Patient leaflet - Rasagiline 1 mg tablets

1. What Rasagiline is and what it is used for

Rasagiline is used for the treatment of Parkinson’s disease in adults. 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 helps to increase and sustain levels of dopamine in the brain.

2. What you need to know before you take Rasagiline

Do not take Rasagiline

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.
If you are taking 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.
If you are taking pethidine (a strong pain reliever).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Rasagiline

If you have any liver problems
If you notice 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).

Use in children and adolescents

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

Other medicines and Rasagiline

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

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 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.
The antibiotic ciprofloxacin used to treat infections
The cough suppressant dextromethorphan
Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine

Tell your doctor if you are smoking or intend to stop smoking as smoking could decrease the amount of Rasagiline in the blood.

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.

You should avoid taking Rasagiline if you are pregnant, as the effects of

Rasagiline on pregnancy and the

unborn child are not known.

Driving and using machines

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, if you take other 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.

3. How to take Rasagiline

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

The recommended dose of Rasagiline is one 1 mg tablet taken orally once a day. Rasagiline may be taken with or without food.

If you take more Rasagiline than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of overdose include: slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).

If you forget to take Rasagiline

Take it as soon as you remember, unless it is time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Rasagiline

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Rasagiline 1 mg

Tablets

2014318

Rasagiline 1 mg Tabs

Package leaflet

2014318

TW235523 (design)

All

2189

9 points (Reg text)

14/10/2025 16/10/2025 28/10/2025 01/04/2026

Black C

& TW229002 (launch)

4. Possible side effects

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

Seek medical advice immediately if you develop any of the following symptoms:

Allergic reaction: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis).
If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
If you see or hear things which are not there (hallucinations).
Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome).
If you notice any suspicious skin changes because there may be an increased risk of skin cancer (melanoma) with the use of this medicine.

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

Involuntary movements (dyskinesia)
Headache

Common (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 (leukopenia)
- 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 (may affect up to 1 in 100 people)

Stroke (cerebrovascular accident)
Heart attack (myocardial infarction)
Blistering rash (vesiculobullous rash)

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

Elevated blood pressure
Excessive drowsiness
Sudden onset of sleep
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 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.

5. How to store Rasagiline

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, bottle or blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 1 mg tablets contains

Each tablet contains 1 mg rasagiline (as tartrate).

The other ingredients are: mannitol, maize starch, pregelatinised starch, hydroxypropylcellulose (E463), tartaric acid, magnesium stearate (E572), colloidal anhydrous silica.

What Rasagiline looks like and contents of the pack

White to off-white, round, flat, bevelled tablets debossed with “I” on one side and “67” on other side.

The tablets are available in blister packs of 28 tablets.

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer