Agapurin Sr 400

Package Leaflet: Information for the User

AGAPURIN SR 400

400 mg, prolonged-release 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.
• 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Agapurin SR 400 and what is it used for
• 2. Important information before taking Agapurin SR 400
• 3. How to take Agapurin SR 400
• 4. Possible side effects
• 5. How to store Agapurin SR 400
• 6. Contents of the pack and other information

1. What is Agapurin SR 400 and what is it used for

Indications for use of Agapurin SR 400:

• peripheral arterial and arteriovenous circulatory disorders caused by atherosclerosis, diabetes, as well as inflammatory or functional disorders; 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);
• inner ear disorders (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 SR 400 is intended for use in adult patients.

2. Important information before taking Agapurin SR 400

When not to take Agapurin SR 400

Warnings and precautions

Before starting treatment with Agapurin SR 400, discuss it with your doctor or pharmacist.
Your doctor should consider the benefit-risk ratio of using Agapurin SR 400 in patients with arterial hypotension, severe heart rhythm disorders,
advanced coronary and cerebral atherosclerosis, recent heart attack, diabetes,
severe renal function disorders.
If symptoms of anaphylactic or pseudo-anaphylactic reaction occur, discontinue use of Agapurin SR 400 and contact your doctor immediately.
During treatment with Agapurin SR 400, 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.
Renal function disorders (creatinine clearance <30 ml min) and severe liver function disorders
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 SR 400 simultaneously with vitamin K antagonists, platelet aggregation inhibitors or antidiabetic drugs should be under constant medical supervision.
Patients taking Agapurin SR 400 simultaneously with antidiabetic drugs should be under constant medical supervision (see "Agapurin SR 400 and other medicines", below).
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 SR 400 with cimetidine may increase pentoxifylline and its active metabolite levels in the blood.

Agapurin SR 400 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 400 may enhance the effects 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 taking Agapurin SR 400, a decrease in blood glucose levels may occur. Therefore, diabetic patients should be under constant medical supervision.
In patients taking pentoxifylline simultaneously with vitamin K antagonists, cases of enhanced anticoagulant effect have been reported. When starting or modifying the dose of Agapurin SR 400 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 acetylsalicylic acid lysine, 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.

Agapurin SR 400 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 400

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 1 tablet 2 or 3 times a day.
Patients with low or variable blood pressure may require a special dosing schedule.
Dosing in patients with renal impairment
In patients with renal impairment (creatinine clearance <30 ml min), the doctor will reduce dose to 50-70% of usual recommended dose, depending on individual tolerance treatment, and recommend taking 1 or 2 tablets a day.
Dosing in patients with hepatic impairment
In patients with severe liver failure, the dose should be reduced. The decision on the dose to be used is made by the treating doctor, depending on the degree of liver failure and individual tolerance to treatment.
Other
In patients with severe circulatory disorders, the effect of pentoxifylline can be accelerated by concomitant administration of Agapurin SR 400 and pentoxifylline in the form of intravenous infusion.

Use in children and adolescents

There is no experience with the use of Agapurin SR 400 in children.
Method of administration
Tablets should be swallowed whole during or immediately after a meal, with a sufficient amount of water.

Overdose of Agapurin SR 400

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 a hospital.
In case of overdose or accidental ingestion of the medicine by a child, contact your doctor immediately.

Missed dose of Agapurin SR 400

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

Discontinuation of Agapurin SR 400

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

4. Possible side effects

Like all medicines, Agapurin SR 400 can cause side effects, although not everybody gets them.
Seek medical attention immediately if you experience:

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

Seek medical attention immediately 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 400, the patient should have regular blood morphology tests.
Gastrointestinal side effects 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 in 100): nausea, vomiting, bloating, abdominal pain, diarrhea.
Uncommon (occurring in 1 to 10 patients in 1000): dizziness, headache, blurred vision, hot flashes.
Rare (occurring in 1 to 10 patients in 10,000): allergic skin reactions, flushing (redness of the skin), itching, urticaria, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (transaminases), hypotension (low blood pressure), tachycardia (rapid heart rate), palpitations (feeling of heart pounding), arrhythmias, angina pectoris (chest pain), anxiety, sleep disorders, hallucinations, hypoglycemia (low blood sugar), anaphylactic shock.
Very rare (occurring in less 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, pseudo-anaphylactic 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 leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl .
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 the medicine.

5. How to store Agapurin SR 400

Keep the 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 400 contains

The active substance is pentoxifylline in a dose of 400 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 400 looks like and contents of the pack

White, smooth, round, biconvex tablets.
Pack size: 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, contact the representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Phone: +48 22 375 92 00
Date of last revision of the leaflet: August 2024