FORMIGRAN

FORMIGRAN film-coated tablets

Important information (mandatory information)

FORMIGRAN 2.5 mg film-coated tablets. Active ingredient: Naratriptan. Areas of application: used as a migraine therapeutic. Warnings: Contains lactose and sodium.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

FORMIGRAN 2.5 mg film-coated tablets for the treatment of migraine in adults between 18 and 65 years of age
Active ingredient: Naratriptan

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. This medicine is also available without a doctor's prescription. Always take it exactly as described in this package leaflet or exactly as instructed by your doctor or pharmacist.

• Keep this package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet (see section 4).

What is in this package leaflet

1. WHAT IS FORMIGRAN AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FORMIGRAN?
3. HOW TO TAKE FORMIGRAN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE FORMIGRAN?
6. CONTENTS OF THE PACK AND FURTHER INFORMATION.

This medicine is only suitable for patients who know they have migraine. If you are not sure whether you suffer from migraine, talk to your doctor or pharmacist.

Typical symptoms of migraine are:
Unilateral, throbbing headache; nausea; sensitivity to light and noise.

1. WHAT IS FORMIGRAN AND WHAT IS IT USED FOR?

Migraine symptoms can be caused by a temporary widening of blood vessels in the head. It is believed that FORMIGRAN reduces this widening of blood vessels. This helps the headache to subside and other migraine symptoms to be relieved, such as a general feeling of illness (nausea or vomiting), as well as sensitivity to light and noise. The safety and efficacy of FORMIGRAN for the treatment of aura symptoms that may occur before the onset of headache has not yet been proven.

FORMIGRAN is a selective serotonin (5-HT1) receptor agonist and is used as a migraine therapeutic. It is used for the acute treatment of the headache phases of migraine attacks with and without aura.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FORMIGRAN?

FORMIGRAN should be used at the first sign of a migraine headache.

Do not take FORMIGRAN,

• if you are allergic to naratriptan or any of the other ingredients of this medicine listed in section 6;
• to prevent a migraine attack;
• if you are under 18 or over 65 years of age;
• if you suffer from heart problems including angina pectoris or have already had a heart attack or show symptoms or signs of reduced blood flow to the heart (ischemic heart disease);
• if you suffer from spasms of the coronary arteries (Prinzmetal's angina) or peripheral vascular diseases or have had them in the past;
• if you have or have had a stroke or a mini-stroke (also known as a transient ischemic attack or TIA);
• if you have high blood pressure or are being treated for high blood pressure;
• if you suffer from kidney or liver disease;
• if you have circulatory disorders of the legs (cramping pain in the legs when walking), or your doctor has told you that you suffer from peripheral circulatory disorders;
• if you have been diagnosed with one of the rare forms of migraine (hemiplegic, basilar or ophthalmoplegic migraine);
• if you are simultaneously using medicines containing ergotamine, ergotamine derivatives, methysergide or triptans (e.g. other naratriptan-containing products, zolmitriptan, rizatriptan, sumatriptan) for the treatment of migraine.

Warnings and precautions

Contact your doctor if:

• your headaches usually last longer than 24 hours or occur more frequently;
• you experience four or more migraine attacks per month;
• you do not fully recover between migraine attacks;
• you are over 50 years old and this type of headache occurs for the first time;
• your migraine attacks worsen or occur more frequently or the associated signs change;
• your migraine is accompanied by the following symptoms:
• unilateral weakness of the body
• double vision
• clumsy or uncoordinated movements
• tinnitus (ringing in the ears)
• disturbances of consciousness
• seizure-like movements
• a recent rash associated with headache.

Please talk to your doctor before taking FORMIGRAN. He will check the following points to ensure that this medicine is suitable for you. If three or more of the points listed below apply to you, you may have an increased risk of heart disease:

• You are male and over 40 years old or a postmenopausal woman
• You are severely overweight
• You smoke regularly (more than 10 cigarettes per day) or use nicotine-containing preparations for smoking cessation
• You are diabetic
• You have high cholesterol
• There has been heart disease in your close relatives (parent, brother, sister) before the age of 60.

Please note that migraine patients have an increased risk of certain vascular diseases of the brain (e.g. stroke, temporary states of reduced blood flow in the brain [transient ischemic attacks]).

After taking FORMIGRAN, the following symptoms may occur: a tingling sensation, feeling of heat or heaviness, pressure and tightness or pain in different parts of the body including the chest, throat and neck (see side effects). Should these symptoms last longer than two hours, or occur particularly intensely (especially chest pain), a medical examination must be carried out immediately (see side effects). Further FORMIGRAN film-coated tablets may only be taken with medical permission.

Women with migraine who also use combined oral contraceptives have an increased risk of stroke. If you are taking oral contraceptives and you have only recently developed migraine symptoms for the first time (in the last 3 months) or your migraine symptoms have worsened, or if you have migraine with aura (migraine attacks that begin with visual disturbances or changes in sensation), you should ask your doctor for advice.

