Pentoxifylline Alter 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pentoxifylline Alter 400 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Always under the prescription of your doctor, pentoxifilina 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 taking Pentoxifylline Alter

Do not take Pentoxifylline Alter

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

Warnings and precautions

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

• If you have severe heart rhythm disorders.
• If you have previously had a myocardial infarction.
• If you have low blood pressure (hypotension).
• If you have severe renal impairment (creatinine clearance less than 30 ml/min).
• If you have severe hepatic impairment.
• If you are at high risk of bleeding, for example, if you are being treated with anticoagulant medicines (which inhibit blood clotting) or patients with coagulation disorders receiving antiplatelet agents (see "Taking Pentoxifylline 400 mg tablets with other medicines").
• If you are taking antidiabetic medicines (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 determine the appropriate dose for you.

Patients with hepatic impairment

Your doctor will determine the appropriate dose for you.

Taking Pentoxifylline 400 mg tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 carry out periodic monitoring.

Concomitant administration of pentoxifylline with drugs that lower blood pressure (antihypertensives) may enhance the effect of the latter, so your doctor may need to adjust the dosage.

Treatment with pentoxifylline in patients receiving antidiabetic medications (insulin or oral therapy) may also enhance their effects. Therefore, periodic monitoring is required.

Concomitant treatment with pentoxifylline and theophylline (a medicine used to treat asthma) may lead to increased theophylline levels and thus increase its side effects.

Similarly, concomitant treatment with pentoxifylline and ciprofloxacin (a medicine used to treat bacterial infections) may lead to increased pentoxifylline levels and consequently increase its adverse effects.

Concomitant treatment with Pentoxifylline and antiplatelet agents (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, other non-selective COX-2 inhibiting non-steroidal anti-inflammatory drugs, acetylsalicylates (acetylsalicylic acid/lysine acetylsalicylate), ticlopidine, dipyridamole) may enhance the anticoagulant effect and increase the risk of bleeding.

Concomitant administration of Pentoxifylline with cimetidine (a medicine used to treat gastric ulcers) may increase pentoxifylline and active Metabolite I levels.

Taking Pentoxifylline 400 mg tablets with food and drinks

The tablets may be swallowed whole during or immediately after meals with sufficient 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 must not be administered during pregnancy.

Breastfeeding

There are insufficient data to establish the safety of Pentoxifylline use during breastfeeding. Therefore, your doctor will assess whether it is appropriate to continue or discontinue treatment while nursing your child.

Driving and using machines

Your ability to drive or operate machinery may be impaired due to possible adverse reactions.

Important information about some of the components of Pentoxifylline Alter

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

3. How to take Pentoxifilina Alter

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

If you think that the effect of pentoxifilina is too strong or too weak, inform your doctor or pharmacist.

The recommended dose is 1 tablet (400 mg of pentoxifilina) 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 condition and your tolerance to this medicine.

If you have low blood pressure, unstable circulation, or suffer from a condition for which a drop in blood pressure could be harmful (severe coronary heart disease or narrowing of the blood vessels supplying the brain), your doctor will prescribe a low starting dose, which will be gradually increased depending on your response to treatment.

If you experience a severe allergic reaction (anaphylactic or anaphylactoid) with swelling of the mouth and airways causing difficulty breathing and a drop in blood pressure, stop taking pentoxifilina immediately and inform your doctor.

Your doctor will advise you on how long your treatment with pentoxifilina should last. Do not stop treatment prematurely.

If you take more Pentoxifilina Alter than you should

Contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you.

If you take too high a dose of pentoxifilina, you may initially experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. Additionally, fever, agitation, hot flushes, loss of consciousness, loss of reflexes, seizures, skin rashes, and vomiting of coffee-ground material (a sign indicating gastrointestinal bleeding) may occur.

In case of overdose or accidental ingestion, contact your doctor immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Pentoxifilina Alter

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Additional investigations:

Increased transaminases (liver enzymes), decreased blood pressure.

Gastrointestinal disorders:

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

Cardiac disorders:

Changes in heart rate with increase or decrease (e.g. palpitations), angina pectoris.

Vascular disorders:

Hot flushes, bleeding (e.g. of the skin and/or mucous membranes located in the stomach and/or intestine), especially in patients with a high tendency to bleed.

Nervous system disorders:

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

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

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

Immune system disorders:

Severe allergic-type reactions (anaphylactic or anaphylactoid) with inflammation of the mouth and airways causing difficulty in breathing and drop in blood pressure. Angioedema (fluid accumulation in the tongue and throat which may cause asphyxiation), bronchospasms (spasms of the bronchi making normal breathing difficult).

Psychiatric disorders:

Agitation and sleep disturbances.

Blood and lymphatic system disorders:

Thrombocytopenia (decrease in the number of platelets), leucopenia/neutropenia (decrease in white blood cells).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 packaging.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pentoxifilina Alter

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

Appearance of the product and contents of the pack

Pentoxifilina Alter are prolonged-release oval pink film-coated tablets.

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

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: August 2024

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