Rizatriptan Flas Kern Pharma 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptán Flas Kern 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; 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

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

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

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

Treatment with Rizatriptán Flas Kern Pharma:

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

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

Do not take Rizatriptan Flas Kern Pharma

• if you are allergic to the active substance (rizatriptan benzoate) or to any of the other ingredients of this medicine (listed in section 6).
• if you have moderately severe, severe, or uncontrolled mild high blood pressure
• if you have or have ever had 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 (cerebrovascular accident, CVA) or a transient ischemic attack (TIA)
• if you have severe arterial blockage problems (peripheral vascular disease)
• if you are taking monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline (medicines for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAOI
• if you are currently taking an ergot-type medicine, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent a migraine attack
• if you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine (see below: Use of Rizatriptan Flas Kern Pharma with other medicines)

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rizatriptan Flas Kern Pharma.

Before taking Rizatriptan Flas Kern Pharma, inform your doctor or pharmacist 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 the 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-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
• you have experienced transient symptoms including chest pain or tightness

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

Inform your doctor or pharmacist about all your symptoms. Your doctor will determine whether you have migraine.

Rizatriptan Flas Kern Pharma should only be taken for a migraine attack. Rizatriptan Flas Kern Pharma must not be used to treat other types of headache that may be caused by more serious conditions.

Use of Rizatriptan Flas Kern Pharma with other medicines

Tell your doctor if you are currently using, have recently used, or might need to use any other medicines. This includes herbal remedies and medicines you usually take for migraine. This is because rizatriptan may affect how some medicines work. Other medicines may also affect rizatriptan.

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

The above-mentioned medicines, when taken with rizatriptan, may increase the risk of adverse reactions.

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

After taking ergot-type medicines, you must wait at least 24 hours before taking Rizatriptan Flas Kern Pharma.

Ask your doctor for advice on how to take Rizatriptan Flas Kern Pharma and information about the risks:

• if you are currently taking propranolol (see section How to take Rizatriptan Flas Kern Pharma);
• 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 currently using, have recently used, or might need to use any other medicines.

Use of Rizatriptan Flas Kern Pharma with food and drink

Rizatriptan Flas Kern Pharma 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 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.

Use in children

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 use of machines

This medicine, like migraine itself, may cause drowsiness. If you experience these effects, avoid driving or operating machinery, as it may be dangerous.

Rizatriptan Flas Kern Pharma contains lactose and aspartame.

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Rizatriptan Flas Kern Pharma

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

Follow exactly the instructions for use of Rizatriptan Flas Kern Pharma provided by your doctor or pharmacist. If in 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 should use the 5 mg dose of rizatriptan. You must wait at least 2 hours between taking propranolol and rizatriptan, and no more than 2 doses should be taken 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 Kern Pharma. Always wait at least 2 hours between doses.

If migraine persists after 2 hours

If you do not respond to the first dose of Rizatriptan Flas Kern Pharma during an attack, you should 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 within a 24-hour period (e.g., 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 Kern Pharma

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

If you take more Rizatriptan Flas Kern Pharma than you should

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

In case of overdose or accidental ingestion, contact the Poison Control Service at telephone: (91) 5620420, indicating the medication and the amount ingested.

Bring the medication packaging with you.

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, Rizatriptan Flas Kern Pharma can cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine.

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

Common (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental alertness, tremor,
• rapid or irregular heartbeat (palpitation), very fast heartbeat (tachycardia),
• flushing (facial redness lasting a short time), hot flashes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• nausea, dry mouth, vomiting, diarrhoea,
• heaviness in parts of the body,
• abdominal or chest pain,
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension); thirst, indigestion (dyspepsia),
• itching and rash with bumps (urticaria), allergic reaction (hypersensitivity); swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema),
• neck pain, sensation 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,
• fainting (syncope), a condition called "serotonin syndrome" which may cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations,
• facial pain, noisy breathing,
• sudden and potentially life-threatening allergic reaction (anaphylaxis); severe peeling of the skin with or without fever (toxic epidermal necrolysis),
• myocardial infarction, spasms of the blood vessels in the heart, stroke. These generally occurred in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine replacement products, 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)).

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

• 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,
• muscle pain,
• changes in heart rhythm or rate (arrhythmia), slow heartbeat (bradycardia), electrocardiogram abnormalities (a test that records the electrical activity of your heart).

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

In addition, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or hives) after taking Rizatriptan Flas Kern Pharma.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Rizatriptan Flas Kern Pharma

Keep out of the sight and reach of children.

Do not use Rizatriptan Flas Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date is 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 medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan Flas Kern Pharma

The active substance is rizatriptan. Each orodispersible tablet contains 10 mg of rizatriptan (as rizatriptan benzoate).

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

Appearance of the product and contents of the pack

The orodispersible tablets are white or almost white, flat-faced, round, with beveled edges.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KERN PHARMA, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

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

Detailed and up-to-date 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