Rizatriptan MSD 10 mg, orodispergeerbare tabletten

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

RIZATRIPTAN is used to treat the headache phase of the migraine attack in adults.

Treatment with RIZATRIPTAN:

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

Do not take RIZATRIPTAN if:

• you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of RIZATRIPTAN
• you have moderately severe or severe high blood pressure, or mild high blood pressure that is not controlled by medication
• you have or have ever had heart problems including heart attack or pain on the chest (angina) or you have experienced heart disease related signs
• you have severe liver or severe kidney problems
• you have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attack TIA)
• you have blockage problems with your arteries (peripheral vascular disease)
• you are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline (drugs against depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAO inhibitors
• you are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other drug in the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see Taking with other medicines below).

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

Take special care with RIZATRIPTAN if you:

Before you take RIZATRIPTAN, tell your doctor or pharmacist, if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you smoke or you are using nicotine substitution, 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 particular problem with the way your heart beats (bundle branch block)
• you have or have had any allergies
• your headache is associated with dizziness, difficulty in walking, lack of coordination or weakness in the leg and arm
• you use herbal preparation containing St. John's wort
• you have had allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression.
• you have had short lived symptoms including chest pain and tightness.

If you take RIZATRIPTAN too often this may result in you getting a chronic headache. In such cases you should contact your doctor as you may have to stop taking RIZATRIPTAN.

Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take RIZATRIPTAN only for a migraine attack. RIZATRIPTAN should not be used to treat headaches that might be caused by other, more serious conditions.

Please tell your doctor if you are taking or have recently taken or plan to take, any other medicines including medicines obtained without a prescription. This includes herbal medicines and those you normally take for a migraine. This is because RIZATRIPTAN can affect the way some medicines work. Also, other medicines can affect RIZATRIPTAN.

Taking with other medicines

Do not take RIZATRIPTAN:

• if you are already taking a 5-HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.
• if you are taking a monoamine oxidase (MAO) inhibitor such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it has been less than two weeks since you stopped taking an MAO inhibitor.
• if you use ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine
• if you use methysergide to prevent a migraine attack.

The above listed medicines when taken with RIZATRIPTAN may increase the risk of side effects.

You should wait at least 6 hours after taking RIZATRIPTAN before you take ergotamine-type medications such as ergotamine or dihydro-ergotamine or methysergide.

You should wait at least 24 hours after taking ergotamine- type medications before taking RIZATRIPTAN.

Ask your doctor for instructions and the risks about taking RIZATRIPTAN

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

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

Taking RIZATRIPTAN with food and drink:

RIZATRIPTAN can take longer to work if it is taken after food. Although it is better to take it on an empty stomach, you can still take it if you have eaten.

Pregnancy and breast-feeding

It is not known whether RIZATRIPTAN is harmful to an unborn baby when taken by a pregnant woman.

Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant or are breastfeeding. Breastfeeding should be avoided for 24 hours after treatment.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children

The use of RIZATRIPTAN oral lyophilisates in children under 18 years of age is not recommended.

Use in patients older than 65 years

There have been no full studies to look at how safe and effective RIZATRIPTAN is amongst patients older than 65 years.

Driving or using machines

You may feel sleepy or dizzy while taking RIZATRIPTAN. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of RIZATRIPTAN

RIZATRIPTAN MSD 5 mg, orodispergeerbare tabletten

Phenylketonuric patients: Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Each 5-mg RIZATRIPTAN oral lyophilisate contains 1.88 mg of aspartame (which contains phenylalanine).

RIZATRIPTAN MSD 10 mg, orodispergeerbare tabletten

Phenylketonuric patients: Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Each 10-mg RIZATRIPTAN oral lyophilisate contains 3.75 mg of aspartame (which contains phenylalanine).

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

Always take RIZATRIPTAN exactly as your doctor has told you. You should check with your doctor or your pharmacist if you are not sure.

The usual 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 leave at least 2 hours between taking propranolol and RIZATRIPTAN up to a maximum of 2 doses in a 24-hour period.

If migraine returns within 24 hours

In some patients, migraine symptoms can return within a 24-hour period. If your migraine does return you can take an additional dose of RIZATRIPTAN. 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 RIZATRIPTAN during an attack, you should not take a second dose of RIZATRIPTAN for treatment of the same attack. It is still likely, however, that you will respond to RIZATRIPTAN during the next attack.

Do not take more than 2 doses of RIZATRIPTAN in a 24-hour period, (for example, do not take more than two 10-mg or 5-mg oral lyophilisates or tablets 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 oral lyophilisates

• RIZATRIPTAN (rizatriptan benzoate) is available as a 5- or 10-mg oral lyophilisate that dissolves in the mouth.
• Open the ‘RIZATRIPTAN’ oral lyophilisate blister pack with dry hands.
• The oral lyophilisate should be placed on your tongue, where it dissolves and can be swallowed with the saliva.
• The oral lyophilisate can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.

