RIZATRIPTAN 5 MG ORODISPERSIBLE TABLETS - patient leaflet, side effects, dosage

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 further questions, ask your doctor, pharmacist or nurse.

• – 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, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

• 1. What rizatriptan is and what it is used for

• 2. What you need to know before you take rizatriptan

• 3. How to take rizatriptan

• 4. Possible side effects

• 5. How to store rizatriptan

• 6. Contents of the pack and other information

1. what rizatriptan is and what it is used for

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. Do not use it to prevent an attack

Treatment with rizatriptan :

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 rizatriptan are allergic to rizatriptan or any of the other ingredients of this medicine (listed in

section 6).

• have moderately severe or severe high blood pressure or mild high blood pressure that

cannot be controlled by medication

• have or have ever had heart disease such as heart attack or chest pain (angina) or you

have had symptoms related to heart disease

• have severe liver or kidney problems.
• have had a stroke (CVA) or have had transient lack of oxygen in the brain (Transient

Ischemic Attack).

• have blockage problems with your arteries (peripheral vascular disease).
• are currently using 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 an MAOI
• are currently using ergotamine type medications such as ergotamine or dihydroergotamine for the treatment of migraine or methysergide in order to prevent a migraine attack.
• are taking other medicines in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine (see Other medicines and rizatriptan).
• are unsure whether one or more of the above points apply to you, please contact your

doctor or pharmacist before you start taking rizatriptan.

Warnings and precautions

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

• have any of the following risk factors for heart disease such as high blood pressure or diabetes, you smoke or you use nicotine substitutes, your family has a history of heart disease, you are a man over 40 years of age, or you are a menopausal/post-menopausal woman
• have kidney or liver problems
• have a particular problem with the way your heart beats (bundle branch block)
• have or have had allergies
• have a headache which is associated with dizziness, difficulty in walking, lack of coordination or weakness in arm and leg
• are using herbal preparations containing St. John's wort
• have had allergic reactions such as swelling of the face, lips, tongue and / or throat, which may cause difficulty in breathing and / or swallowing (angioedema)
• are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, and escitalopram oxalate, fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression
• 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, 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.

Children and adolescents upto 18 years

The use of rizatriptan in children and adolescents under 18 years is not recommended.

Other medicines and rizatriptan

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This also applies if you are using herbal medicines or medicines normally used for migraine.

Do not take rizatriptan if you are taking:

• a 5-HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan,

naratriptan or zolmitriptan.

• a monoamine oxidase (MAO) inhibitor such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it's less than two weeks ago since you stopped taking an MAO inhibitor.
• ergotamine-type medications such as ergotamine or dihydroergotamine to treat your

migraine.

• 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 ergotaminetype 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).
• SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.

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

If you are pregnant or breast-feeding, think you are pregnant or planning to have a baby. Ask your doctor or pharmacist for advice before taking this medicine.

It is not known whether rizatriptan is harmful to an unborn baby when taken by a pregnant women. Breastfeeding should be avoided for 24 hours after treatment.

Driving and using machines

Do not drive or operate machinery or any other equipment, because you may feel sleepy or dizzy after taking rizatriptan

Important information about some of the ingredients in Rizatriptan orodispersible tablets

Rizatriptan contains aspartame a source of phenylalanine which may be harmful for people with phenylketonuria. Each 5 mg tablet contains 1.0 mg of aspartame (which contains phenylalanine).

Rizatriptan also contains mannitol which may have a mild laxative effect. Each 5 mg tablet contains 45.810 mg of mannitol.

3. how to take rizatriptan

Rizatriptan is used for the treatment of migraine attacks. Take rizatriptan as soon as possible after the beginning of your migraine headache. Do not use it to prevent an migraine attack.

Always take rizatriptan exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is 10 mg.

If you are currently taking propranolol or if you have kidney or liver problems, use the 5 mg dose of rizatriptan. You should wait at least two hours between taking propranolol and rizatriptan. Do not take more than 2 doses in a 24 hour period.

Use in patients older than 65 years

There are no full studies to assess the safety and efficacy of rizatriptan in patients over 65 years.

If migraine returns within 24 hours

In some patients, migraine symptoms can return within 24 hours. If the migraine returns, you can still take a dose of rizatriptan. However, you need to wait at least 2 hours between doses.

