Relief rectal ointment tube 28.4 g

Active substance: phenylephrine hydrochloride.

1 g of ointment contains 2.5 mg of phenylephrine hydrochloride.

Excipients: mineral oil, tocopherol, thyme oil, corn oil, glycerin, soft white paraffin, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), lanolin, benzoic acid (E 210), lanolin alcohol, paraffin, purified water , white wax.

Pharmacodynamics

Phenylephrine hydrochloride has a local vasoconstrictor effect. This normalizes the ratio between blood flow to hemorrhoidal nodes and blood outflow from them, and also helps to reduce exudation, swelling, itching, serous secretions in hemorrhoids and other diseases of the anorectal region.

Pharmacokinetics

Drug for local use. Phenylephrine, included in its composition, is inactivated by tissue MAO, inactive metabolites are excreted in mucus or in small amounts by the kidneys.

Symptomatic treatment of itching, burning and discomfort accompanying hemorrhoids and other diseases of the anorectal zone, as well as erosions, cracks, microtraumas in the anus area.

Hypersensitivity to the components of the drug, a significant increase in blood pressure, tachysystolic heart rhythm disorders, decompensated heart failure, cardiac conduction disorders, severe kidney and liver failure, thyrotoxicosis, acute pancreatitis, simultaneous use with MAO inhibitors (MAO) or within 15 days after stopping treatment MAO inhibitors, thromboembolic disease, granulocytopenia.

Adults and children over 12 years of age should use the drug after performing hygienic procedures. Remove the protective cap from the applicator. Attach the applicator to the tube and squeeze out enough ointment to lubricate the applicator. Apply the ointment carefully through the applicator to the affected areas outside or inside the anus in an amount sufficient to treat the affected areas up to 4 times a day, preferably in the evening, in the morning or after each bowel movement. Apply until the symptoms of the disease disappear. After each use, rinse the applicator thoroughly and place it in the protective cap. Do not use if protective coating is missing or damaged.

It is not described in medical practice, there are no data on systemic, including toxic, reactions of the body in response to rectal administration of the drug Relief. However, in case of an overdose, it is possible to increase the manifestations of adverse reactions, especially with long-term use. Arterial hypertension, pain and discomfort in the heart region, palpitations, shortness of breath, non-cardiogenic pulmonary edema, agitation, convulsions, sleep disturbances, anxiety, paranoia, irritability, psychosis with hallucinations, weakness, loss of appetite, nausea, vomiting, oliguria, urinary retention may be observed. , redness of the face, feeling of coldness in the limbs, paresthesias, increased sensitivity, hyperglycemia, hypokalemia, reduction of blood flow to vital organs, which can lead to deterioration of blood supply to the kidneys, metabolic acidosis, increase in the load on the heart due to an increase in the total resistance of peripheral vessels. Treatment is symptomatic.

This medicine is usually well tolerated, but in some cases side reactions due to phenylephrine hydrochloride may be observed.

From the side of the cardiovascular system: reflex bradycardia, arrhythmia, possible heart rhythm disturbances, increased blood pressure.

From the side of the immune system: allergic reactions, including cross-reactions with allergies to other sympathomimetics, which may manifest as a rash, itching, angioedema.

From the endocrine system: increasing symptoms of hyperthyroidism.

From the skin and subcutaneous tissues: contact dermatitis.

From the side of the nervous system: dizziness, nervousness, headache, tremor, insomnia, feeling of fear, feeling of blood flow to the face.

At the site of application, irritation, hyperemia, rash, itching, swelling, moderate pain / burning in case of damage or bleeding from the anus are possible.

Methylparaben and propyl parahydroxybenzoate can cause allergic reactions (perhaps delayed) and in some cases – bronchospasm. Lanolin can cause local skin reactions (eg, contact dermatitis). Benzoic acid is moderately irritating to the skin, eyes and mucous membranes.

Use during pregnancy or breastfeeding

Since the safety of the use of the drug Relief (phenylephrine) during pregnancy has not been studied, the use of the drug is possible if, in the opinion of the doctor, the benefit to the mother exceeds the potential risk to the fetus / child.

Pregnant women should consult a doctor before using the drug.

Because it is not known whether topical application of Relif® (phenylephrine) can result in sufficient systemic absorption to cause measurable excretion in breast milk, the physician should determine the importance of the drug to the mother: whether it is necessary to discontinue breast-feeding or to discontinue the drug. Studies on the effect of the drug on fertility have not been conducted.

Children

The effectiveness and safety of the use of the drug Relif® in children under 12 years of age has not been studied. There are no data.

The ability to influence the speed of reaction when driving vehicles or other mechanisms

No influence on the ability to drive vehicles or other mechanisms was observed.

It should not be used together with other vasoconstrictors (by any route of administration of the latter), as well as with antihypertensive drugs (ß-adrenoblockers), since phenylephrine can cause severe hypertension in some people due to stimulation of α-adrenoceptors.

Atropine sulfate blocks the reflex bradycardia induced by phenylephrine and increases the vasopressor response to phenylephrine. Simultaneous administration of phenylephrine with ß-adrenoblockers can lead to arterial hypertension and excessive bradycardia with possible heart block. It should be used with caution with thyroid hormones, drugs affecting cardiac conduction (cardiac glycosides, antiarrhythmic drugs).

With simultaneous use with drugs that cause the excretion of potassium, for example, with some diuretics such as furosemide, it is possible to increase hypokalemia and reduce arterial sensitivity to such vasopressor drugs as phenylephrine.

Simultaneous reception of phenylephrine and other sympathomimetics can lead to additional stimulation of the central nervous system to an extremely high level, accompanied by nervousness, irritability, insomnia. Seizures are also likely.

When using MAO inhibitors, you should consult a doctor before starting the use of phenylephrine in the anorectal region. MAO inhibitors used before the start of phenylephrine treatment potentiate the cardiac and pressor effects of the latter, since the metabolism of phenylephrine is reduced.

With local use of the drug Relief, rectal ointment, in the anus area, the auxiliary substance white soft paraffin can reduce the strength and safety of latex condoms, which are used simultaneously with the drug.

Store in a place inaccessible to children at a temperature not higher than 25 °C.

Shelf life – 2 years.

Opening the tube and starting to use the drug does not affect the shelf life, provided that the cap is tightly closed each time after use. Do not use after the expiration date indicated on the package.