Relief Pro rectal suppositories 10 pcs — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. Fluocortolone pivalate suppresses inflammatory and allergic skin reactions, and also relieves subjective manifestations such as itching, burning and pain; reduces the expansion of capillaries, edema of interstitial cells and tissue infiltration, inhibits the proliferation of capillaries.

Lidocaine hydrochloride is a standard local anesthetic that has been used in medical practice for many years. Due to its analgesic effect, it is effective when using suppositories and ointments intended for the treatment of disorders associated with hemorrhoidal pathology. A decrease in the severity of pain and itching is associated with inhibition of afferent nerve impulses.

Pharmacokinetics. After a single rectal application by healthy male volunteers, the maximum systemic absorption was about 5% for suppositories and 15% for the cream of the dose of fluocortolone pivalate and about 24 and 30%, respectively, of the dose of lidocaine hydrochloride (active substances labeled with a radioactive isotope).

Indications

Rectal cream. for the symptomatic treatment of pain and inflammation in:

• hemorrhoids;
• proct;
• eczema in the anus.
• Suppositories. For the symptomatic treatment of pain and inflammation in:
• hemorrhoids;
• proktyte.

Application

Rectal cream should be applied 2 times a day, morning and evening (approximately 1 g per application). in the first days of treatment, the preparation can be used 3 times a day. after improvement, it is often sufficient to use the preparation once a day. it is recommended to use Relief® Pro rectal cream after bowel movement. before using the preparation, the anal area should be carefully cleaned.

The duration of the full course of treatment should not exceed 2 weeks.

Apply Relief® Pro rectal cream on the tip of the finger to the anus, overcoming the sphincter resistance with the tip of the finger. One fingertip dose is the amount that is obtained after a single squeeze from the tube and is applied to the surface of an adult's index finger. If it is necessary to inject the rectal cream Relief® Pro into the rectum, screw the applicator onto the tube and insert the tip into the anus. A small amount of cream can be administered by lightly pressing the tube.

Suppositories. Apply 1 suppository 2 times a day, morning and evening. After improvement, it is often enough 1 suppository 1 time per day or 1 time per 2 days. It is recommended to use Relief® Pro suppositories after a bowel movement. Before the introduction of the suppository, the anal area should be carefully cleaned.

Insert the suppository deep into the anus. The duration of treatment with Relief® Pro suppositories should not exceed 2 weeks.

If the suppositories become soft due to the high temperature, immerse them in cold water before removing the casing.

Contraindications

The use of relief® pro is contraindicated in case of local infections in the injection zone, as well as in the presence of clear symptoms of such pathological conditions in the corresponding zones:

• specific skin lesions (syphilis, tuberculosis);
• chickenpox;
• reactions after vaccination;
• genital herpes;
• smallpox;
• other viral infections;
• primary bacterial or fungal infections;
• secondary skin infections in the absence of appropriate antibiotic therapy;
• patients with hypersensitivity to other local anesthesia of the amide type (for example, bupivacaine, mepivacaine and lidocaine).

Relief® Pro should not be used in case of hypersensitivity to active substances or any of the excipients.

Side effects

The incidence of undesirable effects was determined based on the totality of data from clinical trials conducted with the participation of 661 patients.

On the part of the skin and subcutaneous tissue, including allergic reactions, often - pain and burning sensation at the site of application; infrequently - irritation at the site of application.

After long-term therapy with Relief® Pro (which exceeds 4 weeks), there is a risk of developing local pathological conditions of the skin, such as atrophy, striae or telangiectasia.

Adverse reactions due to lidocaine hydrochloride: anaphylactic reactions. The development of systemic adverse reactions is unlikely, since when using the preparation, the intake of lidocaine into the systemic circulation is insignificant; systemic adverse reactions associated with lidocaine, identical in manifestations to those associated with local anesthetics of the amide group.

Sspecial instructions

In the case of application of Relief ® Pro rectal cream in the genital area or anus, excipients such as white soft paraffin and mineral oil can reduce the strength of latex condoms and thus compromise their reliability.

For fungal infections, additional special antifungal therapy is required.

Avoid eye contact with the cream. It is recommended to wash your hands thoroughly after use.

Cetostearyl alcohol can cause local skin reactions (contact dermatitis).

