Prospecto: Information for the Patient

Rizatriptan Teva 10 mg Bucodispersable Tablets EFG

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

2. What you need to know before starting to take Rizatriptan Teva 10 mg

3. How to take Rizatriptan Teva 10 mg

4. Possible adverse effects

5. Storage of Rizatriptan Teva 10 mg

6. Contents of the package and additional information

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

Rizatriptán Teva is used to treat the headaches of migraine attacks in adults.

Rizatriptán Teva treatment:

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

Do not take Rizatriptán 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 hypertension that is not controlled with medication
• You have or have had any heart problems, including myocardial infarction or chest pain (angina), or have experienced symptoms related to heart disease
• You have severe liver or kidney problems
• You have had a stroke or a transient ischemic attack (mini-stroke)
• You have peripheral vascular disease (blockage in your arteries)
• You are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications) or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAOIs
• You are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for your migraine, or methysergide to prevent a migraine attack
• You are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine (See Other Medicines and Rizatriptán Teva below)

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptán Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Teva:

• You have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or taking nicotine substitutes, a family history of heart disease, being a man over 40 years old or a postmenopausal woman
• You have kidney or liver problems
• You have a specific problem with the way your heart beats (left branch block)
• You have or have had any allergies
• Your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm
• You are taking herbal preparations 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)
• 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
• You have had transient symptoms including chest pain or throat pain and pressure.

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

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

Children and adolescents

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

Use in patients over 65 years

There are no completed studies to evaluate the safety and efficacy of Rizatriptán Teva in patients over 65 years.

Other medicines and Rizatriptán Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including over-the-counter medicines, herbal medicines, and those you take regularly for migraines. This is because Rizatriptán Teva may affect the mechanism of action of some medicines. Other medicines may also affect Rizatriptán Teva.

Do not take Rizatriptán Teva:

• You are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan
• 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
• You are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for your migraine
• You are taking methysergide to prevent a migraine attack.

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

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

After taking ergotamine-type medications, wait at least 24 hours before taking Rizatriptán Teva.

Ask your doctor about the instructions and risks of taking Rizatriptán Teva:

• If you are taking propranolol (see section 3 How to take Rizatriptán Teva)
• 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

Rizatriptán Teva with food and drinks

Rizatriptán Teva may take longer to take effect if taken 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The 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.The safety of Rizatriptán Teva for the fetus when taken by a pregnant woman after the first three months of pregnancy is unknown.

If you are breastfeeding, you can postpone breastfeeding for 12 hours after treatment to avoid exposing your baby.

Driving and operating machinery

After taking Rizatriptán Teva, you may feel drowsiness or dizziness. If this occurs, do not drive or use tools or machinery.

Rizatriptán Teva contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult your doctor before taking this medicine.

Rizatriptán Teva contains aspartame (E951)

This medicine contains 2.0 mg of aspartame per buccal dispersible tablet.

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

Rizatriptán Teva contains benzoate

This medicine contains 4.5 mg of benzoate (as rizatriptan benzoate) per buccal dispersible tablet.

Rizatriptán Teva contains sodium

This medicine contains 23 mg of sodium (1 mmol) per buccal dispersible tablet; this is essentially "sodium-free".

Rizatriptan Teva is used to treat migraine attacks. Take Rizatriptan Teva as soon as possible once your migraine headache has started. Do not use it to prevent a migraine attack.

Follow exactly the administration instructions of this medication indicated 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 must use a dose of 5 mg of rizatriptan. You must wait at least 2 hours between the intake of propranolol and rizatriptan up to a maximum of 2 doses in a 24-hour period.

How to administer Rizatriptan Teva

Rizatriptan Teva is a buccal disintegrating tablet that dissolves in the mouth.

The buccal disintegrating tablet can be used in situations where there are no liquids 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 buccal disintegrating tablets can break.

1. Hold the blister strip by the edges and separate one blister from the rest of the strip along the perforations.

2. Carefully separate the back part.

3. Gently push the tablet outwards.

4. Place the tablet on your tongue. It will dissolve directly in the mouth, and you can swallow easily.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine reappears, you can take an additional dose of Rizatriptan Teva. You must 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 an attack, do not take a second dose of Rizatriptan Teva for the same attack.

However, it is still likely that you will 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 buccal disintegrating tablets of 5 mg or 2 buccal disintegrating tablets of 10 mg in a 24-hour period). 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420. Bring the medication packaging with you.

The signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.

In studies in adults, the side effects reported most frequently were dizziness, drowsiness, and fatigue.

Frequent::may affect up to 1 in 10 people

• tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia,
• rapid or irregular heart rate (palpitations),
• flushing (brief facial redness),
• throat discomfort,
• unpleasantness (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia),
• heaviness in parts of the body, neck pain, numbness,
• abdominal or chest pain

Infrequent::may affect up to 1 in 100 people

• bad taste in the mouth,
• unsteadiness (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness,
• high blood pressure (hypertension); thirst, hot flashes, sweating,
• skin rash, itching, and hives (urticaria), facial swelling, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea),
• sensation of stiffness in parts of the body, muscle weakness,
• changes in heart rhythm or frequency (arrhythmia); electrocardiogram alterations (a test that records the heart's electrical activity), 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 fatal allergic reaction (anaphylaxis)
• stroke (this usually occurs in patients with risk factors for cardiovascular disease or blood vessel disease (hypertension, diabetes, smoking, nicotine substitute use, family history of cardiovascular disease or stroke, man over 40 years old, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)),
• slow heart rate (bradycardia)

Unknown::cannot be estimated from available data

• heart attack, spasms of the heart's blood vessels (these usually occur in patients with risk factors for cardiovascular disease or blood vessel disease (hypertension, diabetes, smoking, nicotine substitute use, family history of cardiovascular disease or stroke, man over 40 years old, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)),
• a syndrome called "serotonin syndrome" that can cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination problems, agitation, and hallucinations,
• severe skin peeling with or without fever (toxic epidermal necrolysis),
• seizure (convulsion)
• spasm of the blood vessels of the extremities, including coldness and numbness of the hands or feet,
• contraction of the colon's blood vessels (large intestine), which may cause abdominal pain.

Report any symptoms of allergic reaction, serotonin syndrome, heart attack, or stroke to your doctor immediately.

Also, inform your doctor if you experience any symptoms that suggest an allergic reaction (such as rash or itching) after taking Rizatriptán Teva.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Rizatriptan Teva 10 mg Bucodispersable Tablets Composition

• The active ingredient is rizatriptan. A bucodispersable tablet of 10 mg contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.
• The other components are: Lactose monohydrate, Cornstarch, Mannitol (E421), Pre-gelatinized cornstarch, Aspartame (E951), Peppermint flavor, Colloidal anhydrous silica, Sodium fumarate stearate.

Appearance of the Product and Contents of the Package

Rizatriptan Teva 10 mg Bucodispersable Tablets: are white to off-white, round, smooth, beveled-edge tablets, engraved with ‘IZ’ on one side and ‘10’ on the other side.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Responsible 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 medicine is authorized in the member states of the European Economic Area with the following names:

France:-Rizatriptan Teva 10 mg, orodispersible tablet

Germany:-Rizatriptan-ratiopharm 10 mg Melting tablets

Italy:-Rizatriptan Teva 10 mg Compresse Orodispersibili

Netherlands:-Rizatriptan disp 10 mg Teva, orodispergeerbare tablets

Spain:-Rizatriptán Teva 10 mg bucodispersable tablets EFG

Last review date of this leaflet: July 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/