Package Leaflet: Information for the User

Rizatriptan Flas Qualigen 10 mg Orally Disintegrating Tablets EFG

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

1. What Rizatriptan Flas Qualigen is and what it is used for

2. What you need to know before you start taking Rizatriptan Flas Qualigen

3. How to take Rizatriptan Flas Qualigen

4. Possible side effects

5. Storage of Rizatriptan Flas Qualigen

6. Contents of the pack and additional information

Rizatriptán Flas Qualigen belongs to a group of medicines called selective serotonin receptor agonists 5-HT 1B/1D.

Rizatriptán Flas Qualigen is used to treat headache crises of migraine in adults.

Treatment with Rizatriptán Flas Qualigen:

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

Do not take Rizatriptán Flas Qualigen

• if you are allergic to rizatriptan benzoate or any of the other ingredients of this medication (listed in section 6).
• if you have moderately severe, severe, or uncontrolled mild hypertension.
• if you have or have had any heart problems, including myocardial infarction or chest pain (angina) or have experienced signs related to heart disease.
• if you have severe liver or kidney problems.
• if you have had a stroke (ACV) or a transient ischemic attack (TIA).
• if you have peripheral vascular disease (obstruction in your arteries).
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.
• if you are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for 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 for your migraine. (see belowOther medications and Rizatriptán Flas Qualigen).

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptán Flas Qualigen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Flas Qualigen, if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or using nicotine substitutes, a family history of heart disease, being a man over 40 years old or a postmenopausal woman.
• you have kidney or liver problems.
• you have a specific problem with the way your heart beats (left branch block).
• you have or have had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm.
• you are taking herbal medicines that contain 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 or swallowing (angioedema).
• 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.
• you have had transient symptoms including chest pain and pressure.

If you take Rizatriptán Flas Qualigen frequently, this may cause you to develop chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptán Flas Qualigen.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have a migraine. You should only take Rizatriptán Flas Qualigen for a migraine attack.

Rizatriptán Flas Qualigen should not be used to treat other headaches that may be caused by more serious underlying diseases.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes herbal medicines and those you normally take for your migraine. This is because Rizatriptán Flas Qualigen may affect the way some medications work. Other medications may also affect Rizatriptán Flas Qualigen.

Other medications and Rizatriptán Flas Qualigen

Do not take Rizatriptán Flas Qualigen:

• if you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.
• if 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.
• if you are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for your migraine.
• if you are taking methysergide to prevent migraine attacks.

The medications mentioned above, when taken with Rizatriptán Flas Qualigen, may increase the risk of adverse effects.

After taking Rizatriptán Flas Qualigen, 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 Rizatriptán Flas Qualigen.

Ask your doctor for instructions on how to take Rizatriptán Flas Qualigen and information on the risks

• if you are currently taking propranolol (see section 3How to take Rizatriptán Flas Qualigen).
• if you are currently 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.

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

Taking Rizatriptán Flas Qualigen with food and drinks

Rizatriptán Flas Qualigen may take longer to take effect if taken 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, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The 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 Rizatriptán Flas Qualigen 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.

Children and adolescents

Rizatriptán Flas Qualigen is not recommended for use in children under 18 years old.

Use in patients over 65 years old

There are no completed studies to evaluate the safety and efficacy of Rizatriptán Flas Qualigen in patients over 65 years old.

Driving and operating machinery

After taking Rizatriptán Flas Qualigen, you may feel drowsiness or dizziness. If this occurs, do not drive or use tools or machinery.

Important information about some of the components of Rizatriptán Flas Qualigen

This tablet contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains 3.90 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

Rizatriptan Flas Qualigen is used to treat migraine attacks. Take Rizatriptan Flas Qualigen as soon as possible once your migraine headache has started. Do not use it to prevent a migraine attack.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems, you must use the 5 mg dose of Rizatriptan Flas Qualigen. You must wait at least 2 hours between the intake of propranolol and Rizatriptan Flas Qualigen, up to a maximum of 2 doses in a 24-hour period.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine reappears, you can take an additional dose of Rizatriptan Flas Qualigen. You must always wait at least 2 hours between doses.

Since after 2 hours you still have a migraine

If you do not respond to the first dose of Rizatriptan Flas Qualigen during an attack, do not take a second dose of Rizatriptan Flas Qualigen for the same attack. However, you are still likely to respond to Rizatriptan Flas Qualigen during the next attack.

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

If your condition worsens, seek medical attention.

How to administer Rizatriptan Flas Qualigen

• Open the blister pack of the buccal tablet with dry hands.
• Deposit the buccal tablet on the tongue, where it will dissolve so that it can be swallowed with saliva.
• The buccal 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.

Rizatriptan is also available in tablets to be taken with liquids.

If you take more Rizatriptan Flas Qualigen than you should

If you take more Rizatriptan Flas Qualigen than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 5620420, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.

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

Frequent (affects between 1 and 10 in every 100 patients):

• tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia.
• rapid or irregular heart rate (palpitations).
• flushing (temporary redness of the face).
• throat discomfort.
• uncomfortable feeling (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal or chest pain.

Less frequent (affects between 1 and 10 in every 1,000 patients):

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremors, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flashes, sweating.
• skin rash, itching, and hives (urticaria); swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea).
• sensation 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 electrical activity of the heart), very rapid heart rate (tachycardia).
• facial pain; muscle pain.

Rare (affects between 1 and 10 in every 10,000 patients):

• breathing sounds.
• allergic reaction (hypersensitivity), sudden and potentially life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart disease or blood vessel disease (hypertension, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)).
• slow heart rate (bradycardia).

Unknown frequency (the frequency cannot be estimated from the available data

• heart attack, spasms in the heart's blood vessels (these usually occur in patients with risk factors for heart disease or blood vessel disease (hypertension, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)).
• a syndrome called "serotonin syndrome" that can cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination problems, agitation, and hallucinations.
• severe skin peeling with or without fever (toxic epidermal necrolysis).
• seizures (convulsions/spasms).
• contraction of the blood vessels in the extremities, including cooling and numbness of hands and feet.
• contraction of the blood vessels in the colon (large intestine), which can cause abdominal pain.

Inform 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 symptom that indicates an allergic reaction (such as rash or itching) after taking Rizatriptán Flas Qualigen.

Reporting side effects:
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box/container/package/blister after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rizatriptan Flas Qualigen

• The active ingredient is rizatriptan. A buccal dispersible tablet contains 10 mg of rizatriptan equivalent to 14.53 mg of rizatriptan benzoate.
• The other components are: lactose monohydrate, microcrystalline cellulose (E460a), calcium silicate, crospovidone, aspartame (E951), silica colloidal anhydrous mint flavor (E551) and magnesium stearate (E470b).

Appearance of the product and content of the packaging

The 10 mg buccal dispersible tablets are white, flat-faced, and round.

Rizatriptan Flas Qualigen 10 mg tablets are presented in packs of 2 or 6 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:May 2024

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.