Rizatriptan Teva-Ratiopharm 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Rizatriptán Teva-ratiopharm 10 mg orodispersible tablets EFG

Rizatriptán

Read the entire 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 must not be given to other people, even if they have the same symptoms, as 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 Rizatriptán Teva-ratiopharm is and what it is used for
2. What you need to know before taking Rizatriptán Teva-ratiopharm
3. How to take Rizatriptán Teva-ratiopharm
4. Possible adverse effects
5. Storage of Rizatriptán Teva-ratiopharm
6. Contents of the pack and other information

1. What Rizatriptan Teva-ratiopharm is and what it is used for

Rizatriptan Teva-ratiopharm belongs to a group of medicines called selective serotonin 5-HT_1B/1D receptor agonists.

Rizatriptan Teva-ratiopharm is used to treat headache pain during migraine attacks in adults.

Treatment with Rizatriptan Teva-ratiopharm:

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

2. What you need to know before taking Rizatriptan Teva-ratiopharm

Do not take Rizatriptan Teva-ratiopharm if

• you are allergic to rizatriptan or to any of the other components of this medicine (listed in section 6)
• you have moderately severe or severe high blood pressure, or uncontrolled mild high blood pressure
• you have or have ever had 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 ischaemic attack (TIA, mini-stroke)
• you have arterial obstruction problems (peripheral vascular disease)
• you are currently taking monoamine oxidase inhibitors (MAO inhibitors) 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 MAO inhibitors
• you are currently taking an ergot-type medicine, such as ergotamine or dihydroergotamine for treating your migraine, or methysergide for preventing a migraine attack
• you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan, for treating your migraine (see Use of Rizatriptan Teva-ratiopharm with other medicines below).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rizatriptan Teva-ratiopharm 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, you have a family history of heart disease, you are a man over 40 years of age or a postmenopausal woman
• you have kidney or liver problems
• you have a specific problem with your heart rhythm (bundle branch block)
• you have or have ever had any allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arm or leg
• 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, which may cause difficulty breathing and/or swallowing (angioedema)
• 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
• you have experienced transient symptoms including chest pain and tightness

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

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

Children and adolescents

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

Use in patients over 65 years of age

There are no completed studies evaluating the safety and efficacy of Rizatriptan Teva-ratiopharm in patients over 65 years of age.

Use of Rizatriptan Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription. This includes herbal medicines and those you usually take for migraines. This is because Rizatriptan Teva-ratiopharm may affect the action of certain medicines, and other medicines may affect Rizatriptan Teva-ratiopharm.

Do not take Rizatriptan Teva-ratiopharm if:

• 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 less than two weeks have passed since you stopped taking an MAOI
• you are taking ergot-type medicines, such as ergotamine or dihydroergotamine, to treat your migraine
• you are taking methysergide to prevent a migraine attack

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

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

After taking ergot-type medicines, you must wait at least 24 hours before taking Rizatriptan Teva-ratiopharm.

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

• if you are taking propranolol (see section 3 How to take Rizatriptan Teva-ratiopharm)
• 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

Use of Rizatriptan Teva-ratiopharm with food, drink and alcohol

Rizatriptan Teva-ratiopharm may take longer to work if taken after meals. Although it is preferable to take it on an empty stomach, you may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Available data on the safety of rizatriptan during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown whether Rizatriptan Teva-ratiopharm 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.

Driving and using machines

When taking Rizatriptan Teva-ratiopharm, you may feel drowsy or dizzy. If this occurs, do not drive or operate tools or machinery.

Rizatriptan Teva-ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Rizatriptan Teva-ratiopharm contains aspartame (E951)

This medicine contains 2.0 mg of aspartame per 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 properly eliminate it.

Rizatriptan Teva-ratiopharm contains benzoate

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

Rizatriptan Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet, i.e., essentially "sodium-free".

3. How to take Rizatriptan Teva-ratiopharm

Rizatriptan Teva-ratiopharm is used to treat migraine attacks. Take Rizatriptan Teva-ratiopharm as soon as possible once your migraine headache starts. Do not use it to prevent an attack.

