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 stinging associated with hemorrhoids in adults.

Do not use Hemoal Forte:

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

• if you have been allergic to local anesthetics
• if you have suffered or suspect that you might have an increase in methaemoglobin in the blood (methaemoglobinemia)
• if you are being treated with sulfa drugs
• if you are being treated with cholinesterase inhibitors (medicines for Alzheimer's disease)
• if you are being treated with sympathomimetic agents
• if you suffer from severe coronary artery disease or cardiovascular disorder
• if you suffer from hypertension
• if you have hyperthyroidism
• if you are currently being treated or have been in the last two weeks under treatment with medicines to treat depression such as monoamine oxidase inhibitors (MAOIs).
• on large areas of skin, eczematous, sunburned, infected or cracked skin

Warnings and cautions

Talk to your doctor or pharmacist before using Hemoal Forte.

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

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

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

Use of other medications

Please inform your doctor or pharmacist if you are using, or have recently used any other medicines, even those obtained without a prescription.

This medicine can interact with:

• Phenothiazines (antipsychotic) or MAOI antidepressants can cause increased blood pressure, cardiac arrhythmia or even cause death.

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

• Antidepressants: Tricyclic antidepressants (for example, 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.

• Antihypertensive beta-blocking agents: the use of this medicine at the same time as antihypertensive beta-blocking agents can reduce the effectiveness of these. Sulfamides (medicine to treat infections): should not be used at the same time as benzocaine, as it can decrease the effect of sulfonamides. Cholinesterase inhibitors (medicines for Alzheimer's disease): should not be used at the same time as benzocaine, as it can increase the effect of benzocaine.

• Ergot alkaloids: risk of vasoconstriction and / or increased blood pressure (hypertension) when used in combination with ephedrine.
• Ergot alkaloids: risk of vasoconstriction and / or increased blood pressure (hypertension) when used in combination with ephedrine.
• Linezolid (antibiotic for the treatment of serious bacterial infections): risk of increased blood pressure (hypertension) when used with ephedrine.
• Adrenergic neuron blockers: Ephedrine may reduce or nullify the antihypertensive effects of guanethidine.
• Appetite suppressants and amphetamine-type psychostimulants: Risk of hypertension and increased heart rate with concomitant use of ephedrine and sibutramine.
• Anesthetics: Ephedrine should be used with caution if under anesthesia with halogenated anesthetics, as it can induce a heart rhythm disorder (ventricular fibrillation).
• Other local anesthetics of the benzocaine type: there may be a cross-relationship between benzocaine and other local anesthetics of the ester type.
• Theophylline (antiasthmatic, 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 pancreatic puncture test with bentiromide, since there is the possibility of interference in the result of the test.

Pregnancy and Lactation

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before taking any medicine.

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

Use in people over 65 and debilitated patients:

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

Use in children

It is not recommended due to limited data on efficacy and safety.

Driving and using machines

No effects on the ability to drive or operate machines have been reported in rectal use.

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist again.

This medicine is applied rectally or cutaneously.

Personal hygiene is essential to control hemorrhoidal symptoms. For this reason, the area must be kept clean, for which it is recommended to wash it especially after each defecation, with a little mild soap and dry it, without rubbing, with a clean towel.

Apply a thin layer of ointment to the clean and dry affected area, in the morning, at night and after each bowel movement.

In general 3 to 4 times a day.

To use 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 by applying slight pressure to the tube. If resistance is found at the time of application, it must be interrupted as it can be harmful and harmful.

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 avoid infection, the cannula should only be used by a single patient.

The treatment should not last more than 7 days. If the anorectal symptoms (pain, itching, stinging) do not improve in this time or bleeding appears, you should consult your doctor.

Over 65 years and debilitated patients : they should reduce the dose, see "Use in 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. Telephone (91) 562.04.20 indicating the medicine and the amount applied.

Symptoms that can appear due to overdose are anxiety, nervousness, palpitations and headache.

If you forget to use Hemoal Forte:

Do not take a double dose to make up for a forgotten dose.

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

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

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

• reduced 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)

• increased methemoglobin in the blood (methemoglobinemia) causing a blue discoloration of the skin and mucosa (cyanosis)
• confusion, depression, psychotic states, fear
• irritability, restlessness, weakness, sweating, trembling, increased amount of saliva (hypersalivation)
• fast heartbeat (tachycardia), irregular heartbeat (cardiac arrhythmia), anginal pain, slow heart rate (reflex bradycardia), cardiac arrest, low blood pressure (hypotension)
• high blood pressure (hypertension), brain hemorrhage
• accumulation of fluid in the lungs (pulmonary edema)
• nausea, vomiting, decreased appetite
• urinary retention
• decreased level of potassium in the blood (hypokalaemia), changes in blood glucose levels

Other :

Allergic contact reactions may occur, anal burning sensation

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

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use (www.notificaram.es). By reporting side effects you can help provide more information on the safety of this medicine.

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

Store below 30 ºC.

Do not use after the expiration date that appears on the package. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer needed. This way you will help to protect the environment.

Composition of Hemoal Forte:

For each 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.

What the product looks like and contents of the pack

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

Marketing authorization holder

Reckitt Benckiser Healthcare, SA

C / Mataró, 28

08403 Granollers-Barcelona

Responsible for manufacturing

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, SA

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

- 28923 - Spain

or

ALCALA FARMA, SL

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

Date of last revision of this leaflet: August 2017

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