50 mg and 100 mg tablets
sumatriptan
WHAT SUMATRIPTAN AUROBINDO IS AND WHAT IT IS USED FOR
The drug group triptans.
Sumatriptan Aurobindo belongs to the drug group triptans ( also known as 5-HT 1 – receptor agonists ) which are used to treat migraine headaches.
Migraine symptoms are probably caused by a temporary dilation of the blood vessels in the head. Sumatriptan Aurobindo is thought to reduce the dilation of these blood vessels. This contributes to the disappearance or relief of headaches and other migraine symptoms, such as nausea, vomiting, and light and sound sensitivity.
Sumatriptan Aurobindo only works when a migraine attack has started. It does not stop an attack.
You must not use sumatriptan to prevent a migraine attack.
The sumatriptan contained in Sumatriptan Aurobindo may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
BEFORE YOU TAKE SUMATRIPTAN AUROBINDO
Do not use Sumatriptan Aurobindo
• If you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems, eg narrowed blood vessels ( ischemic heart disease ), chest pain (angina), or have previously had a heart attack.
• If you have problems with blood circulation in your legs that cause cramp-like pain when you walk ( so-called peripheral vascular disease ).
• If you have had a stroke or TIA ( transient circulatory disorder in the brain ).
• If you have high blood pressure. You can use Sumatriptan Aurobindo if you have been treated for mild high blood pressure.
• If you have any serious liver disease.
• If you are being treated with other migraine medicines containing ergotamine or substances similar to ergotamine such as methysergide or any other triptan/5-HT1 receptor agonist (medicines also used to treat migraines ).
• If you are being treated with antidepressants of the monoamine oxidase inhibitor type ( MAO inhibitor ) or if you have been treated with any such medication within the last two weeks.
If any of the above applies to you:
→ Contact your doctor and do not use Sumatriptan Aurobindo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sumatriptan Aurobindo:
If you have any additional risk factors
• If you are a heavy smoker or use nicotine substitutes and especially
• if you are a man over 40, or
• if you are a woman and have passed the age of menstruation.
In very rare cases, serious heart conditions have occurred after taking Sumatriptan Aurobindo even though no signs of heart disease have been demonstrated. If any of the above risk factors apply to you, it may mean that you have a greater risk of developing heart disease.
→ Tell your doctor so that your heart function can be checked before treatment with Sumatriptan Aurobindo.
If you have previously had seizures or if other factors may increase the risk of seizures, such as brain damage or alcoholism.
If you have any liver or kidney disease.
→ Tell your doctor about it so that you can be checked more often.
If you are allergic to antibiotics of the sulfonamide type.
If so, you may also be allergic to Sumatriptan Aurobindo. If you know you are allergic to antibiotics, but if you are not sure if it is sulfonamides:
→ Talk to your doctor or pharmacist before using Sumatriptan Aurobindo.
If you are using antidepressants called SSRIs ( selective serotonin reuptake inhibitors ) or SNRIs ( serotonin-norepinephrine reuptake inhibitors )
→ Talk to your doctor or pharmacist before using Sumatriptan Aurobindo.
See also the section “Other medicines and Sumatriptan Aurobindo”.
If you use Sumatriptan Aurobindo often.
Using Sumatriptan Aurobindo too often can make your headache worse.
→ Tell your doctor if this applies to you. Your doctor may recommend that you stop using Sumatriptan Aurobindo.
If you feel pain or tightness in your chest after using Sumatriptan Aurobindo.
These symptoms can be intense, but they usually disappear quickly. If they do not go away quickly or if they get worse:
→ Seek immediate medical attention. In section 4 of this leaflet, there is more information about these possible side effects.
Other medicines and Sumatriptan Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines should not be taken together with Sumatriptan Aurobindo and others may cause side effects when used at the same time. You must tell your doctor if you use
- ergotamine, which is also used to treat migraines, or similar medicines such as methysergide (see section 2 “Do not use Sumatriptan Aurobindo”). Do not use Sumatriptan Aurobindo at the same time as these medicines. You must stop taking them at least 24 hours before using Sumatriptan Aurobindo. Do not take any medicine containing ergotamine or substances similar to ergotamine until at least 6 hours after taking Sumatriptan Aurobindo.
- another triptan/5-HT 1 – receptor agonist (such as naratriptan, rizatriptan, or zolmitriptan) is also used to treat migraine (see section 2 “Do not use Sumatriptan Aurobindo”). Do not use Sumatriptan Aurobindo at the same time as these medicines. You must stop taking them at least 24 hours before using Sumatriptan Aurobindo. Do not take any other medicine containing a triptan/5-HT 1 – receptor agonist until at least 24 hours after taking Sumatriptan Aurobindo.
- SSRIs ( selective serotonin reuptake inhibitors) or SNRIs ( serotonin and norepinephrine reuptake inhibitors) are used in the treatment of depression. Using Sumatriptan Aurobindo with these medicines can cause serotonin syndrome (a mixture of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, palpitations, and tremors). If you get these symptoms, tell your doctor right away.
- MAO ( monoamine oxidase inhibitors ) are used in the treatment of depression. Do not use Sumatriptan Aurobindo if you have taken such medicines in the last two weeks.
- St. John’s wort ( Hypericum perforatum ). If Sumatriptan Aurobindo is used simultaneously with herbal medicines containing St. John’s wort, side effects may occur to an increased extent.
Pregnancy, breastfeeding, and fertility
- If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is only limited information regarding the safety of Sumatriptan Aurobindo when used in pregnant women, although there is no evidence of any increased risk of birth defects to date. Your doctor will discuss with you whether you should use Sumatriptan Aurobindo during pregnancy.
