Agapurin

Package Leaflet: Information for the User

AGAPURIN, 100 mg, coated tablets

Pentoxifylline

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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Agapurin and what is it used for

The active substance of Agapurin is pentoxifylline. The medicine improves blood circulation by increasing the elasticity of red blood cells, inhibiting blood clotting, and reducing blood viscosity, inhibiting the activity of white blood cells associated with inflammation.
Indications for use:

• peripheral arterial and arteriovenous circulatory disorders caused by atherosclerosis, diabetes, as well as disorders of inflammatory or functional origin; intermittent claudication or rest pain, diabetic angiopathy, obliterating vascular disease, trophic changes (post-thrombotic syndrome, leg ulcers, gangrene), angioneuropathies;
• circulatory disorders in the eye (acute and chronic circulatory disorders in the retina and choroid);
• disorders of the inner ear (hearing disorders, sudden hearing loss, etc.) caused by circulatory disorders;
• brain hypoperfusion states (post-stroke conditions, cerebral functional disorders of vascular origin with symptoms such as lack of concentration, dizziness, memory disorders, etc.).

Agapurin is intended for use in adult patients.

2. Important information before taking Agapurin

When not to take Agapurin

if you are allergic to pentoxifylline, other xanthines, or any of the other ingredients of this medicine (listed in section 6);
if you have recently had a heart attack or stroke;
if you have significantly increased bleeding and diseases with a high risk of bleeding;
if you have had a retinal hemorrhage.
In case of any of the above situations, consult a doctor.

Warnings and precautions

Before starting treatment with Agapurin, discuss it with your doctor or pharmacist.
The doctor should consider the benefit-risk ratio of using Agapurin in patients with arterial hypotension, severe heart rhythm disorders, advanced coronary and cerebral atherosclerosis, acute myocardial infarction, diabetes, severe renal dysfunction.
If symptoms of anaphylactic or pseudoanaphylactic reaction occur, discontinue use of Agapurin and immediately consult a doctor.
During treatment with Agapurin, patients with severe heart rhythm disorders, advanced coronary and cerebral atherosclerosis with arterial hypotension, and after myocardial infarction should be under constant medical supervision.
Renal dysfunction (creatinine clearance below 30 ml/min) and severe liver dysfunction may cause delayed elimination of pentoxifylline. In such cases, the dose of the medicine should be reduced and the patient should be under constant medical supervision.
Patients with increased bleeding tendency, taking Agapurin simultaneously with vitamin K antagonists, platelet aggregation inhibitors, or antidiabetic drugs should be under constant medical supervision.
Patients taking Agapurin simultaneously with antidiabetic drugs should be under constant medical supervision (see "Agapurin and other medicines" below).
In patients with low blood pressure or heart disease, after administration of Agapurin, a sudden drop in blood pressure and, rarely, back pain or chest pain may occur. Therefore, during treatment, blood pressure should be monitored.
Patients taking Agapurin simultaneously with ciprofloxacin should be under constant medical supervision (see "Agapurin and other medicines" below).
Patients taking pentoxifylline simultaneously with theophylline should be under constant medical supervision (see "Agapurin and other medicines").

Agapurin and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Agapurin may enhance the effect of antihypertensive medicines (including angiotensin-converting enzyme inhibitors) or other medicines that lower blood pressure (e.g., nitrates).
In patients treated with insulin or oral antidiabetic medicines, after administration of high doses of Agapurin, a decrease in blood glucose levels may be enhanced. Therefore, diabetic patients should be under constant medical supervision.
In patients taking pentoxifylline simultaneously with vitamin K antagonists, cases of increased anticoagulant effect have been reported. When starting or modifying the dose of Agapurin in these patients, close monitoring of anticoagulant activity is recommended.
Due to the increased risk of bleeding, caution is advised in patients taking pentoxifyllines simultaneously with platelet aggregation inhibitors, such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, non-steroidal anti-inflammatory drugs other than selective COX-2 inhibitors, acetylsalicylic acid (aspirin) or lysine acetylsalicylate, ticlopidine, dipyridamole.
In some patients, concomitant use of pentoxifylline and theophylline may increase theophylline levels in the blood and enhance its adverse effects.
In some patients, concomitant use of pentoxifylline and ciprofloxacin may increase pentoxifylline levels in the serum. Therefore, an increase in the frequency and severity of adverse effects associated with the concomitant use of these two active substances may occur.
Concomitant use of Agapurin with cimetidine may increase pentoxifylline and its active metabolite levels in the blood.

Agapurin with food and drink

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
It is not recommended to use this medicine in pregnant or breastfeeding women.
In breastfeeding women, the doctor will decide whether the potential benefits outweigh the risks to the child.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

Agapurin contains 91.94 mg of lactose monohydrate and 97.168 mg of sucrose in each tablet

If you have been diagnosed with intolerance to some sugars, consult a doctor before taking this medicine.

