RIZATRIPTAN FLAS KERN PHARMA 10 mg ORALLY DISINTEGRATING TABLETS

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

Do not take Rizatriptan Flas Kern Pharma

• if you are allergic to the active substance (rizatriptan benzoate) or 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 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, linezolid, or pargyline (medicines 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 an ergotamine-type medication, such as ergotamine or dihydroergotamine to treat your migraine or methysergide to prevent a migraine attack
• if you are taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see also "Using Rizatriptan Kern Pharma with other medicines").

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan Flas Kern Pharma.

Warnings and precautions

Consult 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 are taking 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 certain problem with the way your heart beats (left bundle branch block)
• you have or have had any allergy
• 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 may 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 Flas too frequently, this can lead to chronic headache. In such cases, you should contact your doctor and stop taking Rizatriptan Flas.

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

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

Using Rizatriptan Flas Kern Pharma with other medicines

Tell your doctor that you are using, have recently used, or might use any other medicine. These include herbal remedies and those medicines you normally take for migraine. This is because rizatriptan can affect the way some medicines work. Other medicines can 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 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 a migraine attack.

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

After taking Rizatriptan 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 Rizatriptan Flas Kern Pharma.

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

• if you are currently taking propranolol (see the 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 and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicine.

Using Rizatriptan Flas Kern Pharma with food and drink

Rizatriptan Flas Kern Pharma may take longer to work if you take it 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Available data on the safety of rizatriptan when used during the first 3 months of pregnancy do not indicate an increased risk of birth defects. It is not known if rizatriptan is harmful to the fetus when taken by a pregnant woman after the first 3 months of pregnancy.

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

Use in children

Rizatriptan is not recommended for use 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

This medicine, like migraine, can cause drowsiness. If you notice these effects, avoid driving or using machines, as it may be dangerous.

Rizatriptan Flas Kern Pharma contains lactose and aspartame.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine may be harmful for 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 after your migraine headache starts. Do not use it to prevent an attack.

Follow exactly the administration instructions of Rizatriptan Flas Kern Pharma given 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 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 the migraine comes back within 24 hours

In some patients, migraine symptoms may come back within 24 hours. If your migraine comes back, you can take another dose of Rizatriptan Flas Kern Pharma. You should always wait at least 2 hours between doses.

If after 2 hours you still have migraine

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 may still 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 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 Kern Pharma

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

Bring the medicine packaging with you.

Signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rizatriptan Flas Kern Pharma can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

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

Frequent (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, decreased sensitivity in the skin (hypoesthesia), decreased mental sharpness, tremor,
• rapid or irregular heartbeat (palpitations), very rapid heartbeat (tachycardia),
• flushing (short-term redness of the face), hot flashes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• nausea, dry mouth, vomiting, diarrhea,
• heaviness in parts of the body,
• abdominal or chest pain,
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• unsteadiness while walking (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension); thirst, indigestion (dyspepsia),
• itching and rash with hives (urticaria), allergic reaction (hypersensitivity); swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema),
• neck pain, 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 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,
• facial pain, breathing sounds
• sudden and potentially life-threatening allergic reaction (anaphylaxis); severe skin peeling with or without fever (toxic epidermal necrolysis),
• heart attack, spasms of the blood vessels of the heart, stroke. These usually occurred in patients with risk factors for heart disease or blood vessel disease (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 certain problem with the way the heart beats (left bundle branch block)).

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

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

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

Also, tell your doctor if you experience any symptoms that indicate an allergic reaction (such as rash or hives) after taking Rizatriptan Flas Kern Pharma.

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

5. Storage of Rizatriptan Flas Kern Pharma

Keep out of 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. Return any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rizatriptan Flas Kern Pharma

The active substance is rizatriptan. Each oral lyophilisate contains 10 mg of rizatriptan (as rizatriptan benzoate).

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

Appearance of the product and pack contents

The oral lyophilisates are white or almost white, with flat faces, round, and with beveled edges.

Rizatriptan Flas Kern Pharma 10 mg oral lyophilisates are available in packs of 2 or 6 oral lyophilisates.

Not all 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 last revision of this leaflet:May 2024

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