Ralago

Package Leaflet: Information for the Patient

Ralago, 1 mg, Tablets

Rasagiline

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ralago and what is it used for
• 2. Important information before taking Ralago
• 3. How to take Ralago
• 4. Possible side effects
• 5. How to store Ralago
• 6. Contents of the pack and other information

1. What is Ralago and what is it used for

Ralago contains the active substance rasagiline and is used in adults to treat Parkinson's disease. This medicine can be taken with or without levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a neurotransmitter in the brain that has an effect on movement control. Ralago increases and maintains dopamine levels in these areas.

2. Important information before taking Ralago

When not to take Ralago

• 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.

While taking Ralago, you must not take the following medicines:

• monoamine oxidase inhibitors (MAOIs) (used for example in the treatment of depression in Parkinson's disease or in any other indications), including medicines and herbal products available without a prescription, such as St. John's Wort - Hypericum perforatum,
• pethidine (a strong painkiller). There must be at least 14 days between stopping Ralago and starting MAOIs or pethidine.

Warnings and precautions

Before starting Ralago, discuss with your doctor:

• if you have any liver problems,
• you should inform your doctor about any worrying changes in your skin. Treatment with Ralago may increase the risk of skin cancer.

Tell your doctor if you or your family members notice any unusual behaviors in you, such as compulsions, obsessive thoughts, gambling, uncontrolled shopping or spending money, impulsive behavior, increased sexual drive, or intense sexual thoughts. These behaviors are called impulse control disorders. In patients taking Ralago and/or other medicines used to treat Parkinson's disease, such behaviors as compulsions, obsessive thoughts, pathological gambling, uncontrolled shopping, impulsive behavior, increased sexual drive, or intense sexual thoughts have been observed. Your doctor may decide to adjust the dose or stop the medicine (see section 4).
Ralago may cause drowsiness and sudden sleepiness during daily activities, especially when taken with other dopaminergic medicines (used to treat Parkinson's disease). For more information, see the section: Driving and using machines.

Children and adolescents

Ralago should not be used in children and adolescents. Therefore, Ralago is not recommended for patients under 18 years of age.

Ralago with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you are taking any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants),
• ciprofloxacin (an antibiotic used in infections),
• dextromethorphan (a cough medicine),
• sympathomimetics, such as those found in eye drops, nasal decongestants, and oral cold medicines containing ephedrine or pseudoephedrine.

Avoid taking Ralago with antidepressants containing fluoxetine or fluvoxamine.
Ralago can be started after at least 5 weeks have passed since stopping fluoxetine.
Fluoxetine or fluvoxamine can be started after at least 14 days have passed since stopping Ralago.
Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may decrease the amount of Ralago in your blood.

Ralago with food, drink, and alcohol

Ralago can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, you should avoid taking Ralago, as it is not known how Ralago affects pregnancy and the unborn baby.

Driving and using machines

Consult your doctor before driving or using machines, as Parkinson's disease and Ralago may affect your ability to perform these activities. Ralago may cause dizziness or drowsiness; it may also cause sudden sleepiness episodes.
These effects are more pronounced when taking other medicines used to treat Parkinson's disease symptoms or other medicines that cause drowsiness, or if you consume alcohol while taking Ralago. Patients who have experienced drowsiness and/or sudden sleepiness before or while taking Ralago should not drive or use machines (see section 2).

3. How to take Ralago

Always take this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
The recommended dose of Ralago is 1 tablet (1 mg) taken orally once a day. Ralago can be taken with or without food.

Overdose of Ralago

If you think you have taken more tablets than you should, contact your doctor or pharmacist immediately.
Take the Ralago package/blister with you to show the doctor or pharmacist.
Symptoms reported after overdose of Ralago included slightly euphoric mood (mild mania), extremely high blood pressure, and serotonin syndrome (see section 4).

Missing a dose of Ralago

Do not take a double dose to make up for a forgotten dose. Take the next dose of Ralago at the usual time.

Stopping Ralago treatment

Do not stop taking Ralago without consulting your doctor first.
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.
If you experience any of the following symptoms, contact your doctor immediately.You may need urgent medical advice or treatment:

• if you experience unusual behaviors, such as compulsions, obsessive thoughts, gambling, uncontrolled shopping, impulsive behavior, increased sexual drive, or intense sexual thoughts (impulse control disorders, see section 2)
• if you see or hear things that are not there (hallucinations)
• if you experience any of the following symptoms: hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome)

Consult your doctorif you notice any suspicious skin changes, as treatment with this medicine may increase the risk of skin cancer (melanoma) (see section 2).
Other side effects
Very common side effects (may affect more than 1 in 10 people)

• involuntary body movements (dyskinesia)
• headache

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

• abdominal pain
• falls
• allergic reaction
• fever
• flu
• malaise (weakness)
• neck pain
• chest pain (angina pectoris)
• low blood pressure when standing up with symptoms similar to dizziness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• bloating with gas
• abnormal blood test results (leukopenia)
• joint pain
• musculoskeletal pain (musculoskeletal pain)
• arthritis
• numbness and weakness of hand muscles (carpal tunnel syndrome)
• weight loss
• nightmares
• impaired coordination of muscle groups (balance disorders)
• depression
• dizziness
• prolonged muscle tension (dystonia)
• runny nose (rhinitis)
• skin irritation (dermatitis)
• rash
• eye redness (conjunctivitis)
• sudden urge to urinate

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

• stroke
• heart attack
• blistering rash (vesiculobullous rash)

Frequency not known: cannot be estimated from the available data

• high blood pressure
• excessive drowsiness
• sudden sleepiness

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ralago

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 packaging after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ralago contains

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

What Ralago looks like and contents of the pack

White to almost white with possible darker spots, round, slightly convex tablets with beveled edges; tablet diameter: 7 mm
Packaging:10, 14, 28, 30, 56, 60, 84, and 90 tablets, in a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For more information about this medicine, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: