Amoclan 125 Mg/31.25 Mg/5 Ml Powder For Oral Suspension
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start giving your child this
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine is usually prescribed for a baby or child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. See section 4.
In this leaflet:
1. What Amoclan 125 mg/31.25 mg/5 ml powder for oral suspension is and what it is used for
2. What you need to know before you take Amoclan
3. How to give this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT AMOCLAN 125MG/ 31.25 MG/5 ML POWDER FOR ORAL SUSPENSION IS AND WHAT IT IS USED FOR
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 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOCLAN Do not give your child this medicine:
• if they are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the other ingredients of this medicine (listed in section 6)
• if they have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck
• if they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
gDo not give this medicine 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 this medicine.
Take special care with this medicine:
Check with their doctor or pharmacist before giving your child this medicine 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 this medicine.
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 this medicine or a different medicine.
Conditions you need to look out for
This medicine 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 this medicine, 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, let the doctor or nurse know that they are taking this medicine. This is because this medicine can affect the results of these types of tests.
Using other medicines
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.
• If your child is taking allopurinol (used for gout) with this medicine, it may be more likely that they will have an allergic skin reaction.
• If your child is taking probenecid (used for gout), your doctor may decide to adjust the dose of this medicine.
• If medicines to help stop blood clots (such as warfarin) are taken with this medicine then extra blood tests may be needed.
This medicine can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Pregnancy and breast-feeding
If your child who is about to take this medicine is pregnant or breast-feeding, please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients in this medicine
Each 5 ml of suspension contains Potassium and Sodium. Therefore, this medicine may not be suitable for your child if he/she is on a controlled potassium diet, controlled sodium diet or if he/she has reduced kidney function. Check with your doctor if you are unsure about this.
This medicine also contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.
3. HOW TO GIVE THIS MEDICINE
Always give this medicine exactly as your doctor has told you. You should 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 Amoclan you should give to your baby or child.
• You may be provided with a plastic measuring spoon or measuring cup.
You should use this to give the correct dose to your baby or child.
• Usual 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 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 this medicine
• Always shake the bottle well before each dose
• Give at the start of a meal or slightly before
• 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 this medicine for more than 2 weeks. If your child still feels unwell they should go back to see the doctor.
If you give more of this medicine than you should
If you give your child too much of this medicine, 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 this medicine
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.
If your child stops taking this medicine
Keep giving your child this medicine 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.
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
4. You should not give antibiotics that were prescribed for you to other people.
5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.
Section 3 continued
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
^Contact a doctor immediately if your child gets any of these symptoms. Stop taking this medicine.
• Inflammation of large intestine
Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
• 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
• 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
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 Gif affected take this medicine before food
• diarrhoea (in children)
Uncommon side effects
These may affect up to 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
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)
Gif 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
Other side effects
Other side effects have occurred in a very small number of people but their exact frequency is unknown.
• blood takes longer to clot
• convulsions (in people taking high doses of this medicine or who have kidney problems)
• black tongue which looks hairy
• stained teeth (in children), usually removed by brushing.
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. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE THIS MEDICINE
Store the reconstituted suspension at 2°C-8°C. Do not freeze.
Discard any unused suspension after 7 days.
Store in the original container. Keep the container tightly closed.
Keep out of the reach and sight of children.
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.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What this medicine contains
• The active substances are: amoxicillin (as trihydrate) 125 mg; clavulanic acid (as potassium clavulanate) 31.25 mg.
• The other ingredients are xantham gum, succinic acid, colloidal silicon dioxide, sodium saccharin, hydroxypropyl methyl cellulose, strawberry powder flavour (containing benzyl alcohol and ethanol), orange powder flavour, lemon powder flavour, silicon dioxide.
What this medicine looks like and contents of the pack
When prepared as directed this medicine is an off-white suspension with a fruity flavour. It comes in a 125 ml amber glass bottle with a white aluminium screw cap.
Marketing Authorisation Holder & Manufacturer
Hikma Farmaceutica (Portugal) S.A., Estrada do Rio da Mo, N°8, 8A e 8B, Ferven9a, 2705-906 Terrugem SNT, Portugal.
This leaflet was last approved in 06/2015
Instructions for reconstitution
Check cap seal is intact before using. Shake bottle to loosen powder. Add volume of water (as indicated below) invert and shake well.
Volume of water to be added At reconstitution (ml)
At reconstitution (ml)
125 mg/31.25 mg/5 ml
Shake the bottle well before each dose.
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)
Actavis, Barnstaple, EX32 8NS, UK
• crystals in urine