ZINNAT SUSPENSION 125MG/5ML
Active substance: CEFUROXIME AXETIL
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Package leaflet: Information for the patient
cefuroxime
Suspension 125 mg/5 ml
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1 What Zinnat is and what it is used for 2 Before you take Zinnat 3 How to take Zinnat 4 Possible side effects 5 How to store Zinnat 6 Further information
3 How to take Zinnat
Always take Zinnat exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. When taking Zinnat Swallow the suspension after a meal. Shake the bottle well before each dose. Zinnat may be diluted in cold fruit juices or milk drinks but should be taken immediately. Do not mix Zinnat with hot liquids. Space the doses evenly during the day. Treatment is usually continued for 7 days unless otherwise stated. If you still feel unwell after the treatment has ended you should go back to see the doctor The usual dose is: Adults, elderly patients and children over 12 years Most infections: 250 mg (two 5 ml spoonfuls) twice a day. Mild to moderate bronchitis or chest infections: 250 mg (two 5 ml spoonfuls) twice a day. Chronic bronchitis: Treatment for chronic bronchitis will start with 750 mg injections twice a day for 48 to 72 hours of another medicine, Zinacef, which contains cefuroxime sodium. After this, the dose of Zinnat will be 500 mg (four 5 ml spoonfuls) twice a day for 5 to 7 days. The duration of treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment. Severe chest infections or pneumonia: Treatment for pneumonia will start with 1.5 g injections twice a day for 48 to 72 hours of another medicine, Zinacef, which contains cefuroxime sodium. After this the dose of Zinnat will be 500 mg (four 5 ml spoonfuls) twice a day for 7 days. The duration of treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment. Urinary tract (water) infections: 125 mg (one 5 ml spoonful) twice a day. Kidney infections: 250 mg (two 5 ml spoonfuls) twice a day. Gonorrhoea (a sexually transmitted disease): a single 1 g dose (eight 5 ml spoonfuls). Lyme disease (an infection spread by infected ticks): 500 mg (four 5 ml spoonfuls) twice a day for 20 days. Children under 12 years Most infections: 125 mg (one 5 ml spoonful) twice a day. Alternatively your doctor may prescribe 10 mg per kilogram of the childs body weight to a maximum of 250 mg per day. In babies and children from 3 months of age to under 2 years, for severe or recurrent ear infections: 125 mg (one 5 ml spoonful) twice a day. Alternatively your doctor may prescribe 10 mg per kilogram of the baby or childs body weight to a maximum of 250 mg per day. In children over 2 years, for severe or recurrent ear infections: 250 mg (two 5 ml spoonfuls) twice a day. Alternatively your doctor may prescribe 15 mg per kilogram of the baby or childs body weight to a maximum of 500 mg per day. Kidney problems If you have kidney problems your dosing will be the same as given above unless you need more than 1 g (eight 5 ml spoonfuls) each day. If you take too much Zinnat If you have too much Zinnat, signs might include fits (convulsions). Talk to your doctor as soon as possible. Take the medicine bottle to show the doctor. If you forget to take Zinnat If you forget to take a dose dont worry, take it as soon as you remember, then go on as before. If you stop taking Zinnat Keep taking Zinnat until the treatment is finished, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
1 What Zinnat is and what it is used for
What Zinnat is Zinnat Suspension 125 mg/5 ml (called Zinnat in this leaflet) is a cephalosporin antibiotic. The suspension contains a medicine called cefuroxime (present as cefuroxime axetil). What Zinnat is used for Zinnat is used to treat infections in different parts of the body caused by bacteria.
