Zolmitriptan Flas Cinfa 2.5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptan Flas Cinfa 2.5 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, because it may 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 Cinfa is and what it is used for
2. What you need to know before taking Zolmitriptan Flas Cinfa
3. How to take Zolmitriptan Flas Cinfa
4. Possible side effects
5. How to store 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 known as triptans.

Zolmitriptan Flas Cinfa is used to treat migraine headache in adults aged 18 years and over.

• Migraine symptoms may be caused by the dilation of blood vessels in the head. Zolmitriptan Flas Cinfa is believed to reduce this dilation of blood vessels, thereby helping to relieve headache pain and other symptoms of a migraine attack, such as feeling unwell (nausea or vomiting) and sensitivity to light and sound.
• Zolmitriptan Flas only works once a migraine attack has started. It will not prevent you from having a migraine attack.

2. What you need to know before taking Zolmitriptán Flas Cinfa

Do not take Zolmitriptán Flas Cinfa

• If you are allergic to zolmitriptan or to 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 exertion), Prinzmetal's angina (chest pain occurring at rest), or have experienced heart-related symptoms such as shortness of breath or pressure in the chest.
• If you have had a stroke (cerebrovascular accident) or brief symptoms similar to a stroke (transient ischaemic attack or TIA).
• If you have severe kidney problems.
• If you are simultaneously taking other migraine medications (e.g. ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For further information, see section "Other medicines and Zolmitriptán Flas Cinfa".

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolmitriptán Flas Cinfa:

• If you are at risk of ischaemic 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 ischaemic heart disease.
• If you have been diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).
• If you have ever had liver problems.
• If you experience headaches different from your usual migraine headaches.
• If you are taking any other medication for depression (see section "Other medicines and Zolmitriptán Flas Cinfa").

If you go to a hospital, inform the medical staff that you are taking Zolmitriptán Flas Cinfa.

Zolmitriptán Flas is not recommended for individuals under 18 years of age or over 65 years of age.

Like other migraine treatments, excessive use of Zolmitriptán Flas 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 Zolmitriptán Flas to resolve the problem.

Other medicines and Zolmitriptán Flas Cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines and medicines you can buy without a prescription.

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

Migraine medications

• If you are taking other triptans different from zolmitriptan: wait 24 hours before taking Zolmitriptán Flas.
• After taking Zolmitriptán Flas Cinfa, wait 24 hours before taking other triptans different from Zolmitriptán Flas Cinfa.
• If you are taking medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptán Flas Cinfa.
• After taking Zolmitriptán Flas Cinfa, wait 6 hours before taking ergotamine or ergot-type medicines.

Medications 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 Zolmitriptán Flas.

Taking Zolmitriptán Flas Cinfa with food and drink

You may take Zolmitriptán Flas with or without food. This does not affect how Zolmitriptán Flas 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 Zolmitriptán Flas during pregnancy is harmful. Before taking Zolmitriptán Flas Cinfa, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding within 24 hours after taking zolmitriptan.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness. If you experience these effects, avoid driving or operating machinery as it could be dangerous.

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

Zolmitriptán Flas Cinfa contains aspartame

This medicine contains 0.9 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Zolmitriptan Flas Cinfa

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

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

• The recommended dose is one 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. The maximum daily dose is 5 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 one blister compartment

Each blister contains six compartments, separated by perforations. Separate one compartment along the perforated lines (Figure 2).

1. Remove the foil

Carefully peel off the foil, starting at the corner marked “peel aluminum” (Figures 3 and 4).

1. Remove the orodispersible tablet

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

If you take more Zolmitriptan Flas Cinfa than you should

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

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.

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

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

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

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

• Angina (chest pain, often triggered by exertion), heart attack, or spasm of the blood vessels in the heart. You may experience chest pain or shortness of breath.
• Spasm of the blood vessels in the intestine, which may damage your intestine. You may experience stomach pain or bloody diarrhea.

Other adverse effects that may occur:

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

• Abnormal sensations such as tingling in the fingers or toes, or skin sensitivity to touch.
• Feeling of drowsiness, dizziness, or 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 rapid heartbeat.
• Slightly increased blood pressure.
• Increase in the amount of urine produced or in the number of times you need to urinate.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 Cinfa

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Keep in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This 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 2.5 mg of active substance.

• The other components are: mannitol (E-421), crospovidone, calcium silicate, aspartame (E-951), orange flavour, strawberry flavour, 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, round, flat-faced, with bevelled edges.

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

Only some pack sizes may be marketed.

Other presentations

Zolmitriptan Flas Cinfa 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 the most recent revision of this leaflet: November 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/

You can access detailed and updated information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74385/P_74385.html

QR code to: https://cima.aemps.es/cima/dochtml/p/74385/P_74385.html