Patient Information

Rizatriptan Flas Cinfa 10 mg Bucodispersable Tablets

Read this leaflet carefully before you start to take 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

Rizatriptán flas cinfa belongs to a group of medicines called selective serotonin receptor agonists 5-HT1B/1D.

Rizatriptán flas cinfa is used to treat the headaches of migraine attacks in adults.Rizatriptán flas cinfa treatment:

Reduces the swelling of blood vessels surrounding the brain. This swelling causes the headache of a migraine attack.

Do not take Rizatriptán Flas Cinfa

• if you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6).
• if you have moderately severe, severe, or uncontrolled high blood pressure.
• if you have or have had any heart problems, including myocardial infarction or chest pain (angina) or have experienced signs related to heart disease.
• if you have severe liver or kidney problems.
• if you have had a stroke or a transient ischemic attack (TIA).
• if you have peripheral vascular disease (obstruction in your arteries).
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.
• if you are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for your migraine, or methysergide to prevent a migraine attack.
• if you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine (see belowOther Medicines and Rizatriptán Flas Cinfa).

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptán Flas Cinfa.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Flas Cinfa.

Before taking Rizatriptán Flas, inform your doctor or pharmacist if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or using nicotine substitutes, a family history of heart disease, being a man over 40 years old or a postmenopausal woman.
• you have kidney or liver problems.
• you have a specific problem with the way your heart beats (left branch block).
• you have or have had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm.
• you are taking herbal medicines that contain St. John's Wort.
• you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have had transient symptoms including chest pain and pressure.

If you take Rizatriptán Flas frequently, this may lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptán Flas Cinfa.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have a migraine. You should only take Rizatriptán Flas Cinfa for a migraine attack. Rizatriptán Flas should not be used to treat other headaches that may be caused by more serious underlying diseases.

Children and Adolescents

Rizatriptán Flas Cinfa tablets are not recommended for use in children and adolescents under 18 years old.

Other Medicines and Rizatriptán Flas Cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes herbal medicines and those you normally take for migraine. This is because Rizatriptán Flas Cinfa may affect the way some medicines work. Other medicines may also affect Rizatriptán Flas Cinfa.

Do not take Rizatriptán Flas Cinfa:

• if you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.
• if you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if it has been less than two weeks since you stopped taking an MAOI.
• if you are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for your migraine.
• if you are taking methysergide to prevent migraine attacks.

The above-mentioned medicines, when taken with Rizatriptán Flas Cinfa, may increase the risk of adverse effects.

After taking Rizatriptán Flas Cinfa, you should wait at least 6 hours before taking ergotamine-type medications, such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medications, you should wait at least 24 hours before taking Rizatriptán Flas Cinfa.

Ask your doctor for instructions on how to take Rizatriptán Flas Cinfa and information on the risks

• if you are currently taking propranolol (see section 3 How to take Rizatriptán Flas Cinfa).
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Taking Rizatriptán Flas Cinfa with Food and Drink

Rizatriptán Flas may take longer to work if taken after meals. Although it is better to take it on an empty stomach, you can still take it even if you have eaten.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The available data on the safety of rizatriptan when used during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown whether rizatriptán Flas is harmful to the fetus when taken by a pregnant woman after the first three months of pregnancy.

If you are breastfeeding, you may postpone breastfeeding for 12 hours after treatment to avoid exposing your baby.

Use in Patients Over 65 Years

There are no completed studies to evaluate the safety and efficacy of rizatriptán Flas in patients over 65 years old.

Driving and Operating Machinery

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

Rizatriptán Flas Cinfa Contains Lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Rizatriptán Flas Cinfa Contains Aspartame

This medicine contains 3.90 mg of aspartame in each tablet.

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

RRizatriptan flas cinfa is used to treat migraine attacks. Take rizatriptan flas cinfa as soon as possible once your migraine headache has started. Do not use it to prevent an attack.

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

The recommended dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems, you must use the 5 mg dose of rizatriptan. You should wait at least 2 hours between the intake of propranolol and rizatriptan, up to a maximum of 2 doses in a 24-hour period.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine reappears, you can take an additional dose of rizatriptan flas cinfa. You should always wait at least 2 hours between doses.

