SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

[Invented name] 12.5 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains almotriptan 12.5 mg (as almotriptan malate 17.5 mg). For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet. Description: white to off-white, round, biconvex film-coated tablets, diameter of tablets max.6.2 mm.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Acute treatment of the headache phase of attacks with or without aura.

4.2 Posology and method of administration

Almotriptan should be taken with liquids as early as possible after the onset of migraine- associated headache but it is also effective when taken at a later stage.

Almotriptan should not be used for migraine prophylaxis.

The tablets can be taken with or without food.

Adults (18-65 years of age) The recommended dose is one tablet containing 12.5 mg of almotriptan. A second dose may be taken if the symptoms reappear within 24 hours. This second dose may be taken provided that there is a minimum interval of two hours between the two doses.

The efficacy of a second dose for the treatment of the same attack when an initial dose is ineffective has not been examined in controlled trials. Therefore if a patient does not respond to the first dose, a second dose should not be taken for the same attack.

The maximum recommended dose is two doses in 24 hours.

Children and adolescents (under 18 years of age) There are no data concerning the use of almotriptan in children and adolescents, therefore its use in this age group is not recommended.

Elderly (over 65 years of age) No dosage adjustment is required in the elderly. The safety and effectiveness of almotriptan in patients older than 65 years has not been systematically evaluated.

Renal Impairment Dosage adjustment is not required in patients with mild or moderate renal impairment. Patients with severe renal impairment should take no more than one 12.5 mg tablet in a 24 hour period.

Hepatic Impairment There are no data concerning the use of almotriptan in patients with hepatic impairment (see section 4.3 and 4.4).

4.3 Contraindications

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  As with other 5-HT1B/1D receptor agonists, almotriptan should not be used in patients with a history, symptoms or signs of o ischaemic heart disease (myocardial infarction, angina pectoris, documented silent ischaemia, Prinzmetal's angina) or o severe and uncontrolled mild or moderate hypertension.  Patients with a previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). Peripheral vascular disease.  Concomitant administration with , ergotamine derivatives (including ) and other 5-HT1B/1D agonists is contraindicated.  Patients with severe hepatic impairment (see section 4.2).

4.4 Special warnings and precautions for use

Almotriptan should only be used where there is a clear diagnosis of migraine. It should not be used to treat basilar, hemiplegic or ophthalmoplegic migraine.

As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraine sufferers and in migraine sufferers who present atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. Cerebrovascular accidents have been reported in patients treated with 5-HT1B/1D agonists. It should be noted that migraineurs may be at increased risk of certain cerebrovascular events (e.g. cerebrovascular accident, transient ischemic attack).

In very rare cases, as with other 5-HT1B/1D receptor agonists, coronary vasospasm and myocardial infarction have been reported. Therefore almotriptan should not be administered to patients who could have an undiagnosed coronary condition without prior evaluation of potential underlying cardiovascular disease. Such patients include postmenopausal women, males over 40 and patients with other risk factors for coronary disease such as uncontrolled hypertension, hypercholesterolaemia, obesity, diabetes, smoking or a clear family history of cardiovascular disease. These evaluations however, may not identify every patient who has cardiac disease and in very rare case, serious cardiac events have occurred in patients without underlying cardiovascular disease when 5-HT1 agonists have been administered.

Following administration, almotriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat (see section 4.8). Where such symptoms are thought to indicate ischaemic heart disease, no further dose should be taken and appropriate evaluation should be carried out.

Caution should be exercised when prescribing almotriptan to patients with known hypersensitivity to sulphonamides.

It is advised to wait at least 6 hours following use of almotriptan before administering ergotamine. At least 24 hours should elapse after the administration of an ergotamine- containing preparation before almotriptan is given. Although additive vasospastic effects were not observed in a in which 12 healthy subjects received oral almotriptan and ergotamine, such additive effects are theoretically possible (see section 4.3).

Patients with severe renal impairment should not take more than one 12.5 mg tablet in a 24 hour period.

Caution is recommended in patients with mild to moderate hepatic disease and treatment is contraindicated in patients with severe hepatic disease (see section 5.2).

Undesirable effects may be more common during concomitant use of and herbal preparations containing St John's Wort (Hypericum perforatum).

As with other 5-HT1B/1D receptor agonists, almotriptan may cause mild, transient increases in blood pressure, which may be more pronounced in the elderly.

Medication overuse headache (MOH) Prolonged use of any painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache .

The maximum recommended dose of almotriptan should not be exceeded.

