Hemovas 400 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hemovás 400 mg prolonged-release tablets

Pentoxifylline

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Hemovás 400 mg tablets are and what they are used for.
2. What you need to know before taking Hemovás 400 mg tablets.
3. How to take Hemovás 400 mg tablets.
4. Possible side effects.
5. How to store Hemovás 400 mg tablets.
6. Contents of the pack and other information.

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

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

Hemovás is used in the treatment of peripheral circulatory disorders due to arteriosclerosis, diabetes, inflammation, or other causes; trophic disturbances; leg ulcers; and gangrene.

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

Do not take 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 experienced an allergic reaction to another xanthine derivative such as theophylline.
• If you have severe bleeding or significant retinal hemorrhage.
• If you have recently had a myocardial infarction.
• If you are pregnant.
• This medicine must not be given to children.

Warnings and precautions

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

Special monitoring is required:

• If you have serious heart rhythm disorders.
• 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 have a coagulation disorder.
• If you are taking antidiabetic medicines (medicines used to lower blood glucose levels), theophylline (a medicine used for asthma and other lung diseases), antivitamin K agents, antiplatelet agents, or ciprofloxacin (a fluoroquinolone antibiotic used to treat certain bacterial infections).

Children and adolescents

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

Taking Hemovás with other medicines

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

The following medicines in particular may interact with Hemovás:

• If you are being treated with oral anticoagulants or antiplatelet agents, as their use together with Hemovás increases the risk of bleeding. For this reason, your doctor may perform periodic monitoring.
• If Hemovás and antihypertensive medicines are taken simultaneously, dose adjustment may be necessary; therefore, you must inform your doctor if you are taking any medicine for high blood pressure.
• Treatment with Hemovás in patients receiving antidiabetic medicines (insulin or oral treatment) may enhance the effect of these medicines; therefore, you must inform your doctor if you are taking any medicine for diabetes.
• Concomitant treatment with Hemovás and theophylline (a medicine used for asthma or other respiratory problems) may increase theophylline levels and thereby increase its side effects; therefore, you must also inform your doctor if you are taking any medicine containing theophylline.
• Concomitant treatment with Hemovás and uricosuric agents (medicines used to reduce uric acid levels) may antagonize the effect of uricosurics, so your doctor may need to adjust the dose.
• If Hemovás and ciprofloxacin (a fluoroquinolone antibiotic that acts by eliminating bacteria causing infections) are administered simultaneously, Hemovás levels may increase, thereby increasing its side effects.
• The concomitant administration of Hemovás with cimetidine (a medicine used for stomach ulcers) may increase levels of Hemovás and its main active metabolite, 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

Hemovás must not be administered during pregnancy.

Breastfeeding

Consult your doctor before using Hemovás if you are breastfeeding, as Hemovás passes into breast milk in small amounts. Your doctor will assess whether it is advisable to continue or discontinue treatment.

Driving and use of machines

No negative effects of Hemovás on the ability to drive or operate machinery have been reported. However, certain adverse effects (e.g., dizziness) may impair the patient's reaction time or concentration, and thus may represent a risk in situations such as driving vehicles or operating machinery.

Hemovás contains Sunset Yellow FCF (E110)

This medicine can cause allergic reactions because it contains Sunset Yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Hemovás 400 mg tablets

Follow exactly the instructions for use of this medicine provided by your doctor. In case of doubt, please consult your doctor or pharmacist again.

This medicine is administered orally.

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

Remember to take your medicine.

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 on each patient's tolerance. It is important that you inform your doctor of any illness you may have, as this information could be useful in determining the correct dose for you.

Do not take more Hemovás than recommended.

Do not stop treatment prematurely, as you will not achieve the desired therapeutic effect. If you feel that the action of Hemovás is too strong or too weak, inform your doctor or pharmacist.

Patients with kidney or liver disease:

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

Patients with blood pressure disorders:

If you have low blood pressure, unstable circulation, or suffer from a condition for which a decrease in blood pressure could be harmful (severe coronary heart disease or narrowing of the blood vessels supplying the brain), your doctor will prescribe a low initial dose, gradually increasing it depending on your response to treatment.

If you experience a severe allergic reaction (anaphylactic or anaphylactoid) with swelling of the mouth and airways causing breathing difficulties and a drop in blood pressure, stop treatment with Hemovás immediately and inform your doctor.

Method of administration

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

If you take more Hemovás than you should

If you take too high a dose of Hemovás, you may experience nausea, dizziness, vertigo, palpitations, or a sudden drop in blood pressure. Additionally, fever, agitation, hot flushes, loss of reflexes, seizures, skin rashes, coffee-ground vomiting, and loss of consciousness may occur.

If you notice these symptoms, go immediately to your doctor or 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 ingested.

If you forget to take Hemovás

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

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.

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

Immune system disorders:

Severe allergic-type reactions (anaphylactic or anaphylactoid) with swelling of the mouth and airways causing breathing difficulties 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:

Flushing, bleeding (e.g. of the skin and/or mucous membranes located in the stomach and/or intestine), especially in patients with a high tendency to bleeding.

Cardiac disorders:

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

Blood and lymphatic system disorders:

Decrease in platelet count, decrease in white blood cells.

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:

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

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:

Increase in transaminases (liver enzymes), decrease in 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. Conservation of Hemovás 400 mg prolonged-release tablets

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

Store in the original packaging to protect it from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

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

6. Contents of the package and other information

Composition of Hemovás

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

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

Tablet coating: Hydroxypropylmethylcellulose (E464), polydextrose (E1200), titanium dioxide (E171), polyethylene glycol 4000 (E1521), quinoline yellow dye (E104), sunset yellow FCF (E110) and indigo carmine (E132).

Appearance of the product and contents of the package

Yellow prolonged-release tablets.

Pack containing 60 prolonged-release 400 mg tablets.

Hospital pack containing 500 prolonged-release 400 mg tablets.

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 latest revision of this leaflet: August 2021

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”