Leaflet: information for the user

Proctosteroid 10 mg rectal foam

Triamcinolone diacetate

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• 1. What Proctosteroid is and for what it is used
• 2. What you need to know before starting to use Proctosteroid
• 3. How to use Proctosteroid
• 4. Possible side effects
• 5. Storage of Proctosteroid
• 6. Contents of the pack and additional information

Proctosteroid belongs to a group of medications known as intestinal anti-inflammatory agents that develop its anti-inflammatory action on the rectal mucosa. This medication is indicated in adults for:

Treatment of ulcerative colitis, proctosigmoiditis, and granular proctitis.

Treatment of rectal inflammatory processes.

Do not use Proctosteroid:

• If you are allergic to triamcinolone diacetate or any of the other components of the medication.
• If you have tuberculosis, chickenpox, acute herpes simplex.
• If you have abscesses, extensive fistulas, 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.

• If you have stopped treatment with systemic corticosteroids, starting treatment with Proctosteroid may cause functional alterations of the hypothalamic-pituitary-adrenal axis.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Use of Proctosteroid with other medications

Inform your doctor if you are taking or have recently taken other medications, including those obtained without a prescription.

Some medications may increase the effects of Proctosteroid, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Use in athletes:

Inform athletes that this medication contains triamcinolone diacetate, which may produce a positive result in doping control tests.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is no evidence that Proctosteroid can harm the mother or child when used during pregnancy or breastfeeding. However, contact your doctor as soon as possible if you become pregnant during treatment with Proctosteroid.

Driving and operating machinery

Proctosteroid does not affect your ability to drive or use tools or machinery.

Important information about some of the components of Proctosteroid:

This medication contains 210 mg of propylene glycol in each application. Propylene glycol may cause skin irritation.

It may cause allergic reactions (delayed) because it contains methyl parahydroxybenzoate (E-218).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

One application inside the rectum one or two times a day, preferably after a bowel movement.

Intermittent breaks of several days without treatment should be taken every two or three weeks.

Once the symptoms have been remitted, it is usually sufficient to apply every other day.

Administration Instructions

Read the instructions carefully before using Proctosteroid for the first time.

Before using for the first time, slide and remove, with the container invertical position, the safety tab from the dosing head.

1. From this moment on and every time it is going to be used, place the container invertical position, as indicated by the following drawings.

Connect firmly the cannula to the discharge tube of the aerosol and align the notch located below the dosing head of the discharge tube.

2. Shake the container vigorously before use.

3. Hold the container in the palm of the hand with the index and middle fingers on the dosing head (the product can only be dispensed when the aerosol is inverted with the head down and the notch aligned).

4. Insert the applicator into the rectum (the applicator tip can be lubricated for greater comfort). A way to use the aerosol is to elevate one foot on a stool or chair, before introducing the cannula.

5. To administer a dose, press the dosing head completely once and release it. Wait at least 15 seconds before removing the applicator. Separate the cannula and discard it.

If you use more Proctosteroid than you should:

If you use more Proctosteroid than you should, consult your doctor or pharmacist immediately.

The excessive or prolonged use of topical corticosteroids and rectal foam can cause systemic effects by absorption of the corticosteroid, such as Cushing's syndrome, adrenal suppression, growth retardation in children and adolescents, bone mineral density decrease, cataracts, glaucoma, among others.

The interruption of the application of the drug quickly corrects the cortisone effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to useProctosteroid:

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects are generally mild and transient.

Less Common 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
• hyperglycemia
• osteoporosis
• collagen disorder (loss of collagen)

Adverse Effect with Unknown Frequency(cannot be estimated from available data)

• blurred vision

Reporting 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 prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use.https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Do not freeze or refrigerate.

Pressurized container.

It must be protected from direct sunlight andmust not be destroyed or burned, not even when empty.

Do not useProctosteroidafter the expiration date that appears on the container after CAD.: The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE tipof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Proctosteroid 10 mg rectal foam

The active ingredient is triamcinolona diacetate

Each application contains approximately a dose of 10 mg of triamcinolona diacetate.

The other components are:

Emulsifying wax, caprilocarproilo macrogolglycerides, polisorbate 20, propylene glycol, methyl parahydroxybenzoate (E-218), disodium phosphate, anhydrous citric acid, purified water, and 1,1,1,2-tetrafluoroethane.

Appearance of the product and contents of the packaging:

Proctosteroid is a white or almost white foam.

It is presented in a 20 g package and 16 applicator canulas.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio Aldo-Unión, S.L.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Last review date of this leaflet: 02/2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es