RIZATRIPTAN RATIOPHARM 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Rizatriptan ratiopharm 10 mg Orodispersible Tablets EFG

Rizatriptan

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 signs of illness are the same as yours.
• If you get 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 and other information:

1. What is Rizatriptan ratiopharm and what is it used for
2. What you need to know before you take Rizatriptan ratiopharm
3. How to take Rizatriptan ratiopharm
4. Possible side effects

5 Storage of Rizatriptan ratiopharm

1. Contents of the pack and other information

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

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

Rizatriptan ratiopharm is used to treat migraine attacks in adults.

Treatment with Rizatriptan ratiopharm:

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

2. What you need to know before you take Rizatriptan ratiopharm

Do not take Rizatriptan ratiopharm 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 ever had heart problems, including heart attack or angina (chest pain) or have experienced symptoms related to heart disease
• you have severe liver or kidney problems
• you have had a stroke (cerebrovascular accident) or a transient ischaemic attack (TIA - a "mini-stroke")
• you have problems with the blood vessels in your arms or legs (peripheral vascular disease)
• you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (for depression) or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAOIs
• you are currently taking ergotamine-type medications (such as ergotamine or dihydroergotamine) for your migraine or methysergide for preventing a migraine attack
• you are taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine (see Using Rizatriptan ratiopharm with other medicinesbelow).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptan ratiopharm if:

• 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 (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 your 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 that can 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 and tightness

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

Tell your doctor or pharmacist about all your symptoms. Your doctor will decide if you have migraines. You should only take Rizatriptan ratiopharm for a migraine attack. Rizatriptan ratiopharm 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 ratiopharm 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 ratiopharm in patients over 65 years of age.

Using Rizatriptan ratiopharm with other medicines

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

Do not take Rizatriptan 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 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 Rizatriptan ratiopharm, may increase the risk of adverse reactions.

After taking Rizatriptan ratiopharm, 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 ratiopharm.

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

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

Using Rizatriptan ratiopharm with food, drink, and alcohol

Rizatriptan ratiopharm 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 during the first three months of pregnancy do not indicate an increased risk of birth defects. It is not known if Rizatriptan 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 postpone breastfeeding for 12 hours after treatment to avoid exposing your baby.

Driving and using machines

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

Rizatriptan ratiopharm contains lactose

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

Rizatriptan ratiopharm contains aspartame (E951)

This medicine contains 2.0 mg of aspartame per orodispersible tablet.

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 ratiopharm contains benzoate

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

Rizatriptan ratiopharm contains sodium

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

3. How to take Rizatriptan ratiopharm

Rizatriptan ratiopharm is used to treat migraine attacks. Take Rizatriptan ratiopharm as soon as possible after the onset of your migraine headache. Do not use it to prevent an attack.

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The usual dose is 10 mg.

If you are taking propranolol or have kidney or liver problems, you should take a 5 mg dose of rizatriptan. This dose may be available for other rizatriptan-containing medicines on the market. 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 ratiopharm

Rizatriptan 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 the ingestion of tablets with liquids.

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

1. Hold the blister strip at the edges and separate one blister from the rest of the strip along the perforations.
2. Carefully separate the back.
3. Gently push the tablet out.
4. Place the tablet on your tongue. It will dissolve directly in your mouth and can be swallowed 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 ratiopharm. 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 ratiopharm during a migraine attack, you should not take a second dose of Rizatriptan ratiopharm for the treatment of the same attack.

However, it is still likely that you will respond to Rizatriptan ratiopharm during the next attack.

Do not take more than 2 doses of Rizatriptan ratiopharm in a 24-hour period (for example, do not take more than 2 orodispersible tablets 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 ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. Bring 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rizatriptan ratiopharm can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

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

Common:may affect up to 1 in 10 people

• tingling sensation (paresthesia), headache, reduced sensitivity in the skin (hypoesthesia),
• decreased mental sharpness, insomnia,
• rapid or irregular heart rate (palpitations),
• flushing (short-term redness of the face),
• 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

• 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 or swallowing (angioedema), difficulty breathing (dyspnea),
• 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

• noisy breathing,
• 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, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, 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, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, 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),
• 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 ratiopharm.

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 to the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan ratiopharm

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 the abbreviation EXP. The expiry date refers to the last day of the month stated.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicine to the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Rizatriptan ratiopharm

The active ingredient is rizatriptan. The other components are: Lactose monohydrate, Corn starch, Mannitol (E421), Pregelatinized corn starch, Aspartame (E951), Mint flavor, Colloidal anhydrous silica, Sodium stearyl fumarate

Appearance of the Product and Packaging Content

Rizatriptan ratiopharm 10 mg orodispersible tablets: are white to off-white, round, smooth, orodispersible tablets with beveled edges, engraved with 'IZ' on one side and '10' on the other side.

Packaging sizes: 2x1, 3x1, 6x1, 12x1, 18x1, 28x1 or 30x1 orodispersible tablets in OPA/Aluminum/PVC-Aluminum precut unit dose blisters.

Only some packaging 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

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 Member States of the European Economic Area under the following names:

Germany: Rizatriptan AbZ 10mg Schmelztabletten

Spain: Rizatriptan ratiopharm 10mg orodispersible tablets EFG

Date of the Last Revision of this Leaflet:July 2024

Updated 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/