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.
Xyloproct 5%/0.275% 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 Hydrocortisone acetate, Lidocaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for What Xyloproct Ointment is The name of your medicine is 'Xyloproct 5%/0.275% Ointment'. It is referred to as 'Xyloproct Ointment' in the rest of this leaflet. Xyloproct Ointment contains two medicines: lidocaine and hydrocortisone.
- Lidocaine (sometimes known as lignocaine) belongs to a group of medicines called local anaesthetics.
- Hydrocortisone belongs to a group of medicines called corticosteroids. What Xyloproct Ointment is used for Xyloproct Ointment may be used in adults and children of all ages for the following reasons:
- to relieve itching around the back passage (anus) or female private parts (genitals).
- to relieve the symptoms of piles (haemorrhoids) and other problems that affect the back passage. These symptoms include pain and inflammation.
What you need to know before you take it
e Xyloproct Ointment Do not use Xyloproct Ointment:
- if you are allergic to lidocaine or hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
if you have ever had an allergic reaction to other local anaesthetics or to other corticosteroid medicines.
- if you have an infection where the ointment is going to be put and the infection is not being treated.
- if you are not in hospital and you are taking medicines for an uneven heart beat (such as amiodarone or sotalol). Do not use Xyloproct Ointment if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Xyloproct Ointment.
•
Warnings and precautions Talk to your doctor or pharmacist before using Xyloproct Ointment if:
- Your skin is very thin or fragile where the ointment is going to be put.
- You have an infection where the ointment is going to be put. If this applies to you, your doctor may ask you to use another medicine as well as Xyloproct Ointment.
- You have ever been told that you have a rare disease of the blood pigment called 'porphyria' or anyone in your family has it. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Xyloproct Ointment. Other medicines and Xyloproct Ointment Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Xyloproct Ointment can affect the way some medicines work and some medicines can have an effect on Xyloproct Ointment. In particular, tell your doctor or pharmacist if you are taking or using any of the following medicines:
- Medicines for an uneven heart beat (such as amiodarone or sotalol).
- Other local anaesthetics. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if you can use Xyloproct Ointment during this time. Driving and using machines It is unlikely that using Xyloproct Ointment will affect your ability to drive or operate machinery. However, depending on how much is applied, Xyloproct Ointment may slightly affect your alertness and co-ordination temporarily. If affected, you should not drive, use tools or operate machinery. Xyloproct Ointment contains cetyl alcohol and stearyl alcohol May cause local skin reactions (e.g. contact dermatitis).
How to take it
Xyloproct Ointment Always use Xyloproct Ointment exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Always wash your hands well before and after using this medicine.
How much Xyloproct Ointment to use
- Your doctor will tell you how much ointment to use and how often to use it.
- Usually the ointment should be put on the affected area several times a day.
- Up to 6 g (grams) of ointment can be used each day. This is about a third of a tube. How long to use Xyloproct Ointment for
- Xyloproct Ointment should only be used for limited periods of time.
- With longer periods of treatment (up to 3 weeks) your doctor may suggest that you have a break from treatment, especially if you are getting irritation around or inside where the ointment is applied.
- If you get irritation, your doctor may do a patch test to see if it is being caused by Xyloproct Ointment. Using the applicator
- The ointment comes with an applicator. Your doctor will tell you if you need to use this.
- If your doctor tells you to use the applicator, be careful not to put too much ointment inside the back passage, especially if it is being given to a child.
- Clean the applicator very well after each use. If you use more Xyloproct Ointment than you should
- If you use too much ointment talk to your doctor as soon as possible.
- It is particularly important to talk to your doctor as soon as possible if a child has been given too much ointment. This is because fits have sometimes happened in children who have been given too much. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Xyloproct Ointment and talk to your doctor straight away if you notice any of the following – you may need urgent medical treatment:
- Sudden onset of rash, itching or hives on the skin.
- Swelling of the face, lips, tongue or other parts of the body.
- Shortness of breath, wheezing or trouble breathing. This may mean that you are having an allergic reaction. Stop using Xyloproct Ointment and talk to your doctor if you notice any of the following:
- Soreness in your back passage.
- Bleeding from your back passage. Other possible side effects:
- Redness, swelling and itching where Xyloproct Ointment has been put on your body. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any 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.
How to store it
Xyloproct Ointment • • • • •
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the tube after EXP. The expiry date refers to the last day of that month. Xyloproct Ointment can be stored between 2°C and 8°C (in a refrigerator). When you start using the ointment, the tube can be stored at room temperature (below 25°C) for up to 2 months. Any remaining ointment should then be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
Contents of the pack and other information
What Xyloproct Ointment contains The active substances are lidocaine and hydrocortisone acetate. Each gram of Xyloproct Ointment contains 50 mg (milligrams) of lidocaine and 2.75 mg of hydrocortisone acetate. The other ingredients are zinc oxide, aluminium acetate, stearyl alcohol, cetyl alcohol, purified water and macrogol (3350 and 400). What Xyloproct Ointment looks like and contents of the pack Xyloproct Ointment is white to slightly yellow in colour. It comes in an aluminium tube that contains 20 g (grams) of the ointment. Each pack contains a CE-certified medical device (applicator). Marketing Authorisation Holder Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland Tel: +44 (0)1 748 828 391 Manufacturer AstraZeneca AB, S-151 85, Södertälje, Sweden. Or Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany Or Meribel Pharma Karlskoga AB Bjorkbornsvagen 5, Karlskoga, Orebro Lan, 691 33, Sweden Or
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire SK10 2 NA, UK
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name Reference number
Xyloproct Ointment 39699/0087
This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in August 2021 Trademarks are owned by or licensed to the Aspen Group of companies. © 2021 Aspen Group of companies or its licensor. All rights reserved.
