ZOLMITRIPTAN FLAS STADA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Flas Stada 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 symptoms are the same as yours.
• If you experience 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 is Zolmitriptan Flas Stada and what is it 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. Storing Zolmitriptan Flas Stada
6. Contents of the pack and other information

1. What is Zolmitriptan Flas Stada and what is it 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 reduces 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 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 on the chest
• you have had a stroke or symptoms of short duration similar to a 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 at the same time. 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 condition caused by poor blood flow in the arteries of the heart (ischaemic heart disease). The risk is greater if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a close relative has a history of heart disease.
• you have been told you have Wolff-Parkinson-White Syndrome (a type of abnormal heartbeat)
• you have ever had liver problems
• you have headaches that are not 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 or over 65 years old.

Like other migraine treatments, taking too much zolmitriptan can cause you to have daily headaches or make your migraine headaches worse.

Talk to your doctor if you think this is happening to you. 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 or have recently taken or might take any other medicines.

In particular, 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 quinolones (such as ciprofloxacin)

If you are using herbal preparations containing St. John's Wort (Hypericum perforatum), it may be more likely that you will 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 how zolmitriptan works.

Pregnancy and breastfeeding

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.

• 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 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 better to wait and see how zolmitriptan affects you before trying to do these activities.

3. How to take Zolmitriptan Flas Stada

Take this medicine exactly as your doctor has told you. If you are not sure, ask 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 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 comes back 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 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 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 mentioned below may be part of the migraine attack itself.

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

• Unusual 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 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 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 of the intestine that can damage your intestine. You may experience stomach pain or bloody diarrhea. If this happens, contact your doctor and do not take any more zolmitriptan.
• Urinary urgency

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 Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 pack after EXP. The expiry date refers to the last day of that month.

Store in the original package 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 is in Zolmitriptan Flas Stada

• The active substance is zolmitriptan.

Each oral dispersible tablet of Zolmitriptan Flas Stada contains 5 mg of zolmitriptan.

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

Appearance and packaging

Zolmitriptan Flas Stada 5 mg oral dispersible tablets are white, round, flat, and have a beveled edge.

Zolmitriptan Flas Stada 5 mg oral dispersible tablets come in aluminum/aluminum 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 authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern

(Barcelona)

[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 authorized in the Member States of the EEA under the following names:

Germany Zolmitriptan Stada 5 mg Schmelztabletten

Belgium Zolmitriptan Instant EG 5 mg orodispergeerbare tabletten

Spain Zolmitriptán Flas Stada 5 mg comprimidos bucodispersables EFG

Luxembourg Zolmitriptan Instant EG 5 mg comprimés orodispersible

Portugal Zolmitriptano Ciclum

Sweden Zolmitriptan Stada 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.es/