Rizatriptan Viso Farmaceutica 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptan Viso Farmacéutica 10 mg orodispersible tablets EFG

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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Rizatriptan Viso Farmacéutica is used to treat migraine attacks. Do not use it to prevent an attack.

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

Rizatriptan Viso Farmacéutica is used to treat the headache phase of migraine attacks in adults.

Treatment with Rizatriptan Viso Farmacéutica:

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

2. What you need to know before taking Rizatriptan Viso Farmacéutica

Do not take Rizatriptan Viso Farmacéutica:

• • if you are allergic to the active substance (rizatriptan, benzoate) or to any of the other ingredients of this medicine (listed in section 6).
• if you have moderately severe, severe, or uncontrolled mild high blood pressure.
  • if you have or have ever had heart problems, including myocardial infarction 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 (cerebrovascular accident, CVA) or transient ischemic attack (TIA).
  • if you have arterial obstruction problems (peripheral vascular disease).
  • if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (medications for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAOI.
  • if you are currently taking ergotamine-type medications, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent a migraine attack.
  • if you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan (see Use of Rizatriptan Viso Farmacéutica with other medicines).

If you are unsure whether any of the above apply to you, speak with 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 using nicotine replacement therapy, a family history of heart disease, you are a man over 40 years of age, or a postmenopausal woman.
• if you have kidney or liver problems.
• if you have a specific condition affecting your heart rhythm (left bundle branch block).
• if you have or have had any allergies.
• if your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in arms and legs.
• if you are taking herbal remedies containing St. John’s wort (Hypericum perforatum).
• if you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (angioedema).
• if you are taking selective serotonin reuptake inhibitors (SSRIs), such as sertraline, escitalopram oxalate, and fluoxetine, or serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine, for depression.
• if you have experienced transient symptoms including chest pain or tightness.

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

Inform your doctor or pharmacist about your symptoms. Your doctor will determine whether 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 more serious conditions.

Tell your doctor if you are currently using, have recently used, or may need to use any other medicines, including those obtained without a prescription. This includes herbal remedies and medicines you usually take for migraine. This is because Rizatriptan Viso Farmacéutica may affect how 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, the use of Rizatriptan Viso Farmacéutica is not recommended in children and adolescents.

Patients over 65 years of age

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

Use of 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 less than two weeks have passed 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.

Taking the above-mentioned medicines together with Rizatriptan Viso Farmacéutica may increase the risk of adverse effects.

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 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.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Use of Rizatriptan Viso Farmacéutica with food and drink

Rizatriptan Viso Farmacéutica 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 if you have eaten.

Pregnancy, breastfeeding, and fertility

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 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Driving and using machines

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

Rizatriptan Viso Farmacéutica contains aspartame (E951)

This medicine contains 8 mg of aspartame per orodispersible tablet.

Aspartame is 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.

3. How to take Rizatriptan Viso Farmacéutica

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

Follow exactly the instructions given by your doctor for this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Rizatriptan Viso Farmacéutica is an orally disintegrating tablet that dissolves in the mouth.

• Remove the orally disintegrating tablet from the blister with dry hands and place it on the tongue, where it will dissolve and can be swallowed with saliva.
• The orally disintegrating tablet may be taken in situations where liquids are not available or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

If you are currently taking propranolol or have kidney or liver problems, you should take the 5 mg dose of Rizatriptan Viso Farmacéutica. You must wait at least 2 hours between taking propranolol and Rizatriptan Viso Farmacéutica, and no more than 2 doses should be taken within a 24-hour period.

If migraine recurs within 24 hours

In some patients, migraine symptoms may recur within a 24-hour period. If your migraine returns, you may take an additional dose of Rizatriptan Viso Farmacéutica. 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 Viso Farmacéutica during an 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 within a 24-hour period (for example, do not take more than 2 orally disintegrating 10 mg or 5 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 Viso Farmacéutica than you should

If you take more Rizatriptan Viso Farmacéutica than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 5620420, stating the medication and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

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, this medicine can cause adverse effects, although not everyone will experience them. This medicine may cause the following adverse effects.

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

Common (may affect up to 1 in 10 people)

• tingling sensation (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, insomnia
• fast or irregular heartbeat (palpitation)
• flushing (brief reddening of the face)
• throat discomfort
• malaise (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
• discomfort or 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, restlessness
• high blood pressure (hypertension), thirst, hot flushes, sweating
• rash, itching and rash with bumps (urticaria), swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea)
• sensation of stiffness in parts of the body, muscle weakness
• changes in heart rate or rhythm (arrhythmia), changes in electrocardiogram (ECG) (a test that records the electrical activity of the heart), very fast heartbeat (tachycardia)
• facial pain, muscle pain

Rare (may affect up to 1 in 1,000 people)

• noisy breathing
• allergic reaction (hypersensitivity); sudden, life-threatening allergic reaction (anaphylaxis)
• stroke (usually in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years, postmenopausal women, and a specific condition related to the way the heart beats (left bundle branch block))
• slow heartbeat (bradycardia)

Frequency not known

• myocardial infarction, spasms of blood vessels in the heart (usually in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years, postmenopausal women, and a specific condition related to the way the heart beats (left bundle branch block))

• 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)

• seizures (convulsions/spasms)

• narrowing of blood vessels in the limbs, including cooling and numbness of hands and feet

• narrowing of blood vessels in the colon (large intestine), which may cause abdominal pain

Contact your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, heart attack, or stroke.

Also, inform your doctor if you experience any symptoms suggesting an allergic reaction (such as rash or hives) after taking Rizatriptan Viso Farmacéutica.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You may 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 Viso Farmacéutica

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan Viso Farmacéutica

• The active substance is rizatriptan.

One 10 mg orodispersible tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

• The other components are mannitol (E421), microcrystalline cellulose (E460a), crospovidone type A, aspartame (E951), magnesium stearate (E572), colloidal silicon dioxide, and mint flavour (containing modified food starch E1450).

Appearance of the product and contents of the pack

The 10 mg orodispersible tablets are white or off-white, round, flat, with bevelled edges and uncoated, marked with "468" on one side and nothing on the other.

The orodispersible tablets are presented in aluminium blisters.

Pack sizes for 10 mg: packs of 2, 3, 6, 12 or 18 orodispersible tablets.

Only some pack sizes may be marketed.

Rizatriptan benzoate is also available as a tablet that can be taken with liquid.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of the last review of this leaflet: July 2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).