Polfilin

Package Leaflet: Information for the Patient

Polfilin, 20 mg/ml (100 mg/5 ml), Solution for Injection

Polfilin, 20 mg/ml (300 mg/15 ml), Concentrate for Solution for Infusion

Pentoxifylline

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Polfilin and what is it used for

Pentoxifylline, the active substance of the medicine, is a synthetic xanthine derivative. It facilitates blood flow in capillaries by reducing blood viscosity and increasing the elasticity of red blood cells. This can increase blood flow to underperfused tissues, including the brain and lower limbs.

The indications for use of the medicine are as follows:

• intermittent claudication;
• circulatory disorders in the eye (acute and chronic circulatory disorders in the retina and choroid);
• disorders of the inner ear (e.g. hearing disorders, sudden hearing loss, etc.) caused by circulatory changes;
• states of cerebral ischemia (e.g. post-stroke conditions, cerebrovascular disorders with symptoms such as lack of concentration, dizziness, memory disorders).

2. Important information before using Polfilin

When not to use Polfilin:

• if the patient is hypersensitive to pentoxifylline, methylxanthine derivatives (caffeine, theophylline, theobromine) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has recently had a myocardial infarction or stroke;
• if the patient has significant bleeding or a disease with a high risk of bleeding;
• if the patient has retinal hemorrhage.

Warnings and precautions

Before starting treatment with Polfilin, the patient should discuss it with their doctor or nurse.

Particular caution should be exercised when using Polfilin in patients:

• with advanced coronary and cerebral atherosclerosis, hypertension, and severe cardiac arrhythmias. Patients with severe cardiac arrhythmias or a history of myocardial infarction should be closely monitored;
• with a high risk of sudden hypotension;
• with certain autoimmune diseases (systemic lupus erythematosus and mixed collagenosis).

In patients with renal impairment (creatinine clearance less than 30 ml/min), the daily dose of pentoxifylline should be reduced to prevent accumulation of the medicine. The dose of the medicine should also be reduced in patients with severe hepatic impairment (see section 3).

Polfilin and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pentoxifylline may enhance the effects of antihypertensive medicines.

During concomitant use with theophylline, the serum concentration of theophylline may increase, leading to an increased risk of adverse effects.

Oral anticoagulants, coumarin or indandione derivatives, heparin, and other medicines that affect blood coagulation may interact with pentoxifylline. Concomitant use of pentoxifylline with these medicines increases the risk of bleeding.

In case of concomitant use with oral hypoglycemic agents or insulin, the effect of hypoglycemic agents may be enhanced, and hypoglycemic reactions may occur.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.

Pregnancy

Since there is insufficient data on the use of pentoxifylline in pregnant women, the use of the medicine during pregnancy is not recommended.

Breastfeeding

Pentoxifylline passes into breast milk.

Driving and using machines

In some patients, adverse effects such as dizziness have been observed, which may impair physical and mental performance. If such adverse effects occur, the patient should not drive or operate machines.

Polfilin contains sodium

Polfilin solution for injection contains 17.7 mg of sodium (the main component of common salt) per 5 ml ampoule. This corresponds to 0.89% of the maximum recommended daily intake of sodium in the diet for adults.

Polfilin concentrate for solution for infusion contains 53.17 mg of sodium (the main component of common salt) per 15 ml ampoule. This corresponds to 2.66% of the maximum recommended daily intake of sodium in the diet for adults.

Polfilin solution for injection and Polfilin concentrate for solution for infusion should be diluted before administration - see below "Information intended for healthcare professionals only". The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared solution.

To obtain accurate information about the sodium content in the solution used for dilution, the patient should consult the package leaflet of the diluent used.

In patients with reduced renal function and patients on a controlled sodium diet, the sodium content in the medicine should be considered.

3. How to use Polfilin

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor.

This medicine can only be administered by qualified medical personnel.

Detailed dosing and administration instructions are provided at the end of the leaflet, in the section "Information intended for healthcare professionals only".

Use in children

The safety and efficacy of the medicine in children have not been established.

Overdose of Polfilin

If the patient suspects that they have received too much of the medicine, they should immediately inform their doctor or nurse, as treatment of overdose symptoms may be necessary.

