Package leaflet: Information for the patient

CLOBET 0.1% eye drops, suspension

clobetasone-17-butyrate
Equivalent medicine
Please read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CLOBET is and what it is used for
What you need to know before using CLOBET
How to use CLOBET
Possible side effects
How to store CLOBET
Contents of the pack and other information

1. What CLOBET is and what it is used for

This medicine is an eye drop containing clobetasone-17-butyrate, an active substance belonging to the
group of corticosteroids, which reduces swelling and inflammation.
CLOBET is indicated for eye irritation, redness and itching due to allergy or inflammatory conditions (such as, for example, conjunctivitis, uveitis, keratitis), including those caused by surgery or
physical or chemical factors (e.g. trauma, fumes, dust, intense light or foreign bodies).
Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after the prescribed duration of treatment.

2. What you need to know before using CLOBET

Do not use CLOBET if:

you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) or to other medicines containing cortisone;
you have eye infections caused by herpes simplex, unless CLOBET has been prescribed to you in combination with other medicines for the treatment of herpes;
you have viral corneal infections associated with ulcers or have active-phase chickenpox;
you have tested positive in the fluorescein test;
you have fungal (mycotic) infections of the eye or skin near the eyes;
you have eye infections characterized by pus (purulent infections);
you have tuberculosis of the eye;
you have eye problems such as: increased eye pressure (endocular hypertension), reduced vision (narrow-angle glaucoma), styes, or conditions causing thinning of the cornea or the white part of the eye (sclera);
you are pregnant or breastfeeding.

Do not use CLOBET with an airtight dressing (occlusive therapy) if you have a skin condition called atopic dermatitis.
Warnings and precautions
Talk to your doctor or pharmacist before using CLOBET.
Do not use ophthalmic steroid anti-inflammatory medicines (corticosteroids, to which clobetasone belongs) after removal of a superficial foreign body from the front part of the eye (cornea).
Be cautious when using CLOBET, as with other ophthalmic cortisone-containing medicines:

prolonged use may cause cataract or increased eye pressure. If long-term treatment is necessary, your doctor will assess whether regular check-ups are needed;
wearing contact lenses increases the risk of eye infections. Therefore, it is preferable not to wear them during treatment and for the days immediately following the end of therapy. With some topical anti-inflammatory medicines of the class to which CLOBET belongs (corticosteroids), the following have been reported:
cases of cataract and corneal perforation;
viral, bacterial, and fungal infections, which may be triggered, worsened, or masked by the use of these products. Fungal infections are particularly likely to develop during prolonged local corticosteroid treatments; if you have persistent corneal lesions (ulcerations), consider the possibility of such infections. If you notice signs of hypersensitivity, discontinue use of CLOBET. Continuous use beyond one month is not recommended. Always use the product under direct medical supervision. Proper use of CLOBET generally does not lead to the adverse effects that might occur if the medicine were taken orally; however, eye drops containing corticosteroids (such as clobetasone) may be absorbed in sufficient amounts to cause partial suppression of the activity of the gland located above the kidney (adrenal gland) in adults, or a hormonal disorder in children (Cushing's syndrome). Hereditary and degenerative eye diseases do not respond to treatment with corticosteroid anti-inflammatory agents such as clobetasone. Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
In very early infancy, this product should only be administered when strictly necessary and under direct medical supervision.
Other medicines and CLOBET
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

medicines for elevated eye pressure (anti-glaucoma medications);
medicines affecting eye muscles, such as cycloplegics and mydriatics, for example atropine.

If you are using other eye drops or ointments different from CLOBET, wait at least 15 minutes between the application of each medicine. Ophthalmic ointment should always be applied last.
Pregnancy, breastfeeding and fertility
Do not use CLOBET if you suspect you are pregnant, if you are already pregnant, or if you are breastfeeding.
Driving and using machines
Avoid using CLOBET while driving or operating machinery.
CLOBET contains benzalkonium chloride.
This medicine contains 2.73 micrograms of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, consult your doctor.

3. How to use CLOBET

Use this medicine exactly as stated in this leaflet or as directed by your doctor, who will determine the correct dose and duration of treatment based on the severity of your condition. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 drop, 2–4 times daily every 6–12 hours, unless otherwise directed by your doctor.
In particularly severe cases, instill 1 drop every 1–2 hours until significant improvement occurs; then reduce the frequency of instillation.
Do not use CLOBET for more than 30 consecutive days and do not exceed the recommended doses.
Consult your doctor if you do not notice any improvement, if the condition recurs repeatedly, or if you notice any change in its characteristics.

Children and adolescents
In early infancy, the product should be administered only when strictly necessary and under direct medical supervision.

Method of administration
CLOBET is a drop solution for the eyes (ophthalmic use). For use, carefully read the following instructions:

Always wash your hands thoroughly and shake the bottle well;
Administer the drops into the eye after gently lifting the eyelids, taking care not to touch the eye or any other surface with the dropper tip;
Immediately close the bottle after each single application.

If you use more CLOBET than you should
The risk of experiencing adverse effects increases. In case of accidental ingestion/ingestion, inform your doctor immediately or go to the nearest hospital.

If you forget to use CLOBET
Do not use a double dose to make up for the forgotten dose.

If you stop using CLOBET
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Inform your doctor if, during treatment with CLOBET, you notice:

burning, itching, redness (hyperemia) of the eye;
delayed healing of eye wounds, which occurs especially with frequent and prolonged use of the eye drops.

Increases in intraocular pressure have been reported in sensitive patients, but are generally milder and less frequent with clobetasone compared to other anti-inflammatory drugs of the same class (corticosteroids) for ophthalmic use.
Long-term treatments may cause:

ocular hypertension and/or glaucoma (a serious eye disease);
optic nerve damage, visual field disturbances, cataract;
delayed wound healing;
infections;

Rarely, patients receiving anti-inflammatory agents (corticosteroids) via other routes of administration or even locally in the eye for other conditions have reported:

eye infections with Herpes simplex virus. Perforation has been described in diseases causing thinning of the front part of the eye (cornea and sclera) following the use of local anti-inflammatory (steroid) therapy.

Although not reported in patients treated with CLOBET, small watery blisters (serous vesicles) have rarely been reported with anti-inflammatory (corticosteroid) therapy following cataract surgery.
Blurred vision has been reported with unknown frequency.
If you use CLOBET in high doses and/or for prolonged periods of time, or in children under 2 years of age, you may experience systemic side effects caused by corticosteroids (suppression of the hypothalamic-pituitary-adrenal axis), which could manifest as symptoms such as loss of appetite, hypotension, abdominal pain, weight loss, fatigue, headache, nausea, vomiting.
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 CLOBET

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. CLOBET should be used within 1 month after first opening the bottle.
Do not use this medicine after the expiry date stated on the carton and on the bottle after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 CLOBET contains

The active substance is: clobetasone-17-butyrate. 1 ml of suspension contains 1 mg of clobetasone-17-butyrate.
The other components are: benzalkonium chloride, polyethylene glycol 300, citric acid, sodium citrate, polysorbate 80, water for injections.

Description of the appearance of CLOBET and contents of the pack
CLOBET is an eye drop solution available in a 5 ml bottle equipped with a dropper and screw cap.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan
Manufacturer
TUBILUX PHARMA S.p.A. – Via Costarica, 20/22 – 00071 Pomezia (ROME)