FROVATRIPTAN DOC GENERICI

Package leaflet: Information for the user

FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets and what is it used for?

What it is and what it is used for
FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets contain frovatriptan (as frovatriptan succinate monohydrate), which belongs to a group of medicines known as triptans (also known as 5-HT receptor agonists).
FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets are used for the treatment of migraine, with or without aura (a temporary subjective sensation that precedes a migraine attack, varying considerably from person to person, and which may affect vision, sense of smell, or hearing).
FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets must not be used to prevent migraine.

2. What you need to know before taking FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets

film-coated tablets
The diagnosis of a migraine attack must have been clearly established by your doctor.

Do not take FROVATRIPTAN DOC Generics 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 heart problems such as heart failure or chest pain (angina), or if you have previously had a heart attack;
• if you have circulation problems in the legs causing cramps and pain while walking (a condition known as peripheral vascular disease);
• if you have had a stroke or a mini-stroke (also called transient ischemic attack or TIA);
• if you have moderate to significantly high blood pressure. You may take FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets if your blood pressure is only slightly elevated and is being treated;
• if you suffer from severe liver disease;
• together with other migraine medications, including those containing ergotamine, or with similar medicines such as methysergide, or with other 5-HT1 receptor agonists such as sumatriptan.

If any of these conditions apply to you, inform your doctor and do not take FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets.
Pay particular attention when using FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets if you are a patient with cardiovascular risk factors, including if:

• you are a heavy smoker or are taking medications to stop smoking;
• you are a post-menopausal woman or a man over 40 years of age.

In these cases, consult your doctor before taking FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets.
In rare cases, symptoms such as chest pain and a sensation of heaviness may occur in patients treated with triptans, even in those with no history of cardiovascular disease.
If you experience any of these symptoms, contact your doctor and do not take further doses of this medicine.

Other medicines and FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take this medicine at the same time as other migraine treatments:

• especially ergotamine and ergotamine derivatives (including methysergide), sumatriptan, or other 5-HT receptor agonists; a minimum interval of 24 hours must be observed between stopping these medicines and taking FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets. Likewise, these medicines should not be taken within 24 hours after taking frovatriptan.
• particularly other triptans (5-HT agonists such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan, and zolmitriptan).

Unless prescribed by your doctor, do not take this medicine together with monoamine oxidase inhibitors (MAOIs), medicines used to treat depression (iproniazid, isocarboxazid, tranylcypromine, moclobemide).
Inform your doctor or pharmacist if you are taking oral contraceptives (the pill) or selective serotonin reuptake inhibitors (SSRIs) (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is not recommended to take FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets together with medicines containing St. John’s wort (Hypericum perforatum).

Taking FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets together with the medicines listed above (particularly monoamine oxidase inhibitors, serotonin reuptake inhibitors, and St. John’s wort) may increase the risk of serotonin syndrome (symptoms of this syndrome include: shivering, sweating, agitation, muscle tremor and spasms, nausea, fever, and confusion).
For any doubts about the use of other medicines together with FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets, ask your doctor or pharmacist.

FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets with food and drink
FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets can be taken with or without food, always with plenty 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.
Unless otherwise advised by your doctor, the use of FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets is not recommended during pregnancy or while breastfeeding.
In any case, you must not breastfeed for 24 hours after taking the medicine. Milk produced during this time should be discarded.

Driving and using machines

• Both migraine symptoms and this medicine may cause drowsiness. If this occurs, do not drive or operate machinery.

FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets contain lactose
FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets contain a small amount of a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets.

3. How to take FROVATRIPTAN DOC 2.5 mg film-coated tablets

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Take FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets as soon as possible after the onset of a migraine attack.
Do not use this medicine to prevent migraine.
Swallow the tablet whole with a full glass of water.
If you do not experience relief after the first dose, do not take a second dose during the same attack. FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets may be used for the next attack.
If you experience relief after the first dose but the headache returns within 24 hours, you may take a second tablet, provided that at least 2 hours have passed between doses.
Do not exceed the maximum daily dose of 5 mg in 24 hours (i.e., 2 tablets).
Prolonged use (repeated use over several days) of FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets is not recommended and may lead to an increase in adverse effects and may cause daily headaches requiring discontinuation of treatment.
Consult your doctor if you suffer from frequent or daily headaches, as the doctor may consider a diagnosis of medication-overuse headache.
FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets must not be given to children under 18 years of age.
Due to limited safety and efficacy data in patients over 65 years of age, FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets are not recommended for use in these patients.

