Amoksiklav Injection 1.2g – Co-amoxiclav is an antibiotic that 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

Amoksiklav Injection 1.2g is used in adults and children to treat the following infections: • severe ear, nose and throat infections • respiratory tract infections • urinary tract infections • skin and soft tissue infections including dental infections • bone and joint infections • intra-abdominal infections • genital organ infections in women. Amoksiklav Injection 1.2g is used in adults and children to prevent infections associated with major surgical procedures.

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: Adults and children weighing 40 kg and over:

Standard dose:  1.2g every 8 hours.

To stop infections during and after surgery:

1.2g before the surgery when you are given your anaesthetic. The dose can differ depending on the type of operation you are having. Your doctor may repeat the dose if your surgery takes longer than 1 hour.

Children weighing less than 40 kg All doses are worked out depending on the child’s bodyweight in kilograms.

Children aged 3 months and over: 25 mg/5 mg for each kilogram of bodyweight every 8 hours.

Children aged less than 3 months or weighing less than 4 kg: 25 mg/5 mg for each kilogram of bodyweight every 12 hours

What you need to know before you have Amoksiklav

You should not have Amoksiklav: • 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 or throat. • if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. ➔ Do not take Amoksiklav if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Amoksiklav. Warnings and Precautions Talk to your doctor or pharmacist or nurse before having Amoksiklav if you: • have glandular fever • are being treated for liver or kidney problems • are not passing water regularly. If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Amoksiklav. 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 Amoksiklav or a different medicine. Conditions you need to look out for Amoksiklav 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 Amoksiklav, 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 Amoksiklav. This is because Amoksiklav can affect the results of these types of tests. Other medicines and Amoksiklav Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. • If you are taking allopurinol (used for gout) with Amoksiklav, it may be more likely that you will have an allergic skin reaction. • If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoksiklav. • If medicines to help stop blood clots (such as warfarin) are taken with Amoksiklav then extra blood tests may be needed. • Amoksiklav can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works. • Amoksiklav can affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works. Pregnancy, breast-feeding and fertility 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 Amoksiklav can have side effects and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you are feeling well. Amoksiklav contains sodium and potassium • Amoksiklav 500 mg/100 mg contains approximately 31.4 mg (1.4 mmol) of sodium (the main component of cooking/table salt) per vial, which is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult. This should be considered if you are on a controlled sodium diet. • Amoksiklav 500 mg/100 mg contains approximately 19.6 mg (0.5 mmol) of potassium per vial, which at less than 39 mg (1 mmol) is considered essentially ‘potassiumfree’. • Amoksiklav 1000 mg/200 mg contains approximately 62.9 mg (2.7 mmol) of sodium (the main component of cooking/table salt) per vial or bottle, which is equivalent to 3.2% of the recommended maximum daily dietary intake of sodium for an adult. This should be considered if you are on a controlled sodium diet. • Amoksiklav 1000 mg/200 mg contains approximately 39.3 mg (1.0 mmol) of potassium per vial or bottle. This should be considered by patients with kidney problems or patients on a controlled potassium diet.

Possible side effects

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 throat (angioedema), causing difficulty in breathing • collapse. ➔ Contact a doctor immediately if you get any of these symptoms. Stop taking Amoksiklav. 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 These may affect up to 1 in 10 people • thrush (candida – a yeast infection of the vagina, mouth or skin folds) • diarrhoea Uncommon side effects These 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 These 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. Frequency not known Frequency cannot be estimated from the available data. • 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 appear yellow • inflammation of tubes in the kidney • blood takes longer to clot • convulsions (in people taking high doses of Amoksiklav 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 (haemolytic anaemia) • crystals in urine. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

1000 mg/200 mg powder for injection/infusion • The active substances are amoxicillin and clavulanic acid.

Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg amoxicillin and potassium clavulanate equivalent to 200 mg of clavulanic acid.

Amoksiklav Intravenous is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist’s information. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date (EXP) shown on the carton. The expiry date refers to the last day of that month. Do not store above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

This product requires a prescription from your Doctor.

Please follow the instruction received from the pharmacy on how to forward your prescription to the pharmacy after you have paid for the medicine.

A prescription drug is a pharmaceutical medication that legally requires a medical prescription to be dispensed. To order this product you confirm that you are under the care of your doctor or consultant and have been given permission by them for purchase, fulfillment & use in treatment with their written consent

Delievry time are estimates. Can vary due to the time of day you order.

Delivery time estimate are subject to the courier company.

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