Rizatriptan Vir 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptan Vir 10 mg orodispersible tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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.

Leaflet contents

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

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

Rizatriptán Vir belongs to a group of medicines called selective serotonin 5-HT_1B/1D receptor agonists.

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

Treatment with Rizatriptán Vir:

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

2. What you need to know before taking Rizatriptan Vir

Do not take Rizatriptan Vir:

• if you are allergic to rizatriptan or to 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 myocardial infarction or chest pain (angina), or have experienced symptoms related to heart disease
• if you have liver or kidney problems
• if you have had a stroke (CVA) or a transient ischemic attack (TIA)
• if you have arterial obstruction problems (peripheral vascular disease)
• if you are taking monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranilcypramine, or pargyline (medications for depression) or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAOI
• if you are currently taking an ergotamine-type medicine, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent a migraine attack
• if you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see below: Use of Rizatriptan Vir with other medicines)

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

Warnings and precautions

Consult your doctor or pharmacist before taking Rizatriptan Vir.

Before taking Rizatriptan Vir, 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 products, your family has a history of heart disease, you are a man over 40 years of age or 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 ever had any allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the leg or arm
• 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 and/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 Rizatriptan Vir too frequently, this may lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Vir.

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

Tell your doctor if you are currently using, have recently used, or may need to use any other medicines. This includes herbal remedies and medicines you usually take for migraine. This is because Rizatriptan may affect how some medicines work. Other medicines may also affect rizatriptan.

Use of Rizatriptan Vir with other medicines

Do not take Rizatriptan Vir:

• 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, tranilcypramine, linezolid, or pargyline, or if less than two weeks have passed since you stopped taking an MAOI
• if you are taking ergotamine-type medicines, 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, may increase the risk of adverse effects.

After taking Rizatriptan Vir, wait at least 6 hours before taking ergotamine-type medicines such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medicines, wait at least 24 hours before taking Rizatriptan Vir.

Ask your doctor for instructions on how to take Rizatriptan Vir and information about the risks:

• if you are currently taking propranolol (see section 3: How to take Rizatriptan Vir)
• 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

Inform your doctor or pharmacist if you are currently using, have recently used, or may need to use any other medicines.

Taking Rizatriptan Vir with food and drink

Rizatriptan may take longer to work if taken after meals. Although it is best to take it on an empty stomach, you may still take it even if you have eaten.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor 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 rizatriptan 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.

Driving and using machines

This medicine may cause drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery.

Rizatriptan Vir contains aspartame

Each 10 mg orodispersible tablet of Rizatriptan Vir contains 2.90 mg of aspartame (which contains phenylalanine).

This medicine contains 2.90 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Rizatriptan Vir

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

Always follow the instructions for use provided by your doctor or pharmacist. If you are unsure, 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 must wait at least 2 hours between taking propranolol and rizatriptan, and no more than 2 doses should be taken within a 24-hour period.

Rizatriptan Vir is available as 10 mg orodispersible tablets that dissolve in the mouth.

• Open the Rizatriptan Vir blister pack with dry hands.

• Place the tablet on the tongue, where it will dissolve and can be swallowed with saliva.

• The orodispersible tablet can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

If migraine returns within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine returns, you may take an additional dose of Rizatriptan Vir.

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 during an attack, you should not take a second dose of rizatriptan to treat the same attack. However, you are still likely to respond to rizatriptan during the next attack.

Do not take more than 2 doses of rizatriptan within a 24-hour period (e.g., do not take more than 2 tablets of 10 mg within 24 hours). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

If you take more Rizatriptan Vir than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested. Bring the medicine packaging with you.

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, this medicine can cause 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, drowsiness and fatigue.

Common (may affect up to 1 in 10 people)

• tingling sensation (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, insomnia.

• fast or irregular heartbeat (palpitation).

• flushing (temporary reddening of the face).

• throat discomfort.

• malaise (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia).

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

• abdominal or chest pain.

Uncommon (may affect up to 1 in 100 people)

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, sweating.
• skin rash, itching and raised rash (urticaria), swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnoea).
• sensation of stiffness in parts of the body, muscle weakness.
• changes in heart rate or rhythm (arrhythmia), electrocardiogram abnormalities (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• facial pain, muscle pain.

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

• breathing noises.
• 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 (hypertension, diabetes, smoker, 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)).
• slow heartbeat (bradycardia).

Frequency not known (cannot be estimated from available data)

• heart attack (myocardial infarction), spasms of the blood vessels in the heart (these usually occur in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, 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)).
• a condition called "serotonin syndrome" which may cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation and hallucinations.
• severe peeling of the skin with or without fever (toxic epidermal necrolysis).
• 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.

Contact 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 suggesting an allergic reaction (such as rash or itching) after taking rizatriptan.

Reporting of adverse effects

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

5. Storage of Rizatriptan Vir

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 refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is rizatriptan. Each tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

• The other components are: microcrystalline cellulose (E460a), corn starch, colloidal anhydrous silica, aspartame (E951), peppermint powder (menthol, menthone, menthyl acetate, menthofuran), and magnesium stearate (E572).

Appearance of the product and contents of the pack

Rizatriptán Vir 10 mg orodispersible tablets are white, round, biconvex orodispersible tablets with a mint flavour, scored on one side. The score line is not intended to divide the tablet into equal doses.

Rizatriptan 10 mg orodispersible tablets are available in aluminum/aluminum blister packs containing 2, 3 or 6 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923- Alcorcón (Madrid)
Spain

Manufacturer

Pharmathen S.A
6th Dervenakion Str
15351, Pallini Athens
Greece

or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.
Laguna, 66-68-70. Poligono Industrial Urtinsa II
28923- Alcorcón (Madrid)
Spain

This patient information leaflet was approved in June 2024.

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