CEFUROXIMA 125 mg Коированная Таблетка
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Инструкция по применению KEFUROXIMA SANDOTS
Содержание инструкции
- Cefuroxima Sandoz 125 mg coated tablets, 250 mg coated tablets, 500 mg coated tablets
- Cefuroxima Sandoz for Lyme disease. This is known as a Jarisch-
Cefuroxima Sandoz 125 mg coated tablets, 250 mg coated tablets, 500 mg coated tablets
Generic medicine
Read this leaflet carefully before taking 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 or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, or pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Cefuroxima Sandoz is and what it is used for
- 2. What you need to know before you take Cefuroxima Sandoz
- 3. How to take Cefuroxima Sandoz
- 4. Possible side effects
- 5. How to store Cefuroxima Sandoz
- 6. Contents of the pack and other information
1. What is Cefuroxima Sandoz and what is it used for
Cefuroxima Sandoz is an antibiotic used in adults and children. It works by killing the bacteria
that cause infections and belongs to a group of medicines called cephalosporins.
Cefuroxima Sandoz is used to treat infections:
- of the throat
- of the nasal sinuses
- of the middle ear
- of the lungs or chest
- of the urinary tract
- of the skin and soft tissues
Cefuroxima Sandoz can also be used:
- to treat Lyme disease (a disease spread by parasites called ticks).
2. What you need to know before taking Cefuroxima Sandoz
Do not take Cefuroxima Sandoz:
- if you are allergic to cefuroxime,to any antibiotic of the cephalosporin classor to any of the other ingredients of this medicine (listed in section 6).
- if you have had a severe allergic reaction (hypersensitivity) to any other types of beta-lactam antibiotics (penicillins, monobactams and carbapenems). If you think this applies to you, do not take Cefuroxima Sandozbefore consulting your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cefuroxima Sandoz.
Cefuroxima Sandoz is not recommended in children under 3 months of ageas
safety and efficacy are not known in this age group.
Pay attention to some symptoms such as allergic reactions, fungal infections (such as Candida) and
severe diarrhea (pseudomembranous colitis)while taking Cefuroxima Sandoz. This will reduce the
risk of any problems. See ‘Conditions for which you should be careful’ in section
- 4.
If you need blood tests
Cefuroxima Sandoz may interfere with the results of tests for blood sugar levels, or
with a blood test known as the Coombs' test. If you need blood tests:
Tell the person taking the samplethat you are taking Cefuroxima Sandoz.
Other medicines and Cefuroxima Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines available without a prescription.
Medicines used to reduce the amount of acid in the stomach(e.g. antacidsused for
treating heartburn) can affect the activity of Cefuroxima Sandoz.
Probenecid
Oral anticoagulants
Tell your doctor or pharmacistif you are taking any of these medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant, or are
planning a pregnancy, ask your doctor or pharmacist for advice before taking this
medicine.
The doctor will assess the benefit of treatment with Cefuroxima Sandoz against the risk to the
child.
Driving and operating machinery
Cefuroxima Sandoz may cause dizzinessand have other side effects that reduce alertness.
Do not drive or operate machineryif you do not feel well.
Cefuroxima Sandoz coated tablets contains aspartame and sodium.
125 mg:coated tablets contains 0.2 mg of aspartame.
250 mg:coated tablets contains 0.3 mg of aspartame.
500 mg:coated tablets contains 0.4 mg of aspartame.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a
rare genetic disorder that causes a build-up of phenylalanine because the body cannot break it
down properly.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e.
essentially ‘sodium-free’.
3. How to take Cefuroxima Sandoz
Take Cefuroxima Sandoz following the instructions of your doctor or pharmacist exactly as given. If you have doubts, consult your doctor or pharmacist.
Take Cefuroxima Sandoz after meals.This will help to make the treatment more effective. Swallow Cefuroxima Sandoz tablets with water.
Do not chew, crush, or divide the tablets -this could make the tablets difficult to swallow and the treatment less effective.
The recommended dose is:
Adults
The appropriate dose of Cefuroxima Sandoz is from 250 mg to 500 mg twice a day and depends on the severity and type of infection.
Use in children and adolescents
The appropriate dose of Cefuroxima Sandoz is from 10 mg/kg (up to a maximum of 125 mg) to 15 mg/kg (up to a maximum of 250 mg) twice a day and depends on: the severity and type of infection.
Cefuroxima Sandoz is not recommended in children under 3 months of agesince safety and efficacy are not known in this age group. Depending on the illness or how you or your child respond to treatment, the initial dose may be modified or more than one treatment cycle may be necessary.
Patients with kidney problems
If you have kidney problems, your doctor may adjust the dose.
Talk to your doctorif this applies to you.
If you take more Cefuroxima Sandoz than you should
If you take too much Cefuroxima Sandoz, you may experience neurological disorders, in particular you are more likely to have seizures.
Do not wait. Contact your doctor or the emergency room of the nearest hospital immediately.If possible, show them the Cefuroxima Sandoz packaging.
If you forget to take Cefuroxima Sandoz
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you stop taking Cefuroxima Sandoz
Do not stop Cefuroxima Sandoz without advice.
