AMOXICILLIN 3G SACHETS S.F

Active substance: AMOXICILLIN TRIHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Ref:

231-30-83834-B LEA AMOXICILLIN 3g SAC TUK <

Version:

2

5 September 2011

Ref:

231-30-83834-B LEA AMOXICILLIN 3g SAC TUK <

Version:

2

5 September 2011

PL Number(s),
MA Holder & Packer:

PL Number(s),
PL 00289/1590. TEVA UK Limited Licence (Responsible Regulatory fficer =
MA Holder & Packer: Packed at

Reason for revision:

Reason for revision: V1: Safety warnings text update to match Brand leader. Using new template 520mm x 170mm. V2: Text amends to Section 4 from
31 August 2011 at 13:03.

Artwork Originator;
Sign & Date:

Artwork Checker;
Sign & Date:

Dimensions:

L:
W:

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

520 mm
170 mm

Fonts: Variants of Univers
Base Font Size: 8 Pt

Pharma Code:
To be added by third party
3rd Party Code:
To be added by third party

Colours:

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

(PANTONE® is a registered
trademark of Pantone, Inc.)

Packing Site Approval (where not TEVA UK Limited)
Sign & Date:

Artwork Originator;
Sign & Date:

Artwork Checker;
Sign & Date:

L:
W:

PANTONE® GREEN
BLACK

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

520 mm
170 mm

Pharma Code:
To be added by third party
3rd Party Code:
To be added by third party

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

Packing Site Approval (where not TEVA UK Limited)
Sign & Date:

