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:

·       severe ear, nose and throatinfections

·       respiratory tractinfections

·       urinary tract infections

·       skin and soft tissue infections including dental infections

·       bone and joint infections

·       intra-abdominal infections

·       genital organ infections inwomen.

Curam is used in adults and children to prevent infections associated with major surgical procedures.

Do not take Curam:

·       if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6)

·       if you have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face orthroat

·       if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Curam if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Curam.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Curam if you:

·       have glandular fever

·       are being treated for liver or kidney problems

·       are not passing waterregularly.

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Curam.

In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given a different strength of Curam or a different medicine.

Conditions you need 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. You must look out for certain symptoms while you are taking Curam, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.

Blood and urine tests

If you are 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 you are taking Curam.

. This is because Curam can affect the results of these types of tests.

Other medicines and Curam

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) with Curam, it may be more likely that you’ll have an allergic skin reaction.

If you are taking probenecid (used for gout), your doctor may decide to adjust your 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.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.

Driving and using machines

Curam can have side effects and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

500 mg/100 mg powder for injection or infusion

·       Curam, 500 mg/100 mg contains approximately 31.4 mg (1.4 mmol) of sodium. This is equivalent to 1.57 % of the recommended maximum daily

You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this medicine.

The recommended doses are:

Curam, 500/100 mg and Curam, 1000/200 mg

Adults, and children weighing 40 kg and over

Children weighing less than 40 kg

•  All doses are worked out depending on the child’s bodyweight in kilograms.

Patients with kidney and liver problems

·       If you have kidney problems you may be given a different dose. A different strength or a different medicine may be chosen by your doctor.

·       If you have liver problems your doctor will keep a close check on you and you may have more regular liver function tests.

How Curam will be given to you

·       Curam will be given as an injection into a vein or by intravenous infusion.

·       Make sure you drink plenty of fluids while having Curam.

·       You will not normally be given Curam for longer than 2 weeks without the doctor reviewing yourtreatment.

If more Curam is given to you than recommended

It is unlikely you will be given too much, but if you think you have been given too much Curam, tell your doctor, pharmacist or nurse immediately. Signs may be an upset stomach (feeling sick, being sick or diarrhoea) or convulsions.

If you have any further questions about how this medicine is given, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

Conditions you need 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 mouth (angioedema), causing difficulty in breathing

·       collapse.

Contact a doctor immediately if you get 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 your doctor as soon as possible for advice if you get these symptoms.

Common side effects (may affect up to 1 in 10 people)

·       thrush (candida - a yeast infection of the vagina, mouth or skin folds)

·       diarrhoea

Uncommon side effects (may affect up to 1 in 100 people)

·       skin rash, itching

·       raised itchy rash (hives)

·       feeling sick (nausea), especially when taking high doses

·       vomiting

·       indigestion

·       dizziness

·       headache.

Uncommon side effects that may show up in your 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 you notice any of these symptoms contact a doctor urgently.

·       swelling and redness along a vein which is extremely tender when touched

Rare side effects that may show up in your blood tests:

·       low number of cells involved in blood clotting

·       low number of white blood cells

Other side effects

Other side effects have occurred in a very small number of people but their exact frequency is unknown.

·       Allergic reactions (see above)

·       Inflammation of the large intestine (see above)

·       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 you get 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 appearyellow

·       inflammation of tubes in the kidney

·       blood takes longer to clot

·       convulsions (in people taking high doses of Curam or who have kidney problems).

Side effects that may show up in your blood or urine tests:

·       severe reduction in the number of white blood cells

·       low number of red blood cells (haemolyticanaemia)

·       crystals in urine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25ºC.

Keep the container in the outer carton.

Reconstituted solution:

Chemical and physical in-use stability has been demonstrated for the reconstituted solution for injection for 15 minutes if stored at 25 °C and for the reconstituted solution for infusion 60 minutes if stored at 25 °C.

From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the injection and infusion solutions should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This measure will help protect the environment.