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CO-TRIMOXAZOLE TABLETS BP

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  Before you take Co-trimoxazole tablets
3 H ow to take Co-trimoxazole tablets
4 Possible side effects
5 H ow 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 target-like 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 are used for adults and children over 12 years.
Co-trimoxazole tablets can be used to treat or prevent:
• lung infections (pneumonia or PCP) caused by a bacteria called
Pneumocystis jiroveci
• 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
• Co-Trimoxazole should not be given to infants during the first 6
weeks of life
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 Cotrimoxazole 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.

Pregnancy and breast-feeding

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

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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 Cotrimoxazole 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.

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
· T he 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.
· M ake sure that you finish the course of Co-trimoxazole tablets which your
doctor has prescribed.
Children over 12 years
The schedules for children are according to the child’s age and body weight
provided in the table below:
12 years and over
Two tablets in a morning and two tablets in
OR
an evening
Weighing 53kg or above
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.

If you take more Co-trimoxazole tablets than you should

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

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.

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

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.

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

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.

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 September 2017.

Uncommon (less than 1 in 100)
• Being sick (vomiting).
Continued top of next column
50937985 BBBA1069

Actavis, Barnstaple, EX32 8NS, UK

130x210 Leaflet Reel Fed Profile (BST)

Co-Trimoxazole Tablets BP
80/400mg

Co-Trimoxazol 80/400mg 28 Tablets PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1069

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

JDE No.:

S.Anson
20.07.17
15.09.17
S.Anson

Date sent:
n/a
Date received: n/a

Dimensions:
130 x 210
Min Body Text Size: 7pt
Supplier:
Actavis UK

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

50937985

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles
Pharmacode: 2574
Date Sent:
17/07/17
Technologist: R.Wrey
Technically Approved

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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