Pentohexal 600 retard

Patient Information Leaflet: Keep this leaflet!

Packaging information in a foreign language.
PentoHEXAL 600 Retard (ПентоХЕКСАЛ)
600 mg, prolonged-release tablets
Pentoxifyllinum
PentoHEXAL 600 Retard and ПентоХЕКСАЛ are different trade names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before using the 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. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What PentoHEXAL 600 Retard is and what it is used for
2. Important information before taking PentoHEXAL 600 Retard
3. How to take PentoHEXAL 600 Retard
4. Possible side effects
5. How to store PentoHEXAL 600 Retard
6. Contents of the pack and other information

1. What PentoHEXAL 600 Retard is and what it is used for

PentoHEXAL 600 Retard contains the active substance pentoxifylline, a medicine which reduces blood viscosity, improves blood flow through peripheral vessels, and enhances tissue blood supply.

PentoHEXAL 600 Retard is indicated for:

• Peripheral circulatory disorders: peripheral arterial disease of the lower limbs with intermittent claudication, Buerger's disease,
• Mild symptoms of cerebral ischemia,
• Circulatory disorders in the retina associated with diabetes or arterial hypertension (provided there has been no retinal haemorrhage).

2. Important information before using Pentohexal 600 Retard

When not to use Pentohexal 600 Retard:

• if the patient is allergic to pentoxifylline or to similar substances (such as theophylline, aminophylline, caffeine), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has recently suffered a myocardial infarction or stroke;
• if the patient has experienced significant bleeding or has a disease associated with a high risk of haemorrhage (e.g. within the brain, gastrointestinal tract, or genital tract);
• if the patient has experienced retinal haemorrhage;
• if the patient has a bleeding disorder;
• if the patient has gastric or duodenal ulcer.

If retinal haemorrhage occurs during treatment with Pentohexal 600 Retard, the medicine must be discontinued immediately and the patient should contact a doctor.
In case of any doubts, consult a doctor or pharmacist.
Warnings and precautions

If the patient experiences an allergic reaction, treatment with the medicine must be stopped immediately and a doctor should be contacted.

Before starting treatment with Pentohexal 600 Retard, discuss this with a doctor if the patient:

• has heart function disorders, especially irregular heartbeat, low blood pressure, ischaemic heart disease (also known as coronary heart disease), or has previously suffered a heart attack;
• has been diagnosed with cerebral atherosclerosis;
• has recently undergone surgery;
• has an autoimmune disease (e.g. systemic lupus erythematosus or mixed connective tissue disease);
• has an increased tendency to bleed (e.g. is taking anticoagulant medicines) or has coagulation disorders – the doctor may order more frequent blood tests due to increased risk of bleeding;
• is taking antidiabetic medicines (oral or insulin) or ciprofloxacin (an antibiotic) – see section "Pentohexal 600 Retard and other medicines";
• has impaired kidney or liver function – the doctor may then recommend a lower dose of the medicine.

Since Pentohexal 600 Retard may reduce blood cell counts, the doctor will regularly monitor the patient's blood count.
The patient must strictly follow the doctor's recommendations regarding control tests.
Consult a doctor if any of the above warnings apply to the patient currently or have applied in the past.

Pentohexal 600 Retard and other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Pentohexal 600 Retard and other medicines may affect each other's action and the occurrence of adverse effects. This especially concerns the following medicines:

• medicines that lower blood pressure (Pentohexal 600 Retard may enhance their antihypertensive effect);
• anticoagulant medicines (Pentohexal 600 Retard may enhance the anticoagulant effect of such medicines, e.g. warfarin, acenocoumarol);
• insulin and oral antidiabetic medicines (Pentohexal 600 Retard may reduce blood glucose levels);
• theophylline, a medicine used in respiratory diseases (Pentohexal 600 Retard may increase theophylline blood levels and thus intensify its effects);
• cimetidine, a medicine that reduces gastric acid secretion (may enhance the effect of Pentohexal 600 Retard);
• ciprofloxacin, an antibiotic (concomitant use with Pentohexal 600 Retard may increase the frequency and severity of adverse effects). If the patient is unsure whether they are taking any of these medicines, they should consult a doctor or pharmacist.

Pentohexal 600 Retard with food and drink

Pentohexal 600 Retard should be taken after meals. The tablets should be swallowed whole with water.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Due to insufficient experience, Pentohexal 600 Retard should not be used during pregnancy.
Pentoxifylline passes into breast milk in small amounts. Pentohexal 600 Retard may be used during breastfeeding only if, in the doctor's opinion, the benefits of treatment outweigh the risks.

Driving and operating machinery

No effect of the medicine on the ability to drive or operate machinery has been observed. However, before engaging in activities requiring full alertness, consult a doctor.

