Agapurin Sr 400

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Agapurin SR 400 (Agapurin)

400 mg, Prolonged-Release Tablets

Pentoxifylline
Agapurin SR 400 and Agapurin are different trade names for the same drug.

Read the Leaflet Carefully Before Taking the Medication, 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. 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 any not listed in this leaflet, please 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 disorders of inflammatory or functional origin; 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;
• states of cerebral ischemia (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.
The 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 myocardial infarction, diabetes, severe renal impairment.
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 post-myocardial infarction should be under constant medical supervision.
Renal impairment (creatinine clearance <30 ml min) and severe hepatic impairment may cause delayed elimination of pentoxifylline.
In such cases, the dose of Agapurin SR 400 should be reduced and the patient should be under constant medical supervision.
Patients with increased bleeding tendency, taking Agapurin SR 400 concomitantly with vitamin K antagonists, platelet aggregation inhibitors, or antidiabetic drugs should be under constant medical supervision.
Patients taking Agapurin SR 400 concomitantly with antidiabetic drugs should be under constant medical supervision (see "Agapurin SR 400 and other medicines", below).
In patients with low blood pressure or heart disease, after administration of Agapurin SR 400, 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 SR 400 concomitantly with ciprofloxacin should be under constant medical supervision (see "Agapurin SR 400 and other medicines", below).
Patients taking pentoxifylline concomitantly with theophylline should be under constant medical supervision (see "Agapurin SR 400 and other medicines", below).

Agapurin SR 400 and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about medicines you plan to take.
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, after administration of Agapurin SR 400, a decrease in blood glucose levels may occur.
Therefore, diabetic patients should be under constant medical supervision.
In patients taking pentoxifylline concomitantly 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 concomitantly 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 plasma levels and enhance its adverse effects.
In some patients, concomitant use of pentoxifylline and ciprofloxacin may increase pentoxifylline plasma levels. Therefore, an increase in the frequency and severity of adverse effects associated with concomitant use of these two active substances may occur.
Concomitant use of Agapurin SR 400 with cimetidine may increase pentoxifylline and its active metabolite plasma levels.

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.
Use of this medicine is not recommended 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.
Usually, the recommended dose is 1 tablet 2 or 3 times a day.
Patients with low or variable blood pressure may require a special dosing regimen.
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, a dose reduction is necessary.
The decision on the dose to be used is made by the treating doctor, depending on the degree of liver failure and individual tolerance of the 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 Agapurin SR 400, 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 hematemesis (vomiting blood 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 miss a dose of Agapurin SR 400, 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.

Stopping treatment with Agapurin SR 400

Do not stop taking Agapurin SR 400 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 400 can cause side effects, although not everybody gets them.
Seek immediate medical attention 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, facial, eyelid, lip, oral, or breathing difficulties. These conditions can be life-threatening.
• retinal hemorrhage.

Seek immediate medical attention 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's blood morphology should be regularly monitored.
Gastrointestinal side effects are dose-dependent and usually disappear after discontinuation of treatment.
Side effects may occur with the following frequency:
Common (affecting 1 to 10 patients in 100): nausea, vomiting, bloating, abdominal pain, diarrhea.
Uncommon (affecting 1 to 10 patients in 1000): dizziness, headache, blurred vision, hot flashes.
Rare (affecting 1 to 10 patients in 10,000): allergic skin reactions, flushing, itching, hives, increased sweating, cholestasis, increased liver enzyme activity, hypotension, tachycardia, palpitations, arrhythmias, angina pectoris, anxiety, sleep disorders, hallucinations, hypoglycemia, anaphylactic shock.
Very rare (affecting 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, rash, aseptic meningitis, gastrointestinal disorders, discomfort in the upper abdomen, feeling of fullness in the stomach, constipation, excessive salivation, hypotension, bronchospasm.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Agapurin SR 400

Keep this medicine out of the sight and reach of children.
There are no special storage precautions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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, macrogol 2000 monostearate, titanium dioxide), simethicone emulsion SE 4 (purified water, dimeticone, colloidal silica, cetylstearyl alcohol with emulsifier, sodium benzoate), macrogol 6000.

What Agapurin SR 400 looks like and contents of the pack

White, smooth, round, biconvex tablets.
Pack sizes: 20, 50, or 100 prolonged-release tablets in blisters, in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Zentiva, k.s., U Kabelovny 130, 102 37 Prague 10, Czech Republic

Manufacturer:

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Zentiva, k.s., U Kabelovny 130, 102 37 Prague 10, Czech Republic

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:83/360/07-C

Parallel import authorization number: 243/22 Date of approval of the leaflet: 03.06.2022

[Information about the trademark]