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SUMATRIPTIN 100 MG FILM-COATED TABLETS

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Sumatriptan 50 mg and 100 mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sumatriptan 50 mg Tablets
Sumatriptan 100 mg Tablets
50 mg and 100 mg film-coated tablets
sumatriptan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Sumatriptan 50 mg & 100 mg Tablets is and what this medicine is used for
2. Before you take Sumatriptan 50 mg & 100 mg Tablets
3. How to take Sumatriptan 50 mg & 100 mg Tablets
4. Possible side effects
5. How to store Sumatriptan 50 mg & 100 mg Tablets
6. Further information

1. WHAT SUMATRIPTAN 50 MG & 100 MG TABLETS IS AND WHAT THIS MEDICINE
IS USED FOR
Your medicine comes as a tablet containing sumatriptan.
Sumatriptan tablets belong to a group of medicines called triptans (5HTreceptor agonists).
Sumatriptan 50 mg & 100 mg Tablets is an antimigraine medicine used to treat migraine attacks. A
migraine causes
attacks of headache, sometimes with sickness or other symptoms e.g. some people become
sensitive to light or noise.
Sumatriptan 50 mg & 100 mg Tablets should only be used when migraine headaches have been
diagnosed by a doctor.
Sumatriptan 50 mg & 100 mg Tablets should not be used for common headaches.

2. BEFORE YOU TAKE SUMATRIPTAN 50 MG & 100 MG TABLETS
Do not take this medicine and tell your doctor if:

you are allergic to sumatriptan or any other ingredients in this tablet, especially E124 –
cochineal red in the 50 mg tablet, which may cause allergic reactions

you have heart problems such as heart disease or angina

you have had a heart attack or stroke in the past

you have severe liver problems

you have significantly high blood pressure, or if your blood pressure is high despite
medication

 

Sumatriptan 50 mg and 100 mg film-coated tablets

you use, or have recently used, ergotamine, derivates of ergotamine (for migraine,
including methysergide), or any other triptan/5-hydroxytryptamine 1 (5-HT1) receptor agonist (for
instance zolmitriptan, rizatriptan, eletriptan for migraine)

you use, or have recently used, MAO inhibitors (for instance moclobemide for depression
or selegiline for Parkinson's disease)
Take special care with Sumatriptan 50 mg & 100 mg Tablets
You must tell your doctor before taking Sumatriptan 50 mg & 100 mg Tablets if:

you have liver or kidney problems

you have symptoms of heart disease, such as transient chest pain or a feeling of pressure in
your chest, which may also radiate towards your throat

if you are considered to be at risk of developing heart disease (e.g. diabetic, heavy smoker
or undergoing nicotine replacement therapy), and particularly if you are a post-menopausal woman
or a man over 40 years with these risk factors, your doctor should check your heart function before
prescribing Sumatriptan 50 mg & 100 mg Tablets. In very rare cases serious heart conditions have
occurred after taking Sumatriptan, even if no signs of any heart disease were found. Contact your
doctor for advice if you have any concerns

if you have epilepsy (fits), a history of fits or any other disease which increases your risk of
fits

if you are allergic to certain antibiotics called sulphonamides
Excessive use of sumatriptan (repeated use over several consecutive days) constitutes incorrect use
of this medicine and may cause an increase in side effects and lead to chronic headaches requiring
the temporary discontinuation of treatment. Consult your doctor if you start having too frequent
or daily headaches as you may suffer from medication overuse headache.
Taking other medicines
Please tell your doctor if you:

are taking medicines containing ergotamine or methysergide (to treat migraine)

are taking MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's
disease) or have stopped MAOI treatment in the last 2 weeks

are taking lithium (for manic/depressive (bipolar) disorders)

are taking selective serotonin re-uptake inhibitors (SSRI's for depression and other mental
conditions), serotonin noradrenaline reuptake inhibitors (SNRIs), or herbal remedies containing St.
Johns wort (Hypericum perforatum)
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without prescription, herbal medicines, or natural
products/remedies.
Pregnancy and breastfeeding
Experience of use during pregnancy is limited. Therefore, ask your doctor or pharmacist for advice
before taking Sumatriptan 50 mg & 100 mg Tablets during pregnancy.
Sumatriptan passes into breast milk. Therefore, breast-feeding should be avoided for 12 hours after
taking Sumatriptan 50 mg & 100 mg Tablets and any milk you express should be thrown away.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Sumatriptan may make you feel drowsy. If you area affected, do not drive or operate machinery.
Important information about some of the ingredients of Sumatriptan 50 mg & 100 mg
Tablets

 

Sumatriptan 50 mg and 100 mg film-coated tablets
Sumatriptan 50 mg & 100 mg Tablets contains lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE SUMATRIPTAN 50 MG & 100 MG TABLETS
Always take Sumatriptan 50 mg & 100 mg Tablets exactly as your doctor has told you. You should
check with your
doctor or pharmacist if you are not sure.
Sumatriptan 50 mg & 100 mg Tablets should not be used to prevent a migraine attack.
Swallow the tablet whole with a glass of water.
Dosage:
Adults

Take one 50 mg tablet as soon as possible at the start of the migraine.
In some cases, a 100 mg dose may be needed (your doctor will tell you which dose to take).


If your symptoms return, you can take a second tablet after two hours.

