SUMATRIPTAN TABLETS 50MG
Active substance: SUMATRIPTAN SUCCINATE
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PATIENT INFORMATION: LEAFLET FOR THE USER
Sumatriptan
Sumatriptan 50mg Tablets Sumatriptan 100mg Tablets
SZ00000LT000
In this leaflet: 1. What Sumatriptan Tablets are and what they are used for 2. Before you take Sumatriptan Tablets 3. How to take Sumatriptan Tablets 4. Possible side effects 5. How to store Sumatriptan Tablets 6. Further information
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 effects not listed in this leaflet, please tell your doctor or pharmacist.
You must not use sumatriptan to prevent a migraine attack.
Sumatriptan works only when a migraine attack has started. It will not stop you from getting an attack.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan is believed to reduce the widening 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.
Sumatriptan belongs to a group of medicines called triptanes, which are used to treat migraine headache.
1
What Sumatriptan Tablets are and what they are used for
If you take Sumatriptan too often, your headache may become worse. In this case, your doctor might recommend you stop taking sumatriptan.
After taking Sumatriptan you may feel pain in your chest and a feeling of pressure for a short time. This can be quite intensive and may radiate up towards your throat. In very rare cases this may be caused by effects on your heart. Therefore, if the symptoms do not disappear, contact your doctor.
Sumatriptan must only be used if a diagnosis of migraine has been clearly established in your case and other factors have been excluded. Certain forms of migraine cannot be treated with sumatriptan.
Take special care with Sumatriptan Before you start using Sumatriptan, you should tell your doctor if: you are a heavy user of tobacco or products containing nicotine (patches or chewing gum), especially if you are a woman past the menopause or a man over 40 years. The doctor should examine you first. you have liver or kidney impairment. The doctor might adjust the dose. you have ever suffered seizures/fits (convulsions) or have a predisposition to seizures/fits (convulsions); sumatriptan can cause seizures/fits. Sumatriptan might increase the risk of seizures. you are allergic (hypersensitive) to certain antibiotics (sulphonamides). You may experience an allergic reaction after taking sumatriptan. Caution is advisable.
Do not take Sumatriptan if you are allergic (hypersensitive) to sumatriptan or any of the other ingredients of Sumatriptan (see also Take special care with Sumatriptan if you are allergic (hypersensitive) to certain antibiotics (sulphonamides). if you have or have ever had heart problems, including a heart attack, angina (chest pain caused by exercise or effort), Prinzmetals angina (chest pain which happens at rest) or have experienced heart related symptoms such as shortness of breath or pressure over the chest if you have problems with the blood circulation to your hands and feet (peripheral vascular disease) if you have had a stroke/cerebral infarction, also described as an attack or cerebral haemorrhage (CVA; cerebrovascular accident) if you have had a temporary disturbance of the blood supply to the brain that left little or no residual symptoms (TIA) if you have severe liver function impairment if you have high blood pressure if you are taking drugs containing ergotamine or ergotamine derivatives (migraine drugs such as methysergide) or any triptan/5-HT1 receptor agonist. These must not be taken at the same time as Sumatriptan (see also Taking other medicines) if you are currently taking or stopped taking MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease) two weeks ago. See also Taking other medicines below.
2
Before you take Sumatriptan Tablets
Important information about some of the ingredients of Sumatriptan If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Driving and using machines Migraine itsself as well as using sumatriptan can cause drowsiness, dizziness and weakness which may adversely affect your speed of reaction. Wait until you have found out how you react to sumatriptan before you drive or use machines.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding Sumatriptan passes into breast milk. You are advised not to breastfeed within 12 hours after taking Sumatriptan. Do not feed your child with milk expressed during this period.
Pregnancy During pregnancy, sumatriptan must only be taken following consultation with your doctor. Sumatriptan should be used during the pregnancy only if the potential benefit to the mother outweighs the potential risk to the unborn child and no other appropriate treatment option is available.
