Pentohexal 600 retard

Patient Information Leaflet

Warning!
Keep this leaflet. The information on the immediate packaging is in a foreign language.
PentoHEXAL 600 Retard (ПентоХЕКСАЛ)
600 mg, prolonged-release tablets
Pentoxifylline
PentoHEXAL 600 Retard and ПентоХЕКСАЛ are different trade names for the same medicine in Polish and Bulgarian, respectively.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• 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:

1. What PentoHEXAL 600 Retard is and what it is used for
2. What you need to know 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 perfusion.
Indications for PentoHEXAL 600 Retard include:

• Peripheral circulation disorders: peripheral arterial disease with intermittent claudication, Buerger's disease
• Mild symptoms of cerebral ischemia
• Circulatory disorders in the retinal vessels due to diabetes or arterial hypertension (provided there has been no hemorrhage into the retina)

2. Important information before using Pentohexal 600 Retard

When not to use Pentohexal 600 Retard

• if the patient is allergic to pentoxifylline or 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. in 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 intestinal ulceration.

If retinal haemorrhage occurs during treatment with Pentohexal 600 Retard, the medicine must be discontinued immediately and the patient should contact their 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 the doctor should be contacted.
Before starting treatment with Pentohexal 600 Retard, discuss this with the 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 diagnosed atherosclerosis of cerebral vessels;
• 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 coagulation disorders – the doctor will then perform blood tests more frequently due to increased bleeding risk;
• is taking antidiabetic medicines (oral or insulin) or ciprofloxacin (an antibiotic) – see section "Pentohexal 600 Retard with 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 currently apply to the patient or applied in the past.
Pentohexal 600 Retard with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Pentohexal 600 Retard and other medicines may interact with each other, affecting their efficacy and increasing the risk of adverse effects. This particularly applies to:

• antihypertensive medicines (Pentohexal 600 Retard may enhance their antihypertensive effect);
• anticoagulant medicines (Pentohexal 600 Retard may enhance the anticoagulant effect of medicines such as warfarin, acenocoumarol);
• insulin and oral antidiabetic medicines (Pentohexal 600 Retard may reduce blood glucose concentration);
• theophylline, a medicine used in respiratory diseases (Pentohexal 600 Retard may increase theophylline blood levels and thereby enhance its effects);
• cimetidine, a medicine that reduces gastric acid secretion (may enhance the effect of Pentohexal 600 Retard);
• ciprofloxacin, an antibiotic (concurrent 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 the listed medicines, they should consult their doctor or pharmacist.
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Pentohexal 600 Retard with food and drink
Pentohexal 600 Retard should be taken after a meal. Tablets should be swallowed whole with water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 influence 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 provided 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 renal and/or hepatic impairment, the physician will determine the appropriate dose
based on the severity of the disease and the patient's tolerance to the medicine.
The duration of treatment will be determined by the physician.
Use in children
Pentohexal 600 Retard should not be used in children due to lack of data on safety and efficacy.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Taking more Pentohexal 600 Retard than recommended
If you have taken more than the recommended dose, seek immediate medical advice from a doctor
or go to the nearest hospital. Bring the medicine packaging with you so that it is clear which medicine
has been taken.
Symptoms of overdose may include: dizziness, nausea, decreased blood pressure, rapid heartbeat,
flushing, loss of consciousness, coma, fever, agitation, absence of reflexes, seizures, metabolic acidosis,
foamy vomiting, and cardiac arrhythmias.
Management in case of overdose
If overdose has recently occurred, the doctor may perform gastric lavage and administer activated
charcoal. Dialysis may also be considered.
There is no known specific antidote for pentoxifylline overdose.
Missing a dose of Pentohexal 600 Retard
If a patient forgets to take a dose, they should take it as soon as they remember.
However, if it is almost time for the next dose, the patient should return to the normal 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 continue taking Pentohexal 600 Retard. Do not stop
treatment without consulting your doctor.
If you have any further questions about 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 will experience them.
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 development of skin petechiae (thrombocytopenia), 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, pallor, fainting or collapse (anaphylactic shock);
• severe allergic reaction with blistering of the skin and/or mucous membranes of the lips, eyes, oral cavity, 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 of the 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); Page 4 of 6
• fever.

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

• chest pain;
• breathing difficulties (dyspnoea);
• decreased blood pressure;
• limb swelling (peripheral oedema).

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

• tingling or numbness, convulsions;
• 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 reactions occur, including any adverse reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pentohexal 600 Retard

• • Keep this medicine out of 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.
  • No special storage instructions are required.
  • 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, magnesium stearate, talc.

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 (3 blisters of 10 tablets each).
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Hexal AG
Industriestrasse 25
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
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Bulgaria, country of export: 20060084
Parallel Import Licence Number: 753/12
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