RIZATRIPTAN 10 MG TABLETS - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rizatriptan 5 mg Tablets

Rizatriptan 10 mg Tablets rizatriptan

Read all of this leaflet carefully before you start taking this medicine.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet

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

• 2. Before you take Rizatriptan

• 3. How to take Rizatriptan

• 4. Possible side effects

• 5. How to store Rizatriptan

• 6. Further information

1. what rizatriptan is and what it is used for

Rizatriptan are used to treat migraine attacks. Do not use them to prevent an attack.

Rizatriptan belongs to a class of medicines called selective serotonin 5-HT receptor agonists.

Your doctor has prescribed Rizatriptan to treat the headache phase of your migraine attack.

Treatment with Rizatriptan:

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

• 2. BEFORE YOU TAKE RIZATRIPTAN

Do not take Rizatriptan if you :

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

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 post-menopausal 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 co-ordination or weakness in the leg or 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.

Use in children and adolescents

There is no experience with the use of Rizatriptan in children and adolescents under 18 years of age, therefore children and adolescents should not be given Rizatriptan.

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.

Taking other medicines

Please tell your doctor or pharmacist 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.

Do not take Rizatriptan if you :

• are already taking a 5HT1B/1D agonist (sometimes referred to as ‚triptans‘), such as sumatriptan, naratriptan or zolmitriptan.
• 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.
• use ergotamine-type medicines such as ergotamine or dihydro-ergotamine to treat your migraine.
• 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 medicines such as ergotamine or dihydro-ergotamine or methysergide.

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

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.

Driving and 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 contains aspartame (E951). Aspartame contains a source of phenylalanine and this may be harmful for people with phenylketonuria.

3. how to take rizatriptan

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 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. You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Take Rizatriptan as soon as possible after your migraine headache has started.

Rizatriptan should be taken by mouth and swallowed whole with liquid.

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 overdose 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, Rizatriptan can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

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.

In 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 (hypaesthesia), 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)

• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension); thirst, indigestion (dyspepsia),
• itching and lumpy rash (hives),
• neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness

Rare (affects 1 to 10 users in 10000)

• bad taste in your mouth,
• fainting (syncope), 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
• facial pain, wheezing
• allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema); rash, severe shedding of the skin including accompanied by fever (toxic epidermal necrolysis).
• heart attack, spasm of blood vessels of the heart, stroke. They 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]).

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

• 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
• muscle pain
• changes in the rhythm or rate of the heartbeat (arrhythmia), slow heartbeat (bradycardia), abnormalities of the electrocardiogram (a test that records the electrical activity of your heart)

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.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. how to store rizatriptan

Keep Rizatriptan out of the reach and sight of children.

Do not use Rizatriptan after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of the month.

This medicinal product does not require any special storage conditions.

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

• 6. FURTHER INFORMATION

What Rizatriptan contains

The active substance of Rizatriptan is rizatriptan.

One 5 mg tablet contains 5 mg rizatriptan as 7.265 mg of rizatriptan benzoate

One 10 mg tablet contains 10 mg rizatriptan as 14.53 mg of rizatriptan benzoate.

The other ingredients of Rizatriptan tablets are mannitol, microcrystalline cellulose (E460a), crospovidone, aspartame (E951), magnesium stearate (E572), Colloidal Silicon Dioxide, peppermint flavor (contains modified food starch).

What Rizatriptan looks like and contents of pack

5 mg tablets are white to off white, approximately 7 mm round, flat, beveled edged uncoated tablets, engraved with ‚467‘ on one side and plain on other side.

10 mg tablets are white to off white, approximately 9mm round, flat, beveled edged uncoated tablets, engraved with ‚468‘ on one side and plain on other side

The tablets are packed in Aluminium/Aluminium blisters.

5 mg Pack sizes: Packs with 3, 6, or 18 tablets.

10 mg Pack sizes: Packs with 3, 6, 12 or 18 tablets.

Not all pack sizes may be marketed.

Rizatriptan is also available as an orodispersible tablet that dissolves in the mouth.

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2 B Draycott Avenue,

Kenton,

Middlesex,

HA3 0BU

UK

Manufacturer

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park,

Croxley Green

Hertfordshire, WD18 8YA

United Kingdom

Glenmark Pharmaceuticals s.r.o.

FiMchova 143, 566 17 Vysoke Myto

Czech Republic

This leaflet was last revised in : 04/2013

SPECIFICATION: 40gsm Bible Paper

Font: 9pt. Times New Roman

Vlaftfaif v.1