Zolmitriptan Viso Farmaceutica 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptan Viso Farmacéutica 2.5 mg film-coated 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Zolmitriptán Viso Farmacéutica contains zolmitriptán, which belongs to a group of medicines known as triptans.

Zolmitriptán Viso Farmacéutica is used to treat migraine headache pain.

• Migraine symptoms may be caused by the dilation of blood vessels in the head. Zolmitriptán is thought to reduce this dilation of blood vessels. This helps relieve headache pain and other symptoms of a migraine attack, such as nausea or vomiting, and sensitivity to light and sound.
• Zolmitriptán works only once a migraine attack has started. It will not prevent you from having a migraine attack.

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

Do not take Zolmitriptan Viso Farmacéutica

• if you are allergic to zolmitriptan or to 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 a heart attack, angina (chest pain caused by physical exertion or stress), Prinzmetal's angina (chest pain occurring at rest), or have experienced heart-related symptoms such as shortness of breath or chest pressure,
• if you have had a stroke (cerebrovascular accident) or transient stroke-like symptoms (transient ischemic attack or TIA),
• if you are currently taking other migraine medications (e.g. ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For further information, see the section below: "Other medicines and Zolmitriptan Viso Farmacéutica".

Do not take Zolmitriptan Viso Farmacéutica if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before starting Zolmitriptan Viso Farmacéutica.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolmitriptan Viso Farmacéutica. Inform your doctor if:

• you are at risk of ischemic heart disease (reduced blood flow in the heart arteries). The risk is higher if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has ischemic heart disease,
• you have been diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm),
• you have or have previously had liver problems,
• you experience headaches different from your usual migraine headaches,
• you are taking any other medication for depression (see "Other medicines and Zolmitriptan Viso Farmacéutica" later in this section for more information),
• you are taking herbal medicines containing St. John's wort (used for the treatment of depression),
• when visiting a hospital, inform medical staff that you are taking Zolmitriptan Viso Farmacéutica.

Zolmitriptan is not recommended for individuals under 18 years of age or over 65 years of age.

Like other migraine treatments, excessive use of zolmitriptan may lead to daily headaches or worsening of migraine headaches. Consult your doctor if you think this applies to you. It may be necessary to stop taking zolmitriptan to resolve the problem.

Other medicines and Zolmitriptan Viso Farmacéutica

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

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

Migraine treatments

• If you are taking 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 are taking medications containing ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), wait 24 hours before taking zolmitriptan.
• After taking zolmitriptan, wait 6 hours before taking ergotamine or ergot-type medications.

Medications used for depression

• Monoamine oxidase inhibitors (also known as MAOIs), such as moclobemide.
• Medications known as SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, paroxetine, fluvoxamine, or sertraline.
• Medications known as SNRIs (serotonin-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 preparations containing St. John's wort (Hypericum perforatum) at the same time as this medicine, potential adverse effects of zolmitriptan may occur. Stop taking this medicine and inform your doctor.

Use of Zolmitriptan Viso Farmacéutica with food and drink

You may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is unknown whether taking zolmitriptan tablets during pregnancy is harmful. Before taking zolmitriptan, inform your doctor if you are pregnant or trying to become pregnant.

Breastfeeding

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

Driving and using machines

• During a migraine attack, your reactions may be slower than usual. Take this into account when driving or operating tools or machinery.
• It is unlikely that zolmitriptan will affect your ability to drive or operate tools or machinery. However, it is advisable to wait and observe how zolmitriptan affects you before attempting these activities.

Zolmitriptan Viso Farmacéutica contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Zolmitriptan Viso Farmacéutica

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

You may take zolmitriptan as soon as a migraine headache begins. You may also take it once an attack has started.

• The recommended dose is 2.5 mg or 5 mg.
• Orally, the tablet should be swallowed with a glass of water.
• You may take another tablet after two hours if the migraine still persists or if it returns within 24 hours.

If the tablet does not provide any relief from your migraine, inform your doctor. Your doctor may change your treatment.

Do not take more than the prescribed dose.

• Do not take more than two doses in one day unless prescribed by your doctor.
• The maximum daily dose is 10 mg.

Use in elderly people

The use of zolmitriptan is not recommended in people over 65 years of age.

Use in children and adolescents

The use of zolmitriptan is not recommended in children and adolescents under 18 years of age.

The tablet may be divided into equal doses.

If you take more Zolmitriptan Viso Farmacéutica than you should

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

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

If you forget to take Zolmitriptan Viso Farmacéutica

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

If you have any other 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 will experience them.

Some of the symptoms described below may be part of the migraine attack itself.

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

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

• Allergic reactions, including raised rash (urticaria) and swelling of the face, lips, mouth, tongue, and throat.

Very rare adverse effects (may affect fewer than 1 in 10,000 people)

• Angina (chest pain, often triggered by exercise), heart attack, or spasm of blood vessels in the heart. Signs include chest pain and difficulty breathing.
• Spasm of blood vessels in the intestine that may damage your intestine. You may experience stomach pain or bloody diarrhoea.
• Cerebral haemorrhage or stroke.

Other possible adverse effects

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

These adverse effects are usually mild and disappear shortly.

• Abnormal sensations such as tingling in the fingers or toes, or skin sensitivity to touch.
• Drowsiness, dizziness, or feeling warm.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest.
• Difficulty swallowing.

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

• Very fast heartbeat.
• Slight increase in blood pressure.
• Increase in the amount of urine produced or in the number of times you need to urinate.

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

• Sudden and urgent need to urinate.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptan Viso Farmacéutica

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

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 Zolmitriptan Viso Farmacéutica

• The active substance is zolmitriptan.

Each film-coated tablet contains 2.5 mg of zolmitriptan.

• The other components are:

Tablet core: 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 of the product and contents of the pack

Zolmitriptan Viso Farmacéutica 2.5 mg are yellow, round, biconvex, film-coated tablets marked with "497" on one side 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56601 Vysoké Mýto

Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorised in the European Economic Area countries under the following names:

Germany Zolmitriptan Glenmark 2.5 mg Filmtabletten

Spain Zolmitriptán Viso Farmacéutica 2.5 mg film-coated tablets EFG

Netherlands Zolmitriptan Glenmark 2.5 mg, Filmomhulde tabletten

Date of the most recent review of this leaflet: May 2016.

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