Product Information for the User

Hemoal Forte Rectal Ointment

Benzocaine, Ephedrine Hydrochloride

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this product information or those indicated by your doctor or pharmacist.

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

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

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

2 What you need to know before starting to use Hemoal Forte

3. How to use Hemoal Forte

4. Possible adverse effects

5. Storage of Hemoal Forte

6. Contents of the pack and additional information

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 Forte:

• 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 paraphenylenediamineor commercial hair dyes

• if you have had an allergic reaction to local anesthetics
• if you have suffered, suspect 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 sympathomimetics
• 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)
• on extensive areas of skin, eczematous skin, sunburned, infected or cracked skin

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hemoal Forte.

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). Taking some laxatives, volume expanders or stool softeners simultaneously may be helpful. Avoid excessive use of laxatives, as it may cause intestinal sluggishness.

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 MAO 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.
• Sympathomimetics: the use of ephedrine with other sympathomimetics 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 amphetamine-type psychostimulants: 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 rhythm disorder (ventricular fibrillation).
• Other local anesthetics of the type of benzocaine: may exist 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 Forte 72 hours before the performance of 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Do not use this medication 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 the scarcity of data on efficacy and safety.

Driving and operating machinery

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

Hemoal Forte 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. If in doubt, consult your doctor or pharmacist again.

This medication is applied rectally.

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

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

Apply it 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 carefully introduce it into the anal canal. Then, apply a small amount of ointment while exerting gentle pressure on the tube. If resistance is encountered during application, the process 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 occurs, you should consult your doctor.

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

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 will 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)

• Reactions of hypersensitivity
• Anxiety
• Headache, nervousness, insomnia
• Palpitations

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

• Increased metahemoglobin in the blood (metahemoglobinemia) that causes a blue discoloration 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 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 reactions upon contact, sensation of anal burning

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

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 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 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.Deposit empty containers and unused medicines at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

Composition of Hemoal Forte:

Per gram:

The active principles 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 content 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 and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es