Ralago

Package leaflet: Information for the patient

Ralago, 1 mg, tablets
rasagilinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ralago is and what it is 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 Ralago is and what it is used for

Ralago contains the active substance rasagiline and is used in adults for the treatment of
Parkinson's disease. This medicine may be given either with levodopa (another medicine used in the treatment of
Parkinson's disease) or without levodopa.
In Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine
acts in the brain as a neurotransmitter influencing movement control. Ralago increases and maintains
dopamine concentration in these areas.

2. Important information before using Ralago

When not to use Ralago

• if the patient is allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver function impairment.

Ralago must not be used together with the following medicines:

• monoamine oxidase inhibitors (MAO inhibitors) (used, for example, in the treatment of depression associated with Parkinson's disease or for any other indication), including over-the-counter medicines and herbal products such as St. John's wort (Hypericum perforatum),
• pethidine (a strong painkiller). At least 14 days must pass between stopping Ralago and starting treatment with monoamine oxidase inhibitors (MAO inhibitors) or pethidine.

Warnings and precautions
Before starting Ralago, discuss with your doctor:

• if the patient has any liver function disorders,
• the patient should inform their doctor about any concerning skin changes. Treatment with Ralago may increase the risk of skin cancer.

Inform your doctor if the patient or their family notice impulsive, compulsive, or obsessive behaviours that are unusual for the patient and are difficult to control, and which may be harmful to the patient or others. These are known as impulse control disorders. In patients treated with Ralago and/or other medicines for Parkinson's disease, such behaviours have been observed, including obsessions, obsessive thoughts, pathological gambling, compulsive spending, impulsive actions, increased sexual drive, or intense sexual thoughts and feelings. Your doctor may decide to adjust the dose or discontinue the medicine (see section 4).

Ralago may cause drowsiness and sudden sleep episodes during daily activities, especially when used together with other dopaminergic medicines (used in the treatment of Parkinson's disease). Further information is provided in the section: "Driving and using machines".

Children and adolescents
Ralago is not intended for use 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

In particular, inform your doctor if the patient is taking any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants),
• ciprofloxacin (an antibiotic used for infections),
• dextromethorphan (a cough suppressant),
• sympathomimetics, such as those contained in eye drops, nasal decongestants (administered nasally or orally), and cold remedies containing ephedrine or pseudoephedrine.

Concomitant use of Ralago with antidepressants containing fluoxetine or fluvoxamine should be avoided.

Ralago treatment may be started at least 5 weeks after discontinuation of fluoxetine.

Fluoxetine or fluvoxamine treatment may be started at least 14 days after stopping Ralago.

Inform your doctor or pharmacist if the patient smokes or plans to stop smoking. Smoking may reduce the amount of Ralago in the blood.

Ralago with food, drink and alcohol
Ralago can be taken with or without food.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

If the patient is pregnant, she should avoid taking Ralago, as the effects of Ralago on pregnancy and the unborn child are unknown.

Driving and using machines
Consult your doctor before driving or operating machinery, as Parkinson's disease and treatment with Ralago may affect the ability to perform these activities. Ralago may cause dizziness or drowsiness and may also cause sudden episodes of falling asleep.

These effects may be more pronounced when other medicines used to treat symptoms of Parkinson's disease or other sedative medicines are taken, or if alcohol is consumed during treatment with Ralago. Patients who experience drowsiness and/or sudden sleep episodes, either before or during treatment with Ralago, should not drive or operate machinery (see section 2).

3. How to use Ralago

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The recommended dose of Ralago is 1 tablet (1 mg) taken orally once daily. Ralago may be taken
with food or independently of meals.
Taking more Ralago than recommended
If a patient thinks they have taken more Ralago tablets than recommended, they should
immediately contact a physician or pharmacist. The packaging/blister of Ralago should be brought
along to show the physician or pharmacist.
Symptoms reported after overdose of Ralago included slightly euphoric mood (a mild form of mania),
extremely high blood pressure, and serotonin syndrome (see section 4).
Missed dose of Ralago
Do not take a double dose to make up for a missed dose. Take the next dose of Ralago at the usual time.
Stopping Ralago treatment
Do not stop taking Ralago without first consulting a physician.
If you have any further questions about the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, contact a doctor immediately. The patient may require urgent medical advice or treatment:

• if the patient develops unusual behaviours such as obsessions, obsessive thoughts, gambling addiction, uncontrolled shopping or spending, impulsive behaviours, excessive sexual drive or increased thoughts about sex (impulse control disorders, see section 2)
• if the patient sees or hears things that are not there (hallucinations)
• if any of the following symptoms occur together: hallucinations, fever, agitation, tremor and sweating (serotonin syndrome)

Contact a doctor if the patient notices suspicious skin changes, as there may be an increased risk of skin cancer (melanoma) during treatment with this medicine (see section 2).

Other adverse reactions
Very common adverse reactions (may occur in more than 1 in 10 patients)

• involuntary body movements (dyskinesias)
• headache

Common adverse reactions (may occur in up to 1 in 10 patients)

• abdominal pain
• fall
• allergic reaction
• fever
• influenza-like illness
• malaise (weakness)
• neck pain
• chest pain (angina pectoris)
• drop in blood pressure upon standing with symptoms resembling dizziness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• bloating with gas release
• abnormal blood test results (leukopenia)
• joint pain
• musculoskeletal pain (muscle and bone pain)
• arthritis
• numbness and weakness in the hand (carpal tunnel syndrome)
• weight loss
• nightmares
• impaired coordination of muscle groups (balance disorders)
• depression
• dizziness
• prolonged muscle tension (dystonia)
• runny nose (nasal congestion)
• skin irritation (dermatitis)
• rash
• eye redness (conjunctivitis)
• sudden urge to urinate

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

• stroke
• myocardial infarction
• blister-like rash (vesiculobullous rash)

Unknown frequency: frequency cannot be estimated from available data

• increased blood pressure
• excessive sleepiness
• sudden sleep attacks

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 stated on the packaging following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines must 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 packaging and other information

What Ralago contains

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

What Ralago looks like and contents of the pack
White to almost white tablets, possibly with darker specks, round, slightly biconvex, with bevelled edges; tablet diameter: 7 mm
Pack sizes: 10, 14, 28, 30, 56, 60, 84 and 90 tablets in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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 further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500