25.5 minutes in the 
placebo-treated group. The adjusted estimated treatment differences were 43.2 minutes in the all 
Randomized Set (MI, p=0 .039). Wake up time was unaffected; after 13 weeks, patients’ wake up time 
was delayed insignificantly by 0.09 hour (0.215) (5.4 minutes) with Slenyto compared to placebo 
treatment. 
 
Slenyto 2 mg/5 mg treatment resulted in a significant improvement over placebo in the child’s 
externalizing behaviours (hyperactivity/inattention+ conduct scores) as assessed by the Strength and 
Difficulties Questionnaire (SDQ) after 13 weeks of double-blind treatment (p=0.021). For the total 
SDQ score after 13 weeks of double blind treatment, there was a trend to benefit in favour of Slenyto 
(p=0.077). For social functioning (CGAS), the differences between Slenyto and placebo were small 
and not statistically significant (Table 1). 
 



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Table 1: CHILD BEHAVIOUR (13 weeks Double-blind) 
Variable Group Adjusted treatment means 

(SE) [95% CI] 
Treatment 
difference 
(SE) 

95% CI p-value* 

SDQ 
Externalizing 
behaviours 

Slenyto -0.70 (0.244)[-1.19;-0.22] 
-0.83 (0.355) -1.54,-0.13 0.021 Placebo 0.13(0.258)[-0.38; 0.64] 

     
Total score Slenyto -0.84 (0.387) [-1.61, -0.07] 

-1.01 (0.563)  -2.12, 0.11  0.077 Placebo 0.17 (0.409) [-0.64, 0.98] 
      

CGAS 
 Slenyto 

Placebo 
 

1.96(1.328)(-0.67,4.60) 
1.84(1.355)(-0.84,4.52) 
 

0.13(1.901) -3.64,3.89 ns 

*MMRM analysis CI = confidence interval; SDQ = Strength and Difficulties Questionnaire; CGAS = the 
Children’s Global Assessment Scale; SE = standard error 
 
The treatment effects on sleep variables were associated with improved parents’ well-being. There was 
a significant improvement with Slenyto over placebo in Composite Sleep Disturbance Index (CSDI) -
assessed parent satisfaction in child sleep pattern (p=0 .005) and in caregivers’ well-being as assessed 
by the WHO-5 after 13 weeks of double-blind treatment (p=0.01) (Table 2). 
 

Table 2: PARENTS WELL BEING (13 weeks Double- blind) 
Variable Group Adjusted treatment means 

(SE) [95% CI] 
Treatment 
difference 
(SE) 

95% CI p-value* 

WHO-5 Slenyto 1.43(0.565)(0.31,2.55) 
2.17(0.831) 0.53,3.82 0.01 Placebo -0.75(0.608)(-1.95,0.46) 

     
CSDI satisfaction Slenyto 1.43(0.175)(1.08,1.78) 

0.72(0.254) 0.22,1.23 0.005 Placebo 0.71(0.184)(0.34,1.07) 
      
*MMRM analysis CI = confidence interval; WHO-5= the World Health Organization Well-Being Index; CSDI = 
Composite Sleep Disturbance Index; SE = standard error 
 
Open label treatment period results (91weeks) 
Patients (51 from the Slenyto group and 44 from the placebo group, mean age 9 ± 4.24 years, range 
2-17.0 years) received open-label Slenyto 2/5 mg according to the double-blind phase dose, for 
91 weeks with optional dose adjustment to 2, 5 or 10 mg/day after the first 13 weeks of follow-up 
period. 74 patients completed 104 weeks of treatment, 39 completed 2 years and 35 completed 
21 months of Slenyto treatment. The improvements in total sleep time (TST), sleep latency (SL) and 
duration of uninterrupted sleep (LSE; longest sleep episode) seen in the double blind-phase were 
maintained throughout the 39 weeks’ follow up period.  
 
