Document: Rasagiline Orion 1 mg tablet ENG PL change

• Rasagiline Orion tablet PL
• Rasagiline Orion 1 mg tablet ENG PL

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Package leaflet: Information for the user

Rasagiline Orion 1 mg tablets

rasagiline

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 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 Rasagiline Orion is and what it is used for

Rasagiline Orion is used for the treatment of Parkinson’s disease. It can be used together with or without Levodopa (another medicine that is used to treat Parkinson’s disease).

With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. Rasagiline Orion helps to increase and sustain levels of dopamine in the brain.

2. What you need to know before you take Rasagiline Orion

Do not take Rasagiline Orion

• 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 Orion:

• 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 Orion treatment and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rasagiline Orion

• If you have mild to moderate liver problems

• You should speak with your doctor about any suspicious skin changes.

Children and adolescents

Rasagiline Orion is not recommended for use under the age of 18.

Other medicines and Rasagiline Orion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines and if you are smoking or intend to stop smoking.

Ask your doctor for advice before taking any of the following medicines together with Rasagiline Orion:

• 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 Orion together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline Orion, 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 Orion treatment.

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 medications 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.

Rasagiline Orion with food and drink

Rasagiline Orion may be taken with or without food.

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.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Ask your doctor for advice prior to driving or using machines.

3. How to take Rasagiline Orion

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

The recommended dose of Rasagiline Orion is 1 tablet of 1 mg taken by mouth once daily. Rasagiline Orion may be taken with or without food.

If you take more Rasagiline Orion than you should

If you think that you may have taken too many Rasagiline Orion tablets, contact your doctor or pharmacist immediately. Take the Rasagiline Orion carton/bottle with you to show the doctor or pharmacist.

If you forget to take Rasagiline Orion

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.

If you stop taking Rasagiline Orion

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

If you have any further questions on the use of this medicine, 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 have been reported in placebo controlled clinical trials.

Very common side effects (may affect more than 1 in 10 people)

• Abnormal movements (dyskinesia)

• Headache.

Common side effects (may affect up to 1 in 10 people)

• Abdominal pain

• Fall

• Allergy

• Fever

• Flu (influenza)

• General feeling of being unwell (malaise)

• Neck pain

• Chest pain (angina pectoris)

• Low blood pressure when rising to a standing position with symptoms like dizziness/light-headedness (orthostatic hypotension)

• Decreased appetite

• Constipation

• Dry mouth

• Nausea and vomiting

• Flatulence

• Abnormal results of blood tests (leucopenia)

• Joint pain (arthralgia)

• Musculoskeletal pain

• Joint inflammation (arthritis)

• Numbness and muscle weakness of the hand (carpal tunnel syndrome)

• Decreased weight

• Abnormal dreams

• Difficulty in muscular coordination (balance disorder)

• Depression

• Dizziness (vertigo)

• Prolonged muscle contractions (dystonia)

• Runny nose (rhinitis)

• Irritation of the skin (dermatitis)

• Rash

• Bloodshot eyes (conjunctivitis)

• Urinary urgency.

Uncommon side effects (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident)

• Heart attack (myocardial infarction)

• Blistering rash (vesiculobullous rash).

In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials. Nevertheless, scientific evidence suggests that Parkinson’s disease, and not any medicine in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). You should speak with your doctor about any suspicious skin changes.

Parkinson's disease is associated with symptoms of hallucinations and confusion. In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with Rasagiline Orion.

There have been cases of patients who, while taking one or more medications for the treatment of Parkinson’s disease, were unable to resist the impulse, drive or temptation to perform an action that could be harmful to themselves or others. These are called impulse control disorders. In patients taking rasagiline and/or other medications used to treat Parkinson’s disease, the following have been observed:

• Obsessive thoughts or impulsive behaviour

• Strong impulse to gamble excessively despite serious personal or family consequences

• Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

• Uncontrollable excessive shopping or spending.

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rasagiline Orion

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

Do not store above 30 ºC.

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

What Rasagiline Orion contains

• The active substance is rasagiline. Each tablet contains rasagiline tartrate equivalent to 1 mg rasagiline

• The other ingredients are trehalose dihydrate, pregelatinised starch, colloidal anhydrous silica, anhydrous citric acid, talc, stearic acid, microcrystalline cellulose, croscarmellose sodium.

What Rasagiline Orion looks like and contents of the pack

Round, white or almost white tablets with diameter of 8 mm.

Pack sizes: 7, 10, 28, 30, 100 and 112 tablets in blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

<[To be completed nationally]>

Manufacturer

<[To be completed nationally]>

This leaflet was last revised in 16 May 2016.