ZOLMITRIPTAN VISO FARMACEUTICA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Viso Farmacéutica 2.5 mg film-coated 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.

What is in this leaflet:

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

1. What Zolmitriptan Viso Farmacéutica is and what it is used for

Zolmitriptan Viso Farmacéutica contains zolmitriptan, which belongs to a group of medicines called triptans.

Zolmitriptan Viso Farmacéutica is used to treat migraine headaches.

• The symptoms of migraine can be caused by the dilation of blood vessels in the head. Zolmitriptan is thought to reduce the dilation of these blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick (nausea) or being sick (vomiting) and sensitivity to light and sound.
• Zolmitriptan only works when a migraine attack has already started. It will not prevent you from getting a migraine attack.

2. What you need to know before you take Zolmitriptan Viso Farmacéutica

Do not take Zolmitriptan Viso Farmacéutica

• if you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6),
• if you have high blood pressure,
• if you have or have ever had heart problems, including heart attacks, angina (chest pain caused by exercise or effort), Prinzmetal's angina (chest pain that occurs at rest), or have experienced symptoms related to the heart such as shortness of breath or pressure in the chest,
• if you have had a stroke (cerebrovascular accident) or symptoms of short duration similar to a stroke (transient ischaemic attack or TIA),
• if you are taking other medicines for migraine (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For more information, see the following section: "Other medicines and Zolmitriptan Viso Farmacéutica".

Do not take Zolmitriptan Viso Farmacéutica if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Zolmitriptan Viso Farmacéutica.

Warnings and precautions

Consult your doctor or pharmacist before taking Zolmitriptan Viso Farmacéutica. Tell your doctor if:

• you are at risk of having a heart condition (ischaemic heart disease) (poor blood flow in the arteries of the heart). The risk is greater if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has a heart condition,
• you have been told you have Wolff-Parkinson-White Syndrome (a type of abnormal heartbeat),
• you have or have had liver problems,
• you have headaches other than your usual migraine headaches,
• you are taking any other medicine for depression (see "Other medicines and Zolmitriptan Viso Farmacéutica" below for more information).
• you are taking herbal remedies containing St John's Wort (used for depression) at the same time as this medicine.
• you go to hospital, tell the medical staff that you are taking Zolmitriptan Viso Farmacéutica.

Zolmitriptan is not recommended for people under 18 years or over 65 years.

As with other migraine treatments, overuse of zolmitriptan can lead to daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. You may need to stop taking zolmitriptan to correct the problem.

Other medicines and Zolmitriptan Viso Farmacéutica

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription or herbal remedies.

In particular, tell your doctor if you are taking any of the following medicines:

Medicines used for migraine

• If you take other triptans different from zolmitriptan (such as sumatriptan or naratriptan), wait 24 hours before taking zolmitriptan.
• After taking zolmitriptan, wait 24 hours before taking other triptans.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking zolmitriptan.
• After taking zolmitriptan, wait 6 hours before taking ergotamine or ergot-type medicines.

Medicines used for depression

• Monoamine oxidase inhibitors (also known as MAOIs) such as moclobemide.
• Medicines called SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, paroxetine, fluvoxamine, or sertraline.
• Medicines called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine.

Other medicines

• Cimetidine (for indigestion or stomach ulcers),
• A quinolone antibiotic (such as ciprofloxacin).

If you are using herbal remedies containing St John's Wort (Hypericum perforatum) at the same time as this medicine, potential side effects of zolmitriptan may occur. Stop taking this medicine and consult your doctor.

Using Zolmitriptan Viso Farmacéutica with food and drink

You can take zolmitriptan with or without food. This does not affect how zolmitriptan works.

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 taking this medicine.

Pregnancy

It is not known if taking zolmitriptan tablets during pregnancy is harmful. Before taking zolmitriptan, tell your doctor if you are pregnant or trying to become pregnant.

Breastfeeding

The active ingredient of your medicine may pass into breast milk. To minimize the risk of exposure to the medicine for your child, avoid breastfeeding for 24 hours after taking zolmitriptan.