As with other medicines for the treatment of acute migraine, chronic, daily headaches or an intensification of headaches have been reported with excessive use of naratriptan, which may require discontinuation of the medicine.

Children, adolescents and elderly patients

FORMIGRAN should not be used if you are under 18 or over 65 years of age.

Taking FORMIGRAN with other medicines

Tell your doctor or pharmacist if you are taking/using other medicines, have recently taken/used other medicines or intend to take/use other medicines, including non-prescription medicines.

Do not take FORMIGRAN with certain other migraine medicines to treat the same migraine attack. FORMIGRAN cannot be taken if you have been prescribed other migraine medicines (products containing ergotamine, ergotamine derivatives (incl. methysergide) or triptans such as sumatriptan) by your doctor.

If you are allergic to antibiotics known as sulfonamides, you may also be allergic to naratriptan. If you know you are allergic to an antibiotic but are not sure if it is a sulfonamide, ask your doctor or pharmacist.

When triptans and herbal preparations containing St. John's wort (Hypericum perforatum) are used together, side effects may occur more frequently.

Interactions with other medicines that are actively excreted by the kidneys, like naratriptan, may be possible. This should be particularly considered for concomitantly taken medicines that are excreted by the kidneys, as naratriptan can inhibit their excretion and potentially enhance their effect.

Antidepressants known as SSRIs or SNRIs (selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors): The concomitant use of FORMIGRAN and this group of medicines can lead to confusion, weakness and/or loss of coordination (serotonin syndrome). Seek medical attention immediately if any of these signs occur.

Taking FORMIGRAN with alcohol

There is no evidence of interactions with alcohol.

Pregnancy and breastfeeding

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

There is no experience regarding the transfer of naratriptan into human breast milk. It is recommended not to breastfeed for up to 24 hours after taking FORMIGRAN to avoid absorption of the active substance by the child.

Driving and operating machinery

Both migraine itself and the use of its medicine can cause fatigue. If you are affected by this, do not drive a vehicle or operate machinery.

FORMIGRAN contains lactose and sodium

Please take FORMIGRAN only after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, i.e. it is almost "sodium-free".

3. HOW TO TAKE FORMIGRAN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor. Ask your doctor or pharmacist if you are not sure.

FORMIGRAN film-coated tablets should be swallowed whole with water.

Only take FORMIGRAN when your migraine headache has already started. Do not take FORMIGRAN until you are sure whether you suffer from migraine or if it is just a headache.

Adults (18 to 65 years)

Take one film-coated tablet, corresponding to 2.5 mg naratriptan, as early as possible after the first signs of migraine headache. However, the film-coated tablets are also effective when used at a later time during the migraine attack.

If symptoms have improved after taking the first film-coated tablet, but the migraine pain returns, a second film-coated tablet can be taken, but no earlier than 4 hours after taking the first film-coated tablet.

Do not take more than 2 film-coated tablets within 24 hours. Do not take more than 2 film-coated tablets for one migraine attack.

If the first dose of FORMIGRAN does not result in an improvement of symptoms, a second dose should not be taken for the same attack, as this will not lead to an improvement of symptoms. FORMIGRAN film-coated tablets can be used again for subsequent attacks. Consult your doctor before continuing to use FORMIGRAN. If FORMIGRAN does not lead to an improvement, it could mean that you do not have migraine.

After taking FORMIGRAN, at least 24 hours should have passed before an ergotamine-containing preparation or another 5-HT1 receptor agonist is administered. Conversely, at least 24 hours should pass between the use of an ergotamine-containing preparation and the taking of FORMIGRAN.

Use in children and adolescents and adults over 65 years of age

The use of FORMIGRAN is not recommended in children and adolescents under 18 years of age or in adults over 65 years of age.

If you have taken more FORMIGRAN than you should

A significant overdose of naratriptan can have an impact on your health. If you have taken more film-coated tablets than intended, contact your doctor immediately.

Take the package and this package leaflet with you.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some people may be allergic to these film-coated tablets. Seek medical attention immediately if you experience allergic reactions. Signs of an allergic reaction include skin rash, wheezing, shortness of breath, swelling of the eyelids, face or lips, circulatory collapse. If you notice any of these signs shortly after taking FORMIGRAN, stop taking it and seek medical attention immediately. Take the package and this package leaflet with you.

Common side effects (affect more than 1 in 100 treated persons):

• Tingling sensation, discomfort or feeling of heat (which is usually short-lived, can be severe and can affect the chest, throat or other parts of the body), dizziness, drowsiness.
• Nausea or vomiting - although this is often part of the migraine attack itself.

Uncommon side effects (affect more than 1 in 1,000 treated persons):

• Visual disturbances, accelerated or slowed heart rate (tachycardia or bradycardia), palpitations, feeling of heaviness, pressure or tightness (which is usually short-lived, can be severe and can affect the chest, throat or other parts of the body), slight increase in blood pressure during the first 12 hours after use.

If the