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 Zinc oxide, Bismuth subgallate, Balsam peru, Bismuth oxide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
this medicine
Anusol Suppositories help to relieve the swelling, itch and irritation of internal piles (haemorrhoids)
This product is for use by adults over the age of
Dose
Adults and the elderly
@
Children (under 18 years): This medicine is not recommended for children
under 18 years old.
What the medicine looks like Anusol Suppositories are white suppositories available in plastic strips with either two strips (12 suppositories) or four strips (24 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 (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: u 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? A number of factors can contribute to the development of piles:
Insert one suppository into the back passage (anus) far enough so that it doesn't slip out, at night, in
ES Do not use this medicine…
1 What the medicine is for
Balsam Peru is mildly antiseptic and has a protective action on sore areas and may help healing.
@ Adults and the elderly: Age
the morning and after each bowel movement,
u Do NOT take orally
Af anyone has used too much or swallowed this product. If anyone has used too much or has accidentally swallowed Anusol Suppositories, contact a doctor or your nearest Accident and Emergency
department (Casualty), taking this leaflet and pack with you.
Aur you forget to use this medicine If you forget a dose, use the next dose when needed. Do not use a double dose.
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 2 in 1,000 people =u Hypersensitivity reactions (such as rash).
Other effects which may occur but it is unknown how often: = Burning, redness, irritation, itching, or pain may
occur on application. This does not usually last a long time, so if this lasts longer than a few days, tell your doctor.
= 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. 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 4R],
United Kingdom. PL 00203 / 0233 MA 1201 / 00102
e@ 22089/01 – 03/16 15-0421
Anusol Suppositories comes as suppository. 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 Suppositories is zinc oxide, bismuth subgallate, balsam peru, bismuth oxide.
This leaflet reproduces the patient information leaflet approved for Anusol Suppositories, 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.
For the relief of internal haemorrhoids and other related ano-rectal conditions.
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.
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.
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Zinc oxide, Bismuth subgallate, Balsam peru, Bismuth 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 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.
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