Zolmitriptan Flas Stada 2.5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Zolmitriptan Flas Stada 2.5 mg orodispersible 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 must not be given to other people, even if they have the same symptoms as you, since 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.

Contents of the leaflet

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

1. What Zolmitriptán Flas Stada is and what it is used for

Zolmitriptán Flas Stada contains zolmitriptán and belongs to a group of medicines known as triptans.

Zolmitriptán is used to treat migraine headache pain.

? The symptoms of migraine may be caused by the dilation of blood vessels in the head. Zolmitriptán is believed to reduce this dilation of blood vessels, helping to 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 starting to take Zolmitriptán Flas Stada

DO NOT take Zolmitriptán Flas Stada if:

• you are allergic to zolmitriptan, menthol, or any of the other ingredients of this medicine (listed in section 6).
• you have high blood pressure.
• you have ever had heart problems, including a heart attack, angina (chest pain caused by exercise or exertion), Prinzmetal's angina (chest pain occurring at rest), or have experienced heart-related symptoms such as shortness of breath or chest pressure.
• you have had a stroke or transient stroke-like symptoms (transient ischemic attack or TIA).
• you have severe kidney problems.
• you are currently taking other migraine medicines (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 following section: “Other medicines and Zolmitriptán Flas Stada”.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor before taking Zolmitriptán Flas Stada 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 ever had liver problems.
• you experience headaches different from your usual migraine headaches.
• you are taking any other medication for depression (see “Other medicines and Zolmitriptán Flas Stada” later in this section).

If you go to a hospital, inform the medical staff that you are taking zolmitriptan.

Zolmitriptan is not recommended for people 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 your migraine headaches.

Consult your doctor if you think this applies to you. It may be necessary to stop using zolmitriptan to resolve the problem.

Other medicines and Zolmitriptán Flas Stada

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

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

Migraine medicines

• If you are taking other triptans different from zolmitriptan, wait 24 hours before taking zolmitriptan.
• After taking zolmitriptan, wait 24 hours before taking other triptans different from zolmitriptan.
• If you are taking 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 for depression

• moclobemide or fluvoxamine
• medicines known as SSRIs (selective serotonin reuptake inhibitors)
• medicines known as SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine

Other medicines

• cimetidine (for indigestion or stomach ulcers)
• an antibiotic from the quinolone group (such as ciprofloxacin)

If you are using herbal remedies containing St. John’s wort (Hypericum perforatum), you may be more likely to experience adverse effects from zolmitriptan.

Taking Zolmitriptán Flas Stada with food and drink

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

Pregnancy and breastfeeding

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.

• It is unknown whether taking zolmitriptan during pregnancy is harmful. Before taking zolmitriptan, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding within 24 hours after taking zolmitriptan.

Driving and using machines

• During a migraine attack, your reactions may be slower than usual. Keep this in mind 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 best to wait and see how zolmitriptan affects you before attempting these activities.

3. How to take Zolmitriptan Flas Stada

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

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

• The normal dose is one tablet (2.5 mg or 5 mg).
• Place the tablet on your tongue, where it will dissolve and be swallowed with saliva. You do not need to drink water to swallow the tablet.
• You may take another tablet after two hours if the migraine still persists or if it returns within 24 hours.

If the tablets have not provided sufficient relief for your migraine, inform your doctor. Your doctor may increase the dose to 5 mg or change your treatment.

Do not use more than the prescribed dose.

• Do not use more than two doses in one day. If you have been prescribed the 2.5 mg tablet, the maximum daily dose is 5 mg. If you have been prescribed the 5 mg tablet, the maximum daily dose is 10 mg.

If you take more Zolmitriptan Flas Stada than you should

If you have taken more zolmitriptan than prescribed by your doctor, inform your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested. Remember to bring the packaging and any remaining tablets with you.

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

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

• Abnormal sensations such as tingling in the fingers of the hands and feet or skin sensitivity to touch
• Drowsiness, dizziness or feeling of warmth
• Headache
• Irregular heartbeat
• Nausea, vomiting
• Stomach pain
• Dry mouth
• Muscle weakness or muscle pain
• Feeling of weakness
• 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
• Slightly increased blood pressure
• Increase in the amount of urine produced or in the number of times you need to urinate

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

• Allergic reactions/hypersensitivity, including raised itchy rash (hives) and swelling of the face, lips, mouth, tongue and throat. If you think zolmitriptan is causing you an allergic reaction, stop using it and contact your doctor immediately.

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

• Angina (chest pain, often triggered by exercise), heart attack or spasm of the blood vessels of the heart. If you experience chest pain or shortness of breath after taking zolmitriptan, contact your doctor and do not take any more zolmitriptan.
• Spasm of the blood vessels in the intestine which may damage your intestine. You may experience stomach pain or bloody diarrhoea. If this occurs, contact your doctor and do not take any more zolmitriptan.
• Urinary urgency

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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptan Flas Stada

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

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

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly 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 Flas Stada

• The active substance is zolmitriptan.

Each orodispersible tablet of Zolmitriptan Flas Stada contains 2.5 mg of zolmitriptan.

• The other components are: mannitol (Ph. Eur.), maltodextrin, microcrystalline cellulose, crospovidone type A, sodium hydrogen carbonate, citric acid, anhydrous colloidal silica, sodium saccharin, magnesium stearate and menthol flavour (maltodextrin, natural menthol, modified corn starch).

Appearance of the product and contents of the pack

Zolmitriptan Flas Stada orodispersible tablets are white, round, flat and bevel-edged.

Zolmitriptan Flas Stada 2.5 mg orodispersible tablets are available in aluminium/aluminium blisters containing 2, 3, 6, 12 or 24 tablets or 2x1, 3x1, 6x1, 12x1 or 24x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Manufacturer

Eurogenerics N.V./S.A.

Heizel Esplanade b22,

B-1020 Brussels

Belgium

or

STADA Arzneimittel AG

Stadastr. 2-18,

61118 Bad Vilbel

Germany

or

STADA M&D SRL?

Str. Trascaului nr. 10,?

Municipiul Turda,

Judet Cluj 401135,

Romania?

This medicinal product is authorised in EEA Member States under the following names:

Germany Zolmitriptan Stada 2.5 mg Schmelztabletten

Belgium Zolmitriptan Instant EG 2.5 mg orodispergeerbare tabletten

Denmark Zolmitriptan Stada

Spain Zolmitriptán Flas Stada 2.5 mg comprimidos bucodispersables EFG

Finland Zolmistad 2.5 mg tabletti, suussa hajoava

Netherlands Zolmitriptan CF 2.5 mg, orodispergeerbare tabletten

Luxembourg Zolmitriptan Instant EG 2.5 mg comprimés orodispersible

Portugal Zolmitriptano Ciclum

Sweden Zolmitriptan Stada 2.5 mg munsönderfallande tabletter

Date of the most recent revision of this leaflet: May 2020

Detailed and up-to-date 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/