Co-amoxiclav: Amoxicillin, clavulanic acid.
The active substances are amoxicillin and clavulanic acid.
Tablet: Each film-coated tablet contains 500 mg amoxicillin and 125 mg clavulanic acid.
Oral suspension: Curam 125 mg/31.25 mg/5 ml powder for oral suspension: 5 ml reconstituted suspension contains 125 mg amoxicillin and 31.25 mg clavulanic acid.
Curam 250 mg/62.5 mg/5 ml powder for oral suspension: 5 ml reconstituted suspension contain 250 mg amoxicillin and 62.5 mg clavulanic acid.
After reconstitution, the ready-for-use suspension is off-white.
Excipients/Inactive Ingredients: The other ingredients are: Tablet: Magnesium stearate, talc, povidone K25, microcrystalline cellulose, croscarmellose sodium, triethyl citrate, hypromellose, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, titanium dioxide (E 171).
Oral suspension: citric acid, trisodium citrate, aspartame (E 951), talc, guar, silicon dioxide, lemon flavouring (contains glucose, sorbitol (E 420) and sulphur dioxide (E 220)), peach-apricot flavouring (contains ethanol, sorbitol (E 420) and sulphur dioxide (E 220)) and orange flavouring (contains benzyl alcohol).
Curam is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins" that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.
Curam is used in adults and children to treat the following infections: middle ear and sinus infections, respiratory tract infections, urinary tract infections, skin and soft tissue infections including dental infections, bone and joint infections.
Always take this medicine exactly as the doctor has told. Check with the doctor or pharmacist, if the patient is not sure.
Adults and children weighing 40 kg and over: Tablet: The usual dose is: 1 tablet three times a day.
Oral suspension: This suspension is not usually recommended for adults and children weighing 40 kg and over. Ask the doctor or pharmacist for advice.
Children weighing less than 40 kg: Tablet: Children aged 6 years or less should preferably be treated with Curam oral suspension or sachets.
Ask the doctor or pharmacist for advice when giving Curam tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.
Oral suspension: All doses are worked out depending on the child's bodyweight in kilograms.
The doctor will advise the patient how much Curam they should give to the baby or child.
The patient may be provided with a plastic measuring spoon or syringe doser. The patient should use this to give the correct dose to the baby or child.
Recommended dose: 20 mg/5 mg to 60 mg/15 mg for each kilogram of body weight a day, given in three divided doses.
Patients with kidney and liver problems: If the patient has kidney problems the dose might be changed. A different strength or a different medicine may be chosen by the doctor.
If the patient has liver problems they may have more frequent blood tests to check how the liver is working.
How to take Curam: Tablet: Swallow the tablets whole with a glass of water with a meal.
Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
Do not take Curam for more than 2 weeks. If the patient still feels unwell they should go back to see the doctor.
Oral suspension: Always shake the bottle well before each dose.
Give with a meal.
Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
Do not give the child Curam for more than 2 weeks. If the child still feels unwell they should go back to see the doctor.
If the patient takes more Curam than they should: If the patient takes too much Curam, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to the doctor as soon as possible. Take the medicine carton or bottle to show the doctor.
If the patient forgets to take Curam: If the patient forgets to take a dose, take it as soon as remembered. The patient should not take the next dose too soon, but wait about 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.
If the patient stops taking Curam: Keep taking Curam until the treatment is finished, even if the patient feels better. The patient needs every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not take Curam: if the patient is allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in Description); if the patient has ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat; if the patient has ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Curam if any of the previously mentioned apply to the patient. If the patient is not sure, talk to the doctor or pharmacist before taking Curam.
Talk to the doctor or pharmacist before taking this medicine if the patient: has glandular fever; is being treated for liver or kidney problems; is not passing water regularly.
If the patient is not sure if any of the previously mentioned apply to them, talk to the doctor or pharmacist before taking Curam.
In some cases, the doctor may investigate the type of bacteria that is causing the infection. Depending on the results, the patient may be given a different strength of Curam or a different medicine.
Conditions the patient needs to look out for: Curam can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. The patient must look out for certain symptoms while they are taking Curam, to reduce the risk of any problems. See 'Conditions the patient needs to look out for' under Side Effects.
Blood and urine tests: If the patient is having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that they are taking Curam. This is because Curam can affect the results of these types of tests.
Tablet: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
Oral suspension: Curam contains aspartame, benzyl alcohol, sorbitol, sulphur dioxide, potassium, glucose, ethanol and sodium.
125 mg + 31.25 mg powder for oral suspension: This medicinal product contains 1.7 mg aspartame in each ml reconstituted suspension. Aspartame is a source of phenylalanine. It may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicinal product contains up to 0.6 mg benzyl alcohol in each ml reconstituted suspension. Benzyl alcohol may cause allergic reactions. Ask the doctor or pharmacist for advice if the patient is pregnant or breast-feeding or if they have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in the body and may cause side effects (called "metabolic acidosis"). Do not use for more than a week in young children (less than 3 years old), unless advised by the doctor or pharmacist.
This medicinal product contains 0.028 mg sorbitol in each ml reconstituted suspension.
This medicinal product contains 20 mg sulphur dioxide in each ml reconstituted suspension. May rarely cause severe hypersensitivity reactions and bronchospasm.
This medicinal product contains 0.14 mg glucose in each ml reconstituted suspension. If the patient has been told by the doctor that they have an intolerance to some sugars, contact the doctor before taking this medicine.