Please note that the above medicines may be known to you by other names, often the brand names. In this section only the active ingredient or therapeutic group of the medicine is given, and not the brand name. Always thoroughly check the pack and information leaflet of the medicines you are already using for the active ingredient or therapeutic group of that medicine.
medicines containing ergotamine (migraine drugs, including methysergide) and triptans/5-HT1 receptor agonists. These must not be taken at the same time as Sumatriptan (see Do not take Sumatriptan). After taking medicines containing ergotamine or another triptan/5-HT1 receptor agonist, you are advised to wait at least 24 hours before taking Sumatriptan. After taking Sumatriptan you are advised to wait at least 6 hours before taking medicines containing ergotamine and at least 24 hours before taking another triptan/5-HT1 receptor agonist. MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease). Sumatriptan must not be taken at the same time as or within two weeks after stopping use of MAO inhibitors. medicines for depression and other mental conditions called SSRIs and SNRIs. Side effects may occur. lithium (for manic/depressive (bipolar) disorders) Herbal products containing St Johns wort (Hypericum perforatum). Side effects may occur with greater frequency.
An interaction means that medicines used at the same time can influence the effect(s) and/or side effect(s) of each other. The following comments may also apply to medicines that you have used any time in the past or are to use in the near future.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Dosage: Adults: The usual dose is 50 mg Sumatriptan in the event of a migraine attack. Some patients may need to take a dose of 100 mg Sumatriptan. Children and adolescents (under 18 years of age): Sumatriptan is not recommended in children and adolescents.
Always take Sumatriptan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
3
How to take Sumatriptan Tablets
Continued on the next page >>
If you forget to take Sumatriptan Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you take more Sumatriptan than you should When you take too much of Sumatriptan, immediately contact your doctor or pharmacist. Side effects such as those mentioned under Possible side effects may occur.
The recommended dose must not be exceeded.
If, after the first dose, your symptoms are reduced, but then return, you may take a second or third dose, provided that there is a minimum interval of 2 hours between the two doses. You must not take more than 300 mg of Sumatriptan in any 24-hour period.
Duration of treatment: If symptoms are not reduced after the first dose, you must not take a second dose for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs, such as ibuprofen. In the event of a subsequent attack, Sumatriptan can be taken again.
If you find the effect of Sumatriptan to be too strong or not strong enough, tell your doctor or pharmacist.
Method of administration: Take the tablet with water, preferably as soon as possible after onset of the migraine attack. The sumatriptan substance has a bitter taste. The bitter taste is masked with the aid of a grapefruit flavour.
Patients with liver impairment: Your doctor may prescribe you low doses of - 1 tablet Sumatriptan 50 mg.
Elderly (over 65 years of age): Sumatriptan is not recommended for this age group.
Do not use Sumatriptan after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
5
How to store Sumatriptan Tablets
Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Side effects, whose frequency is not known according to the available data: Allergic reactions of all degrees of severity varying from skin reactions to allergic shock Temporary disturbances of the blood circulation of the heart, spasms of the blood vessels of the heart, chest pain, heart attack Slow heart beat, fast heart beat, irregular heart beat, palpitations Fits/seizures Tremor, tremor of the eyes Visual field disturbances Muscle tone disturbances Impaired vision, e.g. double vision, flickering and sometimes loss of vision with permanent impairment. Visual disturbances can also occur as a result of the migraine attack itself. Fall in blood pressure, reduced blood flow to the arms and legs and consequent pallor and blue tinge to the fingers and toes Spasms of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea. Diarrhoea Stiff neck, pain in the joints Minor disturbances in liver function tests Feeling anxious Excessive sweating
Very rare side effects (affect less than 1 in 10,000 persons treated): Disturbances in liver function tests
Uncommon side effects (affect 1 to 10 in 1,000 persons treated) Somnolence
Common side effects (affect 1 to 10 in 100 persons treated): Feeling of heaviness or sensations of heat or cold, pressure or tightness.These effects may be intense, affect any part of the body including the chest and throat but generally pass quickly. Feeling dizzy Feeling sleepy Feeling of unusual sensations, including numbness or tingling Temporary increase in blood pressure, soon after intake Hot flushes Breathlessness Feeling sick and vomiting. This may be due to the migraine itself. Aching muscles Pain Feeling of weakness or tiredness. These effects are mostly mild to moderate in intensity and pass quickly.