It is important to complete the entire course of treatment with Cefuroxima Sandoz. Do not stop unless your doctor has advised you to, even if you feel better. If you do not complete the entire course of treatment, the infection may return.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Conditions for which attention is required
A small number of people treated with Cefuroxima Sandoz may experience an allergic reaction or a potentially serious skin reaction. The symptoms of these reactions include:
- severe allergic reaction.Signs include raised and itchy rash, swelling, sometimes on the face or mouth causing difficulty breathing.
- skin rashwith the formation of blistersresembling small targets(a dark spot in the center surrounded by a clear area with a black ring around the edge).
- widespread rashwith blistersand skin peeling. (These may be signs of Stevens-Johnson syndromeor toxic epidermal necrolysis).
- fungal infections.Medicines like Cefuroxima Sandoz can cause an overgrowth of fungi (Candida)in the body, which can lead to fungal infections (such as thrush). This side effect is more likely if you take Cefuroxima Sandoz for a long time.
- severe diarrhea(pseudomembranous colitis).Medicines like Cefuroxima Sandoz can cause inflammation of the colon (large intestine) causing severe diarrhea generally with blood and mucus, stomach pain, and fever.
- Jarisch-Herxheimer reaction.Some patients may experience high temperature (fever), chills, headache, muscle aches, and rash during treatment with
Cefuroxima Sandoz for Lyme disease. This is known as a Jarisch-
Herxheimerreaction. The symptoms usually last for a few hours or up to one day.
Contact your doctor or nurse immediately if you experience any of these symptoms.
Common undesirable effects
These may affect up to 1patient out of 10:
- fungal infections (such as Candida)
- headache
- dizziness
- diarrhoea
- nausea
- stomach pain. Common undesirable effects that can be detected by blood tests:
- an increase in a type of white blood cells (eosinophilia)
- an increase in enzymes produced by the liver.
Uncommon undesirable effects
These may affect up to 1patient out of 100:
- vomiting
- skin rashes. Uncommon undesirable effects that can be detected by blood tests:
- a decrease in the number of platelets in the blood (cells that help blood clotting)
- a decrease in the number of white blood cells
- positive Coombs test.
Other undesirable effects
Other undesirable effects have occurred in a very small number of people, but their exact
frequency is unknown:
- severe diarrhoea (pseudomembranous colitis)
- allergic reactions
- skin reactions (also severe) high temperature (fever)
- yellowing of the whites of the eyes or skin
- inflammation of the liver (hepatitis).Undesirable effects that can be detected by blood tests:
- too fast destruction of red blood cells (hemolytic anemia).
Reporting of undesirable effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse.
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 Cefuroxima Sandoz
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 label and on the packaging after
Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
This medicine does not require any particular storage temperature.
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. Package Contents and Other Information
What Cefuroxima Sandoz coated tablets contain
- The active ingredient is: Cefuroxima. Cefuroxima Sandoz 125 mg contains 150.36 mg of acetoxyethylcefuroxima per coated tablet, equivalent to 125 mg of cefuroxima. Cefuroxima Sandoz 250 mg contains 300.72 mg of acetoxyethylcefuroxima per coated tablet, equivalent to 250 mg of cefuroxima. Cefuroxima Sandoz 500 mg contains 601.44 mg of acetoxyethylcefuroxima per coated tablet (equivalent to 500 mg of cefuroxima).
- The other ingredients (excipients) are: sodium lauryl sulfate, copovidone, sodium croscarmellose (E468), magnesium stearate (E470B), anhydrous colloidal silica (E551), mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202) and talc (E553B), mannitol (E421), soluble starch (potato), titanium dioxide (E171) and aspartame (E951).
Description of the appearance of Cefuroxima Sandoz and package contents
Cefuroxima Sandoz tablets are coated.
Cefuroxima Sandoz 125 mg are tablets of colour from white to slightly yellowish,
biconvex, oblong.
Cefuroxima Sandoz 250 mg are tablets of colour from white to slightly yellowish,
biconvex, oblong, divisible on both sides.
Cefuroxima Sandoz 500 mg are tablets of colour from white to slightly yellowish,
biconvex, oblong.
Cefuroxima Sandoz 125 mg and 250 mg coated tablets are available in cardboard boxes
containing blister packs or strips of 8, 10, 12, 14 and 24 coated tablets.
Cefuroxima Sandoz 500 mg coated tablets are available in cardboard boxes with blister packs or strips of
6, 8, 10, 12, 14 and 24 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturer responsible for batch release
Sandoz GmbH - Biochemiestrasse 10 - 6250 Kundl – Austria
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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- Страна регистрации
- Форма выпускаCoated tablet, 125 MG
- Код АТХJ01DC02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги KEFUROXIMA SANDOTSФорма выпуска: Film-coated tablet, 250 MGДействующее вещество: ЦефуроксимПроизводитель: EG S.P.A.Отпускается по рецептуФорма выпуска: Powder for injectable solution, 750 MGДействующее вещество: ЦефуроксимПроизводитель: K24 PHARMACEUTICALS S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 250 MGДействующее вещество: ЦефуроксимПроизводитель: MYLAN S.P.A.Отпускается по рецепту
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Действующее вещество KEFUROXIMA SANDOTS — Цефуроксим. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KEFUROXIMA SANDOTS производится компанией SANDOZ S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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