Proctostéroid 10 mg rectal foam
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Proctosteroid 10 mg rectal foam
Triamcinolone diacetate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Proctosteroid is and what it is used for
- What you need to know before using Proctosteroid
- How to use Proctosteroid
- Possible side effects
- How to store Proctosteroid
- Contents of the pack and other information
1. What Proctosteroid is and what it is used for
Proctosteroid belongs to a group of medicines called intestinal anti-inflammatory agents, which exerts its anti-inflammatory action on the rectal mucosa. This medicine is indicated in adults for:
Treatment of ulcerative colitis, proctosigmoiditis, and granular proctitis.
Treatment of inflammatory conditions affecting the rectum.
2. What you need to know before starting to use Proctosteroid
Do not use Proctosteroid:
- If you are allergic to triamcinolone diacetate or to any of the other ingredients of the medicine.
- If you have tuberculosis, chickenpox, or acute simple herpes.
- If you have abscesses, extensive fistulas, or recent intestinal sutures.
- If you have intestinal obstruction.
- If you have peritonitis.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Proctosteroid.
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If you have recently discontinued systemic corticosteroid treatment, initiating treatment with Proctosteroid may cause functional disturbances of the hypothalamic-pituitary-adrenal axis.
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Contact your doctor if you experience blurred vision or other visual disturbances.
Use of Proctosteroid with other medicines
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Proctosteroid, so your doctor will perform careful monitoring if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).
Use in athletes:
Athletes are advised that this medicine contains triamcinolona diacetato, which may lead to a positive result in doping control tests.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
There is no evidence that Proctosteroid may harm the mother or child when used during pregnancy or breastfeeding. However, you should contact your doctor as soon as possible if you become pregnant while being treated with Proctosteroid.
Driving and using machines:
Proctosteroid does not affect your ability to drive or operate tools or machinery.
Important information about some of the components of Proctosteroid:
This medicine contains 210 mg of propylene glycol per application. Propylene glycol may cause skin irritation.
It may cause allergic reactions (delayed positive reactions) because it contains methyl parahydroxybenzoate (E-218).
3. How to use Proctosteroid
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
One rectal application one or two times daily, preferably after a bowel movement.
Introduce several treatment-free days every two or three weeks.
Once symptom remission has been achieved, an application every other day is usually sufficient.
Instructions for administration
Read the instructions carefully before using Proctosteroid for the first time.
Before first use, move and remove the safety tab from the dosing head with the container in an upright position.
- From now on, and each time the product is used, place the container in an upright position, as shown in the following illustrations.
Firmly attach the cannula to the discharge tube of the aerosol, aligning the notch located beneath the dosing head of the discharge tube.
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Shake the container vigorously before use.
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Hold the container in the palm of your hand with the index and middle fingers placed over the dosing head (the product can only be dispensed when the aerosol is inverted, with the head downwards and the notch aligned).
- Insert the applicator into the rectum (the tip of the applicator may be lubricated for greater comfort). One way to use the aerosol is by raising one foot onto a stool or chair before inserting the cannula.
- To administer a dose, press the dosing head fully down once and release. Wait at least 15 seconds before removing the applicator. Detach the cannula and discard it.
If you use more Proctosteroid than you should:
If you use more Proctosteroid than recommended, consult your doctor or pharmacist immediately.
Excessive or prolonged use of topical corticosteroids and endorectal foams may lead to systemic effects due to absorption of the corticosteroid, such as Cushing's syndrome, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma, among others.
Discontinuation of the drug administration rapidly reverses corticosteroid-related effects.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.
If you forget to use Proctosteroid:
Do not use a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Adverse effects are generally mild and transient.
Uncommon adverse effects (may affect up to 1 in 100 people):
- irritation at the site of administration
- pruritus at the site of administration
- Cushing's syndrome
- hyperglycaemia
- osteoporosis
- collagen disorder (loss of collagen)
Adverse effect with unknown frequency (cannot be estimated from available data):
- blurred vision
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Proctosteroid
Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
Do not freeze or refrigerate.
Pressurised container.
Protect from direct sunlight. Do not pierce, burn, or destroy, even when empty.
Do not use Proctosteroid after the expiry date stated on the packaging after EXP.: The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and empty containers to the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or containers, please consult your pharmacist. This will help protect the environment.
6. Contents of the pack and other information
Composition of Proctosteroid 10 mg rectal foam
The active substance is triamcinolone diacetate.
Each application contains approximately a dose of 10 mg of triamcinolone diacetate.
The other components are:
Emulsifying wax, caprylic/capric macrogol glycerides, polysorbate 20, propylene glycol, methylparaben (E-218), disodium phosphate, anhydrous citric acid, purified water, and norflurane (HFA-134a).
This medicinal product contains fluorinated greenhouse gases.
Each container contains 3.71 g of norflurane (HFA-134a), equivalent to 0.0053 tonnes of CO2 (global warming potential GWP = 1,430).
Nature of the product and pack contents:
Proctosteroid is a white or almost white foam.
It is supplied in a 20 g container with 16 single-use applicators.
Marketing Authorization Holder and Manufacturer:
Laboratorio Aldo-Unión, S.L.
Calle Baronesa de Maldá, 73
08950 Esplugues de Llobregat (Barcelona)
Spain
Date of the most recent revision of this leaflet: September 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es