Cefixim Stada 100 mg/5 ml, poeder voor orale suspensie

Cefixim STADA belongs to a group of medicines called Cephalosporins, which are used for treating mild to moderate infection caused by susceptible organisms.

Cefixim STADA can be used to treat:

• Acute infection of the middle ear
• Acute throat infection caused by bacteria
• Uncomplicated acute infections in the urinary tract (Uncomplicated acute cystitis)
• Uncomplicated acute gonorrhoea

Do not take Cefixim STADA if you

• are allergic (hypersensitive) to cefixime or to any of the ingredients in the tablet (see section 6 ´Further Information´). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• Are allergic (hypersensitive) to any other cephalosporin type of antibiotic.
• Have ever had a severe allergic reaction to penicillin antibiotic or to any other beta-lactam type of antibiotic.

Take special care with Cefixim STADA

Before you take Cefixim STADA you should tell your doctor if you:

• Are allergic to penicillin antibiotics or to any other beta-lactam type of antibiotics. Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you 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 Cefixim STADA, the medicine should be discontinued and appropriate treatment should be given.

• Have ever been told that your kidneys do not work very well. Also if you are taking any sort of treatment (like dialysis) for kidney failure. You may take Cefixim STADA but you may need a lower dose. (Children with kidney problems should not get Cefixim STADA)
• Have severe or persistent diarrhoea that may be bloody and that may be associated with stomach pain or cramps: these symptoms may occur during or shortly after treatment and signal are rare, but potentially life threatening adverse reaction. Stop taking Cefixim STADA and contact your doctor immediately. Medicines which may slow or stop bowel movements must not be taken.

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

Taking other medicines

You should tell your doctor if you are taking or have taken the following medicine as it may interact with your Cefixim STADA:

• anticoagulant (blood thinning) therapy

Always tell your doctor about any other medicine you are taking, including medicine obtained without a prescription.

Effect on laboratory tests

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

Cefixim STADA can alter the results of some urine tests for sugar of the types called as Benedict’s, Fehling’s or with copper sulfate test. As with other cephalosporins, Cefixim STADA can alter the results of a blood test for antibodies called direct Coomb´s test.

Taking Cefixim STADA with food and drink

Cefixim STADA may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

Other substances from the group of medicines, to which cefixime belongs, are well tolerated during pregnancy.

Your doctor will decide whether the benefit of the therapy outweighes the possible risk for your infant.

Breast-feeding

As cefixime is excreted in small amounts in breast-milk, you should ask your doctor whether you can take Cefixim STADA in breast-feeding.

Driving and using machines

Cefixime can cause dizziness. If affected, you should not drive or operate machinery

Important information about some of the ingredients of Cefixim STADA

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Contains 2.43 g or sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus.

Usual dose for adults and adolescents (12 years and older)

The usual adult dosage is 400 mg daily, either as a single dose or in two divided doses. If your doctor has prescribed one dose a day, it should be taken every 24 hours. If your doctor has prescribed two doses a day, each dose should be taken every 12 hours. The medicine should always be taken at the same time each day.

Children older than 6 months and up to 11 years of age

Children are given Cefixime as an oral suspension (liquid to be taken by mouth). The daily dose is worked out according to the weight of the child.

Usually the total amount each day is 8 mg for each kilogram of body weight in a single dose or divided in 2 doses based on weight.

For exact administration of the dosage the pack is supplied with a 10 ml syringe dosing device marked at each 0.25 ml .

As a general guide to usual doses see following table.

Children less than 6 months of age

Cefixim STADA is not recommended for use in children less than 6 months of age.

Elderly

For elderly patients, the doses are the same as adults provided the kidney function are normal.

Kidney Problems

If you have severe kidney problems or are undergoing dialysis, your doctor will reduce your dose.

There are insufficient data regarding the use of Cefixim STADA in childrenwith kidney problems. Cefixim STADA is therefore not recommended for use in these patients.

How to prepare Cefixim STADA

Add water up to the mark to the powder in the bottle.

After adding water, shake well until the powder is fully dispersed.

After reconstitution with water, Cefixim STADA 100 mg/5 ml Powder for oral suspension gives cream colour to pale yellow coloured viscous suspension.

After few minutes, if suspension level is lower than that indicated by the mark, add more water to bring to the level indicated by the mark. Shake vigorously again.

The suspension thus prepared can be stored for 14 days during which its activity remains unchanged.

Shake the bottle containing the suspension well before use.

If you take more Cefixim STADA than you should

If you take more of this medicine than you or it should, contact your nearest hospital casualty department or your doctor immediately.

If you forget to take Cefixim STADA

If you forget to take a dose, take one 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 double doses.

If you stop taking Cefixim STADA

Do not stop treatment early because it is important that you complete the FULL course of this medicine in order to reduce the chance of the infection returning.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Cefixim STADA can cause side effects, although not everybody gets them.

