SUMATRIPTAN 50 mg Coated Tablet

Зміст інструкції

1. SUMATRIPTAN DOC Generici 50 mg and 100 mg coated tablets
   1. WHAT IS SUMATRIPTAN DOC Generici AND WHAT IT IS USED FOR
   2. BEFORE TAKING SUMATRIPTAN DOC Generici
   3. HOW TO USE SUMATRIPTAN DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE SUMATRIPTAN DOC Generici
   6. OTHER INFORMATION

SUMATRIPTAN DOC Generici 50 mg and 100 mg coated tablets

Generic medicine

• 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 personally. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects become severe, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What SUMATRIPTAN DOC Generici is and what it is used for
• 2. Before you take SUMATRIPTAN DOC Generici
• 3. How to use SUMATRIPTAN DOC Generici
• 4. Possible side effects
• 5. How to store SUMATRIPTAN DOC Generici
• 6. Further information

1. WHAT IS SUMATRIPTAN DOC Generici AND WHAT IT IS USED FOR

SUMATRIPTAN DOC Generici belongs to a group of medicines known as serotonin receptor agonists.
Migraine headache is probably caused by the dilation of blood vessels. It is believed that
sumatriptan constricts these blood vessels, thereby relieving migraine headache.
SUMATRIPTAN DOC Generici is used for the treatment of migraine attacks with or without
aura (a sensation of heat usually accompanied by visual distortions, such as flashes of light,
zigzag lines, stars or waves).

2. BEFORE TAKING SUMATRIPTAN DOC Generici

Do not use SUMATRIPTAN DOC Generici

• if you are allergic(hypersensitive)to sumatriptan or any of the excipients of SUMATRIPTAN DOC Generici
• if you have had a heart attackin the past
• if you suffer from any heart disease
• if you experience symptoms indicative of heart disease,such as temporary chest pain or a feeling of pressure in the chest
• if you have had a strokeor transient ischemic attacks (TIA, a milder form of stroke that lasts less than 24 hours)
• if you have circulatory problemsin your legs that cause cramps in the form of painwhile walking (a condition called peripheral vascular disease)
• if your blood pressureis significantly high,or if your blood pressure remains high despite pharmacological intervention 1/6
• if your liver function is severely impaired
• if you are using, or have recently used medicines containing ergotamineor ergotamine derivatives (for migraine)
• if you are using, or have recently used MAO inhibitors(for example moclobemide for depression or selegiline for Parkinson's disease).

Take care with SUMATRIPTAN DOC Generici

• if you have symptoms of heart disease, such as transient chest pain or a feeling of tightness in the chest, which may also radiate to the throat
• if you are using drugs that belong to the group of selective serotonin reuptake inhibitors (for depression or other mental disorders)
• if your liver or kidney function is impaired
• if you have had seizures or if you suffer from epilepsy or any other condition that lowers the seizure threshold
• if you are hypersensitive to sulfonamides
• if you believe you are at risk of developing heart disease (e.g. if you are diabetic, a heavy smoker or are undergoing nicotine replacement therapy), and particularly if you are a postmenopausal woman or a man over 40 with these risk factors, your doctor should check your heart function before prescribing sumatriptan. In very rare cases, serious heart conditions have developed after taking sumatriptan, even without any signs of heart disease. If you have any doubts, consult your doctor
• if you are using drugs to treat mild high blood pressure.

SUMATRIPTAN DOC Generici must be used only if your headache is definitely
migraine. If the headache is different from your usual headaches, do not take sumatriptan
without first consulting your doctor.
After taking SUMATRIPTAN DOC Generici, you may experience chest pain and
a feeling of tightness for a short time, which may be very intense and radiate to the throat. In rare
cases, this may be caused by heart problems. Therefore, contact your doctor if the symptoms do not
disappear.
Excessive use of sumatriptan can cause chronic daily headache or worsen it.
Ask your doctor if you think this is the case. It may be necessary to stop the
treatment with SUMATRIPTAN DOC Generici to correct this problem.
If symptoms do not disappear after the first dose and the medicine has no effect, you should not
take any further doses during the same migraine attack.

