Apo-pentox 400 Sr

Package Leaflet: Information for the User

Apo-Pentox 400 SR,400 mg, prolonged-release tablets
Pentoxifylline

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

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Apo-Pentox 400 SR and what is it used for
• 2. Important information before taking Apo-Pentox 400 SR
• 3. How to take Apo-Pentox 400 SR
• 4. Possible side effects
• 5. How to store Apo-Pentox 400 SR
• 6. Contents of the pack and other information

1. What is Apo-Pentox 400 SR and what is it used for

Apo-Pentox 400 SR increases the flexibility of red blood cells, making it easier for them to circulate in blood vessels with a diameter close to that of the red blood cell. It reduces blood viscosity, dilates blood vessels, and has an anti-coagulant effect. It improves blood flow in the blood vessels of the lower limbs, cerebral blood vessels, and reduces circulatory disorders of the retina. Improved blood flow in the blood vessels increases oxygen supply to the tissues. Pentoxifylline (the active substance of the medicine) alleviates cerebral ischemic states (lack of concentration, memory disorders, depression, etc.), increases the distance of intermittent claudication, alleviates nocturnal pains in cases of prolonged ischemia of the lower limbs, and accelerates the healing of ischemic ulcers.

Apo-Pentox 400 SR is used in:

• chronic peripheral arterial disease stage IIb according to Fontaine (intermittent claudication), atherosclerotic disease of the arteries, when other measures such as walking or reconstructive surgery to expand the vessel lumen are not possible, or when they cannot be performed or are not indicated
• disorders of the inner ear (hearing disorders, sudden hearing loss, etc.) caused by circulatory disorders
• treatment of leg ulcers.

2. Important information before taking Apo-Pentox 400 SR

When not to take Apo-Pentox 400 SR:

• if you are allergic to pentoxifylline, other similar substances called methylxanthines: caffeine, theophylline, theobromine, or any of the other ingredients of this medicine listed in section 6,
• if you have had severe bleeding and diseases with a high risk of bleeding,
• if you have had a extensive retinal hemorrhage (extensive blood loss from the retina),
• if you have severe heart rhythm disturbances,
• if you have had a myocardial infarction.

Warnings and precautions

Before starting to take Apo-Pentox 400 SR, discuss it with your doctor or pharmacist.
If the first symptoms of a severe and generalized allergic reaction (anaphylactic or pseudo-anaphylactic reaction) occur, discontinue taking Apo-Pentox 400 SR and contact your doctor immediately

Close monitoring is required:

• if you have hypotension or uncontrolled blood pressure, due to the increased risk of further blood pressure drop, see also section 3,
• if you have severe coronary artery disease (abnormal function of the coronary arteries responsible for its blood supply), heart rhythm disorders (its irregular heartbeat), or myocardial infarction (so-called "heart attack") - occlusion of the arteries responsible for its blood supply,
• if you have low blood pressure (drop in blood pressure). You may experience dizziness, malaise, angina pectoris, arrhythmia,
• if you have severe renal impairment (renal function impairment, creatinine clearance less than 30 ml/min),
• if you have severe liver impairment (liver function impairment),
• if you have an increased tendency to bleeding caused by e.g. the use of anticoagulant drugs or blood coagulation disorders, see section "When not to take Apo-Pentox 400 SR",
• if Apo-Pentox 400 SR is taken simultaneously with vitamin K antagonists, drugs that inhibit platelet aggregation,
• if you are taking Apo-Pentox 400 SR simultaneously with drugs that control blood sugar levels (antidiabetic drugs),
• if you are taking Apo-Pentox 400 SR simultaneously with the antibiotic ciprofloxacin,
• if you are being treated with pentoxifylline and drugs containing theophylline.
• children, as there is a lack of data on the use of pentoxifylline in this patient group.

Children and adolescents

There is a lack of experience with the use of pentoxifylline in this patient group.

Apo-Pentox 400 SR and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as the medicines you plan to take.
In rare cases, high doses of pentoxifylline have enhanced the blood sugar lowering effect (hypoglycemic effect) of insulin and other blood sugar lowering medicines (hypoglycemic drugs). However, no changes in insulin release have been observed after pentoxifylline administration.
Therefore, patients taking antidiabetic drugs should be under constant medical supervision.
In patients taking pentoxifylline simultaneously with vitamin K antagonists, events of enhanced anticoagulant effect have been reported. When starting or modifying the dose of Apo-Pentox 400 SR, close monitoring of anticoagulant activity is recommended in these patients.
Apo-Pentox 400 SR may enhance the blood pressure lowering effect caused by antihypertensive drugs (drugs used to treat high blood pressure, such as ACE inhibitors) and other drugs that may lower blood pressure (such as nitrates).
Taking Apo-Pentox 400 SR with another drug containing theophylline may increase theophylline plasma levels in some patients and lead to enhanced or increased frequency of theophylline side effects.
Taking Apo-Pentox 400 SR with the antibiotic ciprofloxacin may lead to enhanced or increased frequency of pentoxifylline side effects.
Potential additive effect with platelet aggregation inhibitors: due to the increased risk of bleeding, caution should be exercised in patients taking pentoxifylline 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 lysine acetylsalicylate, ticlopidine, dipyridamole.
Concomitant use of Apo-Pentox 400 SR with cimetidine may increase pentoxifylline and its active metabolite plasma levels.

