RIZATRIPTAN VISO FARMACÉUTICA 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rizatriptan Viso Farmacéutica 10 mg Tablets EFG

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:

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

1. What is Rizatriptan Viso Farmacéutica and what is it used for

Rizatriptan Viso Farmacéutica belongs to a type of medicines called selective 5-HT1B/1D receptor agonists.

Rizatriptan Viso Farmacéutica is used to treat migraine headaches in adults.

Treatment with Rizatriptan Viso Farmacéutica:

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

2. Before taking Rizatriptan Viso Farmacéutica

Do not take Rizatriptan Viso Farmacéutica:

• • if you are allergic to the active substance (rizatriptan, benzoate) or any of the other ingredients of this medicine (listed in section 6).
• if you have moderately severe, severe, or mild uncontrolled high blood pressure.
• • if you have or have ever had heart problems, including heart attack or chest pain (angina), or if you have experienced signs related to heart disease.
  • if you have had severe liver or kidney problems.
  • if you have had a stroke (CVA) or a transient ischemic attack (TIA).
  • if you have problems with obstruction in your arteries (peripheral vascular disease).
  • if 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 an MAOI.
  • if you are currently taking ergotamine-type medications, such as ergotamine or dihydroergotamine for your migraine, or methysergide to prevent a migraine attack.
  • if you are taking any other medicine of the same class to treat your migraine, such as sumatriptan, naratriptan, or zolmitriptan (see Taking Rizatriptan Viso Farmacéutica with other medicines).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptan Viso Farmacéutica:

• 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.
• if you have kidney or liver problems.
• if you have a specific problem with the way your heart beats (left bundle branch block).
• if you have or have had any allergy.
• if your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your legs and arms.
• if you take herbal remedies containing St. John's Wort.
• if you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (angioedema).
• 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.
• if you have had transient symptoms including pain and pressure in the chest.

If you take Rizatriptan Viso Farmacéutica too frequently, this may lead to you developing chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Viso Farmacéutica.

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

Tell your doctor or pharmacist that you are taking or have recently taken or might take any other medicines, including those obtained without a prescription. These include herbal medicines and those you normally take for your migraine. This is because Rizatriptan Viso Farmacéutica may affect the way some medicines work. Other medicines may also affect Rizatriptan Viso Farmacéutica.

Children and adolescents

There is no experience with the use of Rizatriptan Viso Farmacéutica in children and adolescents under 18 years of age; therefore, Rizatriptan Viso Farmacéutica is not recommended for use in children and adolescents under 18 years of age.

Use in patients over 65 years of age

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

Taking Rizatriptan Viso Farmacéutica with other medicines

Do not take Rizatriptan Viso Farmacéutica if:

• you are already taking a 5-HT1B/1D agonist (sometimes called 'triptans'), such as sumatriptan, naratriptan, or zolmitriptan.
• you are taking monoamine oxidase inhibitors (MAOIs) 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, to treat your migraine.
• you are taking methysergide to prevent a migraine attack.

When these medicines are taken with Rizatriptan Viso Farmacéutica, the risk of side effects may be increased.

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

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

Ask your doctor for instructions on how to take Rizatriptan Viso Farmacéutica and information about the risks if:

• you are currently taking propranolol (see section 3: How to take Rizatriptan Viso Farmacéutica)
• you are currently taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.

Taking Rizatriptan Viso Farmacéutica with food and drink

Rizatriptan Viso Farmacéutica may take longer to work if taken after meals. Although it is better to take it on an empty stomach, you can 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 safety of rizatriptan when used during the first three months of pregnancy do not indicate an increased risk of birth defects. It is not known if Rizatriptan Viso Farmacéutica 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 Viso Farmacéutica, you may feel drowsy or dizzy. If this happens, do not drive or use tools or machines.

Rizatriptan Viso Farmacéutica contains aspartame (E951)

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Rizatriptan Viso Farmacéutica

Rizatriptan Viso Farmacéutica is used to treat migraine attacks. Take Rizatriptan Viso Farmacéutica as soon as possible after your migraine headache starts. Do not use it to prevent an attack.

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The tablets of Rizatriptan Viso Farmacéutica should be taken orally and swallowed whole with a liquid.

The recommended dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems, you should take a lower dose of rizatriptan. You should wait at least 2 hours between taking propranolol and Rizatriptan Viso Farmacéutica, up to a maximum of 2 doses in a 24-hour period.

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 Viso Farmacéutica. 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 Viso Farmacéutica during a migraine attack, you should not take a second dose of Rizatriptan Viso Farmacéutica to treat the same attack. However, you are still likely to respond to Rizatriptan Viso Farmacéutica during the next attack.

Do not take more than 2 doses of Rizatriptan Viso Farmacéutica in a 24-hour period (for example, do not take more than 2 doses 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.

Rizatriptan benzoate is also available in orodispersible tablets that dissolve in the mouth. The orodispersible tablets can be used when liquids are not available, or to avoid nausea or vomiting that may accompany the ingestion of tablets with liquids.

If you take more Rizatriptan Viso Farmacéutica than you should

If you take more Rizatriptan Viso Farmacéutica than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 5620420, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

Signs of overdose may include dizziness, numbness, 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. This medicine can cause the following side effects.

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

Frequent (affect 1 to 10 users in 100)

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

Uncommon (affect 1 to 10 users in 1,000)

• unpleasant taste
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flushes, sweating
• rash, itching, and rash with hives (urticaria), swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea)
• neck pain, stiffness in parts of the body, muscle weakness
• changes in heart rhythm or frequency (arrhythmia), slow heart rate (bradycardia), changes in the electrocardiogram (a test that records the electrical activity of the heart)
• facial pain, muscle pain

Rare (affect 1 to 10 users in 10,000)

• noisy breathing
• allergic reaction (hypersensitivity); sudden life-threatening allergic reaction (anaphylaxis)
• stroke (usually 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 specific problem related to the way the heart beats: left bundle branch block))
• slow heart rate (bradycardia)

Frequency not known

• heart attack, spasms of the blood vessels of the heart (usually 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 specific problem related to the way the heart beats: left bundle branch block))
• serotonin syndrome that can cause side effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations
• seizures (convulsions/fits)
• contraction of blood vessels in the limbs, including cooling and numbness of hands and feet
• contraction of blood vessels in the colon (large intestine), which can cause abdominal pain
• muscle pain
• changes in heart rhythm or frequency (arrhythmia), slow heart rate (bradycardia), changes in the electrocardiogram (a test that records the electrical activity of the heart)

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 hives) after taking Rizatriptan Viso Farmacéutica.

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 through 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 Viso Farmacéutica

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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Rizatriptan Viso Farmacéutica

• The active ingredient is rizatriptan.

A 10 mg tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

• The other ingredients are mannitol, microcrystalline cellulose (E460a), crospovidone, aspartame (E951), magnesium stearate (E572), colloidal silicon dioxide, and peppermint flavor (contains modified cornstarch).

Appearance of the Product and Packaging Contents

The 10 mg tablets are white or off-white, approximately 9 mm, round, flat, beveled-edged, and uncoated, with «468» engraved on one side and nothing on the other.

The tablets are presented in aluminum blisters.

Packaging sizes of 10 mg: packs of 3, 6, 12, or 18 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibíchova 143

566 17 Vysoké Mýto

Czech Republic

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park, Croxley Green

Hertfordshire, WD18 8YA

United Kingdom

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

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/.