Auro – Sumatriptan 50 mg/100 mg Tablets

AURO - SUMATRIPTAN TABLETS belongs to a group of medications called serotonin agonists. It is thought that migraine is due to widening of certain blood vessels in the head. AURO - SUMATRIPTAN TABLETS work by narrowing blood vessels in the head. AURO - SUMATRIPTAN TABLETS are used to relieve the symptoms of a migraine attack. AURO - SUMATRIPTAN TABLETS may be used for migraine attacks with or without what is known as “aura”.

Do not take AURO - SUMATRIPTAN TABLETS:

• If you have ever had an allergic reaction to sumatriptan succinate or any ingredient of the product.
• If you are allergic to any medicine that contains sulphur (e.g. sulphonamide antibiotics).
• If you have or have ever had a heart attack; heart disease; angina, or severe chest pain or tightness; or brain blood vessel disease.
• If you have uncontrolled high blood pressure.
• Together with ergotamine containing preparations.
• If you have taken a monoamine oxidase inhibitor (MAOI), a type of medicine used for depression in the last two weeks.
• If you have severe liver disease.
• If you have certain types of migraines (e.g. Hemiplegic, basilar or ophthalmoplegic).

Take special care with AURO - SUMATRIPTAN TABLETS:

• Do not take more of this medicine or take it more often than prescribed by your doctor.
• AURO - SUMATRIPTAN TABLETS should only be used in patients who have been given a diagnosis of migraine by their doctors.
• Your doctor may decide to check if your heart is healthy before prescribing AURO - SUMATRIPTAN TABLETS.
• Caution is recommended in women after menopause, men over 40 years old and patients with risk factors for heart disease (such as diabetes, smoking, being overweight, family history of heart disease, high blood pressure and high cholesterol).

Tell your doctor:

• If you have high blood pressure, even if it is controlled.
• If you are taking a selective serotonin reuptake inhibitor (SSRI), a type of medicine used to treat depression. Some patients may have a reaction called serotonin syndrome when they use SSRIs, while taking AURO - SUMATRIPTAN TABLETS.
• If you have or have had epilepsy or fits.
• If you have liver disease.
• If you are over 65 years of age or under 18 years of age. Safety and effectiveness of AURO - SUMATRIPTAN TABLETS in these age groups have not been confirmed.

Pregnancy and Breast-feeding: Do not use this medication without telling your doctor if you are pregnant, think you may be pregnant, are planning a pregnancy or are breast-feeding. The safety of this medication in pregnant women and during breast-feeding has not been confirmed. If you are pregnant or breast-feeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Driving and using machinery: AURO - SUMATRIPTAN TABLETS may cause drowsiness. Be careful driving or operating machinery until you know how AURO - SUMATRIPTAN TABLETS affect you.

Taking other medicines with AURO - SUMATRIPTAN TABLETS:

• Do not take AURO - SUMATRIPTAN TABLETS if you have taken ergotamine containing preparations in the last 24 hours. Ergotamine containing preparations should not be taken until 6 hours have passed after taking AURO - SUMATRIPTAN TABLETS.
• Do not take AURO - SUMATRIPTAN TABLETS if you have taken a monoamine oxidase inhibitor (MAOI), a type of medicine used for depression in the last two weeks.
• Tell your doctor if you are taking a selective serotonin reuptake inhibitor (SSRI), a type of medicine used to treat depression. Your doctor may need to change the doses of your medications, or monitor you more carefully for side-effects. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of AURO - SUMATRIPTAN TABLETS with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.

This medication is used to treat migraine attacks once they occur. AURO - SUMATRIPTAN TABLETS SHOULD NOT BE USED TO PREVENT MIGRAINE ATTACKS FROM OCCURRING.

Take this medicine only as directed by your doctor.

The recommended starting dose is 50 mg. However, you may need to have your dose of AURO - SUMATRIPTAN TABLETS increased to 100 mg. Your doctor will tell you which dose is right for you.

If the first AURO - SUMATRIPTAN TABLET helps your migraine, but the symptoms of a migraine come back later, you may take another AURO - SUMATRIPTAN TABLET at any time in the next 24 hours. However, do not take more than 300 mg of AURO - SUMATRIPTAN TABLETS (ie. 3 x 100 mg strength tablets or 6 x 50 mg strength tablets) in any 24 hours and you must wait at least two hours between taking each dose.

If the first AURO - SUMATRIPTAN TABLET does not relieve or help your migraine, do not take another AURO - SUMATRIPTAN TABLET for this same attack.

Your AURO - SUMATRIPTAN TABLET should be swallowed whole with a drink of water.

Tell your doctor if you have liver disease, since your dose should be reduced.

It is best to take your AURO - SUMATRIPTAN TABLET at the first sign of a migraine. Always take AURO - SUMATRIPTAN TABLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of AURO - SUMATRIPTAN TABLETS is too strong or too weak, talk to your doctor or pharmacist.

If you take more AURO - SUMATRIPTAN TABLETS than you should: You may need urgent medical attention, and your doctor will need to monitor you for at least ten hours. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

AURO - SUMATRIPTAN TABLETS can have side-effects. Get emergency medical help immediately if you have any of these symptoms of an allergic reaction:

• Wheezing
• Difficulty in breathing
• Swelling of your face, lips, tongue, or throat
• Hives

Tell your doctor immediately if you:

• have chest pain or feel heaviness, pressure or tightness in any part of the body, including the chest or throat.
• feel abnormal heart beats – too fast, too slow, or irregular heart beats, palpitations.
• have a fit or convulsion.

Inform your doctor of other side-effects which may include:

• tingling, heat or flushing in any part of the body.
• a change in blood pressure
• nausea (feeling sick) or vomiting
• dizziness
• feelings of weakness, tiredness and drowsiness

Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Store at or below 30 °C (room temperature). KEEP OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).