MAXALT MELT 10 MG - patient leaflet, side effects, dosage

Patient leaflet - MAXALT MELT 10 MG

Maxalt Melt 10 mg

(rizatriptan)

Your medicine is known by the above name, but will be referred to as Maxalt® Melt throughout this leaflet

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 further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. what maxalt® melt is and what it is used for

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

Maxalt® Melt is used to treat the headache phase of the migraine attack in adults.

Treatment with Maxalt® Melt:

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

2. what you need to know before you take maxalt® melt

Do not take Maxalt® Melt if:

you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6)
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 Other medicines and Maxalt® Melt below).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Maxalt® Melt, 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 Maxalt® Melt 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 Maxalt® Melt.

Tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take Maxalt® Melt only for a migraine attack. Maxalt® Melt should not be used to treat headaches that might 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, including medicines obtained without a prescription. This includes herbal medicines and those you normally take for a migraine. This is because Maxalt® Melt can affect the way some medicines work. Also, other medicines can affect Maxalt® Melt.

Other medicines and Maxalt® Melt

Do not take Maxalt® Melt:

if you are already taking a 5-HT1 B/1 D 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 dihydroergotamine to treat your migraine
if you use methysergide to prevent a migraine attack.

The above listed medicines when taken with Maxalt® Melt may increase the risk of side effects.

You should wait at least 6 hours after taking Maxalt® Melt 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 Maxalt® Melt.

Ask your doctor for instructions and the risks about taking Maxalt® Melt

if you are taking propranolol (see section 3: How to take Maxalt® Melt)
if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or 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, including medicines obtained without a prescription.

Maxalt® Melt with food and drink

Maxalt® Melt 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

If you are pregnant or breast-feeding, 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 whether Maxalt® Melt is harmful to an unborn baby when taken by a pregnant woman. Breastfeeding should be avoided for 24 hours after treatment.

Children and adolescents

The use of Maxalt® Melt 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 Maxalt® Melt is amongst patients older than 65 years.

Driving or using machines

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

Maxalt® Melt contains aspartame

This medicine contains 3.75 mg aspartame in each 10 mg oral lyophilisate which is equivalent to 2.1 mg phenylalanine.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

3. how to take maxalt® melt

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

Always take this medicine exactly as your doctor has told you. Check with your doctor or 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 Maxalt® Melt. You should leave at least 2 hours between taking propranolol and Maxalt® Melt 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 Maxalt® Melt. 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® Melt during an attack, you should not take a second dose of Maxalt® Melt for treatment of the same attack. It is still likely, however, that you will respond to Maxalt® Melt during the next attack.

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

– Maxalt® Melt (rizatriptan benzoate) is available as a 5 or 10 mg oral lyophilisate that dissolves in the mouth.
– Open the Maxalt® Melt 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.

Maxalt® Melt is also available as a tablet to be taken with liquids.

If you take more Maxalt® Melt than you should:

If you take more Maxalt® Melt 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.

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 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, insomnia
fast or irregular heart beat (palpitation)
flushing (redness of the face lasting a short time)
throat discomfort
feeling sick (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
feeling of heaviness in parts of the body, neck pain, stiffness
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, tremor, fainting (syncope)
confusion, nervousness
high blood pressure (hypertension); thirst, hot flushes, sweating
rash, itching and lumpy rash (hives); swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea)
feeling of tightness in parts of the body, 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), very fast heartbeat (tachycardia)
facial pain; muscle pain.

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

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.

5. how to store maxalt® melt

Keep your wafers out of the sight and reach of children.

Do not use after the expiry date, which is stated on the packaging. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original packaging in order to protect from moisture.

Do not remove the wafers from its blister or the aluminium sachet until you are ready to take it. 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.

If the medicine becomes discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

6. contents of the pack and other information

The name of your medicine is Maxalt® Melt 10mg. Maxalt® Melt 10mg is a freeze-dried wafer (referred to technically as an ‘oral lyophilisate’), which dissolves in the mouth.

Each Maxalt® Melt 10mg tablet contains 14.53mg rizatriptan benzoate equivalent to 10mg rizatriptan and is presented as white to off-white, round, peppermint flavoured wafers embossed with a rounded square. Other ingredients are: gelatine, mannitol (E421), glycine, aspartame (E951) and peppermint flavour (composed of peppermint oil, maltodextrin and dextrin).

Maxalt® Melt is available in packs containing 3 or 6 wafers.

Maxalt® Melt is manufactured by Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands. Procured from within the EU and repackaged by the Product Licence Holder: Beachcourse Limited., 20 Alliance Court, Alliance Road, London W3 ORB, UK.

Revision date: 12.10.2020

PL 16378/0632 |POM|

Maxalt® is a registered trademark of Merck Sharp & Dohme Corp., USA.

How can you obtain more information about Maxalt® Melt?

This leaflet gives you some of the most important information about Maxalt® Melt. If you have any questions after you have read it, ask your doctor or pharmacist who can give you further information.

Further information about migraine is available from the following organisations:

Migraine Action Association

4th Floor, 27 East Street

Leicester

LE1 6NB

Tel: 08456 011 033

Email:

and

The Migraine Trust

4th Floor

Mitre House

44–46 Fleet Street

London

EC4Y 1BN

Tel: 0203 9510 150

(Migraine Action Association and The Migraine Trust are independent organisations and are not associated with Merck Sharp & Dohme Limited.)

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Beachcourse,

Tel: 020 8896 9054 for help.