rectal ointment suppositories lidocaine, hydrocortisone acetate
What Xyloproct is and what it is used for
Xyloproct rectal ointment and suppositories (pills) contain two active substances ( lidocaine and hydrocortisone ) that work in different ways.
Hydrocortisone reduces swelling. Lidocaine is a pain and itching reliever.
Xyloproct is used to treat hemorrhoids and superficial rectal irritations in adults.
What you need to know before using Xyloproct
Do not use Xyloproct
- if you are allergic to lidocaine, hydrocortisone, or any of the other ingredients of Xyloproct (listed in section 6).
Warnings and precautions
- Hemorrhoids often return due to underlying constipation problems.
- Carefully follow the recommended dosage as higher dosages may lead to more side effects.
- You should contact a doctor if there has been no improvement after 2-3 weeks of treatment with Xyloproct.
- If the skin around the rectal opening becomes irritated or begins to bleed, you should stop the treatment and consult a doctor.
- Contact with the eyes must be avoided. After use, hands should be washed thoroughly.
- If you have porphyria (a hereditary metabolic disorder), you should contact your doctor before starting treatment with Xyloproct.
Other medicines and Xyloproct
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Xyloproct can affect or be affected by certain medicines that contain the following active substances:
- other local anesthetics
- drugs against irregular heart activity (so-called antiarrhythmics )
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
No adverse effects on the fetus have been demonstrated. However, the lowest possible dose and the shortest possible treatment period should be sought when using Xyloproct during pregnancy.
Breast-feeding
The active substances in Xyloproct pass into breast milk but are unlikely to affect children who are breastfed. However, consult a doctor if Xyloproct is used more than occasionally during breastfeeding.
Driving ability and use of machinery
Xyloproct used in recommended doses does not affect your ability to drive or use machines.
Xyloproct contains cetyl alcohol and stearyl alcohol
Xyloproct rectal ointment contains cetyl alcohol and stearyl alcohol, which can cause local skin reactions (for example, contact dermatitis).
How to use Xyloproct
Always use Xyloproct as directed by your doctor. Carefully follow the recommended dosage as higher dosages may lead to more side effects. Ask your doctor or pharmacist if you are unsure.
Usual dose
Rectal ointment: Apply in and around the rectal opening one or more times daily. It is also fine to use the rectal ointment for painful bowel movements. You can use up to 6 grams of rectal ointment per day. The rectal ointment is easy to wash off with water. The protective membrane on the tube is perforated by pressing on the protective cap.
Suppositories: 1 suppository is inserted into the outermost part of the rectum morning and evening and, if necessary, after each bowel movement. The suppository is inserted with the straight end first.
The suppository must be allowed to remain until it has melted. You can use up to 5 suppositories per day.
The treatment period should not exceed 3 weeks.
If you have used too much Xyloproct
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Possible side effects
Like all medicines, Xyloproct can cause side effects, although not everybody gets them. The risk of side effects increases with longer treatment times.
Uncommon (may affect up to 1 in 100 people): Skin inflammation caused by hypersensitivity.
Rare (affects less than 1 in 1,000 users): Allergic reactions, in the most severe cases anaphylactic shock (severe allergic reaction with, for example, rash, swelling, fever, difficulty breathing, and fainting). If you experience such severe allergic reactions, you should seek emergency care immediately.
How to store Xyloproct
Rectal ointment: Store in a refrigerator (2 o C – 8 o C). The rectal ointment can be stored at a maximum of 25 o C for 2 months.
Suppositories: Store in a refrigerator (2 o C – 8 o C). Do not freeze. The suppositories can be stored at a maximum of 25 o C for 2 months.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after the Expiration date. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Rectal ointment:
- The active substances are lidocaine 50 mg, and hydrocortisone acetate 2.5 mg.
- Other ingredients are aluminum diacetate, zinc oxide, cetyl alcohol, stearyl alcohol, macrogol, and water.
Suppository:
- The active substances are lidocaine 60 mg, and hydrocortisone acetate 5 mg.
- Other ingredients are aluminum diacetate, zinc oxide, and hard grease.
Appearance and package sizes of the medicine
Rectal ointment:
White to slightly yellow homogeneous ointment.
Package size: Tube of 20 g.
Suppositories:
White or slightly yellow suppositories.
Packaging sizes: Box of 10 and 50 respectively (prescription covered).
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24, Ireland
Tel.: 0046 856642572
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany