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CO-TRIMOXAZOLE TABLETS BP

Active substance(s): SULFAMETHOXAZOLE / TRIMETHOPRIM / SULFAMETHOXAZOLE / TRIMETHOPRIM / SULFAMETHOXAZOLE / TRIMETHOPRIM

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For oral administration as
directed by the doctor.
Also contains lactose (see
patient information leaflet for
further information).

KEEP OUT OF THE SIGHT
AND REACH OF CHILDREN
Protect from heat, light and
moisture.
Product Licence holder:
Crescent Pharma Ltd,
Overton, Hants RG25 3ED
M0234TB PL20416/0052

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Special doses
The dose of Co-trimoxazole tablets and how long you need to take it
depends on the infection you have and how bad it is.
Your doctor may prescribe you a different dose or length of course of
Co-trimoxazole to:
• treat urinary tract (water) infections
• treat and prevent lung infections caused by the bacteria
Pneumocystis jirovecii
• treat infections caused by the bacteria Toxoplasma PM00790102
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(toxoplasmosis) or Nocardia (nocardiosis).
If you have kidney problems your doctor may prescribe a smaller
dose and take blood to test if the medicine is working properly.
If you take more Co-Trimoxazole Tablets than you should
If you think you have taken too many tablets, contact your doctor
straight away or go to the nearest hospital casualty department. Take
with you any remaining tablets and the pack so that the medicine can
be identified.
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If you forget to take Co-Trimoxazole Tablets
If you forget to take a dose of this medicine, take it as soon as you
remember. However, if it is almost time for the next dose, skip the
missed dose and take the next dose at the usual time. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Co-Trimoxazole Tablets
It is important to finish your prescribed dose of this medicine.
If you stop taking this medicine too soon, your infection may
come back. Speak to your doctor, pharmacist or nurse first if you
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plan to stop before you finish the course of treatment.
If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

4. Possible side-effects

Like all medicines, Co-trimoxazole tablets can cause side-effects,
although not everybody gets them. Side-effects may be more severe
if you are taking high doses of these tablets to treat pneumocystis
jirovecii pneumonia.
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If any of the following occur STOP TAKING the tablets IMMEDIATELY
and contact your doctor, as these may be signs of a very rare serious
allergic reaction (affects less than 1 in 10,000 people):
• sudden wheeziness or difficulty breathing
• swelling of the eyelids, face, lips or throat
• raised itchy, red lumps on the skin (hives) or skin rash
• potentially life-threatening skin rashes or blistering of the skin,
mouth, eyes or genitals (these may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis - see section 2)
• chest pain
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• fever, swollen lymph nodes or skin rash (these may be signs of a
serious allergic reaction known as DRESS (Drug rash with
eosinophilia and systemic symptoms). Frequency of this reaction
is not known, can not be estimated from the available data.
If you notice any of the following effects STOP TAKING the tablets
and tell your doctor STRAIGHT AWAY:
• feeling weak or tired, looking pale, easier bruising, high
temperature, sore throat or frequent infections (these may be
signs of a blood disorder). Symptoms may be worse if you are
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elderly or you have liver or kidney problems or low levels of folic
acid
• fever, headache, stiff neck and back, feeling sick, skin rash, eyes
being very sensitive to bright light (these may be signs of aseptic
meningitis)
• jaundice, inflammation of the liver, liver damage, changes in liver
function or an inflamed pancreas. Symptoms include yellowing of
the skin and whites of the eyes, fever and severe stomach and
back pain.
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The following other side-effects have been reported, if you do notice
any of these effects or any others not mentioned in this leaflet, please
inform your doctor or pharmacist.
Very common effects (that could happen to more than 1 in 10 people)
• abnormal heart rhythm (beat), which may be caused by high levels
of potassium in the blood. (This effect is more likely to occur if you
are elderly or taking a high dose of this medicine).
Common effects (that could happen to less than 1 in 10 people):
• an infection called thrush or candidiasis which can affect your
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mouth or vagina. It is caused by a fungus
• headache, feeling sick, diarrhoea.
Uncommon effects (that could happen to less than 1 in 100 people):
• being sick.
Very rare effects (that could happen to less than 1 in 10,000 people):
• convulsions, weakness, tingling, numbness, difficulty controlling
movements, joint and muscle pain
• depression, hallucinations (seeing things that are not there), dizziness
or spinning sensation, ringing in the ears
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• cough or shortness of breath
• skin that is more sensitive to sunlight than normal. You may get a
skin rash, itching, redness or severe sunburn.
• low levels of sodium in the blood which may cause tiredness and
confusion, muscle twitching, fits or coma. (This effect is more likely
to occur if you are elderly or taking a high dose of this medicine)
• changes in blood tests
• low blood glucose levels which may cause weakness, dizziness and
disorientation
• colitis (inflammation that causes abdominal pain or diarrhoea)
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• loss of appetite
• swollen or sore mouth or tongue, mouth ulcers
• difficulty passing urine, passing more or less urine than usual,
blood or cloudiness in your urine, change in electrolyte levels in the
body, crystals in the urine or swollen kidneys causing kidney failure,
fever or rash
• inflammation of the eye which causes pain and redness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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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.

and moisture.
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.