Frequently asked questions about Xyloproct 5%/0.275% Ointment
How do I take Xyloproct 5%/0.275% Ointment?
Xyloproct 5%/0.275% 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 Xyloproct 5%/0.275% Ointment?
The active substance in Xyloproct 5%/0.275% Ointment is hydrocortisone acetate, lidocaine.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Xyloproct 5%/0.275% 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 Xyloproct 5%/0.275% 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: hydrocortisone acetate, lidocaine
- 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
Xyloproct rectal ointment is indicated in adults and children of all ages for the relief of symptoms such as anal and peri-anal pruritus, pain and inflammation associated with haemorrhoids, anal fissure, fistulas and proctitis. Pruritus vulva.
4.2. Posology and method of administration
Route of administration: Topical.To be applied several times daily according to the severity of the condition. For intrarectal use, apply the ointment with the special applicator. Cleanse the applicator thoroughly after use.A daily dose of 6 g ointment is well within safety limits. The duration of treatment may vary between ten days and three weeks. If the treatment is prolonged, a free interval can be recommended, especially if it is suspected that irritation due to lidocaine or hydrocortisone has occurred. If the local irritation disappears after the cessation of treatment, the possibility of sensitivity to lidocaine or hydrocortisone can be investigated, e.g. by a patch test. Older people
Debilitated or elderly patients should be given doses commensurate with their age, weight and physical condition. Paediatric population
Children should be given doses commensurate with their age, weight and physical condition.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to local anaesthetics of the amide type. Use on atrophic skin. Xyloproct Ointment should not be used in patients with untreated infections of bacterial, viral, pathogenic fungal or parasitic origin. Xyloproct should not be used by patients being treated with a class III anti-arrhythmic drug outside of hospital (see sections 4.4 and 4.5).
4.4. Special warnings and precautions for use
Xyloproct is intended for use for limited periods. Excessive dosage of lidocaine or short intervals between doses, may result in high plasma levels of lidocaine and serious adverse effects. Patients should be instructed to strictly adhere to recommended dosage.Hospitalised patients treated with anti-arrhythmic drugs class III (e.g. amiodarone or sotalol) should be kept under close surveillance and ECG monitoring considered, since cardiac effects may be additive (see sections 4.3 and 4.5).Appropriate antibacterial, antiviral or antifungal therapy should be given with Xyloproct if infection is present at the site of application.The possibility of malignancy should be excluded before use.If irritation or rectal bleeding develops treatment should be discontinued.When using the special applicator, care should be taken to avoid instillation of excessive amounts of Xyloproct Ointment into the rectum. This is of particular importance in infants and children.Systemic absorption of lidocaine may occur from the rectum, and large doses may result in CNS side-effects. On rare occasions convulsions have occurred in children.Prolonged and excessive use of hydrocortisone use may produce systemic corticosteroid effects or local effects such as skin atrophy. With the recommended dosage systemic effects of hydrocortisone are unlikely.Xyloproct ointment is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken for vulnerable patients.Xyloproct contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
4.5. Interaction with other medicinal products and other forms of interaction
Lidocaine should be used with caution in patients receiving anti-arrhythmic drugs, local anaesthetics or agents structurally related to local anaesthetics, since the toxic effects of these compounds are additive (see sections 4.3 and 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
Xyloproct should not be used during pregnancy unless considered essential by the physician. Breast-feeding
Lidocaine and hydrocortisone acetate are excreted into breast milk, but at therapeutic doses of Xyloproct, effects on the breastfed newborns/infants are unlikely. Fertility
There is no fertility data available.
4.7. Effects on ability to drive and use machines
Xyloproct has minor influence on the ability to drive and use machines. Depending on the dose local anaesthetics may have a very mild effect on mental function and coordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness. With the recommended doses of Xyloproct adverse effects on the CNS are unlikely.
4.8. Undesirable effects
Contact sensitivity to lidocaine has been reported after perianal use. Contact sensitivity may also occur after the use of topical hydrocortisone.In extremely rare cases amide-type local anaesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock). 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 website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Systemic absorption of lidocaine may occur from the rectum. When using the special applicator care should be taken to avoid instillation of excessive amounts of Xyloproct Ointment into the rectum.Lidocaine can cause acute toxic effects if high systemic levels occur due to rapid absorption or overdosage. With the recommended doses of Xyloproct, toxic effects have not been reported. On rare occasions convulsions have occurred in children following administration of overdose.However, should systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of local anaesthetics by other routes.Local anaesthetic toxicity is manifested by symptoms of nervous system excitation and, in severe cases, central nervous and cardiovascular depression.Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by respiratory support and the administration of anticonvulsive drugs.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Hydrocortisone acetate, Lidocaine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- VERSATIS 700 mg prescription partial — not the same combinationLIDOCAINUM · skin / topical
- INSTILLIDO 20 mg/ml prescription partial — not the same combinationLIDOCAINUM · skin / topical
- HIDROCORTIZON FITERMAN 10 mg/g prescription partial — not the same combinationHYDROCORTISONUM · skin / topical
- HIDROCORTIZON ATB 10 mg/g prescription partial — not the same combinationHYDROCORTISONUM · skin / topical
- PROCTOLIZIN 10 mg/20 mg/50 mg pe gram prescription partial — not the same combinationCOMBINATII (HYDROCORTISONUM+LIDOCAINUM+ZINCI OXIDUM) · skin / topical
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 →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Hydrocortisone acetate, Lidocaine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Hydrocort CHEMA partial — not the same combinationHydrocortisoni acetas · skin / topical
- Versatis partial — not the same combinationLidocainum · skin / topical
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. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Xyloproct 5%/0.275% 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.