Інструкція із застосування KEFIXIMA MYLAN
Зміст інструкції
Cefixima Mylan 400 mg film-coated tablets
cefixima
Generic medicine
Read this leaflet carefully before you start taking 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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Cefixima Mylan is and what it is used for
- 2. What you need to know before you take Cefixima Mylan
- 3. How to take Cefixima Mylan
- 4. Possible side effects
- 5. How to store Cefixima Mylan
- 6. Contents of the pack and other information
1. What is Cefixima Mylan and what is it used for
The active substance contained in Cefixima Mylan is cefixime, an antibiotic belonging to the class of
third-generation cephalosporins. Cefixime works by causing the death of bacteria that cause
infection. It is indicated for the treatment of the following infections, when it is believed that the bacteria
responsible for these infections are sensitive to cefixime:
- Acute ear infection (acute otitis media);
- Bacterial infections of the nasal sinuses (sinusitis), throat (pharyngitis), or tonsils (tonsillitis);
- Bacterial infections in patients with long-term lung inflammation (acute exacerbation of chronic bronchitis);
- Pneumonia contracted outside the hospital (community-acquired pneumonia);
- Urinary tract infection, including the bladder or kidneys (uncomplicated urinary tract infections);
- Genital infections caused by the bacterium gonorrhoeae(uncomplicated acute gonorrhea).
2. What you need to know before taking Cefixima Mylan
Do not take Cefixima Mylan
- if you are allergic (hypersensitivity) to cefixime or to antibiotics of the penicillin class (beta-lactam antibiotics). In rare cases, a sudden and severe allergic reaction (anaphylactic reaction/anaphylactic shock) may occur, even with the first dose of this class of antibiotics. Symptoms may include chest tightness, dizziness, discomfort, lightheadedness or shortness of breath, and rash. If any of these symptoms occur, consult a doctor immediately and stop taking Cefixima Mylan;
- if you are allergic (hypersensitivity) to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cefixima Mylan.
Pay particular attention:
- if you suffer from kidney failure (the dose of Cefixima Mylan may need to be reduced);
- if you are already being treated with diuretics (e.g. furosemide) or other medicines that can cause kidney damage (e.g. aminoglycoside antibiotics);
- if you are pregnant or breastfeeding.
During intake, a certain type of anemia (hemolytic anemia) has been observed which in rare cases can
be fatal. If this anemia has already occurred during treatment with Cefixima Mylan, it may
lead to a recurrence of the disease.
Children
The safety of this medicine has not been established in newborns or children under the age of
12 years.
Other medicines and Cefixima Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, such as:
- some other antibiotics and diuretics, which can affect kidney function;
- anticoagulants in tablet form, your doctor may consider it necessary to perform more frequent control tests.
Cefixima Mylan with food and drink
The effect of cefixime is not affected by the simultaneous intake of food.
The tablets can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
There is insufficient information on the use of Cefixima Mylan in pregnant women and it is
not known whether Cefixima Mylan is excreted in human breast milk.
If treatment is necessary during pregnancy or breastfeeding, your doctor will assess and
discuss the benefits and risks.
If you are breastfeeding while taking Cefixima Mylan and the baby develops diarrhea or
Candida infection, talk to your doctor as soon as possible as you may need to
change treatment or you may have to stop breastfeeding.
Driving and using machines
There are no known cases of cefixime interfering with the ability to drive vehicles or operate
machinery.
3. How to take Cefixima Mylan
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Cefixima Mylan is for oral use. The tablets must be swallowed with a glass of water. The
score line is to facilitate breaking the tablet in case you have difficulty
swallowing it whole and to divide it into equal doses. It is recommended to take Cefixima Mylan every day
at about the same time.
The recommended dose is:
Adults or children over 12 years of age: 400 mg per day (1 tablet) in a single dose or
200 mg (half a tablet) every 12 hours.
For uncomplicated urinary tract infections, a dose of 200 mg (half a tablet) per day is effective.
The elderly can use the same dose as adults, unless they suffer from severe
renal impairment (in which case it is necessary to consult a doctor).
The duration of treatment varies depending on the type of infection to be treated. The doctor will tell you how long
to take this medicine. The treatment must be completed fully.
If you take more Cefixima Mylan than you should
If you take more Cefixima Mylan than you should, inform your doctor as soon as possible. Bring with you the
If you forget to take Cefixima Mylan
If you forget to take a dose, take it as soon as you remember on the same day. If you skip a
day, take the normal dose the next day. Do not take a double dose to make up for the
forgotten dose.
If you stop taking Cefixima Mylan
Continue to take Cefixima Mylan until the end of the treatment, even if you feel better. To
fight the infection it is necessary to take all prescribed doses. If some bacteria survive,
they may cause a new infection, which may recur or worsen (relapse).
