Leaflet: information for the user

Sumatriptan Aurovitas 50 mg tablets EFG

Read this 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, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Sumatriptan Aurovitas

3.How to take Sumatriptan Aurovitas

4.Possible side effects

5.Storage of Sumatriptan Aurovitas

6.Contents of the pack and additional information

Sumatriptán belongs to a group of medications called triptans (also known as 5-HT1 receptor agonists), which are used for the treatment of migraine.

The symptoms of migraine may be caused by the transient dilation of blood vessels in the head. It is believed that sumatriptán reduces the dilation of these vessels. This in turn helps to alleviate headache pain and other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.

Sumatriptán acts only when the migraine attack has begun. It does not serve to prevent an attack.

Do not use sumatriptán to prevent a migraine attack.

Do not take Sumatriptán 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 (coronary artery disease) or chest pain (angina), or have had a heart attack.

•If you have circulation problems in your legs that cause 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 can take sumatriptan if your blood pressure is slightly elevated and you are being treated.

•If you have a severe liver disease.

•With other migraine medicines that contain ergotamine, or similar medicines such as methysergide or any 5-HT1 agonist (medicines used also for the treatment of migraine).

•With antidepressants called MAOIs (monoamine oxidase inhibitors), or if you have taken these medicines in the last 2 weeks.

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

Warnings and precautions

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

If you have any additional risk factors

•If you smoke a lot 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 started menopause.

In very rare cases, some people have developed severe heart problems after taking sumatriptan, despite not having any signs of a pre-existing heart disease. If any of the above points affect you, it may mean that there is a higher risk of developing heart disease, so:

?Inform your doctor to check your heart functionbefore sumatriptan is prescribed to you.

If you have a history ofseizures

Or if you have other conditions that may make you more likely to have seizures – forexample, a head injury or alcoholism.

If you have liver or kidney disease

?Inform your doctor to be monitored more frequently.

If you are allergic to antibiotics called sulfonamides

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

?Inform your doctor or pharmacist before taking sumatriptan.

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

If you take sumatriptan frequently

Frequent use of sumatriptan may worsen your headaches.Inform your doctor if this happens,your doctor may advise you to stop taking sumatriptan.

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

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

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

Other medicines and Sumatriptán Aurovitas

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

Some medicines should not be taken with sumatriptan and others may cause side effects if taken with sumatriptan. You should 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 that contains ergotamine or similar compounds to ergotamine for at least 6 hours after taking sumatriptan.

•Other 5-HT1 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 5-HT1 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. The use of sumatriptan with these medicines may cause serotonin syndrome (a set of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, chills, increased heart rate, and agitation). Inform your doctor immediately if this happens.

•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 to cause side effects if you take herbal preparations that contain St. John's Wort while taking sumatriptan.

Pregnancy, breastfeeding and fertility

•If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. The safety information for sumatriptan in pregnant women is limited, although there is currently no evidence that it increases the risk of birth defects. Your doctor will assess with you whether you should or should not take sumatriptan during pregnancy.

•You should not breastfeed your baby for at least 12 hours after taking sumatriptan.If you express milk during this time, discard the milk and do not give it to your baby.

Driving and operating machinery

The symptoms of migraine and the medicine may cause drowsiness.If this happens, do not drive or operate machinery.

The use of sumatriptan may cause symptoms such as dizziness and weakness that may impair your reaction time. 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”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

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

Use in children and adolescents (under 18 years)

Sumatriptán is not recommended for use in children and adolescents.

Older adults (over 65 years)

Sumatriptán is not recommended for use in this age group.

Patients with liver insufficiency

Your doctor may prescribe 50 mg sumatriptán.

Administration form:

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

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

Treatment duration:

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

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

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

Do not exceed the recommended doses.

If you take more Sumatriptán Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. You may experience side effects as mentioned in “Possible adverse effects”.

If you forgot to take Sumatriptán Aurovitas

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Although the following side effects have occurredtheir exact frequency is unknown.

•Allergic reactions include hives (itching and rash); wheezing (chest sounds); swollen eyelids, face, or lips; complete collapse.

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

?Do not use it again. Contact your doctor immediately.

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

•Pressure, heaviness, or pain in the chest, throat, or other parts of the body, or unusual sensations, including numbness, tingling, and warmth or cold. These effects can be intense, but generally disappear quickly.If these effectscontinue or worsen(especially chest pain)seek immediate medical assistance. In a reduced number of people, these symptoms may be caused by heart attacks.

Other frequent side effects include:

•Nausea or vomiting.

•Tiredness or drowsiness.

•Dizziness, feeling weak, or hot flashes.

•Temporary increase in blood pressure.

•Difficulty breathing.

•Muscle pain.

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

•Liver function abnormalities. Inform your doctor or nurse that you are taking sumatriptan if you are to have blood tests to check liver function.

Some patients may experience any of the following side effects, but the frequency with which they occur is unknown

•Seizures/attacks, tremors, muscle spasms, neck stiffness.

•Visual disturbances, such as blinking, reduced vision, double vision, loss of vision, and in some cases even permanent defects (although these may be due to the migraine attack itself).

•Cardiac problems, in which the heart may beat faster, slower, or with changes in rhythm, chest pain (angina) or heart attack.

•Pallor, blue skin, and/or pain in the fingers of the hands, feet, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon).

•Feeling weak (due to decreased blood pressure).

•Abdominal pain in the lower left side and bloody diarrhea (ischemic colitis).

•Diarrhea.

•Joint pain.

•Anxiety.

•Excessive sweating.

•If you have had a recent injury or have inflammation (such as arthritis or colon inflammation), you may experience pain or worsening of pain at the site of the injury or inflammation.

•Difficulty swallowing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sumatriptán Aurovitas

-The active ingredient is sumatriptan. Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate).

-The other components are: sodium croscarmellose (E468), polisorbate 80 (E433), calcium hydrogen phosphate (E450), microcrystalline cellulose (E460), sodium hydrogen carbonate (E500), and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

Sumatriptán Aurovitas 50 mg tablets EFG are non-coated tablets, white or off-white in color, in the form of a biconvex capsule, with the mark “C” on one face and “33” on the other.

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names: