Megamox 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 “penicillin” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.
Megamox is used in babies 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.

Do not give your child Megamox:

• If they are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Megamox (listed in section 6)
• If they 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 they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Megamox to your child if any of the above apply to your child. If you are not sure, talk to their doctor or pharmacist before giving Megamox.
 

Warning and precautions
Check with their doctor, pharmacist or nurse before giving your child Megamox if they:

• 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 your child, talk to their doctor or pharmacist before giving Megamox.
In some cases, your doctor may investigate the type of bacteria that is causing your child’s infection. Depending on the results, your child may be given a different strength of Megamox or a different medicine.
Conditions you need to look out for
Megamox 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 your child is taking Megamox, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.
 

Blood or urine tests
If your child 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 Megamox. This is because Megamox can affect the results of these types of tests.
Other medicines and Megamox
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

• If your child is taking allopurinol (used for gout) with Megamox, it may be more likely that you’ll have an allergic skin reaction.
• If your child is taking probenecid (used for gout), his doctor may decide to adjust his dose of Megamox.
• If medicines to help stop blood clots (such as warfarin) are taken with Megamox then extra blood tests may be needed.
• Megamox can affect how methotrexate (a medicine used to treat cancer or rheumatic disease) works.
• Megamox may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy and breast feeding
If your child who is about to take this medicine is pregnant or breast-feeding, thinks they may be pregnant or are planning to have a baby, ask their doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Megamox can have side effects and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.
Megamox contains aspartame and maltodextrin:

• Megamox contains aspartame (E951) which is a source of phenylalanine. This may be harmful for children born with a condition called ’phenylketonuria’.
• Megamox contains maltodextrin (glucose). If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg or over
This suspension is not usually recommended for adults and children weighing 40 kg and over. Ask your doctor or pharmacist for advice.
Children weighing less than 40 kg
All doses are worked out depending on the child’s bodyweight in kilograms.

• Your doctor will advise you how much Megamox you should give to your baby or child.
• You may be provided with a measuring cup. You should use this to give the correct dose to your baby or child.
• Recommended dose – 20 mg/5mg to 60mg/15 mg for each kilogram of body weight a day, given in three divided doses.

Patients with kidney and liver problems

• If your child has kidney problems the dose might be lowered. A different strength or a different medicine may be chosen by your doctor.
•  If your child has liver problems they may have more frequent blood tests to see how their liver is working.

How to give Megamox

• 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 your child Megamox for more than 2 weeks. If your child still feels unwell they should go back to see the doctor.

If you give more Megamox than you should
If you give your child too much Megamox, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to their doctor as soon as possible. Take the medicine bottle to show the doctor.
If you forget to give Megamox
If you forget to give your child a dose, give it as soon as you remember. You should not give your child the next dose too soon, but wait about 4 hours before giving the next dose. Do not take a double dose to make up for a forgotten dose.
If your child stops taking Megamox
Keep giving your child Megamox until the treatment is finished, even if they feel better. Your child needs every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.
If you have any further questions on the use of this medicine, 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 your child gets any of these symptoms. Stop taking Megamox.

• 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 your child gets these symptoms.
Very common side effects
These may affect more than 1 in 10 people:

• diarrhoea (in adults).

Common side effects
These 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 Megamox with a meal
• vomiting
• diarrhoea (in children).

Uncommon side effects
These 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 blood tests:

• Increase in some substances (enzymes) produced by the liver.

Rare side effects
These may affect up to 1 in 1000 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.

Rare side effects that may show up in blood tests:

• low number of cells involved in blood clotting
• Low number of white blood cells.

Frequency not known
Frequency cannot be estimated from 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).
Contact a doctor immediately if your child 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 child’s 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 Megamox or who have kidney problems)
• black tongue which looks hairy
• Stained teeth (in children), usually removed by brushing.

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

• severe reduction in the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• Crystals in urine.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Keep this medicine out of the sight and reach of children.
Dry powder
Store in the original package in order to protect from moisture.
Store below 30°C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. The expiry date which is stated on the bottle label is for the pharmacist’s use.
Liquid suspension
Store in a refrigerator (2°C - 8°C). Do not freeze.
Once made up, the suspension should be used within 7 days.
Do not throw away any medicines via wastewater or household waste. Ask our pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.