SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

1 SUMMARY OF PRODUCT CHARACTERISTICS

2 1. NAME OF THE MEDICINAL PRODUCT

Frovatriptan Mylan 2.5 mg Film-coated Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 2.5 mg frovatriptan as frovatriptan succinate monohydrate.

Excipient with known effect: Each film-coated tablet contains 107.09 mg lactose.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet.

White to off white, film-coated, round, biconvex tablet debossed with “M” on one side of the tablet “FR” over “2.5” on the other side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

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

Frovatriptan is indicated in adults.

4.2 Posology and method of administration

Posology Frovatriptan should be taken as early as possible after the onset of a migraine attack but it is also effective when taken at a later stage. Frovatriptan should not be used prophylactically. If a patient does not respond to the first dose of frovatriptan, a second dose should not be taken for the same attack, since no benefit has been shown. Frovatriptan may be used for subsequent migraine attacks.

Adults (18 to 65 years of age) The recommended dose of frovatriptan is 2.5 mg. If the migraine recurs after initial relief, a second dose may be taken, providing there is an interval of at least 2 hours between the two doses. The total daily dose should not exceed 5 mg per day.

Paediatric population (under 18 years) The safety and efficacy of frovatriptan in children and adolescents below the age of 18 years have not been established. Therefore, its use in this age group is not recommended. No data are available.

Older people (over 65 years) Frovatriptan data in patients over 65 years remain limited. Therefore, its use in this category of patients is not recommended.

Renal impairment No dosage adjustment is required in patients with renal impairment (see section 5.2).

Hepatic impairment

3 No dosage adjustment is required in patients with mild to moderate hepatic impairment (see section 5.2). Frovatriptan is contraindicated in patients with severe hepatic impairment (see section 4.3).

Method of administration For oral use. The tablets should be swallowed whole with water.

4.3 Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Patients with a history of myocardial infarction, ischaemic heart disease, coronary vasospasm (e.g. Prinzmetal's angina), peripheral vascular disease, patients presenting with symptoms or signs compatible with ischaemic heart disease. - Moderately severe or severe hypertension, uncontrolled mild hypertension. - Previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). - Severe hepatic impairment (Child-Pugh C). - Concomitant administration of frovatriptan with or ergotamine derivatives (including ) or other 5-hydroxytryptamine (5-HT1) receptor .

4.4 Special warnings and precautions for use

Frovatriptan should only be used where a clear diagnosis of migraine has been established.

Frovatriptan is not indicated for the management of hemiplegic, basilar or ophthalmoplegic migraine.

As with other treatments of migraine attack, it is necessary to exclude other, potentially serious, neurological conditions before treating the headache of patients without a previous diagnosis of migraine, or migraine patients presenting with atypical symptoms. It should be noted that migraineurs present an increased risk of certain cerebral vascular events (e.g. CVA or TIA).

The safety and efficacy of frovatriptan administered during the aura phase, before the headache phase of migraine, has not been established.

As with other 5-HT1 receptor agonists, frovatriptan must not be administered to patients at risk of coronary artery disease (CAD), including heavy smokers or users of nicotine substitution therapy without a prior cardiovascular evaluation (see section 4.3). Specific attention should be given to post-menopausal women and men over 40 years of age presenting with these risk factors.

However, cardiac evaluations may not identify every patient who has cardiac disease. In very rare cases serious cardiac events have occurred in patients with no underlying cardiovascular disease when taking 5- HT1 receptor agonists.

Frovatriptan administration can be associated with transient symptoms including chest pain or 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 doses of frovatriptan should be taken and additional investigations should be carried out.

Patients should be informed of the early signs and symptoms of hypersensitivity reactions including cutaneous disorders, angioedema and anaphylaxis (see section 4.8). In case of serious allergic / hypersensitivity reactions, frovatriptan treatment should be discontinued immediately and it should not be administered again.

It is advised to wait 24 hours following the use of frovatriptan before administering an ergotamine-type . At least 24 hours should be elapse after administration of an ergotamine-containing preparation before frovatriptan is given (see sections 4.3 and 4.5).

4 In case of too frequent use (repeated administration several days in a row corresponding to a misuse of the product), the active substance can accumulate leading to an increase of the side-effects.

