Agapurin sr 400
Poland
Table of Contents
Package leaflet: Information for the user
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 trade names of the same medicinal product.
Please read this leaflet carefully before taking 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 the same.
- If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of 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 circulation disorders caused by atherosclerosis, diabetes, inflammatory or functional causes; 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 disturbances of retinal and choroidal circulation);
- Disorders of inner ear function (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. Important 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 ingredients of this medicine (listed in section 6);
- if the patient has recently suffered an acute myocardial infarction or stroke;
- if the patient has significantly increased bleeding 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 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 coronary and cerebral vessels, acute myocardial infarction, diabetes mellitus, 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 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 with other medicines" below).
In patients with low blood pressure or heart disease, administration of Agapurin SR 400 may cause 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 400 concomitantly with ciprofloxacin should be under continuous medical supervision (see "Agapurin SR 400 with other medicines" below).
Patients taking pentoxifylline concomitantly with theophylline should be under continuous medical supervision (see "Agapurin SR 400 with other medicines" below).
Agapurin SR 400 with other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
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 decrease in blood glucose concentration.
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. Close monitoring of anticoagulant effect is recommended when initiating or modifying the dose of Agapurin SR 400 in these patients.
Due to increased risk of bleeding, caution should be exercised 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, 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 reactions 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 or 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 women who are breastfeeding, the doctor will decide whether potential benefits outweigh the risks to the infant.
Driving and operating machinery
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 used 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 arterial 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 physician will reduce the dose to 50–70% of the normally recommended dose, depending on individual tolerance, and may recommend administration of 1 or 2 tablets per day.
Dosing in patients with hepatic impairment
In patients with severe liver dysfunction, dose reduction is necessary. The treating physician will determine 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 with 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.
Overdose of Agapurin SR 400
In case of accidental overdose, seek immediate medical advice from a doctor or pharmacist.
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, contact a doctor immediately.
Missed dose of Agapurin SR 400
If a dose is accidentally missed, it should be taken as soon as possible. However, if it is almost time for the next dose, only take the next scheduled dose at the regular time. Do not take a double dose to make up for the missed dose.
Discontinuation of Agapurin SR 400
Do not discontinue the 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 experiences them.
Immediately consult a doctor if the patient experiences:
- 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), swelling of the face, eyelids, lips, mouth, or difficulty breathing. These conditions may be life-threatening.
- retinal haemorrhage.
Promptly consult a doctor 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 blood morphology monitoring should be performed during treatment 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, 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), pruritus (itching), urticaria, increased sweating, cholestasis (bile flow stasis), increased liver enzyme activity (aminotransferases), hypotension (low blood pressure), tachycardia (accelerated heart rate), palpitations (awareness of heart beating), cardiac arrhythmias, angina pectoris (chest pain), restlessness, sleep disturbances, hallucinations, hypoglycaemia (low blood glucose levels), 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).
Not known (frequency cannot be estimated 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 disorder, discomfort in the epigastrium, feeling of fullness in the abdomen (satiety), constipation, excessive salivation, hypotension, bronchospasm.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 400
Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, polyglycol monostearate 2000, titanium dioxide),
simethicone emulsion SE 4 (purified water, dimethicone, anhydrous colloidal silicon dioxide, cetyl stearyl alcohol with emulsifier, sodium benzoate), 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 blister packs, packed in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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, 920 27 Hlohovec, Slovak Republic
Zentiva, k.s., U Kabelovny 130, 102 37 Prague 10, Czech Republic
Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, the country of export: 83/360/07-C
Parallel Import Authorisation Number: 243/22