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

The usual dose is 10 mg.

If you are taking propranolol or have kidney or liver problems, you should take the 5 mg dose of rizatriptan. This dose may be available in other rizatriptan-containing medicines on the market. You must wait at least 2 hours between taking propranolol and rizatriptan, up to a maximum of 2 doses within a 24-hour period.

How to administer Rizatriptan Teva-ratiopharm

Rizatriptan Teva-ratiopharm is an orodispersible tablet that dissolves in the mouth.

The orodispersible tablet can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

Do not handle the tablets with wet hands, as the orodispersible tablets may break.

1. Hold the blister strip by the edges and separate one blister from the rest of the strip along the perforations.
2. Carefully peel back the backing.
3. Gently push the tablet out.
4. Place the tablet on your tongue. It will dissolve directly in your mouth, allowing it to be swallowed easily.

If migraine recurs within 24 hours

In some patients, migraine symptoms may recur within a 24-hour period. If your migraine recurs, you may take an additional dose of Rizatriptan Teva-ratiopharm. You must always wait at least 2 hours between doses.

If migraine persists after 2 hours

If you do not respond to the first dose of Rizatriptan Teva-ratiopharm during an attack, you should not take a second dose of Rizatriptan Teva-ratiopharm to treat the same attack.

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

Do not take more than 2 doses of Rizatriptan Teva-ratiopharm within a 24-hour period (for example, do not take more than 2 orodispersible 10 mg tablets within 24 hours). You must always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

If you take more Rizatriptan Teva-ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. Take the medicine packaging 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, Rizatriptán Teva-ratiopharm 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, somnolence, and fatigue.

Frequent: may affect up to 1 in 10 people

• tingling sensation (paresthesia), headache, reduced skin sensitivity (hypoesthesia),
• decreased mental alertness, insomnia,
• fast or irregular heartbeat (palpitation),
• flushing (reddening of the face lasting a brief time),
• throat discomfort,
• malaise (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia),
• sensation of heaviness in parts of the body, neck pain, numbness,
• abdominal or chest pain

Uncommon: may affect up to 1 in 100 people

• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope),
• confusion, restlessness,
• 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 or swallowing (angioedema), difficulty breathing (dyspnea),
• sensation 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

• breathing noises,
• 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 (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).

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),
• seizure (convulsion),
• spasm of blood vessels in the limbs, including coldness and numbness of the hands or feet,
• constriction of blood vessels in the colon (large intestine), which may cause abdominal pain.

Promptly inform your doctor if you experience symptoms of an allergic reaction, serotonin syndrome, myocardial infarction, or stroke.

In addition, inform your doctor if you experience any symptoms suggesting an allergic reaction (such as rash or itching) after taking Rizatriptán Teva-ratiopharm.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

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 usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptán Teva-ratiopharm

The active substance is rizatriptan. The other components are: Monohydrate lactose, Corn starch, Mannitol (E421), Pregelatinized corn starch, Aspartame (E951), Mint flavour, Colloidal anhydrous silica, Sodium fumarate stearyl

Appearance of the product and contents of the pack

Rizatriptán Teva-ratiopharm 10 mg orodispersible tablets: white to off-white, round, smooth, biconvex orodispersible tablets with bevelled edges, marked with 'IZ' on one side and '10' on the other.

Pack sizes: 2x1, 3x1, 6x1, 12x1, 18x1, 28x1 or 30x1 orodispersible tablets in pre-perforated unit dose blisters of OPA/Aluminium/PVC-Aluminium.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid

Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The 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

or

S.C. LABORMED-PHARMA S.A.,

44B Theodor Pallady Blvd., 3rd district,

Bucharest, code 032266,

Romania

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Rizatriptan AbZ 10mg Schmelztabletten

Spain: Rizatriptan ratiopharm 10 mg orodispersible tablets EFG

Date of the most recent review of this leaflet: July 2024

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76107/P_76107.html

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