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ACTAVIS TRIMETHOPRIM 50MG/5ML SUSPENSION

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3280/2/AC Actavis Trimethoprim 50mg/5ml P1.ai ARK 002

Patient Information Leaflet

Pinnaculum Job No.:

01

Iteration No.:

Pantone Process
Black C

100% 95%

50%

3280/2/AC

Profile

5%

Product Name

Actavis Trimethoprim
50mg/5ml
Oral Suspension
UK
Market
PIL
Component
No. of Colours 1 (One)
N/A
Profile
297 x 210mm (W x H)
Dimensions
N/A
Barcode
3280/2/AC
2D Barcode
3280/2/AC
Material No.
Packaging supp. Percuro Medica
28 April 2015
Date
Pinnaculum Ltd
F51 Business & Technology Centre,
Bessemer Drive, Stevenage,
Herts, SG1 2DX, UK.
Percuro Medica
Tel +44 (0)1438 791113
V1 - 03.2015

Artwork Approval Signature Box

Studio

Regulatory 1

Regulatory 2
Approved for
Production

Commercial

TEXT SIZE
The Smallest Body
text on this A/W is:

9 pt

3280/2/AC

Actavis
Trimethoprim 50mg/5ml Oral Suspension
This leaflet contains important information about Actavis Trimethoprim Oral Suspension (now
called Trimethoprim Oral Suspension throughout the leaflet). 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 get serious, or if you have any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet
1. What is Trimethoprim Oral Suspension and what it is used for
2. Before taking Trimethoprim Oral Suspension
3. How to take Trimethoprim Oral Suspension
4. Possible side effects
5. Storing Trimethoprim Oral Suspension
6. Further information

1. What is Trimethoprim Oral
Suspension and what it is used for
Trimethoprim belongs to a group of medicines
called antibiotics. These are used to help fight
infections caused by bacteria and other
sensitive organisms.
It can be used for a wide range of infections
including urinary and chest infections. This
medicine is also sometimes prescribed for
people who suffer from urinary infections a lot,
to stop an infection in the first place.

2. Before taking Trimethoprim
Oral Suspension
X Do not use this medicine if you.....
● have ever had a bad reaction to
trimethoprim or any of the ingredients listed
in section 6 (Further Information).
● have a blood disorder or anaemia.
● think you may be pregnant, or are planning
to become pregnant.
● have liver or kidney problems.
! Take special care with Trimethoprim Oral
Suspension:
● If you have been told your liver or kidneys
are not working properly.
● If you have been told you have low levels of
folic acid in your blood.

● If you are at greater risk of high levels of
potassium (hyperkalaemia), e.g. the elderly
or those on higher doses.
● If you suffer from porphyria (a disorder that
causes skin sensitivity to light, pain attacks
and muscle weakness).
You should let your doctor know and ask his/
her advice if you suffer from or have ever had
any of the above.
! Taking other medicines
Tell your doctor or pharmacist if you are taking
or have recently taken any other medicines
including herbal medicines and those that you
may have bought yourself.
Trimethoprim can affect some of the
medicines you may be taking. The following
drugs can cause some problems when taken
together with Trimethoprim:
• Medicines to treat cancer, which can
depress bone marrow production such as
methotrexate and mercaptopurine
• Medicines for epilepsy such as phenytoin
• Medicines for the heart such as digoxin and
procainamide
• Medicine to thin the blood such as warfarin
and other coumarins
• Repaglinide (antidiabetic)
• Rifampicin and dapsone (for treating
infections)

• Pyrimethamine (for treating malaria)
• Diuretics (e.g. water tablets such as
frusemide or eplerenone)
• Medicines for organ transplant or psoriasis
such as cyclosporin and azathioprine
! Pregnancy and Breast-feeding
● Trimethoprim may be harmful to the unborn
baby. If you are pregnant, think you may be
pregnant or are trying for a baby you should
tell your doctor or pharmacist before you
take this medicine.
● Trimethoprim is present in the breast
milk. If you are breast feeding you should
tell your doctor or pharmacist before you
take this medicine.
! Driving and using machines
● Your medicine is unlikely to affect your ability
to drive or to operate machinery.
i Important information about some of the
ingredients of Trimethoprim Oral Suspension
● Maltitol liquid: If you have been told by your
doctor that you have intolerance to some
sugars, contact your doctor before taking this
medicinal product.
● Sodium methyl parahydroxybenzoate (E219)
and sodium propyl parahydroxybenzoate
(E217): May cause allergic reactions
(possibly delayed).

