AMOXICILLIN CAPSULES BP 250MG

Active substance: AMOXICILLIN TRIHYDRATE

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(Amoxicillin Trihydrate)
Read all of this leaflet carefully before you
start taking this medicine.
• 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 any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Amoxicillin Capsules are and what
are they used for
2. Before you take Amoxicillin Capsules
3. How to take Amoxicillin Capsules
4. Possible side effects
5. How to store Amoxicillin Capsules
6. Further Information.
1.

WHAT AMOXICILLIN CAPSULES ARE AND
WHAT ARE THEY USED FOR?

Amoxicillin is one of the penicillin group of
antibiotics. It is a broad spectrum antibiotic.
It is used to treat infections caused by bacteria
that are susceptible to amoxicillin. It is mostly
used to treat bronchitis, middle ear infections and
urinary tract infections.
2.

BEFORE YOU TAKE AMOXICILLIN
CAPSULES

Do not take Amoxicillin Capsules if you
• are allergic (hypersensitive) to Amoxicillin
Trihydrate or to any of the ingredients of the
capsules listed in Section 6.
• are or have ever had an allergic reaction to
any penicillin-type antibiotic
• are suffering from glandular fever
(infectious mononucleosis)
Take special care and consult your doctor
before taking Amoxicillin Capsules if you:
• suffer from kidney problems

Reflex Blue, Black



are suffering from lymphatic leukaemia or
HIV infection. You may be more at risk of
developing a rash.
Taking Other Medicines:
Please inform your doctor or pharmacist if you
are taking, or have recently taken, any other
medicines, including products you do not need a
prescription for as they may interfere with this
product.
The product may interact with anticoagulants
(used to thin the blood) such as warfarin and
phenindione, and also with probenecid (used to
treat gout, a form of arthritis).
If the product is given at the same time as the oral
contraceptive the contraceptive may not be as
effective and extra precautions should be taken
e.g. use of condoms.
Pregnancy and Breast feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Important information about some of the
ingredients of Amoxicillin Capsules
Methyl Paraben and Propyl Paraben may cause
hives. There may be a delayed reaction such as
contact dermatitis. There is rarely an immediate
reaction with hives and bronchospasm.
3.

HOW TO TAKE AMOXICILLIN CAPSULES

Always take Amoxicillin Capsules exactly as your
doctor has told you. You should check with your
doctor if you are not sure.
The usual dose is 250mg-500mg every 8 hours.
Your doctor will decide on the appropriate dose to
suit the severity and type of infection you have.
Children weighing <40kg.
The daily dosage for children is 40-90mg/kg/day
in two to three divided doses (not exceeding
3g/day) depending on the indication, severity of
the disease and the susceptibility of the pathogen.
Children weighing more than 40kg should be
given the usual adult dosage.
The dose may be reduced in those with kidney
problems or in the elderly.
Amoxicillin Mixture BP 125mg/5ml or

4.

POSSIBLE SIDE EFFECTS:

Like all medicines Amoxicillin Capsules can
cause side effects, although not everybody gets
them.
Very serious side effects
Consult your doctor immediately if you
experience:
• swelling of certain parts of the body,
including the face and neck, accompanied
by difficulty in breathing. This may be a
serious allergic reaction.
Serious side effects
Stop taking Amoxicillin Capsules and consult
your doctor if you experience:
• rashes, hives and pruritus (itchiness). This
is the most common side effect.
• rash, swollen glands, fluid retention, joint
pains, fevers, tiredness ( serum-sicknesslike reactions) paleness, shortness of
breath, headache, dizziness, tiredness
(haemolytic anaemia)
• kidney inflammation
• increased susceptibility to infection and
bruising, and to anaemia (blood and
coagulation disorders). This may occur
rarely as with all penicillins.
Other side effects
Disturbances of the digestive system causing
diarrhoea, nausea and vomiting. It may also
cause paraesthesia (numbness), dizziness.
Effect on Laboratory tests
Rarely it may affect the levels of liver enzymes
If you experience any of the side effects
mentioned in this leaflet or any other side effects
please contact your doctor.

5.

HOW TO STORE AMOXICILLIN CAPSULES

Keep out of reach and sight of children.
Do not use this medicine after the expiry date
shown on the label.
Store in a dry place at or below 25°C.
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.

