AGAPURIN 400 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
3. Agapurin SR 400 (Agapurin)
4. 400 mg, prolonged-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
5. What is Agapurin SR 400 and what is it used for
6. Important information before taking Agapurin SR 400
   1. When not to take Agapurin SR 400
   2. Warnings and precautions
   3. Agapurin SR 400 and other medicines
   4. Agapurin SR 400 with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
7. How to take Agapurin SR 400
   1. Overdose of Agapurin SR 400
   2. Missed dose of Agapurin SR 400
   3. Stopping treatment with Agapurin SR 400
8. Possible side effects
   1. Reporting side effects
9. How to store Agapurin SR 400
10. Contents of the pack and other information
    1. What Agapurin SR 400 contains
    2. What Agapurin SR 400 looks like and contents of the pack
    3. Marketing authorization holder in the Czech Republic, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import authorization number: 99/18 Date of approval of the leaflet: 23.02.2023

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 medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell your 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, 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.
Your 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 heart attack, diabetes, and severe renal dysfunction.
If symptoms of anaphylactic or pseudo-anaphylactic reactions 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 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 concurrently with vitamin K antagonists, platelet aggregation inhibitors, or oral antidiabetic drugs, should be under constant medical supervision.
Patients taking Agapurin SR 400 concurrently with oral 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, blood pressure should be monitored during treatment.
Patients taking Agapurin SR 400 concurrently with ciprofloxacin should be under constant medical supervision (see "Agapurin SR 400 and other medicines" below).
Patients taking pentoxifylline concurrently with theophylline should be under constant medical supervision (see "Agapurin SR 400 and other medicines").

Agapurin SR 400 and other medicines

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 effects 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, patients with diabetes should be under constant medical supervision.
In patients taking pentoxifylline concurrently 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 pentoxifyllines concurrently 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 l-lysine acetylsalicylate, ticlopidine, dipyridamole.
In some patients, concurrent use of pentoxifylline and theophylline may increase theophylline levels in the blood and enhance its adverse effects.
In some patients, concurrent use of pentoxifylline and ciprofloxacin may increase pentoxifylline levels in the serum. Therefore, an increase in the frequency and severity of adverse effects associated with the concurrent use of these two active substances may occur.
Concurrent 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, 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 child.

Driving and using machines

This medicine does not affect the ability to drive or 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, 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 must 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 concurrent 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

If you have taken more than the recommended dose of the medicine, consult 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 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 of the medicine by a child, consult your doctor immediately.

Missed dose of Agapurin SR 400

If you have missed a dose of the medicine, 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 treatment with this medicine without consulting your doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Agapurin SR 400 can cause side effects, although not everybody gets them.
Consult your doctor immediately 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, swelling of the face, eyelids, lips, mouth, or difficulty breathing. These conditions can be life-threatening.
• retinal hemorrhage.

Consult your doctor immediately 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 out of 100): nausea, vomiting, bloating, abdominal pain, diarrhea.
Uncommon (occurring in 1 to 10 patients out of 1000): dizziness, headache, blurred vision, hot flashes.
Rare (occurring in 1 to 10 patients out of 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 (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, 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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 out of sight and reach of children.
No special storage precautions are required.
Do not use 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. 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, povidone 30, talc, magnesium stearate, Sepifilm 752 white (hypromellose, microcrystalline cellulose, macrogol-2000-monostearate, titanium dioxide), simethicone emulsion SE4, 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, consult the marketing authorization holder or 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, 92027 Hlohovec, Slovak Republic
Zentiva, k.s., U kabelovny 130, 102 37, Prague 10 - Dolní Měcholupy, Czech Republic

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Czech Republic, country of export, authorization number: 83/360/07-C

Parallel import authorization number: 99/18 Date of approval of the leaflet: 23.02.2023

[Information about the trademark]