Agapurin Sr 400

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Agapurin SR 400(Pentoxifylline SR Zentiva 400 mg)

400 mg, prolonged-release tablets

Pentoxifylline
Agapurin SR 400 and Pentoxifylline SR Zentiva 400 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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, cerebrovascular disorders 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

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

Warnings and precautions

Before starting treatment with Agapurin SR 400, you should 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, and severe renal dysfunction.
If symptoms of anaphylactic or pseudo-anaphylactic reactions occur, you should discontinue use of Agapurin SR 400 and immediately contact your doctor.
During treatment with Agapurin SR 400, patients with heart rhythm disorders, advanced coronary and cerebral atherosclerosis with arterial hypotension, and post-myocardial infarction should be under constant medical supervision.
Renal dysfunction (creatinine clearance <30 ml min) and severe liver dysfunction 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 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 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. For this reason, during treatment, blood pressure should be monitored.
Patients taking Agapurin SR 400 simultaneously with ciprofloxacin should be under constant medical supervision (see "Agapurin SR 400 and other medicines", below).
Patients taking pentoxifylline simultaneously with theophylline should be under constant medical supervision (see "Agapurin SR 400 and other medicines").

Agapurin SR 400 and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Agapurin SR 400 may enhance the effect of antihypertensive medicines (including ACE 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. For this reason, 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 is advised in patients taking pentoxifylline simultaneously with platelet aggregation inhibitors, such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, non-steroidal anti-inflammatory drugs, 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 blood. For this reason, 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 levels in the blood.

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 plan to have a child, you should consult your doctor before taking this medicine.
This medicine is not recommended for use in pregnant or breastfeeding women.
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 effect on the ability to drive or use machines.

3. How to take Agapurin SR 400

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The usual dose is one tablet, two or three 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 liver 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 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 an 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

In case of overdose, you should immediately consult a doctor or pharmacist.
Initial symptoms may include nausea, dizziness, rapid heartbeat, hypotension, followed by fever, agitation, hot flashes, loss of consciousness, disappearance of reflexes, seizures, 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, you should immediately consult a doctor.

Missed dose of Agapurin SR 400

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

Discontinuation of Agapurin SR 400

Without consulting a doctor, you should not stop taking the medicine.
If you have any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Agapurin SR 400 can cause side effects, although not everybody gets them.
You should 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, such as hives (urticaria), swelling of the face, eyelids, lips, mouth, or difficulty breathing. These conditions can be life-threatening.
• retinal hemorrhage.

You should 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 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 (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 (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 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 parts of the body, 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 any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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, 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

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 2208/15000, povidone 30, talc, magnesium stearate, Sepifilm 752 white (hypromellose, microcrystalline cellulose, polyoxyethylene 40 stearate, titanium dioxide), simethicone emulsion SE 4, 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.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 9191/2016/01
9191/2016/02
9191/2016/03
Parallel import authorization number: 129/24

Date of leaflet approval: 25.03.2024

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