SUMATRIPTAN AUROVITAS 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Sumatriptan Aurovitas 50 mg Tablets EFG

Read all of this leaflet 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.

Contents of the pack

1. What Sumatriptan Aurovitas is and what it is used for
2. What you need to know before you take Sumatriptan Aurovitas
3. How to take Sumatriptan Aurovitas
4. Possible side effects
5. Storage of Sumatriptan Aurovitas
6. Contents of the pack and other information

1. What Sumatriptan Aurovitas is and what it is used for

Sumatriptan belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists), which are used to treat migraine.

The symptoms of migraine can be caused by temporary widening of blood vessels in the head. It is thought that sumatriptan works by reversing this widening of blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick (nausea or vomiting) and being sensitive to light and sound.

Sumatriptan only works when a migraine attack has started. It does not prevent migraine attacks from happening.

Do not use sumatriptan to try to prevent an attack of migraine.

2. What you need to know before you take Sumatriptan Aurovitas

Do not take Sumatriptan Aurovitas

• If you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems such as narrowing of the arteries (ischaemic heart disease) or chest pain (angina), or have had a heart attack.
• If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA).
• If you have high blood pressure. You can take sumatriptan if your blood pressure is mildly elevated and is being treated.
• If you have severe liver disease.
• With other migraine medicines that contain ergotamine, or medicines that are similar to ergotamine (such as methysergide), or other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan).
• With monoamine oxidase inhibitors (MAOIs), or if you have taken MAOIs in the last 2 weeks.

If you think you may have any of these problems, or if you are not sure, consult your doctor before taking sumatriptan.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sumatriptan Aurovitas.

If you have any extra risk factors

• if you smoke heavily or are using nicotine replacement therapy, and especially
• if you are a man over 40 years old, or
• if you are a woman who has entered the menopause.

In very rare cases, some people have developed serious heart problems after taking sumatriptan, even though they had no signs of heart disease before. If any of the above points apply to you, it may mean that you have a greater risk of developing heart disease, so:

? Tell your doctor to check your heart function before you are prescribed sumatriptan.

If you have a history of fits (seizures)

Or if you have other conditions which may make you more likely to have fits – for example, a head injury or alcoholism.

If you have liver or kidney disease

? Tell your doctor so that you can be monitored more closely.

If you are allergic to antibiotics called sulfonamides

If so, you may also be allergic to sumatriptan. If you know you are allergic to sulfonamide antibiotics but are not sure if this is the type you are allergic to:

? Tell your doctor or pharmacist before taking sumatriptan.

If you are taking antidepressants called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors), tell your doctor or pharmacist before taking sumatriptan. See: Other medicines and Sumatriptan Aurovitas.

If you take sumatriptan frequently

Taking sumatriptan too often may make your headaches worse. Tell your doctor if this happens, your doctor may advise you to stop taking sumatriptan.

If you feel pain or tightness in your chest after taking sumatriptan

These effects may be intense but generally pass quickly. If they do not pass quickly, or get worse (especially chest pain), seek medical help immediately. The section 4 of this leaflet contains more information on these possible side effects.

Other medicines and Sumatriptan Aurovitas

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 taken with sumatriptan. You must tell your doctor if you are taking:

• Ergotamine, also used to treat migraine, or medicines similar to ergotamine (such as methysergide) (see section 2). Do not take sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking sumatriptan. Do not take any other medicine containing ergotamine or ergotamine-like compounds for at least 6 hours after taking sumatriptan.
• Other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine (see section 2). Do not take sumatriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking sumatriptan. Do not take another triptan/5-HT1 receptor agonist for at least 24 hours after taking sumatriptan.
• SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression. Taking sumatriptan with these medicines can cause serotonin syndrome (a set of symptoms which can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate and agitation). Tell your doctor immediately if you get any of these symptoms.
• MAOIs (monoamine oxidase inhibitors) used to treat depression. Do not take sumatriptan if you have taken these medicines in the last 2 weeks.
• St John’s Wort (Hypericum perforatum). It is more likely that you will experience side effects if you take herbal remedies containing St John’s Wort while you are taking sumatriptan.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Although there is limited information on the use of sumatriptan in pregnancy, it has not been shown to cause harm to the unborn baby. Your doctor will consider whether you should take sumatriptan during pregnancy.
• Do not breast-feed for 12 hours after taking sumatriptan. If you express breast milk during this time, discard the milk and do not give it to your baby.

