Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Balsam peru, Bismuth oxide, Zinc oxide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
this medicine Anusol Cream is for topical use only, which means it is applied directly to the affected area.
Other ingredients are: Glycerol monostearate,
liquid paraffin, propylene glycol, polysorbate 60, sorbitan stearate, titanium dioxide (E171), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and water. What the medicine looks like Anusol Cream isa light 'buff' coloured cream available in 23 g and 43 g tubes. Product Licence holder: Church & Dwight UK Ltd., Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
occur inside or outside the back passage (anus).
5 Storing this medicine Keep out of the sight and reach of children. Do not store above 25°C. Store in the original packaging.
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.
This medicine is not recommended for children under 18 years old.
@ Adults and the elderly: Age
Dose
Adults and
Anusol Cream should be
the elderly
applied sparingly to the affected area at night, in the morning and after each bowel movement.
= Do NOT take orally
Some of the ingredients can cause problems
Manufacturer: Famar Orléans, 5 avenue de Concyr,
By reporting side effects you can help provide more information on the safety of this medicine.
@ Children (under 18 years):
u lf you are pregnant or breast-feeding, only use this medicine on the advice of your doctor.
45071 Orleans, Cedex 2, France. This leaflet was revised August 2017. Anusol is a registered trade mark.
www.mhra.gov.uk/yellowcard
the back passage and squeeze gently. Clean the nozzle after each use. m Wash your hands before and after using Anusol.
If you are pregnant or breast-feeding
= Burning, redness, irritation, itching, or pain may
occur when applying the cream. This does not usually last a long time, so if this lasts longer than a few days, tell your doctor.
affected area, screw the nozzle provided onto the tube, remove the nozzle cap; insert the nozzle into
If any of these bullet points apply to you, talk to a doctor or pharmacist.
Anusol Cream is a medicine which is used to relieve the swelling, itch and irritation of internal and external piles (haemorrhoids) and other minor ano-rectal
Talk to your doctor or pharmacist…
= Wash the anal area and dry gently with a soft towel before using the medicine. m= There is a nozzle supplied with the product which can be used to apply the cream into the back passage (anus). u For external piles – after washing and drying the affected area, the cream should be gently applied to the affected area. u For internal piles – after washing and drying the
A Healthy Living Plan for Piles Sufferers What are piles? Piles (haemorrhoids) are swollen blood vessels which
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
6 Further information
result, suffer unnecessary discomfort. 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: Zinc oxide 10.75 g, Bismuth oxide 2.14 g, Balsam peru 1.8 g.
A number of factors can contribute to the development of piles:
A
If anyone has swallowed this product If anyone accidentally swallows Anusol Cream, contact a doctor or your nearest Accident & Emergency Department (Casualty), taking this leaflet and pack with you.
If you forget to use this medicine Anusol Cream 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
next time you use it.
= 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.
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.
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. nu 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, Cream 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 / 0231
What causes piles? LN511501-119
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 mu Hypersensitivity reactions (such as rash).
Other effects which may occur but it is unknown how often:
A
A
= Glycerol monostearate may have a mild laxative effect. = Propylene glycol may cause skin irritation. = Methyl (E218) and Propyl (E216) Parahydroxybenzoate may cause an allergic reaction, which may be delayed.
Anusol Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Anusol Cream is balsam peru, bismuth oxide, zinc oxide.
This leaflet reproduces the patient information leaflet approved for Anusol Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
ANUSOL cream provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions.
ANUSOL cream also provides lubricating properties for use with suppositories.
Indicated for the symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures. Also indicated post-operatively in ano-rectal surgical procedures and after incision of thrombosed or sclerosed ano-rectal veins.
Topical
Adults and elderly (over 65 years): apply to the affected area at night, in the morning and after each evacuation until the condition is controlled. Thoroughly cleanse the affected area, dry and apply cream. ANUSOL cream is prepared in a vanishing cream base and may be gently smoothed on to the affected area without the need to apply a gauze dressing. For internal conditions, use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use.
Not to be taken orally.
Children: Not Recommended.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
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.
None known.
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.
None known.
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.
Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, apply oxygen and give general supportive measures.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Balsam peru, Bismuth oxide, Zinc oxide. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Ask anything about Anusol Cream. 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.
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