FROVATRIPTAN TEVA

Package leaflet: Information for the user

Frovatriptan Teva 2.5 mg film-coated tablets

frovatriptan
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Frovatriptan Teva 2.5 mg film-coated tablets are and what they are used for
2. What you need to know before taking Frovatriptan Teva 2.5 mg film-coated tablets
3. How to take Frovatriptan Teva 2.5 mg film-coated tablets
4. Possible side effects
5. How to store Frovatriptan Teva 2.5 mg film-coated tablets
6. Contents of the pack and other information

1. What Frovatriptan Teva 2.5 mg film-coated tablets are and what they are used for

Frovatriptan Teva 2.5 mg film-coated tablets contain frovatriptan (as monohydrate succinate), a medication for the treatment of migraine belonging to the class of triptans (selective 5-hydroxytryptamine (5HT₁) receptor agonists).
Frovatriptan Teva 2.5 mg film-coated tablets are a medicinal product for the treatment of migraine, with or without aura (a transient, unusual sensation experienced before a migraine attack, which varies from person to person but may, for example, affect vision, smell, or hearing).
Frovatriptan Teva 2.5 mg film-coated tablets must not be taken to prevent a migraine attack.
Frovatriptan Teva 2.5 mg film-coated tablets are used to treat migraine attacks in adults.

2. What you need to know before taking Frovatriptan Teva 2.5 mg film-coated tablets

Your doctor must have clearly diagnosed you with migraine.

Do not take Frovatriptan Teva 2.5 mg film-coated tablets

• if you are allergic to frovatriptan or to any of the other ingredients of this medicine (listed in section 6);
• if you have had a heart attack or if you have or have previously had a confirmed cardiovascular disease, such as angina pectoris (characterized by a squeezing chest pain that may extend to the left arm) or circulation problems in the legs or arms (especially in the fingers of the hands and feet);
• if you have had a stroke or a transient ischaemic attack (TIA);
• if you have severely or moderately high blood pressure or if your blood pressure is not adequately controlled;
• if you have severe liver disease;
• in combination with certain other medicines also used to treat migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists)).

Warnings and precautions

Talk to your doctor before taking Frovatriptan Teva 2.5 mg film-coated tablets:

• if you are a patient at risk of coronary heart disease, including:
  • if you are a heavy smoker or are undergoing nicotine replacement therapy;
  • if you are a post-menopausal woman or a man over 40 years of age.

Stop taking Frovatriptan Teva 2.5 mg film-coated tablets and contact your doctor immediately if:

• you experience a sensation of tightness or pain in the chest, difficulty breathing and/or pain or discomfort in one or both arms, back, shoulders, neck, jaw, or upper abdomen; these could be symptoms of a heart attack, which may occur with triptan use, even in patients who have never had cardiovascular disease (see also section 4);
• you develop skin rashes or generalized itching, sudden swelling (especially around the lips, eyes, and tongue), possibly with sudden difficulty breathing, rapid heartbeat, and palpitations. These are all symptoms and signs of allergy and systemic hypersensitivity reactions (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of age) as the safety and efficacy of Frovatriptan Teva 2.5 mg film-coated tablets have not been established in these age groups.

Other medicines and Frovatriptan Teva 2.5 mg film-coated tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

You must not take this medicine together with certain other medicines used to treat migraine:

• particularly ergotamine and ergotamine derivatives (including methysergide); at least 24 hours must pass between stopping treatment with these medicines and taking Frovatriptan Teva 2.5 mg film-coated tablets. Likewise, you must not take these medicines within 24 hours after taking a dose of Frovatriptan Teva 2.5 mg film-coated tablets;
• particularly other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan, or zolmitriptan);
• unless otherwise directed by your doctor, do not take this medicine together with monoamine oxidase inhibitors (MAOIs) used to treat depression (phenelzine, isocarboxazide, tranylcypromine, moclobemide);
• Inform your doctor or pharmacist if you are taking an oral contraceptive or selective serotonin reuptake inhibitors (SSRIs) (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended not to take Frovatriptan Teva 2.5 mg film-coated tablets together with St. John’s wort (Hypericum perforatum).

