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CO-TRIMOXAZOLE TABLETS BP 80/400MG

Active substance(s): SULFAMETHOXAZOLE / TRIMETHOPRIM

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Co-trimoxazole Tablets 80/400mg
(Trimethoprim and Sulfamethoxazole)
Read all of this leaflet carefully before you start
taking this medicine.
•  K eep this leaflet. You may need to read it again.
•  If you have any further questions, ask your
doctor or pharmacist.
•  This medicine has been prescribed for you.
Do 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.

• you don’t have enough folic acid (a vitamin) in your body - which
can make your skin pale and make you feel tired, weak and
breathless. This is known as anaemia
• you have ever had jaundice which can cause yellowing of your skin
or the whites of your eyes
• you have a problem with your metabolism called phenylketonuria
and are not on a special diet to help your condition
• you are elderly
• you are underweight or malnourished
• you have been told by your doctor that you have a lot of potassium
in your blood.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Co-trimoxazole tablets.

In this leaflet
1 What Co-trimoxazole tablets are and
what they are used for
2  B efore you take Co-trimoxazole
tablets
3 How to take Co-trimoxazole tablets
4 Possible side effects
5 How to store Co-trimoxazole tablets
6 Further information

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:
• 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 targetlike spots or circular patches often with central blisters on the trunk.
• 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 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 tablets you
must not be re-started on Co-trimoxazole tablets at any time.

1 What Co-trimoxazole tablets are and what they
are used for

Co-trimoxazole 80 mg/400 mg Tablets (called ‘Co-trimoxazole
tablets’in this leaflet) are made up of two different medicines called
sulfamethoxazole and trimethoprim. Both belong to a group of
medicines called antibiotics. They are used to treat infections caused
by bacteria. Like all antibiotics, Co-trimoxazole only works against
some types of bacteria. This means that it is only suitable for treating
some types of infections.
Co-trimoxazole tablets can be used to treat or prevent:
• lung infections (pneumonia or PCP) caused by a bacteria called
Pneumocystis jiroveci (previously known as Pneumocystis carinii )
• infections caused by a bacteria called Toxoplasma (toxoplasmosis).
Co-trimoxazole tablets can be used to treat:
• bladder or urinary tract infections (water infections)
• lung infections such as bronchitis
• ear infections such as otitis media
• an infection called nocardiosis, it can affect the lungs, skin and
brain.

2 Before you take Co-trimoxazole tablets
Do not take Co-trimoxazole tablets if:

• you are allergic (hypersensitive) to sulfamethoxazole,
trimethoprim or Co-trimoxazole or any of the other ingredients of
Co-trimoxazole tablets (see section 6: Further information)
• you are allergic to sulfonamide medicines. Examples include
sulfonylureas (such as gliclazide and glibenclamide) or thiazide
diuretics (such as bendroflumethiazide – a water tablet)
• you have liver or kidney problems
• you have ever had a problem with your blood
• it is for your child and they are less than 6 weeks old or were
premature. Unless it is for the treatment or prevention of PCP. In
this case, babies should be at least 4 weeks old.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Co-trimoxazole tablets.

Take special care with Co-trimoxazole tablets

Before you take Co-trimoxazole tablets, tell your doctor or
pharmacist if:
• you have severe allergies or asthma
• you have been told that you have a rare blood problem called
porphyria, which can affect your skin or nervous system
Continued top of next column

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. This includes herbal medicines. This is
because Co-trimoxazole tablets can affect the way some medicines
work. Also some other medicines can affect the way Co-trimoxazole
tablets work.
In particular tell your doctor or pharmacist if you are taking any of
the following medicines:
• Diuretics (water tablets), which help increase the amount of urine
you produce
• Pyrimethamine, used to treat and prevent malaria, and to treat
diarrhoea
• Ciclosporin, used after transplant operations or for your immune
system
• Medicines used to thin the blood such as warfarin
• Phenytoin, used to treat epilepsy (fits)
• Medicines for diabetes, such as glibenclamide, glipizide or
tolbutamide (sulfonylureas)
• Medicines to treat problems with the way your heart beats such as
digoxin or procainamide
• Amantadine, used to treat Parkinson’s disease, multiple sclerosis,
‘flu or shingles
• Medicines to treat HIV (Human Immunodeficiency Virus), called
zidovudine or lamivudine
• Medicines that can increase the amount of potassium in your
blood, such as diuretics (water tablets, which help increase the
amount of urine you produce), steroids (like prednisolone) and
digoxin
• Methotrexate, a medicine used to treat cancer or for your immune
system. If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Co-trimoxazole tablets.

Taking Co-trimoxazole tablets with food and drink

You should take Co-trimoxazole tablets with some food or drink.
This will stop you feeling sick (nausea) or having diarrhoea.
Although it is better to take them with food, you can still take them
on an empty stomach.
Drink plenty of fluid such as water while you are taking
Co-trimoxazole tablets.
Continued over page

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Co-Trimoxazole 80mg/400mg 28 Tablets PIL - UK
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Technical Approval

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date sent: n/a

supplier: Actavis UK

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Co-Trimoxazole Tablets BP
80/400mg x 28’s (UK)
JDE No.:

50885281

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Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

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Pharmacode: 4315

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originated by: S.Anson
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Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant,
planning to get pregnant, or breast-feeding.

