Pridinol zentiva

Pridinol Zentiva, 5 mg, tablets
( Pridinoli hydrochloridum )
Read the entire package leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Pridinol Zentiva is and what it is 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. Contents of the pack and other information

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

Pridinol Zentiva is a medicine used in all forms of parkinsonism. It reduces excessive muscle tension and skeletal muscle tremor, facilitates voluntary movements, and suppresses involuntary movements. Pridinol Zentiva also affects smooth muscles. It has an adjuvant effect in the treatment and prevention of nocturnal muscle cramps and in the treatment of sialorrhea occurring in the course of various disorders.

2. Important information before using Pridinol Zentiva

When not to use Pridinol Zentiva

• if the patient is allergic to pridinol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has glaucoma;
• if the patient has been diagnosed with benign prostatic hyperplasia;
• if the patient experiences difficulties or disorders in urination;
• if mechanical obstruction in the gastrointestinal tract has been observed in the patient;
• if the patient has acute colonic dilation;
• if the patient has been diagnosed with acute coronary insufficiency;
• if the patient has circulatory failure;
• if the patient has cardiac arrhythmias;
• if the patient has been diagnosed with dyskinesia (involuntary, uncoordinated movements of limbs or the whole body) occurring in the course of parkinsonism;
• if the patient has been diagnosed with myasthenia gravis (a disease causing abnormal fatigue and muscle weakness).

Warnings and precautions
Before starting treatment with Pridinol Zentiva, discuss the following with your doctor:

• if the patient has been diagnosed with epilepsy;
• if the patient has been diagnosed with coronary artery disease;
• alcohol must not be consumed during treatment with Pridinol Zentiva.

Pridinol Zentiva and other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines planned for future use.
Concomitant use of two anticholinergic drugs (e.g. pridinol, orphenadrine, trihexyphenidyl) should be avoided in the treatment of parkinsonism due to the potential for increased adverse effects of both drugs.
Tricyclic antidepressants (e.g. imipramine, doxepin), antihistamines (medicines used for allergies) (e.g. loratadine, cetirizine), atropine and drugs with similar action, disopyramide, phenothiazine neuroleptics (e.g. chlorpromazine, perazine), amantadine, and quinidine enhance the anticholinergic effect of pridinol.
Metoclopramide reduces the effect of pridinol on gastrointestinal motility.

Pridinol Zentiva with food and drink
This medicine should be taken during meals.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
The use of Pridinol Zentiva is not recommended during pregnancy and breastfeeding.

Driving and operating machinery
Pridinol may significantly impair the ability to drive and operate machinery. Pridinol may cause dizziness and symptoms resembling overdose, such as: pupil dilation, accommodation disorders, visual disturbances, cognitive impairment, agitation, psychosis, and hallucinations.
During treatment with Pridinol Zentiva, patients should not drive motor vehicles, operate moving machinery, or perform tasks requiring full concentration and motor coordination.

Pridinol Zentiva contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Pridinol Zentiva

Adults
This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor. The usual initial dose of Pridinol Zentiva is 1 tablet three times daily, taken during meals.
In justified cases, the dose may be increased to 2 tablets three times daily. Treatment should then be
continued with a daily dose of 1 to 2 tablets.
Use in children and adolescents
Pridinol is not recommended for use in children and adolescents under 18 years of age due to
lack of data on efficacy and safety in this age group.
Taking more Pridinol Zentiva than recommended
In case of overdose, symptoms of poisoning may include dilated pupils, visual disturbances, dryness
of mucous membranes, severe gastrointestinal dysfunction, urinary retention, increased heart rate,
lowered blood pressure, confusion, and psychiatric disturbances.
If you have taken more Pridinol Zentiva than recommended, contact your doctor immediately.
Missed dose of Pridinol Zentiva
Do not take a double dose to make up for a missed tablet.
Stopping Pridinol Zentiva
If you have any doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse reactions have been reported in some patients treated with Pridinol Zentiva:
Common (affects less than 1 in 10 people):
Gastrointestinal disorders: dryness of the oral mucosa, gastrointestinal disturbances.
Uncommon (affects less than 1 in 100 people):
Infections: suppurative parotitis due to inhibition of salivary secretion.
Rare (affects less than 1 in 1,000 people):
General disorders: headache and dizziness.
Skin disorders: rash.
In some individuals, symptoms similar to those observed in overdose may occur, although usually
they are milder in nature.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pridinol Zentiva

Store below 25°C. Keep in the original packaging to protect from light and moisture.
The medicine should be stored out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pridinol Zentiva contains

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

What Pridinol Zentiva looks like and contents of the pack
Pridinol Zentiva is in the form of tablets, packed in a PP container or white PVC/PVDC/Aluminium blisters in a cardboard box.
The pack contains 50 tablets.
Marketing Authorisation 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
For further information about the medicinal product, please contact the
local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00