FURTHER INFORMATION:

What Amoxicillin Capsules contain
These capsules are called Amoxicillin Capsules
BP 250mg or 500mg.
Each capsule contains the active ingredient
Amoxicillin Trihydrate BP equivalent to 250mg or
500mg of Amoxicillin.
Each capsule also contains Magnesium Stearate
(E572), Colloidal Anhydrous Silica, Titanium
Dioxide (E171), Iron Oxides (E172), Erythrosine
(E127), Indigo Carmine (E132), Methyl Paraben
(E218), Propyl Paraben (E216), Sodium Lauryl
Sulphate and gelatin. The ink is composed of
Shellac, Isopropyl Alcohol, Purified Water, NButyl alcohol, Black iron Oxide (E172), Propylene
Glycol, Strong Ammonia Solution, Potassium
Hydroxide and Dehydrated Alcohol.
What Amoxicillin Capsules look like and
contents of the pack
Amoxicillin Capsules BP 250mg are hard gelatin
size 1 buff/scarlet capsules identity marked RAMX
250
Amoxicillin Capsules BP 500mg are hard gelatin
size 0 elongated buff/scarlet capsules identity
marked RAMX 500
Amoxicillin Capsules BP 250mg are available in
packs of 15, 20, 21, 50, 100, 500 and 1000
capsules and the Amoxicillin Capsules BP
500mg are available in packs of 15, 20, 21, 100,
500 and 1000 capsules. Both products are also
available in blister strips of 15 and 21 capsules.
Marketing Authorisation Holder and
Manufacturer
The product licence is held by the manufacturers,
Ranbaxy Ireland Ltd., Spafield, Cork Road,
Cashel, Co. Tipperary, Ireland.
Date of Revision: February 2012

[5092773] AMOXICILLIN CAPS PIL (DWS-UKR) Size : 122 x 192 mm RLL-DWS : 08.02.12vs, (81654)

Clarendon pt # 14 / Swis721 Cn BT pt # 8 & 12

Amoxicillin Capsules BP 250 mg
Amoxicillin Capsules BP 500 mg

250mg/5ml may be required to achieve the
recommended dose.
NOTE:
Always follow your doctors advice about when
and how to take your medicine and always read
the label. It is important that you complete the full
course of antibiotics.
If you forget to take Amoxicillin Capsules at the
correct time, take it as soon as you remember
and carry on as before. If it is almost time for your
next dose, skip the missed dose and continue as
usual.
If you take more Amoxicillin Capsules than you
should contact your doctor or pharmacist who
will recommend what action you should take.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

5092773

PACKAGE LEAFLET: INFORMATION FOR THE USER

5092774

(Amoxicillin Trihydrate)

(Amoxicillin Trihydrate)
Read all of this leaflet carefully before you start
taking this medicine.
• 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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Amoxicillin Capsules are and what are
they used for
2. Before you take Amoxicillin Capsules
3. How to take Amoxicillin Capsules
4. Possible side effects
5. How to store Amoxicillin Capsules
6. Further Information.
1. WHAT AMOXICILLIN CAPSULES ARE AND
WHAT ARE THEY USED FOR?
Amoxicillin is one of the penicillin group of antibiotics.
It is a broad spectrum antibiotic.
It is used to treat infections caused by bacteria that are
susceptible to amoxicillin. It is mostly used to treat
bronchitis, middle ear infections and urinary tract
infections.
2. BEFORE YOU TAKE AMOXICILLIN CAPSULES
Do not take Amoxicillin Capsules if you
• are allergic (hypersensitive) to Amoxicillin
Trihydrate or to any of the ingredients of the
capsules listed in Section 6.
• are or have ever had an allergic reaction to any
penicillin-type antibiotic
• are suffering from glandular fever (infectious
mononucleosis)
Take special care and consult your doctor before
taking Amoxicillin Capsules if you:
Reflex Blue, Black

• suffer from kidney problems
• are suffering from lymphatic leukaemia or HIV
infection. You may be more at risk of developing a
rash.
Taking Other Medicines:
Please inform your doctor or pharmacist if you are
taking, or have recently taken, any other medicines,
including products you do not need a prescription for as
they may interfere with this product.
The product may interact with anticoagulants (used to
thin the blood) such as warfarin and phenindione, and
also with probenecid (used to treat gout, a form of
arthritis).
If the product is given at the same time as the oral
contraceptive the contraceptive may not be as effective
and extra precautions should be taken e.g. use of
condoms.
Pregnancy and Breast feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Important information about some of the
ingredients of Amoxicillin Capsules
Methyl Paraben and Propyl Paraben may cause hives.
There may be a delayed reaction such as contact
dermatitis. There is rarely an immediate reaction with
hives and bronchospasm.
3. HOW TO TAKE AMOXICILLIN CAPSULES
Always take Amoxicillin Capsules exactly as your
doctor has told you. You should check with your doctor
if you are not sure.
The usual dose is 250mg-500mg every 8 hours. Your
doctor will decide on the appropriate dose to suit the
severity and type of infection you have.
Children weighing <40kg.
The daily dosage for children is 40-90mg/kg/day in two
to three divided doses (not exceeding 3g/day)
depending on the indication, severity of the disease
and the susceptibility of the pathogen.
Children weighing more than 40kg should be given the
usual adult dosage.