If after 2 hours you still have a migraine

If you do not respond to the first dose of rizatriptan flas cinfa during an attack, you should not take a second dose of rizatriptan flas cinfa for the same attack. However, you are still likely to respond to rizatriptan flas cinfa during the next attack.

Do not take more than 2 doses of rizatriptan flas cinfa in a 24-hour period (for example, do not take more than two 10 mg tablets in a 24-hour period). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer rizatriptan flas cinfa buccal tablets

Rizatriptan flas cinfa (rizatriptan benzoate) is available in buccal tablets of 10 mg that dissolve in the mouth.

1. Do not crush the buccal tablet

To prevent the buccal tablet from being crushed, do not press the blister (Figure 1).

1. Separate a blister

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

1. Remove the foil

Remove the foil carefully, starting from the corner where it is indicated to "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 so that it can be swallowed with saliva (Figure 5).

The buccal tablet can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

Rizatriptan is also available in tablets to be taken with liquids.

If you take more rizatriptan flas cinfa 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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.

In adult studies, the side effects reported most frequently were dizziness, drowsiness, and fatigue.

Frequent (may affect up to 1 in 10 patients)

-tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia.

-rapid or irregular heart rate (palpitations).

-flushing (brief facial redness).

-sore throat.

-unpleasantness (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).

-heaviness in parts of the body, neck pain, numbness.

- abdominal or chest pain.

Infrequent (may affect up to 1 in 100 patients)

-bad taste in the mouth.

-unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).

-confusion, nervousness.

-high blood pressure (hypertension); thirst, hot flashes, sweating.

-skin rash, itching, and rash with blisters (urticaria); swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea).

-sensation of stiffness in parts of the body, muscle weakness.

-alterations in heart rhythm or frequency (arrhythmia); electrocardiogram (ECG) changes, rapid heart rate (tachycardia).

-facial pain; muscle pain.

Rare (may affect up to 1 in 1,000 patients)

-breathing sounds.

-allergic reaction (hypersensitivity); sudden and potentially fatal allergic reaction (anaphylaxis).

-stroke (usually in patients with cardiovascular risk factors or vascular disease (hypertension, diabetes, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40, postmenopausal woman, and a specific heart rhythm problem (left branch block))).

-slow heart rate (bradycardia).

Unknown frequency (cannot be estimated from available data)

-heart attack, spasms of the heart's blood vessels (usually in patients with cardiovascular risk factors or vascular disease (hypertension, diabetes, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40, postmenopausal woman, and a specific heart rhythm problem (left branch block))).

-a syndrome called "serotonin syndrome" that can cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination problems, agitation, and hallucinations.

-severe skin peeling with or without fever (toxic epidermal necrolysis).

-seizures (convulsions/spasms).

-constriction of blood vessels in the extremities, including coldness and numbness of hands and feet.

-constriction of blood vessels in the colon (large intestine), which can cause abdominal pain.

Inform your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, heart attack, or stroke.

In addition, inform your doctor if you experience any symptoms that indicate an allergic reaction (such as rash or itching) after taking rizatriptan flas.

Reporting of 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 the 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 store at a temperature above 30°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines 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 medicines you no longer need. By doing so, you will help protect the environment.

Composition of rizatriptan flas cinfa

• The active ingredient is rizatriptan. Each buccal dispersible tablet contains 10 mg of rizatriptan, equivalent to 14.52 mg of rizatriptan benzoate.
• The other components are: lactose monohydrate, microcrystalline cellulose (E-460a), calcium silicate, crospovidone, aspartame (E-951), peppermint aroma (contains natural aroma and peppermint extract, corn-derived maltodextrin, modified cornstarch (E-1450)), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

The 10 mg buccal dispersible tablets are white or almost white, with flat faces, rounded edges, and beveled edges.

Rizatriptan flas cinfa 10 mg tablets are presented in peel-off aluminum/aluminum blister packs of 2 or 6 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Last review date of this leaflet: May 2024

Detailed and updated information on this medication 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 medication 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/77121/P_77121.html

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