Halidor

Package Leaflet: Information for the User

Halidor, 100 mg, tablets
Bencyclane fumarate

Read the package 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, pharmacist, or nurse.
• 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Halidor and what is it used for

Bencyclane, the active substance of Halidor, has a vasodilating and smooth muscle relaxing effect on internal organs. The medicine is used to treat symptoms of atherosclerotic obstruction of the lower limbs.

2. Important information before taking Halidor

When not to take Halidor

• if you are allergic to bencyclane or any of the other ingredients of this medicine (listed in section 6);
• if you have severe respiratory failure;
• if you have severe renal or hepatic impairment;
• if you have uncontrolled heart failure, recent myocardial infarction, atrioventricular block;
• if you have epilepsy or a history of seizures;
• if you have recently had a stroke;
• if you have had a head injury within the last 12 months.

Warnings and precautions

Before taking Halidor, consult your 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Be cautious when taking Halidor with any of the following medicines:

• sedatives (possible increased effect);
• sympathomimetic medicines (possible increased risk of rapid heart rate);
• potassium-lowering medicines, such as quinidine (possible increased risk of arrhythmias);
• digitalis glycosides (increased risk of arrhythmias);
• beta-adrenergic blockers (used to treat hypertension and arrhythmias). The dosage of these medicines may need to be adjusted when taken with Halidor;
• medicines used to treat hypertension, including calcium channel blockers. The effects of these medicines may be enhanced;
• any medicines that may cause seizures as a side effect;
• acetylsalicylic acid (increased risk of bleeding).

In case of hospitalization or a dental visit, during which anesthesia will be used, inform your doctor about taking Halidor. It may enhance the effect of anesthetics.
In case of doubts about the medicines you are taking, consult your doctor before starting Halidor.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Halidor should not be used during the first trimester of pregnancy. There is limited data on the use of bencyclane during breastfeeding. Administration of Halidor to breastfeeding women requires careful consideration of the benefits and risks.

Driving and using machines

At the beginning of treatment, driving and performing tasks that require increased attention require special caution.

Halidor contains sodium

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

3. How to take Halidor

Always take this medicine exactly as your doctor has told you.
In case of doubts, consult your doctor or pharmacist.
Oral administration.
The recommended dose is 200 mg (2 tablets) twice a day.
Taking the medicine at the same time every day makes it easier to remember to take it.

What to do if you take more Halidor than you should

Taking more than the recommended dose may cause tachycardia (rapid heart rate), hypotension (excessive lowering of blood pressure), tendency to faint, urinary incontinence, drowsiness, restlessness, or in severe cases, tonic-clonic seizures.
If symptoms of overdose occur, the patient should consult a doctor. The doctor will decide on further action depending on the dose taken and/or symptoms of overdose.

If you take too many tablets or if someone else takes your medicine, go to the nearest hospital emergency department. Bring any remaining tablets and this leaflet to show the doctor.

Missing a dose of Halidor

Miss the dose and continue treatment. Do not take a double dose to make up for the missed dose.
In case of further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Halidor can cause side effects, although not everybody gets them.
During treatment with Halidor, the following symptoms may occur:
Nervous system disorders
Rare (may affect up to 1 in 1000 people): transient confusion, hallucinations.
Very rare (may affect up to 1 in 10,000 people): focal neurological symptoms.
Frequency not known (cannot be estimated from the available data): restlessness, headache, dizziness, gait disturbances, tremor, drowsiness, sleep disturbances, memory disturbances.
Significant overdose may cause tonic-clonic seizures.
Cardiac disorders
Frequency not known: tachycardia (rapid heart rate) atrial or ventricular (mainly when other medicines that cause cardiac arrhythmias are taken at the same time).
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, weight gain.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
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 this medicine.

5. How to store Halidor

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that 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. Contents of the pack and other information

What Halidor contains

The active substance is bencyclane fumarate. Each tablet contains 100 mg of bencyclane fumarate.
Other ingredients are: magnesium stearate, colloidal anhydrous silica, potato starch, carbomer 934P, sodium carboxymethylcellulose (type A), polyvinyl acetate, talc.

What Halidor looks like and contents of the pack

White or almost white, round, flat tablets with "HALIDOR" embossed on one side.
Brown glass bottle with a PE cap, in a carton box.
The pack contains 60 tablets.

Marketing Authorization Holder

EGIS Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65
Hungary
For more detailed information, please contact the representative of the Marketing Authorization Holder in Poland.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone number: +48 22 417 92 00

Date of last revision of the leaflet: 31.12.2024