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AMOXICILLIN ORAL SUSPENSION BP 125MG/5ML

Active substance(s): AMOXICILLIN TRIHYDRATE

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Package leaflet: Information for the user
Amoxicillin Sugar Free Oral Suspension
125 mg/5 ml AND 250 mg/5 ml
Amoxicillin (as amoxicillin trihydrate)
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 pharmacist.
 This medicine has been prescribed for you (or your child) 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
1.

What Amoxicillin Oral Suspension is and what it is used for

What Amoxicillin Oral Suspension is
Amoxicillin Oral Suspension is one an antibiotic. The active ingredient is amoxicillin. This
belongs to a group of medicines called ‘penicillin’.
What Amoxicillin Oral Suspension is used for
Amoxicillin Oral Suspension is used to treat infections caused by bacteria in different parts of
the body.
Amoxicillin Oral Suspension 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).

Amoxicillin Oral Suspension can also be used to treat:
 gonorrhoea (a sexually transmitted infection)

0003



typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella).

Amoxicillin Oral Suspension may also be used in combination with other medicines to treat
stomach ulcers.
2.

What you need to know before you take Amoxicillin Oral Suspension

Do not take Amoxicillin Oral Suspension:





if you are allergic to amoxicillin, penicillin or any of the other ingredients of this
medicine (listed in section 6).
If you have ever had an allergic reaction to any antibiotic. This can include a skin rash or
swelling of the face or throat or shortness of breath.
If you are pregnant, planning to become pregnant or breast feeding.
If you have an intolerance to some sugars (hereditary fructose intolerance).

Do not take Amoxicillin Oral Suspension if any of the above apply. If you are not sure, talk to
your doctor or pharmacist before taking Amoxicillin Oral Suspension.
Prolonged use of an antibiotic may result in infections due to bacteria resistant to the
antibiotic.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Amoxicillin Oral Suspension if you:
 have kidney disease or kidney problems, as you may require a lower dose than
normal
 are not urinating regularly
 have glandular fever (fever, sore throat, swollen glands and extreme tiredness).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Amoxicillin Oral Suspension.
Blood and urine tests
If you are having:
 Urine tests (glucose) or blood tests for liver function
 Oestriol tests (used during pregnancy to check the baby is developing normally)
Tell your doctor or pharmacist that you are taking Amoxicillin Oral Suspension. This is
because Amoxicillin Oral Suspension can affect the results of these tests.
Other Medicines and Amoxicillin Oral Suspension
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
 If you are taking drugs used to treat gout (which can be caused by the build-up of uric
acid) e.g. probenecid, allopurinol, sulfinpyrazone
 If you are taking allopurinol (used for gout) with Amoxicillin Oral Suspension, it may be
more likely that you will have an allergic skin reaction.
 If you are taking probenecid (used for gout), your doctor may decide to adjust your dose
of Amoxicillin Oral Suspension.
 If you are taking medicines to help stop blood clots (such as warfarin), you may need
extra blood tests.
 If you are taking other antibiotics (such a neomycin and tetracycline) Amoxicillin Oral
Suspension may be less effective.

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If you are taking methotrexate (used for the treatment of cancer and severe psoriasis)
Amoxicillin Oral Suspension may cause an increase in side effects.
If you are taking oral typhoid vaccine (may not work if taken with Amoxicillin Oral
Suspension)
Some penicillins may increase the effects of muscle relaxing drugs given as part of an
anaesthetic for surgery. Tell the doctor you are taking Amoxicillin Oral Suspension 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.
Driving and using machines
Amoxicillin Oral Suspension can have side effects and the symptoms (such as allergic
reactions, dizziness and convulsions) may make you unfit to drive.
Do not drive or operate machinery unless you are feeling well.
Amoxicillin Oral Suspension 125 mg/ 5 ml & 250 mg/ 5 ml contains sorbitol and sodium
benzoate
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.
Sorbitol is unsuitable for people with hereditary fructose intolerance. It can cause stomach
upset and diarrhoea.
Sodium benzoate (E211) is a mild irritant to the skin, eyes and mucous membranes and can
cause an increased risk of jaundice (yellowing of the skin or the whites of the eyes) in new
born babies.
3.

How to take Amoxicillin Oral Suspension

Always take your 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 maximum dose needed for most infections is 6 g daily given in divided doses.
Important: One teaspoon is equivalent to 5ml
The usual dose is:
Children weighing less than 40kg
All doses are worked out depending on your child’s body weight in kilograms.
 Your doctor will advise you how much Amoxicillin Oral Suspension you should give
to your baby or child.
 The usual dose is 40mg to 90mg for each kilogram of body weight a day given in two
or three divided doses.