RIZATRIPTAN is also available as a tablet to be taken with liquids.

If you take more RIZATRIPTAN than you should:

If you take more RIZATRIPTAN than you should, talk to your doctor or pharmacist straight away. Take the medicine pack with you.

Signs of overdosage can include dizziness, drowsiness, vomiting, fainting and slow heart rate.

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

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

In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Common (affects 1 to 10 users in 100)

• tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), decreased mental sharpness, tremor.
• fast or irregular heart beat (palpitation), very fast heartbeat (tachycardia).
• flushing (redness of the face lasting a short time), hot flushes, sweating.
• throat discomfort, difficulty breathing (dyspnoea).
• feeling sick (nausea), dry mouth, vomiting, diarrhoea.

• feeling of heaviness in parts of the body.
• pain in abdomen or chest.

Uncommon (affects 1 to 10 users in 1000)

• bad taste in your mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision.
• confusion, insomnia, nervousness.
• high blood pressure (hypertension); thirst, indigestion (dyspepsia).
• rash; itching and lumpy rash (hives); swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).
• neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness.
• changes in the rhythm or rate of the heartbeat (arrhythmia); abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).
• facial pain; muscle pain.

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

• fainting (syncope).
• wheezing.
• allergic reaction (hypersensitivity); sudden life-threatening allergic reaction (anaphylaxis).
• stroke (this generally occurs in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, man over 40 years of age, postmenopausal women, particular problem with the way your heart beats (bundle branch block)).
• slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from the available data):

• heart attack, spasm of the blood vessels of the heart (these generally occur in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, man over 40 years of age, postmenopausal women, particular problem with the way your heart beats (bundle branch block)).
• a syndrome called "serotonin syndrome" that may cause side effects like coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation, and hallucinations.
• severe shedding of the skin with or without fever (toxic epidermal necrolysis).
• seizure (convulsions/fits).
• spasm of blood vessels of the extremities including coldness and numbness of the hands or feet.
• spasm of the blood vessels of the colon (large bowel), which can cause abdominal pain.

Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke.

In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking RIZATRIPTAN.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep RIZATRIPTAN out of the reach and sight of children.

Do not use RIZATRIPTAN after the expiry date which is stated on the carton/carrying case/sachet/blister after "EXP". The expiry date refers to the last day of the month.

Do not store RIZATRIPTAN oral lyophilisates above 30C.

Store in the original packaging in order to protect from moisture.

Do not remove the oral lyophilisate blister from the outer aluminium sachet until you are ready to take the medicine inside. Do not use the medicine if the aluminium sachet is damaged.

Always keep the aluminium sachets in the carrying case.

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

What RIZATRIPTAN contains

RIZATRIPTAN MSD 5 mg, orodispergeerbare tabletten

The active substance of RIZATRIPTAN is rizatriptan. One oral lyophilisate contains 5 mg rizatriptan as 7.265 mg of rizatriptan benzoate.

RIZATRIPTAN MSD 10 mg, orodispergeerbare tabletten

The active substance of RIZATRIPTAN is rizatriptan. One oral lyophilisate contains 10 mg rizatriptan as 14.53 mg of rizatriptan benzoate.

The other ingredients of RIZATRIPTAN oral lyophilisates are: gelatin, mannitol (E421), glycine, aspartame (E951), and peppermint flavour (composed of peppermint oil, maltodextrin, and dextrin).

What RIZATRIPTAN looks like and contents of pack

RIZATRIPTAN MSD 5 mg, orodispergeerbare tabletten

5 mg oral lyophilisates are white to off-white, round with a modified triangle on one side, with a peppermint flavour.

RIZATRIPTAN MSD 10 mg, orodispergeerbare tabletten

10 mg oral lyophilisates are white to off-white, round with a modified square on one side, with a peppermint flavour.

Pack sizes: Packs with 2, 3, 6, 12 or 18 oral lyophilisates

Not all pack sizes may be marketed.
In het register ingeschreven onder nummer:
Rizatriptan MSD 5 mg, orodispergeerbare tabletten	-	RVG 113373
Rizatriptan MSD 10 mg, orodispergeerbare tabletten	-	RVG 113374
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder		Manufacturer

MERCK SHARP & DOHME B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

MERCK SHARP & DOHME B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

RIZATRIPTAN 5 mg Oral Lyophilisate
Italy	RIZATRIPTAN MSD RPD 5 mg
Netherlands	RIZATRIPTAN MSD 5 mg
Portugal	RIZATRIPTANO RPD MSD 5 mg
RIZATRIPTAN 10 mg Oral Lyophilisate
Italy	RIZATRIPTAN MSD RPD 10 mg
Netherlands	RIZATRIPTAN MSD 10 mg
Portugal	RIZATRIPTANO RPD MSD 10 mg
Spain	RIZATRIPTAN MAX MSD 10 mg
This leaflet was last approved in juli 2013.