After 2 weeks withdrawal on placebo, a descriptive reduction in most scores was seen but levels were 
still significantly better than baseline levels with no signs of rebound effects.  
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
In the paediatric population comprising 16 ASD children ages 7-15 years old suffering from insomnia, 
following Slenyto 2 mg (2 x 1 mg mini-tablets) administration after a standardized breakfast, 



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melatonin concentrations peaked within 2 hours after administration and remained elevated for 6 hours 
thereafter with a Cmax (SD) of 410 pg/ml (210) in the saliva. 
 
In adults, following Slenyto 5 mg (1 x 5 mg mini-tablet) administered after food, melatonin 
concentrations peaked within 3 hours after administration; Cmax (SD) was 3.57 ng/ml (3.64) in plasma. 
Under fasted conditions Cmax was lower (1.73 ng/ml) and tmax was earlier (within 2 hours) with a minor 
effect on AUC-∞ that was slightly reduced (-14%) as compared to fed state. 
 
The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% 
in the elderly.  The kinetics of melatonin are linear over the range of 2-8 mg. 
 
Data with 2 mg prolonged release melatonin tablets and data with 1 mg and 5 mg mini-tablets indicate 
that there is no accumulation of melatonin after repeated dosing.  This finding is compatible with the 
short half-life of melatonin in humans. 
 
Bioavailability is in the order of 15%.  There is a significant first pass effect with an estimated first 
pass metabolism of 85%. 
 
Distribution 
 
The in vitro plasma protein binding of melatonin is approximately 60%.  Melatonin is mainly bound to 
albumin, alpha1-acid glycoprotein and high density lipoprotein. 
 
Biotransformation 
 
Melatonin undergoes a fast first hepatic pass metabolism and is metabolised predominantly by CYP1A 
enzymes, and possibly CYP2C19 of the cytochrome P450 system with elimination half life of ca 40 
minutes. Prepubertal children and young adults metabolize melatonin faster than adults. Altogether, 
melatonin metabolism declines with age, with pre-pubertal and pubertal metabolism faster than at 
older age. The principal metabolite is 6-sulfatoxy-melatonin (6-S-MT), which is inactive.  The site of 
biotransformation is the liver.  The excretion of the metabolite is completed within 12 hours after 
ingestion. 
 
Melatonin does not induce CYP1A2 or CYP3A enzymes in vitro at supra-therapeutic concentrations. 
 
Elimination 
 
Terminal half life (t½) is 3.5-4 hours.  Two liver-mediated metabolic pathways account for around 90% 
of melatonin metabolism. The predominant metabolic flux is through hydroxylation at C6 via the 
hepatic microsome P-450 system to yield 6-hydroxymelatonin. The second, less significant, pathway 
is 5-demethylation to yield a physiological melatonin precursor, N-acetylserotonin. Both 6-
hydroxymelatonin and N-acetylserotonin are ultimately conjugated to sulfate and glucoronic acid, and 
excreted in the urine as their corresponding 6-sulfatoxy and 6-glucoronide derivatives. 
 
Elimination is by renal excretion of metabolites, 89% as sulfated and glucoronide conjugates of 
6-hydroxymelatonin (over 80% as 6-sulfatoxy melatonin) and 2% is excreted as melatonin (unchanged 
active substance). 
 
Gender 
 
A 3-4-fold increase in Cmax is apparent for women compared to men.  A five-fold variability in Cmax 
between different members of the same sex has also been observed.  However, no pharmacodynamic 
differences between males and females were found despite differences in blood levels. 
 



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Special populations 
 
Renal impairment 
There is no experience of the use of melatonin in paediatric patients with renal impairment (see 
Section 4.2).  However as melatonin is mainly eliminated via liver metabolism, and the metabolite 6-
SMT is inactive, renal impairment is not expected to influence clearance of melatonin. 
 
Hepatic impairment 
The liver is the primary site of melatonin metabolism and therefore, hepatic impairment results in 
higher endogenous melatonin levels. 
 
Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.  
Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls. 
 
There is no experience of the use of melatonin in paediatric patients with liver impairment. Published 
data demonstrate markedly elevated endogenous melatonin levels during daytime hours due to 
decreased clearance in patients with hepatic impairment (see Section 4.2). 
 