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

Do not exceed the recommended dose of frovatriptan.

Undesirable effects may be more common during concomitant use of (5HT agonists) and herbal preparations containing St John's wort (Hypericum perforatum).

Frovatriptan Mylan contains lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use contraindicated Ergotamine and ergotamine derivatives (including methysergide) and other 5-HT1 agonists Risks of hypertension and coronary artery constriction due to additive vasospastic effects when used concomitantly for the same migraine attack (see section 4.3).

Effects can be additive. It is recommended to wait at least 24 hours after administration of ergotamine-type medication before administering frovatriptan. Conversely it is recommended to wait 24 hours after frovatriptan administration before administering an ergotamine-type medication (see section 4.4).

Concomitant use not recommended Monoamine oxidase inhibitors Frovatriptan is not a substrate for MAO-A, however a potential risk of syndrome or hypertension cannot be excluded (see section 5.2).

Concomitant use requiring caution Selective serotonin-reuptake inhibitors (citalopram, , fluvoxamine, paroxetine, sertraline) Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.

Methylergometrine Risks of hypertension, coronary artery constriction.

Fluvoxamine Fluvoxamine is a potent inhibitor of cytochrome CYP1A2 and has been shown to increase the blood levels of frovatriptan by 27-49%.

Oral contraceptives In female subjects taking oral contraceptives, concentrations of frovatriptan were 30% higher than in females not taking oral contraceptives. No increased incidence in the adverse event profile was reported.

Hypericum perforatum (St. John’s wort) (oral route) As with other triptans the risk of the occurrence of serotonin syndrome may be increased.

4.6 Fertility, pregnancy and lactation

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

5 Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Frovatriptan should not recommended during pregnancy and in women of child bearing potential not using contraception unless clearly necessary.

Breast-feeding Frovatriptan and/or its metabolites are excreted in the milk of lactating rats with the maximum concentration in milk being four-fold higher than maximum blood levels. A risk to the breast-feeding newborns/infants cannot be excluded.

Although it is not known whether frovatriptan or its metabolites are excreted in human breast milk, the administration of frovatriptan to women who are breast-feeding is not recommended, unless is clearly needed. In this case, a 24 hours interval must be observed.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Migraine or treatment with frovatriptan may cause somnolence. Patients should be advised to evaluate their ability to perform complex tasks such as driving during migraine attacks and following administration of frovatriptan.

4.8 Undesirable effects

Frovatriptan has been administered to over 2,700 patients at the recommended dose of 2.5 mg and the most common side effects (<10%) include dizziness, fatigue, paraesthesia, headache and vascular flushing. The undesirable effects reported in clinical trials with frovatriptan were transient, generally mild to moderate and resolved spontaneously. Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.

The table below shows all the adverse reactions that are considered to be related to treatment with 2.5 mg frovatriptan and showed a greater incidence than with placebo in the 4 placebo controlled trials. They are listed in decreasing incidence by body-system. Adverse reactions collected in the post-marketing experience are noted with an asterisk *.

Common Uncommon Rare Not known System organ  1/100 to < 1/10  1/1,000 to <  1/10,000 to < (cannot be class 1/100 1/1,000 estimated from the available data) Blood and Lymphadenopathy lymphatic system disorders Immune system Hypersensitivity disorders reactions* (including cutaneous disorders, angioedema and anaphylaxis) Metabolism and Dehydration Hypoglycaemia nutrition disorders Psychiatric Anxiety, Abnormal dreams, disorders insomnia, personality confusional state, disorder nervousness,

