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- Pharmacotherapeutic group:
Fusidic acid Eye Drops belongs to a group of medicines called antiinfectives. It is a type of antibiotic.
- Therapeutic indications: Fucithalmic® works by killing germs (bacteria) that cause infections.
Fucithalmic® is an eye drop medicine used to treat infections of the eyes caused by germs (bacterial conjunctivitis).
It is useful in Bacterial eye infections caused by susceptible organisms in conjunctivitis, blepharitis, sty, keratitis, dacryocystitis and in connection with removal of foreign bodies.
a. Do not use Fucithalmic®:
- If you are allergic (hypersensitive) to fusidic acid or any of the other ingredients of Fucithalmic®.
b. Take special care with Fucithalmic®:
- If you wear any type of contact lenses whilst using this medicine.
c. Using other medicines, herbal or dietary supplement’s
- Please tell your doctor, health care provider or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
d. Using Fucithalmic® with food and drink
- No data available
e. Pregnancy and breast-feeding
Ask your doctor, health care provider or pharmacist for advice before taking any medicine.
- If you are pregnant, or think you are pregnant.
- If you are breast-feeding.
Tell your doctor if you become pregnant while using this medicine.
f. Driving and using machines
- Do not drive because brief blurring of vision may occur.
- Do not use machinery until your vision is clear. Check with your doctor if you feel any side effect that may stop you from driving or using machines.
g. Important information about some of the ingredients of Fucithalmic®:
- This medicine contains benzalkonium chloride, which may cause eye irritation.
Always use Fucithalmic® exactly as your doctor or health care provider has told you. You should check with your doctor, health care provider or pharmacist if you are not sure.
• Instructions for proper use
This medicine is only for use in your eyes. Do not swallow the drops. Do not put the drops inside your body or in your ears.
Always wash your hands before using Fucithalmic®. Do not use if the cap seal on the tube is broken.
This diagram will help show how to use your medicine. It may be useful to look in a mirror.
Only take the cap off the tube when you are ready to use the medicine. It is important the tip of the tube does not touch your eye.
Tilt your head back. Pull your lower eyelid down gently. Hold the tube over your eye and look up. Squeeze one drop into your lower eyelid.
The drop will come out as a thick drop. It will become more liquid in your eye and you should still see clearly.
After using your medicine you may see a white powder around your eye. This can happen when the drops dry out. It is quite normal and is nothing to worry about. You can wipe the powder off with cotton wool.
If the medicine is for a child, you can put the drops in their eye while they are asleep or lying down if it is easier.
Like all medicines, Fucithalmic® can cause side effects, although not everybody gets them, Possible side effects include:
Common side effects (probably affect more than 1 in 100 people and less than 1 in 10 people)
• Burning, stinging, discomfort, smarting, irritation, itching, soreness or dryness in the eye being treated.
• Blurring of vision in the eye being treated.
Uncommon side effects (probably affect more than 1 in 1000 people and less than 1 in 100 people)
• Watery eyes or crying on application
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.
Keep out of the reach and sight of children Do not Store above 30°C. Store in the original container.
Discard 28 days after opening.
Do not use after the expiry date. This date is printed on your pack. The Expiry date refers to last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
a. What Fucithalmic® contains
The active substance is Fusidic Acid. The other ingredients are Benzalkonium Chloride, Disodium Edetate, Mannitol, Carbomer, Sodium Hydroxide, Water for Injections.
Marketing Authorization Holder: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland.
Tel No: + 353 (0) 1 697 1640.
Fax No: + 353 (0) 1 697 1641.
Email: enquiries@advanzpharma.com
Manufacturer:
LEO Laboratories Ltd.