0003



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

Adults , elderly patients and children weighing 40kg or more (including the elderly):
 The usual dose for most infections is 5ml of 250 mg/5 ml to be taken 3 times a day
 For more serious infections the dose may be doubled to 10 ml of 250 mg/5 ml 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
This suspension is not usually prescribed for adults and children more than 40 kg. Ask your
doctor or pharmacist for advice.
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
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If you take more Amoxicillin Oral Suspension than you should
If you have taken too much Amoxicillin Oral Suspension, 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 Oral Suspension




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 Oral Suspension for?




Keep taking Amoxicillin Oral Suspension 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
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Thrush (a yeast infection of moist areas of the body which can cause soreness, itching and
white discharge) may develop if Amoxicillin Oral Suspension is used for a long time. If this
occurs tell your doctor.
If you take Amoxicillin Oral Suspension 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 Oral Suspension 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 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
Oral Suspension, 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
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
the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin
Oral Suspension for Lyme disease and causes fever, chills, headache, muscle pain and
skin rash.
inflammation of the large bowel (colon) with diarrhoea (sometimes containing
blood), pain and fever
serious liver side effects may occur. 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:
o severe diarrhoea with bleeding
o blisters, redness or bruising of the skin
o darker urine or paler stools
o yellowing of the skin or the whites of the eyes (jaundice). See also anaemia
below which might result in jaundice
Convulsions may occur in patients on high doses or with kidney problems
Difficulty or discomfort in passing urine or having blood in the urine

0003

These can happen when having the medicine or for up to several weeks after.
If any of the above happens 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 (may affect up to 1 in 100 people).
If you have any of these talk to your doctor as Amoxicillin Oral Suspension will need to
be stopped.
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.
The other possible side effects are:
Common (may affect up to1 in 10 people)
 Skin rash
 feeling sick (nausea)
 diarrhoea.
Uncommon (may affect up to 1 in 100 people)
 being sick (vomiting).
Very rare (may affect up to1 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 type of anaemia. Signs include:
tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the
skin and the whites of the eyes
 low number of white blood cells
 low number of cells involved with blood clotting
 the blood may take longer to clot than it normally would. You may notice this if you have
a nosebleed or cut yourself.
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.

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5.

How to store Amoxicillin Oral Suspension

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the pack. The expiry date
refers to the last day of that month.
This medicine should be used within 14 days of the date dispensed.
Store below 25°C in a dry place, away from direct light.
Do not use this medicine if there are visible signs of deterioration.
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

The pharmacist will prepare the suspension for you by adding water to the dry powder.
What Amoxicillin Oral Suspension contains
-

The active substance in each suspension is 125 mg or 250 mg of amoxicillin as
amoxicillin trihydrate.
The other ingredients are: Saccharin Sodium, Sodium Citrate, Microcrystalline
Cellulose and Carboxymethylcellulose Sodium, Disodium Edetate, Sorbitol,
Preservative (Sodium Benzoate E21 l), Lime Flavour, and Water.

What Amoxicillin Oral Suspension looks like and contents of the pack
Amoxicillin Oral Suspension 125 mg/5 ml is a white, lime flavoured suspension.
Amoxicillin Oral Suspension250 mg/5 ml is a white, lime flavoured suspension.

Pack sizes: 60ml and 100ml bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
The product is distributed by
Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL
Marketing Authorisation numbers
PL 30464/0009
PL 30464/0010
This leaflet was last revised in 05/2016.

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General advice regarding the use of antibiotics
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.
----------------------------------------------------------------------------------------------------------------Instructions for reconstitution
Check cap seal is intact before use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark on the bottle label.
Invert and shake well, then top up with water to the mark. Invert and shake again
Shake well before taking each dose.

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Patient leaflet: Information for the user
Respillin 125 mg/5 ml AND 250 mg/5 ml (OPD Pharmaceuticals Ltd)
Amoxicillin (as amoxicillin trihydrate)
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 pharmacist.
 This medicine has been prescribed for you (or your child). Do not pass it on to others. It
may harm them, even if their signs of illiness 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

What Respillin is
Respillin is one an antibiotic. The active ingredient is amoxicillin. This belongs to a group of
medicines called ‘penicillin’.
What Respillin is used for
Respillin is used to treat infections caused by bacteria in different parts of the body.
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.

0003

2.

