AMOXICILLIN 250 MG / 5ML ORAL SUSPENSION BP SUGAR FREE - patient leaflet, side effects, dosage

very rare effects (may occur in less than 1 in 10,000 people):

• Swelling of the face, lips, tongue, body or throat, difficulty in breathing or dizziness. These may be signs of a severe allergic reaction
• Rash or pinpoint flat red round spots under the skin surface or bruising of the skin due to inflammation of blood vessel walls caused by an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems.
• A delayed allergic reaction may occur 7 to 12 days after taking the medicine. Symptoms may include rash, fever, joint pains and enlargement of the lymph nodes especially under the arms
• Blistering of the skin, mouth, eyes and genitals, other serious skin reactions including itchy reddish purple patches on the skin, especially on the palms of hands and soles of the feet,

11

12

which is a skin reaction known as ‚erythema multiforme‘ hives, pustules, swelling, peeling, redness, pain, itching and scaling. These may be associated with fever, tiredness, headache and aching body

• Blood disorders including severe reduction in the number of white or red blood cells which may cause pale yellow skin, weakness, breathlessness, increased risk of bruising or bleeding, high temperature (fever), chills, a sore throat and make infections more likely
• Diarrhoea sometimes containing blood, pain and fever caused by inflammation of the large bowel (colon)
• People having treatment over a long period, males and the elderly must tell your doctor urgently if you find: yellowing of the skin or whites of the eyes, (jaundice), severe diarrhoea with bleeding, pale stools and dark urine, loss of appetite, stomach 13

discomfort which may be caused due to severe liver or blood problems.

The following side effects have also been reported:

Less than 1 in 10 people have experienced:

• Diarrhoea, indigestion, feeling sick
• Skin rash.

Less than 1 in 100 people have experienced:

• A mildly itchy rash (round, pink-red patches), ‚hive-like‘ swollen areas on their forearms, legs, palms, hands or feet.
• Being sick.

Less than 1 in 10,000 people have experienced:

• Tiredness, headache, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes. These may be symptoms of a type of anaemia

14

• Thrush (a yeast infection of the vagina, mouth or skin folds)
• Increased or decreased urine output, fever, rash, swelling of any area of the body or weight gain caused by kidney problems
• Fits (convulsions) which may be seen in patients taking high doses or with kidney problems, hyperactivity, dizziness
• Crystals in the urine which may cause cloudy urine or difficulty or discomfort when passing urine. Make sure to drink plenty of fluids to reduce the chance of these symptoms
• An increase in the length of time it takes to stop bleeding if you cut yourself or have a nosebleed
• Yellow, brown or black hairy tongue
• Tooth discolouration in children which usually returns to normal with brushing.

15

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 at:.

By reporting side effects you can help provide more information on the safety of this medicine.

Do not use your medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

If your doctor tells you to stop taking the medicine, please take any unused medicine back to your pharmacist to be destroyed. Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.

Acid, Colloidal Anhydrous Silica, Sorbitol (E420), Saccharin Sodium, Banana Flavour (containing Gum Arabic, Amyl Acetate, Amyl and Ethyl Butyrates, Euginol, Acetaldehyde, Citral, Ethyl and Allyl Heptanoates, Amyl Valerianate and Orange Oil), Quinoline Yellow E104 and Xanthan Gum.

Manufactured by RX Farma Ltd., Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR.

Product Licence Numbers:

PL 42671/0011

Date of revision: April 2019

If you would like this leaflet in a different format, please contact the licence holder at the above address.

19

11

81 mm

12

80 mm

13

80 mm

14

79.5 mm

15 k 16 k17

79 mm 78.5 mm 79 mm

18 I 19

78.5 mm 78 mm

Open size 809 MM

Removable Glue 4 mm wide

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

• 1. What Amoxicillin Oral Suspension is and what it is used for

• 2. What you need to know before you take Amoxicillin Oral Suspension

• 3. How to take Amoxicillin Oral Suspension

• 4. Possible side effects

• 5. How to store Amoxicillin Oral Suspension

• 6. Contents of the pack and other information

2

2

78.5 mm

• If you have glandular fever (a viral infection which causes a sore throat, high temperature (above 39 deg C (102.2 deg F)), tiredness, muscle pains and headache or lymphocytic leukaemia
• If you are pregnant or trying to become pregnant
• If you are breastfeeding
• If you are not passing water regularly
• If you suffer from any kidney problems.