3. How to take Trimethoprim
Oral Suspension
Trimethoprim Oral Suspension should be
swallowed. Shake the bottle well before
measuring the dose.
Follow your doctor's instructions about when
and how to take your medicine. Also read the
label. Your pharmacist can also help if you
are not sure.
Your doctor will have decided what dose you
should take each day depending on your
condition. The usual dosages are:
Under 6 weeks:

DOSAGE
Not recommended

6 weeks - 5 months: 2.5ml every 12 hours
6 months - 5 years:

5ml every 12 hours

6 years - 12 years:

10ml every 12 hours

Adults:

20ml every 12 hours

Severe or sudden infections:
Your doctor will decide how long you should
continue to take this medicine. This will
depend on the type and severity of infection.
Your doctor may also double your first dose.
For elderly people with a kidney complaint, the
doctor will decide the dose.
Treatment is usually for one to two weeks.
Make sure you finish all the doses prescribed
for you. If you do not finish the treatment, the
infection may come back or get worse.
Long-term treatment and prevention therapy:
DOSAGE
2.5 ml at night
6 months - 5 years:
6 years - 12 years:
Adults:

5 ml at night
10 ml at night

Treatment should continue for as long as your
doctor feels it is needed.
Dialysis patients:
Trimethoprim is removed by dialysis. Blood
tests will be necessary to check your blood
levels before and after dialysis.
! If you have been taking Trimethoprim Oral
Suspension for long term treatment
If you have been taking trimethoprim for a
long time and get the following signs you
must speak to your doctor immediately:
• high temperature (fever)
• sore throat
• rash
• sore mouth (mouth ulcers)
• red or purple spots (purpura)
• bruising or bleeding
These effects happen because of problems
with your blood and you must see a doctor
immediately.
! If you forget to take Trimethoprim Oral
Suspension
If you forget to take your medicine, take your
dose as soon as you remember, unless it is
nearly time for your next dose. Then take your
next dose at the usual time. Don't take two
doses at the same time. If you are worried,
ask your doctor or pharmacist for advice.
If you have kidney problems
If you suffer from kidney problems and forget
to take a dose, ask your doctor or pharmacist
for advice.
please turn over.......

PAGE 1 OF 2

3280/2/AC Actavis Trimethoprim 50mg/5ml P1.ai ARK 002
! If you take more Trimethoprim Oral
Suspension than you should
Pinnaculum Job No.:

01

Iteration No.:

Pantone Process
Black C

100% 95%

50%

3280/2/AC

Profile

If you accidentally take an overdose of your
medicine, either call your doctor straight away
or go to your nearest hospital casualty
department. Always take any remaining
medicine, the container and the label with
you, so that the medicine can be identified.

4. Possible side effects
Like all medicines, Trimethoprim Oral
Suspension can have side effects.

5%

Product Name

Actavis Trimethoprim
50mg/5ml
Oral Suspension
UK
Market
PIL
Component
No. of Colours 1 (One)
N/A
Profile
297 x 210mm (W x H)
Dimensions
N/A
Barcode
3280/2/AC
2D Barcode
3280/2/AC
Material No.
Packaging supp. Percuro Medica
28 April 2015
Date
Pinnaculum Ltd
F51 Business & Technology Centre,
Bessemer Drive, Stevenage,
Herts, SG1 2DX, UK.
Percuro Medica
Tel +44 (0)1438 791113
V1 - 03.2015

Artwork Approval Signature Box

Studio

Regulatory 1

Regulatory 2
Approved for
Production

Commercial

TEXT SIZE
The Smallest Body
text on this A/W is:

