5 mg and 10 mg tablets
rizatriptan

What Maxalt is and what it is used for

MAXALT belongs to a class of drugs called selective serotonin 5HT 1B / 1D – receptor agonists.

Maxalt is used to treat the headache phase of migraine attacks in adults.

Treatment with Maxalt reduces the swelling of the blood vessels that surround the brain. This swelling causes headaches during a migraine attack.

What you need to know before taking 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 moderate or severe high blood pressure, or if you have slightly elevated blood pressure that is not treated with medication
  • if you have or have ever had heart problems including heart attack or chest pain (angina) or if you have had symptoms of heart disease
  • if you have severe liver or kidney disease
  • if you have had a stroke (stroke) or mini- stroke ( transient ischemic attack, TIA )
  • if you have problems with blood clots in your blood vessels ( peripheral vascular disease)
  • if you are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine or pargylin (antidepressants), or linezolid (an antibiotic ) or if it has been less than two weeks since you stopped using MAO inhibitors
  • if you are currently taking ergotamine-type medicines, such as ergotamine or dihydroergotamine, to treat your migraine or methysergide to prevent migraine attacks
  • if you are using another medicine from the same group, such as sumatriptan, naratriptan or zolmitriptan, to treat your migraine (see Other medicines and Maxalt below).

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

Warnings and cautions

Before taking Maxalt, tell your doctor or pharmacist

  • you have any of the following risk factors for heart disease: high blood pressure , diabetes , you are a smoker or use nicotine replacement therapy, there are cases of heart disease in the family, you are a man and over 40 years or you are a woman and have passed menopause
  • you have impaired kidney or liver function
  • you have a special type of heart rhythm problem (branch block)
  • you have or have had any type of allergy
  • your headache is associated with dizziness, difficulty walking, coordination difficulties or weakness in the arms and legs
  • you are using any herbal remedy that contains St. John’s wort
  • you have had an allergic reaction such as swelling of the face, lips, tongue and / or throat which may cause shortness of breath and / or difficulty swallowing ( angioedema )
  • you take 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 had short-term symptoms including chest pain and tightness.

If you take Maxalt too often, it may result in you getting a chronic headache. In these cases, contact your doctor as you may need to stop taking Maxalt.

Describe your symptoms to your doctor or pharmacist. Your doctor can determine if you are suffering from migraines. You should only take Maxalt in case of a migraine attack. Maxalt should not be used to treat headaches that may be due to other more serious conditions.

Tell your doctor if you are taking, have recently taken, or plan to take any other medicines, including medicines obtained without a prescription. This also applies to herbal remedies and the medications you normally take for your migraine. This is because Maxalt can affect the effectiveness of certain drugs. Other medicines may also affect Maxalt.

Other drugs and Maxalt

Do not take Maxalt

  • if you are already taking a 5HT 1B / 1D – receptor agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.
  • if you are using an MAOI such as moclobemide, phenelzine, tranycypromine, linezolid or pargylin or if it has been less than two weeks since you stopped using an MAOI .
  • if you are taking ergotamine-type medicines, such as ergotamine or dihydroergotamine, to treat your migraine .
  • if you are using methysergide to prevent migraine attacks.

Taking Maxalt with the medicines listed above may increase the risk of side effects.

You should wait at least 6 hours after taking Maxalt before taking ergotamine-type medicines such as ergotamine, dihydroergotamine, or methysergide.

You should wait at least 24 hours after taking ergotamine-type medicines before taking Maxalt.

Ask your doctor for advice on how to take and the risks of taking Maxalt

  • if you are taking propranolol (see section 3: How to take Maxalt).
  • if you use SSRIs such as sertraline , escitalopramoxalate and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Maxalt with food and drink

It may take longer for Maxalt to work if taken after eating. Although it is better to take it on an empty stomach, you can still take it after a meal.

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.

It is not known if Maxalt is harmful to the fetus if taken by a pregnant woman.

Breast-feeding should be avoided 24 hours after treatment.

Children and young people

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

Use in patients older than 65 years

There are no complete studies of how safe and effective Maxalt is in patients older than 65 years.

Driving and using machines

You may feel drowsy or dizzy when using Maxalt. Do not drive or use any tools or machines if this happens.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Maxalt contains lactose monohydrate

The 5 mg tablet contains 30.25 mg of lactose monohydrate and the 10 mg tablet contains 60.50 mg of lactose monohydrate.

If your doctor has told you that you are hypersensitive to certain sugars, contact your doctor before taking this medicine.

How to take Maxalt

Maxalt is used to treat migraine attacks. Take Maxalt as soon as possible after your migraine attack. Do not use it to prevent an attack.

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose is 10 mg.

If you are currently using propranolol or have impaired kidney or liver function, you should use a 5 mg dose of one of Maxalt. There should be at least two hours between taking propranolol and Maxalt up to a maximum of 2 doses over 24 hours.

Maxalt (rizatriptan benzoate) tablets should be taken by mouth and swallowed whole with liquid.

Maxalt is also available as 5 and 10 mg lyophilized tablets, respectively, that dissolve in the mouth. These lyophilized tablets can be used when liquid is not available, or to avoid nausea and vomiting caused by taking tablets with liquid.

If migraine one returns within 24 hours

In some patients, migraine symptoms may return within 24 hours. If your migraine returns, you can take another dose. You should always allow at least two hours between doses.