Do not take a second dose if the first dose had no effect. Maximum dose is 300 mg in 24 hours.
If you have problems with your liver your doctor may prescribe a lower dose.
Children and adolescents (under 18 years)
Sumatriptan 50 mg & 100 mg Tablets should not be given to children and adolescents.
If a child or adolescent takes your medicine contact your doctor or local hospital immediately.
Take the pack and any remaining tablets with you.
Elderly patients (over 65 years)
Sumatriptan 50 mg & 100 mg Tablets is not recommended.
If you take more Sumatriptan 50 mg & 100 mg Tablets than you should
If you take too much of your medicine contact your doctor, local hospital, or poisoning information
centre [to be completed nationally] immediately. Take the pack and any remaining tablets with you.
If you forget to take Sumatriptan 50 mg & 100 mg Tablets
Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like most medicines, Sumatriptan 50 mg & 100 mg Tablets can sometimes cause side effects,
although not everybody gets them.
The frequency of the side effects listed below is defined using the following convention:

Common: at least 1 in 100 and less than 1 in 10 patients

Very rare: less than 1 in 10,000
It is not known how often they may occur but the following side effects may be serious and you
should contact your doctor immediately and not take another dose:

Sudden wheeziness, fluttering or tightness in the chest, swelling of eyelids, face or lips,
skin rash – red spots or hives (skin lumps), which may be signs of an allergic reaction.

 

Sumatriptan 50 mg and 100 mg film-coated tablets

Fits (usually in people with a history of epilepsy).

Raynaud’s phenomenon, which might appear as paleness or a blue tinge to the skin and/or
pain of the fingers, toes, ears, nose or jaw in response to cold or stress.

Inflammation of the colon (part of the intestine), which may present as lower left-sided
tummy pain and/or bloody diarrhoea.
Common side effects

Flushing (redness of the face lasting a few minutes), dizziness, feelings of weakness,
tiredness and drowsiness (important if you are driving or working a machine).

Short lasting increases in blood pressure soon after taking the medicine

Feeling sick (nausea) or being sick (vomiting) – when not part of migraine attack.

Pins and needles (paraesthesia), pain in the muscles.

Hypoaesthesia (a condition where the body is much less sensitive than normal to
stimulation from such things as light, touch, or pain).

Pain, sensations of heat or cold, heaviness and pressure or tightness. If these effects
continue or are particularly severe, especially chest or heart pain which spreads to the arms, tell
your doctor immediately as there have been rare reports of such problems being caused by heart
attack.

Shortness of breath, difficult or laboured breathing (dyspnoea)
Very rare side effects

If you have a blood test to check how your liver is working and have taken Sumatriptan 50
mg & 100 mg Tablets, tell your doctor as it may affect the results.
The following side effects have also been reported but it is not known how frequently
they occur.

Visual disturbances including flickering, double vision and reduced vision. There have
been cases where permanent vision loss has occurred.

Lowering of blood pressure that can lead to a feeling of faintness especially on standing up.

Slowing or quickening in the speed of your heart beat, palpitations (feeling of fast heart
beat), changes in heart rhythm, chest pain.

Shaking, tremors or uncontrolled movements.

Diarrhoea, excessive perspiration.

Pain in a joint, neck stiffness, anxiety.

Seizures in patients with a history of seizures, but also in patients where no such
predisposing factors are apparent.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.

5. HOW TO STORE SUMATRIPTAN 50 MG & 100 MG TABLETS

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Sumatriptan 50 mg & 100 mg Tablets after the expiry date which is stated on
the carton after EXP. The expiry date refers to the last day of that month.

Do not use Sumatriptan 50 mg & 100 mg Tablets if you notice any visual damage to
Sumatriptan 50 mg & 100 mg Tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to protect the
environment.


 

Sumatriptan 50 mg and 100 mg film-coated tablets

6. FURTHER INFORMATION
What Sumatriptan 50 mg & 100 mg Tablets contains
For 50 mg:
The active substance is sumatriptan.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium,
magnesium stearate, talc, colloidal anhydrous silica, hypromellose, macrogol 6000, titanium
dioxide (E171), cochineal red (E124 – 50 mg tablets only) and triethyl citrate.
For 100 mg:
The active substance is sumatriptan.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium,
magnesium stearate, talc, colloidal anhydrous silica, hypromellose, macrogol 6000, titanium
dioxide (E171) and triethyl citrate.
What Sumatriptan 50 mg & 100 mg Tablets looks like and contents of the pack
Film-coated tablet
The 50 mg film coated tablets are light pink in colour, oblong, biconvex, tablets with a scoreline.
Pack sizes: 1, 2, 4, 6, 12 or 18 tablets.
The 100 mg film coated tablets are white in colour, oblong, biconvex tablets.
Pack sizes: 1, 2, 3, 4, 6, 12, 18 or 20 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Z.F. Polpharma SA, ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland
Manufacturer:
Z.F. Polpharma SA, ul. Pelplinska 19, 83-200 Starogard Gdanski, Poland
This medicinal product is authorized in the Member States of the EEA under the
following names:
Czech Republic: Sumamigren 50 mg, 100 mg
Hungary: Sumatriptan Polpharma
Slovakia: Sumamigren
United Kingdom: Sumatriptan 50 mg & 100 mg Tablets
Date of leaflet preparation: 07.05.2011


 

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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