PENTOXIFYLLINE ALTER 400 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pentoxifylline Alter 400 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Pentoxifylline Alter and what is it used for
2. What you need to know before you take Pentoxifylline Alter
3. How to take Pentoxifylline Alter
4. Possible side effects.
5. Storage of Pentoxifylline Alter
6. Contents of the pack and further information

1. What is Pentoxifylline Alter and what is it used for

Pentoxifylline is a medicine that belongs to the group of medicines called peripheral vasodilators.

Always under the prescription of your doctor, pentoxifylline is indicated for the treatment of peripheral circulatory disorders due to arteriosclerosis, diabetes, inflammation or other causes such as leg ulcers and gangrene.

2. What you need to know before you take Pentoxifylline Alter

Do not take Pentoxifylline Alter

• If you are allergic to pentoxifylline or any of the other ingredients of this medicine (listed in section 6).
• If you have ever experienced an allergic reaction to another medicine of this group (xanthines).
• If you have a massive hemorrhage or a significant retinal hemorrhage.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pentoxifylline tablets.

• If you have severe heart rhythm disorders.
• If you have had a previous myocardial infarction.
• If your blood pressure is low (hypotension).
• If you have a renal function disorder (creatinine clearance less than 30 ml/min).
• If you have severe liver function impairment.
• If you are at high risk of bleeding, such as in patients being treated with anticoagulant medications (which inhibit blood coagulation) or patients with bleeding disorders, being treated with antiplatelet agents (see "Taking Pentoxifylline 400 mg tablets with other medicines").
• If you are taking antidiabetic medications (medicines used to lower blood glucose levels),
• If you are taking ciprofloxacin
• If you are taking theophylline.

Children and adolescents

There is no experience with the use of Pentoxifylline 400 mg tablets in children.

Patients with renal impairment

Your doctor will indicate the dose you should take at each moment.

Patients with hepatic impairment

Your doctor will indicate the dose you should take at each moment.

Taking Pentoxifylline 400 mg tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Especially if you are being treated with oral anticoagulants or antiplatelet agents, as their use with Pentoxifylline increases the risk of bleeding. For this reason, your doctor may subject you to periodic checks.

The concomitant administration of pentoxifylline with blood pressure-lowering medications (antihypertensives) may potentiate the effect of the latter, so your doctor may need to adjust your dose.

Treatment with pentoxifylline in patients receiving medications for diabetes (insulin or oral treatment) may also potentiate the effect of these medications. For this reason, you should undergo periodic checks.

Simultaneous treatment with pentoxifylline and theophylline (a medication for the treatment of asthma) may cause an elevation of theophylline levels, thereby increasing its side effects.

Similarly, simultaneous treatment with Pentoxifylline and ciprofloxacin (a medication for the treatment of bacterial infections) may cause an elevation of pentoxifylline levels, thereby increasing its adverse effects.

Simultaneous treatment with Pentoxifylline and antiplatelet agents (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, other non-selective non-steroidal anti-inflammatory drugs, acetylsalicylic acid/lysine acetylsalicylate, ticlopidine, dipyridamole), may potentiate the anticoagulant effect and increase the risk of bleeding.

The concomitant administration of Pentoxifylline with cimetidine (a medication for the treatment of gastric ulcers) may increase pentoxifylline and active Metabolite I levels.

Taking Pentoxifylline 400 mg tablets with food and drinks

The tablets can be swallowed whole during or immediately after meals with the help of a sufficient amount of liquid (approximately half a glass of water).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Pentoxifylline should not be administered during pregnancy.

Breastfeeding

There is not enough data to establish the safety of using Pentoxifylline during the breastfeeding period. Therefore, your doctor will assess the convenience of continuing or not continuing treatment while you are breastfeeding your child.

Driving and using machines

The ability to drive and use machines may be impaired due to possible adverse reactions.

Important information about some of the ingredients of Pentoxifylline Alter

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Pentoxifylline Alter

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

If you think the action of pentoxifylline is too strong or too weak, tell your doctor or pharmacist.

The recommended dose is 1 tablet (400 mg of pentoxifylline) 2 or 3 times a day.

If you have severe kidney or liver disease, your doctor may reduce the dose, adjusting it according to your disease and tolerance to this medicine.

If you have low blood pressure, unstable circulation, or suffer from a disease for which a decrease in blood pressure could be harmful (severe coronary heart disease or narrowing of the blood vessels that supply the brain), your doctor will prescribe a low initial dose, which will be gradually increased according to your response to treatment.

If you observe a severe allergic reaction (anaphylactic or anaphylactoid) with inflammation of the mouth and respiratory tract that causes difficulty breathing and a drop in blood pressure, stop your treatment with pentoxifylline immediately and inform your doctor.

Your doctor will indicate the duration of your treatment with pentoxifylline. Do not stop your treatment before.

If you take more Pentoxifylline Alter than you should

Consult your doctor immediately or go to the emergency department of the nearest hospital, accompanied by this leaflet.

If you take a dose that is too high of pentoxifylline, you may initially experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. Additionally, fever, agitation, hot flashes, loss of consciousness, loss of reflexes, convulsions, skin rashes, and, as a sign of gastrointestinal bleeding, coffee-ground vomiting may appear.

In case of overdose or accidental ingestion, consult your doctor immediately or go to the emergency department of the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pentoxifylline Alter

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects of unknown frequency (cannot be estimated from the available data):

Complementary tests:

Increased transaminases (liver enzymes), decreased blood pressure.

Gastrointestinal disorders:

Stomach pressure, gastrointestinal discomfort, feeling of fullness, nausea, vomiting, diarrhea, constipation, hypersalivation (increased saliva production).

Cardiac disorders:

Alterations of heart rhythm with increased or decreased heart rate (e.g., palpitations), angina pectoris.

Vascular disorders:

Hot flashes, bleeding (e.g., skin and/or mucous membrane bleeding localized in the stomach and/or intestine), especially in patients with a high risk of bleeding.

Nervous system disorders:

Dizziness, headache, benign inflammation of the meninges (aseptic meningitis).

Hepatobiliary disorders:

Liver function disorders, such as intrahepatic cholestasis (obstruction of bile in the liver).

Disorders of the skin and subcutaneous tissue:

Erythema (skin redness), itching, skin rash or urticaria (hives, skin irritation, and itching), rash.

Disorders of the immune system:

Severe allergic reactions (anaphylactic or anaphylactoid) with inflammation of the mouth and respiratory tract that cause difficulty breathing and a drop in blood pressure. Angioedema (fluid accumulation in the tongue and throat that can cause asphyxia), bronchospasm (bronchial spasms that make normal breathing difficult).

Psychiatric disorders:

Agitation and sleep disturbances.

Disorders of the blood and lymphatic system:

Thrombocytopenia (decreased platelet count), leucopenia/neutropenia (decreased white blood cell count).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pentoxifylline Alter

Keep this medicine out of the sight and reach of children.

Store in the original package.

Do not use this medicine after the expiry date stated on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Pentoxifylline Alter

• The active ingredient is pentoxifylline
• The other ingredients are stearic acid, carnauba wax, hypromellose, lactose, magnesium stearate, cellulose acetate, triacetin, and "Opadry pink" (lactose, hypromellose, titanium dioxide (E171), triacetin, erythrosine (E127), and carmine indigo (E132)-aluminum lake).

Appearance of the product and pack contents

Pentoxifylline Alter are oval, pink, prolonged-release tablets.

Each pack contains 60 tablets in aluminum + PVDC/PVDC + PVC blisters.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Date of the last revision of this leaflet:August 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.