6 agitation, depression, depersonalisation Nervous system Dizziness, Dysgeusia, Amnesia, disorders paraesthesia, tremor, Hypertonia, headache, disturbance in Hypotonia, somnolence, attention, hyporeflexia, dysaesthesia, lethargy, movement disorder hypoaesthesia hyperaesthesia, sedation, vertigo, involuntary muscle contractions Eye disorders Visual Eye pain, eye Night blindness disturbance irritation, photophobia Ear and Tinnitus, ear pain Ear discomfort, ear labyrinth disorder, ear disorders pruritus, hyperacusis Cardiac Palpitations, Bradycardia Myocardial disorders tachycardia infarction*, arteriospasm coronary* Vascular Flushing Peripheral disorders coldness, Hypertension Respiratory, Throat tightness Rhinitis, Epistaxis, hiccups, thoracic and sinusitis, hyperventilation, mediastinal pharyngolarynge respiratory disorders al pain disorder, throat irritation Gastrointestinal Nausea, dry- Diarrhoea, Constipation, disorders mouth, dysphagia, eructation, gastro- dyspepsia, flatulence, oesophageal reflux abdominal pain stomach disease, irritable discomfort, bowel syndrome, abdominal lip blister, lip pain, distension oesophageal spasm, oral mucosal blistering, peptic ulcer, salivary gland pain, stomatitis, toothache Skin and Hyperhidrosis Pruritus Erythema, subcutaneous piloerection, tissue disorders purpura, urticaria Musculoskeletal Musculoskeletal and connective stiffness, tissue disorders musculoskeletal

7 pain, pain in extremity, back pain, arthralgia Renal and Pollakiuria, Nocturia, renal urinary polyuria pain disorders Reproductive Breast tenderness system and breast disorders General Fatigue, chest Chest pain, Pyrexia disorders and discomfort feeling hot, administration temperature site conditions intolerance, pain, asthenia, thirst, sluggishness, energy increased, malaise Investigations Blood bilirubin increased, blood calcium decreased, urine analysis abnormal Injury, Bite poisoning and procedural complications

In two open long-term clinical studies the observed effects were not different from those listed above.

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 [to be completed nationally].

4.9 Overdose

Symptoms There is limited data on overdose with frovatriptan tablets. The maximum single oral dose of frovatriptan given to male and female patients with migraine was 40 mg (16 times the recommended clinical dose of 2.5 mg) and the maximum single dose given to healthy male subjects was 100 mg (40 times the recommended clinical dose). Both were not associated with side effects other than those mentioned in section 4.8. However, one post-marketing serious case of coronary vasospasm has been reported, following intake of 4 times the recommended dose of frovatriptan on three consecutive days, in a patient taking migraine prophylactic treatment with a tricyclic . The patient recovered.

Treatment There is no specific antidote for frovatriptan. The elimination half-life of frovatriptan is approximately 26 hours (see section 5.2). The effects of haemodialysis or peritoneal dialysis on serum concentrations of frovatriptan are unknown.

In case of overdose with frovatriptan, the patient should be monitored closely for at least 48 hours and be given any necessary supportive therapy.

8 5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics, antimigraine preparations, selective serotonin (5HT1) agonists, ATC code: N02CC07.

Frovatriptan is a selective for 5-HT receptors, which shows high affinity for 5-HT1B and 5-HT1D binding sites in radioligand assays and exhibits potent agonist effects at 5-HT1B and 5-HT1D receptors in functional bioassays. It exhibits marked selectivity for 5-HT1B/1D receptors and has no significant affinity for 5-HT2, 5-HT3, 5-HT4, 5-HT6, α-adrenoreceptors, or histamine receptors. Frovatriptan has no significant affinity for benzodiazepine binding sites.

Frovatriptan is believed to act selectively on extracerebral, intracranial arteries to inhibit the excessive dilatation of these vessels in migraine. At clinically relevant concentrations, frovatriptan produced constriction of human isolated cerebral arteries with little or no effect on isolated human coronary arteries.

The clinical efficacy of frovatriptan for treatment of migraine headache and accompanying symptoms was investigated in three multicenter placebo controlled studies. In these studies frovatriptan 2.5 mg was consistently superior to placebo in terms of headache response at 2 and 4 hours post-dosing and time to first response. Pain relief (reduction from moderate-or severe headache to no or mild pain) after 2 hours was 37- 46% for frovatriptan and 21-27% for placebo.

Complete pain relief after 2 hours was 9-14% for frovatriptan and 2-3% for placebo. Maximum efficacy with frovatriptan is reached in 4 hours.

