HEMOAL FORTE RECTAL OINTMENT

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.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult a doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4. You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

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

2 What you need to know before you start using Hemoal Forte

1. How to use Hemoal Forte
2. Possible side effects
3. Storage of Hemoal Forte
4. Package Contents and Additional Information

1. What is Hemoal Forte and what is it 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 you start 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 anesthetics derived from p-aminobenzoic acid, parabens, or paraphenylenediamine, or commercial hair dyes

• if you have presented an allergy to local anesthetics
• if you have had, suspect you may have, or are at increased risk of an increase in methemoglobin in the blood (methemoglobinemia)
• if you are being treated with sulfonamides
• if you are being treated with cholinesterase inhibitors (medicines for Alzheimer's disease) or have reduced cholinesterase activity
• if you are being treated with sympathomimetic agents
• if you have severe coronary artery disease or cardiovascular disorder
• if you have hypertension
• if you have hyperthyroidism
• if you are currently being treated or have been treated in the last two weeks with medicines for depression, such as Monoamine Oxidase Inhibitors (MAOIs)
• on extensive areas of skin, eczematous skin, sunburned skin, infected skin, or cracked skin

Warnings and Precautions

Consult your doctor or pharmacist before starting to use 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 prostatic hyperplasia.

Maintain normal intestinal function through a suitable diet (fruits, vegetables, adequate fluid intake, and regular exercise). It may be helpful to take a laxative, volume enhancer, or stool softener simultaneously. Excessive use of laxatives should be avoided, as it could cause intestinal laziness.

Use of Other Medicines

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

This medicine may interact with:

• Phenothiazines (antipsychotic) or MAOI antidepressants may cause an increase in blood pressure, cardiac arrhythmia, or even death.

• Cardiac glycosides: the use of cardiac glycosides (such as digoxin) at the same time as ephedrine may increase the risk of irregular heartbeat or heart attack.

• Antidepressants: tricyclic antidepressants (such as amitriptyline) and noradrenergic-serotonergic antidepressants may increase the risk of cardiovascular side effects with ephedrine.
• Sympathomimetic agents: the use of ephedrine with other sympathomimetic agents may increase the risk of hypertension and other cardiovascular effects.

• Beta-blocker antihypertensives: the use of this medicine at the same time as beta-blocker antihypertensives or other antihypertensives may reduce their effectiveness.
• Sulfonamides (medicines for treating infections): they should not be used at the same time as benzocaine, as it may decrease the effect of sulfonamides.
• Cholinesterase inhibitors (medicines for Alzheimer's disease): they should not be used at the same time as benzocaine, as it may increase the effect of benzocaine.

• Alkaloids of ergot: risk of vasoconstriction and/or increased tension (hypertension) when used in combination with ephedrine.
• Linezolid (antibiotic for the treatment of severe bacterial infections): risk of increased tension (hypertension) when used with ephedrine.
• Adrenergic neuron blockers: ephedrine may reduce or cancel the antihypertensive effects of guanethidine.
• Appetite suppressants and psychostimulants of the amphetamine type: risk of hypertension and increased heart rate with concomitant use of ephedrine and sibutramine.
• Halogenated anesthetics: ephedrine should be used with caution if you are undergoing anesthesia with halogenated anesthetics, as it may induce cardiac arrhythmia (ventricular fibrillation).
• Other local anesthetics of the benzocaine type: there may be cross-reactivity between benzocaine and other local anesthetics of the ester type.
• 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 72 hours before performing the pancreas puncture test with bentiromide, as there is a possibility of interference with the test result.

Pregnancy, Breastfeeding, and Fertility

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

Consult your doctor or pharmacist before using any medicine.

Do not use this medicine if you are pregnant or breastfeeding, unless it has been recommended by your doctor, as there is a possibility of absorption.

Use in People Over 65 Years and Debilitated Patients:

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

Use in Children

It is not recommended due to the lack of data on efficacy and safety.

Driving and Using Machines

No effects on the ability to drive or use machines have been described.

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 administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medicine is applied rectally.

Personal hygiene is essential to control hemorrhoidal symptoms. Therefore, the area should be kept clean, washing it, especially after each bowel movement, with a little mild soap and drying it without rubbing with a clean towel.

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

Apply with a finger, using the tip of the finger to overcome the resistance of the sphincter.

To use it inside the anal canal, remove the protection from the cannula, screw it onto the tube, lubricate it with a little ointment, and carefully insert it into the anal canal. Then, apply a small amount of ointment, exerting gentle pressure on the tube. If you encounter resistance during application, it should be interrupted, as it may be harmful and damaging.

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

Wash your hands before and after each application. For hygiene reasons and to avoid infections, the cannula should only be used by a single patient.

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

People Over 65 Years and Debilitated Patients: they should reduce the dose, see "Use in People Over 65 Years and Debilitated Patients".

If You Use More Hemoal Forte Than You Should:

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

The symptoms that may appear due to overdose are anxiety, nervousness, palpitations, headache, and insomnia.

If You Forget to Use Hemoal Forte:

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• reduction of blood flow to the area where the ointment is applied (ischemia)

Very rare side effects (in less than 1 in 10,000 people)

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

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

• increase in methemoglobin in the blood (methemoglobinemia) that causes a bluish coloration of the skin and mucous membranes (cyanosis)
• decreased appetite, decreased potassium levels in the blood (hypokalemia)
• confusion, depression, psychotic states, fear, irritability
• restlessness, tremor
• accelerated heart rate (tachycardia), irregular heartbeats (arrhythmia), angina-like pain, slow heart rate (bradycardia), cardiac arrest
• high blood pressure (hypertension), cerebral hemorrhage, low blood pressure (hypotension)
• fluid accumulation in the lungs (pulmonary edema)
• nausea, vomiting, excessive saliva
• urinary retention
• weakness, increased sweating (hyperhidrosis)
• changes in blood glucose levels
• allergic dermatitis

Others:

Allergic contact reactions, anal burning sensation

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

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.gob.es.

5. Storage of Hemoal Forte

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

Store below 30°C.

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

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

6. Package Contents and Additional Information

Composition of Hemoal Forte:

Per gram:

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

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

Appearance of the Product and Package Contents

Flexible aluminum tube, interior epoxy varnish with a polyethylene screw cap, containing 30g and 50g of rectal ointment. Each package contains a cannula for rectal application.

Marketing Authorization Holder

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers-Barcelona

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 Last Revision of this Leaflet: June 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.