PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Agapurin SR 400 (Agapurin 400 mg)
400 mg, prolonged-release tablets
Pentoxifyllinum
Agapurin SR 400 and Agapurin 400 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before taking this 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Agapurin SR 400 is and what it is used for
What you need to know before taking Agapurin SR 400
How to take Agapurin SR 400
Possible side effects
How to store Agapurin SR 400
Contents of the pack and other information

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

Indications for Agapurin SR 400:

Peripheral arterial and arteriovenous circulation disorders caused by atherosclerosis, diabetes, inflammatory or functional conditions; intermittent claudication or rest pain, diabetic angiopathy, obliterative vascular disease, trophic changes (post-thrombotic syndrome, leg ulcers, gangrene), angioneuropathies;
Circulatory disorders in the eyeball (acute and chronic circulatory disturbances in the retina and choroid);
Inner ear function disorders (hearing disturbances, sudden hearing loss, etc.) caused by circulatory disorders;
Cerebral ischemia (post-stroke conditions, vascular-origin brain dysfunction with symptoms such as lack of concentration, dizziness, memory disturbances, etc.).

Agapurin SR 400 is intended for use in adult patients.

2. Important information before using the medicine Agapurin SR 400

When not to use Agapurin SR 400

if the patient is allergic to pentoxifylline, other methylxanthines, or to any of the other ingredients of this medicine (listed in section 6);
if the patient has recently suffered an acute myocardial infarction or stroke;
if the patient has significantly increased bleeding or diseases with a high risk of haemorrhage;
if the patient has experienced a retinal haemorrhage.

Warnings and precautions
Before starting treatment with Agapurin SR 400, discuss this with your doctor or pharmacist.
Your doctor should consider the benefit-risk ratio of using Agapurin SR 400 in patients with hypotension, severe cardiac arrhythmias, advanced coronary and cerebral atherosclerosis, acute myocardial infarction, diabetes, or severe renal impairment.
If symptoms of anaphylactic or anaphylactoid reactions occur, discontinue use of Agapurin SR 400 immediately and contact your doctor without delay.
Patients with severe cardiac arrhythmias, advanced coronary and cerebral atherosclerosis, hypotension, or history of myocardial infarction should be under continuous medical supervision during treatment with Agapurin SR 400.
Renal impairment (creatinine clearance < 30 ml/min) and severe hepatic dysfunction may delay the elimination of pentoxifylline. In such cases, the dose should be reduced and the patient should remain under continuous medical supervision.
Patients with an increased tendency to bleed who are using Agapurin SR 400 concomitantly with vitamin K antagonists, antiplatelet agents, or antidiabetic medicines should be under continuous medical supervision.
Patients using Agapurin SR 400 together with antidiabetic medicines should be under continuous medical supervision (see "Agapurin SR 400 with other medicines", below).
In patients with low blood pressure or heart disease, administration of Agapurin SR 400 may cause a sudden drop in blood pressure and, rarely, back pain or chest pain. Therefore, blood pressure should be monitored during treatment.
Patients using Agapurin SR 400 concomitantly with ciprofloxacin should be under continuous medical supervision (see "Agapurin SR 400 with other medicines", below).
Patients using pentoxifylline concomitantly with theophylline should be under continuous medical supervision (see "Agapurin SR 400 with other medicines").

Agapurin SR 400 with other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Agapurin SR 400 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, administration of Agapurin SR 400 may intensify the decrease in blood glucose concentration. Therefore, diabetic patients should be under continuous medical supervision.
In patients using pentoxifylline concomitantly with vitamin K antagonists, increased anticoagulant effect has been reported. Close monitoring of anticoagulant activity is recommended when initiating or adjusting the dose of Agapurin SR 400 in these patients.
Due to an increased risk of bleeding, caution should be exercised in patients using pentoxifylline concomitantly with antiplatelet agents such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, non-selective non-steroidal anti-inflammatory drugs (other than selective COX-2 inhibitors), acetylsalicylates (acetylsalicylic acid or lysine acetylsalicylate), ticlopidine, or dipyridamole.
In some patients, concomitant use of pentoxifylline and theophylline may increase theophylline plasma concentrations and intensify adverse effects associated with its use.
In some patients, concomitant use of pentoxifylline and ciprofloxacin may increase serum concentrations of pentoxifylline. Therefore, increased frequency and severity of adverse reactions may occur when these two active substances are used together.
Concomitant use of Agapurin SR 400 with cimetidine may increase plasma concentrations of pentoxifylline and its active metabolite.

