Package Insert: Information for the User

Rizatriptan Flas Kern Pharma 10 mg Bucodispersible 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 read 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 even if they 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.

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

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

Treatment with Rizatriptán Flas Kern Pharma:

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

Do not take Rizatriptán Flas Kern Pharma

• if you are allergic to the active ingredient (rizatriptán benzoate) or any of the other components of this medication (listed in section 6).
• if you have moderately severe, severe, or uncontrolled mild high blood pressure.
• 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 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, linezolid, 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 below for Rizatriptán Kern Pharma use with other medications).

If you are unsure if any of the above cases affect you, talk to your doctor or pharmacist before taking Rizatriptán Flas Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptán Flas Kern Pharma.

Before taking Rizatriptán Flas Kern Pharma, inform your doctor or pharmacist if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or taking 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 Kern Pharma frequently, this may cause you to develop chronic headache. In such cases, contact your doctor and stop taking Rizatriptán Flas Kern Pharma.

Inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have a migraine.

You should only take Rizatriptán Flas Kern Pharma for a migraine attack. Rizatriptán Flas Kern Pharma should not be used to treat other headaches that may be caused by more serious diseases.

Rizatriptán Flas Kern Pharma use with other medications

Inform your doctor that 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 may affect the way some medications work. Other medications may also affect rizatriptán.

Do not take Rizatriptán Flas Kern Pharma:

• 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 a migraine attack.

The medications mentioned above, when taken with rizatriptán, may increase the risk of adverse reactions.

After taking Rizatriptán Flas Kern Pharma, 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 Kern Pharma.

Ask your doctor for instructions on how to take Rizatriptán Flas Kern Pharma and information on the risks:

• if you are currently taking propranolol (see the section on how to take Rizatriptán Flas Kern Pharma);
• 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 that you are using or have used recently or may need to use any other medication.

Rizatriptán Flas Kern Pharma use with food and drink

Rizatriptán Flas Kern Pharma 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 rizatriptán when used during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown if rizatriptán 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.

Use in children

Rizatriptán is not recommended for use in children under 18 years of age.

Use in patients over 65 years of age

There are no completed studies that evaluate the safety and efficacy of rizatriptán in patients over 65 years of age.

Driving and operating machinery

This medication, like migraine, can cause drowsiness. If you experience these effects, avoid driving or operating machinery as it may be hazardous.

Rizatriptán Flas Kern Pharma contains lactose and aspartame.

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

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

Follow exactly the administration instructions for Rizatriptan Flas Kern Pharma indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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 Flas Kern Pharma. You must 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 Flas Kern Pharma during an attack, do not take a second dose of Rizatriptan Flas Kern Pharma for the treatment of the same attack. However, you are still likely to respond to Rizatriptan Flas Kern Pharma during the next attack.

Do not take more than 2 doses of Rizatriptan Flas Kern Pharma 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 Kern Pharma

• Separate the aluminum foil and carefully remove the tablet. Do not push the tablet through the aluminum foil.
• Place the tablet on the tongue, where it will dissolve and swallow 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.

If you take more Rizatriptan Flas Kern Pharma than you should

If you take more Rizatriptan Flas Kern Pharma than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Service, phone: (91) 5620420, indicating the medication and the amount ingested.

Bring the medication packaging with you.

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, Rizatriptán Flas Kern Pharma can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.

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

Frequent (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, tremor,
• rapid or irregular heart rate (palpitations), very rapid heart rate (tachycardia),
• flushing (brief facial redness), hot flashes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• unpleasantness (nausea), dry mouth, vomiting, diarrhea,
• heaviness in parts of the body,
• abdominal or chest pain,
• skin rash.

Infrequent (may affect up to 1 in 100 people)

• unsteadiness (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension); thirst, indigestion (dyspepsia),
• itching and rash with blisters (urticaria), allergic reaction (hypersensitivity); swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema),
• neck pain, feeling of stiffness in parts of the body, numbness, muscle weakness.

Rare (may affect up to 1 in 1,000 people)

• bad taste in the mouth,
• syncope (fainting), a syndrome called "serotonin syndrome" that may cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination problems, agitation, and hallucinations,
• facial pain, breathing sounds
• sudden and potentially life-threatening allergic reaction (anaphylaxis); severe skin peeling with or without fever (toxic epidermal necrolysis),
• myocardial infarction, coronary artery spasms, stroke. These occurred generally in patients with cardiovascular risk factors (hypertension, diabetes, smoking, nicotine substitute use, family history of cardiovascular disease or stroke, male over 40 years old, postmenopausal woman, and a specific problem with the way their heart beats (left branch block)).

Unknown frequency (frequency cannot be estimated from available data)

• seizures (convulsions/spasms),
• contraction of blood vessels in the extremities including cooling and numbness of hands and feet,
• contraction of blood vessels in the colon (large intestine), which may cause abdominal pain,
• muscle pain,
• changes in heart rhythm or frequency (arrhythmia), slow heart rate (bradycardia), electrocardiogram alterations (a test that records the heart's electrical activity).

Inform your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, myocardial infarction, or stroke.

Also, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or urticaria) after taking Rizatriptán Flas Kern Pharma.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus.

Keep out of the sight and reach of children.

Do not use Rizatriptan Flas Kern Pharma after the expiration date that appears on the packaging 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 medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Rizatriptán Flas Kern Pharma

The active ingredient is rizatriptan. Each buccal dispersible tablet contains 10 mg of rizatriptan (as rizatriptan benzoate).

The other components are: lactose monohydrate, microcrystalline cellulose (E460a), calcium silicate, crospovidone, aspartame (E951), peppermint aroma, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

The buccal dispersible tablets are white or almost white, with flat faces, rounded edges, and beveled edges.

Rizatriptán Flas Kern Pharma 10 mg tablets are presented in packs of 2, or 6 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

KERN PHARMA, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Last review date of this leaflet:May 2024

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