Maxalt 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MAXALT 10 mg tablets

rizatriptan

Read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What MAXALT is and what it is used for
2. What you need to know before you take MAXALT
3. How to take MAXALT
4. Possible side effects
5. How to store MAXALT
6. Contents of the pack and other information

1. What MAXALT is and what it is used for

MAXALT belongs to a group of medicines called selective 5-HT1B/1D serotonin receptor agonists.

MAXALT is used to treat headache pain during migraine attacks in adults.

Treatment with MAXALT:

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

2. What you need to know before taking MAXALT

Do not take MAXALT:

• if you are allergic to 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 ischaemic attack (TIA).
• if you have arterial obstruction problems (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 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 Taking MAXALT with other medicines).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking MAXALT 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, you have a family 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 heart rhythm problem (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 and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have experienced transient symptoms including chest pain or tightness.

If you take MAXALT too frequently, this may lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking MAXALT.

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

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

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

After taking MAXALT, 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 MAXALT.

Ask your doctor for instructions on how to take MAXALT and information about the risks.

• 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 oxalate, and fluoxetine, or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetina for depression.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Taking MAXALT with food and drink

MAXALT may take longer to work if taken after meals. Although it is best taken 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 when used during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown whether 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Children and adolescents

The use of MAXALT tablets is not recommended in children under 18 years of age.

Use in patients over 65 years of age

There are no completed studies evaluating the safety and efficacy of MAXALT in patients over 65 years of age.

Driving and using machines

MAXALT may cause drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery.

MAXALT contains lactose monohydrate

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

3. How to take MAXALT

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

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in 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 should use the 5 mg dose of MAXALT. You must wait at least 2 hours between taking propranolol and taking MAXALT, and take no more than 2 doses within a 24-hour period.

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

MAXALT is also available as a 10 mg orally disintegrating tablet that dissolves in the mouth. The orally disintegrating tablet may be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

If migraine recurs within 24 hours

In some patients, migraine symptoms may recur within a 24-hour period. If your migraine recurs, you may take an additional dose of MAXALT. You must always wait at least 2 hours between doses.

If you still have migraine after 2 hours

If you do not respond to the first dose of MAXALT during an attack, you should not take a second dose of MAXALT to treat 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 within a 24-hour period (for example, do not take more than two 10 mg tablets or orally disintegrating tablets within 24 hours). You must 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 Poison Information Service at telephone number 91 5620420, stating the medicine and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

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, this medicine may 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, drowsiness, and fatigue.

Common (affects between 1 and 10 in 100 patients)

• tingling sensation (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental acuity, insomnia.
• fast or irregular heartbeat (palpitation).
• flushing (temporary redness of the face).
• throat discomfort.
• malaise (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal or chest pain.

**Uncommon (affects between 1 and 10 in 1,000 patients )

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flushes, sweating.
• skin rash, itching and rash with bumps (urticaria); swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnoea).
• sensation of stiffness in parts of the body, muscle weakness.
• changes in heart rhythm or rate (arrhythmia); electrocardiogram abnormalities (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• facial pain; muscle pain.

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

• noisy breathing.
• allergic reaction (hypersensitivity); sudden and potentially life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine replacement therapy, 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)).
• slow heartbeat (bradycardia).

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

• myocardial infarction, spasms of the blood vessels of the heart (these usually occur in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine replacement therapy, 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)).
• a syndrome called "serotonin syndrome" which may cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations.
• severe peeling of the skin with or without fever (toxic epidermal necrolysis).
• 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.

Contact 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 MAXALT.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MAXALT

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

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of any unused medicines and their packaging. This 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 components are lactose monohydrate, microcrystalline cellulose (E-460a), pregelatinized corn starch, iron oxide red (E-172), and magnesium stearate (E-572).

Appearance of the product and contents of the pack

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

Pack sizes: packs containing 2, 3, 6, 12 or 18 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

N.V. Organon

Kloosterstraat 6

5349 AB Oss

The Netherlands

This medicinal product is authorized 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 the most recent revision of this leaflet: 07/2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)