SUMATRIPTAN-

SUMATRIPTAN-ratiopharm bei Migräne 50 mg Filmtabl.

Important notes (mandatory information)

Sumatriptan-ratiopharm for Migraine 50 mg film-coated tablets. Areas of application: for the acute treatment of the headache phase of migraine attacks with and without aura, after the initial diagnosis of migraine by a doctor.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sumatriptan-ratiopharm for Migraine 50 mg film-coated tablets
Active ingredient: Sumatriptan

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What this leaflet contains

1. WHAT IS SUMATRIPTAN–RATIOPHARM FOR MIGRAINE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SUMATRIPTAN–RATIOPHARM FOR MIGRAINE?
3. HOW SHOULD SUMATRIPTAN–RATIOPHARM FOR MIGRAINE BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SUMATRIPTAN–RATIOPHARM FOR MIGRAINE BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SUMATRIPTAN-RATIOPHARM FOR MIGRAINE AND WHAT IS IT USED FOR?

What is Sumatriptan-ratiopharm for Migraine?
Sumatriptan-ratiopharm for Migraine is taken orally and contains sumatriptan, which belongs to the group of medicines known as triptans (also known as 5-HT1 receptor agonists). Sumatriptan-ratiopharm for Migraine is used for the acute treatment of the headache phase of migraine attacks with and without aura, after the initial diagnosis of migraine by a doctor. Migraine symptoms can be caused by the temporary widening of blood vessels in the head. Sumatriptan ratiopharm for Migraine is thought to reduce this widening of blood vessels. This helps to relieve headaches and other symptoms of a migraine attack, such as nausea or vomiting, and sensitivity to light and noise.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SUMATRIPTAN RATIOPHARM FOR MIGRAINE?

Sumatriptan-ratiopharm for Migraine must not be taken:

• if you are allergic to sumatriptan or any of the other ingredients of this medicine listed in section 6.
• if you have heart problems, such as narrowing of the coronary arteries (ischemic heart disease) or chest pain (angina pectoris), or if you have already had a heart attack.
• if you have circulatory problems in your legs that cause cramp-like pain when walking (peripheral vascular disease).
• if you have had a stroke or transient episodes of reduced blood flow to the brain (also known as transient ischemic attack).
• if you have high blood pressure. You may be able to take Sumatriptan ratiopharm for Migraine if your blood pressure is slightly elevated and well controlled.
• if you have severe liver disease.
• together with other migraine medications, including those containing ergotamine, or similar medications such as methysergide or another triptan/5–HT1–receptor agonist (medications also used to treat migraines).
• if you are taking certain antidepressants, so-called MAO inhibitors (monoamine oxidase inhibitors) or have taken them up to two weeks ago.

If any of these contraindications apply to you, do not take Sumatriptan ratiopharm for Migraine and talk to your doctor.

Warnings and precautions

Before taking Sumatriptan-ratiopharm for Migraine, a doctor must have determined that your headache is caused by migraine and not by other medical conditions. Please talk to your doctor or pharmacist before taking Sumatriptan ratiopharm for Migraine if you have certain risk factors:

• If you are a heavy smoker or if you are undergoing nicotine replacement therapy, and especially
• if you are a man over 40 years of age, or
• if you are a woman in or after menopause.

In very rare cases, serious heart problems have occurred in patients after taking Sumatriptan-ratiopharm for Migraine, even if there were no previous signs of heart disease. If any of the above applies to you, it could mean that you have an increased risk of developing heart disease, so tell your doctor so that your heart function can be checked before you take Sumatriptan-ratiopharm for Migraine. If you have a history of seizures (epileptic seizures) or if you have risk factors that increase the risk of seizures, such as a head injury or alcohol dependence, tell your doctor so that they can monitor you more closely. If you have liver or kidney disease, tell your doctor so that they can monitor you more closely. If you are allergic to so-called sulfonamide antibiotics, you may also be allergic to sumatriptan. If you know that you are allergic to an antibiotic but do not know if it is a sulfonamide, talk to your doctor or pharmacist before taking Sumatriptan-ratiopharm for Migraine. If you are taking antidepressants, so-called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors), talk to your doctor or pharmacist before taking Sumatriptan-ratiopharm for Migraine. See also "Taking Sumatriptan-ratiopharm for Migraine with other medicines" below.

