Hemovas 300 mg solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Hemovás 300 mg infusion solution

Pentoxifylline

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Hemovás is and what it is used for
2. What you need to know before using Hemovás
3. How to use Hemovás
4. Possible side effects
5. Storage of Hemovás
6. Contents of the pack and other information

1. What Hemovás is and what it is used for

Hemovás contains an active substance called pentoxifylline, which belongs to a group of medicines known as peripheral vasodilators, and works by improving blood circulation.

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

2. What you need to know before using Hemovás

Do not use Hemovás

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Hemovás.

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

Pentoxifylline should be administered with special caution:

• If you have serious heart rhythm disorders.
• If you have had a myocardial infarction in the past (not recent).
• If you have low blood pressure (hypotension) or are at risk of low blood pressure.
• If you have severe kidney disease.
• If you have severe liver disease.
• If you have an increased tendency to bleed.
• If you are taking certain medicines. See section “Use of Hemovás with other medicines”.

Children and adolescents

Use in children and adolescents is not recommended due to lack of experience with pentoxifylline in this population.

Use of Hemovás with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may interact with or be affected by Hemovás:

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

When used together with pentoxifylline, the risk of bleeding increases. Therefore, your doctor may perform periodic monitoring.

• Medicines for high blood pressure (antihypertensives):

When used together with pentoxifylline, the hypotensive effect may be enhanced, and dose adjustment may be necessary.

• Medicines for diabetes, such as insulin or oral antidiabetic agents:

When used together with pentoxifylline, the hypoglycemic effect (lowering of blood sugar levels) may be enhanced.

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

When used together with pentoxifylline, theophylline levels may increase, thereby increasing its side effects.

• Uricosuric agents (medicines used to reduce uric acid levels):

When used together with pentoxifylline, the effect of uricosuric agents may be antagonized, so your doctor may need to adjust the dose.

• Ciprofloxacin (a fluoroquinolone antibiotic that acts by eliminating bacteria causing infections):

When used together with pentoxifylline, pentoxifylline levels may increase, thereby increasing its side effects.

Pregnancy and breastfeeding

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

Pregnancy

The use of pentoxifylline during pregnancy is not recommended.

Breastfeeding

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

Driving and using machines

Although no negative effects of this medicine on the ability to drive or operate machinery have been reported, this ability may be impaired due to possible adverse reactions of pentoxifylline.

Use in patients with renal impairment

Your doctor will determine the appropriate dose for you.

Use in patients with hepatic impairment

Your doctor will determine the appropriate dose for you.

Hemovás contains sodium

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

3. How to use Hemovás

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

Hemovás is administered exclusively by intravenous infusion.

The dose and manner of using this medicine depend on the nature and severity of the circulatory disorder and on each patient's tolerance to the medicine. It is important that you inform your doctor of any illness you may have, as this could be useful in determining the correct dose for you.

The recommended dose is 300 to 900 mg of pentoxifylline per day (1–3 vials per day).

In acute cases, treatment should be initiated with 900 mg of pentoxifylline (3 vials of Hemovás) diluted in 1,500 ml of infusion fluid, administered by continuous intravenous infusion over 24 hours, corresponding to 37.5 mg/h or 62.5 ml/h.

As symptoms improve, the dose may be reduced to 600 mg of pentoxifylline, divided into two daily administrations of 300 mg (1 vial of Hemovás), each diluted in 1,000 ml of infusion fluid. Each infusion should last 150–300 minutes, corresponding 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 fluid. In such circumstances, the use of a controlled infusion pump would be appropriate.

Patients with kidney disease

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

Patients with liver disease

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

Patients with blood pressure disorders

If you have low blood pressure, unstable circulation, or suffer from a condition that could be worsened by a drop in blood pressure (severe coronary heart disease or narrowing of the blood vessels supplying the brain), your doctor will prescribe a low initial dose, gradually increasing it according to your response to treatment.

If you use more Hemovás than you should

If you have been given too high a dose of Hemovás, you may initially experience nausea, dizziness, vertigo, palpitations, or a sudden drop in blood pressure. In addition, fever, agitation, flushing, loss of reflexes, seizures, skin rashes, coffee-ground vomiting, and loss of consciousness may occur.

If you notice these symptoms, seek immediate medical attention from your doctor or go to the nearest hospital emergency department, taking this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915620420, indicating the medicine and the amount used.

If you forget to use Hemovás

Do not use a double dose to make up for a missed dose.

If you stop using Hemovás

Your doctor will advise you on the duration of your treatment with Hemovás. Do not discontinue treatment before consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Immune system disorders:

Severe allergic-type reactions (anaphylactic or anaphylactoid) with inflammation of the mouth and airways causing difficulty in breathing and drop in blood pressure. Angioedema (fluid accumulation in the tongue and throat which may cause asphyxiation), bronchospasms (spasms of the bronchi making normal breathing difficult).

Vascular disorders:

Hot flushes, bleeding (e.g., of the skin and/or mucous membranes located in the stomach and/or intestine).

Cardiac disorders:

Changes in heart rhythm with increase or decrease in heart rate (e.g., palpitations), angina pectoris.

Blood and lymphatic system disorders:

Decrease in the number of platelets.

Skin and subcutaneous tissue disorders:

Erythema (redness of the skin), 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:

Heaviness in the stomach, gastrointestinal discomfort, feeling of fullness, nausea, vomiting or diarrhea.

Hepatobiliary disorders:

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

Psychiatric disorders:

Agitation and sleep disturbances.

Additional investigations:

Elevated transaminases (liver enzymes), decreased blood pressure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hemovás

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 stated on the ampoule and on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hemovás

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

Appearance of the product and contents of the pack

Clear glass ampoule containing a clear, colourless solution.

Each ampoule contains 15 ml.

Cartons 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 the most recent revision of this leaflet: 02/2021

Other sources of information:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es.