Rizatriptan Aurovitas 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rizatriptan Aurovitas 10 mg orodispersible tablets EFG

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

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

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

Rizatriptan is used to treat headache attacks during migraine episodes in adults.

Treatment with Rizatriptan Aurovitas:

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 Rizatriptan Aurovitas

Do not take Rizatriptan Aurovitas

• if you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6).
• you have moderately 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 signs related to heart disease.
• you have severe liver or kidney problems.
• you have had a stroke (CVA) or a transient ischaemic attack (TIA).
• you have arterial obstruction problems (peripheral vascular disease).
• you are taking monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranylcypromine or pargyline (medicines 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 ergotamine-type medicine, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent migraine attacks.
• you are taking any other medicine of the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine (see Other medicines and Rizatriptan Aurovitas).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptan Aurovitas:

• 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 a postmenopausal woman.
• if you have kidney or liver problems.
• if you have a specific condition affecting your heart rhythm (left bundle branch block).
• if you have or have ever had any allergies.
• if your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arm or leg.
• if you are taking herbal remedies containing St. John’s wort.
• if you have had allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing (angioedema).
• if 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.
• if you have experienced transient symptoms including chest pain or tightness.

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

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

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

Other medicines and Rizatriptan Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Do not take rizatriptan:

• 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 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 migraine attacks.

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

After taking rizatriptan, you must wait at least 6 hours before taking ergotamine-type medicines such as ergotamine, dihydroergotamine or methysergide.

After taking ergotamine-type medicines, you must 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-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Taking Rizatriptan Aurovitas with food and drink

Rizatriptan 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, breastfeeding and fertility

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 when used 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Children and adolescents

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

Use in patients over 65 years of age

There are no completed studies evaluating 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 occurs, do not drive or operate tools or machinery.

Rizatriptan Aurovitas contains aspartame

This medicine contains 3.741 mg of aspartame in each orodispersible tablet.

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

Rizatriptan Aurovitas contains sodium

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

3. How to take Rizatriptan Aurovitas

Always follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Rizatriptan is used to treat migraine attacks. Take rizatriptan as soon as possible once 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 must wait at least 2 hours between taking propranolol and rizatriptan, and take no more than 2 doses within a 24-hour period.

If migraine returns within 24 hours

In some patients, migraine symptoms may recur within a 24-hour period. If your migraine returns, you may take an additional dose of rizatriptan. 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 for the same attack. However, you are still likely to respond to rizatriptan during a subsequent attack.

Do not take more than 2 doses of rizatriptan within a 24-hour period (for example, do not take more than two orodispersible tablets or tablets of 10 mg or 5 mg within 24 hours). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer Rizatriptan Aurovitas orodispersible tablets

• Rizatriptan orodispersible tablets dissolve in the mouth.
• Open the blister pack with dry hands.
• Place the orodispersible tablet on the tongue, where it will dissolve and can 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.

Rizatriptan is also available as tablets to be taken with liquid.

If you take more Rizatriptan Aurovitas than you should

If you take more rizatriptan than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount taken. Bring the package 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 (palpitations).
• flushing (reddening of the face lasting a short time).
• throat discomfort.
• malaise (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia).
• feeling of heaviness in parts of the body, neck pain, numbness, stomach 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, hot flushes, sweating.
• skin rash, itching and raised rash (urticaria), swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea).
• feeling of stiffness in parts of the body, muscle weakness.
• changes in the rhythm or rate of heartbeat (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)

• noisy breathing.
• allergic reaction (hypersensitivity): sudden and severe 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 the available data)

• myocardial infarction, spasms of the blood vessels of 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 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.
• 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 or 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.

Also, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or itching) after taking rizatriptan.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, 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 Aurovitas

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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

Composition of Rizatriptan Aurovitas

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

The other components are: microcrystalline cellulose, pregelatinized corn starch, mannitol, crospovidone (Type A), aspartame (see section 2), mint flavour (maltodextrin, natural flavours, modified corn starch), stearic fumarate and sodium.

Appearance of the product and contents of the pack

Orodispersible tablets.

Uncoated white to off-white, circular, biconvex tablets marked “F25” on one side and smooth on the other, with a mint flavour.

Rizatriptan Aurovitas orodispersible tablets are available in blister packs made of Polyamide/Aluminium/PVC-Aluminium foil in pack sizes of: 2, 3, 6, 10, 12 and 18 tablets.

Only certain 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

France: RIZATRIPTAN ARROW 10 mg, comprimes orodispersibles

Germany: Rizatriptan Aurobindo 10 mg Schmelztabletten

Spain: Rizatriptán Aurovitas 10 mg comprimidos bucodispersables EFG

Netherlands: Rizatriptan Aurobindo 10 mg orodispergeerbare tabletten

Italy: Rizatriptan Aurobindo 10 mg compresse orodispersibili

Malta: Rizatriptan 10 mg orodispersible tablets

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

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