PROSPECTO: INFORMATION FOR THE USER

Pentoxifilina Alter 400 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you

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

Pentoxifilina is a medication that belongs to the group of drugs known as peripheral vasodilators.

Under the prescription of your doctor, pentoxifilina is indicated for the treatment of peripheral circulatory disorders due to arterioesclerosis, diabetes, inflammation, or other causes such as leg ulcers and gangrene.

Do not take Pentoxifilina Alter

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

Warnings and precautions

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

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

Children and adolescents

No experience of use of Pentoxifilina 400 mg tablets in children is available.

Patients with renal insufficiency

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

Patients with hepatic insufficiency

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

Taking Pentoxifilina 400 mg tablets with other medications

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

Especially if you are taking oral anticoagulants or antiplatelet medications, as their use with Pentoxifilina increases the risk of bleeding. For this reason, your doctor may require periodic checks.

The concurrent administration of pentoxifilina with medications that lower blood pressure (antihypertensives) may potentiate the effect of these medications, so your doctor may need to adjust your dose.

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

The simultaneous treatment with pentoxifilina and theophylline (medication for the treatment of asthma) may cause an increase in the levels of theophylline and thereby increase the side effects of this medication.

In the same way, the simultaneous treatment of Pentoxifilina with ciprofloxacin (medication for the treatment of bacterial infections) may cause an increase in the levels of pentoxifilina and thereby an increase in the adverse effects of this medication.

The simultaneous treatment of Pentoxifilina with antiplatelet medications (clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelida, other nonsteroidal anti-inflammatory drugs that are not selective COX-2 inhibitors, acetilsalicilates (acetylsalicylic acid/lysine salicylate), ticlopidine, dipiridamol), may potentiate the anticoagulant effect and increase the risk of bleeding.

The concurrent administration of Pentoxifilina with cimetidine (medication for the treatment of gastric ulcers) may increase the levels of pentoxifilina and the active metabolite I.

Taking Pentoxifilina 400 mg tablets with food and drinks

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

Pregnancy, lactation, and fertility

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

Pregnancy

Pentoxifilina should not be administered during pregnancy.

Lactation

No sufficient data are available to establish the safety of the use of Pentoxifilina during lactation. Therefore, your doctor will evaluate the convenience of continuing or not continuing treatment while breastfeeding.

Driving and operating machinery

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

Important information about some of the components of Pentoxifilina Alter

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

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

Remember to take your medication.

If you estimate that the action 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 a severe kidney or liver disease, your doctor may reduce the dose adjusting it according to your disease and your tolerance to this medication.

If you have low blood pressure, unstable circulation, or have 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 starting 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 produces difficulty breathing and a drop in blood pressure, stop taking pentoxifilina immediately and inform your doctor.

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

If you take more Pentoxifilina Alter than you should

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

If you take too much pentoxifilina, you may initially experience nausea, dizziness, palpitations, or a sudden drop in blood pressure. Additionally, you may experience fever, agitation, hot flashes, loss of consciousness, loss of reflexes, seizures, skin eruptions, and, as an indicative sign of gastrointestinal bleeding, coffee-ground vomiting.

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

If you forgot to take Pentoxifilina Alter

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Unknown frequency side effects (frequency cannot be estimated from available data):

Additional diagnostic tests:

Increased transaminases (liver enzymes), decreased blood pressure.

Gastrointestinal disorders:

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

Cardiac disorders:

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

Vascular disorders:

Hot flashes, hemorrhages (e.g. skin and/or mucous membrane bleeding 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 (bile obstruction in the liver).

Skin and subcutaneous tissue disorders:

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

Immune system disorders:

Severe allergic reactions (anaphylactic or anaphylactoid) with inflammation of the mouth and respiratory tract causing breathing difficulties and decreased blood pressure. Angioedema (fluid accumulation in the tongue and throat that can cause asphyxiation), bronchospasm (bronchiole spasms that make normal breathing difficult).

Psychiatric disorders:

Agitation and sleep disturbances.

Blood and lymphatic system disorders:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 container.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at theSIGRE Pointof the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Pentoxifilina Alter Composition

• The active ingredient is pentoxifilina
• 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 (E 132)-aluminum lake).

Appearance of the product and contents of the packaging

Pentoxifilina Alter are oval-shaped, prolonged-release, pink-coated tablets.

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

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet:August 2024

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