5. How to store Co-Trimoxazole Tablets

6. Contents of the pack and other information

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.
Keep the tablets in the pack provided and protect from heat, light
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What Co-Trimoxazole Tablets contains:
Each Co-trimoxazole tablet contains 80mg of trimethoprim and
400mg sulfamethoxazole as the active ingredients. Also contains
lactose, sodium starch glycolate, magnesium stearate and
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pregelatinised maize starch.
What Co-Trimoxazole Tablets look like and contents of the pack
The tablets are round and white with the company logo on one side
and a breakline and A286 on the other side.
They are available in pack sizes of 9, 10, 14, 15, 20, 21, 28, 30, 50,
56, 84, 100, 250, 500 and 1000 tablets. (Not all pack sizes may be
marketed).

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Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hampshire, RG25 3ED, UK.
This leaflet was last revised: April 2017
If you would like this leaflet in a different format please contact the
licence holder at the above address.

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PATIENT INFORMATION LEAFLET

CO-TRIMOXAZOLE Tablets

(Trimethoprim 80mg & Sulfamethoxazole 400mg)

Read all of 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 any further questions, ask your doctor, pharmacist or
nurse.
• This medicine has been prescribed for you only. Do not pass it on
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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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
In this leaflet:
1. What Co-Trimoxazole Tablets are and what they are used for
2. What you need to know before you take Co-Trimoxazole Tablets
3. How to take Co-Trimoxazole Tablets
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4. Possible side effects
5. How to store Co-Trimoxazole Tablets
6. Contents of the pack and other information.

1. What Co-Trimoxazole Tablets are and what they are
used for

Co-trimoxazole belongs to a group of medicines called antibacterials.
These medicines work by killing bacteria. Co-trimoxazole is used for
the:
• treatment and prevention of lung infections (pneumonia or
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Pneumocystis pneumonia (PCP)) caused by the bacteria
Pneumocystis jirovecii (previously known as Pneumocystis carinii)
treatment and prevention of toxoplasmosis (an infectious disease)
treatment of nocardiosis (an infectious disease affecting either the
lungs or whole body)
treatment of urinary tract infections (bladder or kidney infections)
treatment of sudden worsening of chronic bronchitis (long term
lung disease)
treatment of acute otitis media (an ear infection).
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2. What you need to know before you take
Co-Trimoxazole Tablets