4.5 Interaction with other medicinal products and other forms of interaction

Interaction studies were performed with inhibitors, beta-blockers, selective re-uptake inhibitors, calcium channel blockers or inhibitors of Cytochrome P450 isoenzymes 3A4 and 2D6. There are no in vivo interaction studies assessing the effect of almotriptan on other drugs.

As with other 5-HT1 agonists, the potential risk of a serotoninergic syndrome due to a pharmacodynamic interaction in case of concomitant treatment with MAOIs cannot be ruled out.

As with other 5-HT1 agonists the potential risk of a serotoninergic syndrome due to a pharmacodynamic interaction in case of concomitant treatment with selective serotonin reuptake inhibitors (SSRI) or serotonine noradrenaline reuptake inhibitors (SNRI) cannot be ruled out.

Multiple dosing with the , a substrate of CYP3A4, resulted in a 20% increase in Cmax and AUC of almotriptan. The increase is not considered clinically relevant. No clinically significant interactions were observed.

Multiple dosing with did not alter the of almotriptan. No clinically significant interactions were observed.

In vitro studies performed to evaluate the ability of almotriptan to inhibit the major CYP enzymes in human microsomes and human monoamine oxidase (MAO) showed that almotriptan would not be expected to alter the metabolism of drugs metabolised by CYP or MAO-A and MAO-B enzymes.

4.6 Fertility, pregnancy and lactation

Pregnancy For almotriptan, very limited data on pregnant patients are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing almotriptan to pregnant women.

Lactation There are no data regarding excretion of almotriptan in human milk. Studies in rats have shown that almotriptan and/or its metabolites are excreted in milk. Caution should therefore be exercised when prescribing during lactation. Infant exposure may be minimised by avoiding breast feeding for 24 hours after treatment.

4.7 Effects on ability to drive and use machines

There are no studies on the effect of almotriptan on the ability to drive or operate machinery. However, since somnolence may occur during a migraine attack and has been reported as a side effect of treatment with almotriptan, caution is recommended in patients performing skilled tasks.

4.8 Undesirable effects

Almotriptan was evaluated in over 2700 patients for up to one year in clinical trials. The most common adverse reactions at the therapeutic dose were dizziness, somnolence, , vomiting and fatigue. None of the adverse reactions had an incidence superior to 1.5%. The following adverse reactions have been evaluated in clinical studies and/or reported in post- marketing experience. They have been listed by System Organ Class (SOC) and in descending order of frequency. Frequencies are defined as: very common (>1/10), common (1/100 to <1/10), uncommon (1/1000 to <1/100), rare (1/10000 to <1/1000), very rare (<1/10000) including isolated reports, and not known (cannot be estimated from the available data).

MedDRA system organ class Frequency Undesirable effect Nervous system disorders Common dizziness, somnolence Uncommon paraesthesia, headache Not known seizures Ear and labyrinth disorders Uncommon tinnitus Cardiac disorders Uncommon palpitations Very rare coronary vasospasm, myocardial infarction, and tachycardia Respiratory, thoracic and mediastinal Uncommon throat tightness disorders Gastrointestinal disorders Common nausea, vomiting Uncommon diarrhoea, dyspepsia, dry mouth Musculoskeletal and connective tissue Uncommon myalgia, bone pain disorders General disorders and administration Common fatigue site conditions Uncommon chest pain, asthenia

4.9 Overdose

No case of overdose has been reported.

The most frequently reported adverse event in patients receiving 150 mg (the highest dose administered to patients) was somnolence.

Overdose should be treated symptomatically and vital functions should be maintained. Since the elimination half-life is around 3.5 hours monitoring should continue for at least 12 hours or while symptoms or signs persist.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antimigraine preparations. Selective serotonin (5-HT1) agonists. ATC code: N02CC05.

Mechanism of action Almotriptan is a selective 5-HT1B and 5-HT1D receptor agonist. These receptors mediate of certain cranial vessels, as demonstrated in studies using isolated human tissue preparations. Almotriptan also interacts with the trigeminovascular system, inhibiting extravasation of plasma proteins from dural vessels following trigeminal ganglionic stimulation, which is a feature of neuronic inflammation thatseems to be involved in the physiopathology of migraine. Almotriptan has no significant activity on other 5-HT receptor subtypes and no significant affinity for adrenergic, adenosine, angiotensin, , endothelin or tachykinin binding sites.

