Package Insert: Information for the User

Hemovás 400 mg prolonged-release tablets

Pentoxifylline

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

Do not take Hemovás

• If you are allergic to pentoxifilina or to 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 or 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 Hemovás

A special control is required:

• If you have severe heart rhythm disturbances
• If you have suffered a myocardial infarction
• If you have low blood pressure (hypotension)
• If you have a severe kidney disease
• If you have a severe liver disease
• If you have a severe coronary disease with a particular risk of blood pressure reduction
• If you have an increased tendency to hemorrhage due to anticoagulant medication or have a coagulation disorder
• If you are taking antidiabetic medications (medications used to lower blood glucose levels), containing theophylline (medication used for asthma and other respiratory diseases), anti-vitamin K, antiplatelet agents or ciprofloxacin (antibiotic of the fluoroquinolone family used to treat certain bacterial infections)

Children and adolescents

The use of Hemovás is not recommended in children and adolescents due to the lack of experience with the use of pentoxifilina in this population

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 interact with Hemovás:

• Oral anticoagulants or antiplatelet agents, as their use with Hemovás increases the risk of hemorrhage. Your doctor may require periodic checks
• Hemovás and blood pressure medications may require dose adjustment, so inform your doctor if you are taking any blood pressure medication
• The treatment with Hemovás in patients treated with diabetes medications (insulin or oral treatment) may potentiate the effect of these medications, so inform your doctor if you are taking any diabetes medication
• The simultaneous treatment with Hemovás and theophylline (a medication used for asthma or other respiratory problems) may cause an increase in theophylline levels and increase its side effects, so inform your doctor if you are taking any medication containing theophylline
• The simultaneous treatment with Hemovás and uricosúricos (medications used to lower uric acid levels) may antagonize the effect of uricosúricos, so your doctor will need to adjust the dose
• The simultaneous administration of Hemovás and ciprofloxacin (antibiotic of the fluoroquinolone family used to treat certain bacterial infections) may increase Hemovás levels and increase its side effects
• The concomitant administration of Hemovás with cimetidina (medication used for stomach ulcers) may increase Hemovás levels and its main active metabolite, and 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

Hemovás should not be administered during pregnancy

Lactation

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

Driving and operating machinery

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

Hemovás contains yellow orange S (E110)

This medication may cause allergic reactions because it contains yellow orange S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid

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

This medication is administered orally.

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

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 each patient's tolerance. 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.

Do not take more Hemovás than recommended.

Do not discontinue treatment beforehand, as you will not achieve the desired therapeutic effect. If you estimate 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 a severe kidney or liver disease, your doctor will reduce the dose, adjusting it according to the disease and your tolerance to the medication.

Patients with blood pressure alterations

If you have low blood pressure, unstable circulation, or have 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 observe a severe allergic reaction (anaphylactic or anaphylactoid) with inflammation of the mouth and respiratory tract that produces difficulty breathing and a drop in blood pressure, immediately interrupt your treatment with Hemovás and inform your doctor.

Administration form

The tablets should be swallowed whole, without chewing, with a sufficient amount of water (approximately ½ glass) after a meal.

If you take more Hemovás than you should

If you take too much Hemovás, you may experience nausea, dizziness, vertigo, palpitations, or a sudden drop in blood pressure. Additionally, you may experience fever, agitation, hot flashes, loss of reflexes, convulsions, skin eruptions, coffee-ground vomiting, and loss of consciousness.

If you observe these symptoms, go immediately to your doctor or direct yourself to the nearest hospital emergency service, bringing this leaflet with you.

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

If you forgot to take Hemovás

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as possible and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait until it is time to take the next tablet.

If you have any other doubts 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 of 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 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), especially in patients with a high tendency to hemorrhage.

Cardiac disorders:

Alterations in heart rhythm with an increase or decrease in heart rate (for example, arrhythmias, tachycardia), angina pectoris.

Blood and lymphatic system disorders:

Decreased platelet count, decreased white blood cell count

Skin and subcutaneous tissue disorders:

Erythema (redness of the skin), pruritus, 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 discomfort, gastrointestinal discomfort, feeling of fullness, nausea, vomiting, diarrhea, constipation, hypersalivation (increased saliva production).

Hepatobiliary disorders:

Liver function disorders, such as: 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 adverse effects

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

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

Store in the original packaging to protect it from moisture

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

Do not use this medication if you observe that the tablet is deteriorated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hemovás

• The active principle 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 colorant (E104), sunset yellow FCF colorant (E110) and indigo carmine colorant (E132).

Appearance of the product and content of the packaging

Prolonged-release yellow tablets.

Packaging with 60 prolonged-release tablets of 400 mg.

Clinical packaging with 500 prolonged-release tablets of 400 mg.

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:August 2021

“Detailed and updated information on this medication is available onthe Webpageofthe Spanish Agencyof Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/”