285 Cashel Road, Crumlin, Dublin 12, Ireland
اﻟﻤﺠﻤﻮﻋﺔ اﻟﺪواﺋﻴﺔ اﻟﻌﻼﺟﻴﺔ: ﺗﻨﺘﻤﻲ ﻗﻄﺮة اﻟﻌﻴﻦ اﻟﺘﻲ ﺗﺤﺘﻮي ﻋﻠﻰ ﺣﻤﺾاﻟﻔﻴﻮﺳﻴﺪﻳﻚ إﻟﻰ ﻓﺌﺔ ﻣﻀﺎدات اﻟﻌﺪوى؛ وﻫﻲﻧﻮع ﻣﻦ اﻟﻤﻀﺎدات اﻟﺤﻴﻮﻳﺔ.
- اﻟﻤﺆﺷﺮات اﻟﻌﻼﺟﻴﺔ: ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ® ﻳﻌﻤﻞ ﻋﻦ ﻃﺮﻳﻖ ﻗﺘﻞ اﻟﺠﺮاﺛﻴﻢ(اﻟﺒﻜﺘﻴﺮﻳﺎ) اﻟﺘﻲ ﺗﺴﺒﺐ اﻻﻟﺘﻬﺎﺑﺎت. ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ ﻫﻮ دواء ﻗﻄﺮة ﻟﻠﻌﻴﻦ ﻳﺴﺘﺨﺪم ﻟﻌﻼج اﻟﺘﻬﺎﺑﺎت اﻟﻌﻴﻮن اﻟﻨﺎﺗﺠﺔ ﻋﻦ اﻟﺠﺮاﺛﻴﻢ (اﻟﺘﻬﺎب اﻟﻤﻠﺘﺤﻤﺔ اﻟﺒﻜﺘﻴﺮي.) وﻫﻮ ﻣﻔﻴﺪﰲﻋﻼج ﺣﺎﻻت ﻋﺪوى اﻟﻌﻴﻦ اﻟﺒﻜﺘﻴﺮﻳﺔ اﻟﺘﻲ ﺗﺴﺒﺒﻬﺎ اﻟﻜﺎﺋﻨﺎت اﻟﺤﺴﺎﺳﺔ اﰲﻟﺘﻬﺎب اﻟﻤﻠﺘﺤﻤﺔ واﻟﺘﻬﺎب اﻟﺠﻔﻦ وﺷﻌﻴﺮة اﻟﻌﻴﻦ واﻟﺘﻬﺎب اﻟﻘﺮﻧﻴﺔ واﻟﺘﻬﺎب ﻛﻴﺲ اﻟﺪﻣﻊ، وﻓﻴﻤﺎ ﻳﺘﻌﻠﻖ ﺑﺈزاﻟﺔ اﻷﺟﺴﺎم اﻟﻐﺮﻳﺒﺔ.
ﻻ ﺗﺴﺘﺨﺪم ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ:
- إذا ﻛﻨﺖ ﺗﻌﺎﻧﻲ ﻣﻦ ﺣﺴﺎﺳﻴﺔ ﺗﺠﺎه ﺣﻤﺾ
اﻟﻔﻮﺳﻴﺪﻳﻚ أو ﺗﺠﺎه أي ﻣﻜﻮن آﺧر ﻟﻔﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ
اﺣﺘﻴﺎﻃﺎت ﺧﺎﺻﺔ ﻻﺳﺘﺨﺪام ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ:
- إذا ﻛﻨﺖ ﺗﺴﺘﺨﺪم أي ﻧﻮع ﻣﻦ اﻟﻌﺪﺳﺎت اﻟﻼﺻﻘﺔ أﺛﻨﺎء اﺳﺘﺨﺪام ﻫﺬا اﻟﺪواء.
