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CO-TRIMOXAZOLE 160MG/800MG FORTE TABLETS

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

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Ref: 1670/120916/1/F

Co-Trimoxazole 160mg/800mg Forte Tablets
Patient Information 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 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.
Your medicine is called Co-Trimoxazole 160mg/800mg Forte Tablets but will
be referred to as Co-Trimoxazole throughout the rest of this leaflet.
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

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

* 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.
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.

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.

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 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 of Co-Trimoxazole you must not be re-started
on Co-Trimoxazole at any time.
* if you develop a rash or these skin symptoms, stop taking
Co-Trimoxazole, seek urgent advice from a doctor and tell him that you
are taking this medicine.

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.

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

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.
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

Ref: 1670/120916/1/B

Co-Trimoxazole 160mg/800mg Forte Tablets
Patient Information Leaflet (continued)
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
* take blood to test whether the medicine is working properly.
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.
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)

* 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.

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.
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

5

How to store Co-Trimoxazole

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Keep container in the outer carton.
Do not take Co-Trimoxazole after the expiry date which is stated on the
blister label or carton after EXP. The expiry date refers to the last day of that
month.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
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 to protect the environment.

6

Further information

What Co-Trimoxazole contains:
Co-Trimoxazole is made up of two different medicines called
sulfamethoxazole and trimethoprim. Each tablet contains 160mg of
trimethoprim and 800mg sulfamethoxazole.
The other ingredients are: povidone K30, sodium starch glycollate
Type A, docusate sodium and magnesium stearate.
What Co-Trimoxazole looks like and contents of the pack
Co-Trimoxazole is a white elongated tablet, with a score line on one side
and plain in the other side.
Each pack contains 100 Tablets.
Manufacturer and Licence Holder
Manufactured by Alcala Farma, S.L, Avenida de Madrid 82, Alcala de
Henares 28802 Madrid, Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1670

Co-Trimoxazole 160mg/800mg Forte Tablets

Revision date: 12/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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