LOTEMAX 0.5 % Krople do oczu, zawiesina
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Treść ulotki
LOTEMAX 0,5% Eye Drops, Suspension
Loteprednol Etabonate
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 Lotemax is and what it is used for
- 2. What you need to know before you use Lotemax
- 3. How to use Lotemax
- 4. Possible side effects
- 5. How to store Lotemax
- 6. Contents of the pack and other information
1. What is LOTEMAX and what is it used for
Lotemax is an eye drop, suspension.
Lotemax is used to treat post-operative inflammation of the eye.
Sometimes the eye can become inflamed (red and painful). Loteprednolol
etabonate belongs to a category of drugs called corticosteroids. It works by reducing
inflammation and relieving symptoms. Since it is used in small doses
directly on the affected area, its action is limited to the application site.
2. What you need to know before you use LOTEMAX
Do not use LOTEMAX:
- if you are allergic to the active ingredient (loteprednol etabonate) or to any of the other ingredients of this medicine (listed in section 6).
- if you have been allergic to any corticosteroid.
- if you suffer from eye diseases caused by viruses, such as herpes simplex, vaccination rash and chickenpox.
- if you suffer from eye diseases caused by mycobacteria or fungi.
- if you are breastfeeding.
Warnings and precautions
Tell your doctor if you suffer from glaucoma.
Tell your doctor if pain develops, or if the redness, itching or inflammation
worsens.
Consult your doctor if your symptoms do not improve within the first two days. They may
want to recheck your condition.
You must not use Lotemax for a period longer than ten days, unless after
checking your eye pressure by your doctor.
Long-term use of Lotemax or other eye drops containing steroids can cause
glaucoma or increase eye pressure, with damage to the optic nerve,
vision problems and cataracts.
Long-term use of Lotemax or other eye drops containing steroids can decrease
resistance to infections and increase the chances of contracting eye infections, including
herpes simplex.
The use of steroid eye drops such as Lotemax can worsen and prolong the duration of
viral eye diseases.
Contact lenses
The use of contact lenses after cataract surgery is not recommended. If you normally
wear contact lenses, your doctor will recommend the use of glasses for a certain
period of time following cataract surgery. This is to allow your eyes
to heal after surgery. Your doctor will tell you when you can start wearing
contact lenses again (see also “Lotemax contains benzalkonium chloride”).
Other medicines and Lotemax
Tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including those available without a prescription. In particular, tell your doctor if
you use:
- .
- medicines known as anticholinergics (used to treat various conditions such as abdominal cramps, muscle spasms, urge incontinence or asthma),.
- eye drops used to treat high pressure inside the eye.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are
planning a pregnancy, ask your doctor or pharmacist for advice before using
this medicine.
It is possible that you will still be prescribed Lotemax, but it is also possible that an alternative will be used.
Lotemax must not be used during breastfeeding.
Driving and using machines
The eye drops may blur your vision. This usually passes quickly. Do not drive and do not
use machines until your vision has returned to normal.
Lotemax contains benzalkonium chloride.
The preservative Benzalkonium chloride can cause eye irritation.
Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes
before re-applying them. Benzalkonium chloride is known to discolor soft contact
lenses.
3. How to use LOTEMAX
4. How to use LOTEMAX
Use this medicine always as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose in adults and the elderly is 1-2 drops four times a day.
Treatment with Lotemax usually starts 24 hours after surgery and is continued
for two weeks.
Use in adults:
- Shake the Lotemax bottle well before use.
- Look upwards and, carefully, lower the lower eyelid of the affected eye(s).
- Instill one to two drops of Lotemax into the area between the eyeball and the eyelid, four times a day or as prescribed by your doctor.
- Avoid having the tip of the bottle come into contact with any surface, as this may contaminate the medicine.
- Close the bottle immediately after use.
- • Your doctor will give you instructions on the duration of treatment with Lotemax. Do not stop treatment without first consulting your doctor.
Use in children and adolescents
Lotemax should not be used in children and adolescents until new data are
available.
If you use more Lotemax than you should
Tell your doctor or pharmacist.
If you forget to use Lotemax
Do not take a double dose to make up for a missed dose.
Wait until the next application and continue as normal.
If you stop using Lotemax
Use this medicine exactly as your doctor has told you. Do not stop using
Lotemax without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
5. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms: redness, itching or swelling of the membrane that
covers the white part of the eye and/or the eyelid(s) or generalized symptoms such as difficulty
breathing, difficulty swallowing, redness or flushing of the face and swelling
of the face or tongue you should stop using this medicine and seek
immediate medical attention.
