Rasagiline 1 mg Tablets

• 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 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.

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

• If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6)
• If you have severe liver problems.

Do not take the following medicines while taking Rasagiline:

• Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.
• Pethidine (a strong pain killer).

You must wait at least 14 days after stopping Rasagiline treatment before starting treatment with MAO inhibitors or pethidine.

Talk to your doctor before taking Rasagiline

• If you have any liver problems
• You should speak with your doctor about any suspicious skin changes. Treatment with Rasagiline may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others. These are called impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson’s disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson’s disease). For further information please refer to section driving and using machines.

There is no relevant use of rasagiline in children and adolescents. Therefore, Rasagiline is not recommended for use under the age of 18.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,

Especially tell your doctor if you are taking any of the following medicines:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• The antibiotic ciprofloxacin used against infections
• The cough suppressant dextromethorphan
• Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine

The use of Rasagiline together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline, you should wait at least 5 weeks after stopping fluoxetine treatment.

If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline treatment.

Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of rasagiline in the blood.

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.

You should avoid taking rasagiline if you are pregnant, as the effects of rasagiline on pregnancy and the unborn child are not known

Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as well as the treatment with rasagiline may influence your ability to do so. Rasagiline can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.

This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking rasagiline. If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking rasagiline do not drive or operate machinery (see section 2).

If you think that you may have taken too many Rasagiline tablets, contact your doctor or pharmacist immediately. Take the Rasagiline carton/blister or bottle with you to show the doctor or pharmacist. Symptoms reported following overdose of rasagiline included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).

Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is time to take it.

Do not stop taking Rasagiline without first talking to your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as tartrate).
• The other ingredients are microcrystalline cellulose, citric acid, pregelatinised starch, colloidal anhydrous silica, stearic acid, talc.

Rasagiline tablets are presented as white to off-white, circular, flat tablets with "771" debossed on one side and "G" on other side, approximately 8 mm in diameter.

The tablets are available in blister packs of 7, 10, 28, 30, 60, 100 and 112 tablets or in a bottle containing 28 and 30 tablets.

Not all pack sizes may be marketed.

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