Pharmacodynamic effects The efficacy of almotriptan in the acute treatment of migraine attacks was established in four multicentre, placebo-controlled clinical trials including more than 700 patients who were administered 12.5 mg. The decrease in pain began 30 minutes after administration, and the percentage of response (reduction of headache from moderate-severe to mild or absent) after 2 hours was 57-70% with almotriptan and 32-42% after placebo. In addition, almotriptan relieved nausea, photophobia and phonophobia associated with migraine attacks.

5.2 Pharmacokinetic properties

Almotriptan is well absorbed, with an oral of about 70%. Maximum plasma concentrations (Cmax) occur approximately between 1.5 and 3.0 hours after administration. The rate and extent of absorption is unaffected by concomitant ingestion of food. In healthy subjects administered single oral doses ranging from 5 mg to 200 mg, Cmax and AUC were proportional to dose, indicating linear pharmacokinetic behaviour. The elimination half-life (t1/2) is about 3.5 h in healthy subjects. There is no evidence of any gender-related effect on the pharmacokinetics of almotriptan.

More than 75% of the dose administered is eliminated in urine, and the remainder in faeces. Approximately, the 50% of the urinary and faecal excretion is unchanged almotriptan.The major biotransformation route is via monoamine oxidase (MAO-A) mediated oxidative deamination to the indole acetic metabolite. Cytochrome P450 (3A4 and 2D6 isozymes) and flavin mono-oxygenase are other enzymes involved in the metabolism of almotriptan. None of the metabolites is significantly active pharmacologically.

After an intravenous dose of almotriptan administered to healthy volunteers the average values for the distribution volume, total clearance and elimination half-life were 195 L, 40 L/h and 3.4 h respectively. Renal clearance (CLR) accounted for about two-thirds of total clearance and renal tubular secretion is probably also involved. The CLR correlates well with renal function in patients with mild (creatinine clearance: 60-90 ml/min), moderate (creatinine clearance: 30-59 ml/min) and severe (creatinine clearance: < 30 ml/min) renal impairment. The increase of the mean t1/2 (up to 7 hours) is statistically and clinically significant in the case of patients with severe renal impairment only. Compared with healthy subjects, the increase in the maximum plasma concentration (Cmax) of almotriptan was 9%, 84% and 72% respectively for patients with slight, moderate and severe renal impairment, whereas the increase in exposure (AUC) was 23%, 80% and 195% respectively. According to these results, the reduction of the total clearance of almotriptan was -20%, -40% and -65% respectively for patients with slight, moderate and severe renal impairment. As expected, total (CL) and renal (CLR) clearances were reduced but without clinical relevance in healthy elderly volunteers compared with a young control group.

Based on the mechanisms of almotriptan clearance in man, approximately 45% of almotriptan elimination appears to be due to hepatic metabolism. Therefore, even if these clearance mechanisms were totally blocked or impaired, plasma almotriptan levels would be increased a maximum of two-fold over the control state, assuming that renal function (and almotriptan renal clearance) are not altered by hepatic impairment. In patients with severe renal impairment, Cmax is increased twofold, and AUC is increased approximately threefold relative to healthy volunteers. Maximal changes in pharmacokinetic parameters in patients with significant hepatic impairment would not exceed these ranges. For this reason, no study of the pharmacokinetics of almotriptan in patients with hepatic impairment was performed.

5.3 Preclinical safety data

In safety pharmacology, repeated dose toxicity and reproduction toxicity studies, adverse effects were observed only at exposures well above the maximum human exposure. Almotriptan did not show any mutagenic activity in a standard battery of in vitro and in vivo genotoxicity studies, and no carcinogenic potential was revealed in studies conducted in mice and rats. As occurs with other 5-HT1B/1D receptor agonists, almotriptan binds to melanin. However, no ocular adverse effects associated with the drug have been observed in dogs after treatment for up to one year.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core: Mannitol (E421) Microcrystalline cellulose Povidone Sodium starch glycolate type A Sodium stearyl fumarate

Coating material: Sepifilm 752 White: Hypromellose Microcrystalline cellulose Polyoxyl 40 stearate Titanium dioxide (E-171)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

This medicinal product doesn´t require any special temperature storage condition. Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Boxes containing PVC/PVDC/aluminium foil blisters Package size: 2, 3, 6, 9, 12 Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Zentiva, k.s., Prague, Czech Republic

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

PARTICULARS TO APPEAR ON THE OUTER PAKAGING

1. NAME OF THE MEDICINAL PRODUCT

[Invented name] 12.5 mg film-coated tablets almotriptan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains almotriptan 12.5 mg as almotriptan malate.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

2, 3, 6, 9, 12 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use Read the package leaflet before use.