5.3 Preclinical safety data 
 
Non-clinical data revealed no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction 
and development. 
 
A slight effect on post-natal growth and viability was found in rats only at very high doses, equivalent 
to approximately 2000 mg/day in humans. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Slenyto 1 mg prolonged-release tablet 
 
Tablet core 
Ammonio methacrylate copolymer type B 
Calcium hydrogen phosphate dihydrate 
Lactose monohydrate 
Silica, colloidal anhydrous 
Talc 
Magnesium stearate 
 
Film coating 
Carmellose sodium (E466) 
Maltodextrin 
Glucose monohydrate 
Lecithin (E322) 
Titanium dioxide (E171) 
Iron oxide red (E172) 
Iron oxide yellow (E172) 
 



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Slenyto 5 mg prolonged-release tablet  
 
Tablet core 
Ammonio methacrylate copolymer type A 
Calcium hydrogen phosphate dihydrate 
Lactose monohydrate 
Silica, colloidal anhydrous 
Magnesium stearate 
 
Film coating 
Carmellose sodium (E466) 
Maltodextrin 
Glucose monohydrate 
Lecithin (E322) 
Titanium dioxide (E171) 
Iron oxide yellow (E172) 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
3 years 
 
6.4 Special precautions for storage 
 
Do not store above 30°C.   
 
6.5 Nature and contents of container  
 
Slenyto 1 mg prolonged-release tablets 
 
PVC/PVDC opaque blister with aluminium foil backing. Pack size: 30 tablets or 60 tablets. 
 
Slenyto 5 mg prolonged-release tablets 
 
PVC/PVDC opaque blister with aluminium foil backing. Pack size: 30 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 
 
RAD Neurim Pharmaceuticals EEC SARL 
4 rue de Marivaux 
75002 Paris 
France 
e-mail: regulatory@neurim.com 
 
 



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8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1318/001 
EU/1/18/1318/003 
EU/1/18/1318/005 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 September 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{DD month YYYY} 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
 
  



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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 

 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Iberfar Indústria Farmacêutica S.A., 
Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo, 
Barcarena, 
2734-501, 
Portugal 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
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) 
 
The 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. 

 
  



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
  



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON (BLISTER PACK) – 1 MG 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Slenyto 1 mg prolonged-release tablets 
melatonin 
For children and adolescents aged 2-18 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each prolonged-release tablet contains 1 mg melatonin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate 
See leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 prolonged-release tablets 
60 prolonged-release tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
Swallow whole. Do not break, crush or chew the tablet. 
 
 
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 30°C.   
 
 



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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 
 
RAD Neurim Pharmaceuticals EEC SARL 
4 rue de Marivaux 
75002 Paris 
France 
e-mail: regulatory@neurim.com 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1318/005: 30 prolonged-release tablets 
EU/1/18/1318/001: 60 prolonged-release tablets 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Slenyto 1 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 
  



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER OF 30 TABLETS – 1 MG 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Slenyto 1 mg prolonged-release tablets 
melatonin 
For children and adolescents aged 2-18 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
RAD Neurim Pharmaceuticals EEC SARL 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
CARTON (BLISTER PACK) – 5 MG 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Slenyto 5 mg prolonged-release tablets 
melatonin 
For children and adolescents aged 2-18 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each prolonged-release tablet contains 5 mg melatonin. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose monohydrate 
See leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 prolonged-release tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
Swallow whole. Do not break, crush or chew the tablet. 
 
 
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 30°C.   
 
 



21 

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 
 
RAD Neurim Pharmaceuticals EEC SARL 
4 rue de Marivaux 
75002 Paris 
France  
e-mail: regulatory@neurim.com 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1318/003: 30 prolonged-release tablets (blister pack) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Slenyto 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



22 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER STRIP OF 30 TABLETS – 5 MG 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Slenyto 5 mg prolonged-release tablets 
melatonin 
For children and adolescents aged 2-18 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
RAD Neurim Pharmaceuticals EEC SARL 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



24 

Package Leaflet: Information for the user 
 

Slenyto 1 mg prolonged-release tablets 
Slenyto 5 mg prolonged-release tablets 

melatonin 
 

For children and adolescents aged 2-18 
 

Read all of this leaflet carefully before you or your child starts taking this medicine because it 
contains important information.  
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you or your child only.  Do not pass it on to others.  It 

may harm them, even if their signs of illness are the same as yours or your child’s. 
- If you or your child gets any side effects, talk to your doctor or pharmacist.  This includes any 

possible side effects not listed in this leaflet.  See section 4. 
 