In a clinical study comparing frovatriptan 2.5 mg with 100 mg, the efficacy of frovatriptan 2.5 mg was slightly lower than that of sumatriptan 100 mg at 2 hours and 4 hours. The frequency of undesirable events was slightly lower with frovatriptan 2.5 mg compared to sumatriptan 100 mg. No study comparing frovatriptan 2.5 mg and sumatriptan 50 mg has been carried out.

In elderly subjects in good health, transient changes in systolic arterial pressure (within normal limits) have been observed in some subjects, following a single oral dose of frovatriptan 2.5 mg.

5.2 Pharmacokinetic properties

Absorption After administration of a single oral 2.5 mg dose to healthy subjects, the mean maximum blood concentration of frovatriptan (Cmax), reached between 2 and 4 hours, was 4.2 ng/ml in males and 7.0 ng/ml in females. The mean area under the curve (AUC) was 42.9 and 94.0 ng.h/ml for males and females respectively.

The oral was 22% in males and 30% in females. The of frovatriptan were similar between healthy subjects and migraine patients and there was no difference in pharmacokinetic parameters in the patients during a migraine attack or between attacks.

Frovatriptan displayed generally linear pharmacokinetics over the dose range used in clinical studies (1 mg to 40 mg).

Food had no significant effect on the bioavailability of frovatriptan, but delayed tmax slightly by approximately 1 hour.

Distribution The steady state volume of distribution of frovatriptan following intravenous administration of 0.8 mg was 4.2 L/kg in males and 3.0 L/kg in females.

9 Binding of frovatriptan to serum proteins was low (approximately 15%). Reversible binding to blood cells at steady state was approximately 60% with no difference between males and females. The blood: plasma ratio was about 2:1 at equilibrium.

Biotransformation Following oral administration of radiolabelled frovatriptan 2.5 mg to healthy male subjects, 32% of the dose was recovered in urine and 62% in faeces. Radiolabelled compounds excreted in urine were unchanged frovatriptan, hydroxy frovatriptan, N-acetyl desmethyl frovatriptan, hydroxy N-acetyl desmethyl frovatriptan, and desmethyl frovatriptan, together with several other minor metabolites. Desmethyl frovatriptan had about 3-fold lower affinity at 5-HT1 receptors than the parent compound. N-acetyl desmethyl frovatriptan had negligible affinity at 5-HT1 receptors. The activity of other metabolites has not been studied.

The results of in vitro studies have provided strong evidence that CYP1A2 is the cytochrome P450 isoenzyme primarily involved in the metabolism of frovatriptan. Frovatriptan does not inhibit or induce CYP1A2 in vitro.

Frovatriptan is not an inhibitor of human monoamine oxidase (MAO) enzymes or cytochrome P450 isozymes and therefore has little potential for drug-drug interactions (see section 4.5). Frovatriptan is not a substrate for MAO.

Elimination The elimination of frovatriptan is biphasic with a distribution phase prevailing between 2 and 6 hours. Mean systemic clearance was 216 and 132 ml/min in males and females, respectively. Renal clearance accounted for 38% (82 ml/min) and 49% (65 ml/min) of total clearance in males and females, respectively. The terminal elimination half-life is approximately 26 hours, irrespective of the sex of the subjects, however the terminal elimination phase only becomes dominant after about 12 hours.

Gender AUC and Cmax values for frovatriptan are lower (by approximately 50%) in males than in females. This is due, at least in part, to the concomitant use of oral contraceptives. Based on the efficacy or safety of the 2.5 mg dose in clinical use, dosage adjustment with respect to gender is not necessary (see section 4.2).

Older people In healthy elderly subjects (65 to 77 years) AUC is increased by 73% in males and by 22% in females, compared to younger subjects (18 to 37 years). There was no difference in tmax or t1/2 between the two populations (see section 4.2).

Renal impairment Systemic exposure to frovatriptan and its t1/2 were not significantly different in male and female subjects with renal impairment (creatinine clearance 16 - 73 ml/min), compared to that in healthy subjects.

Hepatic impairment Following oral administration in male and female subjects aged 44 to 57, with mild or moderate hepatic impairment (Child-Pugh grades A and B), mean blood concentrations of frovatriptan were within the range observed in healthy young and elderly subjects. There is no pharmacokinetic or clinical experience with frovatriptan in subjects with severe hepatic impairment (see section 4.3).