Agapurin contains sodium

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

3. How to take Agapurin

Always take this medicine exactly as your doctor has told you. If you are not sure, consult a doctor or pharmacist.
The dosage is determined by the doctor.
Adults
The recommended initial dose for the first week of treatment is 200 mg (2 tablets) three times a day. If there is a significant drop in blood pressure or adverse effects in the gastrointestinal tract or central nervous system occur, the doctor will decide to reduce the dose to 100 mg (1 tablet) three times a day. In long-term treatment, a dose of 100 mg (1 tablet) three times a day should be used.

Use in children and adolescents

There is limited experience with the use of this medicine in children and adolescents under 18 years of age. Therefore, it is not recommended to use Agapurin in this age group.
Dosage in patients with renal impairment
In patients with renal failure (creatinine clearance below 30 ml/min), the dose should be reduced to 50-70% of the usual recommended dose, depending on individual tolerance to treatment.
Dosage in patients with liver impairment
In patients with severe liver failure, it is necessary to reduce the dose. The decision on the dose used is made by the treating doctor, depending on the degree of liver failure and individual tolerance to treatment.
Maximum dose: do not exceed a dose of 1200 mg per day.
Method of administration
Tablets should be swallowed whole during or immediately after meals, with a sufficient amount of water.

Overdose of Agapurin

In case of overdose, consult a doctor or pharmacist immediately.
Initial symptoms may include nausea, dizziness, rapid heartbeat, hypotension, followed by fever, excitement, hot flashes, loss of consciousness, disappearance of reflexes, convulsions, and hematemesis (associated with gastrointestinal bleeding). Treatment of overdose is symptomatic.
In case of overdose or accidental ingestion by a child, consult a doctor immediately.

Missed dose of Agapurin

In case of a missed dose, take it as soon as possible. If it is close to the time of the next dose, take only that dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

Discontinuation of Agapurin

Do not stop taking the medicine without consulting a doctor.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Agapurin can cause side effects, although not everybody gets them.
Immediately consult a doctor if you experience:

• symptoms of anaphylactic shock, disorientation, and fainting (due to circulatory disorders and a drop in blood pressure) or anaphylactic reactions, e.g., bulging and itchy rash (hives), swelling of the face, eyelids, lips, mouth, or difficulty breathing. These conditions can be life-threatening.
• retinal hemorrhage

Immediately consult a doctor if you experience a tendency to bruise and bleed, as these may be symptoms of thrombocytopenia (reduced platelet count). In such cases, during treatment with Agapurin, the patient's blood morphology should be regularly monitored.
Side effects may occur with the following frequency:
Common (occurring in 1 to 10 patients out of 100): nausea, vomiting, bloating, abdominal pain, diarrhea.
Uncommon (occurring in 1 to 10 patients out of 1000): dizziness, headache, hot flashes, blurred vision.
Rare (occurring in 1 to 10 patients out of 10,000): allergic skin reactions, flushing (redness of the skin), itching, urticaria, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (rapid heart rate), palpitations (heart pounding), arrhythmias, angina pectoris (chest pain), anxiety, sleep disorders, hallucinations, hypoglycemia (low blood sugar levels), anaphylactic shock.
Very rare (occurring less frequently than 1 in 10,000 patients): aplastic anemia, thrombocytopenia, bleeding (e.g., into the skin, mucous membranes, stomach, intestines).
Unknown (frequency cannot be estimated from available data): anaphylactic reaction, pseudoanaphylactic reaction, leukopenia or neutropenia, excitement, angioedema (swelling of various body parts, most often in the face), rash, aseptic meningitis, gastrointestinal disorders, discomfort in the upper abdomen, feeling of fullness in the stomach (feeling of satiety), constipation, excessive salivation, decreased blood pressure, bronchospasm.

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 Adverse Reaction Monitoring 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 or its representative in Poland.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Agapurin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiration date stated on the package. The expiration date is the last day of the given 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 Agapurin contains

The active substance of Agapurin is pentoxifylline, 100 mg in one coated tablet.
Other ingredients are: lactose monohydrate, cornstarch, talc, magnesium stearate, colloidal silica anhydrous. Coating: sodium carmellose, sucrose, talc, titanium dioxide, colloidal silica anhydrous, arabic gum, white wax, and carnauba wax.

What Agapurin looks like and contents of the pack

Opalescent, white, biconvex coated tablets.
Pack size: 60 coated tablets.

Marketing authorization holder

Zentiva a.s., Einsteinova 24, 851 01 Bratislava, Slovak Republic.

Manufacturer

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovak Republic.
To obtain more detailed information, contact the representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Phone: +48 22 375 92 00

Date of last revision of the leaflet: