Bindoclav 31.25 mg/5 ml/62.5 mg Oral Suspension

BINDOCLAV SUSPENSION is a combination of a penicillin, amoxicillin and a beta-lactamase inhibitor, clavulanic acid. Penicillins and beta-lactamase inhibitors are used to treat many different infections caused by bacteria, such as sinusitis, bronchitis, pneumonia, tonsillitis, ear infections, urinary tract infections and infections of the skin. Amoxicillin works by killing the bacteria. Clavulanic acid is added to the amoxicillin to protect the amoxicillin from certain substances (enzymes) that will destroy the amoxicillin before it can kill the bacteria.

Do not take BINDOCLAV SUSPENSION:

• If you have ever had an allergic reaction to amoxicillin, to any other penicillin antibiotic, or to a cephalosporin antibiotic.
• If you have previously had jaundice (yellow pigmentation of skin and eyes) and/or liver disease when using the combination of amoxicillin and clavulanic acid.

Take special care with BINDOCLAV SUSPENSION:

• A serious form of diarrhoea (pseudomembranous colitis) may occur. Contact your doctor right away if stomach pain or cramps, severe diarrhoea, or bloody stools occur.
• If you are taking high doses, make sure you drink plenty of fluids. Keep all appointments with your doctor and laboratory. If you are taking BINDOCLAV SUSPENSION for a long period of time, your doctor may order certain tests to check your kidneys, liver and blood.
• If you are having tests on or checking your urine for sugar, let the doctor know that you are on BINDOCLAV SUSPENSION. This is because BINDOCLAV SUSPENSION can affect the results of these tests.
• Use of BINDOCLAV SUSPENSION may result in another infection, such as candidiasis that occurs while you are being treated for an infection. If this occurs, BINDOCLAV SUSPENSION should be stopped and suitable treatment given.

Before using BINDOCLAV SUSPENSION, tell your doctor if you:

• have allergies or a history of allergies – Patients with a history of allergies are more likely to have an allergic reaction to BINDOCLAV SUSPENSION which can be serious and possibly fatal. Tell your doctor about any previous allergic reactions to penicillins, cephalosporins, other medicines, food, or other substances.
• have infectious mononucleosis (glandular fever) or a sore throat.
• have syphilis
• have lymphatic leukemia (cancer of the blood)
• have liver disease
• have kidney disease
• are breastfeeding
• have a blood clotting disorder

Taking BINDOCLAV SUSPENSION with food:

BINDOCLAV SUSPENSION should be taken immediately before a meal.

Pregnancy and Breastfeeding:

• The safety of this medicine in pregnant women has not been confirmed - Tell your doctor if you are pregnant or plan to become pregnant.
• BINDOCLAV SUSPENSION can pass into breast milk and may cause a yeast infection, diarrhoea, or allergic reaction in a nursing baby. Do not use this medication without telling your doctor if you are breastfeeding a baby. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other health care professional for advice before taking BINDOCLAV SUSPENSION.

Driving and using machinery:

BINDOCLAV SUSPENSION may cause dizziness, impaired concentration, and/or drowsiness. If you experience these symptoms while taking BINDOCLAV SUSPENSION, do not drive and do not use tools and machines.

Important information about some of the ingredients of BINDOCLAV SUSPENSION:

BINDOCLAV SUSPENSION contains aspartame and therefore should be used with caution if you/your child suffers from phenylketonuria.

Always take BINDOCLAV SUSPENSION exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of BINDOCLAV SUSPENSION is too strong or too weak, talk to your doctor or pharmacist.

• BINDOCLAV SUSPENSION should be taken at the start of a meal, to help prevent stomach upset.
• Shake the liquid well before each use to mix the medication evenly.
• To be sure you get the correct dose, measure the liquid with a marked measuring spoon.
• Take this medication for the entire length of time, prescribed by your doctor.
• The usual dose of BINDOCLAV SUSPENSION in children is 25 - 50 mg/kg/day, taken in divided doses every 8 hours (three times a day).
• The dose for children is based on body weight and must be determined by your doctor.
• Tell your doctor if you suffer from kidney disease – your dosage may need to be adjusted.
• Safety in children under 2 months of age has not been established.

If you take more BINDOCLAV SUSPENSION than you should:

Overdose symptoms may include queasiness or feeling that one is about to vomit, vomiting, diarrhoea, or crystals in the urine, which may be seen as cloudy urine, or problems passing urine. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take BINDOCLAV SUSPENSION:

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

BINDOCLAV SUSPENSION can have side - effects. Not all side effects reported for BINDOCLAV SUSPENSION are included in this leaflet. Should your general health worsen while taking BINDOCLAV SUSPENSION, please consult your doctor, pharmacist or other health care professional for advice.

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

• hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BINDOCLAV SUSPENSION. 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:

• high temperature (fever), chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells.
• Unusual bleeding - your blood may take longer to clot than it normally would. You may notice this if you cut yourself or have a nosebleed.
• pale skin, excessive tiredness.
• a delayed allergic reaction, some signs include: rashes, fever, joint pains and enlargement of the lymph nodes.
• a skin reaction known as “erythema multiforme”, where you may develop: itchy reddish purple patches on the skin. You may have a fever and be very tired.
• other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches, and body aches.
• rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain and kidney problems.
• convulsions (seizures), seen in patients on high doses or with kidney problems.
• nausea, stomach pain, low fever, loss of appetite, yellowing of the skin or eyes, dark urine, or clay-coloured stools.
• inflammation of the large bowel (colon) with severe diarrhoea that is watery or bloody, pain and fever.
• urinating less than usual or not at all.

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

Store all medicines out of the reach and sight of children.

For dry powder: Store at or below 30 °C (room temperature) and away from moisture (not in the bathroom).

For reconstituted suspension: Once reconstituted, the suspension (liquid medication) should be kept in a refrigerator. Throw away any unused medication after 7 days. Do not freeze. Shake the bottle well before use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).