Pentohexal 600 retard

Leaflet attached to the packaging: patient information

Warning!

The leaflet should be kept. Information on the immediate packaging 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 drug in Polish and Bulgarian.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is PentoHEXAL 600 Retard and what is it 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 packaging and other information

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

PentoHEXAL 600 Retard contains the active substance pentoxifylline - a drug that reduces blood viscosity, improves its flow through peripheral vessels, and also increases tissue blood supply.
Indications for the use of PentoHEXAL 600 Retard are:

• peripheral circulation disorders: atherosclerosis of the lower limb arteries with intermittent claudication, Buerger's disease
• mild symptoms of central nervous system ischemia,
• circulatory disorders in the retina in the course of diabetes or hypertension (if there has been no bleeding into the retina).

2. Important information before taking PentoHEXAL 600 Retard

When not to take 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 had a heart attack or stroke;
• if the patient has had significant bleeding or has a disease associated with a high risk of bleeding (e.g. in the brain, gastrointestinal tract, or genital tract);
• if the patient has had bleeding into the retina;
• if the patient has been diagnosed with hemorrhagic diathesis;
• if the patient has stomach or intestinal ulcers.

If, during the use of PentoHEXAL 600 Retard, the patient experiences bleeding into the retina, the medicine should be discontinued immediately and a doctor consulted.
In case of any doubts, a doctor or pharmacist should be consulted.

Warnings and precautions

If the patient experiences an allergic reaction, the use of the medicine should be discontinued immediately and a doctor consulted.
Before starting the use of PentoHEXAL 600 Retard, the patient should discuss this with their doctor if they:

• have heart function disorders, especially irregular heart rhythm, low blood pressure, coronary heart disease (also known as coronary artery disease), or have had a heart attack in the past;
• have been diagnosed with cerebral atherosclerosis;
• have had surgery;
• have an autoimmune disease (e.g. systemic lupus erythematosus or mixed collagenosis);
• have an increased tendency to bleed (e.g. are taking anticoagulant medications) or have coagulation disorders - the doctor will more frequently order blood tests for the patient due to the increased risk of bleeding;
• are taking oral antidiabetic drugs or insulin, or ciprofloxacin (an antibiotic) - see "PentoHEXAL 600 Retard and other medicines";
• have kidney or liver function disorders - the doctor may then recommend a lower dose of the medicine.

Since PentoHEXAL 600 Retard may cause a decrease in the number of blood cells, the doctor will regularly monitor the patient's blood morphology.
The patient should strictly follow the doctor's recommendations regarding the performance of control tests.
The patient should consult a doctor if any of the above warnings apply to them currently or have applied in the past.

PentoHEXAL 600 Retard and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
PentoHEXAL 600 Retard and other medicines may interact with each other and affect their efficacy and the occurrence of side effects. This applies in particular to such medicines as:

• blood pressure-lowering medicines (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 cause a decrease in blood sugar levels);
• theophylline, a medicine used in respiratory diseases (PentoHEXAL 600 Retard may increase theophylline levels in the blood and thus enhance its effect);
• cimetidine, a medicine that reduces stomach acid secretion (may enhance the effect of PentoHEXAL 600 Retard);
• ciprofloxacin, an antibiotic (concomitant use with PentoHEXAL 600 Retard may cause an increase in the number and severity of side effects).

If the patient has doubts about whether they are taking these medicines, they should consult a doctor or pharmacist.

PentoHEXAL 600 Retard with food and drink

PentoHEXAL 600 Retard should be taken after a meal. The tablets should be swallowed whole, washed down with water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.
Due to the lack of sufficient experience, PentoHEXAL 600 Retard should not be used during pregnancy.
Pentoxifylline passes into breast milk in small amounts. PentoHEXAL 600 Retard can be used during breastfeeding only if, in the doctor's opinion, the benefits of therapy outweigh the risks.

Driving and operating machinery

No effect of the medicine on the ability to drive vehicles and operate machinery has been observed. Before performing activities that require full fitness, the patient should consult a doctor.

