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 Plus 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 Anusol Plus HC Ointment is for topical use only, which means it is applied directly to the affected area. mu Wash the anal area and dry gently with a soft towel before using the 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 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.

@

then talk to your pharmacist or doctor for advice.

= Some medicines may increase the effects of Anusol Plus 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.

A

If you are pregnant or breast-feeding

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

Adsome of the ingredients can cause problems

6 Further information 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 Plus HC Ointment is a whitish ointment available in 15 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.

7 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 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

Children (under 18 years): This medicine is not recommended for children under 18 years of age.

e.g. hydrocortisone) If you are not sure about the medicine you are using

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Adults and the elderly:

Age

Dose

Adults and the elderly

Anusol Plus HC Ointment can be applied sparingly to the affected area at night, in the morning and after each bowel movement

= Do not use more than 4 times a day. = Do not use for more than 7 consecutive days.

A

If anyone has swallowed this product If anyone accidentally swallows Anusol Plus HC Ointment, contact a doctor or your nearest

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

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? A number 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. = Heredity: You may be more likely to develop piles if your family has a history of suffering.

Healthy Tips 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. aw 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. mu 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 4R), United Kingdom. @

PL 00203 / 0236

LN510801- 121

Possible side effects

directly via the Yellow Card Scheme at: www.mbhra.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.

2 Before using 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.

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Do not use this medicine…

= If you are allergic to Anusol or any of the other ingredients of this medicine (listed in section 6).

= If you have fungal, viral or bacterial skin sores. If any of these applies, get advice from a doctor or

pharmacist without using Anusol.

A Talk 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. m If you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Including: = corticosteroids (a type of anti-inflammatory drug

= 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.

Frequently asked questions about Anusol Plus HC Ointment

How do I take Anusol Plus HC Ointment?

Anusol Plus 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 Plus HC Ointment?

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

Are there equivalent medicines to Anusol Plus HC Ointment?

Medicines with the same active substance, strength and form include: Anusol 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 Plus 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 Plus 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

Symptomatic treatment of internal and external haemorrhoids and pruritus ani.

4.2. Posology and method of administration

Topical administration.

ADULTS (over 18 years)

To be applied sparingly 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 (under 18 years)

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

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 and use for periods longer than seven days is not recommended. 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

Not known

Application site reactions (including Burn,

Eye Disorders

Not known

Vision, blurred (see also section 4.4)

Administration site conditions

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.

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 oxygen and general supportive measures should be given. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride.

💬 Ask about this leaflet

Ask anything about Anusol Plus 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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