Agapurin SR 400 with food and drink
See section 3.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Use of this medicine is not recommended in pregnant or breastfeeding women.
In breastfeeding women, the doctor will decide whether the potential benefits outweigh the risks to the infant.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

3. How to use Agapurin SR 400

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
The usual dose is 1 tablet two or three times daily.
Patients with low or fluctuating blood pressure may require a special dosing regimen.
Dosing in patients with renal function impairment
In patients with impaired renal function (creatinine clearance < 30 ml/min), the physician will reduce
the dose to 50–70% of the normally recommended dose and may recommend administering 1 or 2
tablets per day, depending on individual treatment tolerance.
Dosing in patients with hepatic function impairment
In patients with severe liver insufficiency, dose reduction is necessary. The treating physician will
decide on the appropriate dose based on the severity of liver impairment and individual treatment
tolerance.
Other
In patients with severe circulatory disorders, the effect of pentoxifylline may be enhanced by
concomitant administration of Agapurin SR 400 and intravenous infusion of pentoxifylline.
Use in children and adolescents
There is no experience regarding use in children.
Method of administration
Tablets should be swallowed whole during or immediately after meals, with an adequate amount of
water.
Taking more Agapurin SR 400 than recommended
If you take more than the recommended dose, contact your physician or pharmacist immediately.
Initial symptoms may include nausea, dizziness, increased heart rate, hypotension, followed by fever,
excitation, hot flushes, loss of consciousness, diminished reflexes, seizures, and coffee-ground
vomiting (indicative of gastrointestinal bleeding). Treatment of overdose is symptomatic. The patient
may require intensive medical care in a hospital.
In case of overdose or accidental ingestion by a child, contact a physician immediately.
Missed dose of Agapurin SR 400
If you accidentally miss a dose, 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 a missed dose.
Stopping Agapurin SR 400
Do not discontinue use of this medicine without consulting your physician.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Immediately consult a doctor if the patient experiences:

symptoms of anaphylactic shock, disorientation and fainting (due to circulatory disturbances and drop in blood pressure) or anaphylactic reactions, such as raised, itchy rash (urticaria), facial swelling, swelling of the eyelids, lips, oral cavity, or difficulty breathing. These conditions may be life-threatening.
retinal haemorrhage

Promptly consult a doctor if the patient develops a tendency to bruising and bleeding, as these may be symptoms of thrombocytopenia (reduced platelet count). In such cases, regular monitoring of blood morphology should be performed during treatment with Agapurin SR 400.
Gastrointestinal adverse reactions are dose-dependent and usually resolve after discontinuation of treatment.
Adverse reactions may occur with the following frequencies:
Common (occurring in 1 to 10 patients out of 100): nausea, vomiting, flatulence, abdominal pain, diarrhoea.
Uncommon (occurring in 1 to 10 patients out of 1,000): dizziness, headache, blurred vision, hot flushes.
Rare (occurring in 1 to 10 patients out of 10,000): skin allergic reactions, erythema (skin redness), pruritus (itching), urticaria, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (increased heart rate), palpitations (awareness of heartbeats), angina pectoris (chest pain), restlessness, sleep disturbances, hallucinations, hypoglycaemia (low blood glucose concentration), anaphylactic shock.
Very rare (occurring in fewer than 1 in 10,000 patients): aplastic anaemia, thrombocytopenia, haemorrhages (e.g. into the skin, mucous membranes, stomach, intestines).
Not known (frequency cannot be estimated from available data): anaphylactic reaction, pseudoanaphylactic reaction, leukopenia or neutropenia, agitation, angioedema (swelling of various body parts, most commonly in the face), rash, aseptic meningitis, gastrointestinal disorder, discomfort in the epigastrium, feeling of fullness in the abdomen (feeling of satiety), constipation, excessive salivation, decrease in blood pressure, bronchospasm.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Agapurin SR 400

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must 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 400 mg.
The other ingredients are: hypromellose, povidone K 30, talc, magnesium stearate, simethicone emulsion SE 4, macrogol 6000, Sepifilm 752 white (hypromellose, microcrystalline cellulose, glyceryl monostearate of macrogol 2000, titanium dioxide).

What Agapurin SR 400 looks like and contents of the pack
White, smooth, round, biconvex tablets.
Pack size: 20 prolonged-release tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Zentiva, k. s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer:
Saneca Pharmaceuticals a. s.
Nitrianska 100
Hlohovec
Slovak Republic
Zentiva, k. s.
U Kabelovny 130
102 37, Prague 10 - Dolní Měcholupy
Czech Republic

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Relabeled in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Czech Republic Marketing Authorisation Number (country of export): 83/360/07-C
Parallel Import Licence Number: 228/19