Sumatriptan Aurovitas 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sumatriptan Aurovitas 50 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Sumatriptan Aurovitas is and what it is used for
2. What you need to know before taking Sumatriptan Aurovitas
3. How to take Sumatriptan Aurovitas
4. Possible side effects
5. How to store 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 may be caused by the temporary dilation of blood vessels in the head. Sumatriptan is thought to reduce this dilation, thereby helping to relieve headache pain and other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.

Sumatriptan works only once a migraine attack has started. It is not effective in preventing an attack.

You should not use sumatriptan to prevent a migraine attack.

2. What you need to know before taking Sumatriptán Aurovitas

Do not take Sumatriptán Aurovitas

• If you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems such as narrowing of the arteries (coronary ischemic disease) or chest pain (angina), or have had a heart attack.
• If you have circulation problems in your legs causing pain, such as cramps when walking (peripheral vascular disease).
• If you have had a stroke or a mini-stroke (also called transient ischemic attack or TIA).
• If you have high blood pressure. You may take sumatriptan if your blood pressure is slightly elevated and is being treated.
• If you have severe liver disease.
• With other migraine medicines containing ergotamine, or similar medicines such as methysergide, or any triptan/5-HT1 receptor agonist (medicines also used to treat migraine).
• With antidepressants known as MAOIs (monoamine oxidase inhibitors), or if you have taken these medicines within the last 2 weeks.

If you think you may have any of these conditions, or if you have any doubts, consult your doctor before taking sumatriptan.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sumatriptán Aurovitas.

If you have any additional risk factors

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

Very rarely, some people have developed serious heart problems after taking sumatriptan, even though they did not have signs of heart disease previously. If any of the above apply to you, it may mean you have a higher risk of developing heart disease, so:

? Inform your doctor so that your heart function can be checked before sumatriptan is prescribed.

If you have a history of seizures (fits)

Or if you have other conditions that may make seizures more likely – for example, head injury or alcoholism.

If you have liver or kidney disease

? Inform your doctor so you can be monitored more frequently.

If you are allergic to antibiotics known as sulfonamides

If so, you may also be allergic to sumatriptan. If you know you are allergic to antibiotics but are not sure whether it is a sulfonamide:

? Inform your doctor or pharmacist before taking sumatriptan.

If you are taking antidepressants known as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Noradrenaline Reuptake Inhibitors), inform your doctor or pharmacist before taking sumatriptan. See: Other medicines and Sumatriptán Aurovitas.

If you take sumatriptan frequently

Taking sumatriptan too frequently may worsen your headaches. Inform your doctor if this happens; your doctor may advise you to stop taking sumatriptan.

If you feel chest pain or tightness after taking sumatriptan

These effects may intensify, but usually pass quickly. If they do not pass quickly, or become more severe:

? Seek medical help immediately. Section 4 of this leaflet contains more information about these possible side effects.

Other medicines and Sumatriptán Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Some medicines should not be taken with sumatriptan, and others may cause adverse effects when taken with sumatriptan. You must inform your doctor if you are taking:

• Ergotamine, also used to treat migraine, or similar medicines 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 until 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 within at least 24 hours after taking sumatriptan.
• SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Noradrenaline Reuptake Inhibitors) used to treat depression. Using sumatriptan with these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate, and agitation). Inform your doctor immediately if this occurs.
• MAOIs (monoamine oxidase inhibitors) used to treat depression. Do not take sumatriptan if you have taken these medicines within the last 2 weeks.
• St. John’s Wort (Hypericum perforatum). You are more likely to experience adverse effects if you take herbal preparations containing St. John’s Wort while taking sumatriptan.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine. Information on the safety of sumatriptan in pregnant women is limited, although so far there is no evidence that it increases the risk of birth defects. Your doctor will assess with you whether or not you should take sumatriptan during pregnancy.
• You must not breast-feed your baby until 12 hours after taking sumatriptan. If you express breast milk during this time, discard the milk and do not give it to your baby.

Some women have reported breast and/or nipple pain after using sumatriptan. The pain is usually temporary and disappears within 3 to 12 hours.

Driving and using machines

Both migraine symptoms and this medicine may cause drowsiness. If this occurs, do not drive or operate machinery.

The use of sumatriptan may cause symptoms such as dizziness and weakness that may negatively affect your reaction speed. Wait until you know how you react to sumatriptan before driving or operating machinery.

Sumatriptán Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Sumatriptan Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Recommended dose:

Adults:

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

Use in children and adolescents (under 18 years of age)

The use of sumatriptan is not recommended in children and adolescents.

Elderly patients (over 65 years of age)

The use of sumatriptan is not recommended in this age group.

Patients with hepatic impairment

Your doctor may prescribe you a 50 mg dose of sumatriptan.

Method of administration:

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

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

Duration of treatment:

If symptoms do not improve after the first dose, you should not take a second dose for the same attack. If you experience another attack later, you may take sumatriptan again.

If after the first dose your symptoms improve but then return, you may take a second or third dose, provided you wait at least 2 hours between doses.

You must not take more than 300 mg of sumatriptan within a 24-hour period.

Recommended doses must not be exceeded.

If you take more Sumatriptan Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Adverse effects such as those mentioned in “Possible side effects” may occur.

If you forget to take Sumatriptan Aurovitas

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some of these symptoms may be caused by migraine itself.

Although the following adverse effects have occurred, their exact frequency is unknown.

• Signs of allergy include rash, hives (itching and rash); wheezing (whistling in the chest); swollen eyelids, face or lips; complete collapse.

If you notice any of these symptoms shortly after using sumatriptan:

? Never use it again. Contact your doctor immediately.

Frequent (may affect up to 1 in 10 people):

• Heaviness, pressure, tightness or pain in the chest, throat or other parts of the body, or feelings of unusual sensations, including numbness, tingling, and hot or cold sensations. These effects may be intense but usually disappear quickly. If these effects persist or worsen (especially chest pain), seek immediate medical attention. In a small number of people, these symptoms may be caused by heart attacks.

Other frequent adverse effects include:

• Nausea or vomiting.
• Tiredness or drowsiness.
• Dizziness, feeling weak or hot flushes.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.

Rare (may affect up to 1 in 1,000 people):

• Breast pain.

Very rare (may affect up to 1 in 10,000 people):

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

Some patients may experience any of the following adverse effects, but their frequency is unknown

• Seizures/attacks, tremors, muscle spasms, 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, in which the heart may beat faster, slower or with changes in rhythm, chest pain (angina) or heart attack.
• Paleness, bluish and/or painful fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud's phenomenon).
• Feeling of weakness (due to decreased blood pressure).
• Pain in the lower left side of the abdomen and bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• Joint pain.
• Anxiety.
• Excessive sweating.
• If you have recently had an injury or have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of injury or inflammation.
• Difficulty swallowing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sumatriptán Aurovitas

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

Nature and contents of the container

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

Sumatriptán Aurovitas 50 mg tablets EFG are available in packs of 2, 3, 4, 6, 8, 12, 18, 20, 30, 50 or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).