Package leaflet: information for the user

Read all of 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 further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Cefixime is and what it is used for

2.    What you need to know before you take Cefixime

3.    How to take Cefixime

4.    Possible side effects

5.    How to store Cefixime

6.    Contents of the pack and other information

1.    What Cefixime is and what it is used for

Cefixime contains an active substance called cefixime. This belongs to a group of antibiotics called “cephalosporins”, which are used for treating infections caused by bacteria.

Cefixime is used in children above 6 months, adolescents and adults to treat:

•    infection of the middle ear,

•    infection causing sudden worsening of long-standing bronchitis,

•    uncomplicated acute infection of the bladder,

•    uncomplicated infection of the kidneys.

2.    What you need to know before you take Cefixime Do not take Cefixime:

•    if you are allergic to cefixime or to any of the other ingredients of this medicine (listed in section 6),

•    if you are allergic (hypersensitive) to any other cephalosporin type of antibiotic,

•    if you have ever had a severe allergic reaction to penicillin antibiotic or to any other beta-lactam type of antibiotic.

This medicine should not be administered to preterm newborns and new-borns.

Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Cefixime oral suspension.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Cefixime if:

•    you have ever had colitis,

•    you have kidney problems,

•    your child is under the age of 6 months.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Cefixime is not suitable for everyone.

Before you take Cefixime you should tell your doctor if you:

•    are allergic to penicillin antibiotics or to any other beta-lactam type of antibiotics. An allergic reaction may include rash, itching, difficulty in swallowing or breathing or swelling of the face, lips, throat and tongue. Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you should take special care if you ever had an allergic reaction to any penicillin. This is because you might also be allergic to this medicine.

In patients who develop severe allergic reaction or anaphylaxis (serous allergic reaction which causes difficulty in breathing or dizziness) after administration of Cefixime, the medicine should be discontinued and appropriate treatment should be given.

•    are taking other medicines which are known to be harmful to you kidneys. Also inform your doctor if you have any kidney problems. Your doctor may perform certain test regularly to measure how well your kidneys are working during the treatment.

•    have severe or persistent diarrhoea with stomach pain or cramps during or shortly after treatment with Cefixime, stop taking this medicine and contact your doctor immediately. Medicines which may slow or stop bowel movements must not be taken.

If you develop syndrome known as DRESS syndrome or Stevens-Johnson syndrome or skin reaction known as toxic epidermal necrolysis (see section 4. Possible side effects) while you are taking Cefixime, stop taking this medicine and contact your doctor immediately.

Having a course of Cefixime can temporarily increase the chance that you can get infections caused by other sort of germs on which Cefixime does not act. For example, thrush (infection caused by a yeast germ called Candida) may occur.

This medicine may cause vomiting and diarrhea (see section

4. Possible side effects). In such case, the efficacy of Cefixime and/ or other medicinal products taken by you (as the birth control pill) may be impaired.

Other medicines and Cefixime

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking:

•    medicines which are known to be harmful to your kidneys like:

-    antibiotics include aminoglycoside antibiotics, colistin, polymyxin and viomycin,

-    medicines that increase the amount of urine your body produces (diuretics) such as ethacrynic acid or furosemide.

•    nifedipine, a medicine used for the treatment of high blood pressure or heart problems,

•    anticoagulants (blood thinning medicines) such as warfarin in some patients. Cefixime causes problems with blood clothing and may increase the time taken for the blood to clot.

Effect on laboratory tests

If you are to undertake any blood or urine tests, inform your doctor that you are taking Cefixime, as cefixime can alter the results of some of these tests.

Cefixime can alter the results of some urine tests for sugar (such as Benedict's or Fehling's tests). If you have diabetes and routinely test for urine, tell your doctor. This is because other tests may have to be used to monitor your diabetes while you are having this medicine.

Cefixime can alter the results of some urine tests for ketones. Tell your doctor that you are taking Cefixime because other tests may have to be used.

Cefixime can alter the results of a blood test for antibodies called the direct Coomb's test.

Cefixime with food and drink

Cefixime may be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Cefixime does not usually affect your ability to drive and use machines.

Cefixime contains sucrose

This medicine contains 2.52 g of sucrose per 5 ml reconstituted suspension. This should be taken into account by patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars (fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency), contact your doctor before taking this medicinal product.

3. How to take Cefixime

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dose your doctor prescribes depends on the type of infection and how bad the infection is. It also depends on how well the kidneys are working. Your doctor or pharmacist will explane this to you.

The reconstituted suspension should be administered undiluted before or during a meal.

The usual dose is:

Adults

400 mg once daily (= 20 ml of the reconstituted suspension) as a single dose or 2 times daily 200 mg (= 10 ml) at intervals of 12 hours.

