Package Insert: Information for the User

Zolmitriptán Viso Pharmaceutical 2.5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

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

Zolmitriptán Viso Farmacéuticacontains zolmitriptan which belongs to a group of medicines called triptans.

Zolmitriptán Viso Farmacéutica is used to treat migraine headache.

• The symptoms of migraine may be caused by a dilation of blood vessels in the head.Zolmitriptan is thought toreduce the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as nausea or vomiting (nausea or vomiting) and sensitivity to light and noise.
• Zolmitriptan acts only when a migraine attack has begun. It will not prevent you from suffering a migraine attack.

Do not take Zolmitriptán Viso Farmacéutica

• if you are allergic to zolmitriptán or any of the other ingredients of this medication (listed in section 6),
• if you have high blood pressure,
• if you have or have had any heart problems, including a heart attack, angina (chest pain caused by exercise or effort), angina of Prinzmetal (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 ischemic attack or TIA),
• if you are taking other medications for migraine (such as ergotamine or ergot-type medications like dihydroergotamine and methysergide) or other medications for migraine in the triptan group. For additional information, see the next section: “Other medications and Zolmitriptán Viso Farmacéutica”.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolmitriptán Viso Farmacéutica. Inform your doctor if:

• you have a risk of suffering from ischemic heart disease (insufficient 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 told that you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm),
• you have or have had liver problems,
• you have headaches other than your usual migraine headache,
• you are taking any other medication for the treatment of depression (see “Other medications and Zolmitriptán Viso Farmacéutica” later in this section for more information),
• you are taking herbal medicines that contain St. John's Wort (used for the treatment of depression) at the same time as this medication,
• you are admitted to a hospital, inform the medical staff that you are taking Zolmitriptán Viso Farmacéutica.

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

Like other treatments for migraine, excessive use of zolmitriptán may cause daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. You may need to stop taking zolmitriptán to correct the problem.

Other medications and Zolmitriptán Viso Farmacéutica

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those obtained without a prescription or if you use any herbal medicine.

Especially, inform your doctor if you are taking any of the following medications:

Medications used for migraine

• If you take other triptans different from zolmitriptán (such as sumatriptán or naratriptán), leave 24 hours before taking zolmitriptán.
• After taking zolmitriptán, leave 24 hours before taking other triptans.
• If you take medications that contain ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), leave 24 hours before taking zolmitriptán.
• After taking zolmitriptán, leave 6 hours before taking ergotamine or ergot-type medications.

Medications used for depression

• Monamine oxidase inhibitors (also known as MAOIs) such as moclobemida.
• Medications known as SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, paroxetine, fluvoxamine or sertraline.
• Medications known as SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine.

Other medications

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

If you are using herbal medicines that contain St. John's Wort (Hypericum perforatum) at the same time as this medication, potential adverse effects of zolmitriptán may occur. Stop taking this medication and inform your doctor.

Use of Zolmitriptán Viso Farmacéutica with food and drinks

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of zolmitriptán tablets during pregnancy is unknown. Before taking zolmitriptán, inform your doctor if you are pregnant or trying to become pregnant.

Breastfeeding

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

Driving and operating machinery

• During a migraine crisis, your reactions may be slower than usual. Take this into account when driving or operating tools or machinery.
• It is unlikely that zolmitriptán will affect driving or operating tools or machinery. However, it is best to wait and see how zolmitriptán affects you before attempting to carry out these activities.

Zolmitriptán Viso Farmacéutica contains lactose

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with him before taking this medication.

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.

You can take zolmitriptán as soon as a migraine headache begins. You can also take it once a headache has started.

• The recommended dose is 2.5 mg or 5 mg.
• Take the tablet orally with a glass of water.
• You can take another tablet after two hours if the migraine persists or reappears within 24 hours.

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

Do not take more than the dose prescribed.

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

Use in elderly people

Zolmitriptán is not recommended for people over 65 years old.

Use in children and adolescents

Zolmitriptán is not recommended for children and adolescents under 18 years old.

The tablet can be divided into equal doses.

If you take more Zolmitriptán Viso Farmacéutica than you should

If you have taken morezolmitriptánthan your doctor prescribed, inform your doctor immediately or go to the nearest hospital. Bring the medication with you.

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.

If you forgot to take Zolmitriptán Viso Farmacéutica

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 the symptoms listed below may be part of the migraine 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 fewer than 1 in 10,000 people)

• Angina (chest pain, often caused by exercise), heart attack, or coronary artery spasm. Symptoms include chest pain and difficulty breathing.
• Intestinal artery spasm that may damage your intestine. You may observe abdominal pain or bloody diarrhea.
• Cerebral hemorrhage or stroke.

Other possible side effects

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

These side effects are usually mild and disappear shortly.

• Abnormal sensations such as tingling in the fingers of the hands and feet or sensitive skin.
• Drowsiness, dizziness, or heat sensation.
• Headache.
• Irregular heartbeat.
• Nausea, vomiting.
• Abdominal pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling of weakness.
• Weight, tension, pain, or pressure in the throat, neck, arms, and legs or chest.
• Difficulty swallowing.

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

• Very rapid heartbeat.
• Moderately higher blood pressure.
• Increased urine production or the need to urinate more frequently.

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

• Urgent and sudden need to urinate.

Reporting of 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: https://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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Zolmitriptán Viso Farmacéutica

• The active ingredient is zolmitriptán.

Each film-coated tablet contains 2.5 mg of zolmitriptán.

• The other components 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 of the product and content of the container

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

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

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

GLENMARK ARZNEIMITTEL GMBH

Industriestr. 31

Gröbenzell 82194

Germany

Responsible for manufacturing:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143, Vysoké Mýto, 56601

Republic of Czech

This medicine is authorized in the member states of the European Economic Area with 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 tablets

Date of the last review of this leaflet: May 2016.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /