Sumatriptan 100mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER_
Sumatriptan 50mg Film-coated Tablets Sumatriptan 100mg Film-coated Tablets (Sumatriptan succinate)
Read all of this carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sumatriptan tablets are and what are they used for
2. What you need to know before you take Sumatriptan tablets
3. How to take Sumatriptan tablets
4. Possible side effects
5. How to store Sumatriptan tablets
6. Contents of the pack and other information_
1. What Sumatriptan tablets are and what are they used for
The name of your medicine is Sumatriptan 50mg and 100mg Film coated Tablets. The active substance present in these tablets is Sumatriptan Succinate.
• Sumatriptan tablets belong to a group medicine called 5-hydroxytryptamine (5HT1), receptor agonists.
• Sumatriptan tablets are used for the acute relief of migraine attacks. The symptoms of migraine may be due to temporary swelling of blood vessels in the head. Medicines like Sumatriptan are believed to work by reducing the size of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.
2. What you need to know before you take Sumatriptan tablets Do not take Sumatriptan tablets:
• if you are allergic to Sumatriptan, any of the other ingredients in Sumatriptan tablets (these are listed in section 6)
• if you have heart problems including heart failure, a previous heart attack, angina (chest pains) or irregular heart beats or narrowing of the arteries (ischaemic heart disease)
• if you have had a stroke or mini-stroke (also known as transient ischaemic attack or TIA, that lasts only a few minutes)
• if you have high blood pressure or are being treated for it
• if you have serious liver disease
• if you have circulation problems in your legs or have cramp-like pains in your legs when you walk, or if your doctor has told you that you suffer from peripheral vascular disease
Do not take Sumatriptan Tablets with the following medicines:
With other migraine medicines, including those which contain ergotamine, or similar medicines such as methysergide maleate; or any triptan or 5-HT1 agonist (such as naratriptan or zolmitriptan)
With any of the following anti-depressants:
• MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI in the last 2 weeks
• SSRIs (selective serotonin reuptake inhibitors) including citalopram, fluoxetine, fluvoxamine, paroxetine and sertaline
• SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine and duloxetine
• for children under 18 years of age Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine;
• If you are a heavy smoker or are using nicotine replacement therapy, and especially
• If you are a man aged over 40, or
• If you are a woman who has been through the menopause.
In very rare cases, people have developed serious heart conditions after using Sumatriptan tablets, even though they had no signs of heart disease before. If any of the points above applies to you it could mean you have a greater risk of developing heart disease -so: tell your doctor so that your heart function can be checked before Sumatriptan is prescribed for you.
• If you have a history of tits (seizures) or if you have other conditions which might make it more likely that you'll have a fit - for example, a head injury or alcoholism.
• If you have liver or kidney disease
• If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Sumatriptan. If you know you are allergic to an antibiotic but you are not sure whether it is a sulphonamide: tell your doctor or pharmacist before using sumatriptan.
• If you are taking anti-depressants called SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors). Tell your doctor or pharmacist before taking Sumatriptan.
• If you use Sumatriptan frequently
Using Sumatriptan too often may make your headaches worse.
Tell your doctor if this applies to you. He or she may recommend you to stop using Sumatriptan.
• If you feel pain or tightness in your chest after you use sumatriptan
These effects may be intense but they usually pass quickly. If they don't pass quickly, or they become severe: get medical help immediately. Section 4 (overleaf) has more information about these possible side effects.
Other medicines and Sumatriptan Tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Some medicines must not be taken with Sumatriptan and others may cause adverse effects if they're taken with Sumatriptan. You must tell your doctor if you are taking:
• ergotamine also used to treat migraine, or similar medicines such as methysergide maleate; or any triptan or 5-HT1 agonist (such as naratriptan or zolmitriptan). Don't use Sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan. Don't take them again for at least 6 hours after using Sumatriptan
• MAOIs used to treat depression. Don't use Sumatriptan if you have taken these in the last 2 weeks
• SSRIs and SNRIs used to treat depression. Using Sumatriptan with these medicines can cause serotonin syndrome (a collection of symptoms which can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heartbeat and shaking). Tell your doctor immediately if you are affected in this way.
• St John's Wort (Hypericum perforatum). Taking herbal remedies that contain St John's Wort together with Sumatriptan may make side effects more likely.
Pregnancy, breast-feeding and fertility Pregnancy
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. There is only limited information about the safety of Sumatriptan for pregnant women, though up till now there is no evidence of any increased risk of birth defects. Your doctor will discuss with you whether or not you should use Sumatriptan while you are pregnant
Breast-Feeding
• Don't breast-feed your baby for 12 hours after using Sumatriptan.
If you express any breast milk during this time, discard the milk and don't give it to your baby.
Driving and using machines
• Sumatriptan tablets may cause drowsiness. If this happens to you then DO NOT drive or use machinery.
