Pridinol Zentiva

Patient Information Leaflet: User Information

Pridinol Zentiva, 5 mg, tablets

(Pridinol hydrochloride)

Read the 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 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Pridinol Zentiva and what is it used for
• 2. Important information before taking Pridinol Zentiva
• 3. How to take Pridinol Zentiva
• 4. Possible side effects
• 5. How to store Pridinol Zentiva
• 6. Package contents and other information

1. What is Pridinol Zentiva and what is it used for

Pridinol Zentiva is a medicine used in all forms of parkinsonism, relieving excessive tension and muscle tremors, facilitating voluntary movements, and inhibiting the occurrence of involuntary movements. Pridinol Zentiva also affects smooth muscles. Pridinol Zentiva has a supportive effect in the treatment and prevention of nocturnal muscle cramps and in the treatment of drooling that occurs in various diseases.

2. Important information before taking Pridinol Zentiva

When not to take Pridinol Zentiva

• if you are allergic to prydinol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have glaucoma;
• if you have prostate enlargement;
• if you have difficulty or disorders in urinating;
• if you have mechanical narrowing in the gastrointestinal tract;
• if you have acute colonic dilation;
• if you have acute coronary insufficiency;
• if you have circulatory failure;
• if you have heart rhythm disorders;
• if you have dyskinesia (uncoordinated and involuntary movements of the limbs or the whole body) in the course of parkinsonism;
• if you have myasthenia gravis (morbid fatigue and muscle weakness).

Warnings and precautions

Before starting to take Pridinol Zentiva, discuss it with your doctor:

• if you have epilepsy;
• if you have coronary artery disease;
• do not drink alcohol while taking Pridinol Zentiva.

Pridinol Zentiva and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
It is recommended to avoid taking two cholinolytic medicines (e.g., prydinol, orphenadrine, trihexyphenidyl) at the same time to treat parkinsonism, due to the possibility of increasing the side effects of both medicines.
Tricyclic antidepressants (e.g., imipramine, doxepin), antihistamines (e.g., loratadine, cetirizine), atropine, and medicines with similar effects, dyzopiramid, neuroleptics from the phenothiazine group (e.g., chlorpromazine, perazine), amantadine, and quinidine enhance the cholinolytic effect of prydinol.
Metoclopramide reduces the effect of prydinol on gastrointestinal motility.

Pridinol Zentiva with food and drink

The medicine should be taken during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
Pridinol Zentiva is not recommended during pregnancy and breastfeeding.

Driving and using machines

Pridinol can significantly impair your ability to drive and use machines. Pridinol can cause dizziness and symptoms similar to those of an overdose, such as: dilated pupils, accommodation disorders, vision disorders, cognitive disorders, excitement, psychosis, and hallucinations.
During the treatment with Pridinol Zentiva, do not drive vehicles, operate moving machinery, or perform tasks that require full concentration and motor fitness.
Pridinol Zentiva contains lactose.
If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Pridinol Zentiva

Adults

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. The usual initial dose of Pridinol Zentiva is 1 tablet 3 times a day during meals. In justified cases, the dose may be increased to 2 tablets 3 times a day. The treatment should be continued with 1 to 2 tablets per day.

Use in children and adolescents

Pridinol is not recommended for use in children and adolescents under 18 years of age due to the lack of data on efficacy and safety in this age group.

Taking a higher dose of Pridinol Zentiva than recommended

In case of overdose, symptoms such as dilated pupils, vision disorders, dryness of mucous membranes, severe gastrointestinal disorders, urinary retention, increased heart rate, decreased blood pressure, confusion, mental disorders may occur.
If you have taken more Pridinol Zentiva than you should, contact your doctor.

Missing a dose of Pridinol Zentiva

Do not take a double dose to make up for a missed tablet.

Stopping the treatment with Pridinol Zentiva

If you have any doubts about the treatment, ask your doctor.

4. Possible side effects

Like all medicines, Pridinol Zentiva can cause side effects, although not everybody gets them.
Some patients taking Pridinol Zentiva have experienced the following side effects:
Common (affects less than 1 in 10 people):
Gastrointestinal disorders: dryness of the oral mucosa, gastrointestinal disorders.
Uncommon (affects less than 1 in 100 people):
Infections: purulent parotitis due to inhibition of saliva secretion.
Rare (affects less than 1 in 1,000 people):
General disorders: headache and dizziness.
Skin disorders: rash.
Some people may also experience symptoms similar to those of an overdose, usually mild, however.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pridinol Zentiva

Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use Pridinol Zentiva after the expiry date stated on the packaging (EXP). The expiry date refers to the last day of the month.
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. Package contents and other information

What Pridinol Zentiva contains

• The active substance is prydinol hydrochloride;
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl cellulose, magnesium stearate.

What Pridinol Zentiva looks like and contents of the pack

Pridinol Zentiva is in the form of tablets, packaged in a PP container or white PVC/PVDC/Aluminum blisters in a cardboard box.
The package contains 50 tablets.

Marketing authorization holder

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

S.C. Labormed-Pharma S.A.
44B, Theodor Pallady Blvd.
3rd District
Bucharest 032266, Romania

To obtain more detailed information on the medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Phone: +48 22 375 92 00
Date of the last update of the leaflet:September 2022