If you take Sumatriptan-ratiopharm for Migraine frequently

Taking Sumatriptan-ratiopharm for Migraine too often can make your headaches worse. Tell your doctor if this applies to you. They may recommend that you stop taking Sumatriptan-ratiopharm for Migraine.

If you experience chest pain or tightness after taking Sumatriptan-ratiopharm for Migraine, these effects can be intense, but usually pass quickly. If they do not pass quickly or if they get worse, see a doctor immediately. You can find more information about these possible side effects in section 4 of this leaflet.

Taking Sumatriptan-ratiopharm for Migraine with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. Some medicines must not be taken together with Sumatriptan-ratiopharm for Migraine and others may cause unwanted effects if taken together with Sumatriptan-ratiopharm for Migraine. You must talk to your doctor if you are taking the following medicines:

• Ergotamine, which is also used to treat migraines, or similar medicines, such as methysergide (see 2. under "Sumatriptan ratiopharm for Migraine must not be taken"). Do not use Sumatriptan–ratiopharm for Migraine at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Sumatriptan–ratiopharm for Migraine. Do not take any medicines containing ergotamine or substances related to ergotamine for at least the next 6 hours after taking Sumatriptan–ratiopharm for Migraine.
• Other triptans/5–HT1–receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), which are also taken to treat migraines (see 2. under "Sumatriptan–ratiopharm for Migraine must not be taken"). Do not use Sumatriptan–ratiopharm for Migraine at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Sumatriptan–ratiopharm for Migraine. Do not take any other triptans/5–HT1–receptor agonists for at least the next 24 hours after taking Sumatriptan–ratiopharm for Migraine.
• SSRIs (selective serotonin–reuptake inhibitors) or SNRIs (serotonin–norepinephrine–reuptake inhibitors) to treat depression. Taking Sumatriptan–ratiopharm for Migraine at the same time as these medicines can cause a so-called serotonin syndrome (symptoms may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle cramps, shivering/chills, increased heart rate and shaking).
• MAO inhibitors (monoamine oxidase inhibitors) to treat depression. Do not use Sumatriptan–ratiopharm for Migraine if you have taken such a medicine within the last two weeks.
• St. John's wort (Hypericum perforatum). Side effects may be more likely to occur if Sumatriptan–ratiopharm for Migraine is taken together with herbal preparations containing St. John's wort.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is only limited information on the safety of sumatriptan in pregnant women, although there is no evidence of an increased risk of malformations to date. Your doctor will discuss with you whether or not you should take Sumatriptan ratiopharm for Migraine during pregnancy.

Breastfeeding

Do not breastfeed your baby for 12 hours after taking Sumatriptan-ratiopharm for Migraine. If you pump milk during this time, discard it and do not give it to your baby.

Driving and operating machinery

Both the migraine attack and taking Sumatriptan ratiopharm for Migraine can cause fatigue. If you are affected in this way, do not drive or operate machinery.

Sumatriptan-ratiopharm for Migraine contains lactose and sodium

Please only take Sumatriptan-ratiopharm for Migraine after consulting your doctor if you know that you have an intolerance to certain sugars. This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, i.e. it is virtually "sodium-free".

3. HOW SHOULD SUMATRIPTAN-RATIOPHARM FOR MIGRAINE BE TAKEN?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Do not take Sumatriptan-ratiopharm for Migraine until the migraine headache has started. Do not take Sumatriptan-ratiopharm for Migraine to prevent a migraine attack.

