RIZATRIPTAN AUROVITAS 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

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

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

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

Rizatriptan is used to treat migraine headaches in adults.

Treatment with Rizatriptan Aurovitas:

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 Aurovitas

Do not takeRizatriptan Aurovitas

• 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 or uncontrolled high blood pressure.
• if you have or have ever had heart problems, including heart attack or angina (chest pain) or have experienced symptoms related to heart disease.
• if you have severe liver or kidney problems.
• if you have had a stroke (cerebrovascular accident) or a transient ischaemic attack (TIA).
• if you have problems with blood circulation (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 migraine, or methysergide for preventing migraine attacks.
• if you are taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan for migraine (see Other medicines and Rizatriptan Aurovitas).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Rizatriptan Aurovitas:

• 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 being a postmenopausal woman.
• if you have kidney or liver problems.
• if you have a certain problem with the way your heart beats (left bundle branch block).
• if you have or have had any allergies.
• if your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the leg and arm.
• if you take herbal remedies containing St. John's Wort.
• if you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (angioedema).
• if 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.
• if you have had transient symptoms including pain and pressure in the chest.

If you take rizatriptan too frequently, this can cause you to have chronic headaches. In such cases, you should contact your doctor, as you may need to stop taking rizatriptan.

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

Tell your doctor or pharmacist about all the medicines you are taking, including those you have bought without a prescription, herbal remedies, and those you normally take for migraine. This is because rizatriptan can affect how some medicines work, and other medicines can affect rizatriptan.

Other medicines and Rizatriptan Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take rizatriptan:

• if you are already taking a 5-HT1B/1D agonist (sometimes called a “triptan”), 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 migraine.
• if you are taking methysergide to prevent migraine attacks.

The above-mentioned medicines, when taken with rizatriptan, can increase the risk of side effects.

After taking rizatriptan, you should wait at least 6 hours before taking ergotamine-type medications like ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medications, you should wait at least 24 hours before taking rizatriptan.

Ask your doctor for instructions on how to take rizatriptan and information about the risks

• if you are currently taking propranolol (see section 3 How to take Rizatriptan Aurovitas).
• 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 Aurovitas with food and drinks

Rizatriptan may take longer to work if you take it after meals. Although it is best 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 or pharmacist for advice before taking this medicine.

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 not known if rizatriptan is harmful 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.

Children and adolescents

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

Use in patients over 65 years of age

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

Driving and using machines

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

Rizatriptan Aurovitas contains aspartame

This medicine contains 3.741 mg of aspartame in each oral lyophilisate.

Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Rizatriptan Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per oral lyophilisate; it is essentially “sodium-free”.

3. How to take Rizatriptan Aurovitas

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

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

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.

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. 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 a migraine attack, you should not take a second dose of rizatriptan for the treatment of the same attack. However, you may still respond to rizatriptan during the next attack.

Do not take more than 2 doses ofRizatriptanin a 24-hour period (for example, do not take more than two 10 mg oral lyophilisates or tablets in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer Rizatriptan Aurovitas oral lyophilisates

• Rizatriptan oral lyophilisates dissolve in the mouth.
• Open the blister pack with dry hands.
• Place the oral lyophilisate on the tongue, where it will dissolve to be swallowed with saliva.
• The oral lyophilisate can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany taking tablets with liquids.

Rizatriptan is also available in tablets to be taken with liquids.

If you take more Rizatriptan Aurovitas than you should

If you take more rizatriptan than you should, talk to your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. Bring the pack with you.

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, 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.

Frequent (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 heartbeat (palpitations).
• flushing (short-term redness of the face).
• throat discomfort.
• nausea (feeling sick), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).
• feeling of heaviness in parts of the body, neck pain, numbness, stomach or chest pain.

Infrequent (may affect up to 1 in 100 people)

• unpleasant taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension), thirst, hot flushes, sweating.
• skin rash, itching, and rash with hives (urticaria), swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea).
• feeling of stiffness in parts of the body, muscle weakness.
• changes in heart rhythm or frequency (arrhythmia), changes 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 1,000 people)

• breathing sounds.
• allergic reaction (hypersensitivity): sudden and severe life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart disease or blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, being a man over 40 years old, being a 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 disease or blood vessel disease [high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, being a man over 40 years old, being a 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 or 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan Aurovitas

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 blister pack and carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan Aurovitas

• The active substance is rizatriptan. Each oral lyophilisate contains 14.530 mg of rizatriptan benzoate, equivalent to 10 mg of rizatriptan.

The other ingredients are: microcrystalline cellulose, pregelatinized corn starch, mannitol, crospovidone (Type A), aspartame (see section 2), peppermint flavor (maltodextrin, natural flavors, modified corn starch), sodium stearyl fumarate, and sodium.

Appearance of the product and pack contents

Oral lyophilisates.

White to off-white, circular, biconvex, uncoated tablets with the mark “F25” on one side and smooth on the other, with a peppermint flavor.

Rizatriptan Aurovitas oral lyophilisates are available in blister packs of Polyamide/Aluminum/PVC-aluminum foil of: 2, 3, 6, 10, 12, and 18 oral lyophilisates.

Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: RIZATRIPTAN ARROW 10 mg, orodispersible tablets

Germany: Rizatriptan Aurobindo 10 mg orodispersible tablets

Spain: Rizatriptán Aurovitas 10 mg oral lyophilisates EFG

Netherlands: Rizatriptan Aurobindo 10 mg orodispersible tablets

Italy: Rizatriptan Aurobindo 10 mg orodispersible tablets

Malta: Rizatriptan 10 mg orodispersible tablets

Date of last revision of this leaflet: June 2024

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