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

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

Return unused drug into the pharmacy.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Zentiva, k.s., Prague, Czech Republic

12. MARKETING AUTHORISATION NUMBER(S)

13. MANUFACTURER’S BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE BLISTER

1. NAME OF THE MEDICINAL PRODUCT

[Invented name] 12.5 mg film-coated tablets almotriptan

2. NAME OF THE MARKETING AUTHORISATION HOLDER logo Zentiva

3. EXPIRY DATE

EXP:

4. BATCH NUMBER

Lot:

5. OTHER

PACKAGE LEAFLET: INFORMATION FOR THE USER

[Invented name] 12.5 mg film-coated tablets Almotriptan

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 or pharmacist.  This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet: 1. What [Invented name] is and what it is used for 2. What you need to know before you take [Invented name] 3. How to take [Invented name] 4. Possible side effects 5. How to store [Invented name] 6. Contents of the pack and other information

1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR

[Invented name] contains a active substance called almotriptan. It belongs to the group of antimigraine medicines called triptans (also known as selective serotonin 5 HT1 receptor agonists).

[Invented name] is used to relieve headaches associated with migraine attacks with or without aura.

Migraine symptoms may be caused by temporary widening of blood vessels in the head. [Invented name] reduces the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound.

[Invented name] is used to treat acutual migraine attack. Do not use it to prevent an attack.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [INVENTED NAME]

Do not take [Invented name] if you  are allergic to almotriptan or any of the other ingredients of [Invented name] (listed in section 6)  have or have ever had heart problem including o heart attack o chest pain or discomfort that occurs with activity or stress (angina) or that occurs when you are resting (Prinzmetal angina) o restricted blood supply to the heart without pain o severe high blood pressure or high blood pressure that cannot be stabilized with  have circulatory problem (restricted blood flow in your legs or arms)  have had a or short-lasting symptoms similar to stroke (restricted blood flow to the brain)  are at the same time taking some other medicines for migraine; e.g. ergotamine or ergot-type medicines like and methysergide or other medicines (see section below: 'Other medicines' and [Invented name]).  suffer from severe liver disease

Warnings and precautions Check with your doctor before taking this product if  your type of migraine has not been diagnosed  you are allergic (hypersensitive) to antibacterial medicines mainly used for treatment of urinary tract infections (sulphonamides)  your headache symptoms are different from your usual attacks i.e. you have a noise in your ears or vertigo, you have short lived paralysis of one side of the body or paralysis of the muscles that control eye movement or if you have any new symptoms  you have any of the following risk factors for heart and blood vessel disease: high blood pressure, diabetes, obesity, you smoke or you are using a nicotine substitute, your family has a history of heart disease, you are a man over 40 years of age, or a post-menopausal woman  if you have mild to moderate liver disease  if you suffer from severe kidney disease  if you are over 65 years of age (as you are more likely to experience blood pressure increases)

If you go into hospital tell the medical staff you are taking [Invented name].

Prolonged use of any type of painkiller for headaches can make them worse. Therefore, as with other migraine treatments, using [Invented name] too often this may result in you getting a chronic (constant) headache. Ask your doctor if you think that this is the case for you. You may need to stop taking [Invented name] to correct the problem.

Children and Adolescents Children under the age of 18 should not take [Invented name].

Elderly (over 65 years of age) If you are over 65 years of age you should speak to your doctor before using this medicinal product as you are more likely to experience blood pressure increases.

Other medicines and [Invented name] Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking any of the following medicines:  Medicines for migraine o If you take a triptan other than [Invented name] (such as or ) leave 12 hours before taking [Invented name]. o After taking [Invented name] leave 12 hours before taking another triptan. o If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking [Invented name]. o After taking [Invented name] leave 6 hours before taking ergotamine or ergot-type medicines.  Medicines for depression o Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as ). o Selective serotonin reuptake inhibitors (such as , paroxetine, fluvoxamine or sertraline) or serotonin noradrenaline reuptake inhibitors (such as venlafaxine). o Concomitant use with these medicines may cause serotonin syndrome, a potentially life- threatening drug reaction. The symptoms of serotonin syndrome include; confusion, restlessness, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle twitches or diarrhoea.  herbal preparation containing St John’s Wort (Hypericum perforatum) as this may increase the likelihood of side effects

[Invented name] with food and drink You can take [Invented name] with or without food. It does not affect the way that [Invented name] works.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. [Invented name] should only be used during pregnancy if instructed by your doctor and only after they have carefully considered the benefits and risks. Caution should be taken when using this medicine whilst breast-feeding. You should avoid breast-feeding for 24 hours after taking this medicine.