Use of SUMATRIPTAN DOC Generici with other medicines
Some medicines can affect the effect of SUMATRIPTAN DOC Generici and
SUMATRIPTAN DOC Generici can affect the effects of other medicines. Tell your doctor or
pharmacist if you are taking or have recently taken any other medicine, including
those that can be obtained without a prescription, herbal remedies and natural products.
This is particularly important when using medicines that contain

• ergotamine or ergotamine derivatives (for migraine), 2/6
• MAO inhibitors (such as moclobemide for depression or selegiline for Parkinson's disease),
• lithium (for manic/depressive disorders (bipolar)),
• selective serotonin reuptake inhibitors (SSRIs for depression and other mental disorders) or herbal remedies containing St. John's wort (Hypericum perforatum).

Pregnancy and breastfeeding
Experience with use during pregnancy is limited. Therefore, ask your doctor or
pharmacist for advice beforetaking SUMATRIPTAN DOC Generici during pregnancy. Ask your
doctor or pharmacist for advice before taking any medicine during breastfeeding. The
sumatriptan passes into breast milk. Therefore, breastfeeding should be avoided for 12 hours
after taking sumatriptan and the milk produced during this time should be
discarded.

Driving and operating machinery
A patient suffering from migraines may feel drowsy due to the migraine attack or
treatment with SUMATRIPTAN DOC Generici. This should be taken into consideration when
a high degree of attention is required, for example when driving. See also the section “Possible
side effects”.

Important information about some excipients of SUMATRIPTAN DOC Generici
SUMATRIPTAN DOC Generici contains lactose. If your doctor has told you that you are intolerant
to some sugars, contact him before taking this medicine.

3. HOW TO USE SUMATRIPTAN DOC Generici

Always use SUMATRIPTAN DOC Generici following exactly the doctor's instructions. If you have
any doubts, consult your doctor or pharmacist. The doctor will decide a dose suitable for you. The
recommended dose must not be exceeded.
This medicine has been prescribed for you personally. Never give it to others. In fact, for
other individuals this medicine could be dangerous, even if their symptoms are
the same as yours.

How to take SUMATRIPTAN DOC Generici

• The tablets must be swallowed whole with half a glass of water. The 50 mg tablets can be divided into two equal halves.
• SUMATRIPTAN DOC Generici should be taken at the first signs of a migraine attack, but it can also be taken during an ongoing attack.
• SUMATRIPTAN DOC Generici should not be used as prevention (prophylaxis).

Dosage
Adults
The usual dose for adults is one 50 mg tablet per migraine attack. Some
patients may need 100 mg. The maximum daily dose is 300 mg.
Use in children and adolescents (under 18 years of age)
SUMATRIPTAN DOC Generici is not recommended in children and adolescents.
3/6
Elderly (patients over 65 years of age)
SUMATRIPTAN DOC Generici is not recommended in patients of this age group.

If the migraine symptoms initially disappear after the first dose,but reappear
later, you can take another dose within the next 24 hours, if at least 2 hours
have passed since taking the previous tablet, but you must not exceed the maximum
daily dose of 300 mg.

If the migraine symptoms do NOT disappear after the first dose and the medicine has
no effect,do not take any more doses during the same migraine attack. Next time
you get a migraine, you can try SUMATRIPTAN DOC Generici again.
If you think that the effect of SUMATRIPTAN DOC Generici is too weak or too strong, talk to your doctor or pharmacist.

If you take more SUMATRIPTAN DOC Generici than you should
The symptoms of an overdose are the same as those listed in section 4 “Possible side
effects”. If you have taken too many tablets, contact your doctor or a hospital.

