Hemoal Forte rectal ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hemoal Forte rectal ointment

Benzocaine, Ephedrine hydrochloride

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.

• If you need advice or more information, ask your pharmacist.

• If you experience any adverse effects, consult a doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4. You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the package leaflet

1. What Hemoal Forte is and what it is used for

2. What you need to know before using Hemoal Forte

3. How to use Hemoal Forte

4. Possible side effects

5. How to store Hemoal Forte

6. Contents of the pack and other information

1. What Hemoal Forte is and what it is used for

It is a local anesthetic due to the action of benzocaine and a vasoconstrictor due to the action of ephedrine.

It is indicated for the symptomatic relief of pain, itching, or burning associated with hemorrhoids in adults.

2. What you need to know before using Hemoal Forte

Do not use Hemoal Forte:

• if you are allergic (hypersensitive) to benzocaine, ephedrine hydrochloride, or any of the other components of this medicine (listed in section 6), to other local anaesthetics derived from p-aminobenzoic acid, parabens, or paraphenylenediamine or commercial hair dyes

• if you have had an allergic reaction to local anaesthetics

• if you have had, suspect you may have, or are at increased risk of elevated methemoglobin levels in the blood (methemoglobinemia)

• if you are being treated with sulfonamides

• if you are being treated with cholinesterase inhibitors (medications for Alzheimer's disease) or have reduced cholinesterase activity

• if you are being treated with sympathomimetic agents

• if you have severe coronary heart disease or cardiovascular disorders

• if you have hypertension

• if you have hyperthyroidism

• if you are currently being treated or have been treated in the last two weeks with medications for depression such as monoamine oxidase inhibitors (MAOIs)

• on large areas of skin, eczematous skin, sunburned skin, infected or cracked skin

Warnings and precautions

Talk to your doctor or pharmacist before using Hemoal Forte.

This medicine should not be used if you have serious heart problems (complete heart block).

This medicine should be used with caution if you have diabetes, closed-angle glaucoma, Raynaud's phenomenon, pheochromocytoma, or benign prostatic hyperplasia.

Maintain normal bowel function through an appropriate diet (fruits, vegetables, adequate fluid intake, and regular exercise). It may be helpful to take a laxative, stool bulking agent, or stool softener at the same time. Avoid excessive use of laxatives, as this could lead to lazy bowel syndrome.

Use with other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

This medicine may interact with:

• Phenothiazines (antipsychotics) or antidepressants MAOIs, which may cause increased blood pressure, cardiac arrhythmia, or even death.

• Cardiac glycosides: using cardiac glycosides (e.g., digoxin) together with ephedrine may increase the risk of irregular heartbeat or heart attack.

• Antidepressants: tricyclic antidepressants (e.g., amitriptiline) and noradrenergic-serotonergic antidepressants may increase the risk of cardiovascular side effects with ephedrine.

• Sympathomimetic agents: using ephedrine with other sympathomimetic agents may increase the risk of hypertension and other cardiovascular effects.

• Beta-blocking antihypertensive agents: using this medicine together with beta-blocking antihypertensives or other antihypertensives may reduce their effectiveness.

• Sulfonamides (medications for treating infections): should not be used together with benzocaine, as this may reduce the effect of sulfonamides.

• Cholinesterase inhibitors (medications for Alzheimer's disease): should not be used together with benzocaine, as this may increase the effect of benzocaine.

• Ergot alkaloids: risk of vasoconstriction and/or increased blood pressure (hypertension) when used in combination with ephedrine.

• Linezolid (an antibiotic for the treatment of serious bacterial infections): risk of increased blood pressure (hypertension) when used with ephedrine.

• Adrenergic neuron-blocking agents: ephedrine may reduce or cancel the antihypertensive effects of guanethidine.

• Appetite suppressants and amphetamine-type psycho stimulants: risk of hypertension and increased heart rate with concomitant use of ephedrine and sibutramine.

• Halogenated anaesthetics: ephedrine should be used with caution if undergoing anaesthesia with halogenated anaesthetics, as it may induce cardiac rhythm disturbances (ventricular fibrillation).

• Other local anaesthetics of the benzocaine type: cross-reactivity may occur between benzocaine and other ester-type local anaesthetics.

• Theophylline (anti-asthmatic, bronchodilator): increased risk of adverse reactions after concomitant administration of theophylline and ephedrine.

• Dexamethasone (glucocorticoid): ephedrine increases the elimination of dexamethasone.

• Doxapram (respiratory stimulant): risk of hypertension when used in combination with ephedrine.

• Oxytocin: risk of hypertension when used in combination with ephedrine.

Interactions with diagnostic tests:

Do not use Hemoal Forte within 72 hours before undergoing a pancreatic function test with bentiromide, as it may interfere with the test results.