If you take more FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets than you should
If you have accidentally taken more than the prescribed dose of FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Take the remaining tablets and this leaflet with you.
Symptoms of overdose include: dizziness, drowsiness, vomiting, general malaise, and decreased heart rate.

If you stop taking FROVATRIPTAN DOC Generics 2.5 mg film-coated tablets
No special precautions are required when stopping treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Description of side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences
them.
A sensation of heaviness or pain in the chest, sometimes intense, and which may spread to
the throat, may occur a few minutes after taking the medicine. If you experience these
symptoms, contact your doctor and do not take any further doses of this medicine.
The side effects reported during clinical studies with frovatriptan are temporary, mild to
moderate in intensity, and resolve spontaneously.
Some of the symptoms reported as side effects may be due to the migraine episode itself.

Side effects common (affect more than 1 user in 100 but less than 1 in 100) :

• Nausea, dry mouth, indigestion, stomach pain,
• Fatigue, chest discomfort (sensation of heaviness, pressure, or tightness in the chest),
• Migraine, dizziness, tingling in arms and legs, reduced or increased sensitivity to touch, strong desire to sleep,
• Hot flushes,
• Throat tightness,
• Visual disturbances,
• Increased sweating.

Side effects uncommon (affect more than 1 user in 1000 but less than 1 in 100) :

• Taste disturbances, tremor, difficulty concentrating, lethargy, skin hypersensitivity, somnolence, involuntary muscle contractions,
• Diarrhea, difficulty swallowing, bloating, stomach discomfort, flatulence,
• Increased heart rate, palpitations, high blood pressure, chest pain (intense sensation of tightness or pressure in the chest),
• Feeling of warmth, decreased tolerance to heat and cold, pain, weakness, fever, thirst, lack of energy, hyperactivity, malaise, feeling of intoxication, dizziness,
• Anxiety, insomnia, confusion, agitation, nervousness, depression, personality disorders, cold extremities,
• Rhinitis, sinusitis, sore throat,
• Muscle stiffness, bone and muscle pain, pain in hands and feet, joint pain, back pain, eye pain, eye irritation, discomfort when looking at light,
• Itching,
• Ringing in the ears, earache,
• Dehydration,
• Urgency of urination, increased urination,
• Elevated blood pressure.

Side effects rare (affect more than 1 user in 10,000 but less than 1 in 1000) :

• Muscle spasms, decreased muscle tone, reduced muscle reflexes (hyporeflexia), movement disorders,
• Constipation, belching, heartburn, intestinal irritation, mouth ulcers, lip pain, esophageal spasm, gastro-duodenal ulcer, pain in salivary glands, inflammation of the mouth, toothache,
• Fever,
• Memory loss, nightmares, personality disorders,
• Nosebleeds (epistaxis), increased respiratory rate, hiccups, throat irritation,
• Night blindness,
• Purple spots on the skin or mucous membranes, skin redness, urticaria, goosebumps,
• Bradycardia,
• Hearing disturbances, ear discomfort, ear itching, hypersensitivity to sounds,
• Increased bilirubin in the blood, decreased calcium in the blood, altered urine tests,
• Hypoglycemia,
• Nocturnal urgency to urinate, kidney pain,
• Self-mutilation (such as biting, bruising),
• Swollen lymph nodes,
• Breast pain.

With FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets, some cases of allergic
reaction have been reported, manifesting as skin rash, as well as severe generalized
allergic reaction (anaphylaxis) which may cause breathing difficulties, increased heart
rate, and palpitations. In such cases, contact your doctor immediately.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting
system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets

film
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 which is stated on the blister and
on the 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 DOC Generici 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, anhydrous lactose*, silicon dioxide, sodium starch glycolate (Type A) and magnesium stearate.
Coating:
Film-coating: hypromellose (E464), monohydrate lactose*, polyethylene glycol 3350 (E1521), triacetin and titanium dioxide (E171).
*Contains approximately 107 mg of lactose per tablet.

Description of the appearance of FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets and contents of the pack
FROVATRIPTAN DOC Generici 2.5 mg film-coated tablets are white or almost white, smooth on both sides, film-coated tablets.
They are available in blisters in packs of 2 or 6 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici srl
Via Turati, 40
20121 Milan
Italy

Batch release responsible manufacturer:
Chanelle Medical
Loughrea, Co. Galway
Ireland
JSC Grindeks
53 Krustpils street, Riga, LV-1057
Latvia

This medicinal product is authorized in the European Economic Area countries with the following names:
Netherlands: FROVATRIPTAN DOC Generici 2.5 mg
Italy: FROVATRIPTAN DOC Generici