Sumatriptan 50mg Tablets
GALPHARM MIGRAINE RECOVERY 50 MG TABLETS
Sumatriptan
PATIENT INFORMATION LEAFLET
This medicine is used to relieve migraine attacks (with or without an aura), in people who have been diagnosed with migraine.
• This medicine is for use by adults aged between 18 and 65 years.
• Do not take this medicine:
• There are some people who should not use this medicine. To find out if you are one of them see section 2
• Speak to your doctor or pharmacist:
• If you suffer from any of the conditions mentioned in section 2. See section 2
• If you are taking any other medicines. See section 2
• Follow the dosage instructions carefully.
These are shown in the dosage table. See Section 3
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
IN THIS LEAFLET:
1. What this medicine is for
2. Before taking this medicine
• Do not take this medicine.
• Talk to your doctor or pharmacist before taking this medicine.
• Talk to your doctor or pharmacist before taking this medicine if you are taking any of these medicines.
• If you are pregnant or breast-feeding.
• Driving and using machines.
• Some of the ingredients may cause problems.
• Special warnings about this medicine.
3. How to take this medicine
• Dosing Information .
• Special warnings whilst taking this medicine.
• If anyone takes too much of this medicine.
• If you forget to take the medicine.
4. Possible Side-Effects
• If you experience any of the following, stop using the medicine and seek immediate medical help.
• If you experience any of the effects stop using the medicine and talk to your doctor.
• Other effects which may occur include.
5. Storing this medicine
6. Further Information
• What’s in this medicine?
• What the medicine looks like.
7. Information on Migraine
1 WHAT THIS MEDICINE IS FOR
This medicine is a medicine which is used to relieve migraine attacks (with or without an aura), in those people who have been diagnosed with Migraine.
The tablets contain sumatriptan, which belongs to a group of medicines called triptans (5-HT1 receptor agonists). The tablets are believed to work on the imbalance of the body’s natural chemicals which have caused the blood vessels in the head to temporarily swell. The tablets help to relieve the headache and other symptoms of a migraine, such as feeling sick and sensitivity to light and sound. They start to relieve the headache within about 30 minutes of taking them.
This medicine is for use in adults between the age of 18 and 65 years.
2 BEFORE TAKING THIS MEDICINE
This medicine is suitable for most adults, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Do not take this medicine:
• If you have not been diagnosed with migraine by a doctor or pharmacist.
• To try and prevent a migraine attack - only take it when your headache begins.
• If you have ever had a bad reaction to triptans, sulphonamide antibiotics or any of the ingredients in this medicine (see section 6).
• If you have heart problems including heart failure, a previous heart attack, angina (chest pains) or irregular heart beat.
• If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA).
• If you have high blood pressure or are being treated for it.
• If you have kidney or liver disease.
• If you have epilepsy or are prone to fits.
• If you have circulation problems in your legs and have cramp-like pains in your legs when you walk, or if your doctor has told you that you suffer from peripheral vascular disease.
• If you have been told by your doctor that you have one of the rare types of migraine known as hemiplegic, basilar or ophthalmoplegic migraine.
• If you are taking any of the following medicines:
• Ergotamine or derivatives of ergotamine (drugs which are also used to treat migraines such as methysergide).
• Triptans (5-HT1 receptor agonists) (drugs which are also used to treat migraines such as zolmitriptan, rizatriptan and naratriptan or any other sumatriptan containing products).
• Monoamine Oxidase Inhibitors (MAOIs) (drugs used to treat mood disorders) either now or within the past 2 weeks.
If any of these apply to you, get advice from a doctor or pharmacist without using this medicine.
Talk to your doctor or pharmacist before taking this medicine:
• If your headache normally lasts for longer than 24 hours.
• If your pattern of symptoms has changed.
• If your migraine attacks have become more frequent, are worse than usual and last longer.
• If you do not recover completely between attacks.
• If you have four or more migraine attacks each month.
• If you are over 50 and this is your first headache of this type.
• If your migraine includes symptoms such as:
• weakness on one side of your body
• double vision
• clumsy and uncoordinated movements
• tinnitus (ringing in the ears)
• reduced level of consciousness
• seizure (fit)- like movements
• a recent rash with a headache
If any of these bullet points apply to you now, or in the past, talk to a doctor or pharmacist before taking this medicine.