Pregnancy, breastfeeding and fertility

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

Consult your doctor or pharmacist before using any medicine.

You should not use this medicine if you are pregnant or breastfeeding unless advised by your doctor, as absorption is possible.

Use in people aged 65 years and older and in debilitated patients:

People aged 65 years and older and debilitated patients may be more sensitive to benzocaine, so the dose should be reduced.

Use in children

Not recommended due to lack of data on efficacy and safety.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Hemoal Forte contains acetylated lanolin alcohols

This medicine may cause local skin reactions (such as contact dermatitis) because it contains acetylated lanolin alcohols.

3. How to use Hemoal Forte

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

This medicine is administered rectally.

Personal hygiene is essential for controlling hemorrhoidal symptoms. Therefore, the area should be kept clean; it is recommended to wash it, especially after each bowel movement, with a mild soap, and dry gently with a clean towel without rubbing.

Apply a thin layer of ointment (approximately 1 cm) onto the clean and dry affected anal area, in the morning, at night, and after each bowel movement. Generally, 3 to 4 times a day.

Apply using a finger, using the fingertip to gently overcome sphincter resistance.

To apply inside the anal canal, remove the protective cap from the cannula, screw the cannula onto the tube, lubricate it with a small amount of ointment, and carefully insert it into the anal canal. Then, apply a small amount of ointment by gently squeezing the tube. If resistance is encountered during application, stop the procedure, as it could be harmful and damaging.

After application, unscrew the cannula from the tube and wash it before storing.

Wash your hands before and after each application. For hygiene reasons and to prevent infections, the cannula must be used by only one patient.

Treatment should not last longer than 7 days. If anorectal symptoms (pain, itching, burning) do not improve within this time or if bleeding occurs, consult your doctor.

Patients over 65 years of age and debilitated patients: the dose should be reduced; see “Use in patients over 65 years of age and debilitated patients”.

If you use more Hemoal Forte than you should:

If you have used more Hemoal Forte than recommended, consult your doctor or pharmacist or contact the Toxicology Information Service at telephone number (91) 562.04.20, indicating the medicine and the amount applied.

Symptoms that may occur due to overdose include anxiety, nervousness, palpitations, headache, and insomnia.

If you forget to use Hemoal Forte:

Do not apply a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Rare adverse effects (may affect up to 1 in 1,000 people):

• reduction in blood flow to the area where the ointment is applied (ischaemia)

Very rare adverse effects (affect fewer than 1 in 10,000 people):

• hypersensitivity reactions
• anxiety
• headache, nervousness, insomnia
• palpitations

Adverse effects of unknown frequency: (cannot be estimated from available data)

• increased methaemoglobin in the blood (methaemoglobinaemia), leading to a blue discolouration of the skin and mucous membranes (cyanosis)
• decreased appetite, decreased blood potassium levels (hypokalaemia)
• confusion, depression, psychotic states, fear, irritability
• restlessness, tremor
• increased heart rate (tachycardia), irregular heartbeat (cardiac arrhythmia), angina-like chest pain, slow heart rate (bradycardia), cardiac arrest
• high blood pressure (hypertension), cerebral haemorrhage, low blood pressure (hypotension)
• fluid accumulation in the lungs (pulmonary oedema)
• nausea, vomiting, excessive salivation
• urinary retention
• weakness, increased sweating (hyperhidrosis)
• changes in blood glucose levels
• allergic dermatitis

Others:

Allergic contact reactions, sensation of anal burning may occur.

Dehydration of the skin area where the product is applied (epithelium) and hardening of mucous membranes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Hemoal Forte

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

Store below 30 ºC.

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

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

6. Contents of the package and other information

Composition of Hemoal Forte:

Per gram:

The active substances are: benzocaine 60 milligrams and ephedrine (hydrochloride) 2 milligrams.

The other components (excipients) are: zinc oxide, white vaseline, and acetylated lanolin alcohols.

Appearance of the product and contents of the package

Flexible aluminum tube with epoxy-lined interior and polyethylene screw cap, containing 30 g and 50 g of rectal ointment. Each package includes one rectal applicator nozzle.

Marketing Authorization Holder

Reckitt Benckiser Healthcare, S.A.

Paseo de Gracia, 9, 08007, Barcelona, Spain

Manufacturer

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Laguna, 66-68-70. Poligono Industrial Urtinsa II (Alcorcón)

• 28923 – Spain

or

ALCALA FARMA, S.L.

Carretera M-300 Km 29,920 (Alcalá de Henares) - 28802 - Spain

Date of the most recent review of this leaflet: June 2025

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) http://www.aemps.gob.es