The following symptoms may occur: dizziness, nausea, vomiting, hypotension, tachycardia, arrhythmias, sudden flushing of the face, tonic-clonic seizures, loss of consciousness, fever, agitation, and loss of reflexes.

Missed dose of Polfilin

If the patient suspects that a dose of the medicine has been missed, they should inform their doctor or nurse as soon as possible.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

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

Many side effects associated with parenteral administration of the medicine can be prevented by reducing the infusion rate.

The following side effects have been reported during treatment with the medicine:

• rare (occurring in less than 1 in 1,000 patients):
• hypersensitivity reactions, such as itching, flushing, urticaria (characterized by blisters and itching);
• arrhythmias (e.g. tachycardia);
• dizziness and headaches.

very rare (occurring in less than 1 in 10,000 patients):

• bleeding (e.g. on the skin, mucous membranes, stomach, intestines). In single cases, thrombocytopenia (reduced platelet count in peripheral blood) has been observed;
• severe hypersensitivity reactions in the first minutes after administration of the medicine (anaphylactoid reaction, bronchospasm, anaphylactic shock);
• hypotension, sudden symptoms of angina pectoris; these symptoms occur mainly during treatment with high doses of pentoxifylline;
• intrahepatic cholestasis (bile stasis), increased activity of liver enzymes (aminotransferases, alkaline phosphatase);
• restlessness, sleep disorders, aseptic meningitis - patients with autoimmune diseases (systemic lupus erythematosus, mixed collagenosis) are predisposed.

Hot flashes (flushing of the face, feeling of heat) may also occur, as well as gastrointestinal disorders such as nausea, vomiting, bloating, feeling of fullness, and diarrhea.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Polfilin

Store in a temperature below 25°C.

Store in the original packaging to protect from light.

Keep the medicine out of the sight and reach of children.

Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.

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 pack and other information

What Polfilin contains

• The active substance of the medicine is pentoxifylline. Each ml of solution for injection or concentrate for solution for infusion contains 20 mg of pentoxifylline.
• The other ingredients are: sodium chloride, water for injection.

What Polfilin looks like and contents of the pack

Polfilin is a clear, colorless or almost colorless solution in glass ampoules.

One pack of solution for injection contains 5 ampoules of 5 ml each, each ampoule containing 100 mg of pentoxifylline.

One pack of concentrate for solution for infusion contains 10 ampoules of 15 ml each, each ampoule containing 300 mg of pentoxifylline.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA SA

ul. Pelplińska 19

83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

During administration of the medicine, the patient should be lying down. Polfilin should be administered only as an intravenous infusion.

Recommended dose for adults:

100 to 600 mg of pentoxifylline per day in 1 or 2 divided doses, diluted in 100 to 500 ml of infusion solution, such as 0.9% sodium chloride solution or Ringer's solution (in other cases, the pharmaceutical compatibility of the solution used for dilution should be checked).

The infusion should be administered at a rate of 100 mg of pentoxifylline per 60 minutes. The recommended infusion time should be observed.

In cases of advanced disease, particularly in patients with severe rest pain, gangrene, or ulceration, continuous 24-hour infusion of pentoxifylline may be indicated. The dose of the medicine should be calculated taking into account the infusion rate of 0.6 mg/kg body weight per hour. In adults with average body weight, however, the daily dose should not exceed 1200 mg. When determining the volume of the infusion, the indication for use should be taken into account. Generally, the infusion volume is within the range of 1 to 1.5 liters per day.

The dose of pentoxifylline administered as an intravenous infusion can be supplemented with oral treatment. However, the total daily dose of pentoxifylline, administered both parenterally and orally, should not exceed 1200 mg.

In patients with low or unstable blood pressure, modification of the dosing regimen may be necessary.

In patients with renal impairment (creatinine clearance less than 30 ml/min), the dose of the medicine should be reduced to 50-70% of the standard dose.

In patients with severe hepatic impairment, dose reduction is necessary. The treating doctor determines the dose based on the severity of symptoms and tolerance to the medicine.

In patients with hypotension or unstable cardiovascular function, the infusion should be started with a small dose of pentoxifylline, as a transient sudden drop in blood pressure with a tendency to fainting, and in rare cases, symptoms of angina pectoris, may occur.

Appropriate management is also necessary in patients with circulatory failure. In these patients, administration of a high-volume infusion should be avoided.