Driving and using machines

• During a migraine attack, your reactions may be slower than usual. Bear this in mind when driving or using tools or machines.
• It is unlikely that zolmitriptan will affect your ability to drive or use machines. However, it is best to wait and see how zolmitriptan affects you before attempting to do these activities.

Zolmitriptan Viso Farmacéutica contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Zolmitriptan Viso Farmacéutica

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

You can take zolmitriptan as soon as a migraine headache starts. You can also take it once the headache has started.

• The recommended dose is 2.5 mg or 5 mg.
• Take the tablet with a glass of water.
• You can take another tablet after 2 hours if the migraine is still present or if it returns within 24 hours.

If the tablet did not give you any relief from your migraine, tell your doctor. Your doctor may change your treatment.

Do not take more than the dose that has been prescribed for you.

• Do not take more than two doses in a 24-hour period unless your doctor has told you to
• The maximum daily dose is 10 mg.

Use in elderly people

Zolmitriptan is not recommended for people over 65 years of age.

Use in children and adolescents

Zolmitriptan is not recommended for children and adolescents under 18 years of age.

The tablet can be divided into equal doses.

If you take more Zolmitriptan Viso Farmacéutica than you should

If you have taken more zolmitriptan than your doctor has prescribed, tell your doctor or go to the nearest hospital. Take the medicine with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Zolmitriptan Viso Farmacéutica

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

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 the symptoms mentioned below may be part of the migraine attack itself.

Stop taking zolmitriptan and contact your doctor immediately if you notice any of the following side effects:

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

• Allergic reactions, including hives and swelling of the face, lips, mouth, tongue, and throat.

Very rare side effects (may affect less than 1 in 10,000 people)

• Angina (chest pain, often caused by exercise), heart attack, or spasm of the heart's blood vessels. Signs include chest pain and difficulty breathing
• Spasm of the intestine's blood vessels that can damage your intestine. You may notice stomach pain or bloody diarrhea.
• Brain hemorrhage or stroke

Other possible side effects

Common side effects (may affect up to 1 in 10 people)

These side effects are usually mild and go away on their own

• Abnormal sensations such as tingling in the fingers and toes or sensitive skin.
• Feeling sleepy, dizzy, or warm.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tension, pain, or pressure in the throat, neck, arms, and legs, or chest.
• Difficulty swallowing.

Uncommon side effects (may affect up to 1 in 100 people)

• Very fast heartbeat.
• Slightly higher blood pressure.
• Increased amount of urine produced or increased frequency of urination.

Very rare side effects (may affect less than 1 in 10,000 people)

• Sudden and urgent need to urinate.

Reporting of side effects:

If you experience 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptan Viso Farmacéutica

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 the month shown.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

What Zolmitriptan Viso Farmacéutica contains

• The active substance is zolmitriptan.

Each film-coated tablet contains 2.5 mg of zolmitriptan.

• The other ingredients are:

Core of the tablet: anhydrous lactose, microcrystalline cellulose, sodium starch glycolate type A, magnesium stearate;

Coating: hypromellose, titanium dioxide (E 171), macrogol 400, macrogol 8000, yellow iron oxide (E 172)

Appearance and packaging of Zolmitriptan Viso Farmacéutica

Zolmitriptan Viso Farmacéutica 2.5 mg are yellow, round, biconvex film-coated tablets, marked with 497 on one face and a deep score line on the other (approximate diameter: 7 mm).

Zolmitriptan Viso Farmacéutica 2.5 mg film-coated tablets are available in blisters of 3, 6, and 12 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56601 Vysoké Mýto

Czech Republic

You can ask for more information about this medicine from the representative of the marketing authorisation holder in your country:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Germany Zolmitriptan Glenmark 2,5 mg Filmtabletten

Spain Zolmitriptán Viso Farmacéutica 2,5mg film-coated tablets EFG

Netherlands Zolmitriptan Glenmark 2.5mg, filmomhulde tabletten

Date of last revision of this leaflet:May 2016.

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