PANTONE® GREEN
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Pregnancy and breast-feeding
• If you are pregnant, planning to become
pregnant or are breast-feeding, ask your
doctor for advice before taking this
PACKAGE LEAFLET: INFORMATION FOR THE USER
medicine.
Read all of this leaflet carefully before
Driving and using machines
you start taking this medicine.
• Amoxicillin is not known to affect
• Keep this leaflet. You may need to
your ability to drive or operate
read it again.
machinery.
• If you have any further questions,
ask your doctor or pharmacist.
3 HOW TO TAKE AMOXICILLIN
• This medicine has been prescribed
for you. Do not pass it on to others. Always take Amoxicillin exactly as
your doctor or dentist has told you.
It may harm them, even if their
You should check with your doctor,
symptoms are the same as yours.
• If any of the side effects get serious, dentist or pharmacist if you are
or if you notice any side effects not not sure.
listed in this leaflet, please tell your You should empty the powder from
doctor or pharmacist.
the sachet into a glass of water, stir
the mixture, and swallow it immediately.
IN THIS LEAFLET:
1. What Amoxicillin is and what it is used for The usual dose is:
Adults and the Elderly
2. Before you take Amoxicillin
The standard dose for treatment of
3. How to take Amoxicillin
infections is normally 250 mg three times
4. Possible side effects
daily increasing to 500 mg three times daily
5. How to store Amoxicillin
for more severe infections. The maximum
6. Further information
adult dose is 3 g (1 sachet) twice a day.
1 WHAT AMOXICILLIN IS AND WHAT IT The dosage for treatment of some specific
IS USED FOR
conditions is given below:
Amoxicillin belongs to a group of drugs
• Urinary tract infections
known as penicillin antibiotics.
The recommended treatment is a 3 g
dose (1 sachet), repeated after 10-12
Amoxicillin is used to treat a variety of
hours.
infections caused by a wide range of
• Gonorrhoea
bacteria, such as:
A single dose of 3 g (1 sachet).
• severe infections of the respiratory tract
• Dental abscesses
(airways)
The recommended treatment is a 3 g
• middle ear infections (including severe
dose (1 sachet), repeated after 8 hours.
and re-occurring ear infections in
• Before dental treatment
children)
• If you are NOT having an anaesthetic
• urinary tract infections (“water works”)
You will be given a 3 g dose orally an
e.g. cystitis, urethritis or pyelonephritis
hour before the procedure, followed by
• infection that may occur during childbirth
a second dose of 3 g if needed 6 hours
or after an abortion
later.
• gonorrhoea
• If you are having an anaesthetic (where
• inflammation or infections in the
oral antibiotics are appropriate)
abdomen (peritonitis, abdominal sepsis)
You will be given a 3 g dose orally
• infections in the blood (septicaemia)
4 hours before the procedure, followed
• infections of the heart valves or inner
by either a second dose of 3 g orally or
surfaces (endocarditis)
an injection of 1 g given to you either
• digestive problems that cause
into a vein or into a muscle, as soon as
dehydration and diarrhoea (typhoid or
possible after the operation.
paratyphoid)
• If you are having an anaesthetic (where
• skin and soft tissue infections
oral antibiotics are NOT appropriate)
• inflammation of the bone and bone
You will be given an injection of a 1 g
marrow (osteomyelitis)
dose either into a vein or into a muscle
• dental abscesses.
immediately before the anaesthetic is
Amoxicillin may also be used before dental
given, followed by 500 mg orally
procedures such as having your teeth out, if
6 hours later.
you are at risk of getting endocarditis.
Patients with kidney problems
2 BEFORE YOU TAKE AMOXICILLIN
The dose you should take may be lower
than those given above, and a different
DO NOT take Amoxicillin if you:
dosage form may be more appropriate.
• are allergic (hypersensitive) to
Amoxicillin or any of the other
Children weighing more than
ingredients of this medicine, to any other 40 kilogram (kg)
penicillin antibiotics or to other
• They should be given the usual adult
beta-lactam antibiotics e.g. cephalosporin
dose.
• are suffering from glandular fever
Children weighing less than 40 kg
• have severe kidney disease.
• The dose depends on your weight.
Take special care with Amoxicillin
• The usual starting dose is between
Tell your doctor before you start to take this
40-90 mg/kilogram daily (in two or three
medicine if you:
doses).
• have an intolerance to some sugars e.g.
• The maximum dose is 3g daily.
fructose
For children (weighing less than 40 kg)
• have kidney problems, as your dose may
who have severe infections such as
need to be reduced
tonsillitis, recurrent ear infection,
• know that you are allergic to pollen, fur,
kidney problems or dental problems
dust, cosmetics etc
• Your doctor will decide the correct dose
• have an infection caused by a virus
for you.
known as cytomegalovirus
Children under 6 months old
• have acute or chronic lymphocytic
• Amoxicillin sachets should not be used
leukaemia.
for children under 6 months; instead
Having urine or blood test
Amoxicillin oral suspension 125 mg/5 ml
If you have any tests such as blood or urine
should be given.
tests while you are taking Amoxicillin
Sachets, make sure you tell your doctor or
If you take more Amoxicillin than you
nurse, as amoxicillin can affect the results
should
of some tests, e.g.
If you (or someone else) take too many
• blood test for cell counts
sachets, or if you think a child has
• urine test for glucose.
swallowed any of the sachets, contact your
nearest hospital casualty department or
Taking other medicines
Talk to your doctor if you are taking any of your doctor immediately.
An overdose is likely to cause feeling sick,
the following:
being sick, diarrhoea, or urinating a lot.
• are taking methotrexate (for psoriasis,
Please take this leaflet, any remaining
rheumatoid arthritis or cancer)
sachets, and the container with you to the
• probenecid or allopurinol (for gout)
hospital or doctor so that they know which
• anticoagulants such as acenocoumarol
sachets were consumed.
or warfarin (to thin the blood)
• the oral contraceptive pill.
If you forget to take Amoxicillin
Please tell your doctor, pharmacist, or
If you forget to take a dose at the right time,
dentist if you are taking or have recently
take one as soon as you remember, unless
taken any other medicines, including
it is nearly time to take the next one. DO
medicines obtained without a prescription. NOT take a double dose to make up for a
forgotten dose.
Important information about some of the
ingredients of Amoxicillin
If you stop taking Amoxicillin
• Amoxicillin sachets contain a sugar
DO NOT stop taking your sachets as soon as
substitute, sorbitol (E420). If your doctor you feel better. Take all the sachets your
has told you that you have an intolerance doctor or dentist has given you to complete
to some sugars, contact your doctor
the course of treatment.
before taking this medicine.
If you have any further questions on the use
• Each 3 g sachet contains a minimum of
of this product, ask your doctor or
5.4 g of sorbitol. If you are taking the
pharmacist.
maximum daily dose of 6 g of amoxicillin