The use of topical preparations, especially over a long period, can cause sensitization phenomena. In this case, the use of these preparations should be discontinued and appropriate treatment initiated. When topical preparations are applied to large areas of the body, to damaged skin, or under an airtight dressing, corticosteroids may be absorbed in quantities that can cause undesirable systemic effects. Do not apply under perineal occlusive dressings. Suppression of adrenal function can develop even without occlusion. Local use of high doses of corticosteroids can lead to absorption of systemically active amounts of GCS. There are literature data on the development of cataracts in patients using corticosteroids for a long period, therefore, in order to exclude manifestations of the systemic action of corticosteroids, one should be aware of their possible role in the development of cataracts.

Use with caution in acute diseases, in debilitated patients, elderly patients; patients with severe cardiac, renal and hepatic insufficiency.

It is necessary to avoid contact of Relief® Pro suppositories with the eyes. It is recommended that you wash your hands thoroughly after using them.

For fungal infections, additional special antifungal therapy is required.

There are literature data on the development of cataracts in patients using corticosteroids for a long period, therefore, in order to exclude manifestations of the systemic action of corticosteroids, one should be aware of their possible role in the development of cataracts.

Use with caution in debilitated patients, elderly patients; patients with severe cardiac, renal and hepatic insufficiency.

Use during pregnancy and lactation. The data regarding the use of Relief® Pro during pregnancy are insufficient. Animal studies of glucocorticoids have shown reproductive toxicity.

Some epidemiological studies indicate the possibility of an increased risk of palatoschisis in newborns if their mothers received treatment with systemic glucocorticoids in the first trimester of pregnancy. Palatoschisis (cleft palate) is a rare pathology and, despite the fact that the systemic use of glucocorticoids causes a teratogenic effect, their use can be considered the cause of this pathology only if the number of cases increases to 1 or 2 per 1000 women who took the indicated treatment during pregnancy.

There are insufficient data related to the local use of glucocorticoids during pregnancy, but the risk can be considered low, since glucocorticoids, in the case of topical application, are characterized by very low systemic bioavailability.

In general, topical preparations containing glucocorticoids should not be used in the first trimester of pregnancy.

When prescribing treatment for pregnant women and women during lactation, a thorough assessment of the clinical indications for the use of Relief® Pro, as well as the risk-benefit ratio, should be carried out. In particular, prolonged use of the preparation should be avoided.

Children. Not recommended for use in children due to the lack of safety and efficacy data.

The ability to influence the reaction rate when driving vehicles and other mechanisms. Does not affect.

Interactions

Interaction studies have not been conducted. patients taking antiarrhythmic preparations should use Relief® Pro with caution, since it contains lidocaine as an active ingredient.

Use with caution in patients taking other local anesthetics, as there may be a risk of increased severity of adverse reactions; MAO inhibitors enhance the local anesthetic effect of lidocaine.

It is believed that concomitant use with CYP 3A inhibitors, including cobicistat tablets, may increase the risk of systemic side effects. This combination should be avoided unless the benefit outweighs the risk of systemic side effects associated with taking GCS. In the case of concomitant use, it is necessary to monitor the patient's condition to make sure that there are no systemic side effects associated with the use of GCS.

Overdose

The results of studies of potential acute toxicity associated with the active ingredients of Relief ® Pro indicate that there is no risk of developing symptoms associated with acute toxicity, which develops as a result of accidental overdose due to a single rectal administration of the preparation.

In case of accidental ingestion of the preparation (for example, swallowing several suppositories or several grams of cream), the main symptoms that are expected to occur are systemic symptoms caused by the use of lidocaine hydrochloride, and, depending on the dose, they can manifest themselves in the form of severe cardiovascular disorders (decreased blood pressure, increased sweating, pallor of the skin, bradycardia, arrhythmia, depression of heart function, shock or, in especially severe cases, cardiac arrest), or reactions associated with disorders of the central nervous system (headache, dizziness, blurred vision, diplopia, tinnitus, drowsiness, numbness of the limbs, chills, anxiety, vomiting, convulsions, shortness of breath or, in severe cases, respiratory failure). Methemoglobinemia is possible.

Overdose treatment includes close monitoring of vital functions, supportive actions that maintain oxygen levels, and symptomatic treatment of CNS and cardiovascular disorders such as short-acting barbiturates, β-sympathomimetics, and atropine. Dialysis is not effective enough.

Storage conditions

Relief® pro cream - at a temperature not higher than 30 ° С, Relief® Pro suppositories - at a temperature not higher than 25 ° С.