Leaflet: information for the user

Hemoal rectal ointment

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

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

Do not use Hemoal:

• If you are allergic (hypersensitive) to benzocaine, hydrochloride of ephedrine or to any of the other components of this medication (including those listed in section 6), to other local anesthetics derived from p-aminobenzoic acid, parabens or paraphenylenediamine or commercial hair dyes
• If you have had an allergic reaction to local anesthetics
• If you have suffered, suspect that you may suffer or have a higher 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 (medications for Alzheimer's disease) or have reduced cholinesterase activity
• If you are being treated with sympathomimetic agents
• If you have severe coronary 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 medications for depression such as Monoamine Oxidase Inhibitors (MAOIs)
• In extensive areas of skin, eczematous skin, sunburned, infected or cracked skin

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hemoal.

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

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

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

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used other medications, including those purchased without a prescription.

This medication may interact with:

• Phenothiazines (antipsychotic) or MAOIs (antidepressants) may produce an increase in blood pressure, cardiac arrhythmia or even death.
• Cardiac glycosides: the use of cardiac glycosides (e.g. digoxin) at the same time as ephedrine may increase the risk of irregular heartbeat or heart attack.
• Antidepressants: tricyclic antidepressants (e.g. amitriptyline) and noradrenergic-serotoninergic 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 medication at the same time as beta-blocker antihypertensives or other antihypertensives may reduce the effectiveness of these.

• Sulfonamides (medication for treating infections): should not be used at the same time as benzocaine, as it may reduce the effect of sulfonamides.
• Cholinesterase inhibitors (medications for Alzheimer's disease): should not be used at the same time as benzocaine, as it may increase the effect of benzocaine.

• Corniculine alkaloids: risk of vasoconstriction and/or increased blood pressure when used in combination with ephedrine.
• Linezolid (antibiotic for treating severe bacterial infections): risk of increased blood pressure when used with ephedrine.
• Adrenergic neuron blockers: ephedrine may reduce or neutralize the anti-hypertensive effects of guanetidine.
• Appetite suppressants and anorexics: risk of hypertension and increased heart rate with concomitant use of ephedrine and sibutramine.
• Halogenated anesthetics: ephedrine should be used with caution if undergoing anesthesia with halogenated anesthetics, as it may induce cardiac arrhythmia (ventricular fibrillation).
• Other local anesthetics of the type of benzocaine: there may be cross-reaction between benzocaine and other local anesthetics of the ester type.
• Theophylline (antihistamine, 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 72 hours before performing pancreatic puncture with bentiromide, as there is a possibility of interference with the test result.

Pregnancy, lactation and fertility

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

Consult your doctor or pharmacist before using any medication.

This medication should not be used if you are pregnant or breastfeeding, unless recommended by your doctor, as there is a possibility of absorption.

Use in patients over 65 years and debilitated patients:

Older patients over 65 years 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 operating machinery

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

Hemoal contains lanolin acetate alcohols

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

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

This medication is applied rectally.

Personal hygiene is fundamental for controlling hemorrhoidal symptoms. Therefore, the area should be kept clean, washing it especially after each defecation, with a small amount of mild soap and drying it without rubbing, with a clean towel.

Applya thin layer of ointment (approx. 1 cm) tothe clean and dry affected anal area, in the morning, at night, and after each defecation. 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, wind it around the tube, lubricate it with a small amount of ointment, and introduce it into the anal canal with care. Then, apply a small amount of ointment while exerting gentle pressure on the tube. In case of resistance during application, the procedure 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 prevent infections, the cannula should only be used by one patient.

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

Patients over 65 years and weakened patients:should reduce the dose, see “Use in patients over 65 years and weakened patients”

If you use more Hemoal than you should:

If you have used more Hemoal than you should, consult your doctor or pharmacist or the Toxicological Information Service. Phone 91 562.04.20 indicating the medication and the amount applied.

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

If you forgot to use Hemoal:

Do not apply a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

• Reduced blood flow to the area where the cream is applied (ischemia)

Very rare adverse effects (in 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 methemoglobin in blood (methemoglobinemia) that causes blue discoloration of skin and mucous membranes (cyanosis)
• Decreased appetite, decreased potassium levels in blood (hypokalemia)
• Confusion, depression, psychotic states, fear, irritability
• Restlessness, tremor
• Accelerated heart rate (tachycardia), irregular heart rhythm (cardiac arrhythmia), angina-like pain, slow heart rate (bradycardia), cardiac arrest
• High blood pressure (hypertension), cerebral hemorrhage, low blood pressure (hypotension)
• Pulmonary edema
• Nausea, vomiting, excessive salivation
• Urinary retention
• Weakness,increased sweating (hyperhidrosis)
• Changes in blood glucose levels

Others:

Allergic contact reactions and burning sensation in the anal area may occur.

Drying out of the skin area where the cream is applied (epithelium) and hardening of mucous membranes may occur.

Reporting 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 prospectus. You can also report them directly through the Spanish System for 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 medication.

Keep this medication 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 through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Hemoal:

Per gram:

The active principles are: benzocaine 30 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 packaging

Flexible aluminum tube, epoxy interior coating with polyethylene screw cap, containing 30 g and 50 g of rectal ointment. Each package contains a rectal applicator.

Holder of the marketing authorization

Reckitt Benckiser Healthcare, S.A.

C/ Mataró, 28

08403 Granollers-Barcelona

Responsible for manufacturing

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

- 28923 – Spain

or

ALCALA FARMA, S.L.

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

Last review date of this leaflet: September 2020

The detailed information of this medication is available on the website oftheSpanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).