RIZATRIPTAN FLAS CINFA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Prospect: Information for the user

Rizatriptan Flas Cinfa 10 mg Oral Disintegrating Tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus

1. What Rizatriptan Flas Cinfa is and what it is used for.
2. What you need to know before starting to take Rizatriptan Flas Cinfa.
3. How to take Rizatriptan Flas Cinfa.
4. Possible adverse effects.
5. Storage of Rizatriptan Flas Cinfa.
6. Package contents and additional information.

1. What Rizatriptan Flas is and what it is used for

Rizatriptan Flas Cinfa belongs to the group of medications called selective serotonin 5-HT1B/1D receptor agonists.

Rizatriptan Flas Cinfa is used to treat migraine headaches in adults. Treatment with Rizatriptan Flas Cinfa:

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

2. What you need to know before starting to take Rizatriptan Flas Cinfa

Do not take Rizatriptan Flas Cinfa

• if you are allergic to rizatriptan benzoate or any of the other components of this medication (listed in section 6).
• if you have moderately severe, severe, or uncontrolled mild high blood pressure.
• if you have or have ever had heart problems, including heart attack 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 (CVA) or a transient ischemic attack (TIA).
• if you have problems with obstruction in your arteries (peripheral vascular disease).
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (medications for depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.
• if you are currently taking ergotamine-type medications, such as ergotamine or dihydroergotamine for migraine, or methysergide to prevent migraine attacks.
• if you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see also Other medications and Rizatriptan Flas Cinfabelow).

If you are not sure if any of the above cases apply to you, talk to your doctor or pharmacist before taking Rizatriptan Flas Cinfa.

Warnings and precautions

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

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

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or use nicotine substitutes, your family has a history of heart disease, you are 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 take herbal remedies 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 norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have had transient symptoms including pain and pressure in the chest.

If you take Rizatriptan Flas too frequently, it can produce chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Flas Cinfa.

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

Children and adolescents

Rizatriptan Flas Cinfa oral disintegrating tablets are not recommended for use in children and adolescents under 18 years of age.

Other medications and Rizatriptan Flas Cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes herbal remedies and medications you normally take for migraine. This is because Rizatriptan Flas Cinfa may affect how some medications work. Other medications may also affect Rizatriptan Flas Cinfa.

Do not take Rizatriptan 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 migraine.
• if you are taking methysergide to prevent migraine attacks.

The medications mentioned above, when taken with Rizatriptan Flas Cinfa, may increase the risk of adverse effects.

After taking Rizatriptan 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 Rizatriptan Flas Cinfa.

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

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

Taking Rizatriptan Flas Cinfa with food and drinks

Rizatriptan Flas may take longer to work if you take it after meals. Although it is best 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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 not known if Rizatriptan 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 the baby.

Use in patients over 65 years of age

There are no complete studies that evaluate the safety and efficacy of Rizatriptan Flas in patients over 65 years of age.

Driving and using machines

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

Rizatriptan Flas Cinfa contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Rizatriptan Flas Cinfa contains aspartame

This medication contains 3.90 mg of aspartame in each tablet.

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

3. How to take Rizatriptan Flas Cinfa

Rizatriptan Flas Cinfa is used to treat migraine attacks. Take Rizatriptan Flas Cinfa as soon as possible once your migraine headache starts. Do not use it to prevent an attack.

Follow the administration instructions of this medication exactly as 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 should use the 5 mg dose of Rizatriptan. You should wait at least 2 hours between taking propranolol and Rizatriptan, up to a maximum of 2 doses in a 24-hour period.

If the migraine recurs within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine recurs, 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 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 to treat the same attack. However, you are 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). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer Rizatriptan Flas Cinfa oral disintegrating tablets

Rizatriptan Flas Cinfa (rizatriptan benzoate) is available in 10 mg oral disintegrating tablets that dissolve in the mouth.

1. Do not crush the oral disintegrating tablet

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

1. Separate a blister

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

1. Remove the foil

Remove the foil carefully, starting from the corner where it says "peel off aluminum" (Figures 3 and 4).

1. Remove the oral disintegrating tablet

Remove the oral disintegrating 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 oral disintegrating tablet can be used in situations where liquids are not available or to avoid nausea and vomiting that may accompany taking tablets with liquids.

Rizatriptan is also available in tablets to take 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 package and prospectus of the medication to the healthcare professional.

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.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medication.

In adult studies, the most frequently reported adverse effects 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 heartbeat (palpitations).
• flushing (transient redness of the face).
• throat discomfort.
• 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.
• ataxia, vertigo, blurred vision, tremors, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flashes, sweating.
• skin rash, itching, and hives (urticaria); swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea).
• stiffness in parts of the body, muscle weakness.
• changes in heart rate or rhythm (arrhythmia); alterations in the electrocardiogram (a test that records the electrical activity of your heart), very 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 life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, and a specific problem with the way the heart beats (left branch block))).
• slow heart rate (bradycardia).

Frequency not known (cannot be estimated from available data)

• heart attack, spasms of the blood vessels of the heart (these usually occur in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, and a specific problem with the way the heart beats (left branch block))).
• a syndrome called "serotonin syndrome" that can cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations.
• severe skin peeling with or without fever (toxic epidermal necrolysis).
• seizures (convulsions/fits).
• contraction of the blood vessels of the extremities, including cooling and numbness of hands and feet.
• contraction of the blood vessels of the colon (large intestine), which can cause abdominal pain.

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

Additionally, inform your doctor if you experience any symptoms that indicate an allergic reaction (such as rash or itching) after taking Rizatriptan Flas.

Reporting adverse effects

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

5. Storage of Rizatriptan Flas Cinfa

Keep this medication out of 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 package after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

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 flavor (contains natural peppermint flavor and peppermint extract, corn-derived maltodextrin, modified corn starch, (E-1450)), anhydrous colloidal silica, and magnesium stearate.

Product Appearance and Packaging Content

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Date of the Last Revision of this Prospectus: May 2024

Detailed and updated information on this medication 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 updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77121/P_77121.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77121/P_77121.html