Agapurin sr 400 mg
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Agapurin SR 400 (Pentoxifilinǎ SR Zentiva 400 mg)
400 mg, prolonged-release tablets
Pentoxifyllinum
Agapurin SR 400 and Pentoxifilinǎ SR Zentiva 400 mg are different trade names for the same
medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any doubts, please 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 another person, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What Agapurin SR 400 is and what it is used for
- Important information before taking Agapurin SR 400
- How to take Agapurin SR 400
- Possible side effects
- How to store Agapurin SR 400
- Contents of the pack and other information
1. What Agapurin SR 400 is and what it is used for
Indications for Agapurin SR 400:
- 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 disturbances in the eyeball (acute and chronic disturbances in retinal and choroidal circulation);
- 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 400 is intended for use in adult patients.
2. Important information before using Agapurin SR 400
When not to use Agapurin SR 400
- if the patient is allergic to pentoxifylline, other methylxanthines, or to any of the other ingredients of this medicine (listed in section 6);
- if the patient has recently suffered an acute myocardial infarction or stroke;
- if the patient has significant bleeding disorders or diseases with a high risk of haemorrhage;
- if the patient has experienced a retinal haemorrhage.
Warnings and precautions
Before starting treatment with Agapurin SR 400, discuss this with your doctor or pharmacist.
Your doctor should consider the benefit-risk ratio of using Agapurin SR 400 in patients with hypotension, severe cardiac arrhythmias, advanced atherosclerosis of the coronary and cerebral vessels, acute myocardial infarction, diabetes, or severe renal impairment.
If symptoms of anaphylactic or pseudoanaphylactic reactions occur, treatment with Agapurin SR 400 must be discontinued immediately and the patient should contact their doctor without delay.
Patients with cardiac arrhythmias, advanced atherosclerosis of the coronary and cerebral vessels, hypotension, or history of myocardial infarction should be under continuous medical supervision during treatment with Agapurin SR 400.
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 must remain under continuous medical supervision.
Patients with an increased tendency to bleed who are taking Agapurin SR 400 concomitantly with vitamin K antagonists, antiplatelet agents, or antidiabetic drugs should be under continuous medical supervision.
Patients taking Agapurin SR 400 together with antidiabetic drugs should be under continuous medical supervision (see "Agapurin SR 400 and other medicines" below).
In patients with low blood pressure or heart disease, administration of Agapurin SR 400 may result in a sudden drop in arterial blood pressure and, rarely, back pain or retrosternal pain. Therefore, blood pressure should be monitored during treatment.
Patients taking Agapurin SR 400 concomitantly with ciprofloxacin should be under continuous medical supervision (see "Agapurin SR 400 and other medicines" below).
Patients taking pentoxifylline concomitantly with theophylline should be under continuous medical supervision (see "Agapurin SR 400 and other medicines").
Agapurin SR 400 and other medicines
Inform your doctor about all medicines currently used, recently taken, or planned for use.
Agapurin SR 400 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 400 may intensify the reduction in blood glucose levels. Therefore, diabetic patients should be under continuous medical supervision.
Cases of enhanced anticoagulant effect have been reported in patients taking pentoxifylline concomitantly with vitamin K antagonists. When initiating or modifying the dose of Agapurin SR 400 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, selective COX-2 inhibitors, nonsteroidal anti-inflammatory drugs, acetylsalicylic acid (acetylsalicylic acid or lysine acetylsalicylate), ticlopidine, or 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 lead to increased serum pentoxifylline concentrations. This may result in increased frequency and severity of adverse effects associated with the combined use of these two active substances.
Concomitant use of Agapurin SR 400 with cimetidine may increase plasma concentrations of pentoxifylline and its active metabolite.
Agapurin SR 400 with food and drink
See section 3.
Pregnancy and breastfeeding
If the patient is pregnant, 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 or breastfeeding women.
In breastfeeding women, 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 400
This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor or pharmacist.
The usual dose is 1 tablet two or three times daily.
Patients with low or fluctuating blood pressure may require a special dosing regimen.
Dosing in patients with renal function impairment
In patients with impaired renal function (creatinine clearance < 30 ml/min), the physician may reduce the dose to 50-70% of the normally recommended dose and may recommend administering 1 or 2 tablets per day, depending on individual tolerance to treatment.
Dosing in patients with hepatic function impairment
In patients with severe liver impairment, 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.
Other
In patients with severe circulatory disorders, the effect of pentoxifylline may be enhanced by concomitant administration of Agapurin SR 400 and intravenous pentoxifylline infusion.
Use in children and adolescents
There is no experience regarding the use of this medicine in children.
Method of administration
Tablets should be swallowed whole during or immediately after meals, with an adequate amount of water.
Taking more than the recommended dose of Agapurin SR 400
If more than the recommended dose is taken, seek immediate advice from a doctor or pharmacist.
Initial symptoms may include nausea, dizziness, tachycardia, hypotension, followed by fever, restlessness, 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 400
If a dose is accidentally missed, take it as soon as possible. If it is almost time for the next dose, take only the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
Stopping Agapurin SR 400
Do not discontinue treatment without consulting a 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.
Immediate medical attention must be sought 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), facial swelling, eyelids, lips, oral cavity, or breathing difficulties. These conditions may be life-threatening.
- haemorrhage into the retina.
Prompt medical advice should be sought if the patient develops a tendency to bruising or bleeding, as these may be symptoms of thrombocytopenia (reduced number of blood platelets).
In such cases, regular monitoring of blood morphology should be performed in patients treated with Agapurin SR 400.
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, flatulence, 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), pruritus, urticaria, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (accelerated heart activity), palpitations (awareness of heartbeats), cardiac arrhythmias, angina pectoris (chest pain), restlessness, sleep disturbances, hallucinations, hypoglycaemia (too low blood glucose concentration), anaphylactic shock.
Very rare (occurring in fewer than 1 in 10,000 patients): aplastic anaemia, thrombocytopenia, haemorrhages (e.g. into the skin, mucous membranes, stomach, intestines).
Frequency not known (frequency cannot be estimated from the 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 epigastrium, feeling of fullness in the abdomen (feeling of satiety), constipation, excessive salivation, hypotension, 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 enables better assessment of the medicine's safety profile.
5. How to store Agapurin SR 400
Keep this medicine out of sight and reach of children.
Store 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 indicated.
Medicines should 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 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, polyoxyl 40 stearate, titanium dioxide),
simethicone emulsion SE 4, macrogol 6000.
What Agapurin SR 400 looks like and contents of the packaging
White, smooth, round, biconvex tablets.
Pack sizes: 20, 50 or 100 prolonged-release tablets in blister packs contained in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Marketing authorisation numbers in Romania, the country of export: 9191/2016/01
9191/2016/02
9191/2016/03
Parallel import authorisation number: 129/24