ج. اﺳﺘﺨﺪام أدوﻳﺔ أﺧﺮى أو ﻣﻜﻤﻼت أﻏﺬﻳﺔ ﻋﺸﺒﻴﺔ أو ﻏﺬاﺋﻴﺔ
- اﺣﺮص داﺋﻤﺎ ﻋﻠﻰ إﺧﻄﺎر اﻟﻄﺒﻴﺐ أو ﻣﻘﺪم اﻟﺮﻋﺎﻳﺔ اﻟﺼﺤﻴﺔ أو اﻟﺼﻴﺪﻟﻲ اﻟﺨﺎص ﺑﻚ إذا ﻛﻨﺖ ﺗﺴﺘﺨﺪم أدوﻳﺔ أﺧﺮى أو ﺳﺒﻖ أن ﻓﻌﻠﺖ ذﻟﻚ ﺑﺎﻟﻔﻌﻞ. وﻳﻨﻄﺒﻖ ذﻟﻚ ﻋﻠﻰ اﻷدوﻳﺔ اﻟﺘﻲ ﹸﺗﺼﺮف دون وﺻﻔﺔ ﻃﺒﻴﺔ.
د. اﺳﺘﺨﺪام ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ® ﻣﻊ اﻷﻛﻞ واﻟﺸﺮب
- ﻻ ﺗﺘﻮﻓﺮ ﺑﻴﺎﻧﺎت.
ه. اﻟﺤﻤﻞ واﻟﺮﺿﺎﻋﺔ
ﻳﺮﺟﻰ اﺳﺘﺸﺎرة اﻟﻄﺒﻴﺐ أو ﻣﻘﺪم اﻟﺮﻋﺎﻳﺔ اﻟﺼﺤﻴﺔ أو اﻟﺼﻴﺪﻟﻲ اﻟﺨﺎص ﺑﻚ ﻗﺒﻞ ﺗﻌﺎﻃﻲ أي أدوﻳﺔ.
- إذا ﻛﻨﺖ ﺣﺎﻣﻼ أو ﺗﻌﺘﻘﺪﻳﻦ أﻧﻚ ﺣﺎﻣﻞ.
- إذا ﻛﻨﺖ ﻣﺮﺿﻌﺎ.
أﺧﺒﺮي ﻃﺒﻴﺒﻚ إذا أﺻﺒﺤﺖ ﺣﺎﻣﻼ أﺛﻨﺎء اﺳﺘﺨﺪام ﻫﺬا اﻟﺪواء.
و. ﻗﻴﺎدة اﻟﻤﺮﻛﺒﺎت واﺳﺘﺨﺪام اﻵﻻت
- ﻻ ﹶﺗﻘﺪ ﻓﻘﺪ ﻳﺤﺪث ﻋﺪم وﺿﻮح ﰲاﻟﺮؤﻳﺔ.
- ﻻ ﹸﺗﻘﺪم ﻋﻠﻰ ﺗﺸﻐﻴﻞ اﻵﻻت ﺣﺘﻰ ﺗﺘﻀﺢ اﻟﺮؤﻳﺔ.
اﺳﺘﺸﺮ ﻃﺒﻴﺒﻚ إذا ﺷﻌﺮت ﺑﺄي أﺛﺮ ﺟﺎﻧﺒﻲ ﻗﺪ ﻳﻤﻨﻌﻚ ﻣﻦ اﻟﻘﻴﺎدة أو اﺳﺘﺨﺪام اﻵﻻت.
ز. ﻣﻌﻠﻮﻣﺎت ﻫﺎﻣﺔ ﻋﻦ ﺑﻌﺾ اﻟﻤﻜﻮﻧﺎت اﻷﺧﺮىﻟﻔﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ:®
- ﺗﺤﺘﻮي ﻗﻄﺮة اﻟﻌﻴﻦ ﻋﻠﻰ ﻛﻠﻮرﻳﺪ اﻟﺒﻨﺰاﻟﻜﻮﻧﻴﻮم اﻟﺬي ﻳﻤﻜﻦ أن ﻳﻬﻴﺞ اﻟﻌﻴﻨﻴﻦ.
