Agapurin Sr 600

Package Leaflet: Information for the User

AGAPURIN SR 600

600 mg, prolonged-release tablets

Pentoxifylline

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What Agapurin SR 600 is and what it is used for

Indications for use of Agapurin SR 600:

• peripheral arterial and arteriovenous circulatory disorders caused by atherosclerosis, diabetes, as well as inflammatory or functional disorders; intermittent claudication or rest pain, diabetic angiopathy, obliterative 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, cerebrovascular disorders with symptoms such as lack of concentration, dizziness, memory disorders, etc.).

Agapurin SR 600 is intended for use in adult patients.

2. Important information before taking Agapurin SR 600

When not to take Agapurin SR 600

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;

Warnings and precautions

Before starting treatment with Agapurin SR 600, discuss it with your doctor or pharmacist.
The doctor should consider the benefit-risk ratio of using Agapurin SR 600 in patients with arterial hypotension, severe heart rhythm disorders, advanced coronary and cerebral atherosclerosis, recent heart attack, diabetes, severe kidney function disorders.
If symptoms of anaphylactic or pseudoanaphylactic reaction occur, discontinue use of Agapurin SR 600 and immediately contact your doctor.
During treatment with Agapurin SR 600, patients with severe heart rhythm disorders, advanced coronary and cerebral atherosclerosis with arterial hypotension and after a heart attack should be under constant medical supervision.
Kidney function disorders (creatinine clearance <30 ml min) and severe liver function disorders may cause delayed elimination of pentoxifylline. in such cases, the dose medicine should be reduced patient under constant medical supervision.
Patients with an increased tendency to bleeding, taking Agapurin SR 600 simultaneously with vitamin K antagonists, platelet aggregation inhibitors or antidiabetic drugs should be under constant medical supervision.
Patients taking Agapurin SR 600 simultaneously with antidiabetic drugs should be under constant medical supervision (see "Agapurin SR 600 and other medicines", below).
In patients with low blood pressure or heart disease, after administration of Agapurin SR 600, a sudden drop in blood pressure and, rarely, back pain or chest pain may occur.
For this reason, during treatment, blood pressure should be monitored.
Patients taking Agapurin SR 600 simultaneously with ciprofloxacin should be under constant medical supervision (see "Agapurin SR 600 and other medicines", below).
Patients taking pentoxifylline simultaneously with theophylline should be under constant medical supervision (see "Agapurin SR 600 and other medicines").

Agapurin SR 600 and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Agapurin SR 600 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 Agapurin SR 600, a decrease in blood glucose levels may occur. For this reason, 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 SR 600 in these patients, close monitoring of anticoagulant activity is recommended.
Due to the increased risk of bleeding, caution should be exercised in patients taking pentoxifylline 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 side effects.
In some patients, concomitant use of pentoxifylline and ciprofloxacin may increase pentoxifylline levels in the blood. For this reason, an increase in the frequency and severity of side effects associated with the concomitant use of these two active substances may occur.
Concomitant use of Agapurin SR 600 with cimetidine may increase pentoxifylline and its active metabolite levels in the blood.

Agapurin SR 600 with food and drink

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
This medicine should not be used during pregnancy and breastfeeding.
In breastfeeding women, the doctor will decide whether the potential benefits outweigh the risks to the baby.

Driving and using machines

This medicine has no influence on the ability to drive and use machines.

3. How to take Agapurin SR 600

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
The usual dose is one tablet once or twice a day.
Patients with low or variable blood pressure may require a special dosing schedule.
Dosing in patients with kidney function disorders
In patients with kidney function disorders (creatinine clearance <30 ml min), the doctor will reduce dose to 50-70% of usual recommended dose, depending on individual tolerance treatment.
Dosing in patients with liver function disorders
In patients with severe liver failure, the dose must be reduced. The decision on the dose used is made by the attending physician, depending on the degree of liver failure and individual tolerance to treatment.

Use in children and adolescents

There is no experience with the use of Agapurin SR 600 in children.
Method of administration
Tablets should be swallowed whole during or immediately after meals, with a sufficient amount of water.

Take more Agapurin SR 600 than recommended

If you have taken more than the recommended dose of the medicine, contact your doctor or pharmacist immediately.
Initial symptoms may include nausea, dizziness, rapid heartbeat, hypotension, followed by fever, agitation, hot flashes, loss of consciousness, disappearance of reflexes, convulsions and coffee-ground vomiting (associated with gastrointestinal bleeding). Treatment of overdose is symptomatic. The patient may require intensive medical care in the hospital.
In case of overdose or accidental ingestion of the medicine by a child, contact your doctor immediately.

Miss a dose of Agapurin SR 600

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, take only the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stop taking Agapurin SR 600

Do not stop taking the medicine without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Agapurin SR 600 can cause side effects, although not everybody gets them.
Immediately inform your 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 inform your 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 SR 600, the patient's blood morphology should be regularly monitored.
Side effects from the gastrointestinal system are dose-dependent and usually disappear after discontinuation of treatment.
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, blurred vision, hot flashes.
Rare (occurring in 1 to 10 patients out of 10,000): allergic skin reactions, flushing (redness of the skin), itching, hives, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (rapid heart rate), palpitations (feeling of heartbeat), 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, agitation, 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 package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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, e-mail: .
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Agapurin SR 600

Keep this medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the 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 SR 600 contains

The active substance is pentoxifylline in a quantity of 600 mg.
The other ingredients are: hypromellose, povidone 30, talc, magnesium stearate, Sepifilm 752 white (hypromellose, microcrystalline cellulose, polyoxyethylene 40 stearate, titanium dioxide), simethicone emulsion, macrogol 6000.

What Agapurin SR 600 looks like and contents of the pack

White or almost white, oval, biconvex tablets with a dividing line.
Pack sizes: 20, 50 or 100 prolonged-release tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Zentiva k.s. U kabelovny 130, Dolní Měcholupy, 102 37 Prague, Czech Republic.
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00
Date of last revision of the package leaflet: August 2024