Amoclan 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.

Amoclan 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.

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

Do not take Amoclan

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

Warnings and Precautions

Talk to your doctor or pharmacist or nurse before  having Amoclan 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 Amoclan.

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 Amoclan or a different medicine.

Conditions you need to look out for

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

Taking other medicines, herbal or dietary supplements

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 Amoclan,  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 Amoclan.
• If medicines to help stop blood clots (such  as warfarin) are taken  with Amoclan then extra blood tests may be needed.
• Amoclan can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
• Amoclan can 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

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

Important information about  some of the ingredients of Amoclan

Amoclan contains sodium and potassium:

Amoclan 500 mg/100  mg and 1000 mg/200  mg contain  sodium.  This should  be considered if you are on a controlled  sodium  diet.

Amoclan 500 mg/100  mg and 1000 mg/200  mg contain  potassium. This should be considered by patients with kidney problems or patients on a controlled potassium diet.

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: 1000 mg/200  mg every 8 hours.
• To stop infections  during and after surgery: 1000 mg/200  mg 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.

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 Amoclan will be given to you

• Amoclan will be given as an injection into a vein or by intravenous infusion.
• Make sure you drink plenty of fluids while having Amoclan.   
• You will not normally be given Amoclan for longer than 2 weeks without the doctor reviewing your treatment.

If you take more Amoclan than you should

It is unlikely you will be given too much,  but if you think you have  been given too much Amoclan,  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 throat (angioedema), causing difficulty in breathing
• Collapse.

Contact a doctor immediately  if you get any of these symptoms. Stop taking Amoclan.

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 puscontaining blisters  (bullous exfoliative dermatitis)

‐ A red, scaly rash  with bumps under  the skin and blisters  (exanthemous pustulosis).

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 Amoclan 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.

The hospital  will keep Amoclan according to the correct  storage conditions.

Keep out of the reach and sight of children.

Store  dry powder  below 25°C. Store  in the original carton.

The doctor,  pharmacist or nurse will make  up your medicine. It should  be used within 20 minutes of reconstitution.

Do not use Amoclan after the expiry date  which is stated on the label and carton  after Exp. Date. The expiry date  refers  to the last day of that month.

Do not use  Amoclan if you notice visible signs  of deterioration.

Medicines should  not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect  the environment.