4. POSSIBLE SIDE EFFECTS:
Like all medicines Amoxicillin Capsules can cause
side effects, although not everybody gets them.
Very serious side effects
Consult your doctor immediately if you
experience:
• swelling of certain parts of the body, including the
face and neck, accompanied by difficulty in
breathing. This may be a serious allergic
reaction.
Serious side effects
Stop taking Amoxicillin Capsules and consult your
doctor if you experience:
• rashes, hives and pruritus (itchiness). This is the
most common side effect.
• rash, swollen glands, fluid retention, joint pains,
fevers, tiredness ( serum-sickness-like reactions)
paleness, shortness of breath, headache,
dizziness, tiredness (haemolytic anaemia)
• kidney inflammation
• increased susceptibility to infection and bruising,
and to anaemia (blood and coagulation disorders).
This may occur rarely as with all penicillins.
Other side effects
Disturbances of the digestive system causing
diarrhoea, nausea and vomiting. It may also cause
paraesthesia (numbness), dizziness.
Effect on Laboratory tests
Rarely it may affect the levels of liver enzymes
If you experience any of the side effects mentioned in
this leaflet or any other side effects please contact
your doctor.

5. HOW TO STORE AMOXICILLIN CAPSULES
Keep out of reach and sight of children.
Do not use this medicine after the expiry date shown on
the label.
Store in a dry place at or below 25°C.
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. FURTHER INFORMATION:
What Amoxicillin Capsules contain
These capsules are called Amoxicillin Capsules BP
250mg or 500mg.
Each capsule contains the active ingredient Amoxicillin
Trihydrate BP equivalent to 250mg or 500mg of
Amoxicillin.
Each capsule also contains Magnesium Stearate
(E572), Colloidal Anhydrous Silica, Titanium Dioxide
(E171), Iron Oxides (E172), Erythrosine (E127), Indigo
Carmine (E132), Methyl Paraben (E218), Propyl
Paraben (E216), Sodium Lauryl Sulphate and gelatin.
The ink is composed of Shellac, Isopropyl Alcohol,
Purified Water, N-Butyl alcohol, Black iron Oxide
(E172), Propylene Glycol, Strong Ammonia Solution,
Potassium Hydroxide and Dehydrated Alcohol.
What Amoxicillin Capsules look like and contents
of the pack
Amoxicillin Capsules BP 250mg are hard gelatin size 1
buff/scarlet capsules identity marked RAMX 250
Amoxicillin Capsules BP 500mg are hard gelatin size 0
elongated buff/scarlet capsules identity marked RAMX
500
Amoxicillin Capsules BP 250mg are available in packs
of 15, 20, 21, 50, 100, 500 and 1000 capsules and the
Amoxicillin Capsules BP 500mg are available in packs
of 15, 20, 21, 100, 500 and 1000 capsules. Both
products are also available in blister strips of 15 and 21
capsules.
Marketing Authorisation Holder and Manufacturer
The product licence is held by the manufacturers,
Ranbaxy Ireland Ltd., Spafield, Cork Road, Cashel, Co.
Tipperary, Ireland.
Date of Revision: February 2012

[5092774] AMOXICILLIN CAPS PIL (DWS-UKR) Size : 122 x 192 mm RLL-DWS : 09.02.12vs, 08.02.12vs, (81655)

Clarendon pt # 9 & 14 / Arial Narrow pt # 8 & 12

Amoxicillin Capsules BP 250 mg
Amoxicillin Capsules BP 500 mg

The dose may be reduced in those with kidney
problems or in the elderly.
Amoxicillin Mixture BP 125mg/5ml or 250mg/5ml may
be required to achieve the recommended dose.
NOTE: Always follow your doctors advice about when
and how to take your medicine and always read the
label. It is important that you complete the full course
of antibiotics.
If you forget to take Amoxicillin Capsules at the
correct time, take it as soon as you remember and
carry on as before. If it is almost time for your next
dose, skip the missed dose and continue as usual.
If you take more Amoxicillin Capsules than you
should contact your doctor or pharmacist who will
recommend what action you should take.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

5092774

Amoxicillin
Capsules BP 250 mg
Amoxicillin
Capsules BP 500 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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