AMOXICILLIN 3 g SACHETS SF
SUGAR FREE
(amoxicillin trihydrate)

you will also be taking a minimum of
10.8 g of sorbitol each day. At daily doses
of 10 g or more sorbitol may have a mild
laxative effect.
• Sorbitol also has a calorific value of
2.6 kcal per gram, so the sorbitol content
in each Amoxicillin 3 g sachet is
equivalent to 14 kcal.
• Each sachet also contains 1.22 mmol (or
28 mg) sodium and should be taken into
consideration if you are on a controlled
sodium diet.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Amoxicillin can cause
side effects, although not everybody gets
them.
Stop taking Amoxicillin sachets and tell
your doctor immediately or go to the
casualty department at your nearest
hospital if the following happens:
• an allergic reaction causing swelling of
the lips, face or neck leading to severe
difficulty in breathing, or severe skin rash
or hives

• 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
• 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
• 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
• a delayed allergic reaction can occur
usually 7 to 12 days after having
amoxicillin, some signs include: rashes,
fever, joint pains and enlargement of the
lymph nodes especially under the arms
• 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 are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.
The following side effects have been
reported at the approximate frequencies
shown
Common
• skin rash
• diarrhoea
• feeling sick (nausea).
Uncommon
• indigestion
• being sick (vomiting)
• urticaria (nettle rash)
• itching.
Very rare
• some people can get thrush (a yeast
infection of the vagina, mouth or skin
folds) during or after treatment
• an excessive breakdown of red blood
cells causing a form of anaemia.
• the blood may take longer to clot than it
normally would. You may notice this if
you have a nosebleed or cut yourself
• abnormal increase in muscular activity
(hyperkinesia)
• dizziness
• fits (convulsions), seen in patients on
high doses or with kidney problems
• the tongue may change to yellow, brown
or black and it may have a hairy
appearance
• teeth may appear stained, usually
returning to normal with brushing (this
has been reported in children)
• the skin and the whites of your eyes
becoming yellow (jaundice)
• inflammation of the kidney which can
cause swollen ankles or high blood
pressure
• 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.
Other effects you may experience include:
• the sachets contain sorbitol which can
cause gas to be produced in the stomach
and this can cause wind and belching and
your stomach to feel swollen
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

5

6

FURTHER INFORMATION

What Amoxicillin Sachets contain:
• The active ingredient is Amoxicillin
Trihydrate, equivalent to amoxicillin
3 grammes (g).
• The other ingredients (inactive
ingredients) are sodium citrate, citric acid,
colloidal anhydrous silica, sorbitol (E420),
saccharin sodium, orange bramble
flavour, quinoline yellow (E 104),
monoammonium glycyrrhizinate and
xanthan gum.
What Amoxicillin Sachets look like and
contents of the pack:
• The powder in amoxicillin sugar free
sachets is a cream/pale yellow colour.
• The sachets come in boxes of 2 and 14.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder is:
TEVA UK Limited. Eastbourne, BN22 9AG.
The Manufacturer is:
Laboratrio Reig Jofre S.A., C/Jarama S/N,
(Poligono Industrial), 45007 Toledo, Spain.
This leaflet was last revised: August 2011
PL 00289/1590

HOW TO STORE AMOXICILLIN

Keep out of the reach and sight of children.
You should keep these sachets in a dry
place, below 25°C. Keep them in the pack
they came in. Do not put them into another
container.
Do not use Amoxicillin Sachets after the
expiry date that is stated on the outer
packaging. The expiry date refers to the last
day of that month.
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.

TEVA UK Limited

83834-B

Expand view ⇕

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.

Hide
(web4)