Rizatriptan Normon 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptan Normon 10 mg orodispersible tablets EFG

rizatriptan benzoate

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Rizatriptan Normon is and what it is used for
2. What you need to know before taking Rizatriptan Normon
3. How to take Rizatriptan Normon
4. Possible side effects
5. How to store Rizatriptan Normon
6. Contents of the pack and other information

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

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

Rizatriptán Normon is used to treat headache pain during migraine attacks in adults.

Treatment with Rizatriptán Normon: Reduces swelling of the blood vessels surrounding the brain. This swelling causes the headache associated with a migraine attack.

2. What you need to know before taking Rizatriptán Normon

Do not take Rizatriptán Normon

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptán 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, you are a smoker or using nicotine replacement therapy, your family has a history of heart disease, you are a man over 40 years of age, or you are a postmenopausal woman.
• you have kidney or liver problems.
• you have a specific problem with your heart rhythm (left bundle branch block).
• you have or have had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arm or leg.
• you are taking herbal remedies containing St. John’s wort.
• you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have experienced transient symptoms including chest pain and tightness.

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

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

Children and adolescents

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

Patients over 65 years of age

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

Other medicines and Rizatriptán Normon

Using Rizatriptán Normon with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies and medicines you usually take for migraine. This is because Rizatriptán Normon may affect how some medicines work. Other medicines may also affect Rizatriptán Normon.

Do not take Rizatriptán Normon:

• if you are already taking a 5-HT1B/1D agonist (sometimes referred to as "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 less than two weeks have passed since you stopped taking an MAOI.
• if you are taking ergot-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 Rizatriptán Normon, may increase the risk of adverse reactions.

After taking Rizatriptán Normon, you must wait at least 6 hours before taking ergot-type medications such as ergotamine, dihydroergotamine, or methysergide.

After taking ergot-type medications, you must wait at least 24 hours before taking Rizatriptán Normon.

Ask your doctor for instructions on how to take Rizatriptán 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-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Taking Rizatriptán Normon with food and drink

Rizatriptán Normon may take longer to work if taken after meals. Although it is better to take it on an empty stomach, you may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Available data on the safety of rizatriptan 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness or dizziness. If you experience these effects, avoid driving or using machinery, as it may be dangerous.

Rizatriptán Normon contains aspartame and sodium

This medicine contains 7.5 mg of aspartame per tablet.

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

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

3. How to take Rizatriptan Normon

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

Follow exactly the instructions for use given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

• Open the blister pack containing the Rizatriptan Normon orodispersible tablets with dry hands.
• Place the orodispersible tablet on the tongue, where it will dissolve and be swallowed with saliva.
• The orodispersible tablet may be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

If you are currently taking propranolol or have kidney or liver problems, you should use the 5 mg dose of Rizatriptan Normon. You must wait at least 2 hours between taking propranolol and Rizatriptan Normon, and take no more than 2 doses within a 24-hour period.

If migraine recurs within 24 hours

In some patients, migraine symptoms may recur within a 24-hour period. If your migraine recurs, you may take an additional dose of Rizatriptan Normon. Always wait at least 2 hours between doses.

If you still have migraine after 2 hours

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 to treat 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 within a 24-hour period (for example, do not take more than two 10 mg orodispersible tablets within 24 hours). 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 5620420, stating the medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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

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

4. Possible adverse effects

Like all medicines, Rizatriptan Normon may produce adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine.

In studies in adults, the most frequently reported adverse effects were dizziness, somnolence, and fatigue.

Frequent (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, tremor,
• fast or irregular heartbeat (palpitation), very rapid heartbeat (tachycardia),
• flushing (temporary redness of the face), hot flushes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• malaise (nausea), dry mouth, vomiting, diarrhoea,
• heaviness in parts of the body,
• abdominal or chest pain,
• skin 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 raised rash (urticaria), allergic reaction (hypersensitivity); swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema),
• neck pain, sensation of stiffness in parts of the body, numbness, muscle weakness.

Rare (may affect up to 1 in 1000 people)

• unpleasant taste in the mouth,
• fainting (syncope), a syndrome called "serotonin syndrome" which may cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations,
• facial pain, noisy breathing,
• sudden and potentially life-threatening allergic reaction (anaphylaxis); severe peeling of the skin with or without fever (toxic epidermal necrolysis),
• myocardial infarction, spasms of blood vessels in the heart, stroke.

These events generally occurred in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block)).

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

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

Contact your doctor immediately if you experience symptoms of an allergic reaction, serotonin 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 Rizatriptan Normon.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptán Normon

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store Rizatriptán Normon below 30 °C.

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

Medicines should not be disposed of via drains or in household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. In this way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptán Normon

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

Nature and content of the product and pack sizes

Rizatriptán Normon is available in packs containing 2 or 6 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es