RIZATRIPTAN FLAS DARI PHARMA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Rizatriptan Flas Dari Pharma 10 mg Oral Lyophilisates 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 questions, 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 is Rizatriptan Flas Dari Pharma and what is it used for
2. What you need to know before taking Rizatriptan Dari Pharma
3. How to take Rizatriptan Flas Dari Pharma
4. Possible side effects
5. Storage of Rizatriptan Flas Dari Pharma
6. Package Contents and Additional Information

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

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

Rizatriptan is used to treat migraine headaches in adults.

Treatment with rizatriptan:

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

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 components of this medication (listed in section 6).
• if you have moderately severe, severe, or uncontrolled high blood pressure.
• if you have or have had heart problems, including heart attack 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 (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 (an 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 migraine attacks.
• if you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine (see also "Other medications and Rizatriptan Flas Dari Pharma" below).

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Rizatriptan.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take rizatriptan if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or use nicotine substitutes, your family has a history of heart disease, you are 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 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 leg and arm.
• 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 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 norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have had transient symptoms including pain and pressure in the chest.

If you take rizatriptan too frequently, it may cause you to develop chronic headaches. In such cases, you should contact your doctor, as you may need to stop taking rizatriptan.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have migraines. 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 headaches that may be caused by more serious conditions.

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medications. This includes herbal remedies and medications you normally take for migraines. This is because Rizatriptan Flas Dari Pharma may affect how some medications work, and other medications may also affect Rizatriptan Dari Pharma.

Other medications 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 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, to treat your migraine.
• if you are taking methysergide to prevent migraine attacks.

The medications mentioned above, when taken with rizatriptan, may increase the risk of side effects.

After taking rizatriptan, 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.

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 and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medications.

Taking Rizatriptan Flas Dari Pharma with food and drinks

Rizatriptan may take longer to work if you take it after meals. Although it is best 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, 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 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 postpone breastfeeding for 12 hours after treatment to avoid exposing your 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 that evaluate 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 use tools or machines.

Important Information About Some of the Components of Rizatriptan Dari Pharma

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet; 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 after 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 or pharmacist. If you are unsure, 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 should wait at least 2 hours between taking propranolol and rizatriptan, up to a maximum of 2 doses in a 24-hour period.

If your migraine recurs within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine recurs, you can take an additional dose of rizatriptan. 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 during an attack, you should not take a second dose of rizatriptan for the treatment of the same attack. However, you may still respond to rizatriptan 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 two 10 mg oral lyophilisates in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to Administer Rizatriptan Flas Dari Pharma

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

Rizatriptan is also available in tablets for taking with liquids.

If you take more Rizatriptan Flas Dari Pharma than you should

If you take more rizatriptan 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 questions 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. The following side effects may occur with this medication.

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

Frequent (affecting 1 to 10 in every 100 patients):

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

Uncommon (affecting 1 to 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 can cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea).
• stiffness in parts of the body, muscle weakness.
• changes in heart rhythm or frequency (arrhythmia); alterations in the electrocardiogram (a test that records the physical activity of your heart), very rapid heart rate (tachycardia).
• facial pain; muscle pain.

Rare (affecting 1 to 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 or blood vessel disease, such as 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 specific problem with the way the heart beats, left bundle branch block).
• slow heart rate (bradycardia).

Frequency Not Known (frequency cannot be estimated from available data)

• heart attack, spasms of the blood vessels of the heart (these usually occur in patients with risk factors for heart or blood vessel disease, such as 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 specific problem with the way the heart beats, left bundle branch block).
• a syndrome called "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.

Inform your doctor immediately if you have symptoms of an allergic reaction, serotonin syndrome, heart attack, or stroke.

Also, inform your doctor if you experience any symptoms that indicate an allergic reaction (such as rash or itching) after taking Rizatriptan Dari Pharma.

5. Storage of Rizatriptan Flas Dari Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton/outer packaging/foil/blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rizatriptan Flas Dari Pharma

• The active ingredient is rizatriptan. Each oral lyophilisate 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), peppermint flavor, anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of the Product and Package Contents

The 10 mg oral lyophilisates are white, flat-faced, and round.

They are available in packs of 2 or 6 oral lyophilisates.

Marketing Authorization Holder:

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avenida de Barcelona, 69

08970, Sant Joan Despí, Barcelona

Spain

Date of Last Revision of this Package Leaflet:March 2025

Other Sources of Information:

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/.