ﻳﺮﺟﻰ دوﻣﺎ اﺳﺘﺨﺪام اﻟﺪواء ﺑﺤﺴﺐ ﺗﻌﻠﻴﻤﺎت ﻃﺒﻴﺒﻚ أو ﻣﻘﺪم اﻟﺮﻋﺎﻳﺔ اﻟﺼﺤﻴﺔ اﻟﺨﺎص ﺑﻚ. إذا ﻛﺎﻧﺖ اﻟﺸﻜﻮك ﺗﺴﺎورك، ﻓﺎﺳﺘﺸﺮ ﻃﺒﻴﺒﻚ أو مقدم الرعايةاﻟﺼﺤﻴﺔ أو اﻟﺼﻴﺪﻟﻲ اﻟﺨﺎص ﺑﻚ
ﻳﺴﺘﺨﺪم ﻫﺬا اﻟﺪواء ﻟﻠﻌﻴﻨﻴﻦ ﻓﻘﻂ. ﻻ ﺗﺒﺘﻠﻊ اﻟﻘﻄﺮات.
ﻻ ﺗﻀﻊ اﻟﻘﻄﺮات داﺧﻞ ﺟﺴﻤﻚ أو أﰲذﻧﻴﻚ. اﻏﺴﻞ ﻳﺪﻳﻚ داﺋﻤﺎ ﻗﺒﻞ اﺳﺘﺨﺪام ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ.® ﻻﺗﺴﺘﺨﺪﻣﻪ إذا ﻛﺎن ﺧﺘﻢ اﻟﻐﻄﺎء ﻋﻠﻰ اﻷﻧﺒﻮبﻣﻜﺴﻮرا. ﺳﻴﺴﺎﻋﺪك ﻫﺬا اﻟﺮﺳﻢ اﻟﺒﻴﺎﻧﻲ ﻋﻠﻰ ﺗﻮﺿﻴﺢ ﻛﻴﻔﻴﺔ اﺳﺘﺨﺪام اﻟﺪواء. ﻗﺪ ﻳﻜﻮنﻣﻦ اﻟﻤﻔﻴﺪ اﻟﻨﻈﺮ اﰲﻟﻤﺮآة.
ﻗﻢ ﻓﻘﻂ ﺑﺮﻓﻊ اﻟﻐﻄﺎء ﻋﻦ اﻷﻧﺒﻮب ﻋﻨﺪﻣﺎ ﺗﻜﻮن ﻣﺴﺘﻌﺪا ﻻﺳﺘﺨﺪام اﻟﺪواء. اﺣﺮص ﻋﻠﻰ ﺗﺠﻨﺐ ﻟﻤﺲﻃﺮف اﻟﻘﻄﺎرة ﻟﻠﻌﻴﻦ. أدر رأﺳﻚ إﻟﻰ اﻟﻮراء. اﺳﺤﺐ اﻟﺠﻔﻦ اﻟﺴﻔﻠﻲ ﺑﺮﻓﻖ إﻟﻰ أﺳﻔﻞ. أﻣﺴﻚ اﻷﻧﺒﻮب ﻓﻮق ﻋﻴﻨﻴﻚ واﻧﻈﺮ إﻟﻰ أﻋﻠﻰ. ﺿﻊ ﻗﻄﺮة واﺣﺪةﰲﺟﻔﻨﻚ اﻟﺴﻔﻠﻲ. ﺳﺘﺨﺮج اﻟﻘﻄﺮة ﻛﻘﻄﺮة ﺳﻤﻴﻜﺔ. ﺳﻮف ﺗﺼﺒﺢ أﻛﺜﺮ ﺳﻴﻮﻟﺔ
ﻗﺪ ﻳﺤﺪث ﻫﺬا ﻋﻨﺪ ﺟﻔﺎف اﻟﻘﻄﺮات. إﻧﻪ أﻣﺮ ﻃﺒﻴﻌﻲ ﺗﻤﺎﻣﺎ وﻻ داﻋﻲ ﻟﻠﻘﻠﻖ. ﻳﻤﻜﻨﻚ ﻣﺴﺢ
اﻟﻤﺴﺤﻮق ﺑﺎﺳﺘﺨﺪام ﻗﻄﻦ ﻃﺒﻲ. إذا ﻛﺎن اﻟﺪواء ﻣﺨﺼﺼﺎ ﻟﻄﻔﻞ ، ﻓﻴﻤﻜﻨﻚ وﺿﻊ اﻟﻘﻄﺮات ﰲاﻟﻌﻴﻦ أﺛﻨﺎء ﻧﻮﻣﻪ أو اﻻﺳﺘﻠﻘﺎء إذا ﻛﺎن اﻷﻣﺮأﺳﻬﻞ.
