Rizatriptan Flas Dari Pharma 10 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Rizatriptan Flas Dari Pharma 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Rizatriptán Flas Dari Pharma is and what it is used for

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

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

Treatment with rizatriptan:

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

2. What you need to know before taking Rizatriptan Flas Dari Pharma

Do not take Rizatriptan Flas Dari Pharma

• if you are allergic to rizatriptan benzoate or 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 signs related to heart disease.
• you have severe liver or kidney problems.
• you have had a stroke (CVA) or transient ischemic attack (TIA).
• you have arterial obstruction 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 in the same class, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine (see below, Other medicines and Rizatriptan Flas Dari Pharma).

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

Warnings and precautions

Consult your doctor or pharmacist before taking rizatriptan if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or using nicotine replacement products, 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 had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your arm or leg.
• you are taking 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-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have experienced transient symptoms including chest pain and tightness.

If you take rizatriptan very frequently, this may lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking rizatriptan.

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

Rizatriptan Flas Dari Pharma should not be used to treat other types of headache that may be caused by more serious conditions.

Inform your doctor or pharmacist if you are currently using, have recently used, or may need to use any other medicines. This includes herbal remedies and any medications you usually take for migraine. This is because Rizatriptan Flas Dari Pharma may affect how some medicines work. Other medicines may also affect Rizatriptan Flas Dari Pharma.

Other medicines and Rizatriptan Flas Dari Pharma

Do not take rizatriptan:

• 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, may increase the risk of adverse effects.

After taking rizatriptan, 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.

Ask your doctor for instructions on how to take rizatriptan and information about the risks:

• if you are currently taking propranolol (see section 3, How to take Rizatriptan Flas Dari Pharma).
• if you are currently 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.

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

Taking Rizatriptan Flas Dari Pharma with food and drinks

Rizatriptan may take longer to work if taken after meals. Although it is best taken 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 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 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 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 in patients over 65 years of age.

Driving and using machines

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

Important information about some of the components of Rizatriptan Dari Pharma

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 3.90 mg of aspartame per tablet. Aspartame contains 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 eliminate it properly.

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

3. How to take Rizatriptan Flas Dari Pharma

Rizatriptan is used to treat migraine attacks. Take rizatriptan 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. You must wait at least 2 hours between taking propranolol and rizatriptan, and take no more than 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. You must 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 during an attack, you should not take a second dose of rizatriptan for the treatment of the same attack. However, you are still likely to respond to rizatriptan 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 two 10 mg orodispersible tablets within 24 hours). You must always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer Rizatriptan Flas Dari Pharma

• Open the orodispersible tablet blister pack 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 liquid intake.

If you take more Rizatriptan Flas Dari Pharma than you should

If you take more rizatriptan 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 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 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 in every 100 patients):

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

Uncommon (affects between 1 and 10 in every 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.
• skin rash, itching and rash with lumps (urticaria); swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea).
• 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 fast heartbeat (tachycardia).
• facial pain; muscle pain.

Rare (affects between 1 and 10 in 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, smoker, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block)).
• slow heartbeat (bradycardia).

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

• myocardial infarction, spasms of the blood vessels of the heart (these usually occur in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, and a specific problem with the way the 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 skin peeling with or without fever (toxic epidermal necrolysis).
• 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.

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 indicating an allergic reaction (such as rash or itching) after taking Rizatriptan Dari Pharma.

5. Storage of Rizatriptan Flas Dari Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton/pack/foil/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. Unused medicines and waste materials, including packaging, should be handed over to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan Flas Dari Pharma

• The active substance is rizatriptan. Each 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), peppermint flavour, colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Nature of the product and pack contents

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

They are available in packs of 2 or 6 tablets.

Marketing Authorization Holder:

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970, Sant Joan Despí, Barcelona

Spain

Date of the most recent revision of this leaflet: March 2025

Other sources of information:

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