Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Stop taking Amoxicillin 3g Sachets 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 (affects less than 1 in 10,000 people)

1. What Amoxicillin 3g Sachets is and what it is used for

Amoxicillin Sugar Free 3g Powder for Oral Suspension Sachets (in this leaflet it will be referred to as 'Amoxicillin 3g Sachets') is an antibiotic. The sachets contain a medicine called amoxicillin. This belongs to a group of medicines called 'penicillins'.

Amoxicillin is used to treat infections in different parts of the body caused by bacteria. It is also used to stop infections when you have a tooth removed or other surgery, if you are likely to have an infection of the heart called bacterial endocarditis.

2. What you need to know before you take Amoxicillin 3g Sachets

Do not take Amoxicillin 3g Sachets if you:

•    are allergic (hypersensitive) to amoxicillin, penicillin or any of the other ingredients of Amoxicillin 3g Sachets (listed in section 6)

•    have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash or swelling of the face or neck.

Do not take Amoxicillin 3g Sachets if any of the above applies. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin 3g Sachets.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

•    have glandular fever

•    are being treated for kidney problem

•    are not passing water regularly.

•    are using oral anticoagulant.

If you are not sure, if any of above applies to you, talk to your doctor or pharmacist before taking amoxicillin.

Having urine or blood tests If you are having tests on your water (urine glucose tests) or blood tests for liver function, let the doctor or nurse know that you are taking Amoxicillin. This is because Amoxicillin may affect the results of these tests.

Other medicines and Amoxicillin 3g Sachets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines that can be bought without a prescription and herbal medicines. This is because amoxicillin can affect the way some other medicines work. Also some other medicines can affect the way amoxicillin works.

•    If you are taking allopurinol (used for gout) with amoxicillin, it may be more likely that you'll have an allergic skin reaction.

•    If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of amoxicillin.

•    If medicines to help stop blood clots (such as warfarin) are taken with amoxicillin then extra blood tests may be needed.

•    Amoxicillin may stop the contraceptive pill working. You will need to use extra contraceptive precautions, such as using a condom. If you need any advice, talk to your doctor or pharmacist.

•    Some other antibiotics (e.g. Neomycin and tetracyclines can reduce the effect of amoxicillin)

Amoxicillin 3g Sachets with food and drink

Check with your doctor or pharmacist before taking this medicine if:

•    You are taking guar gum (used as a thickening agent and normally found in puddings, ice-cream and benefiber) as it can reduce the absorption of Amoxicillin.

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 or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin 3g Sachets has no effect on the ability to drive and use machines.

Important information about some of the ingredients of Amoxicillin 3g Sachets

•    Amoxicillin 3g Sachets does not contain sugar.

•    Amoxicillin 3g Sachets contains 4.2 g of sorbitol (E420). If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

•    Each sachet contains 11.9 mg of sodium. This should be considered if you are on a controlled sodium diet.

3. How to take Amoxicillin 3g Sachets

Always take this medicine exactly as your doctor has told you. Your doctor will tell you how many sachets you should take. You should check with your doctor or pharmacist if you are not sure.

When taking Amoxicillin 3g Sachets

•    Instructions for reconstitution: Check that the sachet is intact before use

1.    Cut sachet along dotted line.

2.    Empty contents into a glass

3.    Half-fill sachet with water

4.    Pour into the glass, stir well and drink immediately

•    The maximum recommended dose is 6 g per day given as 2 x 3 g sachets.

•    Space the doses evenly during the day, at least 4 hours apart. If you need to have 2 sachets in a day, have one in the morning and one in the evening unless your doctor has advised otherwise.

•    Never take 2 doses in 1 hour.

Usual dose is:

Children aged under 10 years

Amoxicillin 3g Sachets is not recommended.

Adults, elderly patients and children weighing more than 40 kg

•    Severe or recurrent chest infection: 3 g (1 x sachet) twice a day.

•    Urinary tract (water) infection: 2 x 3 g doses (2 x sachets) with 10 to 12 hours between each dose.

•    Dental abscess (infection under the gums and teeth): 2 x 3 g doses (2 x sachets) with 8 hours between each dose.

•    Gonorrhoea (a sexually transmitted infection): 1 x 3 g dose (1 x sachet).

To stop infection during surgery

•    The dose will vary according to the type of surgery. Other medicines may also be given at the same time.

•    Your doctor, pharmacist or nurse can give you more details.

Kidney problems

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

If you take more Amoxicillin 3g Sachets than you should

If you have too much Amoxicillin 3g Sachets, 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 passing urine. Talk to your doctor as soon as possible. Take the medicine to show the doctor.

•    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 3g Sachets, 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 private parts. 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

•    high temperature (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

•    inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever

•    serious liver side effects may occur which are often reversible. They are mainly associated with people having treatment over a long period, males and the elderly.

You must tell your doctor urgently if you get:

-    severe diarrhoea with bleeding

-    blisters, redness or bruising of the skin

-    darker urine or paler stools

-    yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which

-    might result in jaundice.

These can happen when having the medicine or for up to several weeks after.

If any of the above happen stop taking the medicine and see your doctor straight away. Sometimes you may get less severe skin reactions such as:

a mildly itchy rash (round, pink-red patches), 'hive-like' swollen areas on forearms, legs, palms, hands or feet. This is uncommon (affects less than 1 in 100 people).

If you have any of these talk to your doctor as Amoxicillin 3g Sachets will need to be stopped.

The other possible side effects are:

Common (affects less than 1 in 10 people)

•    skin rash

•    feeling sick (nausea)

•    diarrhoea

Uncommon (affects less than 1 in 100 people)

•    being sick (vomiting)

•    itching

Very rare (affects less than 1 in 10,000 people)

•    thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist

•    kidney problems

•    fits (convulsions), seen in patients on high doses or with kidney problems

•    dizziness

•    hyperactivity

•    crystals in the urine, which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms

•    teeth may appear stained, usually returning to normal with brushing (this has been reported in children)

•    the tongue may change to yellow, brown or black and it may have a hairy appearance

•    an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes

•    the blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or cut yourself.

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. You can also report side effects directly via 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 Amoxicillin 3g Sachets

•    Keep this medicine out of the sight and reach of children.

•    Do not use Amoxicillin 3g Sachets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

•    Before reconstitution: Store below 25°C.

•    In use shelf-life following reconstitution: To be used immediately.

•    Do not use Amoxicillin 3g Sachets if the sachets have been tampered with or opened.

•    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 Amoxicillin 3g Sachets contains

•    The active substance is amoxicillin. Each sachet contains 3g amoxicillin (as trihydrate)

•    The other ingredients are sorbitol (E 420), saccharine sodium (E 954), xanthan gum (E 415), colloidal anhydrous silica (E 551), raspberry flavour, orange flavour & golden caramel flavour.

•    See also important information about some of the ingredients of Amoxicillin 3g Sachets in section 2.

What Amoxicillin 3g Sachets looks like and contents of the pack

Amoxicillin 3g Sachets are packaged in a carton.

Each pack contains 2 or 14 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Brown & Burk UK Ltd 5 Marryat Close Hounslow West Middlesex TW4 5DQ United Kingdom

This leaflet was last approved in 06/2014.