FUCITHALMIC 10MG EYE DROPS
Active substance: FUSIDIC ACID
View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fucithalmic fusidic acid
Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet: 1. 2. 3. 4. 5. 6. What Fucithalmic is and what it is used for Before you use Fucithalmic How to use Fucithalmic Possible side effects How to store Fucithalmic Further information
1. WHAT FUCITHALMIC IS AND WHAT IT IS USED FOR
Fucithalmic belongs to a group of medicines called anti-infectives. It is a type of antibiotic. 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).
2. BEFORE YOU USE FUCITHALMIC
Do not use Fucithalmic If you are allergic (hypersensitive) to fusidic acid, or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet. Take special care with Fucithalmic Do not wear any type of contact lenses whilst using this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. Pregnancy and breast-feeding Please ask your doctor or pharmacist for advice before using Fucithalmic: 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.
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 1 of 4
Driving and using machines Following application of your medicine, a brief blurring of vision may occur. Do not drive or 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. Important information about some of the ingredients of Fucithalmic Fucithalmic contains: Benzalkonium chloride. This is a preservative. It may cause eye irritation. Please ask your doctor if you are worried about any of the ingredients in this medicine.
3.
HOW TO USE FUCITHALMIC
Always use Fucithalmic exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. How to use Fucithalmic 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. [DIAGRAM] 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. How much Fucithalmic to use Your doctor will tell you how many drops to use, or to give to your child. You should use your medicine twice each day. To remind you to use your medicine it may help to use it when you do another regular action, such as brushing your teeth. Adults, the elderly and children: The usual dose is one drop twice each day, in the morning and in the evening.
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 2 of 4
Taking all the course of Fucithalmic It is very important to use all the medicine that your doctor has told you to use. You must use your medicine for at least 48 hours after you feel better and your eye looks normal. You must do this because otherwise your eye infection may come back. What to do if you use more Fucithalmic than you should If you accidentally apply too many drops in the eye(s) or a small quantity of the drops are accidentally swallowed, it is unlikely to cause any harm. If a larger quantity of the drops are accidentally swallowed or you are worried contact your doctor, pharmacist or A+E department for advice. If you forget to use Fucithalmic If you forget to use your medicine, use it as soon as you remember. Then next use your medicine at the usual time. If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucithalmic can cause side effects, although not everybody gets them. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction: You have difficulty breathing Your face, especially around your eyes or your eyelids, or throat swell Your skin develops a severe rash You have burning or stinging in your eye that does not go away Other possible side effects: Common side effects (probably affect 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 less than 1 in 100 people) Watery eyes or crying on application Side effects where the number of people affected is not known: Itching Rash Hives Conjunctivitis may get worse If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE FUCITHALMIC
Keep out of the reach and the sight of children. Do not use the drops after the expiry date on the carton. The expiry date is the last day of that month.
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 3 of 4
Do not keep the tube for more than one month after you first open it. Store below 25C. Keep the tube tightly closed.
Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.
6. FURTHER INFORMATION
What Fucithalmic contains The active ingredient is fusidic acid. Fucithalmic contains 10 milligrams of fusidic acid in each gram of drops.
The other ingredients are benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injections.
You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What Fucithalmic looks like and contents of the pack Fucithalmic is a white to off-white, slightly thick liquid. Fucithalmic comes in tubes of 5 g. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LEO Laboratories Limited, Princes Risborough, Bucks., HP27 9RR, UK. Manufacturer: LEO Laboratories Limited, Dublin 12, Ireland. This leaflet was last revised in August 2011. This leaflet was last approved in August 2011.
Registered Trade Mark
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 4 of 4
Fucithalmic fusidic acid
Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet: 1. 2. 3. 4. 5. 6. What Fucithalmic is and what it is used for Before you use Fucithalmic How to use Fucithalmic Possible side effects How to store Fucithalmic Further information
1. WHAT FUCITHALMIC IS AND WHAT IT IS USED FOR
Fucithalmic belongs to a group of medicines called anti-infectives. It is a type of antibiotic. 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).
2. BEFORE YOU USE FUCITHALMIC
Do not use Fucithalmic If you are allergic (hypersensitive) to fusidic acid, or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet. Take special care with Fucithalmic Do not wear any type of contact lenses whilst using this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. Pregnancy and breast-feeding Please ask your doctor or pharmacist for advice before using Fucithalmic: 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.
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 1 of 4
Driving and using machines Following application of your medicine, a brief blurring of vision may occur. Do not drive or 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. Important information about some of the ingredients of Fucithalmic Fucithalmic contains: Benzalkonium chloride. This is a preservative. It may cause eye irritation. Please ask your doctor if you are worried about any of the ingredients in this medicine.
3.
HOW TO USE FUCITHALMIC
Always use Fucithalmic exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. How to use Fucithalmic 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. [DIAGRAM] 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. How much Fucithalmic to use Your doctor will tell you how many drops to use, or to give to your child. You should use your medicine twice each day. To remind you to use your medicine it may help to use it when you do another regular action, such as brushing your teeth. Adults, the elderly and children: The usual dose is one drop twice each day, in the morning and in the evening.
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 2 of 4
Taking all the course of Fucithalmic It is very important to use all the medicine that your doctor has told you to use. You must use your medicine for at least 48 hours after you feel better and your eye looks normal. You must do this because otherwise your eye infection may come back. What to do if you use more Fucithalmic than you should If you accidentally apply too many drops in the eye(s) or a small quantity of the drops are accidentally swallowed, it is unlikely to cause any harm. If a larger quantity of the drops are accidentally swallowed or you are worried contact your doctor, pharmacist or A+E department for advice. If you forget to use Fucithalmic If you forget to use your medicine, use it as soon as you remember. Then next use your medicine at the usual time. If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucithalmic can cause side effects, although not everybody gets them. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction: You have difficulty breathing Your face, especially around your eyes or your eyelids, or throat swell Your skin develops a severe rash You have burning or stinging in your eye that does not go away Other possible side effects: Common side effects (probably affect 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 less than 1 in 100 people) Watery eyes or crying on application Side effects where the number of people affected is not known: Itching Rash Hives Conjunctivitis may get worse If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE FUCITHALMIC
Keep out of the reach and the sight of children. Do not use the drops after the expiry date on the carton. The expiry date is the last day of that month.
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 3 of 4
Do not keep the tube for more than one month after you first open it. Store below 25C. Keep the tube tightly closed.
Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.
6. FURTHER INFORMATION
What Fucithalmic contains The active ingredient is fusidic acid. Fucithalmic contains 10 milligrams of fusidic acid in each gram of drops.
The other ingredients are benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injections.
You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What Fucithalmic looks like and contents of the pack Fucithalmic is a white to off-white, slightly thick liquid. Fucithalmic comes in tubes of 5 g. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LEO Laboratories Limited, Princes Risborough, Bucks., HP27 9RR, UK. Manufacturer: LEO Laboratories Limited, Dublin 12, Ireland. This leaflet was last revised in August 2011. This leaflet was last approved in August 2011.
Registered Trade Mark
Fucithalmic Tamper Evident Cap Variation Clean PIL 25.08.10
Page 4 of 4
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
