MAXALT 10 mg TABLETS

2. What you need to know before you take MAXALT

Do not take MAXALT:

• if you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (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 attacks, angina, or signs related to heart disease.
• if you have severe liver or kidney problems.
• if you have had a stroke (cerebrovascular accident) or a transient ischaemic attack (TIA).
• if you have problems with blood vessel obstruction (peripheral vascular disease).
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, 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 ergotamine or dihydroergotamine (medicines for migraine) or methysergide (for preventing migraine).
• if you are taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan for migraine (see also Taking MAXALT with other medicinesbelow).

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

Warnings and precautions

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

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or using nicotine substitutes, your family has a history of heart disease, you are a man over 40 years old or a postmenopausal woman.
• you have liver or kidney problems.
• you have a specific heart rhythm problem (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 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 which may cause difficulty breathing or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram, and fluoxetine or serotonin and noradrenaline 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 MAXALT too frequently, this may lead to you getting chronic headache. In such cases, you should contact your doctor, as you may have to stop taking MAXALT.

Tell your doctor or pharmacist about all your symptoms. Your doctor will decide if you have migraine. You should only take MAXALT for a migraine attack. MAXALT should not be used to treat other types of headaches that may be caused by other, more serious conditions.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These include herbal medicines and those you normally take for migraine. This is because MAXALT may affect how some medicines work, and some medicines may affect MAXALT.

Taking MAXALT with other medicines

Do not take MAXALT:

• 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 or dihydroergotamine (for migraine) or methysergide (for preventing migraine).

The above-mentioned medicines, when taken with MAXALT, may increase the risk of side effects.

After taking MAXALT, you should wait at least 6 hours before taking ergotamine-type medicines such as ergotamine or dihydroergotamine or methysergide.

After taking ergotamine-type medicines, you should wait at least 24 hours before taking MAXALT.

Ask your doctor for instructions on how to take MAXALT and information about the risks, especially:

• if you are currently taking propranolol (see section 3 How to take MAXALT).
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking MAXALT with food and drink

MAXALT may take longer to work if you take it after food. Although it is better to take it on an empty stomach, you can still take it 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.

Data available 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 not known if MAXALT 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

MAXALT tablets are not recommended for use in children under 18 years of age.

Use in patients over 65 years

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

Driving and using machines

When taking MAXALT, you may feel drowsy or dizzy. If this happens, do not drive or use tools or machines.

MAXALT contains lactose monohydrate

This medicine contains lactose. The 10 mg tablet contains 60.50 mg of lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take MAXALT

MAXALT is used to treat migraine attacks. Take MAXALT as soon as possible after the headache starts. Do not use it to prevent an attack.

Follow exactly the administration instructions given by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is 10 mg.

If you are currently taking propranolol or have liver or kidney problems, you should use the 5 mg dose of MAXALT. You should wait at least 2 hours between taking propranolol and MAXALT, up to a maximum of 2 doses in a 24-hour period.

MAXALT tablets should be taken by mouth and swallowed whole with a liquid.

MAXALT is also available as a 10 mg oral lyophilisate that dissolves in the mouth. 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 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 MAXALT. 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 MAXALT during a migraine attack, you should not take a second dose of MAXALT for the treatment of the same attack. However, you are still likely to respond to MAXALT during the next attack.

Do not take more than 2 doses of MAXALT in a 24-hour period (for example, do not take more than two 10 mg tablets or oral lyophilisates in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

If you take more MAXALT than you should

If you take more MAXALT than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 5620420, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

Signs of overdose may include dizziness, drowsiness, 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, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

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

Frequent (affect 1 to 10 users in 100)

• tingling sensation (paraesthesia), headache, reduced sensitivity in the skin (hypoesthesia), decreased mental sharpness, insomnia.
• rapid or irregular heart rhythm (palpitations).
• flushing (short-term reddening of the face).
• throat discomfort.
• nausea, dry mouth, vomiting, diarrhea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal pain or chest pain.

Infrequent (affect 1 to 10 users in 1,000)

• unpleasant taste.
• ataxia (lack of coordination), vertigo, blurred vision, tremor, fainting.
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flushes, sweating.
• skin rash, itching, and rash with hives (urticaria); swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea).
• stiffness in parts of the body, muscle weakness.
• changes in heart rhythm or rate (arrhythmia); changes in the electrocardiogram (a test that records the electrical activity of your heart), very rapid heart rate (tachycardia).
• facial pain; muscle pain.

Rare (affect 1 to 10 users in 10,000)

• breathing sounds.
• allergic reaction (hypersensitivity); severe, potentially life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart 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 specific heart rhythm problem (left bundle branch block)).
• slow heart rate (bradycardia).

Frequency not known (cannot be estimated from the 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 (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 heart rhythm problem (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 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.

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 suggest an allergic reaction (such as rash or itching) after taking MAXALT.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing MAXALT

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton/blister after "EXP". The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of MAXALT

• The active substance is rizatriptan. One tablet contains 10 mg of rizatriptan, equivalent to 14.53 mg of rizatriptan benzoate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E-460a), pregelatinized maize starch, red iron oxide (E-172), and magnesium stearate (E-572).

Appearance and packaging

The 10 mg tablets are pale pink, capsule-shaped, with the code "MAXALT" on one side and "MSD 267" on the other.

Packet sizes: packs of 2, 3, 6, 12, or 18 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria, Finland, France, Greece, Iceland, Norway, Netherlands, Portugal, Sweden, and United Kingdom: MAXALT

Belgium, Luxembourg, and Spain: MAXALT 10 mg

Germany: MAXALT 10 mg Tabletten

Denmark: MAXALT, tabletter

Italy: MAXALT 10 mg compresse

Ireland: Rizatriptan MSD 10 mg Tablets

Czech Republic: MAXALT 10 mg, tablety

Romania: MAXALT 10 mg comprimate

Date of last revision of this leaflet:07/2024.

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