ЦЕФУРОКСИМ 250 мг Фильм-coated таблетки
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Инструкция по применению KEFUROXIMA MYLAN
Содержание инструкции
Cefuroxima Mylan 250 mg film-coated tablets
Cefuroxima Mylan 500 mg film-coated tablets
Generic medicine
Read this leaflet carefully before you start to take this medicine because
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 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. See section 4.
Contents of this leaflet:
- 1. What Cefuroxima Mylan is and what it is used for
- 2. What you need to know before you take Cefuroxima Mylan
- 3. How to take Cefuroxima Mylan
- 4. Possible side effects
- 5. How to store Cefuroxima Mylan
- 6. Contents of the pack and other information
1. What is Cefuroxima Mylan and what it is used for
Cefuroxima Mylan 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 Mylan is used to treat infections:
- of the throat
- of the nasal sinuses
- of the middle ear
- of the lungs and chest
- of the urinary tract
- of the skin and the tissue around organs and bones (this is called soft tissue).
Cefuroxima Mylan can also be used to:
- treat Lyme disease (a disease spread by parasites called ticks).
The doctor may check the type of bacteria that cause the infection and check if the bacteria are
sensitive to Cefuroxima Mylan during treatment.
2. What you need to know before taking Cefuroxima Mylan
Do not take Cefuroxima Mylan:
- if you are allergic to cefuroxime axetil or to any antibiotic of the cephalosporin class or to any of the other components of this medicine (listed in section 6).
- if you have developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after treatment with cefuroxime or with any other antibiotic of the cephalosporin class.
- if you have had a severe allergic reaction (hypersensitivity) to any of the other types of beta-lactam antibiotics (penicillins, monobactams and carbapenems).
- if you think this applies to you, do not take Cefuroxima Mylan before consulting your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cefuroxima Mylan.
Pay particular attention with Cefuroxima Mylan
Serious skin reactions have been reported in association with cefuroxime treatment, which
include Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with
eosinophilia and systemic symptoms (DRESS). Contact your doctor immediately if you notice any
of the symptoms related to these serious skin reactions described in section 4.
Children and adolescents
Cefuroxima Mylan is not recommended for children under 3 months of age, as 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 Mylan. 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 Mylan 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 sample that you are taking Cefuroxima Mylan.
Other medicines and Cefuroxima Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
- Medicines used to reduce the amount of acid in the stomach (e.g. antacids used to treat heartburn) may affect the activity of Cefuroxima Mylan.
- Probenecid (used to treat gout).
- Oral anticoagulants (e.g. warfarin).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you
are breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Driving and operating machinery
Cefuroxima Mylan may cause dizziness and have other side effects that reduce
vigilance. Do not drive or operate machinery if you do not feel well.
Cefuroxima Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
essentially “sodium-free”.
3. How to take Cefuroxima Mylan
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. Take Cefuroxima Mylan after a meal. This will help to make the treatment more effective. Swallow the Cefuroxima Mylan tablets with a little water. Do not chew, break or divide the tablets – this could decrease the effectiveness of the treatment. Other formulations more suitable are available, for example, oral suspension for patients who are unable to swallow the tablets.
The recommended dose of Cefuroxima Mylan is 250 mg - 500 mg twice a day depending on the severity and type of infection.
Use in children and adolescents
The recommended dose of Cefuroxima Mylan is 10 mg/kg (up to a maximum of 125 mg) – 15 mg/kg (up to a maximum of 250 mg) twice a day depending on:
- the severity and type of infection.
Cefuroxima Mylan is not recommended for children under 3 months, as safety and efficacy are not known in this age group.
Depending on the disease or how your child responds to treatment, the initial dose may change or more than one treatment cycle may be necessary.
Patients with kidney problems
If you have kidney problems, your doctor may adjust the dose.
Tell your doctor if this applies to you.
If you take more Cefuroxima Mylan than you should
If you take too much Cefuroxima Mylan, you may experience neurological disorders, in particular you are more likely to have seizures (fits).
- Do not wait. Contact your doctor or the emergency room of the nearest hospital immediately. If possible, show them the Cefuroxima Mylan box.