3 How to take Co-trimoxazole tablets

Always take Co-trimoxazole tablets exactly as your doctor has told you.
The label on your pack will tell you how much to take and how often to
take them. You should check with your doctor or pharmacist if you are
not sure.
Usual Dose
Adults and children over 12 years
• The usual dose is two tablets in a morning and two tablets in an evening.
• Co-trimoxazole tablets should be taken for at least five days.
• Make sure that you finish the course of Co-trimoxazole tablets which your
doctor has prescribed.
Co-trimoxazole tablets are not usually given to children under 12 years
old. If they have been given to your child please speak to your doctor or
pharmacist for more information.
Special Dose
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
jiroveci
• treat infections caused by the bacteria Toxoplasma (toxoplasmosis) or
Nocardia (nocardiosis).
If you have kidney problems your doctor may
• prescribe a lower dose of Co-trimoxazole tablets
• take blood to test whether the medicine is working properly.
If you take Co-trimoxazole tablets for a long time your doctor may
• take blood to test whether the medicine is working properly
• prescribe folic acid (a vitamin) for you to take at the same time as
Co-trimoxazole tablets.

Very Rare (less than 1 in 10,000 people)
• Fever (high temperature) or frequent infections
• Sudden wheeziness or difficulty breathing
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported (see Take special care with
Co-trimoxazole tablets).
• Mouth ulcers, cold sores and ulcers or soreness of your tongue
• Skin lumps or hives (raised, red or white, itchy patches of skin)
• Blisters on your skin or inside your mouth, nose, vagina or bottom
• Inflammation of the eye which causes pain and redness
• The appearance of a rash or sunburn when you have been outside (even
on a cloudy day)
• Low levels of sodium in your blood
• Changes in blood tests
• Feeling weak, tired or listless, pale skin (anaemia)
• Heart problems
• Jaundice (the skin and the whites of your eyes turn yellow). This can occur
at the same time as unexpected bleeding or bruising
• Pains in your stomach, which can occur with blood in your faeces (poo)
• Pains in your chest, muscles or joints and muscle weakness
• Arthritis
• Problems with your urine. Difficulty passing urine. Passing more or less
urine than usual. Blood or cloudiness in your urine.
• Kidney problems
• Sudden headache or stiffness of your neck, accompanied by fever (high
temperature)
• Problems controlling your movements
• Fits (convulsions or seizures)
• Feeling unsteady or giddy
• Ringing or other unusual sounds in your ears
• Tingling or numbness in your hands and feet
• Seeing strange or unusual sights (hallucinations)
• Depression
• Muscle pain and/or muscle weakness in HIV patients
• Loss of appetite
• Cough.

If you take more Co-trimoxazole tablets than you should

Not Known
•D
 rug reaction with eosinophilia and systemic symptoms (DRESS)

If you have taken too many Co-trimoxazole tablets you may
• feel or be sick
• feel dizzy or confused.

Reporting of side effects
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.

If you take more Co-trimoxazole tablets than you should, talk to your
doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Co-trimoxazole tablets

• If you forget to take a dose, take it as soon as you remember it.
• Do not take a double dose to make up for the forgotten dose.

4 Possible side effects

Like all medicines, Co-trimoxazole tablets can cause side-effects, although
not everbody gets them.
You may experience the following side effects with this medicine.
Stop taking Co-trimoxazole tablets and tell your doctor immediately if you
have an allergic reaction. Chances of an allergic reaction is very rare (fewer
than 1 in 10,000 people are affected), signs of an allergic reaction include

Allergic reactions

• Difficulty in breathing
• Fainting
• Swelling of face
• Swelling of mouth, tongue or throat which may be red and painful and/or
cause difficulty in swallowing
• Chest pain
• Red patches on the skin.
Very Common (more than 1 in 10 people)
• High levels of potassium in your blood, which can cause abnormal heart
beats (palpitations).
Common (less than 1 in 10 people)
• An infection called thrush or candidiasis which can affect your mouth or
vagina. It is caused by a fungus
• Headache
• Feeling sick (nausea)
• Diarrhoea
• Skin rashes.

5 How to store Co-trimoxazole tablets

Keep out of the reach and sight of children.
Store below 25ºC in a dry place and protect from light.
Do not use Co-trimoxazole tablets after the expiry date
stated on the label/carton/bottle. The expiry date refers to
the last day of that month.
Ask your pharmacist how to dispose of medicines no
longer required.

6 F urther information

What Co-trimoxazole tablets contain

• T he active substances (the ingredients that make the
tablets work) are 80mg of trimethoprim and 400mg of
sulfamethoxazole.
• T he other ingredients are docusate sodium, magnesium
stearate, maize starch, silica, sodium lauryl sulfate and
stearic acid.

What Co-trimoxazole tablets look like and
contents of the pack
Co-trimoxazole tablets are white, circular, biconvex
uncoated tablets. Pack sizes are 28 tablets.

Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in January 2016.

Uncommon (less than 1 in 100)
• Being sick (vomiting).
Continued top of next column
50885281 AAAI6839

Actavis, Barnstaple, EX32 8NS, UK

130x210 Leaflet Reel Fed Profile (BST)

Co-Trimoxazole 80mg/400mg 28 Tablets PIL - UK
item no: AAAI6839

dimensions: 130 x 210

print proof no: 1

pharmacode:

origination date: 20.01.16

min pt size: 7

1. Black
2.

revision date:

Technical Approval

revised by:

date sent: n/a

supplier: Actavis UK

technically app. date:

Co-Trimoxazole Tablets BP
80/400mg x 28’s (UK)
JDE No.:

50885281

4.

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

5.

Pharmacode: 4315

3.

6.

originated by: S.Anson
approved for print/date

colours/plates:

Non Printing Colours
1. Profile
2.
3.

Date Sent:
19/01/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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