Sumatriptan Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

SUMATRIPTAN DOC Generici 50 mg and 100 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before taking this 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. For other individuals, this medicine could be harmful, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform 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 SUMATRIPTAN DOC Generici IS 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. Sumatriptan is thought to constrict these blood vessels, thereby relieving migraine headache.
SUMATRIPTAN DOC Generici is used to treat migraine attacks with or without aura (a sensation of warmth usually accompanied by visual disturbances 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 to any of the excipients in SUMATRIPTAN DOC Generici
• if you have previously had a heart attack
• if you suffer from any heart disease
• if you experience symptoms suggestive of heart disease, such as transient chest pain or pressure in the chest
• if you have had a stroke or transient ischemic attacks (TIA, a milder form of stroke lasting less than 24 hours)
• if you have circulatory problems in the legs causing cramp-like pain while walking (a condition known as peripheral vascular disease)
• if your blood pressure is significantly elevated, or if your blood pressure remains high despite pharmacological treatment 1/6
• if your liver function is severely impaired
• if you are currently using, or have recently used, medicines containing ergotamine or ergotamine derivatives (for migraine)
• if you are currently using, or have recently used, MAO inhibitors (e.g., moclobemide for depression or selegiline for Parkinson’s disease).

Be cautious with SUMATRIPTAN DOC Generici

• if you have symptoms of heart disease, such as transient chest pain or chest tightness, which may also radiate to the throat
• if you are taking medicines belonging to the group of selective serotonin reuptake inhibitors (SSRIs, for depression or other mental disorders)
• if your liver or kidney function is reduced
• if you have had seizures or 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 undergoing nicotine replacement therapy), and particularly if you are a postmenopausal woman or a man over 40 years of age with these risk factors, your doctor should assess your cardiac function before prescribing sumatriptan. In very rare cases, serious heart conditions have developed after taking sumatriptan, even in the absence of any prior signs of heart disease. If in doubt, consult your doctor
• if you are taking medicines for mild high blood pressure.

SUMATRIPTAN DOC Generici should be used only if your headache is definitely
migraine. If your headache is different from those you usually experience, do not take sumatriptan
without first consulting your doctor.
After taking SUMATRIPTAN DOC Generici, you may briefly experience chest pain and
a sensation of tightness, which can be intense and may radiate to the throat. In very
rare cases, this may be caused by heart problems. Therefore, contact your doctor if symptoms
do not resolve.
Excessive use of sumatriptan may cause chronic daily headache or worsen it.
Ask your doctor if you think this may apply to you. It may be necessary to discontinue
treatment with SUMATRIPTAN DOC Generici to correct this problem.
If symptoms do not resolve after the first dose and the medicine has no effect, you must
not take additional doses during the same migraine attack.
Use of SUMATRIPTAN DOC Generici with other medicines
Some medicines may affect the effect of SUMATRIPTAN DOC Generici and
SUMATRIPTAN DOC Generici may affect the effects of other medicines. Inform your doctor or
pharmacist if you are taking or have recently taken any other medicine, including
those available 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 disorder)),
• 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, consult your doctor or
pharmacist before taking SUMATRIPTAN DOC Generici during pregnancy. Consult your
doctor or pharmacist before taking any medicine during breastfeeding. Sumatriptan
passes into breast milk. Therefore, breastfeeding should be avoided for 12 hours
after taking sumatriptan, and 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 account when
high attention is required, for example when driving. See also the section “Possible
side effects”.
Important information about some excipients in SUMATRIPTAN DOC Generici
SUMATRIPTAN DOC Generici contains lactose. If your doctor has informed you that you are intolerant
to certain sugars, contact them before taking this medicine.

3. HOW TO USE SUMATRIPTAN DOC Generici

Always use SUMATRIPTAN DOC Generici exactly as directed by your doctor. If you have
any doubts, you must consult your doctor or pharmacist. Your doctor will determine the
appropriate dose for you. The recommended dose must not be exceeded.
This medicine has been prescribed for you personally. Never give it to others. For other
individuals, this medicine could be dangerous, even if their symptoms are similar to yours.

How to take SUMATRIPTAN DOC Generici

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

Dosage
Adults
The usual dose for adults is one 50 mg tablet per migraine attack. Some patients may require 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 for use in children and adolescents.
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Elderly patients (patients over 65 years of age)
SUMATRIPTAN DOC Generici is not recommended for patients in this age group.