5.3 Preclinical safety data

During toxicity studies after single or repeated administration, preclinical effects were only observed at exposure levels in excess of the maximum exposure level in man.

Standard genotoxicity studies did not reveal a clinically relevant genotoxic potential of frovatriptan.

Frovatriptan was foetotoxic in rats, but in rabbits foetotoxicity was observed only at maternally toxic dose levels.

10 Frovatriptan was not potentially carcinogenic in standard rodent carcinogenicity studies and in p53 (+/-) mouse studies at exposures considerably higher than anticipated in humans.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core: Lactose, anhydrous Cellulose, microcrystalline Sodium starch glycolate (Type A) Magnesium stearate Silica, colloidal anhydrous

Film-coating: Hypromellose Titanium dioxide (E171) Macrogol 8000 Macrogol 400

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

OPA/Alu/PVC – aluminium blisters in pack sizes of 2, 6 and 12 film-coated tablets.

OPA/Alu/PVC – aluminium perforated unit dose blisters in pack sizes of 2 x 1, 6 x 1, 12 x 1 film-coated tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7. MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

11 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed nationally]

10. DATE OF REVISION OF THE TEXT

[To be completed nationally]

12 LABELLING

13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARDBOARD CARTON (FOR BLISTER STRIPS)

1. NAME OF THE MEDICINAL PRODUCT

Frovatriptan Mylan 2.5 mg Film-coated Tablets frovatriptan

2. STATEMENT OF ACTIVE SUBSTANCE

Each film-coated tablet contains 2.5 mg frovatriptan as frovatriptan succinate monohydrate.

3. LIST OF EXCIPIENTS

Also contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

2 film-coated tablets 6 film-coated tablets 12 film-coated tablets 2 x 1 film-coated tablets 6 x 1 film-coated tablets 12 x 1 film-coated tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For 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:

14 9. SPECIAL STORAGE CONDITIONS

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

[To be completed nationally]

12. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

13. BATCH NUMBER

Batch/Lot.:

14. GENERAL CLASSIFICATION FOR SUPPLY

[To be completed nationally]

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Frovatriptan Mylan 2.5 mg Film-coated Tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: SN: NN:

15 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Frovatriptan Mylan 2.5 mg Film-coated Tablets frovatriptan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

[To be completed nationally]

3. EXPIRY DATE

EXP: MMM YYYY

4. BATCH NUMBER

Batch/Lot.:

5. OTHER

16 PACKAGE LEAFLET

17 Package leaflet: Information for the patient

Frovatriptan Mylan 2.5 mg Film-coated Tablets

frovatriptan

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 signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What Frovatriptan Mylan is and what it is used for

Frovatriptan Mylan contains the active ingredient frovatriptan which belongs to a group of medicines called triptans.

Frovatriptan Mylan is used to treat migraine headache in adults.

 Migraine symptoms may be caused by the widening of blood vessels in the head. Frovatriptan Mylan is thought to reduce 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.  Frovatriptan Mylan works only when a migraine headache has started. You should not take Frovatriptan Mylan to prevent occuring.

2. What you need to know before you take Frovatriptan Mylan

Do not take Frovatriptan Mylan: - if you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6). - if you have moderately high or very high blood pressure or mild high blood pressure that is not being treated. - if you have or have had heart disease, a heart attack, angina (chest pain as a result of lack of oxygen in the heart muscle) or other signs of coronary heart disease such as breathlessness, extreme tiredness or ankle swelling. - if you have peripheral vascular disease (narrowing of the vessels that carry blood to the legs and arms). - if you have had a stroke or if you have had the symptoms of a stroke, which only lasted a short time and from which you made a complete recovery (transient ischaemic attack). - if you are taking medicines containing ergotamine or medicines similar to ergotamine to treat migraine (including methysergide) or other triptans (see “Other medicines and Frovatriptan Mylan” for further information). - if you have severe problems with your liver.