If you still have migraine after two hours

If you do not respond to rizatriptan during an attack, you should not take a second dose for the treatment of the same attack. However, if you have not reacted to rizatriptan during a migraine attack, there is a chance 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 5 mg tablets in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, contact your doctor.

How to take Rizatriptan orodispersible tablets

• Rizatriptan (rizatriptan benzoate) is available as a 5 mg or 10 mg orodispersible tablet that dissolves in the mouth.
• Open the blister pack with dry hands.
• The orodispersible tablet should be placed on your tongue, where it dissolves and can be swallowed with the saliva.
• The orodispersible tablet 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.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In studies in adults, the most commonly reported adverse events were dizziness, sleepiness and fatigue.

The following side effects may happen with this medicine

Common (occurring in less than 1 in 10 users)

• tingling (paraesthesia), headache, decreased skin sensitivity (hypoesthesia) decreased sharpness of mind, lack of sleep (insomnia)
• heart beat (palpitations)
• flushing (transient redness of the face)
• throat symptoms
• feeling sick (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia)
• regional heaviness, neck pain, stiffness
• abdominal pain, chest pain.

Uncommon (affecting less than 1 in 100 users)

• bad taste in the mouth
• feeling of being out of balance when walking (ataxia), dizziness (vertigo), blurred vision, trembling, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flashes, sweating
• rash, itching, hives, swelling of the face, lips, tongue and / or throat which may cause difficulty in breathing and / or swallowing can cause (angioedema), shortness of breath (dyspnoea)
• regional tightness, muscle weakness
• changes in the rhythm or rate of the heartbeat (arrhythmia), derogations from the electrocardiogram (a test that measures the electrical activity of your heart), fast heart rate (tachycardia)
• facial pain, muscle pain.

Rare (occurring in less than 1 in 1,000 users)

• wheezing
• allergic reaction (hypersensitivity), sudden life-threatening allergic reaction (anaphylaxis)
• stroke (this is especially common in patients with risk factors for cardiovascular disease [high blood pressure, diabetes, smoking, use of nicotine replacement, heart disease or stroke in the family, arrhythmia (bundle), or if you are a man over 40 or a menopausal woman])
• slow heart rate (bradycardia).

Not known (based on the available data, the frequency can not be determined)

• heart attack, spasm of blood vessels of the heart (this is especially common in patients with [high blood pressure risk factors for cardiovascular disease, diabetes, smoking, use of nicotine replacement, heart disease or stroke in the family, arrhythmia (bundle), or if you are a man over 40 or a woman in menopause])
• a syndrome ‚serotonin syndrome‘ with side effects such as coma, fluctuations in blood pressure, extremely high body temperature, lack of muscle coordination, can cause agitation and hallucinations
• severe blisters on the skin / peeling of the skin with or without fever (toxic epidermal necrolysis)
• seizures (convulsions / fits)
• constriction of blood vessels in the hands and feet, with coldness and numbness
• contraction of the blood vessels in the colon, which may cause abdominal pain.

If you experience symptoms of an allergic reaction, serotonin syndrome, heart attack or stroke, contact your doctor immediately.

If you get an allergic reaction like phenomena after taking rizatriptan, such as rash or itching, you should contact your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Yellow Card Scheme By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rizatriptan

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 after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is rizatriptan. one orodispersible tablet contains 5 mg of rizatriptan as 7.265 mg of rizatriptan benzoate

• – The other ingredients are mannitol (E 421), calcium silicate (E 552), crospovidone, aspartame (E 951), peppermint flavor, silica colloidal anhydrous, sodium stearyl fumarate

What Rizatriptan orodispersible tablet looks like and contents of the pack

Rizatriptan 5 mg orodispersible tablets are white, round, flat faced beveled edge tablets, debossed with “HP” on one side and “238” on other side.

Pack size: Blister pack of 3 , 6 and 18 orodispersible tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Nexcape Pharmaceuticals Ltd

20–22 Wenlock Road

London

N1 7GU

UK

Manufacturer

Emcure Pharma UK Ltd

Basepoint Business Centre

110 Butterfield, Great Marlings

Luton, LU2 8DL

United Kingdom

Tillomed Laboratories Ltd

220 Butterfield, Great Marlings

Luton, LU2 8DL

United Kingdom

Tillomed Pharma GmbH

Manhagener Allee 36

22926, Ahrensburg

Germany

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

This leaflet was last revised in 09/2020

Only actual batch release site listed on printed leaflet