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.

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Anusol HC Ointment

⚠ 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 Zinc oxide, Benzyl benzoate, Bismuth oxide, Bismuth subgallate, Balsam peru, Hydrocortisone acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Zinc oxide, Benzyl benzoate, Bismuth oxide, Bismuth subgallate, Balsam peru, Hydrocortisone acetate

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

How to take it

this medicine

hydrocortisone acetate, zinc oxide, bismuth oxide, bismuth subgallate, balsam peru, benzyl benzoate

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.

= This medicine is used for the relief of internal and external piles and anal itching. = This medicine is for use in adults over the age of 18 years. = Do not use this medicine: a If you are allergic to Anusol or any of the other ingredients of this medicine. See section 6 >

a If you are allergic to Anusol or any of the other ingredients of this medicine (listed in section 6). a If you have fungal, viral or bacterial skin sores. If the above bullet points apply to you, get advice from a doctor or pharmacist without using Anusol.

Anusol HC Ointment is for topical use only, which means it is applied directly to the affected area. = Wash the anal area and dry gently with a soft towel before using this medicine. = There is a nozzle supplied with the product which can be used to apply the ointment into the back passage (anus). = For external piles – after washing and drying

Anusol

'ca

ointment

148mm

=| you have fungal, viral or bacterial skin

sores. See section 2 > = Speak to your doctor: a If you have rectal bleeding or blood in the stool which has not been diagnosed as piles. See section 2. > = If your symptoms have worsened or not improved within 7 days of using this product. See section 2 > = Follow the instructions on how to use this product carefully. See section 3 > This medicine has been prescribed for you by your doctor. Do not pass it onto others. It may harm them even if their symptoms are the same as yours. Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

1 What the medicine is for Anusol HC Ointment helps to relieve the swelling, itch and irritation of internal and irritation of internal and external piles (haemorrhoids) and anal itching.

It contains the following ingredients: Hydrocortisone acetate is a mild steroid which helps reduce inflammation. Zinc oxide and Bismuth salts are mildly astringent and antiseptic. They soothe and protect raw areas. Balsam Peru is mildly antiseptic and has a protective action on sore areas and may help healing. Benzyl benzoate has mild antiseptic properties. This product is for use by adults over the age of 18 years old.

Accident and Emergency department (Casualty), taking this leaflet and pack with you.

Alt you forget to use this medicine Anusol HC Ointment should be used on an as required basis. However, if you were unable to use this product when needed, do not use a double dose.

4 Possible side-effects Like all medicines, this medicine can cause side

effects, although not everybody gets them.

If you experience the following, stop using the medicine and talk to your doctor: Rare: may affect up to 1 in 1,000 people = Hypersensitivity reactions (such as rash).

Other effects which may occur but it is unknown how often: = Burning, redness, irritation, itching, or pain

may occur when applying the ointment. This does not usually last a long time, so if this lasts

longer than a few days, tell your doctor. = Blurred vision.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

Possible side effects

not listed in this leaflet. You can also report 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.

Do not use this medicine…

Arak to your doctor or pharmacist… = If you have rectal bleeding or blood in the stool or if you are in doubt whether any bleeding you have experienced is caused by piles. = 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. = Some medicines may increase the effects of Anusol HC Ointment 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.

Aut

you are pregnant or breast feeding

= If you are pregnant or breast-feeding do not use this medicine.

Asome of the ingredients can cause problems

the affected area, the ointment should be

applied using a gauze dressing. = For internal piles – after washing and drying the affected area, screw the nozzle provided onto the tube, remove the nozzle cap; insert

the nozzle into the back passage and squeeze gently. Clean the nozzle after each use. = Wash your hands before and after using Anusol.

@ Children (under 18 years): This medicine is not recommended for children under 18 years old.

@ Adults and the elderly: Age

Dose

Adults and the elderly

Apply sparingly to the affected area. You should use as often as prescribed by your doctor, however Anusol HC Ointment is usually used at night, in the morning and after each bowel movement.

= Do NOT take orally = Do not use more than 4 times a day unless prescribed otherwise by your doctor = Do not use for more than 7 consecutive days

= Castor oil may cause skin reactions. = Lanolin anhydrous may cause local skin reactions e.g. contact dermatitis which is a local irritation at the site of use.

Air anyone swallowed this product

6 Further information

Fortunately, there is much you can do to ease the situation and relieve the symptoms.

What's in this medicine? The active substances are per 100 g: Hydrocortisone acetate 0.25 g, Zinc oxide 10.75 g,

Bismuth subgallate 2.25 g, Balsam Peru 1.875 g, Bismuth oxide 0.875 g and Benzyl benzoate 1.25 g. Other ingredients are: Magnesium stearate, cocoa butter, lanolin anhydrous, castor oil, kaolin light, calcium hydrogen phosphate and petroleum jelly white.

What the medicine looks like Anusol HC Ointment is a buff coloured ointment available in 30 g tubes. Product Licence holder: Church & Dwight UK Ltd., Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom. Manufacturer: Famar Orléans, 5 avenue de Concyr,

45071 Orleans, Cedex 2, France. This leaflet was revised August 2017. Anusol is a registered trade mark.

A Healthy Living Plan for Piles Sufferers What are piles? Piles (haemorrhoids) 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 embarassed to seek advice or treatment and, as a result, suffer unnecessary discomfort.

If anyone accidentally swallows Anusol HC Ointment, contact a doctor or your nearest

What causes piles? Anumber of factors can contribute to the development of piles: = 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. = Eat a high fibre diet including foods like brown rice, wholemeal bread, wholewheat pasta etc.

= 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. mw 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. PL 00203 / 0238

LN510701-120

Frequently asked questions about Anusol HC Ointment

How do I take Anusol HC Ointment?

Anusol HC Ointment comes as ointment. 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 HC Ointment?

The active substance in Anusol HC Ointment is zinc oxide, benzyl benzoate, bismuth oxide, bismuth subgallate, balsam peru, hydrocortisone acetate.

Are there equivalent medicines to Anusol HC Ointment?

Medicines with the same active substance, strength and form include: Anusol Plus HC Ointment, Anusol Soothing Relief Ointment. 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 HC Ointment, 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 HC Ointment 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: zinc oxide, benzyl benzoate, bismuth oxide, bismuth subgallate, balsam peru, hydrocortisone acetate
  • Official document: view the original leaflet on emc →
Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Hydrocortisone acetate (14 medicines), Zinc oxide (16 medicines), Zinc oxide, benzyl benzoate, bismuth oxide, bismuth subgallate, balsam peru, hydrocortisone acetate (5 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Anusol-HC Ointment is indicated for the comprehensive symptomatic treatment of internal and external haemorrhoids and pruritus ani.

4.2. Posology and method of administration

Anal application.

ADULTS

Apply ointment to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use. Use for a maximum period of one week.

Not to be taken orally.

ELDERLY (OVER 65 YEARS)

As for adults.

CHILDREN

Not recommended.

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 breast-feeding.

4.4. Special warnings and precautions for use

Following symptomatic relief, definitive diagnosis should be established.

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.

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

Prolonged or excessive use may produce systemic corticosteroid effects. Do not use for more than 7 days unless under the direction of a doctor.

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 HPA 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

Not applicable.

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 methylthioninium chloride.

💬 Ask about this leaflet

Ask anything about Anusol HC Ointment. 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.

Medicines containing Zinc oxide, Benzyl benzoate, Bismuth oxide, Bismuth subgallate, Balsam peru, Hydrocortisone acetate

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