18 Warnings and precautions Talk to your doctor or pharmacist before taking Frovatriptan Mylan if:

- you are at a higher risk of heart disease for example if you are a heavy smoker or you use nicotine replacement therapy. Your doctor should make additional checks especially if you are a woman after menopause or a man older than 40 years old. - you have unusual forms of migraine caused by brain or eye problems. - you are taking herbal medicines containing St John’s wort (side effects may be more frequent).

During treatment

If you get a serious allergic reaction when taking Frovatriptan Mylan such as flushing of the skin, nettle rash, swelling of the mouth, lips, tongue or throat causing difficulty breathing or swallowing, feeling sick (nausea) or being sick (vomiting), collapse or unconsciousness stop taking this medicine and contact your doctor or go immediately to the nearest hospital emergency department (see section 4 ‘Possible side effects’).

When taking Frovatriptan Mylan, you may notice pain or a feeling of tightness in your chest and throat. If these symptoms do not pass quickly, stop taking frovatriptan and tell your doctor immediately.

If you have frequent or daily headaches while taking this medicine, stop taking Frovatriptan Mylan and contact your doctor. Using painkillers to treat headaches for longer than normal can make the headaches worse.

Children and adolescents Frovatriptan Mylan should not be given to children and adolescents under the age of 18 as it is not known how this medicine may affect them.

Other medicines and Frovatriptan Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, inform your doctor if you are taking:

- Triptans other than frovatriptan (such as sumatriptan, , , , or ). Do not take these medicines at the same time as Frovatriptan Mylan. After taking Frovatriptan Mylan leave 24 hours before taking other triptans as this may result in high blood pressure, narrowing of the blood vessels of the heart or serotonin syndrome, a potentially life threatening drug reaction (see section 4 ‘Possible side effects’). - Ergotamine or medicines similar to ergotamine (used to treat migraines including methysergide and ). Do not take these medicines at the same time as Frovatriptan Mylan as this may also result in high blood pressure, narrowing of the veins of the heart or serotonin syndrome. Wait at least 24 hours after taking Frovatriptan Mylan before taking these medicines or similarly, wait at least 24 hours after taking these medicines before taking Frovatriptan Mylan. - Medicines for depression called selective serotonin re-uptake inhibitors (SSRIs) such as fluoxetine, citalopram, fluvoxamine, paroxetine or sertraline as this may result in high blood pressure, narrowing of the blood vessels of the heart or serotonin syndrome. - St John’s wort (Hypericum perforatum), a herbal remedy used to treat depression as this may result in serotonin syndrome. - Medicines used to treat depression called monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, isacarboxazid, tranylcypromine as these may cause high blood pressure or serotonin syndrome. - Oral contraceptives as these may increase the amount of frovatriptan in your body.

Pregnancy and breast-feeding Pregnancy Frovatriptan Mylan is not recommended in pregnant women and in women of child bearing age who do not use contraception unless clearly necessary as it is not known if it is safe to use.

19 Breast-feeding Frovatriptan may be present in breast milk. Breast-feeding is not recommended unless necessary, in which case avoid breast-feeding for 24 hours after taking Frovatriptan Mylan.

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.

Driving and using machines This medicine and the migraine itself may make you feel drowsy. Do not drive or operate machinery if you feel drowsy, are affected by a migraine attack or after taking Frovatriptan Mylan.

Frovatriptan Mylan contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Frovatriptan Mylan

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

The recommended dose is 2.5 mg to treat a migraine attack. Take this medicine as soon as possible after you start to get a headache. Do not take this medicine before you start to have a headache.

If the symptoms of migraine return within 24 hours, you may take a second dose of Frovatriptan Mylan. The second dose should not be taken within 2 hours of your first dose.

You should not take more than 2 doses of Frovatriptan Mylan a day. The maximum daily dose is 5 mg Frovatriptan Mylan in 24 hours.

The tablets should be swallowed whole and with water. You can take this medicine with or without food as it does not affect the way the medicines works.

Use in older patients (over 65 years) The use of Frovatriptan Mylan is not recommended.

Patients with liver problems Do not take Frovatriptan Mylan if you have serious liver problems (see section 2 ‘Do not take Frovatriptan Mylan’).

If you take more Frovatriptan Mylan than you should Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you.

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.