Elderly

No change in dose is needed for elderly patients, provided the kidneys are normal.

Adolescents 12 years of age and older

Adolescents 12 years of age and older may be given the same dose as adults.

Children under 12 years

Cefixime 8 mg / kg body weight / day, either as a single dose or two divided doses 12 hourly.

The dosing recommendations are given in the following table:

Body weight	Daily dose (ml) Once daily	Daily dose (ml) Twice daily	daily dose (mg)
6.0 kg-9 kg (for infants above 6 months)	1 x 2.5 ml	2 x 1.25 ml	50 mg
10.0 kg	4 ml	2 x 2 ml	80 mg
12.5 kg	5 ml	2 x 2.5 ml	100 mg
15.0 kg	6 ml	2 x 3 ml	120 mg
17.5 kg	7 ml	2 x 3.5 ml	140 mg
20.0 kg	8 ml	2 x 4 ml	160 mg
22.5 kg	9 ml	2 x 4.5 ml	180 mg
25.0 kg	10 ml	2 x 5 ml	200 mg
27.5 kg	11 ml	2 x 5.5 ml	220 mg
30.0 kg	12 ml	2 x 6 ml	240 mg
37.5 kg	15 ml	2 x 7.5 ml	300 mg
>37.5 kg	20 ml	2 x 10 ml	400 mg

For adolescents and adults without swallowing problems, the use of cefixime tablets is recommended.

Renal insufficiency

Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20 ml/min/1.73 m², it is recommended that a dose of 200 mg once daily should not be exceeded.

In children under 12 years with a creatinine clearance of <20 ml/min/1.73 m2, a dose of 4 mg cefixime/kg body weight should be given only once a day.

Preparation of the suspension

60 ml oral suspension: To reconstitute, use the plastic measuring cup provided in the cardboard box. Add 40 ml of water in two portions shaking after each addition.

100 ml oral suspension: To reconstitute, use the plastic measuring cup provided in the cardboard box. Add 66 ml of water in two portions shaking after each addition.

The reconstituted suspension is an almost white to pale yellow viscous liquid.

Shake the medicine bottle well before each use.

A graduated plastic oral syringe is used for measuring the required prescribed amount of suspension. The plastic oral syringe is included in the package.

How to use the oral syringe:

1.    Shake the bottle well before use and remove the bottle cap.

2.    Remove the cap from the syringe and insert the syringe into the bottle.

3.    Pull the plunger up the barrel until the barrel's rim is aligned with the mark on the plunger corresponding to the required dose.

4.    Remove the syringe from the bottle.

5.    With the patient seated in an upright position, place the tip of the syringe just inside the patient's mouth, pointing towards the inside of the cheek.

6.    Press the plunger of the syringe in slowly to expel the medicine without causing choking. Do NOT squirt the medicine out in a jet.

7.    Repeat steps 2-6 in the same way until the whole dose has been given.

8.    After giving the dose replace the bottle cap. Dismantle the syringe and wash it thoroughly in fresh drinking water. Allow the plunger and the barrel to dry naturally.

Duration of treatment

The usual course of treatment is 7 days. This may be continued for up to 14 days according the severity of the infection.

For acute uncomplicated cystitis in women, the treatment period is 1-3 days.

If you take more Cefixime than you should

If you or your child have taken more of this medicine than you should, talk to your doctor or contact your nearest hospital emergency department immediately.

If you forget to take Cefixime

If you forget to take a tablet, take it as soon as you remember. However, if the next dose is due in less than 6 hours, skip the missed dose and go back to your regular dosing schedule.

Do not take a double dose.

If you stop taking Cefixime

It is important that you take this medicine until you finish the prescribed course. You should not stop taking Cefixime just because you feel better. If you stop too soon, the infection may start up again. If the person being treated still feels unwell at the end of the prescribed course of treatment or feels worse during treatment, tell your doctor.

If you have any further questions on 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.

The following side effects are important and will require immediate action if you experience them. You should stop taking Cefixime and see your doctor immediately if the following symptoms occur:

Very rare (may affect up to 1 in 10,000 people):

•    watery and severe diarrhoea that may also be bloody,

•    sudden severe allergic reactions (anaphylactic shock) such as skin rash or hives, itchiness, swelling of the face, lips, tongue or other parts of the body, tightness of the chest, wheezing and collapse,

•    severe skin illness with blistering of the skin, mouth, eyes and genitals (Stevens Johnson syndrome, toxic epidermal necrolysis) (see section 2. What you need to know before you take Cefixime - Warnings and Precautions).

Not known (frequency cannot be estimated from the available date)

•    Severe skin eruption, fever, enlarged lymph nodes, increase in the numbers of white blood cells called eosinophils (DRESS syndrome) (see section 2. What you need to know before you take Cefixime - Warnings and Precautions).

