Sandoz Cefpodoxime Film-Coated Tablets

SANDOZ CEFPODOXIME belongs to the antibiotic group of medicines known as the cephalosporins. SANDOZ CEFPODOXIME 100 is used for the treatment of the following in adults:

• Lung infection (bronchitis) and bacterial pneumonia
• Tonsillitis, throat infection (pharyngitis)
• Community-acquired bronchopneumonia
• Sinus infection

SANDOZ CEFPODOXIME 40 mg/5 mL is used for the treatment of the following in children:

• Ear infection
• Tonsillitis, throat infection (pharyngitis)
• Pneumonia

Do not take SANDOZ CEFPODOXIME:

• If you or your child are hypersensitive (allergic) to other cephalosporin antibiotics, penicillin, any other beta-lactam class of antibiotics or to any of the ingredients of SANDOZ CEFPODOXIME (see section 6)
• SANDOZ CEFPODOXIME 40 mg/5 mL suspension must not be given to children with phenylketonuria (a rare inherited disorder that causes an amino acid called phenylalanine to build up in your body) since the formulation contains aspartame
• If your child is under 1 year old.

Warnings and precautions

Take special care with SANDOZ CEFPODOXIME:

• SANDOZ CEFPODOXIME should be taken with caution in patients who are generally allergic. Please tell your doctor about all allergic reactions you or your child may have had previously, especially to medicines
• If you or your child are allergic to penicillin antibiotics, as there may be an increased chance of being allergic to cephalosporins (including SANDOZ CEFPODOXIME) as well
• If you or your child previously had or currently has gastrointestinal disease, including a condition called colitis (inflammation of the large intestine with symptoms of abdominal pain, diarrhoea and fever) or if you or your child develop diarrhoea while using SANDOZ CEFPODOXIME. This may be an indication of inflammation of the large intestine (colitis). Please consult your doctor immediately
• If you or your child have kidney problems (the dose may need to be adjusted)
• If you or your child have to receive certain blood or urine tests as SANDOZ CEFPODOXIME may interfere with the results.
• If you or your child experience symptoms such as seizure, confusion, consciousness disorders or abnormal movements (especially with kidney problems or if you or your child have been given more medicine than required), contact your doctor or healthcare provider immediately.
• If you or your child are taking SANDOZ CEFPODOXIME for a prolonged period of time, it may result in overgrowth of organisms that are not susceptible to SANDOZ CEFPODOXIME. Please contact your healthcare provider as soon as possible if you think this might be applicable
• Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with cefpodoxime treatment. Stop using cefpodoxime and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Other medicines and SANDOZ CEFPODOXIME

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) SANDOZ CEFPODOXIME works better when taken with food. Medicines that may interact with SANDOZ CEFPODOXIME are:

• Medicines used to treat ulcers such as ranitidine or cimetidine and antacids (used to treat indigestion such as aluminium hydroxide, sodium bicarbonate) may delay how SANDOZ CEFPODOXIME works
• Pentagastrin (medicine used to stimulate stomach acid secretion) may increase the effects of SANDOZ CEFPODOXIME
• Probenecid (used for the treatment of gout) may increase the blood levels of SANDOZ CEFPODOXIME and increase the chance of side effects
• Certain diuretics (water tablets, e.g. furosemide) used to increase the amount of urine you pass, may affect your kidneys
• Aminoglycoside antibiotics (e.g. gentamicin) (used to treat infections) may affect the way your kidneys work
• Please ensure that your doctor knows that you or your child are taking SANDOZ CEFPODOXIME if it is required to take any tests (blood, urine or diagnostic), as this medicine may interfere with the test results
• Anti-coagulants such as warfarin (used to thin the blood) taken with SANDOZ CEFPODOXIME may increase the risk of bleeding

Do not share medicines prescribed for you with any other person. Always use SANDOZ CEFPODOXIME exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you have the impression that the effect of SANDOZ CEFPODOXIME is too strong or too weak, talk to your doctor or pharmacist.

Adults: The usual dose is 1 or 2 tablets every 12 hours with meals, depending on the diagnosis made by your doctor:

• One tablet every 12 hours for tonsillitis, throat infection (pharyngitis) and lung infection (bronchitis)
• Two tablets every 12 hours for sinus infection, acute lung infection (bronchitis) in patients with chronic bronchitis and pneumonia

Children: The usual dose is 8 mg/kg/day administered in two doses every 12 hours with meals. Your doctor will adjust the dose according to the child’s weight. The following may be used as a dosage guide:

• Children weighing between 10 and 15 kg the dose is 5 mL every 12 hours.
• Children weighing 15 kg or more, the dose is 10 mL every 12 hours.

Shake the bottle before use. Administration of SANDOZ CEFPODOXIME 40 mg/5 mL suspension in children under one year of age is not indicated as safety has not been established (see section 2 “Do not take SANDOZ CEFPODOXIME”).

