HEMOVAS 600 mg PROLONGED-RELEASE TABLETS

Introduction

Prospectus: information for the user

Hemovas 600 mg prolonged-release tablets

Pentoxifylline

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What Hemovas 600 mg tablets are and what they are used for.
2. What you need to know before starting to take Hemovas 600 mg tablets.
3. How to take Hemovas 600 mg tablets.
4. Possible adverse effects.
5. Storage of Hemovas 600 mg tablets.
6. Package contents and additional information.

1. What Hemovas 600 mg tablets are and what they are used for

Hemovas contains an active ingredient called pentoxifylline, which belongs to the group of medications known as peripheral vasodilators, acting by improving blood circulation.

Hemovas is used in the treatment of 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 starting to take Hemovas 600 mg tablets

Do not take Hemovas

• If you are allergic to pentoxifylline or 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.
• If you have a severe hemorrhage or a significant retinal hemorrhage.
• If you have recently suffered a myocardial infarction.
• If you are pregnant.
• This medication should not be administered 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 hemorrhage due to the use of anticoagulant medication or have a coagulation disorder.
• If you are taking antidiabetic medications (medications used to decrease blood glucose levels), which contain theophylline (a medication used for asthma and other pulmonary diseases), anti-vitamin K medications, antiplatelet agents, or ciprofloxacin (a fluoroquinolone antibiotic used to treat certain bacterial infections).

Children and adolescents

The use of this medication is not recommended 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.

Especially the following medications may interact with Hemovas:

• If you are being treated with oral anticoagulants or antiplatelet agents, as their use with Hemovas increases the risk of hemorrhage. 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.
• 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, so you should also inform your doctor if you are taking any medication containing theophylline.

The simultaneous treatment with Hemovas and uricosuric agents (medications used to decrease uric acid levels) may counteract the effect of uricosuric agents, 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, which may 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, which may increase 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.

3. How to take Hemovas 600 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, twice a day, which means a maximum daily dose of two 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 the patient's tolerance. It is essential that you 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, 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 may 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. You may also 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 prospectus 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 the usual schedule. However, if it is almost time for the next dose, do not take the forgotten dose and wait until it is time for the next tablet.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

The frequency of adverse effects of 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, hemorrhages (e.g., skin and/or mucous membrane hemorrhages localized in the stomach and/or intestine), especially in patients with an increased tendency to hemorrhage.

Cardiac disorders:

Alterations in heart rhythm 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 upset, gastrointestinal discomfort, 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.

Complementary tests:

Increased transaminases (liver enzymes), decreased blood pressure.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hemovas 600 mg prolonged-release tablets

Keep this medication out of sight and reach of children.

Do not store above 25°C.

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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. 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

Composition of Hemovas

• The active ingredient is pentoxifylline. Each tablet contains 600 mg of pentoxifylline.

• The other components (excipients) are:

Core:Hydroxypropylmethylcellulose (E464), Microcrystalline cellulose (E460), Crospovidone, Colloidal anhydrous silica (E551), Magnesium stearate (E470b)

Coating:Polyethylene glycol 6,000 (E1521), Hydroxypropylmethylcellulose (E464), Titanium dioxide (E171), Talc (E553), and Polycrylate 30%.

Appearance of the product and package contents

Prolonged-release tablets.

Package with 60 prolonged-release tablets of 600 mg.

Clinical package with 500 prolonged-release tablets of 600 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 prospectus:October 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/ "

HEMOVAS 600.PR6