Do not take Co-Trimoxazole Tablets if you:
• are allergic to trimethoprim, sulfamethoxazole or any of the other
ingredients in the tablets which are listed in section 6. (An allergic
reaction may be recognised as shortness of breath, blocked nose,
rash, itching, swollen face or lips)
• are allergic to sulfonamide medicines. Examples include
sulfonylureas (such as gliclazide and glibenclamide) or thiazide
diuretics (such as bendroflumethiazide - a water tablet)
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• have severe kidney damage or disease
• have severe liver damage
• have a serious blood disorder
Do not give Co-trimoxazole to premature babies or full term babies
less than 6 weeks old. Unless it is for the treatment or prevention of
PCP and in this case, babies should be at least 4 weeks old. Another
form of this medicine is more suitable for use in babies.
Warnings and precautions
Talk to your doctor before taking Co-Trimoxazole Tablets if you:
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suffer from a lack of folic acid in your body
have mild to moderate liver or kidney damage or disease
are underweight or malnourished
suffer from glucose-6-phosphate dehydrogenase deficiency (G6PD)
suffer from a severe allergy or bronchial asthma
have a rare blood disorder called porphyria or any other blood
disorder
• have phenylketonuria (a genetic disorder of metabolism)
• are elderly
• have high levels of blood potassium
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• concomitant administration of Co-trimoxazole with certain
medicines, potassium supplements and food rich in potassium
may lead to severe hyperkalaemia (increased potassium blood
level). The symptoms of severe hyperkalaemia might include
muscle cramps, irregular heart rhythm, diarrhoea, nausea,
dizziness or headache
Skin reactions - if you develop a rash or any of the following
symptoms, seek immediate advice from a doctor and tell them
that you are taking this medicine:
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• Potentially life-threatening skin rashes (Stevens-Johnson
syndrome, toxic epidermal necrolysis and drug reaction with
eosinophilia and systemic symptoms (DRESS)) have been reported
with the use of Co-trimoxazole, appearing initially as reddish
target-like spots or circular patches often with central blisters on the
trunk of the body.
• Additional signs to look for include ulcers in the mouth, throat,
nose, genitals and conjunctivitis (red and swollen eyes).
• These potentially life-threatening skin rashes are often
accompanied by flu-like symptoms. The rash may progress
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to widespread blistering or peeling of the skin.
• The highest risk for occurrence of serious skin reactions is within
the first weeks of treatment.
• If you have developed Stevens-Johnson syndrome, toxic
epidermal necrolysis or DRESS with the use of Co-trimoxazole,
you must not be re-started on Co-trimoxazole at any time.
Other medicines and Co-Trimoxazole Tablets
Check with your doctor or pharmacist before taking these tablets if
you are taking any other medicines especially:
• pyrimethamine in doses greater than 25mg per week (used for the
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treatment of malaria or toxoplasmosis)
warfarin or acenocoumarol (to prevent blood clotting)
phenytoin (used to treat epilepsy)
rifampicin or dapsone (antibacterials)
procainamide or digoxin (used to treat heart conditions)
amiodarone (used to treat an irregular heartbeat)
clozapine (used to treat mental illness)
amantadine (used to treat Parkinson’s disease)
ciclosporin or azathioprine (used to prevent rejection after an organ
or tissue transplant)
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• methotrexate or mercaptopurine (used to treat some cancers or
severe rheumatoid arthritis)
• zidovudine or lamivudine (used to treat HIV infection)
• thiopental or prilocaine (anaesthetics)
• potassium aminobenzoate (used to treat inflammation or thickening
of the skin)
• any medicines used to treat diabetes
• spironolactone or other medicines that increase the amount of
potassium in your blood such as diuretics (also known as water
tablets) e.g. bendroflumethiazide.
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Regular blood tests may be performed by your doctor if you:
• are taking these tablets for a long time
• have low levels of folic acid in your body
• are elderly.
Your doctor may prescribe folic acid (a vitamin) for you to take at the
same time as Co-trimoxazole tablets.
Drink plenty of fluid such as water while you are taking these tablets.
Pregnancy, breast-feeding and fertility
Talk to your doctor before taking this medicine if you are pregnant,
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planning to get pregnant or breast-feeding.
Driving and using machines
When you take these tablets you may get a headache, see things that
are not there or feel dizzy. Do not drive or operate machinery if you
experience any of these effects.
Co-Trimoxazole Tablets contain Lactose:
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

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3. How to take Co-Trimoxazole Tablets

You should take Co-trimoxazole tablets with some food or drink. This
will stop you feeling sick (nausea) or having diarrhoea.
The dose will be different for different medical conditions and patients.
Your doctor has decided the dose which is best for you. Always follow
your doctor’s instructions. The pharmacist’s label will also tell you
how many tablets to take and how often. If you do not understand
anything, ask your doctor or pharmacist.

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The usual dosage(s) are:Standard dosage for treatment of infections:
Adults and children over 12 years:
Take two tablets twice a day, usually for 5 days.
Children aged 6-12 years: Give one tablet twice a day
Children under 6 years: Not recommended
Other forms of this medicine may be more suitable for children.

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Expiry Date:

Batch No.:

M0234TB

Code: DD/DRUGS/DD/375

Crescent Pharma Limited, Units 3 & 4,
Quidhampton Business Units, Polhampton Lane,
Overton, Hampshire, RG25 3ED, UK.

Peel here to open but do not remove

Date 11/04/2017

Proof 3

Base Label Size

30 x 100mm

Overall Leaflet Size

30 x TBCmm

Page Widths:

72
65
66
66

Market Trade Name

CO-Trimoxazole Leaflet Label

Leaflet Page 1

30 x 72mm

Item Number

M0234TB

Left Hand Opening

Yes

Body Text Size

8 pt

Printed Colours

Black

P2655

P2655 50% Tint

P286

P339

P100

67
64
69
66

66
66
69
66

For oral administration as
directed by the doctor.
Also contains lactose (see
patient information leaflet for
further information).

KEEP OUT OF THE SIGHT
AND REACH OF CHILDREN

65
67
66
65

Protect from heat, light and
moisture.
Product Licence holder:
Crescent Pharma Ltd,
Overton, Hants RG25 3ED
M0234TB PL20416/0052

Page 1

72 x 30

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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