Instructions Relief Pro suppositories rectal strip No. 10
Composition
active ingredients: 1 suppository contains: 1 mg of fluocortolone pivalate and 40 mg of micronized lidocaine hydrochloride monohydrate;
excipients: solid fat.
Dosage form
Rectal suppositories.
Main physicochemical properties: yellowish-white suppositories.
Pharmacotherapeutic group
Topical agents for the treatment of hemorrhoids and anal fissures. Corticosteroids. Fluocortolone. ATC code C05AA08.
Pharmacological properties
Pharmacodynamics
Fluocortolone pivalate suppresses inflammatory and allergic skin reactions, and also alleviates subjective manifestations such as itching, burning sensation and pain; reduces capillary dilation, interstitial cell edema and tissue infiltration, inhibits capillary proliferation.
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 in the use of suppositories and ointments intended for the treatment of disorders associated with hemorrhoidal pathology. The reduction of pain and itching is associated with the inhibition of afferent nerve impulses.
Pharmacokinetics
After a single rectal administration of a suppository to healthy male volunteers, the maximum systemic absorption was about 5% of the dose of fluocortolone pivalate and about 24% of the dose of lidocaine hydrochloride.
Indication
For symptomatic treatment of pain and inflammation in the case of:
hemorrhoids;
proctitis.
Contraindication
The use of the drug Relief® Pro is contraindicated in case of local infections in the injection area, as well as in the presence of clear symptoms of the following pathological conditions in the relevant areas:
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.
Contraindicated in patients with hypersensitivity to other amide-type local anesthetics (e.g., bupivacaine, mepivacaine, and lidocaine).
Relief® Pro should not be used in case of hypersensitivity to the active substances or to any of the excipients.
Special safety precautions
Contact of Relief® Pro suppositories with the eyes should be avoided. It is recommended to wash hands thoroughly after use.
For fungal infections, additional special antifungal therapy is required.
There is evidence in the scientific literature of the development of cataracts in patients using corticosteroids for a long period of time, therefore, in order to exclude manifestations of systemic effects of corticosteroids, one should be aware of the possible role of corticosteroids in the development of cataracts.
Use with caution in debilitated patients, elderly patients; patients with severe heart failure, renal failure, and hepatic failure.
The excipient solid fat may reduce the effectiveness of latex products such as condoms.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted. Relief® Pro, rectal suppositories, contain the active ingredient lidocaine hydrochloride (anhydrous). About 30% of the applied dose of lidocaine enters the systemic circulation. This should be taken into account in patients who use drugs for the treatment of heart rhythm disorders (arrhythmias).
Concomitant use with CYP3A inhibitors, including cobicistat in tablet form, is thought to increase the risk of systemic adverse effects. This combination should be avoided unless the benefit outweighs the risk of systemic adverse effects associated with corticosteroid use. In case of concomitant use, the patient should be monitored to ensure that there are no systemic adverse effects associated with corticosteroid use.
Use during pregnancy or breastfeeding
There are insufficient data on the use of Relief® Pro suppositories in pregnant women. Studies of glucocorticoids in animals have shown reproductive toxicity.
Some epidemiological studies suggest a possible increased risk of cleft palate in newborns whose mothers received systemic glucocorticoid treatment during the first trimester of pregnancy. Cleft palate is a rare condition, and although systemic glucocorticoid use is teratogenic, its use can only be considered a cause if the incidence increases to one or two per 1000 women who received this treatment during pregnancy.
In general, topical preparations containing glucocorticoids should not be used during the first trimester of pregnancy.
When prescribing treatment to pregnant and lactating women, the clinical indications for the use of Relief® Pro suppositories should be carefully assessed, as well as the risk-benefit ratio. In particular, long-term use of the drug should be avoided.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Apply 1 suppository 2 times a day, morning and evening. After improvement, 1 suppository once a day or once every two days is often sufficient. It is recommended to use Relief® Pro suppositories after defecation. Before inserting 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 exposure to high temperatures, dip them in cold water before removing the shell.
Children
Not recommended for use in children due to lack of data on safety and efficacy.
Overdose
The results of studies on the potential acute toxicity associated with the active ingredients of Relief® Pro suppositories indicate that there is no risk of developing symptoms associated with acute toxicity that develops as a result of accidental overdose as a result of a single rectal application of the drug.
In case of accidental ingestion of the medicinal product (e.g. in case of ingestion of several suppositories), mainly systemic symptoms caused by lidocaine hydrochloride are expected. Depending on the dose, these may manifest themselves in the form of severe cardiovascular disorders (decreased blood pressure, increased sweating, pallor of the skin, bradycardia, arrhythmia, depression of cardiac function, shock or, in particularly severe cases, cardiac arrest) or reactions associated with disorders of the central nervous system (headache, dizziness, blurred vision, diplopia, tinnitus, drowsiness, numbness of the extremities, chills, anxiety, vomiting, convulsions, dyspnea or, in particularly severe cases, respiratory failure). Methaemoglobinaemia is possible.
Treatment of overdose includes close monitoring of vital signs, supportive measures to maintain oxygen levels, and symptomatic treatment of central nervous system and cardiovascular disorders, such as short-acting barbiturates, beta-sympathomimetics, and atropine. Dialysis is not effective.
Side effects
The incidence of adverse effects was calculated based on pooled clinical trial data from 367 patients.
Skin and subcutaneous tissue disorders, including allergic reactions: common: pain and burning sensation at the application site; uncommon: irritation at the application site.
After long-term therapy with Relief® Pro suppositories (exceeding 4 weeks), there is a risk of developing local skin conditions such as atrophy, striae or telangiectasia.
Adverse reactions due to lidocaine hydrochloride: the development of systemic adverse reactions to lidocaine is unlikely, since with proper use of the drug, the entry of lidocaine into the systemic circulation is insignificant.
Expiration date
4 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
5 suppositories in a strip, 2 strips in a pack with labeling in Ukrainian.
Vacation category
Without a prescription.
Producer
Istituto de Angeli S.r.l.
Istituto De Angeli Srl
Location of the manufacturer and its business address
Localita Prulli n. 103/s – 50066 Reggello (FI), Italy.
Applicant
Bayer Consumer Care AG.
Location of the applicant.
Peter Merian-Strasse 84, 4052 Basel, Switzerland.