Concomitant use of Frovatriptan Teva 2.5 mg film-coated tablets with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, and St. John’s wort) may also increase the risk of serotonin syndrome (symptoms of which include: chills, sweating, agitation, tremor, sudden muscle contractions, nausea, fever, confusion).

If you have any doubts about taking other medicines together with Frovatriptan Teva 2.5 mg film-coated tablets, consult your doctor or pharmacist.

Frovatriptan Teva 2.5 mg film-coated tablets with food and drink

Frovatriptan Teva 2.5 mg film-coated tablets can be taken with or without food, always with an adequate amount of water.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Frovatriptan Teva 2.5 mg film-coated tablets should not be taken during pregnancy or while breastfeeding unless advised by your doctor.

In any case, you must not breastfeed for 24 hours after taking the medicine, and during this period, the breast milk produced should be discarded.

Driving and using machines

Frovatriptan Teva 2.5 mg film-coated tablets and migraine itself may cause drowsiness. In such cases, driving a vehicle or operating machinery may be dangerous and should be avoided.

Frovatriptan Teva 2.5 mg film-coated tablets contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Frovatriptan Teva 2.5 mg film-coated tablets contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Frovatriptan Teva 2.5 mg film-coated tablets

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor or pharmacist.
Take Frovatriptan Teva 2.5 mg film-coated tablets as soon as possible after the onset of a migraine attack.
Swallow the tablet whole with water.
If the first dose has no effect, do not take a second dose during the same attack. However, for subsequent attacks, you may take Frovatriptan Teva 2.5 mg film-coated tablets.
If you obtain relief after the first dose but the migraine recurs within 24 hours, you may take a second dose, provided that at least 2 hours have passed between the two doses.
Do not exceed the maximum dose of 5 mg (two tablets) within 24 hours.
Excessive use (repeated for several consecutive days) of Frovatriptan Teva 2.5 mg film-coated tablets constitutes improper use of the medicine and may lead to an increase in adverse effects and may result in chronic daily headache, in which case treatment should be temporarily discontinued. Consult your doctor if you begin to experience headaches that are too frequent or occur daily, as this may indicate medication-overuse headache.
Do not use this medicine to prevent migraine.

Use in children and adolescents
Frovatriptan Teva 2.5 mg film-coated tablets must not be used in patients under 18 years of age.

Elderly
Due to limited experience in patients over 65 years of age, the use of Frovatriptan Teva 2.5 mg film-coated tablets is not recommended in patients within this age group.

If you take more Frovatriptan Teva 2.5 mg film-coated tablets than you should
If you accidentally take an excessive dose of Frovatriptan Teva 2.5 mg film-coated tablets, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department, remembering to bring the medicine pack or this leaflet with you.

If you stop treatment with Frovatriptan Teva 2.5 mg film-coated tablets
No special precautions are required when stopping treatment with this medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Frovatriptan Teva 2.5 mg film-coated tablets and contact your doctor immediately if you experience any of the following symptoms:

• a feeling of tightness or pain in the chest, difficulty breathing, and/or pain or discomfort in one or both arms, back, shoulders, neck, jaw, or upper stomach; these could be symptoms of a heart attack (myocardial infarction), which may occur with triptan use, even in patients who have never had cardiovascular disease;
• skin rash or generalized itching, sudden swelling (especially around the lips, eyes, tongue, or mucous membranes), possibly with sudden difficulty breathing, rapid heartbeat, and palpitations. These are all symptoms and signs of allergy and systemic hypersensitivity reactions (hypersensitivity reactions, angioedema, anaphylaxis).

