Package leaflet: Information for the user

Halidor 100 mg tablets
Bencyclane fumarate
Please read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Halidor is and what it is used for
What you need to know before taking Halidor
How to take Halidor
Possible side effects
How to store Halidor
Contents of the pack and other information

1. What Halidor is and what it is used for

Bencyclane, the active substance in Halidor, has vasodilatory and smooth muscle relaxant properties. The medicine is used in the treatment of symptoms of arteriosclerotic occlusive disease of the lower limb arteries.

2. Important information before using Halidor medicine

When not to use Halidor

if the patient is allergic to bencyclane or any of the other ingredients of this medicine (listed in section 6);
if the patient has severe respiratory insufficiency;
if the patient has severe renal or hepatic impairment;
if the patient has uncompensated heart failure, acute myocardial infarction, or atrioventricular block;
if the patient has epilepsy or a predisposition to seizures;
if the patient has recently suffered a stroke;
if the patient has sustained a head injury within the past 12 months.

Warnings and precautions
Before starting treatment with Halidor, consult a doctor or pharmacist.
During treatment with Halidor, your doctor may recommend regular laboratory tests (e.g. every two months). Follow your doctor's instructions carefully.
Other medicines and Halidor
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to use.
Exercise caution when using any of the following medicines concomitantly with Halidor:

sedatives (possible enhancement of effect);
sympathomimetic agents (possible increased risk of rapid heart rate);
medicines that reduce blood potassium levels, e.g. quinidine (possible increased risk of cardiac arrhythmias);
cardiac glycosides (increased risk of cardiac arrhythmias);
beta-blocking agents (used in the treatment of hypertension and cardiac arrhythmias). Dosage adjustment of these agents may be required when used concomitantly with Halidor;
medicines used to treat hypertension, including calcium channel blockers. The effects of these medicines may be enhanced;
any medicines that may cause seizure predisposition as an adverse effect;
acetylsalicylic acid (antiplatelet aggregation effect may be enhanced).

If hospitalization or a visit to a dentist is required, during which anesthesia will be administered, inform the doctor about the use of Halidor. It may enhance the effects of anesthetic agents.
If in doubt about concomitant medications, consult your doctor before starting Halidor.
Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if pregnancy is suspected, or if planning pregnancy, consult a doctor or pharmacist before using this medicine.
Use of Halidor is not recommended during the first trimester of pregnancy. There is insufficient data on the use of bencyclane during breastfeeding. Administration of Halidor to breastfeeding women requires careful consideration of benefits versus risks.
Driving and operating machinery
At the beginning of treatment, driving and performing tasks involving increased risk of accidents require special caution.
Halidor contains sodium
Halidor contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Halidor

This medicine should always be taken exactly as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Oral administration.
The recommended dose is 200 mg (2 tablets) twice daily.
Taking the medicine at fixed times each day makes it easier to remember.
Use of a higher than recommended dose of Halidor
Taking a higher than recommended dose may cause tachycardia (rapid heart rate),
hypotension (excessive lowering of blood pressure), predisposition to collapse, urinary incontinence,
drowsiness, motor restlessness, or in severe cases, epileptic seizure.
If symptoms of poisoning occur, the patient should consult a doctor. The doctor will decide on further
management depending on the dose taken and/or symptoms of overdose.
In case the patient accidentally takes too many tablets or if the medicine is taken by someone else,
go immediately to the emergency room of the nearest hospital. Bring along any remaining tablets and this
package leaflet to show to the doctor.
Missed dose of Halidor
If a dose is missed, skip that dose and continue with the next scheduled dose. Do not take a double dose
to make up for the missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During treatment with Halidor, the following symptoms may occur:

Nervous system disorders
Rare (may occur in up to 1 in 1,000 people): transient confusion, hallucinations.
Very rare (may occur in up to 1 in 10,000 people): focal symptoms of the central nervous system (CNS).
Frequency not known (frequency cannot be estimated from available data): motor restlessness, headache, dizziness, gait disturbances, tremor, somnolence, sleep disorders, memory disturbances.
Significant overdose may cause tonic-clonic seizures.

Cardiac disorders
Frequency not known: atrial or ventricular tachycardia (accelerated heart rate), mainly when other drugs causing cardiac dysfunction are used concomitantly.

Gastrointestinal disorders
Frequency not known: dryness of the oral mucosa, stomach pain, feeling of fullness, nausea, vomiting.

Skin and subcutaneous tissue disorders
Frequency not known: allergic reactions.

General disorders and administration site conditions
Frequency not known: malaise.

Investigations
Transient increase in liver enzyme activity (AspAT and AlAT), decrease in white blood cell count, increase in body weight.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a physician or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions may 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 Halidor

Do not store above 30°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following the term "EXP". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Halidor contains
The active substance is fumaric acid bencyclane. Each tablet contains 100 mg of bencyclane fumarate.
The other ingredients are: magnesium stearate, colloidal anhydrous silica, potato starch,
carbomer 934 P, sodium carboxymethyl starch (type A), polyvinyl acetate, talc.
What Halidor looks like and contents of the pack
White or almost white, round, flat tablets with the imprint "HALIDOR" on one side.
Brown glass bottle with a PE cap, in a cardboard box.
The pack contains 60 tablets.
Marketing Authorisation Holder
EGIS Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38
Hungary
Manufacturer
EGIS Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65
Hungary
For further information, please contact the representative office of the Marketing Authorisation Holder in Poland.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Telephone number: +48 22 417 92 00