ﺷﺄن أي دواء ﻳﻤﻜﻦ أن ﻳﺘﺴﺒﺐ ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ® ﻓﻲ ﺣﺪوث آﺛﺎر ﺟﺎﻧﺒﻴﺔ، ﻟﻜﻨﻬﺎ ﻻ ﺗﺼﻴﺐ ﺟﻤﻴﻊاﻟﻤﺮﺿﻰ.
ﺗﺘﻀﻤﻦ اﻵﺛﺎر اﻟﺠﺎﻧﺒﻴﺔ اﻟﻤﺤﺘﻤﻠﺔ اﻵﺛﺎر اﻟﺠﺎﻧﺒﻴﺔ اﻟﺸﺎﺋﻌﺔ )ﺗﺼﻴﺐ ﺷﺨﺼﺎ ﺗﻘﺮﻳﺒﺎ ﻣﻦ ﻛﻞ 100 ﺷﺨﺺ، وأﻗﻞ ﻣﻦ ﺷﺨﺺ من كل 10 اشخاص
ﺣﺮﻗﺔ ﰲاﻟﻌﻴﻦ، أو اﻟﺸﻌﻮر ﺑﻌﺪم اﻟﺮاﺣﺔ، أو وﺧﺰ أو ﺗﻬﻴﺞ أو ﺣﻜﺔ أو ﻗﺮﺣﺔ أو ﺟﻔﺎف ﰲاﻟﻌﻴﻦ اﻟﺘﻲ ﻳﺘﻢ ﻋﻼﺟﻬﺎ.
• ﻋﺪم وﺿﻮح اﻟﺮؤﻳﺔ ﰲاﻟﻌﻴﻦ اﻟﺘﻲ ﻳﺘﻢ ﻋﻼﺟﻬﺎ.
ااﻵﺛﺎر اﻟﺠﺎﻧﺒﻴﺔ ﻏﻴﺮ اﻟﺸﺎﺋﻌﺔ )ﺗﺼﻴﺐ ﺗﻘﺮﻳﺒﺎ أﻛﺜﺮ ﻣﻦ ﺷﺨﺺ ﻣﻦ ﻛﻞ 1000 ﺷﺨﺺ، وأﻗﻞ ﻣﻦ ﺷﺨﺺ ﻣﻦﻛﻞ 10 أﺷﺨﺎص.
ﻋﻴﻮن داﻣﻌﺔ أو اﻟﺒﻜﺎء ﻋﻨﺪ اﺳﺘﺨﺪام اﻟﻘﻄﺮة إذا ﺗﻄﻮرت أي ﻣﻦ اﻵﺛﺎر اﻟﺠﺎﻧﺒﻴﺔ وأﺻﺒﺤﺖ ﺧﻄﻴﺮة أو ﻻﺣﻈﺖ أي آﺛﺎر ﺟﺎﻧﺒﻴﺔ ﻏﻴﺮ اﻟﻤﺪرﺟﺔﰲﻫﺬه النشره يرجى اخبار الطبيب لو مقدم الرعاية الصحية او الصيدلي الخاص بكز
أأﺑﻘﻪ ﺑﻌﻴﺪا ﻋﻦ ﻣﺘﻨﺎول اﻷﻃﻔﺎل. ﻳﺤﻔﻆ اﻟﺪواء دﰲرﺟﺔ ﺣﺮارة ﻻ ﺗﺰﻳﺪ ﻋﻦ 30 درﺟﺔﻣﺌﻮﻳﺔ، وﻳﺤﻔﻆ اﰲﻟﻌﻠﺒﺔ اﻷﺻﻠﻴﺔ.