If you forget to take Cefuroxima Mylan
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 Mylan
Do not stop treatment with Cefuroxima Mylan without recommendation.
It is important to complete the entire treatment with Cefuroxima Mylan. Do not stop treatment unless your doctor has advised you to, even if you feel better. If you do not complete the entire treatment cycle, 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 everybody gets them.
Conditions for which you should pay attention
A small number of people treated with Cefuroxima Mylan experience an allergic reaction or a potentially serious skin reaction. The symptoms of these reactions include:
- severe allergic reaction. Signs include raised, 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).
- widespread rash, high body temperature, enlarged lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).
- chest painin the context of allergic reactions, which may be a symptom of a heart attack caused by an allergy (Kounis syndrome)
Other conditions for which you should pay attention during the use of Cefuroxima Mylan include:
- fungal infections. Medicines like Cefuroxima Mylan 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 Mylan for a long time.
- severe diarrhea (pseudomembranous colitis). Medicines like Cefuroxima Mylan can cause inflammation of the colon (large intestine) that causes severe diarrhea usually with blood and mucus, stomach pain, and fever.
- Jarisch-Herxheimer reaction.Some patients may experience high temperature (fever), chills, headache, muscle pain, and rash during treatment with Cefuroxima Mylan for Lyme disease. This is known as the Jarisch-Herxheimer reaction. Symptoms usually last for a few hours or up to a day.
Contact your doctor or nurse immediately if you experience any of these symptoms.
Other possible side effects
Common side effects (may affect up to 1 in 10 people)
- fungal infections (such as Candida)
- headache
- dizziness
- diarrhea
- feeling unwell
- stomach pain.
Common side effects that can be highlighted in blood tests:
- an increase in a type of white blood cells (eosinophilia)
- an increase in enzymes produced by the liver.
Uncommon side effects (may affect up to 1 in 100 people)
- feeling unwell
- skin rashes.
Uncommon side 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.
Not known: (frequency cannot be estimated based on available data)
- severe diarrhea (pseudomembranous colitis)
- allergic reactions
- skin reactions (also serious)
- high temperature (fever)
- yellowing of the whites of the eyes or skin
- inflammation of the liver (hepatitis).
Side effects that can be detected by blood tests:
- too fast destruction of red blood cells (hemolytic anemia).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://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 Mylan
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 box and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 Mylan contains
Cefuroxima Mylan 250 mg film-coated tablets contain 250 mg of cefuroxime (as
cefuroxime axetil)
Cefuroxima Mylan 500 mg film-coated tablets contain 500 mg of cefuroxime (as
cefuroxime axetil)
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate
(E487), anhydrous colloidal silica, hydrogenated vegetable oil, hypromellose, titanium dioxide (E171),
macrogol
Description of the appearance of Cefuroxima Mylan and package contents
Cefuroxima Mylan 250 mg film-coated tablets: white to off-white tablets,
film-coated, capsule-shaped (approximately 16.1 mm x 6.6 mm) with “A 33” imprinted on one side
and smooth on the other side.
Cefuroxima Mylan 250 mg film-coated tablets are available in blisters of 8, 10, 12,
14 and 16 tablets.
Cefuroxima Mylan 500 mg film-coated tablets: white to off-white tablets,
film-coated capsule-shaped (approximately 20.1 mm x 8.6 mm) with “A 34”
imprinted on one side and smooth on the other side.
Cefuroxima Mylan 500 mg film-coated tablets are available in blisters of 6, 10, 14,
16 and 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Manufacturer
McDermott Laboratories operating as Gerard Laboratories operating as Mylan Dublin
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Member StateMedicinal Product Name
Italy Cefuroxima Mylan
Netherlands Cefuroxim Mylan 250 mg, 500 mg, filmomhulde tabletten
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- Страна регистрации
- Форма выпускаFilm-coated tablet, 250 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 MYLANФорма 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: Coated tablet, 125 MGДействующее вещество: ЦефуроксимПроизводитель: SANDOZ S.P.A.Отпускается по рецепту
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