This medicinal product contains 1.35 mg potassium in each ml reconstituted suspension. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicinal product contains small amounts of ethanol, less than 100 mg in each ml reconstituted suspension.
This medicinal product contains less than 1 mmol (23 mg) sodium in each ml reconstituted suspension, that is to say essentially sodium free.
250 mg + 62.5 mg powder for oral suspension: This medicinal product contains 1.7 mg aspartame in each ml of reconstituted suspension. Aspartame is a source of phenylalanine. It may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicinal product contains up to 0.6 mg benzyl alcohol in each ml of reconstituted suspension. Benzyl alcohol may cause allergic reactions. Ask the doctor or pharmacist for advice if the patient is pregnant or breast-feeding or if they have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in the body and may cause side effects (called "metabolic acidosis"). Do not use for more than a week in young children (less than 3 years old), unless advised by the doctor or pharmacist.
This medicinal product contains 0.0.28 mg sorbitol in each ml of reconstituted suspension.
This medicinal product contains 20 mg sulphur dioxide in each ml of reconstituted suspension. May rarely cause severe hypersensitivity reactions and bronchospasm.
This medicinal product contains 0.14 mg glucose in each ml of reconstituted suspension. If the patient has been told by the doctor that they have an intolerance to some sugars, contact the doctor before taking this medicine.
This medicinal product contains 2.7 mg potassium in each ml of reconstituted suspension. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicinal product contains small amounts of ethanol, less than 100 mg in each ml of reconstituted suspension.
This medicinal product contains less than 1 mmol (23 mg) sodium in each ml of reconstituted suspension, that is to say essentially sodium free.
Driving and using machines: Curam can have side effects and the symptoms may make the patient unfit to drive. Do not drive or operate machinery unless the patient is feeling well.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions the patient needs to look out for: Allergic reactions: skin rash; inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body; fever, joint pain, swollen glands in the neck, armpit or groin; swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing; collapse.
Contact a doctor immediately if the patient gets any of these symptoms. Stop taking Curam.
Inflammation of large intestine: Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
Contact the doctor as soon as possible for advice if the patient gets these symptoms.
Very common side effects (may affect more than 1 in 10 people): diarrhoea (in adults).
Common side effects (may affect up to 1 in 10 people): thrush (candida - a yeast infection of the vagina, mouth or skin folds); feeling sick (nausea), especially when taking high doses. If affected take Curam with a meal; vomiting; diarrhoea (in children).
Uncommon side effects (may affect up to 1 in 100 people): skin rash, itching; raised itchy rash (hives); indigestion; dizziness; headache.
Uncommon side effects that may show up in the blood tests: increase in some substances (enzymes) produced by the liver.
Rare side effects (may affect up to 1 in 1,000 people): skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme).
If the patient notices any of these symptoms contact a doctor urgently.
Rare side effects that may show up in the blood tests: low number of cells involved in blood clotting; low number of white blood cells.
Frequency not known (frequency cannot be estimated from the available data): Other side effects have occurred in a very small number of people but their exact frequency is unknown.
Allergic reactions (see previously mentioned).
Inflammation of the large intestine (see previously mentioned).
Inflammation of the protective membrane surrounding the brain (aseptic meningitis).
Serious skin reactions: a widespread rash with blisters and peeling skin, particularly around the mouth, nose eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis); widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis); a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis); flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
Contact a doctor immediately if the patient gets any of these symptoms: inflammation of the liver (hepatitis); jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow; inflammation of tubes in the kidney; blood takes longer to clot; hyperactivity; convulsions (in people taking high doses of Curam or who have kidney problems); black tongue which looks hairy; stained teeth in children, usually removed by brushing (oral suspension only).
Side effects that may show up in the blood or urine tests: severe reduction in the number of white blood cells; low number of red blood cells (haemolytic anaemia); crystals in urine.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
The patient can also report side effects directly via the national reporting system. By reporting side effects the patient can help provide more information on the safety of this medicine.
Other medicines and Curam: Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.
If the patient is taking allopurinol (used for gout) with Curam, it may be more likely that they'll have an allergic skin reaction.
If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Curam.
If medicines to help stop blood clots (such as warfarin) are taken with Curam then extra blood tests may be needed.
Curam can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Curam may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.
Oral suspension: Instructions for reconstitution: Check cap seal is intact before using. Shake bottle to loosen powder. Fill the bottle with water to just below the mark on bottle label, invert and shake well, then top up with water exactly to the mark, invert and again shake well.
A 5 ml syringe marked at each half ml is provided with this medicine. It comes with an adaptor which fits onto the bottle.
To measure the medicine: Shake the bottle.
Put the adaptor into the mouth of the bottle.
Put the end of the syringe into the adaptor.
Turn the bottle upside down.
Pull the plunger to measure the dose the patient needs.
Turn the bottle upright, remove the syringe, leave the adaptor on the bottle and close the bottle.
Do not store above 25°C. Store in the original package, in order to protect from moisture.
Oral suspension: After preparation of the ready-to-use suspension: Store in a refrigerator (2°-8 °C) and use within 7 days.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines the patient no longer uses. These measures will help protect the environment.
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
FC tab 625 mg (white to light-yellow, oval, biconvex and scored on both sides) x 3 x 5's. Powd for oral susp (off-white) 156.25 mg/5 mL x 100 mL x 1's. 312.5 mg/5 mL x 100 mL x 1's.
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