What you need to know before you take Respillin

Do not take Respillin:
 if you are allergic to amoxicillin, penicillin or any of the other ingredients of this
medicine (listed in section 6).
 if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or
swelling of the face or throat or shortness of breath
 if you are pregnant, planning to become pregnant or breast feeding
 If 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.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Respillin if you:
 havekidney disease or kidney problems, as you may require a lower dose than normal
 are not urinating regularly
 have glandular fever (fever, sore throat, swollen glands and extreme tiredness),
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before
taking Respillin.
Blood and urine tests:
If you are having:
 Urine tests (glucose) or blood tests for liver function
 Oestriol tests (used during pregnancy to check the baby is developing normally)
Tell your doctor or pharmacist that you are taking Respillin Oral Suspension. This is because
Respillin Oral Suspension 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.
 If you are taking drugs used to treat gout (which can be caused by the build-up of uric
acid) e.g. probenecid, allopurinol, sulfinpyrazone.
 If you are taking allopurinol (used for gout) with Respillin, it may be more likely that you
will have an allergic skin reaction.
 If you are taking probenecid (used for gout), your doctor may decide to adjust your dose
of Respillin.
 If you are taking medicines to help stop blood clots (such as warfarin), you may need
extra blood tests.
 If you are taking other antibiotics (such a neomycin and tetracycline) Respillin may be
less effective.
 If you are taking methotrexate (used for the treatment of cancer and severe psoriasis)
Respillin may cause an increase in side effects.
 If you are taking 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.

0003

Driving and using machines
Respillin can have side effects and the symptoms (such as allergic reactions, dizziness and
convulsions) may make you unfit to drive.
Do not drive or operate machinery unless you are feeling well.
Respillin 125 mg/5 ml and 250 mg/5 ml 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 and can cause an
increased risk of jaundice in new born babies.
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.
3.

How to take Respillin

Always take your 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 maximum dose needed for most infections is 6 g daily given in divided doses.
Important: One teaspoon is equivalent to 5ml
The usual dose is:
Children weighing less than 40kg
All doses are worked out depending on your child’s body weight in kilograms.
 Your doctor will advise you how much Respillin you should give to your
baby or child.
 The usual dose is 40mg to 90mg 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 40kg or more:




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)

0003

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
This suspension is not usually prescribed for adults and children more than 40 kg. Ask your
doctor or pharmacist for advice.
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
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If you take more Respillin than you should
If you have taken too much Respillin, 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 Respillin
 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 Respillin for?


Keep taking Respillin 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 Respillin is used for a long time. If this occurs tell your
doctor.
If you take Respillin 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.

0003

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Stop taking Respillin 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 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 Respillin, 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
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
the Jarisch-Herxheimer reaction which occurs during treatment with Respillin for
Lyme disease and causes fever, chills, headache, muscle pain and skin rash.
inflammation of the large bowel (colon) with diarrhoea (sometimes containing
blood), pain and fever
serious liver side effects may occur. 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:
o severe diarrhoea with bleeding
o blisters, redness or bruising of the skin
o darker urine or paler stools
o yellowing of the skin or the whites of the eyes (jaundice). See also anaemia
below which might result in jaundice
Convulsions may occur in patients on high doses or with kidney problems
Difficulty or discomfort in passing urine or having blood in the urine

These can happen when having the medicine or for up to several weeks after.
If any of the above happens 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 (may affect up to 1 in 100 people).
If you have any of these talk to your doctor as Respillin will need to be stopped.

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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.
The other possible side effects are:
Common (may affect up to 1 in 10 people)
 skin rash
 feeling sick (nausea)
 diarrhoea.
Uncommon (may affect up to1 in 100 people)
 being sick (vomiting)
Very rare (may affect up to1 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 apperance
 an excessive breakdown of red blood cells causing a type of anaemia. Signs include:
tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the
skin and the whites of the eyes
 low number of white blood cells
 low number of cells involved with blood clotting
 the blood may take longer to clot than it normally would. You may notice this if you have
a nosebleed or cut yourself.
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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is printed on the pack. The expiry date
refers to the last day of that month.
This medicine should be used within 14 days of the date dispensed.

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Store below 25°C in a dry place, away from direct light.
Do not use this medicine if there are visible signs of deterioration.
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 Respillin contains
-

The active substance in each suspension is 125 mg or 250 mg of Respillin as
amoxicillin trihydrate.
The other ingredients are: Saccharin Sodium, Sodium Citrate, Microcrystalline
Cellulose and Carboxymethylcellulose Sodium, Disodium Edetate, Sorbitol,
Preservative (Sodium Benzoate E21 l), Lime Flavour, and Water.

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 is a white, lime flavoured suspension.
Respillin 250 mg/5 ml is a white, lime flavoured suspension.
Pack sizes: 60ml and 100ml bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
The product is distributed by
Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL
Marketing Authorisation numbers:
30464/0009
30464/0010
This leaflet was last revised in 05/2016.

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General advice regarding the use of antibiotics
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.
----------------------------------------------------------------------------------------------------------------Instructions for reconstitution
Check cap seal is intact before use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark on the bottle label.
Invert and shake well, then top up with water to the mark. Invert and shake again
Shake well before taking each dose.

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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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