CLORADEX 0.2% + 0.5% Krople do oczu, zawiesina
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Treść ulotki
CLORADEX 0.2 % + 0.5 % eye drops, suspension
Dexamethasone/Chloramphenicol
Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What CLORADEX is and what it is used for
- 2. What you need to know before you use CLORADEX
- 3. How to use CLORADEX
- 4. Possible side effects
- 5. How to store CLORADEX
- 6. Contents of the pack and other information
1. What is CLORADEX and what is it used for
CLORADEX contains the active ingredients desamethasone and chloramphenicol.
Desamethasone is a substance that belongs to a group of medicines known as corticosteroids and
has anti-inflammatory activity. Chloramphenicol is an antibiotic that acts against various bacteria that
can cause infections.
CLORADEX is indicated for the treatment of non-purulent eye infections due to germs
sensitive to chloramphenicol, when it is useful to associate the anti-inflammatory action of desamethasone, in
particular in case of:
- bacterial and allergic conjunctivitis;
- corneal inflammations (keratitis);
- inflammation of the anterior part of the eye, especially after surgical intervention.
2. What you need to know before using CLORADEX
Do not use CLORADEX
- if you are allergic to desamethasone, chloramphenicol or any of the other ingredients of this medicine (listed in section 6).
- if you have high pressure inside your eye;
- if you have an acute infection from Herpes simplexor corneal viral diseases, in an acute ulcerative phase, except when used together with specific antiviral chemotherapeutic agents and in conjunctivitis with corneal inflammation (keratitis) that is ulcerative, even in the initial stage;
- if you suffer from tuberculosis of the eye;
- if you have a fungal infection of the eye;
- if you suffer from a severe acute purulent eye infection, purulent conjunctivitis and purulent eyelid inflammation (blepharitis) and due to the herpes virus, because they can be masked or aggravated by corticosteroids;
- if you have a stye.
Warnings and precautions
Talk to your doctor or pharmacist before using CLORADEX.
Pay particular attention during treatment with CLORADEX:
- do not apply Cloradex for prolonged periods, because it can cause undesirable effects such as glaucoma, with consequent damage to the optic nerve, reduction of visual acuity and visual field, formation of posterior subcapsular cataract, or may promote the onset of eye infections or the development of corneal infections, due to viruses, bacteria or fungi;
- intraocular pressure must be checked frequently; this is particularly important in children under 6 (six) years of age receiving products containing desamethasone;
- prolonged local use of antibiotics can lead to the development of microorganisms resistant to the medicine, i.e. that are no longer sensitive to its action; if this occurs or if you do not notice any improvement of symptoms after 7-10 days of treatment with CLORADEX, consult your doctor;
- chloramphenicol should be used for short periods of time, unless explicitly indicated by your doctor, because rare cases of bone marrow hypoplasia (reduction in bone marrow volume) have been described following prolonged local use over time.
Your doctor will have you undergo frequent checks during treatment with CLORADEX in case of:
- treatment of stromal Herpes simplex;
- prolonged treatments over time;
- diseases that cause thinning of the cornea and sclera, because cases of corneal perforation have been described with the use of steroids.
Talk to your doctor if you feel swelling and weight gain in the trunk and face, as these
are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression
of adrenal gland function can develop after discontinuation of prolonged or
intensive treatment with CLORADEX. Talk to your doctor before stopping treatment on your own. These
risks are particularly important in children and patients treated with a medicine called ritonavir
or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.
The use of contact lenses during treatment of eye inflammation or infection is
not recommended.
Children
Do not use in children under 2 (two) years of age.
The medicine should only be administered if absolutely necessary and under the direct supervision of a doctor.
Other medicines and CLORADEX
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines may increase the effects of CLORADEX and your doctor may want to monitor you
closely if you are taking these medicines (including some medicines for
the treatment of HIV: ritonavir, cobicistat).
Talk to your doctor if you are using ritonavir or cobicistat, as they may increase the level of
desamethasone in the blood.
Concomitant use of topical corticosteroids and topical NSAIDs (non-steroidal anti-inflammatory drugs)
may potentially slow down the wound healing process.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, your doctor will assess whether the benefits for you clearly outweigh the
risks to the fetus/child, before prescribing CLORADEX.
Driving and operating machinery
CLORADEX does not alter the state of alertness and can therefore be used even in patients who need to
drive vehicles or operate machinery.
If you experience transient blurred vision or other visual disturbances, wait
until your vision returns to clear before driving vehicles or using machinery.
CLORADEX in a 5 ml bottle contains sodium ethylmercury thiosalicylate (thimerosal)
Sodium ethylmercury thiosalicylate may cause allergic reactions.
3. How to use CLORADEX
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Shake well before use.
