RIZATRIPTAN 10 mg Orally Disintegrating Tablets

Contents of the leaflet

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

Introduction

Package Leaflet: Information for the User

Rizatriptan Vir 10 mg Oral Lyophilisates EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Rizatriptan Vir is used to treat migraine headaches in adults.

Treatment with Rizatriptan Vir:

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 you take Rizatriptan Vir

Do not take Rizatriptan Vir:

• if you are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6)
• if you have moderately severe, severe, or mild uncontrolled high blood pressure.
• if you have or have had heart problems, including heart attack or chest pain (angina) or have experienced signs 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 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 for your migraine or methysergide to prevent a migraine attack
• if you are taking another 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 not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan Vir.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 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 certain 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 the 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 and/or swallowing (angioedema).
• if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, oxalate escitalopram, 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 Vir too frequently, this may cause you to develop chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Vir.

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

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines. These include herbal remedies and those medicines that you take normally for your migraine. This is because Rizatriptan can affect the way some medicines work. Other medicines can 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, 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 above-mentioned medicines, when taken with rizatriptan, can increase the risk of side effects.

After taking Rizatriptan Vir, 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 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, oxalate escitalopram, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicines.

Taking Rizatriptan Vir with food and drinks

Rizatriptan 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor 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 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

When taking this medicine, you may feel drowsy or dizzy. If this happens, do not drive or use tools or machines.

Rizatriptan Vir contains aspartame

Each Rizatriptan Vir 10 mg oral lyophilisate contains 2.90 mg of aspartame (which contains phenylalanine).

This medicine contains 2.90 mg of aspartame in each lyophilisate. 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 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.

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.

Rizatriptan Vir is available as 10 mg oral lyophilisates that dissolve in the mouth.

• Open the Rizatriptan Vir blister pack with dry hands.

• Place the lyophilisate on your tongue, where it will dissolve to be swallowed with your 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 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 another dose of Rizatriptan Vir.

You should 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 during an attack, you should not take a second dose of rizatriptan for the treatment of 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 in a 24-hour period (for example, do not take more than 2 tablets of 10 mg 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 Vir 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 medicine and the amount ingested. Bring the medicine package with you.

Signs of overdose may include dizziness, drowsiness, 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, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

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

Common (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, decreased sensitivity in the skin (hypoesthesia), decreased mental sharpness, insomnia.
• rapid or irregular heart rate (palpitations).
• flushing (short-term redness of the face).

• throat discomfort.
• nausea, dry mouth, vomiting, diarrhea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal pain 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 rash with hives (urticaria), swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea)
• feeling of 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 1000 people)

• 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, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years old, postmenopausal woman, and a certain problem with the way the heart beats (left bundle branch block).
• slow heart rate (bradycardia)

Frequency not known (cannot be estimated from the 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, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years old, postmenopausal woman, and a certain problem with the way the heart beats (left bundle branch block).
• 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.
• 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.

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 symptoms that suggest an allergic reaction (such as rash or itching) after taking rizatriptan.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side 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 which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

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

-The other ingredients 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 pack contents

Rizatriptan Vir 10 mg oral lyophilisates are white, round, biconvex, scored on one side, and have a mint flavor. The score line is not intended to break the lyophilisate.

Rizatriptan Vir 10 mg oral lyophilisates are available in aluminum/aluminum blister packs of 2, 3, or 6 lyophilisates.

Not all 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 leaflet was approved in June 2024

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