Allergic reactions

All medicines can cause allergic reactions, although severe allergic reactions are rare (affects 1 to 10 users in 10000). These can include:

• Sudden wheeziness and tightness of chest

• Swelling of the eyelids, face or lips
• Severe skin rashes that can blister and may involve the eyes, mouth and throat and genitals

All of these allergic reactions need urgent medical attention. If you think you are having any of these types of reaction, stop taking this medicine and contact your doctor or your nearest hospital accident and emergency department.

The following other side-effects have been reported:

Common side effects (affects 1 to 10 users in 100) include:

• diarrhoea (if you have severe diarrhoea or if you see blood in your stools, you should stop taking this medicine and talk to your doctor immediately because you may have a very rare infection of the large bowel that needs special treatment)

Uncommon side effects (affects 1 to 10 users in 1000) include:

• headache
• nausea
• vomiting
• stomach pain
• rash
• changes in blood tests that check how your liver is working

Rare side effects (affects 1 to 10 users in 10000 ) include:

• Serious allergic reaction which causes swelling of the face or throat (angioneurotic oedema)
• hypersensitivity reactions (these are skin rashes that are less severe allergic reactions than mentioned above, lumpy rash [hives], itching)
• dizziness/vertigo
• loss of appetite (anorexia)
• flatulence (wind)
• itching
• fever
• abnormal increase in the number of cells (eosinophils) in the blood characteristic of allergic states
• inflammation of mucous membranes
• Repeated infections caused by bacteria
• Repeated infections caused by funghi

Very rare side effects (affects less than 1 user in 10000) include:

• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever (Stevens-Johnson syndrome)

• Severe blistering rash where layers of the skin may peel off to leave large areas of raw, exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles (Toxic epidermal necrolysis)
• Serious allergic reaction which causes difficulty in breathing or shock (anaphylactic shock)
• inflammation of the intestines that sometimes occurs following antibiotic treatment (antibiotic associated colitis)
• Severe reduction in number of white blood cells which makes infections more likely (agranulocytosis)
• Severe reduction in blood cells which can cause weakness, bruising or make infections morelikely (pancytopenia)
• decreases in the numbers of small cells that are needed for clotting of the blood, which increases the risk of bleeding or bruising (thrombocytopenia) (if you are having a blood test for any reason, tell the person who is taking your blood sample that you are taking this medicine as it may affect your result)
• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
• low counts of white blood cells (leucopenia)
• Hypersensitivity reaction causing symptoms like rash, joint pain, fever and shock (serum sickness)
• a feeling of restlessness associated with increased activity (psychomotor hyperactivity)
• reversible inflammation of the kidney affecting its structure and function
• Inflammation of the liver (hepatitis)
• Bile disorder (cholestatic jaundice)
• Changes in special blood tests that show how your kidney is working (blood creatinine increased)

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.

Keep out of the reach and sight of children.

• Do not use Cefixim STADA after the end of the expiry month (use by date) shown on the product packaging. The expiry date refers to the last day of that month.
• The powder should be stored below 25°C.
• The reconstituted suspension may be stored for 14 days below 25°C.
• Shake well before use.
• Do not refrigirate or freeze.
• Keep the bottle tightly closed.

• Discard any unused suspension after 14 days.
• If your doctor tells you to stop your treatment, return any leftover Cefixim STADA to your pharmacist for safe destruction.

What Cefixim STADA contains

The active ingredient is cefixime.

The other ingredients are Xanthan gum, Sodium benzoate, Silica colloidal anhydrous, Sucrose and Flavour Strawberry.

What Cefixim STADA looks like and contents of the pack

Off-white to pale yellow coloured powder with characteristic odour and gives cream colour to pale yellow coloured viscous suspension after reconstitution with water.

The product is available in Type III molded, amber colored, round glass bottle closed with plastic child resistant cap packed in a carton with a package leaflet. A 10 millilitre (ml) syringe dosing device marked at each 0.25 ml is supplied with this pack.

Pack sizes of 50ml and 100 ml.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisatioin Holder:

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel, Germany

Manufacturer:

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel, Germany

STADA Production Ireland Ltd.

Waterford Road

Clonmel

Co Tipperary, Ireland

ALIUD Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen, Germany

Registration number:

RVG 106305

This medicinal product is authorized in the member states of the EEA under the following names

Bulgaria: Zefacet 100 mg/5 ml прах запероралнасуспензия Germany: Cefixim STADA 100 mg/5 ml Pulver zur Herstellung einer

Suspension zum Einnehmen

Italy: CEFIXIMA EG 100 mg/5 ml granulato per sospensione orale Netherlands: Cefixim STADA 100 mg/5 ml, poeder voor orale suspensie

This leaflet was last revised in July / 2013 <to be completed nationally>