The side effects reported with Frovatriptan Teva 2.5 mg film-coated tablets were temporary, generally mild to moderate in intensity, and resolved spontaneously. Some of the symptoms reported may be caused by migraine itself.
The following side effects were observed commonly (estimated frequency: more than 1 in 100 and less than 1 in 10):

• nausea, malaise, dry mouth, indigestion, stomach discomfort;
• fatigue, chest discomfort (feeling of mild heaviness, pressure, or tightness in the chest);
• headache, dizziness, tingling and prickling sensations, especially in arms and legs, reduced or altered tactile sensation, strong drowsiness;
• hot flushes;
• throat tightness;
• visual disturbances;
• increased sweating;

The following side effects were observed uncommonly (estimated frequency: more than 1 in 1,000 and less than 1 in 100):

• altered taste, tremor, poor concentration, lethargy, increased tactile sensation, drowsiness, involuntary muscle contractions;
• diarrhoea, difficulty swallowing, gas in stomach or intestines, stomach discomfort, bloated abdomen;
• increased awareness of heartbeat (palpitations), rapid heartbeat, increased blood pressure, chest pain (intense tightness or pressure sensation in the chest);
• sensation of warmth, reduced tolerance to heat and cold, pain, weakness, thirst, weakness, increased energy, general feeling of malaise, sensation of dizziness;
• anxiety, inability to sleep, confusion, nervousness, restlessness, agitation, depression, loss of sense of personal identity, cold sensation in hands and feet;
• nasal irritation, sinus inflammation (sinusitis), sore throat and/or vocal cords;
• muscle stiffness, muscle and bone pain, pain in hands and feet, back pain, joint pain;
• eye pain, eye irritation, pain due to light sensitivity;
• itching sensations;
• ringing in the ears, earache;
• dehydration;
• frequent need to urinate, increased volume of urine produced;

The following side effects were observed rarely (estimated frequency: more than 1 in 10,000 and less than 1 in 1,000):

• muscle cramps, muscle flaccidity, decreased reflexes (hyporeflexia), movement disorders;
• constipation, belching, heartburn, irritable bowel syndrome, blistering on the lips, lip pain, oesophageal spasm, blistering in the mouth, stomach or upper small intestine ulcer, pain in salivary glands, mouth inflammation, toothache;
• fever;
• memory loss, abnormal dreams, personality disorders;
• nosebleeds, hiccups, laboured breathing, respiratory disorders, throat irritation;
• night blindness;
• skin redness, piloerection (goosebumps), purpuric spots on skin and mucous membranes, urticaria;
• slowed heart rate;
• ear discomfort and disturbances, ear itching, sensitive hearing;
• increased bilirubin (a substance produced by the liver) in the blood, decreased blood calcium, altered urine tests;
• low blood sugar levels;
• frequent need to urinate at night, kidney pain;
• self-inflicted injuries (e.g. biting or bruising);
• swollen lymph nodes;
• breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events have also been reported:

• allergic (hypersensitivity) reactions including skin rash or generalized itching, sudden swelling (especially around the lips, eyes, or tongue), possibly with sudden difficulty breathing, rapid heartbeat, and palpitations (anaphylaxis);
• heart attack (myocardial infarction);
• chest discomfort or pain caused by a temporary spasm (constriction) of the coronary arteries (the blood vessels supplying oxygen or nutrients to the heart, e.g. coronary artery spasm).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Frovatriptan Teva 2.5 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the blister and carton after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Frovatriptan Teva 2.5 mg film-coated tablets contain
The active substance is frovatriptan.
Each film-coated tablet contains 2.5 mg of frovatriptan (as frovatriptan succinate monohydrate).
The other components are:
Tablet core: silicified microcrystalline cellulose, lactose, silicon dioxide, sodium starch glycolate (type A) and magnesium stearate.
Coating: hypromellose (E464), monohydrate lactose, macrogol 3350 (E1521), triacetin and titanium dioxide (E171).

Description of the appearance of Frovatriptan Teva 2.5 mg film-coated tablets and pack sizes
Frovatriptan Teva 2.5 mg film-coated tablets are round, film-coated tablets, white to off-white in colour, smooth on both sides. They are available in packs containing 1, 2, 3, 4, 6 or 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy

Manufacturer
Chanelle Medical Unlimited Company
Dublin Road, Loughrea, H62 FH90,
Ireland
Merckle GmbH
Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names: