RIZATRIPTAN TEVA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Rizatriptan Teva 10 mg Oral Lyophilisates EFG

Contents of the pack:

1. What Rizatriptan Teva 10 mg is and what it is used for
2. What you need to know before you take Rizatriptan Teva 10 mg
3. How to take Rizatriptan Teva 10 mg
4. Possible side effects
5. Storage of Rizatriptan Teva 10 mg
6. Contents of the pack and other information

1. What Rizatriptan Teva 10 mg is and what it is used for

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

Rizatriptan Teva is used to treat migraine headaches in adults.

Treatment with Rizatriptan Teva:

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 Teva 10 mg

Do not take Rizatriptan Teva if

• you are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6)
• you have moderately severe or severe high blood pressure, or mild high blood pressure that is not controlled with medication
• you have or have had heart problems, including heart attack or angina (chest pain) or have experienced signs related to heart disease
• you have severe liver or kidney problems
• you have had a stroke (cerebrovascular accident) or a mini-stroke (transient ischaemic attack)
• you have problems with blood circulation (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 it has been less than two weeks since you stopped taking MAOIs
• you are currently taking a medicine of the ergotamine type, such as ergotamine or dihydroergotamine to treat your migraine or methysergide to prevent a migraine attack
• 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 Tevabelow)

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rizatriptan Teva:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or are taking 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 preparations 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, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
• you have had transient symptoms including chest pain or throat tightness and pressure.

If you take Rizatriptan Teva too frequently, this may lead to you getting chronic headache. In such cases, you should contact your doctor and stop taking Rizatriptan Teva.

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

Children and adolescents

The use of Rizatriptan Teva in children and adolescents under 18 years of age is not recommended.

Use in patients over 65 years of age

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

Other medicines and Rizatriptan Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, herbal medicines, and those you normally take for migraines. This is because Rizatriptan Teva may affect the way some medicines work. Also, other medicines may affect Rizatriptan Teva.

Do not take Rizatriptan Teva:

• 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 to treat your migraine
• if you are taking methysergide to prevent a migraine attack.

The above-mentioned medicines, when taken with Rizatriptan Teva, may increase the risk of adverse reactions.

After taking Rizatriptan Teva, you should wait at least 6 hours before taking ergotamine-type medications, such as ergotamine or dihydroergotamine or methysergide.

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

Ask your doctor about the instructions and risks of taking Rizatriptan Teva

• if you are taking propranolol (see section 3 How to take Rizatriptan Teva)
• if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression

Rizatriptan Teva with food and drink

Rizatriptan Teva 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 and breastfeeding

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 use of rizatriptan in pregnant women during the first 3 months of pregnancy do not indicate an increased risk of birth defects. It is not known if Rizatriptan Teva 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 your baby.

Driving and using machines

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

Rizatriptan Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Rizatriptan Teva contains aspartame (E951)

This medicine contains 2.0 mg of aspartame per oral lyophilisate.

Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria (a rare genetic disorder in which phenylalanine accumulates in the body because it is not properly broken down).

Rizatriptan Teva contains benzoate

This medicine contains 4.5 mg of benzoate (as rizatriptan benzoate) per oral lyophilisate.

Rizatriptan Teva contains sodium

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

3. How to take Rizatriptan Teva

Rizatriptan Teva is used to treat migraine attacks. Take Rizatriptan Teva as soon as possible after the start of your migraine headache. 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 usual 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.

How to administer Rizatriptan Teva

Rizatriptan Teva is an oral lyophilisate that dissolves in the mouth.

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.

Do not handle the tablets with wet hands as the oral lyophilisates may break.

1. Hold the blister strip by the edges and separate one blister from the rest of the strip along the perforations.
2. Separate the back carefully.
3. Gently push the tablet out.
4. Place the tablet on your tongue. It will dissolve directly in your mouth, so you can swallow easily.

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 Teva. 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 Teva during a migraine attack, you should not take a second dose of Rizatriptan Teva for the treatment of the same attack.

However, you are still likely to respond to Rizatriptan Teva during the next attack.

Do not take more than 2 doses of Rizatriptan Teva in a 24-hour period (for example, do not take more than 2 oral lyophilisates of 5 mg or 2 oral lyophilisates 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 Teva than you should

If you take more Rizatriptan Teva than you should, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915 620 420. Take 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 happen 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 (paraesthesia), headache, decreased sensitivity in the skin (hypoesthesia), decreased mental sharpness, insomnia,
• rapid or irregular heart rate (palpitations),
• flushing (redness of the face that lasts a short time),
• throat discomfort,
• nausea, dry mouth, vomiting, diarrhea, indigestion (dyspepsia),
• feeling of 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, hot flushes, sweating,
• skin rash, itching, and rash with bumps (urticaria), swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnoea),
• feeling of stiffness in parts of the body, muscle weakness,
• changes in heart rate or rhythm (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 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)

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” which 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),
• seizure (convulsions)
• spasm of the blood vessels of the limbs, including coldness and numbness of the 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 Teva.

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan Teva

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.

Store in the original package to protect from moisture.

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

6. Package Contents and Additional Information

Composition of Rizatriptan Teva 10 mg Orally Disintegrating Tablets

• The active ingredient is rizatriptan. One 10 mg orally disintegrating tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.
• The other ingredients are: Lactose monohydrate, Corn starch, Mannitol (E421), Pregelatinized starch (derived from corn), Aspartame (E951), Mint flavor, Colloidal anhydrous silica, Sodium stearyl fumarate.

Appearance of the Product and Package Contents

Rizatriptan Teva 10 mg Orally Disintegrating Tablets: are white to off-white, round, smooth, orally disintegrating tablets with beveled edges, engraved with 'IZ' on one side and '10' on the other side.

Package sizes: 2, 3, 6, 12, 18, 28, or 30 orally disintegrating tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie BV

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Krakow

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

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

France: Rizatriptan Teva 10 mg, orodispersible tablet

Germany: Rizatriptan-ratiopharm 10 mg Schmelztabletten

Italy: Rizatriptan Teva 10 mg Orodispersible Tablets

Netherlands: Rizatriptan disp 10 mg Teva, orodispergeerbare tabletten

Spain: Rizatriptán Teva 10 mg Orally Disintegrating Tablets EFG

Date of the Last Revision of this Leaflet: July 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/