Talk to your doctor before taking this medicine if you are taking any of these medicines:
• Antidepressants:
• Monoamine Oxidase Inhibitors (drugs used to treat mood disorders) - see Do not take this medicine section.
• Tricyclic Antidepressants (drugs used to treat mood disorders including doxepin and amitriptyline).
• SSRIs and SNIRs
• Selective Serotonin Reuptake Inhibitors (SSRIs) (drugs used to treat mood disorders including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline).
• Serotonin Noradrenaline Reuptake Inhibitors (SNRIs) (drugs used to treat mood disorders including venlafaxine and duloxetine).
• Combined oral contraceptives (“the pill”).
• St John’s Wort (hypericum perforatum) (a herbal medicine).
If you are pregnant or breast-feeding
If you are pregnant, think you are pregnant or you are breast-feeding, do not take this medicine unless your doctor has told you that it is safe to do so.
Driving and using machines
Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, do not drive or operate machinery.
Some of the ingredients can cause problems
The tablets contain lactose. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor or pharmacist before taking the tablets.
Special warnings about this medicine
• Your pharmacist will have checked the points listed below to make sure this medicine is right for you.
• If you are a man over 40, or a woman who has had the menopause
• If you are very overweight
• If you are a regular smoker (more than 10 cigarettes a day) or use Nicotine Replacement Therapy (NRT)
• If you have diabetes
• If you have high cholesterol
• If you have a close relative who developed early heart disease - either your father or brother developed heart disease before the age of 55, or your mother or sister developed heart disease before the age of 65.
If three or more of the points apply to you, you may be at higher risk of heart disease- see your doctor without taking this medicine. If you are not sure, your doctor or pharmacist can help.
• Prolonged use of any type of painkiller for headaches can make them worse. If your headaches are daily or very frequent or getting worse you should contact your doctor.
3 HOW TO TAKE THIS MEDICINE
Check the table below to see how much medicine to take.
• For oral use only.
• Do not use more than the stated dose shown in the table.
• Swallow the tablet whole with a drink of water.
Children and Adolescents under the age of 18 years
This medicine should not be taken by children and adolescents under the age of 18 years. Contact your doctor.
Adults aged 18 to 65 years
|
Age |
Dose |
|
Adults aged 18 to 65 years |
• Take one tablet as soon as possible at the first signs of a migraine headache. • If your symptoms start to come back you can take a second tablet after 2 hours. You must leave at least 2 hours after the first tablet |
|
• Don’t take more than two tablets in 24 hours. • Don’t take more than two tablets for the same attack. • If the first tablet does not provide any relief: Don’t take a second tablet. | |
Adults over the age of 65 years
This medicine should not be taken by adults over the age of 65 years. Contact your doctor.
Special Warnings whilst taking this medicine
• This medicine is only to relieve migraine symptoms. Don’t take it to try to prevent an attack. Don’t take them until you are sure it is a migraine and not just a headache.
• If you do not get relief from the pain whilst taking these tablets it may mean that you do not have a migraine and you should talk to your doctor or pharmacist.
• If you are taking antidepressants called SSRIs or SNRIs whilst taking this medicine it can make some side-effects more likely. If you experience weakness and/or lack of coordination, talk to your doctor. If you are not sure if you are taking an SSRI or SNRI, talk to your doctor or pharmacist.
• If you are on the combined pill whilst taking this medicine there is an increased risk of stroke. If your migraines have only begun within the last 3 months or your symptoms have worsened or you have migraine with an aura (attacks that start with disturbed vision or a change in sensation such as ‘pins and needles’), you should contact your doctor.
• Sometimes you can develop chest pain or tightness that may involve the throat. These effects usually occur within 30 minutes, are not usually troublesome and do not last too long, they can
however be intense. If they last for more than 2 hours or are very severe you should contact your doctor straight away. You should not take any more of this medicine.
If anyone takes too much of this medicine
If anyone takes too many tablets, contact your doctor or nearest Accident and Emergency department (Casualty) taking this leaflet with you.
If you forget to take the medicine
You should only take this medicine as required following the dosage instructions above carefully. Do not take a double dose.
