PROCTOSTEROID 10 mg RECTAL FOAM

2. What you need to know before you use Proctosteroid

Do not use Proctosteroid:

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

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

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

Using Proctosteroid with other medicines

Tell 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 monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Use in athletes:

Athletes are informed that this medicine contains triamcinolone diacetate, which may produce a positive result in doping 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 can 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 during treatment with Proctosteroid.

Driving and using machines

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

Important information about some of the components of Proctosteroid:

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

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

3. How to use Proctosteroid

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

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

Pause for several days without treatment every two or three weeks.

Once symptoms have subsided, one application on alternate days is usually sufficient.

Administration instructions

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

Before using for the first time, slide and tear off, with the container in vertical position, the safety tab from the dosing head.

1. From this moment on and every time you use it, place the container in a vertical position, as indicated by the following drawings.

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

1. Shake the container vigorously before use.

1. Hold the container in the palm of your hand with your 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).

1. Insert the applicator into the rectum (the end of the applicator can be lubricated for greater comfort). One way to use the aerosol is by raising one foot onto a stool or chair before introducing the cannula.

1. 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.

Excessive or prolonged use of topical and rectal corticosteroids may cause 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.

Stopping the application of the drug quickly corrects the corticosteroid effects.

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

If you forget to use Proctosteroid:

Do not use a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are generally mild and transient.

Uncommon side effects (may affect up to 1 in 100 people)

• irritation at the application site
• pruritus at the application site
• Cushing's syndrome
• hyperglycemia
• osteoporosis
• collagen disorder (collagen loss).

Side effect with unknown frequency (cannot be estimated from available data)

• blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting side 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 above 30°C.

Do not freeze or refrigerate.

Pressurized container.

Protect from direct sunlight and do not destroy or burn, even when empty.

Do not use Proctosteroid after the expiry date stated on the container after EXP.: The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Proctosteroid 10 mg Rectal Foam

The active ingredient is triamcinolone diacetate.

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

The other components are:

Emulsifying wax, caprylocaproyl macrogolglycerides, polysorbate 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 container:

Proctosteroid is a white or almost white foam.

It is presented in a 20 g container and 16 applicator cannulas.

Marketing authorization holder and manufacturer:

Laboratorio Aldo-Unión, S.L.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Date of last revision of this leaflet: 02/2019

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