If migraine symptoms initially disappear after the first dose, but return later, another dose may be taken within the following 24 hours, provided at least 2 hours have passed since the previous tablet was taken; however, the maximum daily dose of 300 mg must not be exceeded.

If migraine symptoms do NOT disappear after the first dose and the medicine has no effect, do not take additional doses during the same migraine attack. The next time you have a migraine, you may try SUMATRIPTAN DOC Generici again.

If you think that the effect of SUMATRIPTAN DOC Generici is too weak or too strong, discuss this with your doctor or pharmacist.

If you take more SUMATRIPTAN DOC Generici than you should
Symptoms of 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 immediately.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, SUMATRIPTAN DOC Generici may cause adverse reactions, although
not everyone experiences them. Some of the symptoms described below may be caused
by migraine itself.
The following frequency categories are used to describe the incidence of adverse reactions:
Common: affects less than 1 in 10 but more than 1 in 100 patients
Uncommon: affects less than 1 in 100 but more than 1 in 1,000 patients
Rare: affects less than 1 in 1,000 but more than 1 in 10,000 patients
Very rare: affects less than 1 in 10,000 patients
Not known: frequency cannot be estimated from the available data.

Common:

• Flushing (reddening of the face for a few minutes), dizziness, feeling of weakness, fatigue, somnolence, tiredness, altered sensation in limbs or other body parts.
• Brief increase in blood pressure shortly after taking the medicine.
• Difficulty breathing.
• Feeling unwell (nausea) or malaise (vomiting) – when not caused by the migraine attack itself.
• Sensation of heaviness (usually transient, which may be intense and affect any part of the body, including chest and throat), muscle pain, tingling sensations, warmth, cold, pressure or tightness. If these effects persist or are particularly severe, especially if they involve chest or cardiac pain radiating to the arms, consult your doctor immediately, as there have been rare reports of similar problems caused by a heart attack.

Very rare:

• Minor disturbances in liver function.

Not known:

• Allergic reactions ranging from skin reactions (rash – red spots or urticaria – skin blisters) to anaphylaxis (sudden breathlessness, palpitations or chest tightness, swelling of eyelids, face or lips).
• Seizures (usually in individuals with a history of epilepsy), chills, tremors, uncontrolled movements, motor difficulties.
• Visual disturbances including flickering vision, double vision and blurred vision. Cases of permanent visual defects have been reported.
• Inflammation of the colon (a part of the intestine), diarrhoea.
• Drop in blood pressure which may cause a feeling of faintness, especially when standing up.
• Slowing or speeding up of heartbeat, palpitations (awareness of rapid heartbeat), changes in heart rhythm.
• Neck stiffness, joint pain.
• Anxiety.
• Excessive sweating.

If you have had a blood test to check your liver function and have taken SUMATRIPTAN DOC Generici at the same time, inform your doctor, as the medicine may have influenced the test results.
If any of the following symptoms occur, stop taking SUMATRIPTAN DOC Generici and
contact your doctor immediately:

• Sudden breathlessness, palpitations or chest tightness, difficulty breathing, swelling of eyelids, face or lips, skin rash – red spots or urticaria (skin lumps), which may be signs of an allergic reaction.
• Seizures (usually in individuals 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 diarrhoea.
• Raynaud's syndrome, which may present as paleness or bluish discoloration of the skin and/or pain in fingers, toes, ears, nose or jaw in response to cold or stress.

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE SUMATRIPTAN DOC Generici

Keep SUMATRIPTAN DOC Generici out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use SUMATRIPTAN DOC Generici after the expiry date stated on the packaging
following the word 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

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What SUMATRIPTAN DOC Generici contains

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

Description of the appearance of SUMATRIPTAN DOC Generici and the contents of the pack
Coated tablet (tablet).
50 mg: white, oval, biconvex tablets with a break line on both sides and edges,
engraved with "SN" on one side and "50" on the other.
100 mg: white, oval, biconvex tablets, engraved with "SN" on one side and "100" on the other.
Pack sizes:
Blister packs: 2, 3, 4, 6, 18 and 24 tablets.
Plastic containers for tablets: 2, 3, 4, 6, 18 and 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano
Manufacturer
Actavis hf., P.O. Reykjavíkurvegur 78, IS-222 Hafnarfjörður, Iceland.
Lachifarma S.r.l. Laboratorio Chimico Salentino S.S. 16 Zona Industriale, 73010 Zollino (LE), Italy
This patient information leaflet was last approved in:
March 2013
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