RIZATRIPTAN NORMON 10 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before you take Rizatriptan Normon

Do not takeRizatriptan Normon

• 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 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 (medicines 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 an ergotamine-type medication, such as ergotamine or dihydroergotamine to treat your migraine or methysergide to prevent a migraine attack.
• if you are taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see also Other medicines and Rizatriptan Normonbelow).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan Normon.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rizatriptan Normon.

Before taking Rizatriptan Normon, tell 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 bundle branch block).
• you have or have had any allergy.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in leg and arm.
• you take herbal remedies containing 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 pain and pressure in the chest.

If you take Rizatriptan Normon too frequently, this can lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Normon.

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

Children and adolescents

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

Patients over 65 years

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

Other medicines and Rizatriptan Normon

Using Rizatriptan Normon with other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include herbal remedies and those medicines you normally take for migraine. This is because Rizatriptan Normon can affect how some medicines work. Other medicines can also affect Rizatriptan Normon.

Do not take Rizatriptan 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 to treat your migraine.
• if you are taking methysergide to prevent a migraine attack.

The above-mentioned medicines, when taken with Rizatriptan Normon, can increase the risk of adverse reactions.

After taking Rizatriptan 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 Rizatriptan Normon.

Ask your doctor for instructions on how to take Rizatriptan Normon and information about 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.

Taking Rizatriptan Normon with food and drinks

Rizatriptan Normon may take longer to work if you take it 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Available data on the safety of rizatriptan when used during the first 3 months of pregnancy do not indicate an increased risk of birth defects. It is not known if Rizatriptan Normon is harmful to the fetus when taken by a pregnant woman after the first 3 months of pregnancy.

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

Driving and using machines

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

Rizatriptan Normon contains aspartame and sodium

This medicine contains 7.5 mg of aspartame in each tablet.

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

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

3. How to take Rizatriptan Normon

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

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

The recommended dose is 10 mg.

• Open the blister pack with the Rizatriptan Normon oral lyophilisates with dry hands.
• Place the oral lyophilisate on the tongue, where it will dissolve and swallow with saliva.
• The oral lyophilisate 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 should use the 5 mg dose of Rizatriptan Normon. You should 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 comes back within 24 hours

In some patients, migraine symptoms may come back within 24 hours. If your migraine comes back, you can take an additional dose of Rizatriptan Normon. 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 Normon during an attack, you should not take a second dose of Rizatriptan Normon for the treatment of 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 oral lyophilisates in a 24-hour period). You should 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, talk to your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 5620420, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rizatriptan Normon can cause side effects, although not everybody gets 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 sensitivity in the skin (hypoesthesia), decreased mental sharpness, tremor,
• rapid or irregular heartbeat (palpitations), very rapid heartbeat (tachycardia),
• flushing (short-term redness of the face), hot flashes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• nausea, dry mouth, vomiting, diarrhea,
• heaviness in parts of the body,
• abdominal or chest pain.
• rash

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

• bad taste in the mouth,
• fainting (syncope), a syndrome called "serotonin syndrome" that can cause side effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, 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),
• heart attack, spasms of the blood vessels of the heart, stroke.

These occurred generally in patients with risk factors for heart disease or blood vessel disease (high blood pressure, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years old, postmenopausal woman, and a specific problem with the way the heart beats (left bundle branch block)).

Frequency not known (frequency cannot be estimated from the available data)

• seizures (convulsions/fits),
• contraction of the blood vessels of the limbs including cooling and numbness of hands and feet,
• contraction of the blood vessels of the colon (large intestine), which can cause abdominal pain,
• muscle pain,
• changes in the rhythm or frequency of the heartbeat (arrhythmia), slow heartbeat (bradycardia), alterations in the electrocardiogram (a test that records the electrical activity of your heart).

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

Also, tell your doctor if you experience any symptom that indicates an allergic reaction (such as rash or itching) after taking Rizatriptan Normon.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan Normon

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month shown.

Store Rizatriptan Normon below 30°C.

Do not use this medicine if you notice any change in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rizatriptan Normon

• The active substance is rizatriptan (benzoate). Each oral lyophilisate contains 10 mg of rizatriptan (as benzoate).
• The other ingredients of the oral lyophilisate are Pearlitol flash (contains mannitol), peppermint flavor, aspartame E-951, colloidal silica, sodium starch glycolate (from potato), and magnesium stearate.

Appearance of the product and pack contents

Rizatriptan Normon is available in packs of 2 or 6 oral lyophilisates.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:May 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es