Adults and children over 2 (two) years of age:
The recommended dose is 1 or 2 drops, 3 to 5 times a day or as prescribed by your doctor. Apply the
eye drops into the conjunctival sac, i.e. inside the lower eyelid of the eye.
After instilling CLORADEX, keep your eyes closed for as long as possible (about 3-5 minutes) and press for
two minutes on the corner of the eye near the nose. This will help prevent the active ingredients contained in
this medicine from penetrating into the rest of the body.
Wash your hands before and after instillation.
Paediatric population
The product should be administered only when actually necessary, under direct medical supervision.
How to use CLORADEX in single-dose containers
- Before use, make sure the single-dose container is intact.
- Detach the container from the strip and open it by twisting the top, without pulling.
- Avoid contact between the end of the container and the eye or any other surface.
If you use more CLORADEX than you should
In case of accidental ingestion or use of an excessive dose of CLORADEX, contact
your doctor immediately or go to the nearest hospital.
If you forget to use CLORADEX
Do not use a double dose to make up for a missed dose.
If you stop using CLORADEX
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment and consult your doctor if you experience one or more of the following effects
locally:
- burning sensation;
- irritation;
- hypersensitivity reactions to the components of this medicine, which require discontinuation of treatment and the adoption of appropriate therapeutic measures.
Following the use of this medicine, the following side effects have occurred with a frequency of
“not known” (frequency cannot be estimated based on available data):
- hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, increased blood pressure, irregular or absent periods, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain of the body and face (called “Cushing’s Syndrome”) (see section 2 “Warnings and precautions”);
- blurred vision;
- increased intraocular pressure, ocular hypertension;
- rapid swelling of the skin, mucous membranes and subcutaneous tissues: difficulty breathing, swelling of the neck, face and lips (angioedema).
Side effects due to systemic absorption of the active ingredients of this medicine are
unlikely. The risk of bone marrow hypoplasia due to the presence of
chloramphenicol should be considered, particularly in the case of prolonged treatments at high doses, and the development of
side effects due to high amounts of steroids.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 CLORADEX
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 - 8°C). Store in the original packaging.
CLORADEX in 5 ml bottle
Use the medicine within 15 days of first opening the bottle.
CLORADEX in single-dose containers
The medicine does not contain preservatives; use it immediately after opening the container. Throw away
the single-dose container even if it still contains some medicine.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What CLORADEX contains
CLORADEX in a 5 ml bottle
- The active ingredients are desamethasone and chloramphenicol. 1 ml of eye drops contains 2.0 mg of desamethasone and 5.0 mg of chloramphenicol.
- The other ingredients are macrogol 300, macrogol 1500, macrogol 4000, boric acid, borax, polysorbate, hypromellose, thiomersal, purified water.
CLORADEX in single-dose containers
- The active ingredients are desamethasone and chloramphenicol. 1 ml of solution contains 2.0 mg of desamethasone and 5.0 mg of chloramphenicol.
- The other ingredients are macrogol 300, macrogol 1500, macrogol 4000, boric acid, borax, polysorbate, hypromellose, water for injections.
Description of the appearance of CLORADEX and contents of the pack
CLORADEX in a 5 ml bottle
Each pack contains a bottle fitted with a dropper.
CLORADEX in single-dose containers
Each pack contains 20 single-dose containers in strips of 10 units.
Marketing Authorisation Holder
Bausch & Lomb - IOM S.p.A.
Viale Martesana, 12
20090 Vimodrone (MI)
Italy
Manufacturer
5 ml bottle
TUBILUX PHARMA S.p.A.
Via Costarica, 20/22
00040 Pomezia (RM)
Single-dose containers
DR. GERHARD MANN CHEM.-PHARM. FABRIK GmbH
Brunsbütteler Damm 165-173
13581 Berlin, Germany
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, suspension, 0.2% + 0.5%
- Kod ATCS01CA01
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KLORADEXPostać farmaceutyczna: Eye drops, suspension, 3 mg/ml + 1 mg/mlSubstancja czynna: dexamethasone and antiinfectivesProducent: BRUSCHETTINI S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, <3 mg/ml + 1 mg/mlSubstancja czynna: dexamethasone and antiinfectivesProducent: FIDIA FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 1 MG/ML + 5 MG/MLSubstancja czynna: dexamethasone and antiinfectivesProducent: SANTEN OYWymaga recepty
Odpowiedniki KLORADEX w innych krajach
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Odpowiednik KLORADEX w Hiszpania
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Często zadawane pytania
KLORADEX nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KLORADEX jest dexamethasone and antiinfectives. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KLORADEX jest produkowany przez BAUSCH & LOMB-IOM S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie KLORADEX jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić KLORADEX w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (dexamethasone and antiinfectives) to m.in. KOMBISTILL, KOMBITIMOR, DUKRESSA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
