Rizatriptan disp 10 mg ratiopharm, orodispergeerbare tabletten

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

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

Treatment with Rizatriptan-CT:

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

Rizatriptan-CT is used to treat migraine attacks. Do not use it to prevent an attack.

Do not take Rizatriptan-CT

• if you are allergic to rizatriptan 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 (medicines agains 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 medicines, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other medicine 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-CT.

Warnings and precautions

Talk to your doctor or pharmacist before you take Rizatriptan-CT. 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)
• 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 the 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 as this combination can cause a severe reaction (see section 4 for possible side effects).
• you have had short lived symptoms including chest or throat pain and tightness.

If you take Rizatriptan-CT 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-CT.

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

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

Children and adolecents

There is limited experience with the use of Rizatriptan-CT in children and adolecents under 18 years of age, therefore children and adolecents should not be given Rizatriptan-CT.

Other medicines and Rizatriptan-CT

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and those you normally take for a migraine. This is because Rizatriptan-CT can affect the way some medicines work. Also other medicines can affect Rizatriptan-CT.

Do not take Rizatriptan-CT:

• if you are already taking a 5HT1B/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 medicines 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-CT may increase the risk of side effects.

You should wait at least 6 hours after taking Rizatriptan-CT 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-CT.

Ask your doctor for instructions and the risks about taking Rizatriptan-CT

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

Rizatriptan-CT with food and drink

Rizatriptan-CT 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-CT 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. Your doctor will decide whether you can take this medicine if you are pregnant. Breast- feeding 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-CT. If this happens, do not drive or use any tools or machines.

Rizatriptan-CT contains aspartame (E951) and lactose

Aspartame (E951), a source of phenylalanine, may be harmful for people with phenylketonuria.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor has told you. Check with your doctor or your pharmacist if you are not sure.

The recommended 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-CT. You should leave at least 2 hours between taking propranolol and Rizatriptan-CT 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-CT. You should always wait at least 2 hours between doses.

If the first tablet does not provide any relief, do not take a second tablet.

If you do not get relief from the pain within 2 hours of taking a dose of Rizatriptan-CT, you should not take a second dose to treat the same attack.

It is still likely, however, that you will respond to Rizatriptan-CT during your next attack.

Do not take more than 2 doses of Rizatriptan-CT in a 24-hour period, You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Oral use.

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

Do not handle the orodispersible tablets with wet hands as the orodispersible tablets may break up.

1. Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.
2. Carefully peel off the backing.
3. Gently push the tablet out.
4. Put the tablet in your mouth. It will dissolve directly in your mouth, so that it can be easily swallowed.

If you take more Rizatriptan-CT than you should

If you take more Rizatriptan-CT 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 medicine ask your doctor or pharmacist.

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

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

Common (may affect up to 1 in 10 people)

• tingling (paresthesia), headache, decreased sensitivity of skin (hypesthesia), 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, rash,
• throat discomfort, difficulty breathing (dyspnoea),
• feeling sick (nausea), dry mouth, vomiting, diarrhea,
• feeling of heaviness in parts of the body,
• pain in abdomen or chest

Uncommon (may affect up to 1 in 100 people)

• 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
• hypersensitivity reaction
• allergic reaction like swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema);

Rare (may affect up to 1 in 1,000 people)

• 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

• 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))
• serious allergic reaction which causes difficulty in breathing or dizziness (anaphylaxis/anaphylactoid reaction)
• rash, severe shedding of the skin including accompanied by fever (toxic epidermal necrolysis)

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
• irregular or slower heart beat, ECG abnormalities
• pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis).
• muscle 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-CT.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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

Store in original package in order to protect from moisture.

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.

What Rizatriptan-CT contains

The active substance is rizatriptan.

The other ingredients are: Lactose monohydrate, maize starch, mannitol (E421), pregelatinized starch (maize), aspartame (E951), peppermint flavour, Silica colloidal anhydrous, sodium stearyl fumarate.

What Rizatriptan-CT looks like and contents of the pack

Rizatriptan-CT 10 mg orodispersible tablets: white to off white, round, flat orodispersible tablets with bevelled edges, embossed with ‘IZ’ on one side and ‘10’ on the other side.

2 x 1, 3 x 1, 6 x 1, 12 x 1, 18 x 1, 28 x 1, 30 x 1 orodispersible tablets in OPA/Aluminium/PVC-Aluminium perforated unit dose blisters in cartons

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Vergunninghouder ratiopharm Nederland bv Florapark 4

2012 HK Haarlem

Fabrikanten

TEVA Pharmaceutical Works Private Limited Company Pallagi út 13

4042 Debrecen Hongarije

TEVA Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82

H-2100 Gödöllő,

Hongarije

TEVA UK Ltd

Brampton Road, Hampden Park

Eastbourne, East Sussex,

BN22 9AG

Engeland

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Nederland

TEVA Santé

Rue Bellocier

89100 Sens

Frankrijk

Teva Operations Poland Sp.z.o.o. ul. Mogilska 80

31-546, Krakow Polen

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Duitsland

In het register ingeschreven onder nummer

RVG 110095

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

Germany: Rizatriptan-CT 10mg Schmelztabletten

Finland: Rizatriptan ratiopharm 10mg tabletti, suussa hajoava

Netherlands: Rizatriptan disp 10mg ratiopharm, orodispergeerbare tabletten

Spain: Rizatriptan ratiopharm 10mg comprimidos bucodispersables EFG

This leaflet was last revised in mei 2012