Rasagiline Accord

Patient Information Leaflet: Information for the User

Rasagilina Accord 1 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rasagilina Accord is and what it is used for

Rasagilina Accord contains the active substance rasagilina and is used in the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical in the brain involved in controlling movement. Rasagilina Accord helps increase and maintain stable levels of dopamine in the brain.

2. What you need to know before taking Rasagilina Accord

Do not take Rasagilina Accord:

• if you are allergic to rasagiline or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver problems. Do not take the following medicines in combination with Rasagilina Accord:
• monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease or used for any other indication), including over-the-counter medicines and herbal products such as St. John’s wort.
• meperidine (a strong analgesic). You must wait at least 14 days after stopping treatment with Rasagilina Accord before starting treatment with MAO inhibitors or meperidine.

Warnings and precautions
Tell your doctor or pharmacist before taking Rasagilina Accord

• if you have any liver problems.
• if you notice any suspicious skin changes, consult your doctor.

Inform your doctor if you, your family members or your caregiver notice that you are developing
unusual behaviours that make you unable to resist the impulse, drive or urge to carry out certain activities that may be dangerous or harmful to you or others. These behaviours are known as impulse control disorders. In patients taking Rasagilina Accord and/or other medicines used to treat Parkinson’s disease, such behaviours as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviours, abnormally increased sexual desire or increased sexual thoughts or urges have been observed. Your doctor may need to adjust your dose or stop treatment (see section 4).
Rasagilina Accord may cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, refer to the section on Driving and use of machinery.
Children and adolescents
There is no indication for specific use of Rasagilina Accord in children and adolescents. Therefore, the use of Rasagilina Accord is not recommended in children and adolescents under 18 years of age.
Other medicines and Rasagilina Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

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

Avoid concomitant use of Rasagilina Accord and antidepressants containing fluoxetine or fluvoxamine.
If you are starting treatment with Rasagilina Accord, you must wait at least five weeks after stopping treatment with fluoxetine.
If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with Rasagilina Accord.
Inform your doctor or pharmacist if you are a smoker or if you plan to stop smoking. Smoking may reduce the amount of Rasagilina Accord in your blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking Rasagilina Accord if you are pregnant, as the effects of Rasagilina Accord on pregnancy and the unborn baby are unknown.
Driving and use of machinery
Ask your doctor for advice before driving or using machines, as both Parkinson’s disease itself and treatment with Rasagilina Accord may affect your ability to do so.
Rasagilina Accord may cause dizziness and drowsiness; it may also cause sudden onset of sleep. This effect may be increased if you are taking other medicines to treat symptoms of Parkinson’s disease, or if you are taking medicines that cause drowsiness, or if you drink alcohol while taking Rasagilina Accord. If you have previously experienced drowsiness and/or sudden onset of sleep episodes, or if you experience them while taking Rasagilina Accord, do not drive or use machinery (see section 2).

3. How to take Rasagilina Accord

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose of Rasagilina Accord is 1 tablet of 1 mg taken orally once daily.
Rasagilina Accord may be taken with or without food.
If you take more Rasagilina Accord than you should
If you think you have taken more tablets of Rasagilina Accord than you should, contact your doctor or
pharmacist immediately. Take the pack/blister or bottle of Rasagilina Accord with you to show to the doctor or
pharmacist.
Symptoms reported after overdose with rasagiline include slightly euphoric mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome (see section 4).
If you forget to take Rasagilina Accord
Do not take a double dose to make up for the missed tablet. Take the next dose as scheduled, at the usual time.
If you stop taking Rasagilina Accord
Do not stop treatment with Rasagilina Accord without first talking to your doctor.
If you have any questions about how to use 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.
Contact your doctor immediately if you notice any of the following symptoms. You may need immediate
medical advice or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behaviour, or abnormally increased sexual desire or an increase in sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not real (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).
• If you notice suspicious skin changes, as patients with Parkinson’s disease have an increased risk of skin cancer (not only melanoma) (see section 2).

Other side effects

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
• falls
• allergy
• fever
• flu-like illness (influenza)
• general feeling of being unwell (malaise)
• neck pain
• chest pain (angina pectoris)
• drop in blood pressure upon standing, accompanied by symptoms such as dizziness/light-headedness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal results in blood tests (leucopenia)
• joint pain (arthralgia)
• musculoskeletal pain
• inflammation of the joints (arthritis)
• numbness and weakness of the hand muscle (carpal tunnel syndrome)
• loss of body weight
• abnormal dreams
• difficulty with muscle coordination (balance disorders)
• depression
• dizziness
• prolonged muscle contractions (dystonia)
• runny nose (rhinitis)
• skin irritation (dermatitis)
• rash
• red eyes (conjunctivitis)
• urinary urgency

Uncommon (may affect up to 1 in 100 people)

• stroke (cerebrovascular stroke)
• heart attack (myocardial infarction)
• skin blisters (vesiculobullous rash)

Frequency not known: frequency cannot be estimated from the available data

• high blood pressure
• excessive sleepiness
• sudden onset of sleep

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rasagilina Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle or blister pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rasagilina Accord contains

• The active substance is rasagilina. Each tablet contains 1 mg of rasagilina (as rasagilina tartrate).
• The excipients are microcrystalline cellulose, maize starch, pregelatinized starch (from maize), talc, sodium stearil fumarate.

Description of the appearance of Rasagilina Accord and package contents
Rasagilina Accord tablets are white to off-white, round, flat, bevel-edged (6.5 mm).
Pack sizes of 7, 10, 28, 30, 60, 100 and 112 tablets in blisters.
Pack sizes of 30 tablets are available in child-resistant containers with screw caps, containing a desiccant (silica gel). The desiccant, used to keep the tablets dry, must not be ingested.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area,
2643 Ergates Lefkosia,
Cyprus
Iberfar – Indústria Farmacêutica, S.A.
Rua Consiglieri Pedroso, no. 121-123
Queluz de Baixo, Barcarena,
Portugal
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias – Alto do Colaride, Cacém,
Portugal

This medicinal product is authorized in the European Economic Area Member States under the following names: