Leaflet: information for the user

Rizatriptán Normon 10 mg buccal dispersible tablets EFG

Rizatriptan benzoate

Read this 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, 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.

1. What Rizatriptán Normon is and what it is used for

2. What you need to know before you start taking Rizatriptán Normon

3. How to take Rizatriptán Normon

4. Possible side effects

5. Storage of Rizatriptán Normon

6. Contents of the pack and additional information

Rizatriptán Normon belongs to a group of medicines called selective serotonin receptor agonists 5-HT 1B/1D.

Rizatriptán Normon is used to treat headache crises of migraine in adults.

Rizatriptán Normon treatment: Reduces the swelling of blood vessels surrounding the brain. This swelling causes the headache of a migraine crisis.

Do not takeRizatriptán Normon

• if you are allergic to rizatriptan (benzoate) or any of the other ingredients of this medication (listed in section 6).
• if you have moderately severe, severe, or mild hypertension that is not controlled with medication.
• if you have or have had any heart problems, including myocardial infarction or chest pain (angina) or have experienced symptoms 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 medications and Rizatriptán Normon).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to takeRizatriptán Normon.

Before taking Rizatriptán Normon, 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 Normon frequently, this may cause you to develop chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptán Normon.

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

Children and adolescents

Rizatriptán Normon is not recommended for use in children under 18 years of age.

Patients over 65 years of age

There are no complete studies evaluating the safety and efficacy of Rizatriptán Normon in patients over 65 years of age.

Other medications andRizatriptán Normon

Use of Rizatriptán Normon with other medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes herbal medicines and those medications you take regularly for your migraine. This is because Rizatriptán Normon may affect the way some medications work. Other medications may also affect Rizatriptán Normon.

Do not take Rizatriptán Normon:

• 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 a migraine attack.

The medications mentioned above may increase the risk of adverse reactions when taken with Rizatriptán Normon.

After taking Rizatriptán Normon, 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 Normon.

Ask your doctor for instructions on how to take Rizatriptán Normon and information on the risks:

• if you are currently taking propranolol (see section 3).
• 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.

TakingRizatriptán Normonwith food and drinks

Rizatriptán Normon may take longer to take effect 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, consult your doctor or pharmacist before using this medication.

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 Normon 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.

Driving and operating machinery

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

Rizatriptán Normon contains aspartame and sodium

This medication contains 7.5 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.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Rizatriptan Normonis used to treat migraine attacks. TakeRizatriptan Normonas soon as possible once your migraine headache has started. Do not use it to prevent an attack.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

• Open the blister pack with the Rizatriptan Normon buccal dispersible tablets with dry hands.
• Place the buccal dispersible tablet on the tongue, where it will dissolve and be swallowed with saliva.
• The buccal dispersible 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.

If you are currently taking propranolol or have kidney or liver problems, you must use a dose of 5 mg of Rizatriptan Normon. You must wait at least 2 hours between taking propranolol and Rizatriptan Normon, 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 Normon. You must 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 Normon during an attack, do not take a second dose of Rizatriptan Normon for the same attack. However, you are still likely to respond to Rizatriptan Normon during the next attack.

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

If your condition worsens, seek medical attention.

If you take more Rizatriptan NORMON than you should

If you take more Rizatriptan NORMON than you should, consult your doctor or pharmacist immediately,or call the Toxicological Information Service, phone 91 5620420, indicating the medication and the amount taken. 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 product, ask your doctor or pharmacist.

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

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

Frequent (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, tremor,
• rapid or irregular heart rate (palpitations), very rapid heart rate (tachycardia),
• flushing (brief facial redness), hot flashes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• nausea, dry mouth, vomiting, diarrhea,
• heaviness in parts of the body,
• abdominal or chest pain.
• skin rash

Infrequent (may affect up to 1 in 100 people)

• unsteadiness (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension);
• thirst, indigestion (dyspepsia),
• itching and rash with blisters (urticaria), allergic reaction (hypersensitivity); swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema).
• neck pain, feeling of stiffness in parts of the body, numbness, muscle weakness.

Rare (may affect up to 1 in 1000 people)

• bad taste in the mouth,
• syncope (fainting), a syndrome called "serotoninergic" that may cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination disorder, agitation, and hallucinations,
• facial pain, breathing sounds,
• sudden and potentially life-threatening allergic reaction (anaphylaxis); severe skin peeling with or without fever (toxic epidermal necrolysis),
• myocardial infarction, coronary artery spasms, stroke.

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

Unknown frequency (frequency cannot be estimated from available data)

• seizures (convulsions/spasms),
• contraction of blood vessels in the extremities, including hand and foot cooling and numbness,
• contraction of blood vessels in the colon (large intestine), which may cause abdominal pain,
• muscle pain,
• changes in heart rhythm or rate (arrhythmia), slow heart rate (bradycardia), electrocardiogram alterations (a test that records the heart's electrical activity).

Inform your doctor immediately if you experience symptoms of an allergic reaction, serotoninergic syndrome, myocardial infarction, or stroke.

Also, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or itching) after taking Rizatriptán Normon.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. 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.

StoreRizatriptan Normonbelow 30 °C.

Do not usethis medicationif you observe any change in the appearance of the tablets.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medication at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medication. By doing so, you will help protect the environment.

Composition of Rizatriptán Normon

- The active ingredient is rizatriptan (benzoate). Each buccal dispersible tablet contains 10 mg of rizatriptan (as benzoate).

- The other components of the buccal dispersible tablet are Pearlitol flash (contains mannitol), peppermint aroma, aspartame E-951, colloidal silica, sodium glycolate starch (from potato) and magnesium stearate.

Appearance of the product and content of the packaging

Rizatriptán Normon is presented in packs of 2 or 6 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:May 2024

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