Driving and using machines During a migraine attack your reactions may be slower than usual. Bear this in mind when you drive or use any tools or machines. [Invented name] is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how [Invented name] affects you before you try these activities.

3. HOW TO TAKE [INVENTED NAME]

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

[Invented name] should only be used to treat an actual migraine attack. Take [Invented name] as soon as possible after your migraine headache has started. You can also take it once an attack is underway. Do not use it to prevent an attack.

How much to take Do not use more than the dose prescribed for you. The maximum daily dose is two (12.5 mg) tablets within 24 hours.

Adults (aged over 18 years and under 65 years) The usual dose is one 12.5 mg tablet.

If your migraine attack does not subside, you should not take more than one tablet for the same attack.

If migraine returns within 24 hours, a second 12.5 mg tablet can be taken but → always wait at least 2 hours between doses. → do not take more than 2 doses of [Invented name] (12.5 mg) tablets within 24 hours.

If the tablets did not give you enough help with your migraine, tell your doctor. Your doctor may change your treatment. If your condition worsens, counsult your doctor.

Special patient groups People aged over 65 years Your dosage can be the same as in adults, but special caution is necessary.

People with liver problems If you have severe liver problems, you shouln´t take this product at all. If you have mild to moderate liver problems, consult your doctor first.

People with kidney problems If you have severe kidney disease do not take more than one 12.5 mg tablet every 24 hours.

Children and adolescents under 18 years of age [Invented name] should not be given to children or adolescents under 18 years of age.

Taking this medicine  Swallow your tablet with a drink of water as soon as possible after your migraine headache has started.  You can take [Invented name] with or without food. It does not affect the way that [Invented name] works.

If you take more [Invented name] than you should If you accidentally take too many tablets, or if someone else or a child takes this medicine, contact your doctor or go to the nearest hospital straight away. Take the medicine pack and any remaining tablets with you so that the doctor knows what has been taken.

If you forget to take [Invented name] Try to take [Invented name] as you have been prescribed. Do not take a double dose to make up for a forgotten tablet.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

 Stop taking the medication and seek the doctor immediately if you experience chest pain, tightness in your chest or throat, or any other symptoms that resembles a heart attack. Please tell your doctor straight away and do not take any more [Invented name] tablets.

In the course of the treatment with active substance of the product following side effects have also been observed Common side effects (1 to 10 users in 100): - dizziness, sleepiness (somnolence), tiredness - nausea, vomiting Uncommon side effects (1 to 10 users in 1,000): - sensation of tingling, pricking or numbness of the skin (paraesthesia) - headache - ringing, roaring or clicking noise in the ears (tinnitus) - heart pounding (palpitations) - tightening of the throat - diarrhoea, discomfort when digesting food (dyspepsia), dry mouth - pain of your muscles, bones or chest - feeling weak (asthenia) Very rare side effects (less than 1 user in 10,000): - spasm of the heart blood vessels (coronary vasospasm) - heart attack (myocardial infarction) - increased heart rate (tachycardia) Frequency unknown (frequency cannot be setimated from the available data): - convulsion (seizure)

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

5. HOW TO STORE [INVENTED NAME]

Keep out of the sight and reach of children. Do not use [Invented name] after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month. This medicinal product doesn´t require any special temperature storage condition. Store in the original package in order to protect from moisture. 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 [Invented name] contains The active substance is almotriptan 12.5 mg (as almotriptan malate). The other ingredients are: Tablet core: Mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate type A, sodium stearyl fumarate Coating material: Sepifilm 752 White [Hypromellose, Microcrystalline cellulose, Polyoxyl 40 stearate, Titanium dioxide (E-171)]

What [Invented name] looks like and contents of the pack [Invented name] are white to off-white, round, biconvex film-coated tablets, diameter of tablets max.6.2 mm. Boxes contain PVC/PVDC/aluminium foil blisters. Pack sizes: 2, 3, 6, 9, 12 Not all pack sizes may be marketed.

Marketing Authorisation Holder Zentiva, k.s., Prague, Czech Republic

Manufacturer Zentiva, a.s., Hlohovec, Slovak Republic

This medicinal product is authorised in the Member States of the EEA under the following names: Almozen in Bulgaria, the Czech Republic, Poland, Romania, the Slovak Republic and Almotriptan Zentiva in Estonia, Latvia, Lithuania.

This leaflet was last revised in