ZOLMITRIPTAN FLAS CINFA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Flas Cinfa5 mgorodispersible 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 Cinfa is and what it is used for
2. What you need to know before you take Zolmitriptan Flas Cinfa
3. How to take Zolmitriptan Flas Cinfa
4. Possible side effects
5. Storage of Zolmitriptan Flas Cinfa
6. Contents of the pack and other information

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

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

Zolmitriptan Flas Cinfa is used to treat migraine headaches in adults over 18 years of age.

• Migraine symptoms may be caused by the swelling of blood vessels in the head. It is thought that Zolmitriptan Flas Cinfa works by narrowing these blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick (nausea or vomiting) and being sensitive to light and sound.
• Zolmitriptan Flas 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 Cinfa

Do not take Zolmitriptan Flas Cinfa

• If you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have high blood pressure.
• If 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 heart-related symptoms such as shortness of breath or pressure on the chest.
• If you have had a stroke (cerebrovascular accident) or symptoms of short duration similar to a stroke (transient ischaemic attack or TIA).
• If you have severe kidney problems.
• If you are taking other medicines for migraine (e.g. ergotamine or ergot-type medicines such as dihydroergotamine and methysergide) or other triptan medicines for migraine. For more information, see the section "Other medicines and Zolmitriptan Flas Cinfa".

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Zolmitriptan Flas Cinfa:

• 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 levels of cholesterol, diabetes, or if a close relative has had heart disease.
• If you have been told you have Wolff-Parkinson-White syndrome (a type of irregular heartbeat).
• If you have ever had liver problems.
• If you get headaches that are not like your usual migraine headaches.
• If you are taking any other medicines for depression (see the section "Other medicines and Zolmitriptan Flas Cinfa").

If you go to hospital, tell the medical staff that you are taking Zolmitriptan Flas Cinfa.

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

Like other migraine treatments, taking too much Zolmitriptan Flas may make your headaches worse. Tell your doctor if you think this is happening to you. You may need to stop taking Zolmitriptan Flas to correct the problem.

Other medicines and Zolmitriptan Flas Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and medicines you have bought without a prescription.

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 Flas.
• After taking Zolmitriptan Flas Cinfa, wait 24 hours before taking other triptans different from Zolmitriptan Flas Cinfa.

• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptan Flas Cinfa.

• After taking Zolmitriptan Flas Cinfa, 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).
• An antibiotic of the quinolone group (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 Flas.

Taking Zolmitriptan Flas Cinfa with food and drink

You can take Zolmitriptan Flas with or without food. This does not affect how Zolmitriptan Flas 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.

• The use of Zolmitriptan Flas during pregnancy is not recommended. If you are pregnant, inform your doctor before taking Zolmitriptan Flas Cinfa.
• Avoid breastfeeding for 24 hours after taking zolmitriptan.

Driving and using machines

This medicine, like migraine itself, can make you feel sleepy. If you experience these effects, do not drive or use machines, as it may be dangerous.

During a migraine attack, your reactions may be slower than usual. Bear this in mind when driving or using tools or machines.

Zolmitriptan Flas Cinfa contains aspartame

This medicine contains 1.80 mg of aspartame in each orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (a rare, inherited disorder in which phenylalanine builds up in the body because it is not properly broken down).

3. How to take Zolmitriptan Flas Cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

• The recommended dose is one orodispersible tablet.
• You can take another orodispersible tablet after 2 hours, if the migraine has not improved or if it returns within 24 hours.

If the orodispersible tablets do not give you enough help for your migraine, tell your doctor. Your doctor may increase the dose to 10 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. The maximum daily dose is 10 mg.

Take the orodispersible tablet as follows:

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press on the blister (Figure 1).

1. Separate a blister

Each blister pack contains six blisters, separated by perforations. Separate one blister by following the perforations (Figure 2).

1. Remove the foil

Carefully remove the foil, starting from the corner where it says "peel off aluminium" (Figures 3 and 4).

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on your tongue, where it will dissolve and be swallowed with your saliva. You do not need to drink water to swallow your orodispersible tablet (Figure 5).

If you take more Zolmitriptan Flas Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

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.

Stop taking Zolmitriptan Flas Cinfa and contact your doctor immediately if you experience any of the following side effects:

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

• Allergic reactions/hypersensitivity, including rash, swelling of the face, lips, mouth, tongue or throat; difficulty swallowing or breathing difficulties.

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 heart's blood vessels. You may feel chest pain or shortness of breath.
• Spasm of the blood vessels of the intestine, which can damage your intestine. You may feel stomach pain or bloody diarrhea.

Other side effects that may occur:

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

• Unusual sensations such as tingling in the fingers and toes or sensitive skin.
• Feeling sleepy, dizzy, or warm.
• Headache.
• Irregular heartbeat.
• Nausea. Vomiting.
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tension, pain, or pressure 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 frequency of urination.

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 Agency's website: 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 Cinfa

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 the month shown.

Do not store above 30°C.

Store in the original package.

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

Composition of Zolmitriptan Flas Cinfa

• The active substance is zolmitriptan. Each orodispersible tablet contains 5 mg of active substance.

• The other ingredients are: mannitol (E-421), crospovidone, calcium silicate, aspartame (E-951), orange flavor, strawberry flavor, citric acid monohydrate (E-330), and magnesium stearate (E-470).

Appearance of Zolmitriptan Flas Cinfa and contents of the pack

Zolmitriptan Flas Cinfa orodispersible tablets are white or almost white, with flat faces, round, and with beveled edges.

They are available in Alu/Alu blisters. Each pack contains 2, 6, or 12 (6x2) orodispersible tablets.

Not all pack sizes may be marketed.

Other presentations

Zolmitriptan Flas Cinfa 2.5 mg orodispersible tablets: packs of 2, 6, or 12 (6x2) orodispersible tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:November 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/

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74386/P_74386.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74386/P_74386.html