Rizatriptan Viso Farmacéutica 10 mg tablets EFG

Package leaflet: Information for the user

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 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 other people, even if they have the same symptoms as you, because it could 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 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 belongs to a class of medicines known as selective 5-HT1B/1D receptor agonists.

Rizatriptan Viso Farmacéutica is used to treat headache pain during migraine attacks in adults.

Treatment with Rizatriptan Viso Farmacéutica:

Reduces the swelling of 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 Viso Farmacéutica

Do not take Rizatriptan Viso Farmacéutica:

• • if you are allergic to the active substance (rizatriptan, benzoate) or to any of the other components 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 symptoms related to heart disease.
  • if you have had severe liver or kidney problems.
  • if you have had a stroke (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 an ergotamine-type medication, such as ergotamine or dihydroergotamine to treat 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 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, your family has a history of heart disease, you are a man over 40 years of age, or you are a postmenopausal woman.
• if you have kidney or liver problems.
• if you have a specific problem with 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.
• 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 and tightness.

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

Inform your doctor or pharmacist about all 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 headache that may be caused by more serious conditions.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This includes herbal remedies and any medications 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 under 18 years.

Use in 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 referred to as "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.

When the above-mentioned medicines are taken together with Rizatriptan Viso Farmacéutica, the risk of adverse effects may increase.

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

After taking ergotamine-type medications, you must 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.

Use of Rizatriptan Viso Farmacéutica with food and drinks

Rizatriptan Viso Farmacéutica may take longer to work if taken after meals. Although it is better to take it on an empty stomach, you may take it even if you have eaten.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 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 use of 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 tablet.

Aspartame contains a source of phenylalanine, which may be harmful in individuals with 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.

Always follow your doctor's instructions for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Rizatriptan Viso Farmacéutica tablets 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 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 returns within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine returns, you may take an additional dose of Rizatriptan Viso Farmacéutica. Always wait at least 2 hours between doses.

If you still have migraine 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 a subsequent attack.

Do not take more than 2 doses of Rizatriptan Viso Farmacéutica within a 24-hour period (for example, do not take more than two 10 mg doses in 24 hours. Always wait at least 2 hours between doses).

If your condition worsens, seek medical attention.

Rizatriptan benzoate is also available in orally disintegrating tablets that dissolve in the mouth. Orally disintegrating tablets may be used when liquids are not available, or to avoid nausea or vomiting that may accompany swallowing tablets with liquid.

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 telephone number 91 5620420, stating the medication and the amount taken. It is recommended to bring the medicine's packaging 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 may cause adverse effects, although not everyone experiences them. This medicine may cause the following adverse effects.

In adult studies, the most frequently reported adverse effects were dizziness, somnolence, and fatigue.

Frequent (affects between 1 and 10 out of 100 patients)

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

Uncommon (affects between 1 and 10 out of 1,000 patients)

• bad taste in the mouth
• unsteadiness while walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flushes, sweating
• rash, itching and raised rash (urticaria), swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea)
• neck pain, sensation of stiffness in parts of the body, muscle weakness
• changes in heart rate or rhythm (arrhythmia), electrocardiogram abnormalities (test recording the heart's electrical activity), very rapid heartbeat (tachycardia)
• facial pain, muscle pain

Rare (affects between 1 and 10 out of 10,000 patients)

• 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 substitutes, 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 the blood vessels in the heart (usually in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine substitutes, 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

• seizures (convulsions/spasms)

• constriction of blood vessels in the extremities, including cooling and numbness of hands and feet

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

• muscle pain

• changes in heart rate or rhythm (arrhythmia), slow heartbeat (bradycardia), electrocardiogram abnormalities (test recording the heart's electrical activity)

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 effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 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 unused medicines and their containers at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

• The other components are mannitol, microcrystalline cellulose (E460a), crospovidone, aspartame (E951), magnesium stearate (E572), colloidal silicon dioxide, and peppermint flavour (contains modified food corn starch).

Appearance of the product and contents of the pack

The 10 mg tablets are white or off-white, approximately 9 mm in diameter, round, flat, bevelled-edged, uncoated tablets, marked with "468" on one side and blank on the other.

The tablets are presented in aluminium blisters.

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

Only some pack 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

Further information on this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
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 about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.