Pentoxifylline Vir 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Pentoxifylline Vir 400 mg prolonged-release tablets EFG

Pentoxifylline

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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine, always under medical prescription, is indicated for the treatment of peripheral circulatory disorders due to arteriosclerosis, diabetes, inflammation, or other causes; leg ulcers and gangrene.

Pentoxifylline improves blood circulation.

2. What you need to know before starting to take Pentoxifilina Vir

Do not take Pentoxifilina Vir

• if you are allergic (hypersensitive) to pentoxifylline or to any of the other components of this medicine (listed in section 6).
• if you have ever had an allergic reaction to another xanthine derivative such as theophylline (which are used in the treatment of asthma and respiratory tract spasms), you may experience a similar reaction when taking this medicine.
• if you have severe bleeding or significant retinal hemorrhage.
• if you have recently had a myocardial infarction.

If you are unsure whether you should take this medicine, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pentoxifilina Vir:

• in patients with severe cardiac arrhythmias.
• in patients with myocardial infarction.
• in patients with hypotension.
• in patients with severe kidney disease (creatinine clearance less than 10 ml/min).
• in patients with severe liver disease.
• in patients with increased tendency to bleeding due to anticoagulant medication or coagulation disorders (see section "Do not take Pentoxifilina Vir").

Children and adolescents

There is no experience with the use of pentoxifylline in children.

Taking Pentoxifilina Vir with other medicines

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

If pentoxifylline is taken simultaneously with antihypertensive drugs, the dose may need to be individually adjusted; therefore, you must inform your doctor if you are taking any medication for high blood pressure.

Treatment with pentoxifylline in patients receiving antidiabetic medications (insulin or oral therapy) may enhance the effect of these drugs; therefore, you must inform your doctor if you are taking any medication for diabetes.

Likewise, concomitant treatment with pentoxifylline and theophylline may lead to increased theophylline levels and thereby increase its side effects; therefore, you must also inform your doctor if you are taking any medicine containing theophylline.

Pregnancy and breastfeeding

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

Pentoxifylline is not recommended during pregnancy.

Since pentoxifylline passes into breast milk in small amounts, your doctor will assess whether it is advisable to continue treatment during breastfeeding.

Driving and using machines

No negative effects of pentoxifylline on the ability to drive vehicles or operate machinery have been reported.

Pentoxifilina Vir 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 Vir

Follow exactly the instructions given by your doctor or pharmacist regarding the number of tablets to take and how often, as the dose is tailored according to the nature and severity of the disease, as well as the individual patient's tolerance. If in doubt, ask your doctor or pharmacist.

It is important that you inform your doctor of any medical conditions you may have, as this information may be useful in determining the correct dose for you.

The recommended dose is one tablet two or three times daily. The tablet should be swallowed whole with some liquid, after meals.

If you have severe kidney or liver disease, your doctor will reduce the dose, adjusting it according to your condition and your tolerance to the medication.

If you have low or unstable blood pressure, or suffer from a condition for which a drop in blood pressure could be harmful (such as severe coronary heart disease or stenosis of the blood vessels supplying the brain), your doctor will prescribe a low initial dose, gradually increasing it depending on your response.

The tablets should be swallowed whole with a little water, after meals.

If you take more Pentoxifilina Vir than you should

If you take too high a dose of pentoxifylline, you may experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. In addition, fever, restlessness, flushing, loss of reflexes, seizures, skin rashes, coffee-ground vomiting, and loss of consciousness may occur. If you notice these symptoms, go immediately to your doctor or the nearest hospital emergency department, taking this leaflet with you. Alternatively, if you realize you have taken more than prescribed, call your doctor immediately; they will advise you on the necessary steps to take.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Pentoxifilina Vir

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

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

4. Possible adverse effects

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

The following adverse reactions may occur, particularly if pentoxifylline is administered at high doses:

Cardiac disorders

Occasionally, disturbances in heart rhythm (e.g., palpitations).

Rarely, angina pectoris may occur.

Blood and lymphatic system disorders

In isolated cases, a decrease in platelet count.

Rarely, bleeding (e.g., of the skin and/or mucous membranes located in the stomach and/or intestine) may occur, especially in patients with an increased tendency to bleed.

Nervous system disorders

Occasionally, dizziness, headache, agitation, and sleep disturbances may occur.

Gastrointestinal disorders

Frequently, gastrointestinal disturbances such as stomach pressure, bloating, nausea, vomiting, or diarrhea.

Skin and subcutaneous tissue disorders

Occasionally, allergic reactions such as itching, skin rash, and urticaria may occur.

Vascular disorders

Frequently, hot flushes.

Rarely, a drop in blood pressure may occur.

Immune system disorders

In isolated cases, anaphylactic/anaphylactoid reactions, which may progress to angioneurotic edema, breathing difficulties, and a drop in blood pressure. If these manifestations occur, pentoxifylline administration must be immediately discontinued and a doctor notified.

Hepatobiliary disorders

In isolated cases, liver function disorders (intrahepatic cholestasis and elevated transaminases).

If you notice any adverse reaction not described above, consult your doctor or pharmacist.

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 through the national reporting system: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pentoxifylline Vir

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not remove the tablets from the blister pack until the time of taking, to keep them well protected.

Keep the carton and the package leaflet throughout the duration of treatment, as both contain important information about the medicine.

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 indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point located in pharmacies. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pentoxifylline Vir

• The active substance is pentoxifylline.
• The other components are stearic acid, carnauba wax, hypromellose, lactose, magnesium stearate, cellulose acetate, triacetin, and "Opadry pink".

"Opadry pink" consists of: lactose, hypromellose, titanium dioxide (E171), triacetin, erythrosine (E127), and indigo carmine (E132)-aluminum lake.

Appearance of the product and contents of the pack

Prolonged-release, oval-shaped, pink film-coated tablets.

Packs containing 60 and 500 tablets.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Pol. Ind. Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the most recent review of this leaflet: August 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/.