RIZATRIPTAN VISO FARMACEUTICA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Rizatriptan Viso Farmacéutica 10 mg Oral Lyophilisate EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package 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. Storage of Rizatriptan Viso Farmacéutica
6. Package Contents and Additional 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 type of medication 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 of 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 medication (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 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 (medications for depression), or linezolid (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 to treat your migraine, or methysergide to prevent a migraine attack.
  • if you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan (see Using Rizatriptan Viso Farmacéutica with other medications).

If you are not sure if any of the above cases apply 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 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 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, oxalate escitalopram, and fluoxetine, or serotonin and norepinephrine 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, it may cause you to develop 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 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 more serious conditions.

Tell your doctor that you are using, have recently used, or may need to use any other medication, including those obtained without a prescription. These include herbal remedies and medications you normally take for migraines. This is because Rizatriptan Viso Farmacéutica may affect how some medications work. Other medications 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.

Patient Over 65 Years

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

Using Rizatriptan Viso Farmacéutica with Other Medications

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 taking the above medications with Rizatriptan Viso Farmacéutica, the risk of side effects may increase.

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, oxalate escitalopram, and fluoxetine, or SNRIs such as venlafaxine and duloxetine for depression.

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Using Rizatriptan Viso Farmacéutica with Food and Drinks

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

Pregnancy, Breastfeeding, and Fertility

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

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 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 the baby.

Driving and Using Machines

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

Rizatriptan Viso Farmacéutica Contains Aspartame (E951)

Aspartame contains a source of phenylalanine that may be harmful to people with phenylketonuria.

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 the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Rizatriptan Viso Farmacéutica is an oral lyophilisate that dissolves in the mouth.

• Remove the oral lyophilisate from the blister pack with dry hands and place it on your tongue, where it will dissolve and can be swallowed with your saliva.
• The oral lyophilisate can be taken in situations where liquids are not available or to avoid nausea and vomiting that may accompany taking tablets with liquids.

If you are currently taking propranolol or have kidney or liver problems, you should take a 5 mg dose of Rizatriptan Viso Farmacéutica. 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 Returns Within 24 Hours

In some patients, migraine symptoms may return within 24 hours. If your migraine returns, you can take an additional 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 an attack, you should not take a second dose of Rizatriptan Viso Farmacéutica to treat the same attack. However, you may still respond to Rizatriptan Viso Farmacéutica during the next attack.

Do Not Take More Than 2 Doses of Rizatriptan in a 24-Hour Period(for example, do not take more than 2 oral lyophilisates of 10 mg or 5 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 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, phone 91 5620420, indicating the medication and the amount taken. It is recommended to bring the packaging and the package leaflet of the medication to the healthcare professional.

Signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them. This medication can cause the following side effects.

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

Frequent (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, decreased skin sensitivity (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 (may affect up to 1 in 100 people)

• bad taste in the mouth
• instability when walking (ataxia), dizziness (vertigo), blurred vision, tremors, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flashes, sweating
• rash, itching, and rash with hives (urticaria), swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea)
• feeling of stiffness in parts of the body, muscle weakness
• changes in heart rhythm or frequency (arrhythmia), alterations in the electrocardiogram (a test that records the heart's electrical activity), very rapid heart rate (tachycardia)
• facial pain, muscle pain

Rare (may affect up to 1 in 1000 people)

• breathing sounds
• 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 special problem related to the way the heart beats (left branch block)).
• slow heart rate (bradycardia)

Frequency Not Known

• heart attack, spasms of the heart's blood vessels (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 special problem related to the way the heart beats (left 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
• severe skin peeling with or without fever (toxic epidermal necrolysis)

• 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

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 Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Rizatriptan Viso Farmacéutica

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Rizatriptan Viso Farmacéutica

• The active ingredient is rizatriptan.

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

• The other ingredients are mannitol (E421), microcrystalline cellulose (E460a), crospovidone type A, aspartame (E951), magnesium stearate (E572), colloidal silicon dioxide, and peppermint flavor (contains modified cornstarch E1450).

Appearance of the Product and Container Content

The 10 mg orodispersible tablets are white or almost white, round, flat, with beveled edges, and uncoated, with «468» engraved on one side and nothing on the other.

The orodispersible tablets are presented in aluminum blisters.

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

Only some container sizes may be marketed.

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

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

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

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

Date of the Last Revision of this Prospectus:July 2024.

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