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AMOXICILLIN ORAL SUSPENSION BP 250MG/5ML

Active substance(s): AMOXICILLIN TRIHYDRATE

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Patient information leaflet
RESPILLIN 125 mg/5 ml AND 250 mg/5 ml (OPD Pharmaceuticals Ltd)
Read this leaflet carefully BEFORE you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have further questions, please ask your doctor or your pharmacist.
 This medicine has been prescribed for you personally and you should not pass it
on to others. It may harm them, even if their symptoms 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 Respillin is and what it is used for
2. What you need to know before you take Respillin
3. How to take Respillin
4. Possible side effects
5. How to store Respillin
6. Contents of the pack and other information
1. WHAT RESPILLIN IS AND WHAT IT IS USED FOR

Respillin is one of a group of antibiotic medicines called penicillins. Respillin kills bacteria
by interfering in the manufacture of the bacterial cell wall.
Respillin can treat a wide range of bacterial infections including the following:












chest (bronchitis or pneumonia)
tonsils (tonsillitis)
sinuses (sinusitis)
heart (endocarditis)
blood (septicaemia)
kidneys
ears (otitis media)
the bladder or the urethra (the tube which carries urine from the bladder),
infections associated with pregnancy and childbirth (puerperal sepsis and septic
abortion)
abdomen (intra-abdominal sepsis and peritonitis)
skin, bone, teeth and gums (abscesses).

Respillin can also be used to treat:
 gonorrhoea (a sexually transmitted infection)
 typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella).
Respillin may also be used in combination with other medicines to treat stomach ulcers.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RESPILLIN

Do not take Respillin if:






You are allergic to Respillin or any of the other ingredients of this medicine (listed in
section 6)
You have ever had a bad reaction or allergy to any penicillin-type antiobiotic
You are pregnant, planning to become pregnant or breast feeding?
You ever had a skin rash or swelling of the face or neck or shortness of breath when
taking any antibiotic?
You have an intolerance to some sugars (hereditary fructose intolerance)?

Prolonged use of an antibiotic may result in infections due to bacteria resistant to the
antibiotic.
This medicinal product contains sorbitol and sodium benzoate. Sorbitol is unsuitable for
people with hereditary fructose intolerance. It can cause stomach upset and diarrhoea.
Sodium benzoate is a mild irritant to the skin, eyes and mucous membranes. It may increase
the risk of jaundice (yellowing of the skin or the whites of the eyes) in newborn babies.
Warnings and precautions
Talk to your doctor or pharmacist before taking Respillin if:
 You suffer from kidney disease or kidney problems, as you may require a lower dose
than normal
 You are not passing urine regularly
 You have glandular fever
Having urine or blood tests:
If you are having urine tests for diabetes (sugar in the urine) or blood tests for liver function
let the doctor know. Respillin can affect the results of these tests.
Other Medicines and Respillin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, even those not prescribed by a doctor. In particular tell your doctor if you are
taking any of the following:
 )
 Anticoagulants e.g. warfarin, phenindione.
 Chemotherapy drugs e.g. methotrexate.
 Drugs used to treat gout (which can be caused by the build-up of uric acid) e.g.
probenecid, allopurinol, sulfinpyrazone
 Some other antibiotics (e.g. neomycin and tetracyclines can reduce the effect of respillin)
 Oral typhoid vaccine (may not work if taken with respillin)
 Some penicillins may increase the effects of muscle relaxing drugs given as part of an
anaesthetic for surgery. Tell the doctor you are taking respillin if you need to have an
anaesthetic.
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.

3. HOW TO TAKE RESPILLIN

Always take your medicine exactly as your doctor or pharmacist has told you. The
pharmacist's label should tell you how much to take and how often. If it does not or you are
not sure ask your doctor or pharmacist.
The maximum dose needed for most infections is 6 g daily given in divided doses.
Dosage:
Important: One teaspoon is equivalent to 5ml
Adults (including the elderly) and children over 10:




The usual dose for most infections is 5ml of 250mg/5ml to be taken 3 times a day
For more serious infections the dose may be doubled to 10ml of 250mg/5ml 3 times a
day
High doses may be given in the following conditions:
o For severe or recurrent chest infections a dose of 3 g twice daily given orally is
usually recommended
o For simple urinary tract infections the adult dose is two 3g doses given orally with 10
to 12 hours between doses (short course)
o For the treatment of dental abscesses two 3g doses given orally with 8 hours between
doses is recommended
o For gonorrhoea a single 3g dose given orally is recommended