2 Before you take Zinnat
Do not take Zinnat if you: are allergic (hypersensitive) to cefuroxime, cefuroxime axetil, cephalosporin antibiotics or any of the other ingredients of Zinnat (listed in section 6) have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash or swelling of the face or neck Do not take Zinnat if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Zinnat. Having urine or blood tests If you are having tests on your water (urine glucose tests) or blood tests for liver function or a Coombs or rhesus test (red blood cell status test), let the doctor or nurse know that you are on Zinnat. This is because Zinnat can affect the results of these tests. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that can be bought without a prescription and herbal medicines. This is because Zinnat can affect the way some other medicines work. Also some other medicines can affect the way Zinnat works. Zinnat may stop the contraceptive pill working. You will need to use extra contraceptive precautions such as using a condom. If you need any advice, talk to your doctor or pharmacist. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine if you think you might be or if you are pregnant or if you are breast-feeding. Driving and using machines Zinnat may cause dizziness. If you feel affected you should not drive, operate machinery or take part in activities where you may put yourself or others at risk. Important information about some of the ingredients of Zinnat Zinnat contains 3.062 g sucrose per 5 ml of suspension. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. This should also be taken into account if you have diabetes. Zinnat contains aspartame (E951) which is a source of phenylalanine. This may be harmful for people born with a condition called phenylketonuria. This medicine contains 4.08 mg of potassium per 5 ml of suspension (from the ingredient acesulfame potassium). This should be considered if you have kidney problems or are on a controlled potassium diet.
4 Possible side effects
Like all medicines, Zinnat can cause side effects, although not everybody gets them. The side effects below may happen with this medicine: Stop taking Zinnat and see a doctor straight away, if you notice any of the following serious side effects you may need urgent medical treatment: The following are very rare (affects less than 1 in 10,000 people) allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems a delayed allergic reaction can occur usually 7 to 12 days after having Zinnat, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms a skin reaction known as erythema multiforme where you may develop: itchy reddish-purple patches on the skin especially on the palms of the hands or the soles of the feet, hive-like raised swollen areas on the skin, tender areas of the surfaces of the mouth, eyes and private parts. You may have a fever and be very tired other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itch, scaling. These may be associated with fever, headaches and body aches serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get: - severe diarrhoea with bleeding - blisters, redness or bruising of the skin - darker urine or paler stools - yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice. The following is rare (affects less than 1 in 1,000 people) inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever. The following is uncommon (affects less than 1 in 100 people) high temperature (fever), chills, a sore throat or other signs of an infection or if they bruise more easily. These may be signs of a problem with your blood cells. If any of the above happens stop taking the medicine and see your doctor straight away. Sometimes you may get less severe skin reactions such as: a mildly itchy rash (round, pink-red patches), hive-like swollen areas on forearms, legs, palms, hands, or feet. This is rare (affects less than 1 in 1,000 people). If you have any of these talk to your doctor as Zinnat will need to be stopped. The other possible side effects are: Common (affects less than 1 in 10 people) thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist changes to your white blood cells (eosinophilia) headache dizziness feeling sick (nausea) diarrhoea stomach pain increased liver function tests (usually detected by a blood test). Uncommon (affects less than 1 in 100 people) skin rashes sickness (vomiting) false positive red blood cell status tests (Coombs or rhesus test) the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself. Rare (affects less than 1 in 1,000 people) itching. Very rare (affects less than 1 in 10,000 people) a fever associated with an allergic reaction which disappears on discontinuation an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes kidney disease. If any of the side effects get serious, or if you have any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 How to store Zinnat
Keep out of the reach and sight of children. The expiry date which is stated on the bottle label refers to the expiry date of the granules prior to making up as a suspension. The pharmacist will have made up the suspension with water according to the label. The suspension should be stored in a fridge at all times when not taking the medicine. Do not allow it to freeze. It can be kept in the fridge for up to 10 days. Do not use Zinnat if it shows any sign of deterioration. 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.
