Agapurin sr 600

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
AGAPURIN SR 600 (АГАПУРИН SR 600)
600 mg, prolonged-release tablets
Pentoxifyllinum
AGAPURIN SR 600 and АГАПУРИН SR 600 are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the 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 circulation disorders caused by atherosclerosis, diabetes, as well as 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 within the eyeball (acute and chronic disorders of retinal and choroidal circulation);
• Disorders of inner ear function (hearing disturbances, sudden hearing loss, etc.) caused by circulatory disorders;
• Cerebral ischemia states (post-stroke conditions, cerebrovascular disorders with symptoms such as lack of concentration, dizziness, memory disturbances, etc.).

Agapurin SR 600 is intended for use in adult patients.

2. Important information before using Agapurin SR 600

When not to use Agapurin SR 600

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

Warnings and precautions
Before starting treatment with Agapurin SR 600, discuss this with your doctor or pharmacist.
The doctor should consider the benefit-risk ratio of using Agapurin SR 600 in patients with hypotension, severe cardiac arrhythmias, advanced coronary or cerebral atherosclerosis, acute myocardial infarction, diabetes, or severe renal impairment.
If symptoms of anaphylactic or anaphylactoid reactions occur, discontinue use of Agapurin SR 600 immediately and contact your physician without delay.
Patients with severe cardiac arrhythmias, advanced coronary or cerebral atherosclerosis, hypotension, or a history of myocardial infarction should be under continuous medical supervision during treatment with Agapurin SR 600.
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 taking Agapurin SR 600 concomitantly with vitamin K antagonists, antiplatelet agents, or antidiabetic drugs should be under continuous medical supervision.
Patients taking Agapurin SR 600 together with antidiabetic drugs should be under continuous medical supervision (see "Agapurin SR 600 with other medicines", below).
In patients with low blood pressure or heart disease, administration of Agapurin SR 600 may result in a sudden drop in blood pressure and, rarely, back pain or retrosternal pain. Therefore, blood pressure should be monitored during treatment.
Patients taking Agapurin SR 600 concomitantly with ciprofloxacin should be under continuous medical supervision (see "Agapurin SR 600 with other medicines", below).
Patients taking pentoxifylline concomitantly with theophylline should be under continuous medical supervision (see "Agapurin SR 600 with other medicines").

Agapurin SR 600 with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to use.
Agapurin SR 600 may enhance the effect of antihypertensive drugs (including angiotensin-converting enzyme inhibitors) or other drugs that lower blood pressure (e.g., nitrates).
In patients treated with insulin or oral antidiabetic drugs, administration of Agapurin SR 600 may intensify the reduction in blood glucose concentration. Therefore, diabetic patients should be under continuous medical supervision.
In patients taking 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 600 in these patients.
Due to an increased risk of bleeding, caution is advised in patients taking pentoxifylline concomitantly with antiplatelet agents such as: clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, non-selective COX-2 inhibitor nonsteroidal anti-inflammatory drugs, acetylsalicylates (acetylsalicylic acid or lysine acetylsalicylate), ticlopidine, 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 pentoxifylline concentrations. Therefore, increased frequency and severity of adverse effects associated with the concomitant use of these two active substances may occur.
Concomitant use of Agapurin SR 600 with cimetidine may increase plasma concentrations of pentoxifylline and its active metabolite.

Agapurin SR 600 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 have a child, she should consult her doctor before using this medicine.
Use of this medicine is not recommended in pregnant women or in women who are breastfeeding.
In breastfeeding women, the physician will decide whether 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 600

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The usual dose is 1 tablet once or twice daily.
Patients with low or fluctuating blood pressure may require a special dosing regimen.
Dosing in patients with impaired renal function
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, depending on individual tolerance to treatment.
Dosing in patients with impaired liver function
In patients with severe hepatic insufficiency, dose reduction is necessary. The treating physician will decide
on the appropriate dose based on the severity of liver impairment and individual tolerance to treatment.
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 600 than recommended
If you take more than the recommended dose, seek immediate advice from your doctor or
pharmacist.
Initial symptoms may include nausea, dizziness, increased heart rate, hypotension, followed by fever,
agitation, hot flushes, loss of consciousness, diminished reflexes, seizures, and coffee-ground vomiting
(related to 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 doctor immediately.
Missed dose of Agapurin SR 600
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 600
Do not discontinue treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

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

Promptly contact a doctor if the patient develops a tendency to bruising or bleeding, as these may be symptoms of thrombocytopenia (reduced platelet count). In such cases, blood morphology should be monitored regularly in patients receiving Agapurin SR 600.

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, bloating, 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 (reddening of the skin), itching, urticaria, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (increased heart rate), palpitations (awareness of heartbeats), cardiac arrhythmias, angina pectoris (chest pain), restlessness, sleep disturbances, hallucinations, hypoglycaemia (low blood glucose levels), anaphylactic shock.

Very rare (occurring in fewer than 1 out of 10,000 patients): aplastic anaemia, thrombocytopenia, haemorrhages (e.g. into the skin, mucous membranes, stomach, intestines).

Not known (frequency cannot be determined 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 disturbances, discomfort in the epigastrium, sensation of fullness in the abdomen (feeling of satiety), constipation, excessive salivation, decreased blood pressure, bronchospasm.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the medicine.

5. How to store Agapurin SR 600

Keep the medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Agapurin SR 600 contains
The active substance is pentoxifylline 600 mg.
Other components: hypromellose 2208/15000, povidone 30, talc, magnesium stearate; coating:
Sepifilm 752 white (hypromellose, microcrystalline cellulose, polyoxyl 40 stearate, titanium
dioxide (E 171)), simethicone emulsion SE4, macrogol 6000.

What Agapurin SR 600 looks like and contents of the pack
White or almost white, oval, biconvex tablets with a score line.
Pack size: 20, 50 or 100 prolonged-release tablets in blisters packed in a cardboard box.

For more detailed information, please contact the responsible party or parallel importer.

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

Manufacturer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
92027 Hlohovec
Slovakia
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37, Prague 10
Czech Republic

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation number in Bulgaria, country of export: 20010389
Parallel import authorisation number: 129/25