If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.

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 on Amoxil. This is because Amoxil can affect the results of these tests.

5

Other medicines and Amoxicillin Oral Suspension

Amoxicillin Oral Suspension and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking any of the following:

• Anticoagulants (to prevent blood clotting) e.g. warfarin or phenindione, extra blood tests may be needed
• Probenecid or allopurinol (used to treat gout). It may be more likely to have allergic skin reaction
• Oral contraceptives (as it may not work properly and you will need to use other means of contraception e.g. a condom)
• Methotrexate (a cancer drug which can also be used to treat psoriasis)
• Dietary fibre supplements.

for liver function, let the doctor or nurse know you are taking amoxicillin because amoxicillin can affect the results of these tests.

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.

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.

Other special warnings

Thrush (a yeast infection of moist areas of the body) may develop if amoxicillin is used for a long time. If this occurs tell your doctor.

If you have been told by your doctor that you have an intolerance to

7

some sugars, contact your doctor before taking this medicine as it contains sorbitol (E420).

Driving and using machines

Amoxicillin Oral Suspension may very rarely cause dizziness and convulsions. Do not drive or operate machinery if it has this effect on you.

dose given below. For example if your infection is more serious, the dose might be doubled.

The doctor will decide what dose you need to take. Always take the medicine exactly as the doctor has told you. The dose will be on the pharmacist‘s label. If you are not sure, ask your doctor or pharmacist.

Carry on taking the medicine for as long as you have been told unless you have any problems. In that case, check with your doctor.

The recommended doses are as follows:

Adults: To treat an infection, you should usually take 250 mg of your medicine three times a day. This is two 5ml spoonfuls of Amoxicillin Oral Suspension 125 mg or one 5ml spoonful of Amoxicillin Oral Suspension 250 mg three times a day.

Use in children: The doctor will advise you of the dose.

9

It is important that you take your medicine at the right times of day. Space the doses out as evenly as possible throughout the day, at least 4 hours apart. Never give 2 doses in 1 hour. Do not give doses of Amoxicillin at night. If child has kidney problems the dose might be lower than the ususal dose. Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may reoccur or get worse. If some bacteria survive they can cause the infection to come back. Treatment should be continued for 2 to 3 days after the symptoms have gone. Thrush (a yeast infection of moist areas of the bosy) may develop if Amoxicillin is used for a long time.

If you take more Amoxicillin Oral Suspension than you should

You should contact your doctor or go to your nearest hospital casualty department immediately. Take the bottle with you so that the doctor knows

10

<0 CD

CD 3

0

CD

I E

CD cc

50 mm

Removable Glue 4 mm wide

Permanent Glue

4 mm wide

7 – …

। / 95 mm Booklet placement । coding & barcode etc.

37 mm Space for batch

CD

0)

0

0)

I E o CE

Each 5 ml contains 250 mg Amoxicillin (as trihydrate) as the active ingredient Also includes: Sorbitol E420 (See package leaflet for further information). TO THE PATIENT:

For oral use, use as instructed by a physician.

Read the package leaflet before use.

Store in a refrigerator. Do not freeze.

Keep tightly closed.

Shake well before each use.

Use within 7 days of preparation.

Complete the prescribed course of treatment.

KEEP OUT OF THE SIGHT AND REO OF CHILDREN

100 ml

CB

CD

◄—►

7 mm

AMOXICILLIN 250 MG/5 ML ORAL SUSPENSION BP SUGAR FREE

Powder for Oral Suspension

0)

0

E

CD

TO THE PHARMACIST: Do not store above 25°C. Toprepare, add 82ml of potable water and shake until all of the powder is dispersed.

Keep the bottle tightly closed. Store in the original package.

PL 42671/0011

MA Holder:

Cox Pharmaceutical Ltd., Elscot House, Arcadia Avenue, London, N3 2JU

135 mm

35 XI0 mm Space for batch coding.

Space for Batch details

Base Label

5 ____________k „____________­_6____________„ ,_______________7

79 mm " " 79.5 mm "" 80 mm

Amoxicillin #250 mg I #5 ml Oral Suspension

8

80 mm

9

81 mm

10

◄ ----1

7mm

95 mm