If you still have migraines after two hours

If you do not respond to the first dose of Maxalt during an attack, do not take a second dose of Maxalt to treat the same attack. However, you will likely respond to Maxalt during the next attack.

Do not take more than two doses of Maxalt during the same 24-hour period (for example, do not take more than two 10 mg or 5 mg tablets or lyophilized tablets during 24 hours). There should be at least two hours between the dose limits.

Seek care if your condition worsens.

Possible side effects

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

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

Common (affects less than 1 in 10 people)

  • ant crawling ( paresthesias ), headache, decreased sensitivity to skin touch ( hypesthesia ), decreased mental acuity, insomnia
  • fast or irregular heartbeat ( palpitation )
  • redness (short-lived in the face)
  • difficulty swallowing
  • nausea, dry mouth , vomiting, diarrhea, stomach upset ( dyspepsia )
  • feeling of heaviness in parts of the body, neck pain, stiffness
  • abdominal or chest pain.

Uncommon (affects less than 1 in 100 people)

  • bad taste in the mouth
  • unsteady gait ( ataxia ), dizziness (dizziness), blurred vision, tremors, fainting ( syncope )
  • confusion, nervousness
  • high blood pressure ( hypertension ), thirst, feeling hot, sweating
  • skin rash, itching and raised rash (hives), swelling of the face, lips, tongue and / or throat which may cause shortness of breath and / or difficulty swallowing ( angioedema ), shortness of breath ( dyspnoea )
  • feeling of tightness in parts of the body, muscle weakness
  • changes in heart rate or rate ( arrhythmia ), abnormalities on ECG (examination of the heart’s electrical activity), very fast heart rate ( tachycardia )
  • facial pain, muscle pain.

Rare (affects less than 1 in 1,000 people)

  • wheezing
  • allergic reaction (hypersensitivity), sudden life-threatening allergic reaction ( anaphylaxis )
  • stroke (this most often occurs in patients with risk factors for cardiovascular disease (high blood pressure , diabetes , smoking, use of nicotine replacement therapy, heart disease or stroke in the family, men over 40 years, postmenopausal women, special heart rhythm disorders (branch block))
  • slow heartbeat ( bradycardia ).

Has been reported (occurs in an unknown number of users)

  • myocardial infarction, spasm of the blood vessels of the heart (these usually occur in patients with risk factors for cardiovascular disease (high blood pressure , diabetes , smoking, use of nicotine replacement therapy, heart disease or stroke in the family, men over 40 years, postmenopausal women, special heart rhythm disorders) ))
  • a so-called serotonergic syndrome that can cause side effects such as coma , unstable blood pressure , extremely high body temperature, disturbance in the coordination of muscle movements, anxiety and hallucinations
  • severe skin rash with or without fever ( toxic epidermal necrolysis )
  • cramp (seizure)
  • spasm of blood vessels in the arms and legs including feeling cold and numbness of the hands and feet
  • spasm in the blood vessels of the colon which can cause abdominal pain.

Contact a doctor immediately if you experience symptoms of an allergic reaction, serotonergic heart attack, or stroke.

Also, contact your doctor if you notice any symptoms that may indicate an allergic reaction (such as a rash or itching ) after taking Maxalt.

How to store 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 expiration date is the last day of the specified month.

Store Maximum at a maximum of 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 to protect the environment.

Contents of the pack and other information

Content declaration

The active substance in Maxalt is rizatriptan. One tablet contains 5 and 10 mg of rizatriptan, respectively, corresponding to 7.265 and 14.53 mg of rizatriptan benzoate, respectively.

The other ingredients in Maxalt are lactose monohydrate, microcrystalline cellulose (E460a), pregelatinized starch, red iron oxide (E172), and magnesium stearate (E572).

What the medicine looks like and contents of the pack

The 5 mg tablets are light pink, capsule-shaped, and have the code MSD on one side and 266 on the other.

The 10 mg tablets are light pink, capsule-shaped, and have the coded MAXALT on one side and MSD 267 on the other.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

NV Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

Manufacturer

Merck Sharp & Dohme BV.

Waarderweg 39

2031 BN Haarlem

Netherlands

dpoc.sweden@organon.com

This medicinal product is authorized under the European Economic Area under the names:

Maximum 5 mg tablets
Austria, Finland, France, Greece, Iceland, the Netherlands, Norway, Poland, Sweden, the United Kingdom MAXALT
Belgium, Luxembourg MAXALT 5 mg
Czech Republic MAXALT 5mg, tablets
Denmark MAXALT, tablets
Germany MAXALT 5 mg tablets
Ireland Rizatriptan MSD 5 mg Tablets
Italy MAXALT 5 mg compress
Romania MAXALT 5 mg compress
Maximum 10 mg tablets
Austria, Finland, France, Greece, Iceland, the Netherlands, Norway, Poland, Portugal, Sweden, the United Kingdom MAXALT
Belgium, Luxembourg, and Spain MAXALT 10 mg
Czech Republic MAXALT 10 mg, tablets
Denmark MAXALT, tablets
Germany MAXALT 10 mg Tablets
Ireland Rizatriptan MSD 10 mg Tablets
Italy MAXALT 10 mg compress
Romania MAXALT 10 mg compress

Muhammad Nadeem

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