Elderly patients: The same dosage as for adults where kidney function is normal. If kidney function is not normal, refer to section “Kidney disorders” below.

Kidney disorders: If you or your child have a kidney disorder, you will receive lower doses than the normal dose. Your doctor will determine the correct dose according to your condition. SANDOZ CEFPODOXIME 40 mg/5 mL suspension must not be given to you or your child if you have phenylketonuria, since the formulation contains aspartame (see section 2 “Do not take SANDOZ CEFPODOXIME”). Your doctor will tell you how long you or your child’s treatment with SANDOZ CEFPODOXIME will last. If you have the impression that the effect of SANDOZ CEFPODOXIME is too strong or too weak, tell your doctor or pharmacist.

If you take/administer more SANDOZ CEFPODOXIME than you should In the event of overdosage consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose may include:

• any of the symptoms as described under “Possible side effects” in section 4.
• seizure, confusion, consciousness disorders or abnormal movements, especially if you or your child have kidney disorders.

If you forget to take SANDOZ CEFPODOXIME If you forget to administer SANDOZ CEFPODOXIME, administer it as soon as you remember on the same day. If you do not administer a dose on that same day, give the normal dose the next day. Do not administer a double dose to make up for forgotten individual doses.

If you stop taking SANDOZ CEFPODOXIME It is important that you continue the course of treatment as prescribed by your doctor even if you or your child begin to feel better after a few days.

SANDOZ CEFPODOXIME can have side effects. Not all side effects reported for SANDOZ CEFPODOXIME are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SANDOZ CEFPODOXIME, please consult your health care provider for advice.

If any of the following happens, stop taking SANDOZ CEFPODOXIME and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, shock
• rash or itching
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis).

These are all very serious side effects. If you have them, you may have had a serious reaction to SANDOZ CEFPODOXIME. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of the skin or whites of your eyes, dark urine which could be signs of hepatitis (inflammation of the liver) and other liver problems including jaundice, liver injury and increased liver enzymes.
• A severe infection of the lining of the bowel, characterised by diarrhoea, fever and abdominal pain. This may be something called 'Pseudomembranous colitis', blood in stools.
• Blistering, peeling or bleeding on any part of your skin with or without a rash (including your lips, eyes, mouth, nose, genitals, hands or feet), flu-like symptoms (fever, chills or aching muscles) which are symptoms of a serious skin reaction (Stevens Johnson Syndrome or toxic epidermal necrolysis (TEN)) which could be fatal.
• 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 skin allergy called ‘erythema multiforme’.
• Upper abdominal pain that radiates into the back; swollen and tender abdomen; nausea and vomiting, fever and increased heart rate which could be signs of pancreatitis (inflammation of the pancreas).
• Superinfection (a second infection which occurs during the course of the existing infection, by other bacteria or organisms resistant to SANDOZ CEFPODOXIME), including fungal infections such as oral or vaginal thrush.
• Chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark coloured urine. These could be signs of a serious type of anaemia.
• Blood disorders which may make you or your child more likely to get infections, get tired very easily, or bruise very frequently.
• A painful rash of dark red spots under the skin which does not go away when you press on them (purpura).
• Seizures, central nervous system toxicity (with symptoms including anxiety, dizziness, mouth numbness, lightheadedness, ringing or buzzing in the ears and convulsions).
• Little or no urine when you try to urinate, decreased kidney function (with symptoms such as swelling from fluid retention and high blood pressure).
• Hearing loss.

These are all serious side effects. You or your child may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• appetite loss
• nausea, vomiting, diarrhoea, flatulence, abdominal pain
• headache

Less frequent side effects:

• abnormal blood and/or urine test results
• dizziness, sensations of tingling, burning, pricking (pins and needles), or numbness of the skin, asthenia (unusual tiredness or weakness)
• indigestion
• ringing in the ears
• abnormal liver test results
• skin rashes or other skin conditions
• fatigue
• false positive blood test (Coombs’ test).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SANDOZ CEFPODOXIME. Suspected side effects can also be reported directly to the HCR via https://pvi1j.solutions.iqvia.com or the e-mail address, [email protected].

• Store all medicines out of reach of children.

SANDOZ CEFPODOXIME 100 film-coated tablets:

• Store at or below 25 °C.
• Protect from light and moisture.
• Store in the original packaging.

SANDOZ CEFPODOXIME 40 mg/5 mL suspension:

Before reconstitution:

• Store at or below 25 °C.
• Keep container tightly closed.
• Protect from light

After reconstitution:

• Use within 14 days. Store in a refrigerator (2 to 8°C). Shake the bottle before use.
• Discard any unused portion.
• Do not use after the expiry date stated on the bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).