ﺗﺨﻠﺺ ﻣﻦ اﻟﺪواء ﺑﻌﺪ 28 ﻳﻮﻣﺎ ﻣﻦ ﻓﺘﺢ اﻟﻌﺒﻮة. ﻻ ﺗﺴﺘﺨﺪم ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ ﺑﻌﺪ ﺗﺎرﻳﺦ اﻧﺘﻬﺎء اﻟﺼﻼﺣﻴﺔ اﻟﻤﻜﺘﻮب ﻋﻠﻰ اﻟﻌﻠﺒﺔ. ﺗﺎرﻳﺦ اﻧﺘﻬﺎء اﻟﺼﻼﺣﻴﺔ ﻳﺸﻴﺮ إﻟﻰ اﻟﻴﻮم اﻷﺧﻴﺮ ﻣﻦ ذﻟﻚ اﻟﺸﻬﺮ.
ﻳﺠﺐ ﻋﺪم اﻟﺘﺨﻠﺺ ﻣﻦ اﻷدوﻳﺔ ﻋﻦ ﻃﺮﻳﻖ ﻣﻴﺎه اﻟﺼﺮف اﻟﺼﺤﻲ أو اﻟﻨﻔﺎﻳﺎت اﻟﻤﻨﺰﻟﻴﺔ. اﺳﺄل اﻟﺼﻴﺪﻟﻲ ﻋﻦ ﻛﻴﻔﻴﺔ اﻟﺘﺨﻠﺺ ﻣﻦ اﻷدوﻳﺔ اﻟﺘﻲ ﻟﻢ ﺗﻌﺪ ﻣﻄﻠﻮﺑﺔ. ﺳﻮف ﺗﺴﺎﻋﺪ ﻫﺬه اﻟﺘﺪاﺑﻴﺮ ﻋﻠﻰ ﺣﻤﺎﻳﺔ اﻟﺒﻴﺌﺔ.
اﻟﻤﺎدة اﻟﻔﻌﺎﻟﺔ ﻫﻲ ﺣﻤﺾ اﻟﻔﻮﺳﻴﺪﻳﻚ.
اﻟﻤﻜﻮﻧﺎت اﻷﺧﺮى ﻫﻲ ﻛﻠﻮرﻳﺪ اﻟﺒﻨﺰاﻟﻜﻮﻧﻴﻮم وﺛﻨﺎﺋﻲﺻﻮدﻳﻮم اﻹﻳﺪﻳﺘﺎت وﻣﺎﻧﻴﺘﻮل وﻛﺎرﺑﻮﻣﻴﺮ
وﻫﻴﺪروﻛﺴﻴﺪ اﻟﺼﻮدﻳﻮم وﻣﺎء ﻟﻠﺤﻘﻦ
ﻣﺤﻠﻮل ﻟﺰج أﺑﻴﺾ إﻟﻰ ﺿﺎرب إﻟﻰ اﻟﺒﻴﺎض. ﻳﺘﻮﻓﺮ ﻓﻴﻮﺳﻴﺜﺎﻟﻤﻴﻚ في أﻧﺒﻮب أﻟﻮﻣﻨﻴﻮم ﻣﻐﻠﻒ ﻣﻦ اﻟﺒﻮﻟﻲ إﻳﺜﻴﻠﻴﻦ ﻣﻊ ﻏﻄﺎء ﻣﻦ اﻟﺒﻮﻟﻲ إﻳﺜﻴﻠﻴﻦ ﻋﺎﻟﻲ اﻟﻜﺜﺎﻓﺔ. وﻳﺤﺘﻮي ﻋﻠﻰ 5 ﺟﺮاﻣﺎت و3 ﺟﺮاﻣﺎت ﻣﻦ ﻣﺤﻠﻮل ﻗﻄﺮات اﻟﻌﻴﻦ.
اﻟﺸﺮﻛﺔ Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland.
