Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Anusol Soothing Relief Suppositories
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Benzyl benzoate, Bismuth oxide, Bismuth subgallate, Balsam peru, Hydrocortisone acetate, Zinc oxide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
How to take it
this medicine
This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Anusol Soothing Relief Suppositories should be inserted into the anus = Wash anal area and dry gently with a soft towel before using this medicine. u Remove plastic cover from the suppository before use. = Wash your hands before and after using Anusol. = The suppository will melt after insertion.
by
Do not use this medicine…
a If you are allergic to Anusol or any of the other ingredients of this medicine (listed in section 6). = Do not use on broken or infected skin. Common skin infections include anal warts, genital herpes, thrush and jock itch. = Ifyou are pregnant or breastfeeding. u Ifyou are under 18 years of age. If any of these apply to you, get advice from a doctor or pharmacist without using Anusol.
A
Oo
@ Adutts and the elderly:
Talk to your doctor or pharmacist…
u Ifyou have rectal bleeding or blood in the stool or if you are in doubt whether any bleeding you have experienced is caused by piles. u If symptoms worsen or do not improve after you have used the medicine for 7 days. = If you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Including: = corticosteroids (a type of anti-inflammatory medicine), e.g. betamethasone or hydrocortisone (used in eczema and dermatitis), dexamethasone, prednisolone. = Some medicines may increase the effects of Anusol Soothing Relief Suppositories and your doctor may wish to monitor you carefully if you are taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
Contact you doctor if you experience blurred vision or other visual disturbances. If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.
Children (under 18 years): This medicine is not for use in children under 18 years old.
Age
Dose
Adults and the elderly
Insert one suppository into the back passage (anus) far enough so that it doesn't slip out, at night, in the morning and after each bowel movement.
= Do NOT take orally = Do not use more than 3 suppositories a day = Do not use for more than 7 consecutive days
A
If anyone has used too much or swallowed this product. If anyone has used too much or has accidentally swallowed Anusol Soothing Relief Suppositories, contact a doctor or your nearest Accident and Emergency department (Casualty), taking this leaflet and pack with you.
If you forget to use this medicine If you forget a dose, use the next dose when needed. Do not use a double dose.
If you are pregnant or breast-feeding If you are pregnant or breastfeeding do not use this medicine.
49 mg, Bismuth oxide 24 mg and Benzyl benzoate 33 mg. Other ingredients are: Kaolin light, suppocire BS2 pastilles (hard fat).
What the medicine looks like Anusol Soothing Relief Suppositories are white suppositories available in plastic strips with two strips (12 suppositories) in a box. Product Licence holder: Church & Dwight UK Ltd., Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. Manufacturer: Farmea, 10, rue Bouché Thomas, ZAC Sud d'Orgemont, 49000 ANGERS Cedex, France. This leaflet was revised May 2017. Anusol is a registered trade mark.
A Healthy Living Plan for Piles Sufferers What are piles? Piles (naemorrhoids) are swollen blood vessels which occur inside or outside the back passage (anus).
Symptoms Some people have piles without experiencing any symptoms, but sufferers may notice the following: = Bleeding: Although streaks of bright red blood on the toilet paper are not uncommon in people with piles, it may be a sign of a more serious condition and you should see your doctor to check this. = Swelling: The swollen blood vessels may be felt as a lump or blockage in the anus. = Pain, itching and irritation in the anal region. At least 40% of people suffer from piles at some time in their lives. However, many people are too embarrassed to seek advice or treatment and, as a result, suffer unnecessary discomfort. Fortunately, there is much you can do to ease the situation and relieve the symptoms.
What causes piles? Anumber of factors can contribute to the development of piles: u The most common cause is straining during bowel movement, usually as a result of constipation. = During pregnancy, the growing baby exerts increased pressure on the anal vessels, which can lead to piles. u Heredity: you may be more likely to develop piles if your family has a history of suffering.
A Healthy Living Plan for Piles Sufferers You can reduce the risk of piles by following a healthy diet and lifestyle that helps to keep your bowels working regularly and prevents constipation. This can also help to speed recovery from piles. =u Eat a high fibre diet including foods like brown rice, wholemeal bread, wholewheat pasta etc. u Eat plenty of fresh fruit, vegetables and salads. = Drink plenty of water. = Don't eat too much salty, fatty or sugary foods such as crisps, burgers and cakes. = Cut back on the amount of alcohol, tea and coffee you drink. u Exercise regularly. A healthy diet and lifestyle will reduce the likelihood of constipation and encourage a regular bowel habit. Go to the toilet regularly and try to avoid straining. Leaning forward from the hips may help. For external and internal piles, Ointment can be used, If internal haemorrhoids are the problem, Suppositories deliver a measured dose to the affected area. For further information, please contact: MA Holder: Church & Dwight UK Ltd.,
Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. 22097/01PL 00203 / 0235
@ @ 03/16 15-0427
Possible side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5 Storing this medicine Keep out of the sight and reach of children. Do not store above 25°C. Do not use your medicine after the date shown as an expiry date on the packaging. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Further information What's in this medicine? The active substances per suppositories are: Hydrocortisone acetate 10 mg, Zinc oxide 296 mg, Bismuth subgallate 59mg, Balsam Peru
2 Before using this medicine
Frequently asked questions about Anusol Soothing Relief Suppositories
How do I take Anusol Soothing Relief Suppositories?
Anusol Soothing Relief Suppositories comes as suppository. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Anusol Soothing Relief Suppositories?
The active substance in Anusol Soothing Relief Suppositories is benzyl benzoate, bismuth oxide, bismuth subgallate, balsam peru, hydrocortisone acetate, zinc oxide.
Are there equivalent medicines to Anusol Soothing Relief Suppositories?
Medicines with the same active substance, strength and form include: Anusol HC Suppositories, Anusol Plus HC Suppositories. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Anusol Soothing Relief Suppositories, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Anusol Soothing Relief Suppositories without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: benzyl benzoate, bismuth oxide, bismuth subgallate, balsam peru, hydrocortisone acetate, zinc oxide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Symptomatic treatment of uncomplicated internal haemorrhoids and pruritis ani.
4.2. Posology and method of administration
Anal insertion
Adults (over 18 years)
Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation up to a maximum of three per day for a maximum period of one week.
Not to be taken orally
Elderly (over 65 years)
As for adults
Children (under 18 years)
Do not use.
4.3. Contraindications
Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Do not use in pregnancy or breastfeeding.
4.4. 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.
As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind.
Prolonged or excessive use may produce systemic corticosteroid effects. Do not use for more than 7 days unless under the direction of a doctor.
The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent use with other corticosteroid preparations, either topically or orally, may increase the likelihood of systemic effects.
Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
4.6. Fertility, pregnancy and lactation
There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals
Do not use in pregnancy or breastfeeding.
4.7. Effects on ability to drive and use machines
No effects have been reported on ability to drive or use machinery.
4.8. 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)
Eye Disorders
Not known
Vision, blurred (see also section 4.4)
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
4.9. Overdose
No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide.
If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion.
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.
Hydrocortisone normally does not produce toxic effects in an acute single overdose.
Prolonged, use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low, however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression.
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. Methaemoglobinaemia should be treated by intravenous methylene blue.
💬 Ask about this leaflet
Ask anything about Anusol Soothing Relief Suppositories. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.