Like all medicines Sumatriptan can cause side effects, although not everybody gets them. Some of the symptoms reported as undesirable effects may be associated symptoms of migraine. The side effects are listed by the following frequency:
4
Possible side effects
Sumatriptan 100 mg tablets are available in packs of 2, 3, 4, 6, 12, 18, 19, 20, 24 and 30 tablets. Marketing Authorisation Holder Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. Not all pack sizes may be marketed.
Sumatriptan 50 mg tablets are available in packs of 2, 3, 4, 6, 8, 12, 18, 20, 24, 30, 50 and 100 tablets.
Sumatriptan 100 mg tablets are white/off-white, biconvex, oblong tablets with a break-line on both sides. The tablet can be divided into equal halves.
What Sumatriptan looks like and contents of the pack Sumatriptan 50 mg tablets are pink, biconvex, oblong tablets with a break-line on both sides. The tablet can be divided into equal halves.
The other ingredients are: Ammonium methacrylate copolymer type A, carmellose sodium (E466), microcrystalline cellulose (E450), croscarmellose sodium (E468), lactose monohydrate, magnesium stearate (E470b), flavouring (grapefruit). The 50mg tablet also contains red iron oxide (E172) and yellow iron oxide (E172)
What Sumatriptan contains The active substance is sumatriptan. Each tablet contains 50 mg sumatriptan (as sumatriptan succinate). Each tablet contains 100 mg sumatriptan (as sumatriptan succinate).
6
Further information
Tillomed Laboratories Ltd., 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 3ET, UK. This leaflet was last revised in 02/2013.
Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork, Ireland or
Manufacturer Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or
SZ00000LT000
Sumatriptan
Sumatriptan 50mg Tablets Sumatriptan 100mg Tablets
SZ00000LT000
In this leaflet: 1. What Sumatriptan Tablets are and what they are used for 2. Before you take Sumatriptan Tablets 3. How to take Sumatriptan Tablets 4. Possible side effects 5. How to store Sumatriptan Tablets 6. Further information
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 effects not listed in this leaflet, please tell your doctor or pharmacist.
You must not use sumatriptan to prevent a migraine attack.
Sumatriptan works only when a migraine attack has started. It will not stop you from getting an attack.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan is believed to reduce the widening 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.
Sumatriptan belongs to a group of medicines called triptanes, which are used to treat migraine headache.
1
What Sumatriptan Tablets are and what they are used for
If you take Sumatriptan too often, your headache may become worse. In this case, your doctor might recommend you stop taking sumatriptan.
After taking Sumatriptan you may feel pain in your chest and a feeling of pressure for a short time. This can be quite intensive and may radiate up towards your throat. In very rare cases this may be caused by effects on your heart. Therefore, if the symptoms do not disappear, contact your doctor.
Sumatriptan must only be used if a diagnosis of migraine has been clearly established in your case and other factors have been excluded. Certain forms of migraine cannot be treated with sumatriptan.
Take special care with Sumatriptan Before you start using Sumatriptan, you should tell your doctor if: you are a heavy user of tobacco or products containing nicotine (patches or chewing gum), especially if you are a woman past the menopause or a man over 40 years. The doctor should examine you first. you have liver or kidney impairment. The doctor might adjust the dose. you have ever suffered seizures/fits (convulsions) or have a predisposition to seizures/fits (convulsions); sumatriptan can cause seizures/fits. Sumatriptan might increase the risk of seizures. you are allergic (hypersensitive) to certain antibiotics (sulphonamides). You may experience an allergic reaction after taking sumatriptan. Caution is advisable.
