Leaflet: information for the user

Pentoxifilina Sejmet 400 mg prolonged-release tablets EFG

Pentoxifilina

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Pentoxifilina Sejmet

4. Possible side effects

5. Storage of Pentoxifilina Sejmet

6. Contents of the pack and additional information

The active ingredient is pentoxifilina, a compound that promotes blood circulation.

This medication is used:

• For the treatment of peripheral circulatory disorders due to arterioesclerosis, diabetes, inflammation, or other causes.
• For the treatment of leg ulcers and gangrene.

Do not take Pentoxifilina Sejmet

• If you are allergic (hypersensitive) to pentoxifilina or to any of the other components of this medication (listed in section 6).
• If you have ever experienced an allergic reaction to another xanthine derivative such as theophylline (which are used in the treatment of asthma and bronchial spasms), you may experience a similar reaction when taking this medication.
• If you suffer from severe bleeding or significant retinal bleeding.
• If you have recently had a heart attack.

In case of doubt about whether you should take this medication, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pentoxifilina Sejmet

• In patients with severe heart rhythm disturbances.
• In patients with heart attack.
• In patients with low blood pressure.
• In patients with severe kidney disease (creatinine clearance less than 10 ml/min).
• In patients with severe liver disease.
• In patients with an increased tendency to bleeding due to anticoagulant medication or coagulation disorders (see “Do not take Pentoxifilina Sejmet”)

Children and adolescents

No experience is available on the use of pentoxifilina in children.

Pentoxifilina Sejmet use with other medications

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

• If pentoxifilina and blood pressure medications are administered simultaneously, it may be necessary to adjust the dose individually, so you should inform your doctor if you are taking any blood pressure medication.
• The treatment with pentoxifilina in patients treated with diabetes medications (insulin or oral treatment) may potentiate the effect of these latter, so you should inform your doctor if you are taking any diabetes medication.
• In the same way, simultaneous treatment with pentoxifilina and theophylline may cause an increase in theophylline levels and thus increase the side effects of this, so you will also need to inform your doctor if you are taking any medication containing theophylline.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pentoxifilina is not recommended during pregnancy.

Since pentoxifilina passes into breast milk in small amounts, your doctor will assess the convenience of continuing or not continuing treatment during breastfeeding.

Driving and operating machines

No negative effects of pentoxifilina on the ability to drive vehicles or operate machines have been described.

Pentoxifilina Sejmet contains lactose

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

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist regarding the number of tablets to take and how often, as the dose is directed according to the nature and severity of the disease as well as the tolerance of each patient. If in doubt, ask your doctor or pharmacist.

It is essential to inform your doctor of any disease you suffer from, as it may be useful in determining the correct dose for you.

The recommended dose is one tablet, two or three times a day, which should be taken whole with a small amount of liquid, after meals.

If you suffer from a severe kidney or liver disease, your doctor will reduce the dose, adjusting it according to this disease and your tolerance to the medication.

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

Pentoxifilina tablets should be swallowed whole, without chewing, with a little water after meals.

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication.

Your doctor will indicate the duration of treatment with Pentoxifilina Sejmet. Do not discontinue treatment beforehand, as the effect may not occur.

If you take more Pentoxifilina Sejmet than you should

If you take too much pentoxifilina, you may experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. Additionally, fever, agitation, hot flashes, loss of reflexes, seizures, skin eruptions, coffee-ground vomiting, and loss of consciousness may occur. If you observe these symptoms, go to your doctor or the nearest hospital emergency service, bringing this leaflet with you. Or, if you realize you have taken more doses than prescribed, call your doctor immediately, who will indicate the measures to take.

In case of overdose or accidental ingestion, consult your pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pentoxifilina Sejmet

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as possible and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait until it is time to take the next tablet.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

Cardiac Disorders

Occasionally, irregular heartbeat (e.g., palpitations) may occur.

Angina pectoris may rarely appear.

Blood and Lymphatic System Disorders

In isolated cases, a decrease in platelet count may occur.

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

Nervous System Disorders

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

Gastrointestinal Disorders

Common gastrointestinal disturbances, such as stomach pressure, feeling full, nausea, vomiting, or diarrhea, may occur.

Skin and Subcutaneous Tissue Disorders

Allergic reactions, such as itching, skin rash, and urticaria, may occasionally occur.

Vascular Disorders

Hot flushes may frequently occur.

Low blood pressure may rarely occur.

Immune System Disorders

In isolated cases, anaphylactic/anaphylactoid reactions may occur, which may progress to angioneurotic edema, difficulty breathing, and low blood pressure. If these manifestations are observed, pentoxifylline administration should be immediately discontinued, and a doctor should be informed.

Hepatobiliary Disorders

In isolated cases, liver function disturbances (intrahepatic cholestasis and elevated transaminases) may occur.

If any adverse reaction not previously described is observed, consult a doctor or pharmacist.

Reporting 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 prospectus. You can also report them through the national notification system:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in its original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pentoxifilina Sejmet

• The active ingredient is pentoxifilina
• The other components (excipients) 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 content of the packaging

Pink, oval-shaped coated tablets.

Packages of 60 and 500 prolonged-release tablets.

Holder of the marketing authorization

Sejmet Pharmaceuticals S.L.

Avenida Baja Navarra, 1

31002, Pamplona (Navarra)

Spain

Responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: August 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.