Relief^® Ultra (Suppositories) Instructions for Use

Marketing Authorization Holder

Bayer Consumer Care, AG (Switzerland)

Manufactured By

Instituto De Angeli S.r.l. (Italy)

Contact Information

BAYER AG (Germany)

ATC Code

C05AX03 (Preparations for the treatment of hemorrhoids and anal fissures in combination)

Active Substances

Hydrocortisone (Rec.INN registered by WHO)

Zinc sulfate (BP British Pharmacopoeia)

Dosage Form

Relief® Ultra

Rectal suppositories 10 mg+11 mg: 10 or 12 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from pale white to light yellow in color, opaque, torpedo-shaped.

Excipients: cocoa butter, methylparahydroxybenzoate, propylparahydroxybenzoate, anhydrous calcium hydrogen phosphate, magnesium stearate.

5 pcs. – blisters (2) – cardboard packs.
6 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Drug for topical treatment of hemorrhoids

Pharmacotherapeutic Group

Antihemorrhoidal agent

Pharmacological Action

Hydrocortisone acetate – a steroid hormone of the adrenal cortex; with topical application, it has anti-inflammatory, desensitizing, anti-allergic, vasoconstrictive, and antipruritic effects. It inhibits the release of inflammatory mediators.

Zinc sulfate promotes the healing of wounds and erosions.

Pharmacokinetics

Pharmacokinetic data for the drug Relief^® Ultra are not provided.

Indications

• External and internal hemorrhoids;
• Anal fissures and erosions;
• Proctitis;
• Anal itching, eczema, dermatitis of the perianal area.

ICD codes

Dosage Regimen

Administer rectally.

Perform thorough hygiene procedures prior to each application.

Insert one suppository into the rectum.

Apply in the morning and at night.

Apply additionally after each bowel movement.

Do not exceed four applications in a 24-hour period.

The maximum treatment duration is seven consecutive days.

Discontinue use if no clinical improvement is observed after seven days.

Consult a physician if symptoms worsen or new symptoms appear during therapy.

Avoid exceeding the recommended daily dose unless specifically instructed by a physician.

Adverse Reactions

Adverse reactions are listed by system-organ class with frequency indication according to the following classification: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from the available data).

Immune system disorders: frequency not known – allergic reactions (allergic contact dermatitis, hyperemia, itching).

General disorders and administration site conditions: frequency not known – irritation, pain, skin discoloration at the application site, dryness and swelling of the mucous membrane, rectal bleeding.

If the patient experiences side effects listed in the instructions, or if they worsen, or if the patient notices any other side effects not listed in the instructions, they should inform their doctor.

Contraindications

• Hypersensitivity to hydrocortisone and/or zinc sulfate, or other components of the drug;
• Presence of bacterial, fungal, viral infection in the anorectal area;
• Neoplasms of the anorectal zone;
• Tuberculosis;
• Cushing’s syndrome;
• Severe forms of diabetes mellitus;
• Hypernatremia;
• Abscess;
• Intestinal obstruction, symptoms of intestinal perforation, peritonitis, intestinal fistulas (including multiple), intestinal anastomoses;
• Pregnancy;
• Breastfeeding period;
• Age under 18 years (safety and efficacy have not been established).

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use under the age of 18 years (safety and efficacy have not been established).

Special Precautions

Rectal therapy with corticosteroids should be used with caution and only after adequate proctological examination due to the risk of intestinal perforation.

In severe arterial hypertension, cardiac arrhythmias, immunodeficiency states, osteoporosis, diabetes mellitus, and other endocrine pathologies, the use of the drug is permissible only under strict medical indications, if the expected therapeutic effect outweighs the potential risk of side effects or complications of the underlying disease.

The excipients methylparahydroxybenzoate and propylparahydroxybenzoate may cause allergic reactions (including delayed-type reactions).

If no improvement occurs after 7 days of therapy, or if symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.

The recommended daily dose should not be exceeded, except when prescribed by a doctor.

If an infection develops in the area of drug application, its use should be discontinued and a doctor should be consulted.

Effect on the ability to drive vehicles and machinery

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Overdose

Cases of drug overdose with disorders of vital body functions have not been described in medical practice.

Symptoms it is assumed that long-term use of the drug Relief^® Ultra in high doses can lead to the same consequences as systemic use of glucocorticosteroids in excessive doses – hyperglycemia, hypernatremia, Cushing’s syndrome, immunosuppression, gastrointestinal erosions and ulcers, osteoporosis.

Treatment drug withdrawal, conventional detoxification and symptomatic therapy.

Drug Interactions

When used in combination with other drugs containing steroids (both topically and orally), the likelihood of systemic effects may increase.

Concomitant use of the drug and CYP3A inhibitors may increase the risk of systemic side effects. The combination of these drugs should be avoided, except in cases where the expected benefit of therapy outweighs the increased risk of systemic side effects of corticosteroids. Appropriate patient monitoring should be carried out.

Caution should be exercised when used concomitantly with anticoagulants, oral hypoglycemic drugs, barbiturates, diuretics, cardiac glycosides.

If the patient is taking the above or other medications (including over-the-counter), they should consult a doctor before using Relief^® Ultra.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.