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects common(may affect up to 1 in 10 people)
- Diarrhoea
Side effects uncommon(may affect up to 1 in 100 people)
- Headache
- Abdominal pain
- Discomfort (nausea)
- Vomiting
- Skin rash
- Abnormalities in liver function tests (increased transaminases and alkaline phosphatase)
Side effects rare(may affect up to 1 in 1,000):
- Bacterial superinfection
- Fungal superinfection
- Eosinophilia (increased number of eosinophils, a type of white blood cell)
- Hypersensitivity (allergic reactions)
- Reduced appetite (anorexia)
- Dizziness
- Flatulence (gas)
- Inflammation of the liver (hepatitis)
- Yellowing of the skin and eyes (jaundice)
- Drug reaction with eosinophilia and systemic symptoms (DRESS) (a serious reaction affecting the skin, blood and internal organs)
- Inflammation of the moist surfaces of the body (mucosa), such as the lining of the mouth and nose
- Fever
- Increased urea in the blood
Side effects very rare(may affect up to 1 in 10,000):
- Antibiotic-associated colitis (inflammation of the colon causing pain and diarrhoea)
- Hemolytic anemia (excessive breakdown of red blood cells causing fatigue and paleness)
- Anaphylactic shock (sudden and severe allergic reaction with difficulty breathing, swelling, mild confusion, rapid heartbeat, sweating and loss of consciousness)
- Rheumatoid arthritis (a disease with painful swelling and damage to the joints)
- Restlessness (psychomotor hyperactivity)
- Raised, red patches on the skin that can appear all over the body (erythema multiforme)
- Itching
- Life-threatening reaction with flu-like symptoms and painful rash affecting skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
- Life-threatening reaction with flu-like effects and blisters on skin, mouth, eyes and genitals (toxic epidermal necrolysis)
- Itchy rash (urticaria)
- Kidney inflammation (interstitial nephritis)
- Increased creatinine (a muscle breakdown product removed by the kidneys) in the blood
Reporting of side 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 Cefixima 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 pack after “Exp.”. The expiry
date refers to the last day of that month.
Store at a temperature below 25 C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Cefixima Mylan contains
- The active ingredient is cefixime. Each film-coated tablet contains 447.68 mg of cefixime trihydrate equivalent to 400 mg of cefixime.
- The other ingredients are: Tablet core: microcrystalline cellulose, dihydrated calcium hydrogen phosphate, pregelatinized starch, magnesium stearate.
Film coating:Opadry II white 85F18422, [poly(vinyl alcohol), titanium dioxide (E171),
macrogol (PM 3350, 4000 JP), talc], red iron oxide (E172), yellow iron oxide (E172).
Description of the appearance of Cefixima Mylan and contents of the pack
Cefixima Mylan 400 mg tablets are film-coated tablets, light brown
in colour, oval, biconvex and with a score line on both sides.
The tablets are packaged in PVC-aluminium blisters.
Packs of 5, 7 or 10 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy
Manufacturer
Medochemie Ltd Factory C
Michael Irakleous 2,
Agios Athanassios Industrial Area,
4101, Agios Athanassios, Limassol
Cyprus
This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Bulgaria Цефиксим Виатрис 400 mg филмирани таблетки
Cyprus Cefixime Viatris
Germany Cefixim Viatris 400 mg Filmtabletten
Italy Cefixima Mylan
Slovakia Cefixime Viatris 400 mg
[To be completed at national level]
- Країна реєстрації
- Лікарська формаFilm-coated tablet, 400 MG
- Код АТХJ01DD08
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до KEFIXIMA MYLANЛікарська форма: Film-coated tablet, 400 MGДіюча речовина: цефиксимВиробник: AUROBINDO PHARMA (ITALIA) S.R.L.Потрібен рецептЛікарська форма: Film-coated tablet, 400 MGДіюча речовина: цефиксимВиробник: DOC GENERICI SRLПотрібен рецептЛікарська форма: Film-coated tablet, 400 MGДіюча речовина: цефиксимВиробник: SANDOZ S.P.A.Потрібен рецепт
Аналоги KEFIXIMA MYLAN в інших країнах
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Часті запитання
KEFIXIMA MYLAN потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у KEFIXIMA MYLAN — цефиксим. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
KEFIXIMA MYLAN виробляється компанією MYLAN S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування KEFIXIMA MYLAN з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати KEFIXIMA MYLAN у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (цефиксим) включають KEFIXIMA AUROBINDO, KEFIXIMA DOK JENERIKI, KEFIXIMA SANDOTS. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















