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CO-TRIMOXAZOLE 800MG/160MG FORTE TABLETS

Active substance(s): SULFAMETHOXAZOLE / TRIMETHOPRIM

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Package Leaflet: Information for the User

Co-Trimoxazole 160 mg/800 mg Forte Tablets
co-trimoxazole

1 What Co-Trimoxazole is and what it is used for
Co-Trimoxazole 160 mg/800 mg Forte Tablets (called ‘Co-Trimoxazole’
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 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 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
Do not take Co-Trimoxazole if:
• you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim
or any of the other ingredients of Co-Trimoxazole (see section
6: Further information)
• you are allergic to sulphonamide medicines. Examples include
sulphonylureas (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.
Take special care with Co-Trimoxazole
Before you take Co-Trimoxazole, tell your doctor or pharmacist if:
• you have severe allergies or asthma
• potentially life-threatening skin rashes (Stevens-Johnson syndrome,
toxic epidermal necrolysis) 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 or toxic epidermal
necrolysis with the use ofCo-Trimoxazole you must not be re-started
on Co-Trimoxazole at any time.
• if you develop a rash or these skin symptoms, stop taking CoTrimoxazole, seek urgent advice from a doctor and tell him that you
are taking this medicine.

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In this leaflet:
1 What Co-Trimoxazole is and what it is used for
2 Before you take Co-Trimoxazole
3 How to take Co-Trimoxazole 160 mg/800 mg Forte Tablets
4 Possible side effects
5 How to store Co-Trimoxazole
6 Further information

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 can affect the way some medicines work. Also some
other medicines can affect the way Co-Trimoxazole works.
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 (sulphonylureas)
• 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.
Taking Co-Trimoxazole with food and drink
You should take Co-Trimoxazole with some food or drink. This will stop
you feeling sick (nausea) or having diarrhoea. Although it is better to
take it with food, you can still take it on an empty stomach.
Drink plenty of fluid such as water while you are taking CoTrimoxazole.
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 160 mg/800 mg Forte Tablets
Always take Co-Trimoxazole exactly as your doctor has told you. The
label on your pack will tell you how much to take and how often
to take it. 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 one tablet in a morning and one tablet in
an evening.
• Co-Trimoxazole should be taken for at least five days.
• Make sure that you finish the course of Co-Trimoxazole which
your doctor has prescribed. Co-Trimoxazole 160 mg/800 mg Forte
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.

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• Keep 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 have been told that you have a rare blood problem called
porphyria, which can affect your skin or nervous system
• 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.

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Read all of this leaflet carefully before you start taking
this medicine

If you take Co-Trimoxazole 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.

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If you take more Co-Trimoxazole than you should
If you take more Co-Trimoxazole than you should, talk to your doctor
or go to a hospital straight away. Take the medicine pack with you.
If you have taken too much Co-Trimoxazole you may
• feel or be sick
• feel dizzy or confused.
If you forget to take Co-Trimoxazole
• 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 can cause side effects, although not
everybody gets them. You may
experience the following side effects with this medicine. Stop taking
Co-Trimoxazole 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.
Uncommon (less than 1 in 100)
• Being sick (vomiting).
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).
• 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)

5 How to store Co-Trimoxazole
• Keep out of the reach and sight of children.
• Do not store above 25ºC.
• Do not take the tablets after the expiry date shown on the bottle
label and carton.
• Store in the original package with this leaflet.
• 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 protect the environment.

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If you have kidney problems your doctor may
• prescribe a lower dose of Co-Trimoxazole
• take blood to test whether the medicine is working properly.

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. 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.

6 Further information
What Co-Trimoxazole contains
Co-Trimoxazole is made up of two different medicines called
sulfamethoxazole and trimethoprim. Each Co-Trimoxazole
160 mg/800 mg Forte Tablet contains 800 mg sulfamethoxazole and
160 mg trimethoprim.
The other ingredients of Co-Trimoxazole 160 mg/800 mg Forte Tablets
are: povidone, sodium starch glycollate, magnesium stearate and
docusate sodium.
What Co-Trimoxazole looks like and contents of the pack
Co-Trimoxazole 160 mg/800 mg Forte Tablets are white elongated
tablets, coded S3 on one side. They are biconvex and are scored along
the shorter axis.
Co-Trimoxazole 160 mg/800 mg Forte Tablets are supplied to you in:
• a propylene container with a propylene snap fit closure, containing
100 tablets, or
• a round enamelled tin, containing 200 tablets, or
• a PVC/aluminium foil blister pack, containing 5 tablets (sample
pack) or 100 tablets.

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Pneumocystis jiroveci
• treat infections caused by the bacteria Toxoplasma (toxoplasmosis)
or Nocardia (nocardiosis).










Marketing authorisation holder and manufacturer
Marketing authorisation holder:
UK:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36, D-23843 Bad Oldesloe, Germany
Medical Information Enquiries
For any Medical Information enquires about this product,
please contact:
24 Hour Helpline +441748 828 391 (free phone UK only
0800 0087 392)
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:

Braille RNIB Helpline 0303 123 9999 (UK Only).
Please be ready to give the following information:

Product name Co-Trimoxazole 160 mg/800 mg Forte Tablets
Reference number PL 39699/0035
This is a service provided by the Royal National Institute of
Blind People.
Leaflet date: July 2015

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Special Dose
The dose of Co-Trimoxazole 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

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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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