AMOXICILLIN 125 MG / 5ML ORAL SUSPENSION BP - patient leaflet, side effects, dosage

15. How to store this medicine |

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Keep the bottle tightly closed. Store in the original packaging.
• Do not use this medicine after the expiry date shown on the label after EXP. The expiry date refers

to the last day of that month.

• 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.

| 6. Contents of the pack and other information |

What Amoxicillin Oral Suspension SF contains

• There are two strengths available, each 5ml of the suspension either contains 125mg or 250mg of the active ingredient Amoxicillin (as amoxicillin trihydrate).
• The other ingredients are: sodium benzoate (E211), disodium edetate, sodium citrate, citric acid anhydrous, sorbitol (E420), colloidal anhydrous silica, saccharin sodium, banana flavour, quinoline yellow (E104) and xanthan gum.

Amoxicillin Oral Suspension SF is a banana flavoured suspension.

Amoxicillin Oral Suspension is presented as a powder in bottles for preparing 100ml of suspension.

Marketing Authorisation Holder and Manufacturer

Name and address:

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted,

Hertfordshire, United Kingdom, HP4 1EG

Telephone: 0044 (0)1442 200922

Fax: 0044(0)1442 873717

Email:

| 3. How to take this medicine |

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

• Shake bottle well before each dose.
• Space the doses evenly during the day, at least 4 hours apart

The usual dose is:

Children weighing less than 40 kg

• All doses are worked out depending on the child's body weight in kilograms.
• Your doctor will advise you how much Amoxicillin you should give to your baby or child.
• The usual dose is 40 mg to 90 mg for each kilogram of body weight a day given in two or three

divided doses.

• The maximum recommended dose is 100 mg for each kilogram of body weight a day.

Adults, elderly patients and children weighing 40 kg or more

This suspension is not usually prescribed for adults and children weighing more than 40 kg. Ask your doctor or pharmacist for advice.

Kidney problems

If you have kidney problems the dose might be lower than the usual dose.

If you take more Amoxicillin than you should

If you have taken too much Amoxicillin, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems urinating. Talk to your doctor as soon as possible. Take the medicine to show the doctor.

If you forget to take Amoxicillin

• If you forget to take a dose, take it as soon as you remember.
• Do not take the next dose too soon, wait about 4 hours before taking the next dose.
• Do not take a double dose to make up for a forgotten dose.

How long should you take Amoxicillin for?

• Keep taking Amoxicillin for as long as your doctor has told you to, even if you feel better. You need

every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.

• Once you finish treatment, if you still feel unwell you should go back to see the doctor.

Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and white discharge) may develop if Amoxicillin is used for a long time. If this occurs tell your doctor.

If you take Amoxicillin for a long time, your doctor may perform additional tests to check your kidneys, liver and blood are working normally.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

| 4. Possible Side Effects |

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Amoxicillin and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:

The following are very rare (may affect up to 1 in 10,000 people)

• allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue,

body or breathing difficulties. These can be serious and occasionally deaths have occurred

• rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to

inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems

• a delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin, some signs

include: rashes, fever, joint pains and enlargement of the lymph nodes especially under the arms

• a skin reaction known as ‚erythema multiforme‘ where you may develop: itchy reddish purple

patches

• on the skin especially on the palms of the hands or soles of the feet, ‚hive-like‘ raised swollen areas

on the skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired

• other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering,

pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches

• 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)).

• fever, chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs

of a problem with your blood cells

What is in this leaflet:

• 1. What this medicine is and what it is used for

• 2. What you need to know before you take this medicine

• 3. How to take this medicine

• 4. Possible side effects

• 5. How to store this medicine

• 6. Contents of the pack and other information

14 MM BLANK FOR GLUE AREA

| 1. What this medicine is and what it is used for |

Amoxicillin is an antibiotic. The active ingredient is amoxicillin. This belongs to a group of medicines called ‚penicillin‘.

Amoxicillin is used to treat infections caused by bacteria in different parts of the body. Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.

| 2. What you need to know before you take this medicine |

Do not take this medicine if you:

• Are allergic to amoxicillin, PENICILLINS, cephalosporins or to any of the other ingredients

of this medicine (listed in section 6).