4. POSSIBLE SIDE EFFECTS

Like all medicines, SUMATRIPTAN DOC Generici can cause side effects, although
not everyone gets them. Some of the symptoms described below may be caused
by the migraine itself.
To indicate the frequency of side effects, the following descriptions are used:
Common: less than 1 in 10 patients but more than 1 in 100
Uncommon: less than 1 in 100 patients but more than 1 in 1000
Rare: less than 1 in 1000 patients but more than 1 in 10,000
Very rare: less than 1 in 10,000
Not known: the frequency cannot be estimated based on the available data.
Common:

• Flushing (redness of the face for a few minutes), dizziness, feeling of weakness, fatigue, drowsiness, tiredness, changes in sensitivity to the limbs or other parts of the body.
• Brief increase in blood pressure shortly after taking the medicine.
• Difficulty breathing.
• Feeling unwell (nausea) or sickness (vomiting) - when not caused by the attack itself.
• Feeling of heaviness (usually temporary which can be intense and affect any part of the body, including chest and throat), muscle pain, sensations of tingling, heat, cold and pressure or constriction. If these effects persist or are particularly severe, especially if it is chest or heart pain that spreads to the arms, consult a doctor immediatelyas there have been rare reports of similar problems caused by a heart attack.

Very rare

• Minor disturbances of liver function.

Not known:
4/6

• Allergic reactions that can range from a skin reaction (rash - red spots or hives - skin blisters) to anaphylaxis (suddenly wheezing, palpitations or a feeling of tightness in the chest, swelling of eyelids, face or lips).
• Convulsions (usually in people with a history of epilepsy), chills, tremors, involuntary movements, difficulty with movement.
• Vision disorders including flickering, double vision and reduced vision. There have been cases where permanent visual defects have occurred.
• Inflammation of the colon (a part of the intestine), diarrhea.
• Lowering of blood pressure which can cause a feeling of fainting, especially when getting up.
• Slowing or acceleration of your heart rate, palpitations (feeling of a fast heartbeat), changes in heart rhythm.
• Stiffness of the neck, joint pain.
• Anxiety.
• Excessive sweating.

If you have had a blood test to check your liver function and
simultaneously have taken SUMATRIPTAN DOC Generici, tell your doctor because the
medicine may have affected the results.

If you experience any of the following symptoms, stop taking SUMATRIPTAN DOC Generici and
contact your doctor immediately:

• Sudden shortness of breath, palpitations or a feeling of tightness in the chest and difficulty breathing, swelling of eyelids, face or lips, rash - red spots or hives (skin bumps), which may be signs of an allergic reaction.
• Convulsions (usually in people with a history of epilepsy).
• Inflammation of the colon (part of the intestine), which may present as pain in the lower left side of the stomach and/or bloody diarrhea.
• Raynaud's syndrome, which can manifest as paleness or bluish discoloration of the skin and/or pain in the fingers of the hands, feet, ears, nose or jaw in response to cold or stress.

If any of the side effects become severe, or if you notice any side effect

5. HOW TO STORE SUMATRIPTAN DOC Generici

Keep SUMATRIPTAN DOC Generici out of the reach and sight of children.
This medicine does not require any special storage conditions
Do not use SUMATRIPTAN DOC Generici after the expiry date indicated on the packaging
after the wording EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. OTHER INFORMATION

5/6

What SUMATRIPTAN DOC Generici contains

• The active ingredient is sumatriptan. One tablet contains 50 mg or 100 mg of sumatriptan (as sumatriptan succinate).
• The excipients are: Core: Lactose monohydrate, anhydrous lactose, sodium croscarmellose, microcrystalline cellulose, magnesium stearate. Coating: Lactose monohydrate, mannitol, triacetin, talc and titanium dioxide (E 171).

Description of the appearance ofSUMATRIPTAN DOC Generici and contents of the pack
Coated tablet (tablet).
50 mg: white, oval, biconvex tablets with a fracture line on both sides and edges,
with the inscription “SN” on one side and “50” on the other.
100 mg: white, oval, biconvex tablets, with the inscription “SN” on one side and “100” on the other.
Pack sizes:
Blisters: 2, 3, 4, 6, 18 and 24 tablets.
Plastic tablet containers: 2, 3, 4, 6, 18 and 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milano

Manufacturer
Actavis hf., P.O. Reykjavíkurvegur 78, IS-222 Hafnarfjörđur, Iceland.
Lachifarma S.r.l. Laboratorio Chimico Salentino S.S. 16 Zona Industriale, 73010 Zollino (LE), Italy
March 2013
6/6