ZOLMITRIPTAN FLAS STADA 2.5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Flas Stada 2.5 mg Oral Dispersible 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.

Contents of the pack

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

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

Zolmitriptan Flas Stada contains zolmitriptan and belongs to a group of medicines called triptans.

Zolmitriptan is used totreat migraine headaches.

The symptoms of migraine can be caused by the dilation of blood vessels in the head. It is thought that zolmitriptan works by decreasing 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 Flas Stada

Do not take Zolmitriptan 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 that occurs at rest) or have experienced symptoms related to the heart such as shortness of breath or pressure on the chest.
• you have had a stroke or symptoms of a short-term stroke (transient ischaemic attack or TIA).
• you have severe kidney problems.
• you are taking other medicines for migraine (e.g. ergotamine or ergot-type medicines such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For more information, see the next section: "Other medicines and Zolmitriptan Flas Stada".

If you are not sure if any of these apply to you, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor before taking Zolmitriptan Flas Stada, if:

• you are at risk of having a heart attack (ischaemic heart disease). The risk is greater if you smoke, have high blood pressure, high cholesterol levels, diabetes or if a close relative has had heart disease.
• you have been told you have Wolff-Parkinson-White Syndrome (a type of abnormal heartbeat).
• you have ever had liver problems.
• you get headaches that are not like your usual migraine headaches.
• you are taking any other medicine for treating depression (see "Other medicines and Zolmitriptan Flas Stada" below).

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

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

Like other migraine treatments, taking too much zolmitriptan may lead to daily headaches or make your migraine headaches worse.

Talk to your doctor if you think you might be getting this problem. You may need to stop taking zolmitriptan to correct the problem.

Other medicines and Zolmitriptan Flas Stada

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

Migraine medicines

• If you take 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 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 for depression

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

Other medicines

• cimetidine (for indigestion or stomach ulcers)
• a type of antibiotic called a quinolone (such as ciprofloxacin)

If you are taking herbal preparations containing St John's Wort (Hypericum perforatum), you may be more likely to experience side effects of zolmitriptan.

Taking Zolmitriptan Flas Stada with food and drink

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• It is not known if taking zolmitriptan during pregnancy is harmful. Before taking zolmitriptan, tell your doctor if you are pregnant or trying to become pregnant.
• Avoid breast-feeding 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 better to wait and see how zolmitriptan affects you before trying to do these activities.

3. How to take Zolmitriptan Flas Stada

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

• The usual dose is one tablet (2.5 mg or 5 mg).
• Place the tablet on your tongue, where it will dissolve and be swallowed with your saliva. You do not need to drink water to swallow your tablet.
• You can take another tablet after 2 hours, if the migraine is still present orif it returns within 24 hours.

If the tablets do not give you enough help with your migraine, tell your doctor. Your doctor may increase the dose to 5 mg or 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. 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 your doctor has prescribed, talk to your doctor or go to the nearest hospital immediately. Take the medicine pack with you.

If you have any further questions on the use of this product, 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 that are mentioned below may be part of the migraine attack itself.

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

• Abnormal sensations such as tingling in the fingers and toes or skin sensitive to touch
• Feeling sleepy, dizzy or warm
• Headache
• Irregular heartbeat
• Feeling sick (nausea). Being sick (vomiting)
• Stomach pain
• Dry mouth
• Muscle weakness or muscle pain
• Feeling weak
• Heaviness, pressure, pain or tightness 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 number of times you need to urinate.

Rare side 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 you are having an allergic reaction to zolmitriptan, stop taking it and contact your doctor immediately.

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

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

Reporting of side effects

If you get 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 Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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 Flas Stada contains

• The active substance is zolmitriptan.

Each oral dispersible tablet of Zolmitriptan Flas Stada contains 2.5 mg of zolmitriptan.

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

Appearance and packaging

Zolmitriptan Flas Stada 2.5 mg oral dispersible tablets are white, round, flat and with a bevelled edge.

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

Not all 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 medicine is authorised in the Member States of the EEA 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 last revision of this leaflet:May 2020

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