Package Insert: Information for the User

Rizatriptan Flas Dari Pharma 10 mg Bucodispersable Tablets EFG

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

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Rizatriptan Dari Pharma

3. How to take Rizatriptan Flas Dari Pharma

4. Possible adverse effects

5. Storage of Rizatriptan Flas Dari Pharma

6. Contents of the package and additional information

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

Rizatriptán is used to treat the headaches of migraine attacks in adults.

Rizatriptán treatment:

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

Do not take Rizatriptán FlasDari Pharma

-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 or 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 for migraine prevention.

-if you are taking any other medication in the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine (see belowOther Medications and Rizatriptán Flas Dari Pharma).

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

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

-you have had transient symptoms including chest pain and pressure.

If you take rizatriptan 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.

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

Rizatriptán Flas Dari Pharma 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 medications you normally take for migraine. This is because Rizatriptán Flas Dari Pharma may affect how some medications work. Other medications may also affect Rizatriptán Dari Pharma.

Other Medications and Rizatriptán 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 zolmitriptán.

-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 for migraine prevention.

The medications mentioned above, when taken with rizatriptan, may increase the risk of adverse 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 on the risks

-if you are currently taking propranolol (see section 3How to Take Rizatriptán Flas Dari PharmaDari 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 used recently, or may need to use any other medication.

Taking Rizatriptán Flas Dari Pharma with Food and Drinks

Rizatriptan 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, 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 rizatriptan is harmful to the fetus when taken by a pregnant woman after the first three months of pregnancy.

If you are breastfeeding, you can delay breastfeeding for 12 hours after treatment to avoid exposing your baby.

Children and Adolescents

Rizatriptan is not recommended for use in children under 18 years old.

Use in Patients Over 65 Years Old

There are no complete studies evaluating the safety and efficacy of rizatriptan in patients over 65 years old.

Driving and Operating Machinery

After taking rizatriptan, 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 Dari Pharma

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

Rizatriptan is used to treat migraine attacks. Take rizatriptan as soon as possible once your migraine headache has started. Do not use it to prevent an 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 a dose of 5 mg of rizatriptan. You must wait at least 2 hours between the intake of propranolol and rizatriptan 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. 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 during an attack, do not take a second dose of rizatriptan for 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 in a 24-hour period (for example, do not take more than two oral disintegrating tablets of 10 mg 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 Dari Pharma

-Open the blister pack of the oral disintegrating tablet with dry hands.

-Deposit the oral disintegrating tablet on the tongue, where it will dissolve so that it can be swallowed with saliva.

-The oral disintegrating 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 Dari Pharma than you should

If you take more rizatriptan 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 may 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 100 patients):

-tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia.

-rapid or irregular heart rate (palpitations).

-flushing (brief facial redness).

-throat discomfort.

-unpleasantness (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).

-heaviness in parts of the body, neck pain, numbness.

-abdominal or chest pain.

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

-bad taste in the mouth.

-gait instability (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).

-confusion, nervousness.

-high blood pressure (hypertension); thirst, hot flashes, sweating.

-skin rash, itching, and rash with blisters (urticaria); facial, lip, tongue, or throat swelling 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); electrocardiogram alterations (a test that records the heart's physical activity), very rapid heart rate (tachycardia).

-facial pain; muscle pain.

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

-breathing sounds.

-allergic reaction (hypersensitivity), sudden and potentially fatal allergic reaction (anaphylaxis).

-stroke (this usually occurs in patients with cardiovascular disease or blood vessel risk factors (hypertension, diabetes, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)).

-slow heart rate (bradycardia).

Unknown frequency (frequency cannot be estimated from available data)

-heart attack, spasms of the heart's blood vessels (these usually occur in patients with cardiovascular disease or blood vessel risk factors (hypertension, diabetes, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40, 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 loss, 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 may 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 symptoms indicating an allergic reaction (such as rash or itching) after taking Rizatriptán Dari Pharma.

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/packaging/blister after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Composition of Rizatriptan Flas Dari Pharma

-The active ingredient is rizatriptan. Each 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), peppermint aroma, anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

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

They are presented in packs of 2 or 6 tablets.

Holder of the marketing authorization:

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970, Sant Joan Despí, Barcelona

Spain

Last review date of this leaflet:March 2025

Other sources of information:

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