How much should you take?
The usual dose for adults between 18 and 65 years of age is one Sumatriptan-ratiopharm for Migraine 50 mg film-coated tablet. Some patients may need 100 mg sumatriptan (equivalent to 2 Sumatriptan ratiopharm for Migraine 50 mg film-coated tablets). No improvement in efficacy is to be expected when taking doses higher than 100 mg sumatriptan. Do not take more than 300 mg sumatriptan (equivalent to 6 Sumatriptan ratiopharm for Migraine 50 mg film-coated tablets) within 24 hours. The tablet can be divided into equal doses.

When should you take Sumatriptan?
It is best to use Sumatriptan-ratiopharm for Migraine as soon as you notice that the migraine headache is starting. However, it can also be taken at any later time during a migraine attack.

If your symptoms return

If symptoms that have already subsided recur, you can take another Sumatriptan-ratiopharm for Migraine 50 mg film-coated tablet within the next 24 hours, but at least 2 hours apart. Do not take more than 300 mg sumatriptan (equivalent to 6 Sumatriptan-ratiopharm for Migraine 50 mg film-coated tablets) within 24 hours.

How should Sumatriptan-ratiopharm for Migraine be taken?
Sumatriptan-ratiopharm for Migraine is taken whole with water.

If the first film-coated tablet does not work

Do not use a second film-coated tablet or any other dosage form of sumatriptan for the same migraine attack. If Sumatriptan-ratiopharm for Migraine does not provide any relief, consult your doctor or pharmacist.

Use in children, adolescents and elderly patients

Sumatriptan-ratiopharm for Migraine is not recommended for use in children, adolescents and elderly patients (over 65 years of age).

If you have taken more Sumatriptan than you should

Taking too much Sumatriptan-ratiopharm for Migraine can make you sick. If you have taken more than 6 Sumatriptan-ratiopharm for Migraine 50 mg film-coated tablets within 24 hours, consult your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some symptoms may be caused by the migraine itself. Allergic reactions: See a doctor immediately.

The following side effects have occurred, but the exact frequency of their occurrence is not known. Signs of an allergy may include: rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; circulatory collapse. If you notice any of these symptoms shortly after taking Sumatriptan ratiopharm for Migraine, do not take Sumatriptan-ratiopharm for Migraine again. See a doctor immediately.

Common (may affect up to 1 in 10 people)

Pain, heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, unusual sensations or sensory impressions such as numbness, tingling, heat or cold sensations. These symptoms can be intense, but generally pass quickly. If these symptoms persist or worsen (especially chest pain), see a doctor immediately. In very few patients, these symptoms may be caused by a heart attack.

Other common side effects:

• Nausea or vomiting, but this may be triggered by the migraine attack itself.
• Tiredness or drowsiness.
• Dizziness, feeling faint, hot flushes/facial redness.
• Temporary increase in blood pressure.
• Shortness of breath.
• Aching muscles.

Very rare (may affect up to 1 in 10,000 people)

Changes in liver function. If your blood is tested for liver function, tell your doctor or nurse that you are taking Sumatriptan-ratiopharm for Migraine.

Some patients may experience the following side effects, but it is not known how often they occur (frequency not estimable from the available data):

• Seizures (epileptic seizures), tremors, muscle cramps, stiff neck.
• Visual field defects, eye twitching.
• Visual disturbances, such as flickering eyes, decreased visual acuity, double vision, loss of vision and in some cases even permanent loss of vision (these symptoms can also be triggered by the migraine attack itself).
• Heart problems, in which the heartbeat may speed up, slow down or change rhythm, chest pain (angina pectoris) or heart attack.
• Pale, blue-tinged skin and/or pain in the fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud's syndrome).
• Feeling faint (blood pressure may drop).
• Pain in the lower left abdomen and bloody diarrhea (ischemic colitis).
• Diarrhea
• Joint pain
• Anxiety/restlessness
• Excessive sweating
• Difficulty swallowing
• If you have recently had an injury or if you have an inflammation (such as rheumatism or inflammation of the colon), you may experience pain at the site of the injury or inflammation, or the pain may worsen.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD SUMATRIPTAN-RATIOPHARM FOR MIGRAINE BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister packs after "Use by