These may be signs of a serious allergic reaction.
Since you may need urgent medical attention, contact your doctor
immediatelyif you experience any of the following adverse events:
- worsening eye pain, especially when exposed to bright light and eye redness during use of the medicine. This may be due to inflammation of the colored part of the eye, called iritis - uncommon side effect (may occur in up to 1 in 100 people),
- a lump or thickening in an area of the breast, change in size, shape or sensitivity of the breast, swelling or lump under the armpit or change in the shape of the nipple. These may be symptoms of breast cancer, which is a rare side effect (may occur in up to 1 in 1,000 people),
- involuntary muscle contraction (muscle twitching) - rare side effect (may occur in up to 1 in 1,000 people),
- nervousness - rare side effect (may occur in up to 1 in 1,000 people),
- noise (ringing) in the ears (tinnitus) - rare side effect (may occur in up to 1 in 1,000 people),
- chest pain - rare side effect (may occur in up to 1 in 1,000 people).
The following side effects reported below may occur during treatment
with this medicine:
Common side effects (may affect up to 1 in 10 people):
Ocular side effects:
corneal defects, eye secretions, feeling of discomfort in the eye, dry eye,
tearing, foreign body sensation in the eye, eye redness, eye itching,
burning sensation at the site of instillation and increased intraocular pressure.
burning sensation at the site of instillation and increased intraocular pressure.
General side effects:
headache.
Uncommon side effects (may affect up to 1 in 100 people):
Ocular side effects:
abnormal vision, blurred vision, swelling of the conjunctiva, conjunctivitis, eye irritation, eye pain, mild lifting of the conjunctiva, sensitivity to light,
eye inflammation, inflammation of the cornea and conjunctiva, eye infection and
opacification of the lenses.
General side effects:
fatigue, runny nose and sore throat.
Rare side effects (may affect up to 1 in 1,000 people):
General side effects:migraine, taste distortion, feeling of dizziness,
numbness, feeling of cold, fever and pain, cough, infection or inflammation of the urinary tract, hives, rash, dry skin, eczema, diarrhea, nausea and vomiting, weight gain.
Reporting of side effects
If you experience any side effects, including those not listed in
this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store LOTEMAX
Keep this medicine out of the sight and reach of children.
Keep the container in an upright position.
Store at a temperature not exceeding 25° C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the packaging and
on the bottle after Expiry. The expiry date refers to the last day of that month.
Discard the product 28 days after opening.
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.
DO NOT USE IF THE PROTECTIVE SEAL IS DAMAGED
6. Contents of the pack and other information
What Lotemax contains
- The active ingredient is Loteprednol Etabonate. Each ml contains 5 mg (0.5%) of Loteprednol Etabonate.
- The excipients are: Disodium Edetate, Glycerol, Povidone, Purified Water and Tyloxapol.
- Benzalkonium Chloride (0.01%) is added as a preservative.
- Sodium Hydroxide and/or Hydrochloric Acid are added to adjust the pH.
Description of the appearance of Lotemax and contents of the pack
Lotemax is a milky suspension eye drop.
Lotemax is available in bottles of 2.5 ml, 5ml, or 10 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch & Lomb-IOM S.p.A
Viale Martesana 12
20090 Vimodrone (MI), Italy
Manufacturer
Dr. Mann Pharma
Brunsbütteler Damm 173
13581 Berlin
Germany
Other sources of information
For any information on this medicine, please contact Bausch & Lomb, -
IOM S.p.A Via Pasubio, 34 20846 Macherio (MB), Italy
Lotemax is a registered trademark of Bausch & Lomb Incorporated.
©Bausch & Lomb Incorporated
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- Kraj rejestracji
- Postać farmaceutycznaEye drop, suspension, 0.5 %
- Kod ATCS01BA14
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki LOTEMAXPostać farmaceutyczna: Eye drops, suspension, 5 MG/MLSubstancja czynna: loteprednolBez receptyPostać farmaceutyczna: Eye drops, solution, 0.1%Substancja czynna: clobetasoneProducent: OMNIVISION ITALIA SRLBez receptyPostać farmaceutyczna: Eye drops, solution, 0.3 MLSubstancja czynna: hydrocortisoneProducent: DOC GENERICI SRLWymaga recepty
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LOTEMAX 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 LOTEMAX jest loteprednol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LOTEMAX 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 LOTEMAX 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 LOTEMAX 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 (loteprednol) to m.in. NOLOK, KLOBET, KORTIVIS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
