HEMOVAS 400 MG PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Hemovas 400 mg prolonged-release tablets

Pentoxifylline

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Hemovas 400 mg tablets are and what they are used for.
2. What you need to know before taking Hemovas 400 mg tablets.
3. How to take Hemovas 400 mg tablets.
4. Possible side effects.
5. Storage of Hemovas 400 mg tablets.
6. Package contents and additional information.

1. What Hemovas 400 mg tablets are and what they are used for

Hemovas contains the active ingredient pentoxifylline, which belongs to the group of medications known as peripheral vasodilators, and it works by improving blood circulation.

Hemovas is used to treat peripheral circulatory disorders due to arteriosclerosis, diabetes, inflammation, or other causes; trophic disorders; ulcers on the legs; and gangrene.

2. What you need to know before taking Hemovas 400 mg tablets

Do not take Hemovas

• If you are allergic to pentoxifylline or any of the other ingredients of this medication (listed in section 6).
• If you have ever experienced an allergic reaction to another xanthine derivative, such as theophylline.
• If you have a severe hemorrhage or a significant retinal hemorrhage.
• If you have recently had a myocardial infarction.
• If you are pregnant.
• This medication should not be given to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hemovas.

Special monitoring is required:

• If you have severe cardiac arrhythmias.
• If you have had a myocardial infarction.
• If you have low blood pressure (hypotension).
• If you have severe kidney disease.
• If you have severe liver disease.
• If you have severe coronary artery disease with a particular risk of reduced blood pressure.
• If you have an increased tendency to bleeding due to anticoagulant medication or a coagulation disorder.
• If you are taking antidiabetic medications (medications used to lower blood glucose levels), medications containing theophylline (used for asthma and other pulmonary diseases), anti-vitamin K medications, platelet aggregation inhibitors, or ciprofloxacin (a fluoroquinolone antibiotic used to treat certain bacterial infections).

Children and adolescents

This medication is not recommended for use in children and adolescents, as there is no experience with the use of pentoxifylline in this population.

Taking Hemovas with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Particularly, the following medications may interact with Hemovas:

• If you are being treated with oral anticoagulants or platelet aggregation inhibitors, as their use with Hemovas increases the risk of bleeding. For this reason, your doctor may subject you to periodic checks.
• If Hemovas and medications for hypertension are administered simultaneously, it may be necessary to adjust the dose, so you should inform your doctor if you are taking any medication for blood pressure.
• Treatment with Hemovas in patients treated with medications for diabetes (insulin or oral treatment) may potentiate the effect of these medications, so you should inform your doctor if you are taking any medication for diabetes.
• Simultaneous treatment with Hemovas and theophylline (a medication used for asthma or other respiratory problems) may cause an increase in theophylline levels, which may increase its side effects. Therefore, it is also necessary to inform your doctor if you are taking any medication containing theophylline.
• Simultaneous treatment with Hemovas and uricosurics (medications used to decrease uric acid levels) may counteract the effect of uricosurics, so your doctor will need to adjust the dose.
• If Hemovas and ciprofloxacin (a fluoroquinolone antibiotic that acts by eliminating bacteria that cause infections) are administered simultaneously, it may increase Hemovas levels and thereby increase its side effects.
• The concomitant administration of Hemovas with cimetidine (a medication used for stomach ulcers) may increase Hemovas levels and its main active metabolite, thereby increasing its side effects.

Pregnancy and lactation

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

Pregnancy

Hemovas should not be administered during pregnancy.

Breastfeeding

Consult your doctor before using Hemovas if you are breastfeeding, as Hemovas passes into breast milk in small amounts. Your doctor will assess the convenience of continuing or not continuing treatment.

Driving and using machines

No negative effects of Hemovas on the ability to drive vehicles or operate machines have been described. However, certain undesirable effects (e.g., dizziness) may alter the patient's reaction or concentration capacity and therefore constitute a risk in situations such as driving vehicles and operating machines.

Hemovas contains orange yellow S (E110)

This medication may cause allergic reactions because it contains orange yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Hemovas 400 mg tablets

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

This medication is administered orally.

The recommended dose is one Hemovas tablet, two or three times a day, which means a maximum daily dose of three Hemovas tablets (1200 mg of pentoxifylline).

Remember to take your medication.

Follow your doctor's instructions regarding the number of tablets you should take and how often, as the dose depends on the nature and severity of the disease, as well as each patient's tolerance. It is essential to inform your doctor of any disease you may have, as this may be useful in determining the correct dose for you.

Do not take more Hemovas than recommended.

Do not stop treatment before completing it, as you will not achieve the desired therapeutic effect. If you think the effect of Hemovas is too strong or too weak, inform your doctor or pharmacist.

Patient with kidney or liver disease:

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

Patient with blood pressure disorders

If you have low blood pressure, unstable circulation, or have a disease for which a decrease in blood pressure could be harmful (severe coronary artery disease or narrowing of the blood vessels that supply the brain), your doctor will prescribe a low initial dose that 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 treatment with Hemovas immediately and inform your doctor.

Method of administration

The tablets should be swallowed whole, without chewing, with a sufficient amount of water (approximately 1/2 glass) after a meal.

If you take more Hemovas than you should

If you take a dose of Hemovas that is too high, you may experience nausea, dizziness, vertigo, palpitations, or a sudden drop in blood pressure. Additionally, you may experience fever, agitation, hot flashes, loss of reflexes, convulsions, skin rashes, vomiting like coffee grounds, and loss of consciousness.

If you observe these symptoms, go immediately to your doctor or the emergency department of the nearest hospital, bringing this package leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forget to take Hemovas

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as possible and then follow your regular schedule. However, if it is almost time for your next dose, do not take the forgotten dose and wait until it is time for your next tablet.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The frequency of side effects with this medication cannot be estimated from the available data.

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

Immune system disorders:

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).

Vascular disorders:

Hot flashes, bleeding (e.g., skin and/or mucous membrane bleeding localized in the stomach and/or intestine), especially in patients with an increased tendency to bleeding.

Cardiac disorders:

Heart rhythm disorders with increased or decreased heart rate (e.g., arrhythmias, tachycardias), angina pectoris.

Blood and lymphatic system disorders:

Decreased platelet count, decreased white blood cell count.

Skin and subcutaneous tissue disorders:

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

Nervous system disorders:

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

Gastrointestinal disorders:

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

Hepatobiliary disorders:

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

Psychiatric disorders:

Agitation and sleep disturbances.

Investigations:

Increased transaminases (liver enzymes), decreased blood pressure.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hemovas 400 mg prolonged-release tablets

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

Store in the original packaging to protect it from moisture.

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

Do not use this medication if you notice that the tablet is damaged.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Hemovas composition

• The active ingredient is pentoxifylline. Each tablet contains 400 mg of pentoxifylline.
• The other ingredients (excipients) are:

Tablet core:Guar gum (E412), talc (E553b), and magnesium stearate (E470b).

Tablet coating:Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), polyethylene glycol 4000 (E1521), quinoline yellow (E104), orange yellow S (E110), and indigotine (E132).

Appearance of the product and package contents

Prolonged-release tablets of yellow color.

Package with 60 prolonged-release tablets of 400 mg.

Clinical package with 500 prolonged-release tablets of 400 mg.

Marketing authorization holder and manufacturer:

Marketing authorization holder

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

Date of the last revision of this package leaflet:August 2021

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