- You should not breastfeed your baby for the next 12 hours after using Sumatriptan Aurobindo. Breast milk expressed during these 12 hours should not be given to your baby but discarded.
Driving ability and use of machinery
Both the migraine symptoms and your medication can make you drowsy. If you are affected, do not drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
HOW TO TAKE SUMATRIPTAN AUROBINDO
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults:
The recommended dose is 50 mg Sumatriptan Aurobindo for a migraine attack. Some patients may need to take a dose of 100 mg of Sumatriptan Aurobindo.
Children and young people (under 18 years of age) :
Sumatriptan Aurobindo is not recommended for children and adolescents.
Elderly (patients over 65):
Sumatriptan Aurobindo is not recommended for this age group.
Patients with liver problems
The doctor can prescribe a reduced dose.
Take the tablet at the first sign of a migraine attack. The tablet should be swallowed with water, not chewed or crushed.
Consult a doctor or pharmacist if the effect of Sumatriptan Aurobindo is felt to be too strong or insufficient.
Processing time:
You must not take a second dose for the same attack if the symptoms do not decrease after the first dose. In the event of a subsequent attack, you can take Sumatriptan Aurobindo again.
If the symptoms decrease after the first dose but then return, you can take a second or third dose but there must be at least 2 hours between doses.
You must not take more than 300 mg of Sumatriptan Aurobindo per day.
The recommended dose must not be exceeded.
If you have taken too much Sumatriptan Aurobindo
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Sumatriptan Aurobindo
Do not take a double dose to make up for a missed dose.
If you have further questions about this medicine, contact your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms can be caused by the migraine disease itself.
Allergic reactions: seek immediate medical attention
The following side effects have occurred but the exact frequency is not known.
• Signs of allergy include skin rash, hives (itchy rash), wheezing, swollen eyelids, face or lips, and unconsciousness.
If you get any of these symptoms soon after taking Sumatriptan Aurobindo:
→ Do not take any more of this medicine. Contact a doctor immediately.
Common (may affect up to 1 in 10 users):
• Pain, heaviness, pressure or tightness, or pain in the chest, throat, or other parts of the body. Unusual sensory experiences such as numbness, tingling, and feeling hot or cold. These symptoms can be intense but usually pass quickly.
If these symptoms persist or worsen (especially chest pain):
→ Seek medical help immediately. In a small number of people, these symptoms can be caused by a heart attack.
Other common side effects include:
• Nausea or vomiting.
• Tiredness or drowsiness.
• Dizziness, feeling of powerlessness, feeling of heat and redness ( flush ).
• Transient increase in blood pressure
• Shortness of breath
• Muscle aches
Very rare (may affect up to 1 in 10,000 users)
• Changes in liver function. If you are having a blood test to check liver function, tell the doctor or nurse that you are using Sumatriptan Aurobindo.
Some patients may experience any of the following side effects, but it is not known how often they occur
- Seizures, tremors, muscle cramps, neck stiffness
- Visual disturbances such as visual flicker, visual impairment, double vision, and loss of vision which in some cases can become permanent. These visual disturbances can also be caused by the migraine attack itself.
- Heart problems, slow or fast heartbeat (palpitations), changes in heart rhythm, chest pain (angina), or heart attack
- Pale, bluish skin and/or pain in fingers, toes, ears, nose, or jaw when cold or stressed ( Raynaud’s phenomenon )
- Fainting sensation (depending on drop in blood pressure)
- Pain in the lower left part of the abdomen and bloody diarrhea ( ischemic colitis )
- Diarrhea
- Joint pain
- Anxiety feeling
- Profuse sweating
- If you have recently injured yourself or if you have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening pain at the site of the injury or inflammation.
- Difficulty swallowing
HOW TO STORE SUMATRIPTAN AUROBINDO
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the box after ‘Expiry date’. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice any visible signs of deterioration of the tablet.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
PACKAGING CONTENTS AND OTHER INFORMATION
Contents declaration
– The active substance is sumatriptan.
– Other ingredients are croscarmellose sodium (E468), polysorbate 80 (E433), anhydrous calcium hydrogen phosphate (E450), microcrystalline cellulose (E460), sodium bicarbonate (E500), and magnesium stearate (E470b).
Appearance and package sizes of the medicine
Tablets
Sumatriptan Aurobindo 50 mg tablets are white, capsule-shaped, biconvex uncoated tablets debossed with ‘C’ on one side and ’33’ on the other side.
Sumatriptan Aurobindo 100 mg tablets are white, capsule-shaped, biconvex uncoated tablets debossed with ‘C’ on one side and ’34’ on the other side.
Sumatriptan Aurobindo 50 mg/ Sumatriptan Aurobindo 100 mg tablets are available in packs of 2, 3, 4, 6, 8, 12, 18, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta
Manufacturer
Milpharm Limited.
Ares, Odyssey Business Park
West End Road.
South Ruislip HA4 6QD
UK
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
For further information about this medicine, contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
This medicine is approved in the European Economic Area under the names:
Denmark: Sumatriptan Aurobindo
Germany: Sumatriptan Aurobindo 50 mg / 100 mg Tablet
Netherlands: Sumatriptan Aurobindo 50 mg / 100 mg tablet
Norway: Sumatriptan Aurobindo 50 mg / 100 mg tablets
Spain: Sumatriptán Aurobindo 50 mg / 100 mg comprimidos EFG
United Kingdom: Sumatriptan 50 mg / 100 mg tablets