Leaflet: information for the user

Zolmitriptán Flas Cinfa5 mgorally disintegrating tablets EFG

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Zolmitriptán Flas Cinfa is used to treat migraine headache in adults aged 18 years and above.

• The symptoms of migraine may be caused by a dilation of blood vessels in the head. It is believed that Zolmitriptán Flas Cinfa reduces the dilation of these blood vessels. This helps in the disappearance of headache pain and other symptoms of a migraine attack, such as a feeling of discomfort (nausea or vomiting) and sensitivity to light and sound.
• Zolmitriptán Flas acts only when a migraine attack has begun. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Flas Cinfa

• If you are allergic to zolmitriptán or any of the other components of this medication (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), angina of Prinzmetal (chest pain that occurs at rest) or have experienced symptoms related to the heart 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 ischemic attack or TIA).
• If you have severe kidney problems.
• If you are taking other medications for migraine (for example ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other medications for migraine in the triptan group. For additional information, see the section Other Medications and Zolmitriptán Flas Cinfa.

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Zolmitriptán Flas Cinfa:

• If you are at risk of suffering from ischemic heart disease (insufficient blood flow to 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.
• If you have been informed that you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).
• If you have ever had liver problems.
• If you have headaches other than your usual migraine headache.
• If you are taking any other medication for the treatment of depression (see the section Other Medications 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 people under 18 years or over 65.

Like other migraine treatments, excessive use of Zolmitriptán Flas may cause daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. You may need to stop using Zolmitriptán Flas to correct the problem.

Other Medications and Zolmitriptán Flas Cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This includes herbal remedies and medications you purchase without a prescription.

Especially, inform your doctor if you are taking any of the following medications:

Migraine Medications

• If you take other triptans different from zolmitriptán: 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 take medications containing ergotamine or ergot-type medications (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 medications.

Depression Medications

• Moclobemida or fluvoxamina.
• Medications called SSRIs (selective serotonin reuptake inhibitors).
• Medications called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine.

Other Medications

• Cimetidina (for indigestion or stomach ulcers).
• A quinolone antibiotic (such as ciprofloxacin).

If you are using herbal remedies that contain St. John's Wort (Hypericum perforatum), it may be more likely that adverse effects of Zolmitriptán Flas will occur.

Taking Zolmitriptán Flas Cinfa with Food and Drinks

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

• The safety of taking Zolmitriptán Flas during pregnancy is unknown. Before taking Zolmitriptán Flas Cinfa, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding within 24 hours after taking zolmitriptán.

Driving and Operating Machines

This medication, like migraine, can cause drowsiness. If you experience these effects, avoid driving or using machines as it may be hazardous.

During a migraine crisis, your reactions may be slower than usual. Take this into account when driving or using tools or machines.

Zolmitriptán Flas Cinfa contains aspartame

This medication contains 1.80 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You can take Zolmitriptán Flas as soon as a migraine headache begins. You can also take it once a headache has started.

- The recommended dose is one tablet.

- You can take another tablet after two hours if the migraine persists or recurs within 24 hours.

If the tablets do not provide sufficient relief for your migraine, inform your doctor. Your doctor may increase the dose to 10 mg or change your treatment.

Do not use more than the dose prescribed.

• Do not use more than two doses in a day. The maximum daily dose is 10 mg.

Take the buccal tablet in the following way:

1. Do not crush the buccal tablet

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

1. Separate a blister

Each blister contains six blisters, separated by perforations. Separate a blister following the perforated lines (Figure 2).

1. Remove the foil

Remove the foil carefully, starting from the corner indicated "remove aluminum" (Figures 3 and 4).

1. Remove the buccal tablet

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

If you take more Zolmitriptán Flas than you should

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Stop taking Zolmitriptán 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 hives and 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 coronary artery spasm. You may observe chest pain or shortness of breath.
• Intestinal artery spasm that may damage your intestine. You may observe abdominal pain or bloody diarrhea.

Other side effects that may occur:

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

• Abnormal sensations such as tingling in the fingers of the hands and feet or sensitive skin.
• Sensation of drowsiness, dizziness, or heat.
• Headache.
• Irregular heartbeat.
• Nausea. Vomiting.
• Abdominal pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Sensation of weakness.
• Weight, tension, pain, or pressure in the throat, neck, arms, and legs or chest.
• Difficulty swallowing.

Infrequent side effects (may affect up to 1 in 100 people):

• Very rapid heartbeat.
• Slightly higher blood pressure.
• Increased urine production or the need to urinate more frequently.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zolmitriptán Flas Cinfa

• The active ingredient is zolmitriptan. Each buccal dispersible tablet contains 5 mg of active ingredient.

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

Appearance of Zolmitriptán Flas Cinfa and content of the container

Zolmitriptán Flas Cinfa buccal dispersible tablets are white or almost white, with flat faces, rounded, and beveled edges.

It is presented in Alu/Alu blisters. Each container contains 2, 6, or 12 (6 x 2) buccal dispersible tablets.

Only some container sizes may be commercially marketed.

Other presentations

Zolmitriptán Flas Cinfa 2.5 mg buccal dispersible tablets: containers of 2, 6, or 12 (6 x 2) tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

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

Last review date of this leaflet: November 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on 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