Do not take Sumatriptan if you are allergic (hypersensitive) to sumatriptan or any of the other ingredients of Sumatriptan (see also Take special care with Sumatriptan if you are allergic (hypersensitive) to certain antibiotics (sulphonamides). if you have or have ever had heart problems, including a heart attack, angina (chest pain caused by exercise or effort), Prinzmetals angina (chest pain which happens at rest) or have experienced heart related symptoms such as shortness of breath or pressure over the chest if you have problems with the blood circulation to your hands and feet (peripheral vascular disease) if you have had a stroke/cerebral infarction, also described as an attack or cerebral haemorrhage (CVA; cerebrovascular accident) if you have had a temporary disturbance of the blood supply to the brain that left little or no residual symptoms (TIA) if you have severe liver function impairment if you have high blood pressure if you are taking drugs containing ergotamine or ergotamine derivatives (migraine drugs such as methysergide) or any triptan/5-HT1 receptor agonist. These must not be taken at the same time as Sumatriptan (see also Taking other medicines) if you are currently taking or stopped taking MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease) two weeks ago. See also Taking other medicines below.
2
Before you take Sumatriptan Tablets
Important information about some of the ingredients of Sumatriptan If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Driving and using machines Migraine itsself as well as using sumatriptan can cause drowsiness, dizziness and weakness which may adversely affect your speed of reaction. Wait until you have found out how you react to sumatriptan before you drive or use machines.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding Sumatriptan passes into breast milk. You are advised not to breastfeed within 12 hours after taking Sumatriptan. Do not feed your child with milk expressed during this period.
Pregnancy During pregnancy, sumatriptan must only be taken following consultation with your doctor. Sumatriptan should be used during the pregnancy only if the potential benefit to the mother outweighs the potential risk to the unborn child and no other appropriate treatment option is available.
Please note that the above medicines may be known to you by other names, often the brand names. In this section only the active ingredient or therapeutic group of the medicine is given, and not the brand name. Always thoroughly check the pack and information leaflet of the medicines you are already using for the active ingredient or therapeutic group of that medicine.
medicines containing ergotamine (migraine drugs, including methysergide) and triptans/5-HT1 receptor agonists. These must not be taken at the same time as Sumatriptan (see Do not take Sumatriptan). After taking medicines containing ergotamine or another triptan/5-HT1 receptor agonist, you are advised to wait at least 24 hours before taking Sumatriptan. After taking Sumatriptan you are advised to wait at least 6 hours before taking medicines containing ergotamine and at least 24 hours before taking another triptan/5-HT1 receptor agonist. MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease). Sumatriptan must not be taken at the same time as or within two weeks after stopping use of MAO inhibitors. medicines for depression and other mental conditions called SSRIs and SNRIs. Side effects may occur. lithium (for manic/depressive (bipolar) disorders) Herbal products containing St Johns wort (Hypericum perforatum). Side effects may occur with greater frequency.
An interaction means that medicines used at the same time can influence the effect(s) and/or side effect(s) of each other. The following comments may also apply to medicines that you have used any time in the past or are to use in the near future.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Dosage: Adults: The usual dose is 50 mg Sumatriptan in the event of a migraine attack. Some patients may need to take a dose of 100 mg Sumatriptan. Children and adolescents (under 18 years of age): Sumatriptan is not recommended in children and adolescents.
Always take Sumatriptan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
3
How to take Sumatriptan Tablets
Continued on the next page >>
If you forget to take Sumatriptan Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you take more Sumatriptan than you should When you take too much of Sumatriptan, immediately contact your doctor or pharmacist. Side effects such as those mentioned under Possible side effects may occur.
The recommended dose must not be exceeded.
If, after the first dose, your symptoms are reduced, but then return, you may take a second or third dose, provided that there is a minimum interval of 2 hours between the two doses. You must not take more than 300 mg of Sumatriptan in any 24-hour period.
