Rizatriptan Flas Qualigen 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptan Flas Qualigen 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

Leaflet contents:

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

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

Rizatriptán Flas Qualigen belongs to a group of medicines called selective serotonin 5-HT1B/1D receptor agonists.

Rizatriptán Flas Qualigen is used to treat headache pain during migraine attacks in adults.

Treatment with Rizatriptán Flas Qualigen:

Reduces swelling of the 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 Flas Qualigen

Do not take Rizatriptan Flas Qualigen

• if you are allergic to rizatriptan benzoate or to any of the other ingredients of this medicine (listed in section 6).
• you have moderately severe, severe, or uncontrolled mild high blood pressure.
• you have or have ever had heart problems, including myocardial infarction or chest pain (angina), or have experienced symptoms related to heart disease.
• you have severe liver or kidney problems.
• you have had a stroke (cerebrovascular accident, CVA) or a transient ischemic attack (TIA).
• you have serious arterial blockage problems (peripheral vascular disease).
• 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.
• you are currently taking an ergot-type medication, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent migraine attacks.
• you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine. (see below Other medicines and Rizatriptan Flas Qualigen).

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before taking Rizatriptan Flas Qualigen.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rizatriptan Flas Qualigen 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.
• you have kidney or liver problems.
• you have a specific problem with your heart rhythm (left bundle branch block).
• you have or have ever had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your arm or leg.
• you take herbal remedies containing St. John's wort.
• you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have experienced transient symptoms including chest pain and tightness.

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

Inform your doctor or pharmacist about all your symptoms. Your doctor will determine whether you have migraine. You should only take Rizatriptan Flas Qualigen for a migraine attack.

Rizatriptan Flas Qualigen must 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 using, have recently used, or might need to use any other medicines. This includes herbal remedies and any medications you usually take for migraine. This is because Rizatriptan Flas Qualigen may affect how some medicines work. Other medicines may also affect Rizatriptan Flas Qualigen.

Other medicines and Rizatriptan Flas Qualigen

Do not take Rizatriptan 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 less than two weeks have passed since you stopped taking an MAOI.
• if you are taking ergot-type medications, such as ergotamine or dihydroergotamine to treat your migraine.
• if you are taking methysergide to prevent migraine attacks.

The above-mentioned medicines, when taken with Rizatriptan Flas Qualigen, may increase the risk of adverse effects.

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

After taking ergot-type medications, you must wait at least 24 hours before taking Rizatriptan Flas Qualigen.

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

• if you are currently taking propranolol (see section 3 How to take Rizatriptan Flas Qualigen).
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin-noradrenaline reuptake inhibitors (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 medicine.

Taking Rizatriptan Flas Qualigen with food and drink

Rizatriptan Flas Qualigen may take longer to work if taken after meals. Although it is best to take it on an empty stomach, you may still 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 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Children and adolescents

The use of Rizatriptan Flas Qualigen is not recommended in children under 18 years of age.

Use in patients over 65 years of age

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

Driving and using machines

Rizatriptan Flas Qualigen may cause drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery.

Important information about some of the ingredients of Rizatriptan Flas Qualigen

This tablet contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 3.90 mg of aspartame per tablet. Aspartame contains a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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

3. How to take Rizatriptan Flas Qualigen

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

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in 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 should use the 5 mg dose of Rizatriptan Flas Qualigen. You must wait at least 2 hours between taking propranolol and taking Rizatriptan Flas Qualigen, up to a maximum of 2 doses 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 Flas Qualigen. Always wait at least 2 hours between doses.

I f you still have migraine after 2 hours

If you do not respond to the first dose of Rizatriptan Flas Qualigen during an attack, you should not take a second dose of Rizatriptan Flas Qualigen to treat 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 within a 24-hour period (for example, do not take more than two 10 mg orodispersible tablets within 24 hours). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer Rizatriptan Flas Qualigen

• Open the orodispersible tablet blister with dry hands.
• Place the orodispersible tablet on the tongue, where it will dissolve and can be swallowed with saliva.
• The orodispersible tablet can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

Rizatriptan is also available in tablets for oral administration with liquid.

If you take more Rizatriptan Flas Qualigen than you should

If you take more Rizatriptan Flas Qualigen 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 packaging and leaflet to the healthcare professional.

Signs of overdose may include dizziness, drowsiness, vomiting, weakness, 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 experiences them. The following adverse effects may occur with this medicine.

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

Common (affects between 1 and 10 out of every 100 patients):

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

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

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flushes, sweating.
• skin rash, itching and rash with bumps (urticaria); swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnoea).
• sensation of stiffness in parts of the body, muscle weakness.
• changes in the rhythm or frequency of the heartbeat (arrhythmia); electrocardiogram abnormalities (a test that records the electrical activity of your heart), very rapid heartbeat (tachycardia).
• facial pain; muscle pain.

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

• noisy breathing.
• allergic reaction (hypersensitivity), sudden and potentially life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs 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 problem with the way your heart beats (left bundle branch block)).
• slow heartbeat (bradycardia).

Frequency not known (frequency cannot be estimated from available data):

• myocardial infarction, spasms in the blood vessels of the heart (these usually occur 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 problem with the way your heart beats (left bundle branch block)).
• a syndrome called "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).
• constriction of blood vessels in the limbs, including cooling and numbness of hands and feet.
• constriction 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.

Additionally, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or itching) after taking Rizatriptán Flas Qualigen.

Reporting of adverse effects: If you experience any type of adverse effect, consult 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 Flas Qualigen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton/packaging/pouch/blister after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan Flas Qualigen

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

Appearance of the medicine and contents of the pack

The 10 mg orodispersible tablets are white, round and flat on both sides.

Rizatriptan Flas Qualigen 10 mg tablets are available in packs containing 2 or 6 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent review of this leaflet: May 2024

Other sources of information

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