3. How to use PentoHEXAL 600 Retard

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The recommended dosage and method of administration are given below. Please read the following
information carefully.
The usual dose is 1 tablet of PentoHEXAL 600 Retard in the morning and 1 tablet in the evening (1200 mg
of pentoxifylline per day).
For patients with impaired renal and/or hepatic function, the physician will determine the dosage
according to the severity of the disease and the patient's tolerance to the drug.
The duration of treatment will be determined by the physician.
Use in children
PentoHEXAL 600 Retard must not be used in children due to lack of data on safety and efficacy.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Taking more PentoHEXAL 600 Retard than prescribed
If you take more than the prescribed dose of this medicine, seek medical advice immediately or go
to the nearest hospital. Take the medicine package with you so that it is clear which medicine has been
taken.
Symptoms of overdose may include: dizziness, nausea, decreased arterial blood pressure, increased
heart rate, hot flushes, loss of consciousness, coma, fever, agitation, loss of reflexes, seizures,
metabolic acidosis, frothy vomiting, and cardiac arrhythmias.
Management in case of overdose
If the overdose occurred recently, the physician may perform gastric lavage and administer activated
charcoal. Dialysis may also be considered.
There is no specific antidote known for pentoxifylline overdose.
Missed dose of PentoHEXAL 600 Retard
If the patient forgets to take the medicine, it should be taken as soon as remembered.
However, if it is almost time for the next dose, return to the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping PentoHEXAL 600 Retard
Your doctor will advise how long you should take PentoHEXAL 600 Retard. Do not stop treatment
without consulting your doctor.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the serious adverse reactions listed below occur in the patient, treatment with PentoHEXAL 600 Retard must be discontinued immediately and medical advice must be sought without delay.
Very rare, serious adverse reactions (may occur in fewer than 1 in 10,000 people):

• low platelet count, unusual bleeding or appearance of small skin hemorrhages (thrombocytopenic purpura), low blood cell count (aplastic anaemia)
• bleeding within the brain or eye (retinal haemorrhage)
• allergic reactions, sometimes very severe, including swelling of the face, lips, tongue and throat, which may cause difficulty breathing, speaking or swallowing (angioedema)
• breathing difficulties (bronchospasm)
• sudden drop in blood pressure, paleness, fainting or collapse (anaphylactic shock)
• severe allergic reaction with blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genital organs (Stevens-Johnson syndrome) or skin peeling (toxic epidermal necrolysis)
• aseptic meningitis with symptoms such as headache, neck stiffness, eye pain or discomfort in bright light. In all observed cases, symptoms resolved after discontinuation of pentoxifylline.

Rare, serious adverse reactions (may occur in fewer than 1 in 1,000 people):

• bleeding into the skin and mucous membranes, stomach, intestines, urinary tract or genital tract

Very rare, serious adverse reactions (may occur in fewer than 1 in 10,000 people):

• perception of flashes of light, loss of vision (retinal detachment)

Other possible adverse reactions
Common (may occur in fewer than 1 in 10 people):

• hot flushes (facial flushing, sensation of warmth)
• gastrointestinal disturbances (such as nausea, vomiting, bloating, discomfort, diarrhoea)

Uncommon (may occur in fewer than 1 in 100 people):

• restlessness, sleep disturbances
• headache, dizziness, tremor
• visual disturbances, redness, itching and tearing of the eyes (conjunctivitis)
• irregular heartbeat, increased heart rate
• skin hypersensitivity reactions (such as itching, erythema, urticaria)
• fever

Rare (may occur in fewer than 1 in 1,000 people):

• chest pain
• breathing difficulties (dyspnoea)
• low blood pressure
• limb swelling (peripheral oedema)

Very rare (may occur in fewer than 1 in 10,000 people):

• tingling or numbness, seizures
• increased blood pressure
• itching, jaundice, dark urine, pale stools (intrahepatic cholestasis)
• increased liver enzyme activity
• excessive sweating

Frequency not known (frequency cannot be estimated from the available data):

• decreased white blood cell count
• constipation
• rash

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Pentohexal 600 Retard

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• There are no special storage instructions.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What PentoHEXAL 600 Retard contains
The active substance is pentoxifylline. Each prolonged-release tablet contains
600 mg of pentoxifylline.
The other ingredients are: copovidone, hypromellose K 15 M, hypromellose K 100 M, talc, magnesium stearate.

What PentoHEXAL 600 Retard looks like and contents of the pack
PentoHEXAL 600 Retard prolonged-release tablets are white, elongated, biconvex, with a break line on both sides to facilitate splitting.
PentoHEXAL 600 Retard is available in PP/Al blisters, packed in a cardboard box. The pack contains 30 prolonged-release tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Bulgaria, the country of export:
Hexal AG
Industriestrasse 25
D-83607 Holzkirchen
Germany

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Poland

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Bulgaria, the country of export: 20060084
Parallel Import Licence Number: 511/15