Asanix Pph

Package Leaflet: Information for the Patient

Asanix PPH, 1 mg, Tablets

Rasagiline

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. 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 package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

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

1. What is Asanix PPH and what is it used for

Asanix PPH contains the active substance rasagiline and is used in adults to treat Parkinson's disease. It can be taken with or without levodopa (another medication 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 that has an effect on movement control. Asanix PPH increases and maintains dopamine levels in these areas.

2. Important information before taking Asanix PPH

When Not to Take Asanix PPH

• if you are allergic to rasagiline or any of the other ingredients of this medication (listed in section 6);
• if you have severe liver problems.

Do not take the following medications while taking Asanix PPH:

• monoamine oxidase inhibitors (MAOIs) (used for example to treat depression in Parkinson's disease or for other indications), including medications and herbal products available without a prescription, such as St. John's Wort.
• pethidine (a strong painkiller). There must be at least 14 days between stopping Asanix PPH and starting MAOIs or pethidine.

Warnings and Precautions

Before starting Asanix PPH, discuss with your doctor or pharmacist:

• if you have any liver problems
• if you have any worrying changes to your skin. Treatment with Asanix PPH 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, or urges to perform certain actions that are harmful to you or others. Such behaviors are called impulse control disorders. In patients taking Asanix PPH and/or other medications for Parkinson's disease, such behaviors as compulsions, obsessive thoughts, pathological gambling, uncontrolled spending, impulsive behavior, excessive sexual drive, or increased sexual thoughts and feelings have been observed. Your doctor may decide to adjust the dose or stop the medication (see section 4).
Asanix PPH may cause drowsiness and sudden sleepiness during daily activities, especially when taken with other dopaminergic medications (used to treat Parkinson's disease). For more information, see the section "Driving and using machines".

Children and Adolescents

Asanix PPH should not be used in children and adolescents. Therefore, it is not recommended to use Asanix PPH in patients under 18 years of age.

Asanix PPH and Other Medications

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

• certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• ciprofloxacin - an antibiotic used to treat infections
• dextromethorphan - a cough medication
• sympathomimetics, such as those found in eye drops, nasal decongestants, and oral medications for colds that contain ephedrine or pseudoephedrine.

Avoid taking Asanix PPH with antidepressants containing fluoxetine or fluvoxamine.
Asanix PPH 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 Asanix PPH.
Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may decrease the amount of Asanix PPH in your blood.

Pregnancy, Breast-feeding, and Fertility

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 medication.
If you are pregnant, you should avoid taking Asanix PPH, as its effects on pregnancy and the unborn child are not known.

Driving and Using Machines

Ask your doctor for advice before driving or using machines, as Parkinson's disease and Asanix PPH may affect your ability to perform these activities. Asanix PPH may cause dizziness or drowsiness. It may also cause sudden sleepiness episodes.
These effects are more common when taking other medications for Parkinson's disease symptoms or other medications that cause drowsiness, or if you consume alcohol while taking Asanix PPH. Patients who have experienced drowsiness and/or sudden sleepiness before or while taking Asanix PPH should not drive or use machines (see section 2).

Asanix PPH Contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to Take Asanix PPH

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Asanix PPH is one 1 mg tablet taken orally once a day.
Asanix PPH can be taken with or without food.

If You Take More Asanix PPH Than You Should

If you think you have taken too many Asanix PPH tablets, contact your doctor or pharmacist immediately. Take the package leaflet with you to show the doctor or pharmacist.
Symptoms reported after overdose of Asanix PPH include: slightly euphoric mood (mild mania), severely high blood pressure, and serotonin syndrome (see section 4).

If You Forget to Take Asanix PPH

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

Stopping Asanix PPH Treatment

Do not stop taking Asanix PPH without talking to your doctor first.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Asanix PPH 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 attention or treatment:

• if you experience unusual behaviors, such as compulsions, obsessive thoughts, pathological gambling, uncontrolled spending, impulsive behavior, excessive sexual drive, or increased sexual thoughts and feelings (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 changes to your skin, as treatment with Asanix PPH may increase the 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 of the body (dyskinesia)
• headache

Common (may affect up to 1 in 10 people)

• abdominal pain
• falls
• allergic reactions
• fever
• flu-like symptoms
• 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
• abnormal blood test results (leukopenia)
• joint pain
• musculoskeletal pain
• arthritis
• numbness and weakness of the hand (carpal tunnel syndrome)
• weight loss
• vivid dreams
• difficulty coordinating muscle groups (balance disorders)
• depression
• vertigo (of labyrinthine origin)
• prolonged muscle tension (dystonia)
• common cold (rhinitis)
• skin irritation (dermatitis)
• rash
• eye redness (conjunctivitis)
• sudden urge to urinate

Uncommon (may affect up to 1 in 100 people)

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

Rare (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 package leaflet, tell your doctor or pharmacist. 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
tel.: +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 medication.

5. How to Store Asanix PPH

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton, blister, or bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation LOT means the batch number.
There are no special precautions for storage.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Asanix PPH Contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
• The other ingredients are: microcrystalline cellulose, corn starch, pregelatinized starch (corn), talc, sodium stearyl fumarate.

What Asanix PPH Looks Like and Contents of the Pack

Asanix PPH tablets are white or almost white, round, flat tablets with beveled edges.
Pack sizes: 28, 30, 60, 84, 98, 100, and 112 tablets in blisters
Pack sizes: 30 and 100 tablets in containers with a child-resistant closure and a desiccant (silica gel). The desiccant is not intended for consumption.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area
2643 Ergates
Cyprus
Iberfar – Indústria Farmacêutica, S.A.
Rua Consiglieri Pedroso, no. 121-123
Queluz de Baixo,
2734-501 Barcarena
Portugal
Date of last revision of the package leaflet:December 2021