 
What is in this leaflet 
1. What Slenyto is and what it is used for 
2. What you need to know before you or your child takes Slenyto 
3. How to take Slenyto 
4. Possible side effects 
5. How to store Slenyto 
6. Contents of the pack and other information 
 
 
1. What Slenyto is and what it is used for 
 
What Slenyto is 
Slenyto is a medicine that contains the active ingredient, melatonin. Melatonin is a hormone produced 
naturally by the body. 
 
What it is used for 
Slenyto is for use in children and adolescents (2 to 18 years old) with autism spectrum disorder 
(ASD) and/or Smith-Magenis syndrome, a neurogenetic disease (inherited condition affecting the 
nerves and brain). 
 
Slenyto shortens the time it takes to fall asleep and lengthens the duration of sleep. 
It is for the treatment of insomnia (sleeplessness) when a healthy sleeping routine (such as a regular 
bedtime and soothing sleeping environment) has not worked well enough.  The medicine can help you 
or your child fall asleep and may help you or your child sleep for longer during the night. 
 
 
2. What you need to know before you or your child takes Slenyto 
 
DO NOT take Slenyto if you or your child: 
- is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6). 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Slenyto if you or your child: 
 
- has liver or kidney problems. You should speak to your doctor before taking/giving Slenyto as 

its use is not recommended in such cases. 



25 

- suffers from an autoimmune disease (where the body’s own immune (defence) system attacks 
parts of the body). You should speak to your doctor before taking/giving Slenyto as its use is 
not recommended in such cases. 

- feels drowsy (see section below on “Driving and using machines”). 
 
Children under 2 years old  
Do not give this medicine to children below the age of 2 years as it has not been tested and its effects 
are unknown. 
 
Other medicines and Slenyto 
 
Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other 
medicines.   
 
In particular, taking Slenyto with the following medicines can increase the risk of side effects, or it can 
affect the way that Slenyto or the other medicine works: 
 
• fluvoxamine (used for the treatment of depression and obsessive compulsive disorder) 
• methoxypsoralens (used in the treatment of skin disorders e.g. psoriasis) 
• cimetidine (used in the treatment of stomach problems such as ulcers) 
• quinolones (for example ciprofloxacin and norfloxacin) and rifampicin (used in the treatment 

of bacterial infections) 
• oestrogens (used in contraceptives or hormone replacement therapy)  
• carbamazepine (used in the treatment of epilepsy) 
• non-steroidal anti-inflammatory medicines such as aspirin and ibuprofen (used for treating 

pain and inflammation). These medicines should be avoided, especially in the evening. 
• beta-blockers (used to control blood pressure). These medicines should be taken in the 

morning. 
• benzodiazepines and non-benzodiazepine hypnotics such as zaleplon, zolpidem and zopiclone 

(used to induce sleep) 
• thioridazine (used for the treatment of schizophrenia) 
• imipramine (used for the treatment of depression) 
 
Smoking 
Smoking can increase the breakdown of melatonin by the liver, which may make this medicine less 
effective. Please tell your doctor if you or your child starts or stops smoking during treatment. 
 
Slenyto with alcohol 
Do not drink alcohol before, during or after taking Slenyto, because alcohol weakens the effect of the 
medicine. 
 
Pregnancy and breast-feeding 
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
Tell your doctor or pharmacist before using Slenyto if you or your daughter: 
• is pregnant or might be pregnant.  As a precautionary measure, it is preferable to avoid the use 

of melatonin during pregnancy. 
• is breast-feeding or planning to breast-feed. It is possible that melatonin is passed into human 

breast milk, therefore your doctor will decide whether you or your daughter should breastfeed 
whilst taking melatonin. 

 
Driving and using machines 
Slenyto may cause drowsiness.  After taking this medicine, you or your child should not drive a 
vehicle, ride a bicycle, or use machinery until completely recovered. 
 



26 

If you or your child suffers from continued drowsiness, you should consult your doctor. 
 
Slenyto contains lactose  
Slenyto contains lactose monohydrate.  If you or your child has been told by your doctor that you have 
an intolerance to some sugars, contact your doctor before taking this medicinal product.  
 
 
3. How to take Slenyto 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. 
 
How much 
Slenyto is available in two strengths: 1 mg and 5 mg.  The recommended starting dose is 2 mg (two 
1-mg tablets) once daily. If there is no improvement in your/your child’s symptoms, your doctor may 
increase the dose of Slenyto to find the most suitable dose for you/your child. The maximum daily 
dose that you/your child will receive is 10 mg (two 5-mg tablets). 
 
When  
Slenyto should be taken in the evening, 30 to 60 minutes before bedtime. The tablets should be taken 
after the evening meal, i.e. on a full stomach. 
 
How to take Slenyto 
Slenyto is for oral use. The tablets should be swallowed whole and NOT broken, crushed or 
chewed.  Crushing and chewing damages the special properties of the tablet and means that they will 
not work properly. 
 
The whole tablets can be put into food like yoghurt, orange juice or ice-cream to help with 
swallowing. If the tablets are mixed with these foods, they should be given immediately and not left or 
stored, as this may affect the way the tablets work.  If the tablets are mixed with any other type of 
food, the tablets may not work properly. 
 
How long 
Slenyto is for use in the treatment of insomnia.  You or your child should be monitored by your doctor 
at regular intervals (recommended every 6 months) to check that Slenyto is still the right treatment for 
you/them.   
 
If you or your child takes more Slenyto than you/they should 
If you/your child has accidentally taken too much medicine, contact the doctor or pharmacist as soon 
as possible. 
 
Taking more than the recommended daily dose may make you/your child feel drowsy. 
 
If you or your child forgets to take Slenyto 
If you or your child forgets to take a tablet, it could be taken before going to sleep that night, but after 
this time, no other tablet should be taken before the next evening. 
Do not take a double dose to make up for a forgotten dose. 
 
If you or your child stops taking Slenyto 
You should talk to your doctor before you/your child stops taking Slenyto. It is important to continue 
taking this medicine to treat the condition. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 



27 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Unexpected changes in behaviour, such as aggression, may occur commonly (affecting between 1 in 
100 to 1 in 10 people). If this change in behaviour occurs, you must tell your doctor. The doctor 
may want you/your child to stop taking this medicine. 
 
If any of the following side effects get serious or are troublesome, contact your doctor or seek medical 
advice:- 
 
Common: may affect between 1 in 100 to 1 in 10 people 
 
• Changes in mood 
• Aggression 
• Irritability 
• Drowsiness 
• Headache 
• Sudden onset of sleep 
• Swelling and inflammation of the sinuses associated with pain and blocked nose (sinusitis) 
• Tiredness 
• Hangover feeling 
 
Frequency not known (reported from use in adults) 
 
• Fits (epilepsy) 
• Visual impairment 
• Breathlessness/shortness of breath (dyspnoea) 
• Nose bleeds (epistaxis) 
• Constipation 
• Decreased appetite 
• Swelling of the face 
• Skin lesion 
• Feeling abnormal 
• Abnormal behaviour 
• Low levels of white blood cells (neutropenia) 
 
Reporting of side effects 
If you or your child gets 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. 
 
 
5. How to store Slenyto 
 
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 after EXP.  The 
expiry date refers to the last day of that month. 
 
Do not store above 30°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 to protect the environment. 
 