4 POSSIBLE SIDE-EFFECTS
This product can cause side-effects, like all medicines, although these don’t affect everyone and are usually mild.
If you experience any of the following, stop using the medicine and seek immediate medical help: Very rare: (affect less than 1 in 10,000 people)
• Allergic reactions: sign of allergy include rash (such as hives); wheezing; breathlessness; swollen eyelids, face or lips; complete collapse.
• Seizures/fits.
• Pain in the lower left side of your stomach and bloody diarrhoea
• Heart problems, including heart attack and heart or chest pains
If you experience any of the effects stop using the medicine and talk to your doctor:
Very rare: (affect less than 1 in 10,000 people)
• Bad circulation which is shown by pale, blue- tinged skin and/or pain in your fingers, toes, ears, nose or jaw in response to cold or stress.
Common: (affect less than 1 in 10 people)
• Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, breathlesness or feelings of tingling, cold or warmth. These effects usually develop within 30 minutes of treatment, and are not usually troublesome. They may be intense, but they do not last long. If these effects continue for more than two hours, or are particularly severe (especially the chest pain), tell your doctor straight away.
Other effects which may occur include:
Very rare: (affect less than 1 in 10,000 people)
• Visual disturbances - although this is often part of the migraine attack itself.
• Heart beat may go faster, slower or change rhythm.
• Neck stiffness.
• Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are taking this medicine.
• Heart function changes. If you have an ECG to check your heart function tell your doctor or nurse that you are taking this medicine.
Common: (affect less than 1 in 10 people)
• Tingling, dizziness, drowsiness, flushing, decreased sensitivity (particularly to touch).
• Feeling sick, sickness.
• Feeling faint as your blood pressure may go up and down.
• Feeling weak or heavy.
Muscle pain. Shortness of breath.
Side-effects which occur but it is unknown how often:
• Diarrhoea.
• Pain in your joints.
• Anxiety.
• Excessive sweating.
• Shaking.
• Abnormal muscle rigidity.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5 STORING THIS MEDICINE
Keep the product out of the reach and sight of children.
There are no special storage precautions for these tablets.
Do not use your medicine if the pack is damaged, or after the expiry date on the packaging.
6 FURTHER INFORMATION What’s in this medicine?
The active ingredient in this medicine is: 50 mg Sumatriptan base (as sumatriptan succinate).
Other ingredients are: Lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol, glycerol triacetate, iron oxide red (E172), iron oxide yellow (E172) and iron oxide black (E172).
What the medicine looks like
This medicine is available in packs of 2 tablets which are peach coloured, scored oblong shaped film coated tablets marked with “5” and “0”.
Marketing Authorisation holder and manufacturer: TEVA UK Limited, Eastbourne, BN22 9AG, England.
Distributed by: Galpharm International Ltd, South Yorkshire, S75 3SP.
Leaflet approved: MM/YYYY
7 INFORMATION ON MIGRAINE
Most migraine attacks occur for no apparent reason. However, something may trigger migraine attacks in some people. Triggers can be all sorts of things. For example:
Diet. Dieting too fast, irregular meals, cheese, chocolate, red wines, citrus fruits.
Environmental. Smoking and smoky rooms, glaring light, VDU screens or flickering TV sets, loud noises, strong smells.
Psychological. Stress, anxiety, anger, tiredness, etc.
Other. Periods (menstruation), shift work, different sleep patterns, the menopause, some medicines e.g
the Pill.
It may help if you keep a migraine diary. Note down when and where each migraine attack started, what you were doing, and what you had eaten that day. A pattern may emerge, and it may be possible to avoid one or more things that may trigger your migraine attacks.
Further sources of help and information:
Migraine Action: Unit 6, Oakley Hay Lodge Business Park, Great Folds Road, Great Oakley, Northants, NN18 9AS. Tel: 01536 461 333.
Migraine Trust: 2nd Floor, 55-56 Russell Square, London, WC1B 4HP. Tel: 020 7436 1336.
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V 1.3.1 pil-uk-pl-00289-0586-sumatriptan-50mg-tablets-galpharm
Approvals
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Signed by |
Meaning of Signature |
Server Date |
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Darryl Hill |
Regulatory Affairs Approval |
19-Aug-2015 02:31:37 PM |
REG0075797 Version 1.10 Approved Page 8 of 8