The following are the usual adult dosages for preventing infection during dental
procedures or other surgery:
 If a general anaesthetic is not used, 3g given orally one hour before surgery and another
dose six hours later if necessary
 If a general anaesthetic is used, 3g given orally four hours before anaesthesia and 3g six
hours after the initial dose
 Children under 10:
 The usual dose for most infections is 5ml of 125mg/5ml to be given 3 times a day (or
2.5ml of 250mg/5ml 3 times a day)
 For more serious infections the dose may be doubled to 10ml of 125mg/5ml 3 times a day
(or 5ml of 250mg/5ml 3 times a day).
 In severe or frequent ear infections, a dose of 750mg (15 ml of the 250mg/5ml) may be
given twice a day for two days in children aged 3 to 10 years
If you take more Respillin than you should
If you take more Respillin than you should, tell your doctor or pharmacist immediately. You
should take this leaflet and any medicine you still have to show the doctor.
Severe cases of nausea, vomiting and diarrhoea can be treated with rehydration therapy, by
drinking fluids containing sodium, water and sugar to prevent dehydration.
If you forget to take Respillin
If you forget to take a dose, take it as soon as you remember, unless it is within an hour of
your next dose, then carry on as before. Do not take a double dose to make up for a forgotten
dose.

If you stop taking Respillin
Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop
taking it just because you feel better. If you stop taking the medicine, some bacteria may
survive and cause the infection to come back, or your condition may re-occur or get worse.
You should make sure you have several drinks of water each day unless told otherwise by
your doctor.
If you are still unwell after taking all the medicine, go and see your doctor. Never take more
than the recommended dose each day.
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.
If you or your child experience any of the following events STOP taking your medicine
and tell your doctor or go to your nearest hospital immediately:








Hypersensitivity or severe allergic reaction including swollen face or breathing problems.
If these symptoms occur, STOP taking respillin right away and tell your doctor.
Severe diarrhoea with bleeding
Allergic skin reactions with itching e.g. hives, nettle rash, blistering or peeling of the skin.
If you start to itch or get a rash, STOP taking respillin and tell your doctor immediately.
Convulsions may occur in patients on high doses or with kidney problems
Notice your urine becoming darker or your faeces becoming paler
Notice your skin or the white of your eyes turning yellow (jaundice)
Difficulty or discomfort in passing urine or having cloudy urine

The following symptoms are less serious but you may wish to discuss them with your
doctor or pharmacist if they become troublesome or last a long time.
Common side effects of respillin (i.e. more than 1 in 100 people):
 Nausea (feeling sick) or diarrhoea
Uncommon side effects (i.e. between 1 in 100 and 1 in 1,000 people):
 Vomiting
Very rare side effects (i.e. less that 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.
 Tooth discolouration. The colour usually returns to normal with brushing.
 Blackening of the tongue
 Inflammation of the kidney.
 Excessive body movements (hyperkinesia) or dizziness
 Reduction (reversible) in blood cell counts including anaemia (a reduction in the body’s
red blood cells or haemoglobin which may be characterised by feeling weak or lightheaded) or a longer time taken for blood to clot. Tell our doctor that you are taking
respillin if you are having blood tests.
 Crystalluria (forming of crystals in the urine)
Not known (frequency cannot be estimated from available data)
 Meningitis (signs may include stiff neck, fever and vomiting)

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 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 RESPILLIN
KEEP ALL MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use this medicine after the expiry date which is printed on the pack. This medicine
should be used within 14 days of the date dispensed.
Store below 25°C in a dry place, away from direct light.
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 protect the
environment.

6. CONTENT OF PACK AND OTHER INFORMATION
The pharmacist will prepare the suspension for you by adding water to the dry powder.
What Respillin looks like and contents of the pack
Respillin 125 mg/5 ml: White, lime flavoured suspension. Each 5 ml contains amoxicillin
trihydrate equivalent to 125 mg respillin, the active ingredient.
Respillin 250 mg/5 ml: White, lime flavoured suspension. Each 5 ml contains amoxicillin
trihydrate equivalent to 250 mg respillin, the active ingredient.
The suspension also contains the inactive ingredients saccharin sodium, sodium citrate,
microcrystalline cellulose and carboxymethylcellulose sodium, disodium edetate, sorbitol,
preservative (sodium benzoate E21 l), lime flavour, and water.
125 mg suspension: Each 5 ml of suspension contains 3 mg sodium and up to 1.54 g of
sorbitol.
250 mg suspension: Each 5 ml of suspension contains 3.3 mg sodium and up to 1.38g of
sorbitol.
Pack sizes: 60ml and 100ml bottles.
MA holder/Manufacturer:
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Distributed by:
Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL
Marketing authorisation numbers:
Respillin 125 mg/5 ml: PL 30464/0009
Respillin 250 mg/5 ml: PL 30464/0010
This Leaflet was last revised in 08th December 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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