Apo-Pentox 400 SR with food and drink

Tablets should be taken orally, swallowed whole, with a meal or immediately after a meal.
The tablet should be taken with a large amount of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Due to the lack of sufficient data on the use of pentoxifylline in pregnant women, it is not recommended to take Apo-Pentox 400 SR during pregnancy.
Breastfeeding
Pentoxifylline passes into breast milk in small amounts. Due to the lack of sufficient data, the doctor should carefully weigh the potential benefits and risks to the baby.

Driving and using machines

This medicine has no significant influence on the ability to drive and use machines.

3. How to take Apo-Pentox 400 SR

Always take this medicine exactly as described in this package leaflet or as directed by your doctor.
In case of doubt, consult your doctor or pharmacist.
The dose and method of administration of Apo-Pentox 400 SR depend on the type and severity of vascular disorders and how the patient tolerates the medicine.
The recommended initial dose is 3 tablets per day. The maintenance dose is usually 2 tablets per day.
Tablets should be taken without chewing, after a meal, with an adequate amount of fluid (about half a glass of water).
Special patient groups
Children and adolescents
The safety and efficacy of pentoxifylline in these patients have not been established.
Liver function disorders
Since pentoxifylline is slowly eliminated in patients with liver function disorders, caution should be exercised when administering the medicine to these patients.
Kidney function disorders
In patients with kidney function disorders (creatinine clearance less than 30 ml/min), the doctor will reduce the dose to 50-70% of the usual recommended dose.
Others
In patients with hypotension and in patients with severe coronary artery disease and cerebral vascular disease treated with Apo-Pentox 400 SR, caution should be exercised. The doctor will reduce the initial dose and then gradually increase it.

Taking a higher dose of Apo-Pentox 400 SR than recommended

Overdose of this medicine can be dangerous. If you have taken a higher dose of Apo-Pentox 400 SR than recommended, inform your doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Apo-Pentox 400 SR

Do not take a double dose to make up for a missed dose.

Stopping treatment with Apo-Pentox 400 SR

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Apo-Pentox 400 SR can cause side effects, although not everybody gets them.
The following side effects have been reported during clinical trials or after the marketing of the medicine, and their frequency has not been determined.

• Blood and lymphatic system disorders:decreased platelet count, thrombocytopenia; leukopenia/neutropenia
• Immune system disorders:anaphylactic or pseudo-anaphylactic reaction, angioedema (swelling of the face, lips or tongue), bronchospasm, anaphylactic shock
• Psychiatric disorders:agitation, sleep disorders
• Nervous system disorders:dizziness, headache, aseptic meningitis
• Cardiac disorders:arrhythmia (heart rhythm disturbance), tachycardia (increased heart rate), chest pain or discomfort, angina pectoris (chest pain)
• Vascular disorders:hot flashes, hemorrhagic purpura (bleeding into the skin and/or mucous membranes), especially in patients with a tendency to bleeding
• Gastrointestinal disorders:gastrointestinal disorders, feeling of abdominal fullness, feeling of heaviness in the stomach, nausea, vomiting, diarrhea, constipation, excessive salivation (increased saliva production)
• Hepatobiliary disorders:intrahepatic cholestasis (bile retention in the liver)
• Skin and subcutaneous tissue disorders:pruritus, skin redness and urticaria, rash
• Investigations:increased liver enzyme activity (aminotransferases), decreased blood pressure.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apo-Pentox 400 SR

Keep this medicine out of the sight and reach of children.
Store in a room temperature, i.e. between 15°C and 25°C.
Do not use this medicine after the expiry date stated on the packaging after (EXP). 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Pentox 400 SR contains

The active substance is pentoxifylline.
One prolonged-release tablet contains 400 mg of pentoxifylline.
The other ingredients are:
Core:hypromellose 2208K 100M, magnesium stearate, colloidal silicon dioxide.
Coating:hypromellose 2910, macrogol 3350, carnauba wax, titanium dioxide (E 171), purified water.

What Apo-Pentox 400 SR looks like and contents of the pack

Apo-Pentox 400 SR prolonged-release tablets are white, biconvex, capsule-shaped, with the inscription "APO" on one side and "400" on the other.
Packaging: 30 or 90 prolonged-release tablets.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok. 27
01-909 Warsaw
Poland

Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Date of last revision of the leaflet: