BRUMETON COLLOIDALE

Patient Information Leaflet: Information for the User

BRUMETON COLLOIDAL 0.1% + 10% Eye Drops, Solution

Betamethasone and sulfacetamide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BRUMETON COLLOIDAL is and what it is used for
2. What you need to know before using BRUMETON COLLOIDAL
3. How to use BRUMETON COLLOIDAL
4. Possible side effects
5. How to store BRUMETON COLLOIDAL
6. Contents of the pack and other information

1. What BRUMETON COLLOIDAL is and what it is used for

BRUMETON COLLOIDAL is a combination of two active substances: betamethasone and sulfacetamide.
Betamethasone belongs to a group of medicines called corticosteroids, which reduce allergy symptoms and relieve inflammation. Sulfacetamide belongs to a group of medicines called antimicrobials, which slow down or stop the growth of bacteria.

BRUMETON COLLOIDAL is indicated for:

• the prevention and treatment of eye disorders, particularly in cases of:
• superficial ocular infections caused by bacteria sensitive to sulfacetamide, for example: Staphylococcus, Streptococcus, Pneumococcus, Hemophilus influenzae, Moraxella lacunata (Morax-Axenfeld diplobacillus), Klebsiella pneumoniae (Friedländer's bacillus), Escherichia coli and Aerobacter aerogenes;
• allergic and inflammatory diseases of the anterior segment of the eye, especially when there is concern about possible infectious complications, such as in inflammations of the conjunctiva (acute, chronic, allergic and/or phlyctenular conjunctivitis, etc.), eyelids (acute, chronic and allergic blepharitis), cornea (interstitial keratitis, phlyctenular keratoconjunctivitis), sclera (scleritis and episcleritis), iris (acute, chronic and traumatic iritis), and iris and ciliary body (iridocyclitis);
• the treatment of ear disorders such as:
• inflammatory conditions (external and middle otitis);
• inflammatory states of the external part of the ear (external auditory canal), particularly those caused by bacteria, for example furunculosis, eczema and dermatitis.

2. What you should know before using BRUMETON COLLOIDALE

Do not use BRUMETON COLLOIDALE

• if you are allergic to betamethasone, sulfacetamide, or any of the other ingredients of this medicine (listed in section 6);
• if you have corneal inflammation caused by a virus (herpetic viral keratitis), unless otherwise prescribed by your doctor and under strict ophthalmological supervision;
• if you have high pressure inside the eye (endocular hypertension);
• if you have developed an eye infection caused by bacteria (tuberculosis) or fungi (fungal eye infections);
• if you have developed an eye infection caused by a virus, especially if accompanied by lesions (acute herpes simplex, and other viral corneal diseases in ulcerative phase), except when treatment with BRUMETON COLLOIDALE is combined with antiviral medications (chemotherapeutic agents);
• if you have inflammation of the conjunctiva (conjunctivitis) associated with corneal inflammation (ulcerative keratitis), even in the early stages;
• if you have purulent eye inflammation (acute purulent ophthalmia, purulent conjunctivitis, and purulent or herpetic blepharitis), as this medicine may mask or worsen symptoms;
• if you have inflammation of the glands at the base of the eyelashes (stye);
• if you are infected with smallpox or varicella virus;
• if you have kidney problems (renal disorders);

Warnings and precautions
Talk to your doctor or pharmacist before using BRUMETON COLLOIDALE.
Contact your doctor if you experience blurred vision or other visual disturbances.
Prolonged use may lead to undesirable effects (see section “Possible side effects” and “How to use BRUMETON COLLOIDALE”).
If you need to use this medicine for prolonged periods, consult your ophthalmologist for frequent monitoring of intraocular pressure (ocular tonus).
Children and adolescents
Do not use this medicine in children and adolescents of pediatric age, unless otherwise directed by a doctor.
Other medicines and BRUMETON COLLOIDALE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.
BRUMETON COLLOIDALE contains phenylmercuric acetate and parahydroxybenzoates
This medicine contains the preservative phenylmercuric acetate, which may cause allergic reactions.
BRUMETON COLLOIDALE contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).

3. How to use BRUMETON COLLOIDALE

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Once the bottle has been opened, turn it upside down and apply slight pressure to the body of the container.
The recommended dose is 1-2 drops to be administered into the lower part of the eye (conjunctival sac) or into the ear (external auditory canal), 3-4 times during the day and 1-2 times during the night. If you notice an improvement in symptoms, consult your doctor, who will determine whether the dose or frequency of administration should be reduced.
The duration of treatment will be prescribed by your doctor, depending on the severity of symptoms. Do not stop treatment without first consulting your doctor.
It is recommended not to use the medicine for more than 30 consecutive days.
If you use more BRUMETON COLLOIDALE than you should
Cases of overdose are not known.
In case of ingestion/accidental swallowing of this medicine, contact your doctor or the nearest hospital immediately.
If you forget to use BRUMETON COLLOIDALE
Do not use a double dose to make up for the forgotten dose.
Use the next dose at the scheduled time.
If you stop using BRUMETON COLLOIDALE
Do not stop treatment before complete recovery and without consulting your doctor.
In particular, for long-term treatments (chronic conditions), it is recommended to discontinue treatment gradually by reducing the frequency of administration.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• burning;
• irritation;
• allergic reactions (hypersensitivity). In this case, it is recommended to discontinue therapy and consult a doctor, who will determine appropriate treatment;
• increased pressure inside the eye and visual disturbances (posterior subcapsular cataract), when the medicine is applied to the eye for prolonged periods.
• blurred vision. After large amounts of sulfacetamide pass into the bloodstream, side effects typical of sulfonamides may occur.

During treatment, there may possibly be development of infections caused by microorganisms that are not sensitive, particularly fungi (Monilia). In such a case, treatment must be discontinued and the doctor should be informed, so that appropriate therapy can be prescribed.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BRUMETON COLLOIDAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and applies to the product stored
under the recommended conditions.
Store the unopened bottle in a refrigerator at a temperature between +2°C and +8°C.
After opening, store the bottle at a temperature below 25°C, protected from light.
Once the container has been opened, the eye drops must be used within 28 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BRUMETON COLLOIDAL contains

• The active substances are: betamethasone and sulfacetamide. 1 ml of solution contains 1 mg of betamethasone and 100 mg of sodium sulfacetamide.
• The other components are: sodium thiosulfate, sodium bisulfite, sodium edetate, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, ethoxylated lanolin esters, polysorbate 80, phenylmercuric acetate, purified water.

Description of the appearance of BRUMETON COLLOIDAL and contents of the pack
5 ml bottle with dropper.
Marketing Authorization Holder and Manufacturer
Bruschettini s.r.l. - Via Isonzo 6 – 16147 Genova - Italy