6 Further information
What Zinnat contains The active substance is 125 mg per 5 ml of cefuroxime (present as cefuroxime axetil). The other ingredients are aspartame (E951), xanthan gum, acesulfame potassium, Povidone K30, stearic acid, sucrose, tutti fruitti flavour and purified water. See section 2 for further important information about some of the ingredients of Zinnat. What Zinnat looks like and contents of the pack Zinnat Suspension 125 mg/5 ml is supplied in an amber, glass, multidose bottle. The bottle contains 70 ml of suspension. Your pharmacist will have made this up with water using the original granules that were supplied in the bottle. The bottle is contained within a carton. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex. UB11 1BT Manufacturer: Glaxo Wellcome Operations, Harmire Road, Barnard Castle, Co Durham. DL12 8DT Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information: Product name Zinnat Suspension 125 mg/5 ml Reference number 10949/0094 This is a service provided by the Royal National Institute of Blind People. Leaflet Date: November 2007 Zinnat and Zinacef are registered trademarks of the GlaxoSmithKline group of companies 2007 GlaxoSmithKline group of companies
cefuroxime
Suspension 125 mg/5 ml
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1 What Zinnat is and what it is used for 2 Before you take Zinnat 3 How to take Zinnat 4 Possible side effects 5 How to store Zinnat 6 Further information
3 How to take Zinnat
Always take Zinnat exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. When taking Zinnat Swallow the suspension after a meal. Shake the bottle well before each dose. Zinnat may be diluted in cold fruit juices or milk drinks but should be taken immediately. Do not mix Zinnat with hot liquids. Space the doses evenly during the day. Treatment is usually continued for 7 days unless otherwise stated. If you still feel unwell after the treatment has ended you should go back to see the doctor The usual dose is: Adults, elderly patients and children over 12 years Most infections: 250 mg (two 5 ml spoonfuls) twice a day. Mild to moderate bronchitis or chest infections: 250 mg (two 5 ml spoonfuls) twice a day. Chronic bronchitis: Treatment for chronic bronchitis will start with 750 mg injections twice a day for 48 to 72 hours of another medicine, Zinacef, which contains cefuroxime sodium. After this, the dose of Zinnat will be 500 mg (four 5 ml spoonfuls) twice a day for 5 to 7 days. The duration of treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment. Severe chest infections or pneumonia: Treatment for pneumonia will start with 1.5 g injections twice a day for 48 to 72 hours of another medicine, Zinacef, which contains cefuroxime sodium. After this the dose of Zinnat will be 500 mg (four 5 ml spoonfuls) twice a day for 7 days. The duration of treatment with Zinacef or Zinnat will depend on how severe your infection is and how well you are responding to the treatment. Urinary tract (water) infections: 125 mg (one 5 ml spoonful) twice a day. Kidney infections: 250 mg (two 5 ml spoonfuls) twice a day. Gonorrhoea (a sexually transmitted disease): a single 1 g dose (eight 5 ml spoonfuls). Lyme disease (an infection spread by infected ticks): 500 mg (four 5 ml spoonfuls) twice a day for 20 days. Children under 12 years Most infections: 125 mg (one 5 ml spoonful) twice a day. Alternatively your doctor may prescribe 10 mg per kilogram of the childs body weight to a maximum of 250 mg per day. In babies and children from 3 months of age to under 2 years, for severe or recurrent ear infections: 125 mg (one 5 ml spoonful) twice a day. Alternatively your doctor may prescribe 10 mg per kilogram of the baby or childs body weight to a maximum of 250 mg per day. In children over 2 years, for severe or recurrent ear infections: 250 mg (two 5 ml spoonfuls) twice a day. Alternatively your doctor may prescribe 15 mg per kilogram of the baby or childs body weight to a maximum of 500 mg per day. Kidney problems If you have kidney problems your dosing will be the same as given above unless you need more than 1 g (eight 5 ml spoonfuls) each day. If you take too much Zinnat If you have too much Zinnat, signs might include fits (convulsions). Talk to your doctor as soon as possible. Take the medicine bottle to show the doctor. If you forget to take Zinnat If you forget to take a dose dont worry, take it as soon as you remember, then go on as before. If you stop taking Zinnat Keep taking Zinnat until the treatment is finished, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
1 What Zinnat is and what it is used for
What Zinnat is Zinnat Suspension 125 mg/5 ml (called Zinnat in this leaflet) is a cephalosporin antibiotic. The suspension contains a medicine called cefuroxime (present as cefuroxime axetil). What Zinnat is used for Zinnat is used to treat infections in different parts of the body caused by bacteria.
2 Before you take Zinnat
Do not take Zinnat if you: are allergic (hypersensitive) to cefuroxime, cefuroxime axetil, cephalosporin antibiotics or any of the other ingredients of Zinnat (listed in section 6) have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash or swelling of the face or neck Do not take Zinnat if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Zinnat. Having urine or blood tests If you are having tests on your water (urine glucose tests) or blood tests for liver function or a Coombs or rhesus test (red blood cell status test), let the doctor or nurse know that you are on Zinnat. This is because Zinnat can affect the results of these tests. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that can be bought without a prescription and herbal medicines. This is because Zinnat can affect the way some other medicines work. Also some other medicines can affect the way Zinnat works. Zinnat may stop the contraceptive pill working. You will need to use extra contraceptive precautions such as using a condom. If you need any advice, talk to your doctor or pharmacist. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine if you think you might be or if you are pregnant or if you are breast-feeding. Driving and using machines Zinnat may cause dizziness. If you feel affected you should not drive, operate machinery or take part in activities where you may put yourself or others at risk. Important information about some of the ingredients of Zinnat Zinnat contains 3.062 g sucrose per 5 ml of suspension. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine. This should also be taken into account if you have diabetes. Zinnat contains aspartame (E951) which is a source of phenylalanine. This may be harmful for people born with a condition called phenylketonuria. This medicine contains 4.08 mg of potassium per 5 ml of suspension (from the ingredient acesulfame potassium). This should be considered if you have kidney problems or are on a controlled potassium diet.