Contact your doctor immediately or go to your nearest hospital emergency department if you get the following:

Rare (may affect up to 1 in 1,000 people):  Burning stomach pain, usually immediately or 1 to 2 hours after eating. This may be a sign of an ulcer in the stomach or upper part of the small intestine.

20 Not known (frequency cannot be estimated from the available data):  Serious allergic reactions such as flushing of the skin, nettle rash, swelling of the mouth, lips, tongue or throat causing difficulty breathing or swallowing, feeling sick (nausea) or being sick (vomiting), collapse or unconsciousness.  Sudden chest pain that may spread to the neck or arms with a clammy feeling or a shortness of breath. These may be signs of a heart attack (myocardial infarction).  A pressing, tight or heavy sensation on your chest with chest pain that lasts for a short period of time. These may be signs of a temporary narrowing of the blood vessels of the heart (coronary artery spasm)

Other possible side effects include:

Common (may affect up to 1 in 10 people):  Dizziness, headache, abnormal or lack of feeling when touching, tingling, pins and needles in the fingers or toes, sleepiness  Warm sensation (flushing)  Problems with your sight  Increased sweating  Stomach pain, feeling sick (nausea), indigestion, dry mouth  Tiredness, chest discomfort, tightness in the throat

Uncommon (may affect up to 1 in 100 people)  Change in sense of taste, trembling, poor concentration, lethargy, increased sensitivity to touching, twitching muscles  Diarrhoea, difficulty in swallowing, wind, stomach upset, bloated stomach  Fast heartbeat that feels like a thumping in your chest (palpitations), increased heart beat, chest pain  Coldness in feet and hands  Feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, general feeling of being unwell  Foggy head or feeling lightheaded with a sensation of spinning when sitting or standing (vertigo)  Anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity  Runny or stuffy nose, possibly with pain or tenderness in the face, sore throat  Muscle or joint stiffness, muscle or joint pain, pain in the hands and feet, back pain  Pain in the eye, eye irritation, painful oversensitivity to light  Itchiness  Ringing in the ears, earache  Dehydration  Passing abnormally large amounts of urine; urinating more frequently  Increase in blood pressure

Rare side effects (may affect up to 1 in 1,000 people)  An increase or decrease in muscle tone, delay in reflexes, movement problems  Constipation, belching, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the food pipe, blisters in the mouth, pain in the salivary gland, redness, irritation or swelling of the mouth, toothache  Fever  Loss of memory, abnormal dreams, changes to your personality  Nosebleed, hiccups, very quick shallow breathing (hyperventilation), other breathing problems sore throat  Night blindness  Skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives  Slow heart beat

21  Ear discomfort, earache, ear itchiness, sensitive hearing  Increase in bilirubin (a substance produced in the liver) in the blood or a decrease of calcium in the blood which can be seen in a blood test, abnormal urine test results  Low sugar in the blood  Passing urine frequently at night, pain in the kidneys  Self inflicted injury (bite)  Swollen lymph nodes  Breast tenderness

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Frovatriptan Mylan

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 after ‘EXP’. The expiry date refers to the last day of that month.

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 Frovatriptan Mylan contains

Each film-coated tablet contains 2.5 mg of frovatriptan as frovatriptan succinate. The other ingredients are: - Tablet core: anhydrous lactose (see section 2 ‘Frovatriptan Mylan contains lactose’), microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate and colloidal anhydrous silica - Film-coating: hypromellose, titanium dioxide (E171) and macrogol 8000, macrogol 400.

What Frovatriptan Mylan looks like and contents of the pack

The tablets are white to off white, film-coated, round tablet with two sides that curve out marked with “M” on one side of the tablet and “FR” over “2.5” on the other side.

Frovatriptan Mylan is available in blister packs containing 2, 6 and 12 film-coated tablets and in perforated blister packs containing 2 x 1, 6 x 1 and 12 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK. Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary.

22 This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark: Frovatriptan Mylan France: Frovatriptan Mylan 2,5 mg, comprimé pelliculé Italy: Frovatriptan Mylan 2.5 mg compressa rivestita con film United Kingdom: Mylatrip 2.5 mg Film-coated Tablets

This leaflet was last revised in

[To be completed nationally]

23