Agapurin sr 600

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Agapurin SR 600 (AGAPURIN SR 600)
600 mg, prolonged-release tablets
Pentoxifyllinum
Agapurin SR 600 and AGAPURIN SR 600 are the same trade names of the same medicinal product written in Polish and Bulgarian.
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• 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 other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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 Agapurin SR 600:

• Peripheral arterial and arteriovenous circulatory 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);
• Disorders of inner ear function (hearing disturbances, sudden hearing loss, etc.) caused by circulatory disorders;
• Cerebral ischemia (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 taking Agapurin SR 600
When not to use Agapurin SR 600

• if you are allergic to pentoxifylline, other methylxanthines, or to any of the other ingredients of this medicine (listed in section 6);
• if you have recently suffered a myocardial infarction or stroke;
• if you have significant bleeding or diseases associated with a high risk of hemorrhage;
• if you have experienced retinal hemorrhage.

Warnings and precautions
Before starting treatment with Agapurin SR 600, discuss it with your doctor or pharmacist.
Your 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 or hepatic impairment.
If symptoms of anaphylactic or pseudoallergic reactions occur, discontinue Agapurin SR 600 and contact your doctor immediately.
Patients with cardiac arrhythmias, advanced coronary or cerebral atherosclerosis, hypotension, or 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 pentoxifylline elimination. In such cases, the dose should be reduced and the patient should remain under continuous medical supervision.
Patients with an increased tendency to bleeding 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 cause a sudden drop in blood pressure and, rarely, back pain or chest 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 you are currently taking or have recently taken, as well as any medicines you plan to take.
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 decrease 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. When initiating or adjusting the dose of Agapurin SR 600 in these patients, close monitoring of anticoagulant activity is recommended.
Due to 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 nonsteroidal anti-inflammatory drugs (other than selective COX-2 inhibitors), acetylsalicylates (acetylsalicylic acid or lysine acetylsalicylate), ticlopidine, dipyridamole.
In some patients, concomitant use of pentoxifylline and theophylline may increase plasma theophylline concentrations and intensify adverse effects associated with theophylline.
In some patients, concomitant use of pentoxifylline and ciprofloxacin may increase serum pentoxifylline concentrations. Therefore, increased frequency and severity of adverse effects associated with 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 you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
Use of this medicine is not recommended in pregnant women or in women who are breastfeeding.
In women who are breastfeeding, the doctor will decide whether the potential benefits outweigh the risks to the infant.
Driving and using machines
This medicine has no influence 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. If in doubt, 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
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 a meal, with an adequate amount of water.

Use of a higher than recommended dose of Agapurin SR 600
If an overdose is taken, seek immediate medical advice from a doctor or pharmacist.
Initial symptoms may include nausea, dizziness, tachycardia, hypotension, followed by fever, agitation, 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 doctor immediately.

Missed dose of Agapurin SR 600
If a dose is accidentally missed, it should be taken as soon as possible. If the time for the next dose is approaching,
only take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Discontinuation of Agapurin SR 600
Do not discontinue use of this medicine without consulting your doctor.

If you have any further questions regarding 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 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), swelling of the face, eyelids, lips, mouth, or difficulty breathing. These conditions may be life-threatening.
• retinal hemorrhage.

Promptly consult a doctor if the patient develops a tendency to bruising and bleeding, as these may be symptoms of thrombocytopenia (reduced number of blood platelets). In such cases, blood morphology should be regularly monitored in patients treated with Agapurin SR 600.
Gastrointestinal adverse reactions are dose-dependent and usually resolve after discontinuation of treatment.
Adverse reactions may occur with the following frequency:
Common (occurring in 1 to 10 patients out of 100): nausea, vomiting, bloating, abdominal pain, diarrhea.
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), itching, urticaria, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (accelerated heart rate), palpitations (sensation of rapid or irregular heartbeat), cardiac arrhythmias, angina pectoris (chest pain), anxiety, sleep disturbances, hallucinations, hypoglycemia (abnormally low blood glucose levels), anaphylactic shock.
Very rare (occurring in fewer than 1 in 10,000 patients): aplastic anemia, thrombocytopenia, hemorrhages (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, restlessness, angioedema (swelling of various body parts, most commonly in the face), rash, aseptic meningitis, gastrointestinal disorder, discomfort in the upper abdomen, feeling 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Agapurin SR 600
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Agapurin SR 600 contains
The active substance is pentoxifylline 600 mg.
Other ingredients: hypromellose 2208/15000, povidone 30, talc, magnesium stearate, Sepifilm 752
white (hypromellose, microcrystalline cellulose, polyoxy 40 stearate, titanium dioxide),
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 dividing score line.
Pack sizes: 20, 50 or 100 prolonged-release tablets in blister packs contained in a cardboard box.

For further information, please contact the responsible party or the 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
920 27 Hlohovec
Slovakia
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

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

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing Authorisation number in Bulgaria, country of export: 20010389
Parallel import licence number: 30/24