Prospect: information for the user

Epistaxol topical solution

Epinephrine hydrochloride / Rutoside / Naphazoline hydrochloride / Phenazone

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

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor, pharmacist, or nurse.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect.
• You should consult a doctor if it worsens or does not improve after 2 applications.

Epistaxol is a solution applied superficially (topical administration) that facilitates blood coagulation (hemostasis). It causes a rapid contraction of blood vessels (vasoconstriction) and strengthens the walls of blood vessels.

Epistaxol is indicated in cases of mild bleeding in the mucosa (such as in the nasal, oral, genital, or rectal mucosa).

You should consult a doctor if it worsens or does not improve after 2 applications.

No use Epistaxol

• If you are allergic to adrenaline (epinephrine), naphazoline, phenazone, ritodrine, sympathomimetics (medicines that stimulate the nervous system), flavonoids (components of some plants), or any of the other components of this medication (listed in section 6).
• If you have heart problems such as heart dilation, coronary insufficiency, cardiac arrhythmias, or heart failure.
• If you have brain organic injuries such as cerebral arteriosclerosis (chronic inflammation of the brain's arteries with a tendency to obstruct them).
• If you have closed-angle glaucoma (eye condition characterized by increased intraocular pressure).
• If you have high blood pressure, hyperthyroidism (thyroid gland alteration), or pheochromocytoma (adrenal gland tumor).
• During childbirth.

Warnings and Precautions

If after two applications of the product the bleeding does not stop, consult your doctor.

Consult your doctor, pharmacist, or nurse before starting to take Epistaxol:

• If you have or have had cerebrovascular insufficiency (condition affecting the brain's blood vessels),
• Heart disease (such as angina or myocardial infarction), chronic lung disease, or urinary difficulties due to prostate hypertrophy,
• If you have pheochromocytoma, elevated intraocular pressure, and renal damage, high blood pressure, hyperthyroidism, arteriosclerosis,
• If you are diabetic.

Also, pay attention if you have hypercalcemia or hypocalcemia (blood calcium alteration), elderly patients, and pregnant women.

Children and Adolescents

It is not recommended for use in children under 7 years old.

Use of Epistaxol with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is especially important in the case of:

• Adrenergic blockers (medicines that act on neurons and modify the physiology of organs and tissues),
• Digitalis glycosides (heart medications),
• Quinidine, insulin, beta-blockers,
• Certain antidepressants or guanidine (anti-hypertensive agent),
• COMT or MAO inhibitors (medicines that act on the metabolic systems responsible for eliminating adrenaline),
• Thyroid hormones, oxytocin, and certain antihistamines (such as chlorpheniramine), levodopa, and alcohol,
• Medications that may cause potassium loss, such as diuretics (facilitate urination), aminophylline (medication used to facilitate breathing) or theophylline (antiasmatic, facilitates urination),
• Hypoglycemic agents (medicines that decrease blood sugar),
• Use with other sympathomimetics such as isoproterenol, amphetamines, ephedrine, phenylephrine, phenylpropanolamine, as they may increase the effect on the heart and central nervous system.

Laboratory Test Interference

It should be noted that adrenaline (epinephrine) may alter the values of the following blood determinations: increased glucose, false increase in bilirubin values, increased cholesterol, increased lactate and urate, and decreased insulin. An increase in urine vanillylmandelic acid and catecholamines may also be observed.

Pregnancy and Lactation

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

If you are pregnant, do not use Epistaxol unless your doctor considers it absolutely necessary for your treatment.

This medication is excreted in breast milk, so it is recommended to suspend breastfeeding or avoid administering this medication.

Driving and Operating Machines

No problems have been described with the use of this medication.

Epistaxol contains Sodium Metabisulfite (E-223).

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) due to the presence of sodium metabisulfite (E-223)

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

• Children over 7 years and adults: Apply directly to the bleeding area or through a treatment gauze according to the application method.
• Children under 7 years:No safety has been established for Epistaxol in children under 7 years. Do not use in children under 7 years.

Apply the product preferably to a gauze and perform a strong pressure on the bleeding area according to the administration standards.

Standards for correct administration

1. Soak a gauze (or use cotton if gauzes are not available) with the liquid from the bottle (with the bottle inverted and gently squeezing its walls) and proceed to perform a strong pressure on the area that is bleeding for 5-10 minutes.
2. Leave the dressing for at least one hour. Once this time has passed, we can remove the dressing and check that it has stopped bleeding.
3. If after removing the dressing, small, very light bleeding is observed, we will perform touches with a gauze or cotton pad soaked with the product to complete the healing.

If a small blood clot has formed in the bleeding point, or if some fibers from the dressing have adhered, do not forcibly remove them, but rather do so with gentle touches using a gauze soaked with the product to help loosen them and avoid possible bleeding when removing them.

If after two applications of the product the desired effect is not achieved, consult with your doctor, as it is necessary for them to evaluate the importance of your bleeding.

If you use more Epistaxol than you should

Due to the characteristics of this preparation, intended for superficial or topical use, it is not expected to experience intoxication phenomena with the use of this specialty.

Accidental overdose of adrenaline may cause sudden increases in blood pressure, which in extreme cases could cause cerebral hemorrhage, and tachycardia (rapid heart rate).

Arrhythmias (alteration of heartbeats) may also appear.

In case of overdose or improper use, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount used.

If you interrupt treatment with Epistaxol

Try to maintain the pressure with the medication for the indicated time.

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

Like all medications, Epistaxol may produce adverse effects, although not everyone will experience them.

With the topical application of Epistaxol, it is unlikely that adverse effects will appear. However, improper use of the medication could lead to the following adverse effects:

• Frequent (between 1 and 10 in every 100 patients)

Sensation of fear, anxiety, throbbing headache, difficulty breathing, sweating, nausea, vomiting, tremors, and dizziness, tachycardia (palpitations), pallor, mild elevation of blood pressure. These manifestations are not serious and disappear with rest and patient calmness.

• Rare (between 1 and 10 in every 1,000 patients)

Increased blood pressure (hypertension), which in severe cases can cause cerebral hemorrhage or acute heart failure with pulmonary edema, angina pectoris, ventricular arrhythmias, tachycardia, and abnormal heart contraction (ventricular fibrillation), syncope.

Alucinations, hyperglycemia (elevated blood sugar), and mydriasis (pupil dilation) may also appear, as well as difficulty urinating, metabolic acidosis, and renal failure.

• Unknown frequency

Dermatological eruptions, hemolytic anemia, cutaneous allergic manifestations (pruritus, urticaria), allergic reactions (hypersensitivity), general malaise, headache

If you consider adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Epistaxol

• The active principles are epinephrine hydrochloride, rutósido, nafazolina hydrochloride, and phenazone. One milliliter of solution contains 0.5 mg of epinephrine hydrochloride, 0.2 mg of rutósido, 0.5 mg of nafazolina hydrochloride, and 30 mg of phenazone.
• The other components are sodium metabisulphite (E-223), chlorobutanol, and purified water.

Appearance of the product and contents of the packaging

Epistaxol is a transparent and colorless or slightly yellowish solution, presented in a polyethylene bottle containing 10 ml of product.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Medical, S.A.

Pol. Ind. Las Quemadas, Parcela 87

14014 - Córdoba.

Responsible for manufacturing

Laboratorio Generfarma, S.L.

Ronda Isaac Peral, 6 (Parque Tecnológico)

46980 – Paterna. Valencia.

Last review date of this leaflet: October/2012.

“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/”