Agapurin sr 400
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Agapurin SR 400 (Agapurin)
400 mg, prolonged-release tablets
Pentoxifyllinum
Agapurin SR 400 and Agapurin are different brand names for the same medicine.
Please read this 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 questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents:
- What Agapurin SR 400 is and what it is used for
- What you need to know 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 circulation disorders caused by atherosclerosis, diabetes, or 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);
- Inner ear function disorders (hearing disturbances, sudden hearing loss, etc.) caused by circulatory disorders;
- Cerebral ischemia (post-stroke conditions, vascular-origin brain dysfunction with symptoms such as lack of concentration, dizziness, memory disturbances, etc.).
Agapurin SR 400 is intended for use in adult patients.
2. Information before using Agapurin SR 400
When not to use Agapurin SR 400
- if the patient is allergic to pentoxifylline, other methylxanthines, or any of the other components of this medicine (listed in section 6);
- if the patient has recently experienced acute myocardial infarction or stroke;
- if the patient has significant bleeding disorders or diseases with a high risk of hemorrhage;
- if the patient has experienced retinal hemorrhage.
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 hypotension, severe cardiac arrhythmias, advanced atherosclerosis of coronary and cerebral vessels, acute myocardial infarction, diabetes, or severe renal impairment.
If symptoms of anaphylactic or pseudoallergic reactions occur, discontinue use of Agapurin SR 400 immediately and contact your doctor without delay.
Patients with severe cardiac arrhythmias, advanced atherosclerosis of 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 should remain under continuous medical supervision.
Patients with increased bleeding tendency who are using Agapurin SR 400 concomitantly with vitamin K antagonists, antiplatelet agents, or antidiabetic drugs should be under continuous medical supervision.
Patients using Agapurin SR 400 together with antidiabetic drugs should be under continuous medical supervision (see "Agapurin SR 400 with other medicines", below).
In patients with low blood pressure or heart disease, administration of Agapurin SR 400 may lead to a sudden drop in arterial blood pressure and, rarely, back pain or retrosternal pain. Therefore, blood pressure should be monitored during treatment.
Patients using Agapurin SR 400 concomitantly with ciprofloxacin should be under continuous medical supervision (see "Agapurin SR 400 with other medicines", below).
Patients using pentoxifylline together with theophylline should be under continuous medical supervision (see "Agapurin SR 400 with other medicines").
Agapurin SR 400 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 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 concentration. Therefore, diabetic patients should be under continuous medical supervision.
In patients using 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 400 in these patients.
Due to increased risk of bleeding, caution is advised in patients using pentoxifylline together 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, 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 increase serum pentoxifylline concentrations. Therefore, increased frequency and severity of adverse effects may occur when these two active substances are used together.
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 become pregnant, 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 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 400
This medicine should always be taken as prescribed by your doctor. If in doubt, consult your 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 impairment
In patients with impaired renal function (creatinine clearance < 30 ml/min), the doctor will 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 impairment
In patients with severe liver dysfunction, 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 sufficient water.
Taking more Agapurin SR 400 than prescribed
If you take more tablets than prescribed, contact your doctor or pharmacist immediately.
Initial symptoms may include nausea, dizziness, tachycardia, hypotension, followed by fever, excitation, hot flushes, loss of consciousness, diminished reflexes, convulsions, 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, seek medical advice immediately.
Missed dose of Agapurin SR 400
If you accidentally miss a dose, take it as soon as possible. If it is almost time for the next dose, take only the scheduled dose at the correct time. Do not take a double dose to make up for the missed dose.
Stopping Agapurin SR 400
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 effects
Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
Immediately consult a doctor if the patient develops:
- symptoms of anaphylactic shock, disorientation, or fainting (due to circulatory disturbances and drop in blood pressure) or anaphylactic reactions, such as raised, itchy rash (urticaria), facial swelling, eyelid swelling, lip swelling, swelling of the mouth or breathing difficulties. These conditions may be life-threatening.
- retinal haemorrhage.
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 monitored regularly in patients treated with Agapurin SR 400.
Gastrointestinal adverse effects are dose-dependent and usually resolve after discontinuation of treatment.
Adverse effects 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 (skin redness), itching, urticaria, increased sweating, cholestasis (bile stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (rapid heartbeat), palpitations (awareness of heartbeats), cardiac arrhythmias, angina pectoris (chest pain), restlessness, sleep disturbances, hallucinations, hypoglycaemia (low blood glucose levels), anaphylactic shock.
Very rare (occurring less frequently than in 1 out of 10,000 patients): aplastic anaemia, thrombocytopenia, haemorrhages (e.g. into the skin, mucous membranes, stomach, intestines).
Not known (frequency cannot be estimated from available data): anaphylactic reaction, pseudoanaphylactic reaction, leucopenia or neutropenia, agitation, 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, decreased blood pressure, bronchospasm.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Agapurin SR 400
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. This will help protect the environment.
6. Contents of the package 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, polyethylene glycol monostearate, titanium dioxide),
simethicone emulsion SE4, polyethylene glycol 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 blister packs contained in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in the Czech Republic, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 83/360/07-C
Parallel import authorisation number: 99/18