3. How to take PentoHEXAL 600 Retard

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult a doctor or pharmacist.
The recommended dosage and method of taking the medicine are given below. The patient should read the information carefully.
Usually, 1 tablet of PentoHEXAL 600 Retard is taken in the morning and 1 tablet in the evening (1200 mg of pentoxifylline per day).
In patients with kidney and/or liver function disorders, the doctor will determine the dose of the medicine depending on the severity of the disease symptoms and the patient's tolerance to the medicine.
The duration of treatment is determined by the doctor.

Use in children

PentoHEXAL 600 Retard should not be used in children due to the lack of data on safety and efficacy.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.

Taking a higher dose of PentoHEXAL 600 Retard than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or go to the nearest hospital. The patient should take the medicine packaging with them so that it is known which medicine was taken.
Symptoms of overdose may include: dizziness, nausea, decreased blood pressure, accelerated heart rate, hot flashes, loss of consciousness, coma, fever, excitement, lack of reflexes, convulsions, metabolic acidosis, fusiform vomiting, and arrhythmias.
Procedure in case of overdose
If the overdose occurred recently, the doctor may perform gastric lavage and administer activated charcoal. The doctor may also decide to use dialysis.
No specific antidote is known in case of pentoxifylline overdose.

Missing a dose of PentoHEXAL 600 Retard

If the patient forgot to take the medicine, they should do so as soon as they remember.
If it is almost time for the next dose, the patient should return to their normal dosing schedule.
The patient should not take a double dose to make up for the missed dose.

Stopping the use of PentoHEXAL 600 Retard

The doctor will provide information on how long to take PentoHEXAL 600 Retard. The patient should not stop the treatment without consulting a doctor.
In case of any further doubts related to the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking PentoHEXAL 600 Retard and consult a doctor immediately.

Very rare, serious side effects(may occur less frequently than in 1 in 10,000 people):

• low platelet count, unusual bleeding or bruising under the skin (thrombocytopenic purpura), low blood cell count (aplastic anemia);
• bleeding in the brain or eye (retinal hemorrhage);
• allergic reactions, sometimes very serious, including swelling of the face, lips, tongue, and throat, which can cause difficulty breathing, speaking, or swallowing (angioedema);
• difficulty breathing (bronchospasm);
• sudden decrease in blood pressure, paleness, fainting, or shock (anaphylactic shock);
• severe allergic reaction with blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome) or skin peeling (toxic epidermal necrolysis);
• aseptic meningitis with symptoms such as headache, stiff neck;
• eye pain or discomfort when exposed to bright light. In all observed cases, the symptoms disappeared after discontinuation of pentoxifylline.

Rare, serious side effects(may occur less frequently than in 1 in 1,000 people):

• bleeding in the skin and mucous membranes of the stomach, intestines, urinary tract, or genital tract.

Very rare, serious side effects(may occur less frequently than in 1 in 10,000 people):

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

Other possible side effects

Common(may occur less frequently than in 1 in 10 people):

• hot flashes (redness of the face, feeling of heat);
• gastrointestinal disorders (such as nausea, vomiting, bloating, discomfort, diarrhea).

Uncommon(may occur less frequently than in 1 in 100 people):

• excitement, sleep disorders;
• headaches, dizziness, tremors;
• vision disorders, redness, itching, and tearing of the eyes (conjunctivitis);
• irregular heart rhythm, accelerated heart rate;
• skin hypersensitivity reactions (such as itching, redness, urticaria);
• fever.

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

• chest pain;
• difficulty breathing (dyspnea);
• decreased blood pressure;
• peripheral edema (peripheral edema).

Very rare(may occur less frequently than in 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):

• decrease in white blood cell count;
• constipation;
• rash.

Reporting side effects
If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store PentoHEXAL 600 Retard

• The medicine should be stored in a place invisible and inaccessible to children.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
• There are no special recommendations for storage.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What PentoHEXAL 600 Retard contains

The active substance of the medicine 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 what the packaging contains

PentoHEXAL 600 Retard prolonged-release tablets are white, oblong, biconvex, with a score line on both sides.
PentoHEXAL 600 Retard is available in PP/Al blisters, in a cardboard box.
The packaging contains 30 prolonged-release tablets (3 blisters of 10 each).
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20060084

Parallel import authorization number: 753/12

Date of leaflet approval:10.11.2022
[Information about the trademark]
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