Driving and using machines

Both the symptoms of migraine and the medicine may cause you to feel drowsy. If this happens, do not drive or use any tools or machines.

Sumatriptan may cause side effects such as dizziness and weakness that can affect your ability to react. Wait until you know how sumatriptan affects you before driving or using machines.

Sumatriptan Aurovitas contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially ‘sodium-free’.

3. How to take Sumatriptan Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults:

The recommended dose is one 50 mg sumatriptan tablet for the treatment of a migraine attack. Some patients may need a 100 mg dose.

Use in children and adolescents (under 18 years)

Sumatriptan is not recommended for use in children and adolescents.

Use in elderly patients (over 65 years)

Sumatriptan is not recommended for use in this age group.

Use in patients with liver impairment

Your doctor may prescribe you a 50 mg sumatriptan dose.

Method of administration:

Swallow the tablet with water, preferably as soon as you feel the migraine attack starting. Do not crush or chew the tablets.

If you feel that the effect of sumatriptan is too strong or too weak, tell your doctor or pharmacist.

Duration of treatment:

If your symptoms do not improve after the first dose, do not take a second dose for the same attack. If you get another attack, you can take sumatriptan again.

If your symptoms improve but then come back, you can take a second or third dose, providing you leave at least 2 hours between doses.

Do not take more than 300 mg of sumatriptan in a 24-hour period.

Do not exceed the recommended dose.

If you take more Sumatriptan Aurovitas than you should

If you have taken more sumatriptan than you should, talk to your doctor or pharmacist or go to the nearest hospital casualty department immediately. Take the medicine pack with you. You may experience side effects such as those listed in “Possible side effects”.

If you forget to take Sumatriptan Aurovitas

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of these symptoms may be caused by the migraine itself.

Although the following side effects are said to occur, their exact frequency is unknown.

• Signs of allergy include rash, itching, wheezing, swelling of the face, lips, tongue or throat, collapse.

If you notice any of these symptoms soon after taking sumatriptan:

? Do not take sumatriptan again. Contact your doctor immediately.

Common (affects up to 1 in 10 people)

• Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, or unusual sensations, which may include numbness, tingling, warmth, or cold. These effects may be intense but generally pass quickly. If these effects continue or get worse (especially chest pain), seek medical help immediately. In a small number of people, these symptoms can be caused by heart attacks.

Other common side effects include:

• Nausea or vomiting.
• Tiredness or drowsiness.
• Dizziness, feeling of weakness or flushing.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.

Very rare (affects up to 1 in 10,000 people)

• Changes in liver function. Tell your doctor or nurse that you are taking sumatriptan if you are going to have a blood test to check your liver function.

Some people may experience any of the following side effects, but the frequency is not known

• Seizures/convulsions, tremors, muscle spasm, stiffness of the neck.
• 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 the heart beats more quickly, more slowly, or with an irregular rhythm, chest pain (angina) or heart attack.
• Pale, blue-tinged, or painful fingers or toes, ears, nose, or jaw in response to cold or stress (Raynaud’s phenomenon).
• Feeling weak (due to low blood pressure).
• Pain in the lower left side of the abdomen and bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• Pain in the joints.
• Anxiety.
• Excessive sweating.
• If you have had a recent injury or have inflammation (such as rheumatism or inflammation of the bowel), you may experience pain or worsening of pain at the site of the injury or inflammation.
• Difficulty swallowing.

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 Spanish Medicines Agency’s website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sumatriptan Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Composition of Sumatriptan Aurovitas

• The active substance is sumatriptan. Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate).
• The other ingredients are: croscarmellose sodium (E468), polysorbate 80 (E433), calcium hydrogen phosphate (E450), microcrystalline cellulose (E460), sodium hydrogen carbonate (E500) and magnesium stearate (E470b).

Appearance and packaging of the product

Sumatriptan Aurovitas 50 mg Tablets EFG are white or almost white, capsule-shaped, biconvex tablets, marked with “C” on one side and “33” on the other.

Sumatriptan Aurovitas 50 mg Tablets EFG 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 and manufacturer

Marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: December 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).