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Sumatriptan Tablets contain Lactose
• Sumatriptan tablets contain lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, speak to your doctor before taking this medicinal product.
| 3. How to take Sumatriptan tablets ~~|
Always take Sumatriptan tablets exactly as prescribed by your doctor. You should check with your doctor or pharmacist if you are not sure. Swallow each tablet whole with water.
When to take Sumatriptan tablets
• It's best to take sumatriptan as soon as you feel a migraine coming
on, although you can take it at any time during an attack
• Don't use sumatriptan to try to prevent an attack - only use it after your migraine symptoms start.
Dosage: Adults aged 18 to 65
• Usual dose of Sumatriptan 50mg tablets is one tablet at the first sign of a migraine attack. (Some patients may need to take a dose of two Sumatriptan 50mg tablets; you should follow your doctor's instruction.)
• If your tablet does not make your migraine better do not take any more tablets for this attack because it is unlikely that a second dose will work. Sumatriptan tablets can be used for your next attack.
• If, after your first dose, your migraine goes away but then returns, you may take another tablet provided it is at least two hours since you took the first tablet.
• DO NOT TAKE MORE THAN 3 tablets of 100mg strength or 6 tablets of 50mg strength in any 24-hour period. (Total of 300mg).
Children under 18 and adults over 65
Do not take this medicine if you are under 18 or over 65 and have migraine symptoms. Please talk to your doctor.
If you take more Sumatriptan tablets than you should
• It is important to keep to the dose on the label or follow the instructions above. Taking more than this could make you ill. If you have taken more than 300 mg (i.e. six 50mg tablets or three 100mg tablets) in 24 hours then contact your doctor or your nearest accident and emergency department.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
| 4. Possible side effects ~~|
Like all medicines, Sumatriptan tablets can cause side effects, although not everybody gets them. However, some people may experience side effects. If you experience any of the following symptoms soon after taking Sumatriptan tablets, don't take any more. Go to the nearest A&E department, taking the packaging and this leaflet with you.
The following side effects have occurred but their exact frequency is not known.
• The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; complete collapse.
If you get any of these following symptoms soon after using Sumatriptan:
• Don't use any more. Contact your doctor straight away.
Common side effects (affect up to 1 in 10 people)
• Pain, heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations, including numbness, tingling and warmth or cold. These effects may be intense but generally pass quickly. If these effects continue or become severe (especially the chest pain): get medical help urgently. In a very small number of people these symptoms can be caused by a heart attack.
Other common side effects include:
• Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself
• Tiredness or drowsiness
• Dizziness, feeling weak, or getting hot flushes
• Temporary increase in blood pressure
• Shortness of breath
• Aching muscles.
Very rare side effects (affect up to 1 in 10,000 people)
• Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are taking Sumatriptan tablets.
Some patients may get the following side effects but it is not known
how often they occur
• Seizures/fits, tremors, muscle spasm, neck stiffness
• Visual disturbances such as flickering, reduced vision, double vision, loss of vision, and in some cases even permanent defects (although these may be due to the migraine attack itself)
• Heart problems, where your heartbeat may go faster, slower or change rhythm, chest pains (angina) or heart attack
• Pale, blue-tinged skin and/or pain in your fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud's phenomenon)
• Feeling faint (blood pressure may go down)
• Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis)
• Diarrhoea
• Pain in the joints
• Feeling anxious
• Excessive sweating.
Repotting of side effects
If you get any side effect, 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. How to store Sumatriptan tablets ~|
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
| 6. Contents of the pack and other information ~|
What Sumatriptan tablets contain:
• The active ingredient in Sumatriptan tablets is Sumatriptan Succinate
• The other ingredients are lactose monohydrate, microcrystalline cellulose (Avicel PH101), pregelatinised starch (starch 1500), microcrystalline cellulose (Avicel PH200), croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), purified talc, macrogol 6000.
• In addition the 50mg strength also contains ferric oxide yellow (E172) and ferric oxide red (E172).
What Sumatriptan tablets looks like and contents of pack:
• Sumatriptan 100mg Film-Coated Tablets are white, capsule shaped, biconvex film coated tablet with ”BL" embossing on one side and plain on the other side.
• Sumatriptan 50mg Film-Coated Tablets are peach coloured, capsule shaped, biconvex, film coated tablet with ”BL" embossing on one side and plain on the other side
• Each pack of 100mg strength contains 6 or 12 tablets in blister strips.
• Each pack of 50mg strength contains 2, 6 or 12 tablets in blister strips.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder/Manufacturer:
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom.
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Sumatriptan 50mg Film-coated Tablets; PL 17907/0216
Sumatriptan 100mg Film-coated Tablets; PL 17907/0217
This leaflet was last revised in Decmber 2014
To request a copy of this leaflet in braille, large print or audio format, please
contact the licence holder at the address (or telephone, fax, email) above.
V5 16-12-2014 D0 S
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