HEMOVAS 300 MG SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Hemovas300 mg solution for infusion

Pentoxifylline

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Hemovas and what is it used for
2. What you need to know before you use Hemovas
3. How to use Hemovas
4. Possible side effects

5 Conservation of Hemovas

1. Contents of the pack and further information

1. What is Hemovas and what is it used for

Hemovas contains the active substance pentoxifylline, which belongs to a group of medicines called peripheral vasodilators, and it works by improving blood circulation.

Hemovas is used to treat a blood circulation disorder called peripheral vascular disease.

2. What you need to know before you use Hemovas

Do not useHemovas

• If you are allergic to pentoxifylline or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction to another xanthine derivative such as theophylline (used to treat asthma and respiratory spasms), you may have a similar reaction when using this medicine.
• If you have a severe hemorrhage.
• If you have recently had a myocardial infarction.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hemovas.

If you observe a severe allergic reaction (anaphylactic or anaphylactoid), stop treatment with this medicine immediately and inform your doctor.

Pentoxifylline will be administered with special monitoring:

• If you have severe cardiac arrhythmias.
• If you have had a myocardial infarction not recently.
• If you have low blood pressure (hypotension) or are at risk of having low blood pressure.
• If you have severe kidney disease.
• If you have severe liver disease.
• If you have an increased tendency to bleeding.
• If you are taking certain medicines. See the section "Using Hemovas with other medicines".

Children and adolescents

It is not recommended for use in children and adolescents because there is no experience with the use of pentoxifylline in this population.

UsingHemovaswith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The following medicines may affect or be affected by Hemovas:

• Oral anticoagulants (reduce blood viscosity) or antiplatelet agents (prevent blood clot formation):

Their use with pentoxifylline increases the risk of bleeding, so your doctor may subject you to periodic checks.

• Medicines for hypertension (lower blood pressure):

Their use with pentoxifylline may enhance the hypotensive effect, so it may be necessary to adjust the dose.

• Medicines for diabetes such as insulin or oral treatments:

Their use with pentoxifylline may enhance the hypoglycemic effect (lowering blood sugar levels).

• Theophylline (a medicine used for asthma or other respiratory problems):

Their use with pentoxifylline may increase theophylline levels and thereby increase its side effects.

• Uricosurics (medicines used to decrease uric acid levels):

Their use with pentoxifylline may counteract the effect of uricosurics, so your doctor will need to adjust the dose.

• Ciprofloxacin (an antibiotic of the fluoroquinolone family that acts by eliminating bacteria that cause infections):

Their use with pentoxifylline may increase pentoxifylline levels and thereby increase its side effects.

Pregnancy and breastfeeding

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

Pregnancy

The use of pentoxifylline is not recommended during pregnancy.

Breastfeeding

Pentoxifylline passes into breast milk in small amounts. If you are breastfeeding, your doctor will assess whether to continue or stop treatment.

Driving and using machines

Although no negative effect of this medicine on the ability to drive vehicles or operate machines has been described, it may be altered due to possible adverse reactions of pentoxifylline.

Use in patients with renal insufficiency

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

Use in patients with hepatic insufficiency

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

Hemovas contains sodium

This medicine contains approximately 29.48 mg of sodium (main component of table/cooking salt) in each 15 ml ampoule. This is equivalent to 1.47% of the maximum recommended daily sodium intake for an adult.

3. How to use Hemovas

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Hemovas is administered exclusively by intravenous infusion.

The dose and the way to use this medicine depend on the nature and severity of the circulatory disorder and the patient's tolerance to the medicine. It is essential that you 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 300 to 900 mg of pentoxifylline per day (1-3 ampoules per day).

In acute cases, it is recommended to start treatment with 900 mg of pentoxifylline (3 Hemovas ampoules) diluted in 1,500 ml of infusion liquid, administered by continuous infusion in a vein for 24 hours, which corresponds to 37.5 mg/h or 62.5 ml/h.

As symptoms improve, the dose can be reduced to 600 mg of pentoxifylline, divided into 2 daily administrations of 300 mg (1 Hemovas ampoule), diluted in 1,000 ml of infusion liquid. Each administration will last 150-300 minutes, which corresponds to between 120 mg/h and 60 mg/h or between 400 mL/h and 200 mL/h, respectively.

Depending on whether you suffer from other diseases (e.g., congestive heart failure), it may be necessary to reduce the volume of infusion liquid. In these circumstances, it would be appropriate to use a controlled infusion pump.

Patient with kidney disease

If you have severe kidney disease, your doctor will reduce the dose by 30 to 50%, adjusting it according to this disease and your tolerance to the medicine.

Patient with liver disease

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

Patient with blood pressure disorders

If you have low blood pressure, unstable circulation, or suffer from 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 initial dose that will be gradually increased according to your response to treatment.

If you use more Hemovas than you should

If you have been administered too high a dose of Hemovas, you may initially experience nausea, dizziness, vertigo, palpitations, or a sudden drop in blood pressure. Additionally, fever, agitation, hot flashes, loss of reflexes, convulsions, skin rashes, coffee-ground vomiting, and loss of consciousness may appear.

If you observe these symptoms, go immediately to your doctor or the emergency department of the nearest hospital, taking this 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 medicine and the amount used.

If you forget to useHemovas

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

If you stop treatment with Hemovas

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequencies of side effects of this medicine cannot be estimated from the available data.

Disorders of the immune system:

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 (spasm of the bronchi that makes normal breathing difficult).

Vascular disorders:

Hot flashes, hemorrhages (e.g., skin and/or mucous membranes located in the stomach and/or intestine).

Cardiac disorders:

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

Disorders of the blood and lymphatic system:

Decreased platelet count.

Disorders of the skin and subcutaneous tissue:

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

Disorders of the nervous system:

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

Gastrointestinal disorders:

Stomach upset, gastrointestinal discomfort, feeling of fullness, nausea, vomiting, or diarrhea.

Hepatobiliary disorders:

Disorders of liver function, such as intrahepatic cholestasis (obstruction of bile in the liver).

Psychiatric disorders:

Agitation and sleep disorders.

Complementary tests:

Increased transaminases (liver enzymes), decreased blood pressure.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Hemovas

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the ampoule and the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofHemovas

• The active substance is pentoxifylline. Each ampoule contains 300 mg of pentoxifylline.
• The other ingredients (excipients) are: sodium chloride, glacial acetic acid, sodium hydroxide (E-524) for pH adjustment, and water for injectable preparations.

Appearance of the product and pack contents

Transparent glass ampoule containing a clear and colorless solution.

Each ampoule contains 15 ml.

Cases containing 6 and 100 ampoules (EC).

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 last revision of this leaflet:02/2021

Other sources of information:

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): www.aemps.gob.es.