Cepodem Tablets

CEPODEM contains a medicine called cefpodoxime proxetil. This belongs to a group of antibiotics called ‘cephalosporins’. Antibiotics help the body fight infections by destroying certain bacteria that cause infection.

In adults: CEPODEM Tablets are used to treat infections caused by bacteria. These include:

• nose & sinuses infections (such as sinusitis)
• throat infections (such as tonsillitis, pharyngitis)
• chest and lungs infections (such as bronchitis, pneumonia)

In children: CEPODEM Suspension 40 mg/5 ml is used to treat infections caused by bacteria. These include:

• ear infections (otitis media)
• nose & sinuses infections (such as sinusitis)
• throat infections (such as tonsillitis, pharyngitis)
• chest and lungs infections (such as bronchitis, pneumonia)

Do not take or give CEPODEM if:

• You or your child is (hypersensitive) to cefpodoxime or to any of the cephalosporin group of antibiotics, any other antibiotics including penicillin or to any of the other ingredients of CEPODEM (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.
• You are pregnant, you think may be pregnant or currently breastfeeding.
• CEPODEM should not be used in children below 1 year of age.

Do not use this medicine if any of the above applies to you or your child. If you are not sure, talk to your child’s doctor or your pharmacist before giving CEPODEM.

Warnings and precautions

Take special care with CEPODEM and talk with your doctor if:

• You/your child have previously had an allergic (hypersensitive) reaction to penicillin and other beta-lactam antibiotics (such as piperacillin, ticarcillin, ampicillin, amoxicillin, oxacillin, cloxacillin, flucloxacillin, nafcillin etc.); you may also be allergic to cefpodoxime proxetil, you should be strictly monitored while taking this medicine.
• You/your child suffer from kidney problems.
• You/your child develop severe and persistent diarrhoea which may contain blood or mucous along with stomach cramps and fever (pseudomembranous colitis). Immediately stop taking or giving CEPODEM and contact your doctor.
• You have chest pains in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)

If you are not sure if any of the above applies, talk to doctor before taking CEPODEM. The doctor will tell you whether it is safe for you/your child to start taking this medicine. Please consult your doctor, even if these statements were applicable to you at any time in the past.

Do not share medicines prescribed for you with any other person. Always take CEPODEM exactly as your doctor has instructed you. Do not take more than the doctor told you to. Check the label carefully for how much to take and how often to take. You should check with your doctor or pharmacist if you are not sure.

Use in adults

The dosage of CEPODEM Tablets depends on the condition being treated.

• For throat, chest and lungs infections (tonsillitis, pharyngitis, acute bronchitis) One CEPODEM 100 Tablet every 12 hours with meals (200 mg/day). In certain type of infections (streptococcal infections) the dose would be given for at least 10 days by your doctor.
• For sinus, chest and lung infections (acute sinusitis, bronchitis and pneumonia) One CEPODEM 200 Tablet or two CEPODEM 100 Tablets every 12 hours with meals (400 mg/day).

Patients with kidney problems: Your doctor will decide your dose based on your kidney function.

Elderly patients: Where renal function is normal, it is not necessary to adjust the dose.

Use in children

CEPODEM suspension is available for children.

• The constituted product contains cefpodoxime 8 mg/mL
• An average dose of 8 mg/kg/day administered in two doses at 12 hourly intervals with meals. CEPODEM Suspension 40 mg/5 ml is not indicated for use in children less than one year of age.

Directions for reconstitution of suspension: Shake the bottle to loosen the granules. Add 33 ml and 66 ml water for 50 ml and 100 ml packs respectively in two divided portions to the dry mixture in the bottle. Shake well after each addition.

Always take CEPODEM exactly as your doctor has told you. You should check with doctor or pharmacist if you are not sure how you should take your medicine or give medicine to your child.

If you take/give more CEPODEM than you should:

• In the event of overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre.
• Show them the pack of CEPODEM (tablets or suspension).

If you forget to take/give CEPODEM:

• If you miss a dose, take/give the missed dose as soon as possible, and then continue with the normal dose on the regular schedule as prescribed by the doctor.
• Do not take/give a double dose to make up for a forgotten dose.

If you stop taking CEPODEM:

• Do not stop or change the daily dose of CEPODEM without first consulting with the doctor.
• CEPODEM should always be taken every day to help control the infection, no matter how much better you/your child feel.
• Using CEPODEM as recommended should give the best chance of delaying the development of resistance to the product.
• If a side effect is preventing you/your child from taking CEPODEM as directed tell the doctor right away.
• Continue to take this medicine or give this medicine to your child until your doctor tells you otherwise.

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

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

If any of the following happens, stop taking/giving CEPODEM and tell your doctor immediately or go/take your child to the casualty department at your nearest hospital.

• Fever, swelling of the face, lips, tongue, throat, hands/feet, skin rash, enlargement of the lymph nodes, joint pain (serum sickness) or breathing difficulties.
• Chest pains which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)
• Flu-like symptoms followed by blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. This may be a severe skin allergy, called ‘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. This may be a serious condition called ‘Toxic epidermal necrolysis’
• Severe skin reactions such as blisters in a circle with central crusting or like a string of pearls (linear IgA disease), sores or ulceration
• Painful or itchy lesions that have a pink-red centre surrounded by a pale ring border and outer pink-red-ring. The more severe form can affect the mouth, genitals and eyes and can be life-threatening. This may be a serious skin allergy called ‘Erythema multiforme’

These are very serious side effects. If you/your child have them you/your child may have had a serious reaction to CEPODEM. You/your child may need urgent medical attention or hospitalization. Remember to take any medicine that is left so the doctor knows what you/your child have taken.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Skin rash or lesions with a pink or red ring and a pale centre which may be itchy or filled with fluid (bullous eruptions).
• Rash, redness and swelling of skin, itching, hives, pimples (urticaria, purpura, pruritis).
• Numbness or tingling feelings (paresthesia)
• Yellowing of skin, eyes or mouth and feeling tired. You may also be pale than normal (reduction in haemoglobin)
• Severe and persistent diarrhoea which may contain blood or mucous along with stomach cramps and fever (pseudomembranous colitis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• feeling sick (nausea), being sick (vomiting), stomach pain or cramps,
• headache
• increased eosinophils (eosinophillia)

Less frequent side effects:

• loose stool (diarrhoea)
• dizziness, ringing in the ears (tinnitus)
• body pain, feeling uneasy (malaise), tired, weak or lack of energy (asthenia)
• superinfection (a second infection which occurs during the course of the existing infection, by other bacteria or organisms resistant to CEPODEM), including fungal infections such as oral or vaginal thrush.
• liver injury resulting in abnormal liver function tests (increase in AST, ALT, ALP)
• abnormal kidney function tests (increase in BUN and creatinine)
• increased or decreased platelets (thrombocytosis, thrombocytopenia)
• reduced hemoglobin, white blood cells (agranulocytosis), neutrophils (neutropenia), leukocytes (leucopenia)
• taste disturbances, inflamed and sore mouth, dry mouth.

Store all medicines out of reach of children.

Store at or below 25 °C,

Do not use after the expiry date stated on the label/ carton. The expiry date refers to the last day of that month.

Store in the original package/ container.

Keep the container in the outer carton.

Keep the container tightly closed.

Do not remove the blister strips from the cartons until required for use.

Protect from light and moisture.

Do not store in a bathroom.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).