+ 353 (0) 1 697 1640 :رﻗﻢ ﻫﺎﺗﻒ
+ 353 (0) 1 697 1641 :رﻗﻢ ﻓﺎﻛﺲ
اﻟﺒﺮﻳﺪ اﻹﻟﻜﺘﺮوﻧﻲ:
enquiries@advanzpharma.com
اﻟﺠﻬﺔ اﻟﻤﺼﻨﻌﺔ:
LEO Laboratories Ltd.
Cashel Road, Crumlin, Dublin 12, Ireland
285
Treatment of ocular infection due to sensitive organisms.
One drop of Fucithalmic should be applied to the conjunctival sac every 12 hours. Treatment should be continued for 2 days after the eye appears normal.
Contact lenses should not be worn/used when Fucithalmic is used.
The microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Fucithalmic eye gel (in tube) contains benzalkonium chloride, which is known to discolour soft contact lenses.
Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Excipients warning:
Fucithalmic eye gel contains benzalkonium chloride, which may cause eye irritation.
None known.
Pregnancy
Limited clinical data on exposed pregnancies is available. This data and animal studies and many years of clinical experience with systemic and topical fusidic acid suggest that fusidic acid is devoid of teratogenic effect. Consequently any risk to the foetus is unlikely using the very low doses of fusidic acid applied topically in Fucithalmic viscous eye drops. Can be administered during pregnancy if considered necessary.
Lactation
No effects on the suckling child are anticipated since the systemic exposure of the breast- feeding woman to fusidic acid is negligible. Fucithalmic viscous eye drops can be used during breast-feeding.
Fucithalmic may cause a transient blurring of vision following application. When vision is not affected, Fucithalmic has no or negligible influence on the ability to drive and use machines.
Pooled data from clinical studies, including more than 2,600 patients with acute conjunctivitis, showed that undesirable effects occurred in approximately 10% of the patients; primarily short lasting local discomfort in the form of stinging and burning sensation.
The most frequently reported adverse drug reactions are various application site reactions such as transient stinging and burning sensation or transient blurring of vision. Urticaria, rash and allergic reactions have been reported.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.
Immune system disorders
Rare (≥1/10,000 and <1/1,000):
Allergic reaction
Eye Disorders
Common (≥1/100 and <1/10):
Eye burning Eye stinging
Transient blurring of vision
Uncommon (≥1/1,000 and <1/100):
Watery eyes
Rare (≥1/10,000 and <1/1,000): Conjunctivitis aggravated
Skin and subcutaneous tissue disorders
Frequency unknown:
Pruritus Periorbital oedema Rash
Urticaria Angioedema
General disorders and administration site conditions
Common (≥1/100 and <1/10): Application site reaction
To report any side effect(s):
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC) Fax: +966-11-205-7662 Call NPC at +966-11-2038222, Exts: 2317-2356-2340. SFDA Call Center: 19999 E-mail: npc.drug@sfda.gov.sa Website: http://ade.sfda.gov.sa/
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• Other GCC States: Please contact the relevant competent authority.
Overdosage is unlikely to occur. Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fusidic acid eye drops is unlikely to cause any harm. The total quantity of fusidic acid in one 5g tube of Fusidic acid eye drops (50mg) will not exceed the approved total daily oral dose of fusidic acid containing products. The concentration of the excipients is too low to constitute a safety risk.
Pharmacotherapeutic group: Other Antibiotic for topical use ATC code: S01AA13
Fucithalmic is active against a wide range of Gram positive organisms, particularly staphylococci. Cross allergy between fusidic acid and other antibiotics has not been reported.
The formulation of Fucithalmic ensures a prolonged contact with the conjunctival sac. Fusidic acid penetrates into aqueous humour.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Benzalkonium chloride Disodium edetate Mannitol
Carbomer
Sodium hydroxide (for pH adjustment)
Water for injections
Not applicable.
Do not store above 30°C. Keep cap tightly closed.
Polyethylene laminated aluminium tube, with a HDPE cap, containing 5g and 3g of eye drops suspension.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