The following side-effects have also been reported:

Common (may affect up to 1 in 10 people):

•    diarrhoea.

Uncommon (may affect up to 1 in 100 people):

•    headache,

•    nausea,

•    vomiting,

•    abdominal (tummy) pain,

•    changes in blood tests that check how your liver is working,

•    skin rash.

Rare (may affect up to 1 in 1,000 people):

•    an increased chance that you can get infections caused by germs that cefixime does not act on. For example, thrush,

•    increase in the numbers of white blood cells called eosinophils,

•    allergic reaction,

•    loss of appetite,

•    dizziness,

•    flatulence (wind),

•    itchy skin,

•    inflammation of mucus (moist) linings such as the mouth and / or other internal surfaces,

•    fever,

•    changes in blood tests that check how your kidneys are working.

Very rare (may affect up to 1 in 10,000 people):

•    fall in the number of different cells in the blood (symptoms can include tiredness, new infections and easy bruising or bleeding),

•    allergic reaction characterised by skin rashes, fever, joint pains and enlarged organs,

•    restlessness and increased activity,

•    liver problems including jaundice (yellowing of the skin or whites of the eyes),

•    inflammation of the kidney.

Not known (frequency cannot be estimated from the available

date):

•    rise in the number of blood platelets (thrombocytosis),

•    fall in the number of a type of white blood cells (neutropenia),

•    dyspepsia,

•    skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme'.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme,

Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Cefixime

Keep this medicine out of the sight and reach of children. Unreconstituted product should be stored below 25°C. Reconstituted suspension: The reconstituted suspension may be stored for 14 days at ambient conditions (below 25°C) or refrigerated conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Cefixime contains

-    The active substance is cefixime. Each 5 ml of reconstituted oral suspension contains 111.9 mg of cefixime trihydrate equivalent to 100 mg of cefixime (anhydrous).

-    The other ingredients are: sucrose, xanthan gum, sodium benzoate E211, flavour durarome orange (flavouring ingredients, maltodextrin, sucrose, soy-lecithin E322, silicon dioxide E551).

What Cefixime looks like and contents of the pack

Cefixime granules for oral suspension are almost white to pale yellow granules.

The granules for oral suspension is immediate packed in a 150 ml brown neutral glass bottle Ph.Eur. Type III, supplied with an aluminium screw cap with a polyethylene sealing. Cardboard box contains one (1) bottle, one plastic (polypropylene) measuring cup for reconstitution only graduated on 40 ml or 66 ml, one plastic 5 ml oral syringe for dosing with scale from 0.5 ml to 5 ml and graduations on each 0.25 ml imprinted on the plunger of the syringe and an instruction leaflet. Each bottle contains 32 g granules for preparation of 60 ml oral suspension or 53 g granules for preparation of 100 ml oral suspension.

Marketing Authorisation Holder

INN-FARM d.o.o., Maleseva ulica 14, 1000 Ljubljana, Slovenia Tel.: +386 70 390 711 Fax:+ 386 5191 116 e-mail: info@innfarm.si

Manufacturer

ALKALOID-INT d.o.o., Slandrova ulica 4, 1231 Ljubljana -

Crnuce, Slovenia

Tel.: +386 1 300 42 90

Fax: +386 1 300 42 91

email: info@alkaloid.si

This medicine product is authorised in the Member states of the EEA under the following names:

UK    Cefixime

100 mg/5 ml granules for oral suspension

Austria    Cefixim InnFarm

100 mg/5 ml Granulat zur Herstellung einer Suspension zum Einnehmen

Czech Republic Cefixime InnFarm

100 mg/5 ml granule pro peroralni suspenzi

Germany    Cefixim INN-Farm

100 mg/5 ml Granulat zur Herstellung einer Suspension zum Einnehmen

Spain    XIFIA

100 mg/5 ml granulado para suspension oral

Hungary    XIFIA

100 mg/5 ml granulatum belsoleges szuszpenziohoz

Italy    Cefixima INN-FARM

Poland    XIFIA

Portugal    Cefixima    InnFarm

100 mg/5 ml granulado para suspensao oral

Romania    XIFIA

100 mg/5 ml granule pentru suspensie orala

Slovak Republic Cefixime InnFarm

100 mg/5 ml, granulat na peroralnu suspenziu

PL 40168/0005

This leaflet was last revised in 03/2015.

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

•    dosage

•    schedules

•    duration of treatment.

Consequently, to preserve the efficacy of this medicine:

1    - Use antibiotics only when prescribed.

2    - Strictly follow the prescription.

3    - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.

4    - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.

5    - After completion of treatment, return all unused medicines to your chemist's shop to ensure they will be disposed of correctly.