Prospecto: information for the patient

Hemovás300 mg solution for infusion

Pentoxifilina

Read this prospect carefully before starting to use this medication, 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 medication has been prescribed only to you, and you must not give it to other people, 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 prospect. See section 4.

1.What is Hemovás and for what it is used

2.What you need to know before starting to use Hemovás

3.How to use Hemovás

4.Possible adverse effects

5Storage of Hemovás

6.Contents of the package and additional information

Hemovás contains an active ingredient called pentoxifilina that belongs to a group of medications known as peripheral vasodilators, and it acts by improving blood circulation.

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

No useHemovás

• 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 xanthine derivative such as theophylline (which are used in the treatment of asthma and bronchospasm), you may experience a similar reaction when using this medication.
• 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 Hemovás.

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

Pentoxifilina will be administered with special control:

• 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 a severe kidney disease.
• If you have a severe liver disease.
• If you have an increased tendency to hemorrhage.
• If you are taking certain medications. See section “Use of Hemovás with other medications”.

Children and adolescents

It is not recommended for use in children and adolescents due to the lack of experience with the use of pentoxifilina in this population.

Use of Hemovás with other medications

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

The following medications may affect or be affected by Hemovás:

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

Its use with pentoxifilina increases the risk of hemorrhage, so your doctor may perform periodic checks.

• Medications for hypertension (which decrease blood pressure):

Its use with pentoxifilina may potentiate the hypotensive effect, so it may be necessary to adjust the dose.

• Medications for diabetes such as insulin or oral treatments:

Its use with pentoxifilina may potentiate the hypoglycemic effect (decrease in blood sugar levels).

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

Its use with pentoxifilina may increase theophylline levels and thereby increase its side effects.

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

Its use with pentoxifilina may antagonize the effect of uricosurics, so your doctor will need to adjust the dose.

• Ciprofloxacin (an antibiotic of the fluoroquinolone family that eliminates bacteria that cause infections):

Its use with pentoxifilina may increase pentoxifilina levels and thereby increase its side effects.

Pregnancy and lactation

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 is not recommended during pregnancy.

Lactation

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

Driving and operating machinery

Although no negative effects of this medication on the ability to drive vehicles or operate machinery have been described, this may be altered due to the possible adverse reactions of pentoxifilina.

Use in patients with renal insufficiency

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

Use in patients with hepatic insufficiency

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

Hemovás contains sodium

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

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

Hemovás is administered exclusively through intravenous infusion.

The dose and form of use of this medication depend on the nature and severity of the circulatory disorder and the tolerance of each patient to the medication. It is essential to inform your doctor of any disease you may have, 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 initiate treatment with 900 mg of pentoxifylline (3 ampoules of Hemovás) diluted in 1,500 ml of infusion liquid, administered through 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 ampoule of Hemovás), diluted in 1,000 ml of infusion liquid. Each administration will have a duration of 150-300 minutes, which corresponds to between 120 mg/h and 60 mg/h or between 400 mL/h and 200 mL/h, respectively.

In the event that 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 advisable to use a controlled infusion pump.

Patients with kidney disease

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

Patients with liver disease

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

Patients with blood pressure disorders

If you have low blood pressure, unstable circulation, or suffer from any disease that could be detrimental to a decrease in blood pressure (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 Hemovás than you should

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

Immediately consult your doctor or go to the nearest hospital emergency department, bringing this leaflet with you.

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

If you forgot to useHemovás

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

If you interrupt treatment with Hemovás

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

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

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

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

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 (accumulation of fluid in the tongue and throat that can cause asphyxiation), bronchospasm (spasms of the bronchi that make normal breathing difficult).

Vascular disorders:

Hot flashes, hemorrhages (for example, on the skin and/or mucous membranes located in the stomach and/or intestine).

Cardiac disorders:

Alterations in heart rhythm with an increase or decrease in the same (for example, palpitations), angina pectoris.

Blood and lymphatic system disorders:

Decrease in the number of platelets.

Skin and subcutaneous tissue disorders:

Erythema (redness of the skin), pruritus, skin eruption or urticaria (rashes, skin irritation, and pruritus).

Nervous system disorders:

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

Gastrointestinal disorders:

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

Hepatobiliary disorders:

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

Psychiatric disorders:

Agitation and sleep disturbances.

Complementary examinations:

Increased transaminases (liver enzymes), decreased blood pressure.

Reporting of side effects

If you experience any type of side effect, consult your doctoror pharmacist or nurse, even if it is apossible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute toproviding more information about the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the vial and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofHemovás

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

Appearance of the product and contents of the packaging

Transparent glass ampoule containing a transparent and colorless solution.

Each ampoule contains 15 ml.

Boxes containing 6 and 100 ampoules (EC).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

Last review date of this leaflet:02/2021

Other sources of information:

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es.