A few people can be allergic to some
medicines; if any of the following side effects
occur soon after taking the oral suspension,
STOP taking the medicine and tell your doctor
immediately:
• Difficulty breathing
• Chest pain
• Swelling of the eyelids, tongue, face or lips
• Blistering/peeling of the skin
• Skin eruptions/lesions
• Lumpy skin rash (‘hives’) anywhere on the
body
• Unexplained high temperature (fever)
• Feeling faint, especially on standing up.
Tell your doctor or pharmacist if you notice any
of the following side effects:
Very Common (occurs in more than 1 in 10
people)
• High levels of potassium in your blood, which
can cause abnormal heart beats (palpitations).
Common (may affect up to 1 in 10 people)
• feeling and being sick
• diarrhoea
• headache
• skin rashes
• anaemia (may cause you to feel tired and
look pale)
• sore throats or mouth ulcers (due to a
decrease in white blood cells)
• thrush
Very rare (may affect up to 1 in 10,000
people)
• constipation
• severe watery/bloody diarrhoea
• liver problems which may cause jaundice
(yellowing of the skin or whites of the eyes)
• kidney problems (signs may include painful
urination or blood in the urine)

• dizziness
• tiredness
• loss of consciousness
• convulsions
• involuntary movements
• pins and needles
• shakiness
• ringing in the ears
• vertigo
• uveitis (signs may include blurred vision,
eye redness and pain)
• increased sensitivity of the skin to the sun
• low blood sugar
• low levels of sodium in the blood (may
cause nausea, tiredness, muscle cramping)
• anorexia
• depression
• anxiety
• sleeping difficulties
• confusion
• hallucinations
• agitation
• abnormal behaviour
• nightmares
• joint and muscle ache
• wheezing
• cough
• shortness of breath
• nosebleeds
• elevation of serum transaminases (an indication
of liver damage)
• elevation of bilirubin levels
• severe skin reactions (signs may include
blistering)
• Stevens-Johnson Syndrome
• pancreatitis (signs may include a sudden,
severe upper abdominal pain)
• meningitis (signs may include stiff neck,
fever and vomiting)
• lupus erythematosus (an auto-immune
disorder)
• decrease in blood cells, which can make the
skin pale or yellow, cause fever, sore throat,
mild mouth ulcers, flu-like symptoms,
exhaustion or weakness, easy bruising, or
bleeding from the skin or nose.
Not known (frequency cannot be estimated
from the available data)
• sore tongue and mouth
• itching
Do not be alarmed by this list of possible
events. You may not have any of them.

If you notice any side effects not mentioned in
this leaflet, please inform your doctor or
pharmacist.
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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.

5. Storing Trimethoprim Oral
Suspension
• Keep out of the sight and reach of children.
• Do not store above 25ºC. Store in the outer
carton.
• Do not use Trimethoprim Oral Suspension
after the expiry date which is stated on the
bottle after Exp:. The expiry date refers to
the last day of that month.
• Medicines should not be disposed via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
• Always keep the medicine in the bottle in
which it was originally given to you.

Each bottle contains 100ml of oral suspension.
A double ended 5ml and 2.5ml polypropylene
spoon is also included to help measure the
dose.
Product licence holder (PL 17862/0007)
and manufacturer of Trimethoprim Oral
Suspension is:
Orbis Consumer Products Ltd., Cunard Road,
Park Royal, London, NW10 6PN
Distributed by Actavis, Barnstaple, EX32 8NS,
UK

Contact us at the above
address for information in
large print, audio or braille
This leaflet was updated in April 2015.

You may wish to read the leaflet again. Do not
throw it away until you have finished your
medicine.

6. Further information
Trimethoprim Oral Suspension is a white
suspension with a smell of Aniseed.
Each 5ml of Trimethoprim Oral Suspension
contains 50mg Trimethoprim.
It also contains Xanthan gum(E415), maltitol
liquid (E965), polysorbate 80, microcrystalline
cellulose (E460), sodium
carboxymethylcellulose(E466), saccharin
sodium(E954), citric acid monohydrate,
sodium methyl parahydroxybenzoate(E219),
sodium propyl parahydroxybenzoate(E217),
aniseed flavour and purified water.
3280/2/AC

9 pt

PAGE 2 OF 2

Expand Transcript

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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