4 Possible side effects
Like all medicines, Zinnat can cause side effects, although not everybody gets them. The side effects below may happen with this medicine: Stop taking Zinnat and see a doctor straight away, if you notice any of the following serious side effects you may need urgent medical treatment: The following are very rare (affects less than 1 in 10,000 people) allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems a delayed allergic reaction can occur usually 7 to 12 days after having Zinnat, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms a skin reaction known as erythema multiforme where you may develop: itchy reddish-purple patches on the skin especially on the palms of the hands or the soles of the feet, hive-like raised swollen areas on the skin, tender areas of the surfaces of the mouth, eyes and private parts. You may have a fever and be very tired other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itch, scaling. These may be associated with fever, headaches and body aches serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get: - severe diarrhoea with bleeding - blisters, redness or bruising of the skin - darker urine or paler stools - yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice. The following is rare (affects less than 1 in 1,000 people) inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever. The following is uncommon (affects less than 1 in 100 people) high temperature (fever), chills, a sore throat or other signs of an infection or if they bruise more easily. These may be signs of a problem with your blood cells. If any of the above happens stop taking the medicine and see your doctor straight away. Sometimes you may get less severe skin reactions such as: a mildly itchy rash (round, pink-red patches), hive-like swollen areas on forearms, legs, palms, hands, or feet. This is rare (affects less than 1 in 1,000 people). If you have any of these talk to your doctor as Zinnat will need to be stopped. The other possible side effects are: Common (affects less than 1 in 10 people) thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist changes to your white blood cells (eosinophilia) headache dizziness feeling sick (nausea) diarrhoea stomach pain increased liver function tests (usually detected by a blood test). Uncommon (affects less than 1 in 100 people) skin rashes sickness (vomiting) false positive red blood cell status tests (Coombs or rhesus test) the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself. Rare (affects less than 1 in 1,000 people) itching. Very rare (affects less than 1 in 10,000 people) a fever associated with an allergic reaction which disappears on discontinuation an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes kidney disease. If any of the side effects get serious, or if you have any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 How to store Zinnat
Keep out of the reach and sight of children. The expiry date which is stated on the bottle label refers to the expiry date of the granules prior to making up as a suspension. The pharmacist will have made up the suspension with water according to the label. The suspension should be stored in a fridge at all times when not taking the medicine. Do not allow it to freeze. It can be kept in the fridge for up to 10 days. Do not use Zinnat if it shows any sign of deterioration. 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.
6 Further information
What Zinnat contains The active substance is 125 mg per 5 ml of cefuroxime (present as cefuroxime axetil). The other ingredients are aspartame (E951), xanthan gum, acesulfame potassium, Povidone K30, stearic acid, sucrose, tutti fruitti flavour and purified water. See section 2 for further important information about some of the ingredients of Zinnat. What Zinnat looks like and contents of the pack Zinnat Suspension 125 mg/5 ml is supplied in an amber, glass, multidose bottle. The bottle contains 70 ml of suspension. Your pharmacist will have made this up with water using the original granules that were supplied in the bottle. The bottle is contained within a carton. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex. UB11 1BT Manufacturer: Glaxo Wellcome Operations, Harmire Road, Barnard Castle, Co Durham. DL12 8DT Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information: Product name Zinnat Suspension 125 mg/5 ml Reference number 10949/0094 This is a service provided by the Royal National Institute of Blind People. Leaflet Date: November 2007 Zinnat and Zinacef are registered trademarks of the GlaxoSmithKline group of companies 2007 GlaxoSmithKline group of companies
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.