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


28 

 
6. Contents of the pack and other information 
 
What Slenyto contains 
 
1 mg strength 
 
- The active substance is melatonin.  Each tablet contains 1 mg melatonin. 
- The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen 

phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc, magnesium 
stearate, carmellose sodium (E466), maltodextrin, glucose monohydrate, lecithin (E322), 
titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172). 

 
5 mg strength 
 
- The active substance is melatonin.  Each tablet contains 5 mg melatonin. 
- The other ingredients are ammonio methacrylate copolymer type A, calcium hydrogen 

phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), magnesium stearate, 
carmellose sodium (E466), maltodextrin, glucose monohydrate, lecithin (E322), titanium 
dioxide (E171) and iron oxide yellow (E172). 

 
What Slenyto looks like and contents of the pack 
 
1 mg strength 
 
Slenyto 1 mg prolonged-release tablets are pink, film coated, round, biconvex, 3 mm diameter tablets. 
 
Available in blister packs of 30 / 60 tablets. 
 
5 mg strength 
 
Slenyto 5 mg prolonged-release tablets are yellow, film coated, round, biconvex, 3 mm diameter 
tablets. 
 
Available in blister packs of 30 tablets. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
 
RAD Neurim Pharmaceuticals EEC SARL 
4 rue de Marivaux 
75002 Paris 
France  
e-mail: regulatory@neurim.com 
 
Manufacturer 
 
Iberfar - Indústria Farmacêutica, S.A. 
Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo 
Barcarena 
2734-501 
Portugal 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 



29 

België/Belgique/Belgien 
RAD Neurim Pharmaceuticals EEC SARL 
Tél/Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Lietuva 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

България 
RAD Neurim Pharmaceuticals EEC SARL 
Teл.: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Luxembourg/Luxemburg 
RAD Neurim Pharmaceuticals EEC SARL 
Tél/Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Česká republika 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 

Magyarország 
RAD Neurim Pharmaceuticals EEC SARL 
Tel.: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Danmark 
Takeda Pharma A/S 
Tlf: +45 46 77 11 11 
 

Malta 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Deutschland 
INFECTOPHARM Arzneimittel und Consilium 
GmbH 
Tel: +49 6252 957000 
e-mail: kontakt@infectopharm.com 
 

Nederland 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Eesti 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Norge 
Takeda AS 
Tlf: +47 6676 3030 
e-mail: infonorge@takeda.com 
 

Ελλάδα 
RAD Neurim Pharmaceuticals EEC SARL 
Τηλ: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Österreich 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

España 
EXELTIS HEALTHCARE, S.L. 
Tel: +34 91 7711500 
e-mail: comunicación@exeltis.com 
 

Polska 
RAD Neurim Pharmaceuticals EEC SARL  
Tel.: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

France 
BIOCODEX 
Tél: +33 (0)1 41 24 30 00 
e-mail: medinfo@biocodex.com 
 

Portugal 
RAD Neurim Pharmaceuticals EEC SARL  
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Hrvatska 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

România 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Ireland 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Slovenija 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 



30 

Ísland 
RAD Neurim Pharmaceuticals EEC SARL  
Sími: +33 185149776 (FR) 
Netfang: neurim@neurim.com 
 

Slovenská republika 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Italia 
Fidia Farmaceutici S.p.A. 
Tel: +39 049 8232355 
e-mail: info@fidiapharma.it 
 

Suomi/Finland 
Biocodex Oy  
Puh/Tel: +3589 329 59100 
e-mail: info@biocodex.fi  
 

Κύπρος 
RAD Neurim Pharmaceuticals EEC SARL 
Τηλ: +33 185149776 (FR) 
e-mail: neurim@neurim.com 
 

Sverige 
Takeda Pharma AB 
Tel: +46 8 731 28 00 
e-mail: infosweden@takeda.com 
 

Latvija 
RAD Neurim Pharmaceuticals EEC SARL 
Tel: +33 185149776 (FR) 
e-mail: neurim@neurim.com 

United Kingdom 
Flynn Pharma Limited 
Tel: +44 (0) 1438 727822 
e-mail: medinfo@flynnpharma.com 

 
 
This leaflet was last revised in { month/YYYY}. 
 
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