Duration of treatment: If symptoms are not reduced after the first dose, you must not take a second dose for the same attack. In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs, such as ibuprofen. In the event of a subsequent attack, Sumatriptan can be taken again.
If you find the effect of Sumatriptan to be too strong or not strong enough, tell your doctor or pharmacist.
Method of administration: Take the tablet with water, preferably as soon as possible after onset of the migraine attack. The sumatriptan substance has a bitter taste. The bitter taste is masked with the aid of a grapefruit flavour.
Patients with liver impairment: Your doctor may prescribe you low doses of - 1 tablet Sumatriptan 50 mg.
Elderly (over 65 years of age): Sumatriptan is not recommended for this age group.
Do not use Sumatriptan after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
5
How to store Sumatriptan Tablets
Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Side effects, whose frequency is not known according to the available data: Allergic reactions of all degrees of severity varying from skin reactions to allergic shock Temporary disturbances of the blood circulation of the heart, spasms of the blood vessels of the heart, chest pain, heart attack Slow heart beat, fast heart beat, irregular heart beat, palpitations Fits/seizures Tremor, tremor of the eyes Visual field disturbances Muscle tone disturbances Impaired vision, e.g. double vision, flickering and sometimes loss of vision with permanent impairment. Visual disturbances can also occur as a result of the migraine attack itself. Fall in blood pressure, reduced blood flow to the arms and legs and consequent pallor and blue tinge to the fingers and toes Spasms of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea. Diarrhoea Stiff neck, pain in the joints Minor disturbances in liver function tests Feeling anxious Excessive sweating
Very rare side effects (affect less than 1 in 10,000 persons treated): Disturbances in liver function tests
Uncommon side effects (affect 1 to 10 in 1,000 persons treated) Somnolence
Common side effects (affect 1 to 10 in 100 persons treated): Feeling of heaviness or sensations of heat or cold, pressure or tightness.These effects may be intense, affect any part of the body including the chest and throat but generally pass quickly. Feeling dizzy Feeling sleepy Feeling of unusual sensations, including numbness or tingling Temporary increase in blood pressure, soon after intake Hot flushes Breathlessness Feeling sick and vomiting. This may be due to the migraine itself. Aching muscles Pain Feeling of weakness or tiredness. These effects are mostly mild to moderate in intensity and pass quickly.
Like all medicines Sumatriptan can cause side effects, although not everybody gets them. Some of the symptoms reported as undesirable effects may be associated symptoms of migraine. The side effects are listed by the following frequency:
4
Possible side effects
Sumatriptan 100 mg tablets are available in packs of 2, 3, 4, 6, 12, 18, 19, 20, 24 and 30 tablets. Marketing Authorisation Holder Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. Not all pack sizes may be marketed.
Sumatriptan 50 mg tablets are available in packs of 2, 3, 4, 6, 8, 12, 18, 20, 24, 30, 50 and 100 tablets.
Sumatriptan 100 mg tablets are white/off-white, biconvex, oblong tablets with a break-line on both sides. The tablet can be divided into equal halves.
What Sumatriptan looks like and contents of the pack Sumatriptan 50 mg tablets are pink, biconvex, oblong tablets with a break-line on both sides. The tablet can be divided into equal halves.
The other ingredients are: Ammonium methacrylate copolymer type A, carmellose sodium (E466), microcrystalline cellulose (E450), croscarmellose sodium (E468), lactose monohydrate, magnesium stearate (E470b), flavouring (grapefruit). The 50mg tablet also contains red iron oxide (E172) and yellow iron oxide (E172)
What Sumatriptan contains The active substance is sumatriptan. Each tablet contains 50 mg sumatriptan (as sumatriptan succinate). Each tablet contains 100 mg sumatriptan (as sumatriptan succinate).
6
Further information
Tillomed Laboratories Ltd., 3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 3ET, UK. This leaflet was last revised in 02/2013.
Rowa Pharmaceuticals Ltd., Newtown, Bantry, Co. Cork, Ireland or
Manufacturer Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or
SZ00000LT000
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
