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Anusol Suppositories 6′

UGX 36,000

Anusol Suppositories provide effective and soothing relief from discomfort and pain that is associated with internal piles (haemorrhoids).

Anusol Suppositories have a unique 3-way action. They will shrink piles, give you relief from discomfort, soothe the itching, whilst also protecting delicate skin with its mild antiseptic properties. <

Some of the classic signs of piles include an itchy anal area and rectal bleeding after bowel movements (this is usually bright red). The blood is because of damage to the blood vessels surrounding your back passage.

Description

Anusol Suppositories provide effective and soothing relief from discomfort and pain that is associated with internal piles (haemorrhoids).

Anusol Suppositories have a unique 3-way action. They will shrink piles, give you relief from discomfort, soothe the itching, whilst also protecting delicate skin with its mild antiseptic properties. <

Some of the classic signs of piles include an itchy anal area and rectal bleeding after bowel movements (this is usually bright red). The blood is because of damage to the blood vessels surrounding your back passage.

Qualitative and quantitative composition

Each suppository contains:

Zinc oxide 296 mg
Bismuth subgallate 59 mg
Balsam peru 49 mg
Bismuth oxide 24 mg

For full list of excipients, see section 6.1

Pharmaceutical form

Suppository

Therapeutic indications

For the relief of internal haemorrhoids and other related ano-rectal conditions.

 Posology and method of administration

Anal insertion

Adults

Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation. Not to be taken orally.

Elderly (over 65 years)

As for adults

Children

Not recommended.

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

Special warnings and precautions for use

Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder.

If symptoms persist or worsen, patients should be instructed to stop use and consult a physician.

Interaction with other medicinal products and other forms of interaction

None known.

Fertility, pregnancy and lactation

Whilst formal studies on the effect of this product during human pregnancy have not been conducted, there is no epidemiological evidence of adverse effect, either to the pregnant mother or foetus.

This product should not be used during pregnancy and lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant.

Effects on ability to drive and use machines

None known.

Undesirable effects

No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, bismuth oxide and zinc oxide.

ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are included in the Table below. The frequencies are provided according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

System Organ Class (SOC) Frequency Adverse Drug Reaction

(Preferred Term)

Immune System Disorders Rare Hypersensitivity
General Disorders and Administration site conditions Not known Application site reactions (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Urticaria)

Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, bismuth oxide, and zinc oxide.

The ingestion of topical zinc oxide can potentiate gastrointestinal symptoms like stomach pain, nausea, vomiting, and diarrhoea.

Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose.

No cases of Balsam Peru overdose have been identified in the medical literature.

Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, give oxygen and general supportive measures.

Preclinical safety data

The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented.

Shelf life

3 years.

Special precautions for storage

Store at a temperature not exceeding 25°C.

For storage conditions after first opening of the medicinal product, see section 6.3

Nature and contents of container

12 and 24 pack printed strip pack consisting of white opaque PVC/polyethylene laminated film.

Not all pack sizes may be marketed

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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