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CO-TRIMOXAZOLE 80 MG/400 MG PER 5 ML ADULT SUSPENSION

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

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Package leaflet: Information for the patient

Co-Trimoxazole 80 mg/400 mg per 5 ml Adult Suspension

PHARMA CODE N° xxxx

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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on
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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Co-Trimoxazole is and what it is used for
2. What you need to know before you take Co-Trimoxazole
3. How to take Co-Trimoxazole
4. Possible side effects
5. How to store Co-Trimoxazole
6. Contents of the pack and other information
1. What Co-Trimoxazole is and what it is used for
Co-Trimoxazole 80 mg/400 mg per 5 ml Adult Suspension (called
‘Co-Trimoxazole’ in this leaflet) is a combination of two different
antibiotics called sulfamethoxazole and trimethoprim, which is used to
treat infections caused by certain bacteria. This medicine combination
is also named as co-trimoxazole. 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 PJP) 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:
• Urinary bladder or urinary tract infections (water infections).
• respiratory tract infections such as bronchitis.
• Ear infections such as otitis media.
• An infection called nocardiosis which can affect the lungs, skin
and brain.
2. What you need to know before you take Co-Trimoxazole
Do not take Co-Trimoxazole:
• If you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim
or cotrimoxazole or any of the other ingredients of Co-Trimoxazole
(see section 6: Contents of the pack and other information).
• If you are allergic to sulphonamide medicines. Examples include
sulphonylureas (such as gliclazide and glibenclamide) or thiazide
diuretics (such as bendroflumethiazide - a water tablet).
• If you have severe liver or kidney problems.
• If you have ever had a problem with your blood causing bruises or
bleeding (thrombocytopenia).
• If you have been told that you have a rare blood problem called
porphyria, which can affect your skin or nervous system.
If it is for your child, Co-Trimoxazole should not be given if they are less
than 6 weeks old or were premature. Unless it is for the treatment or
prevention of PJP. In this case, Co-Trimoxazole should not be given if
they are less than 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-Trimoxazole:
• 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.
• If you have been told that you are at risk for a rare blood disorder

called porphyria.
• If 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.
• If you have a disease called glucose-6-phosphate dehydrogenase
deficiency, which can cause jaundice or spontaneous destruction of
red blood cells.
• If you have a problem with your metabolism called phenylketonuria
and are not on a special diet to help your condition.
• If you are an older person.
• If you are underweight or malnourished.
• If you have been told by your doctor that you have a lot of
potassium in your blood.
• If you have a kidney disease.
• If you have severe allergy or bronchial asthma.
• If you have a severe blood disorder, such as a low number of
red blood cells (anaemia), a low number of white blood cells
(leucopenia) or a low number of platelets, which may cause
bleeding and bruising (thrombocytopenia).
Other medicines and Co-Trimoxazole
Tell your doctor or pharmacist if you are taking, have recently taken
or may take any other 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 organ transplant surgeries.
• Blood thinners such as warfarin.
• Phenytoin, used to treat epilepsy (fits).
• Medicines used to treat diabetes, such as glibenclamide, glipizide
or tolbutamide (sulphonylureas) and repaglinide.
• 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 certain cancers or certain
diseases affecting your immune system.
• Rifampicin, an antibiotic.
• Folinic acid.
• Contraceptive medicines.
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 .
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
Effects on the ability to drive and operate machinery in patients taking
this medicine have not been studied.
Co-Trimoxazole contains
• 2.5 g sucrose in every 5 ml spoonful. If you have been told by your
doctor that you cannot tolerate or digest some sugars (have an
intolerance to some sugars), contact your doctor before taking this
medicinal product.
• A small amount of ethanol (alcohol), less than 100 mg per
ml spoonful.
• Methyl hydroxybenzoate, which may cause allergic reactions
(possibly delayed).
• Less than 1 mmol sodium (23 mg) per 5 ml, i.e. essentially
‘sodium free’.
3. How to take Co-Trimoxazole
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.

PHARMA CODE N° xxxx

co-trimoxazole

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)
• A fungal infection called thrush or candidiasis which can affect your
mouth or vagina.
• 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 Warnings and
precautions).
• 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.
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 or pharmacist. 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.
5. How to store Co-Trimoxazole
• Keep this medicine out of the sight and reach of children.
• Keep away from direct heat or sunlight.
• Do not store above 25°C.
• Do not take the suspension 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.
6. Contents of the pack and other information
What Co-Trimoxazole contains
- Co-Trimoxazole is made up of two different medicines called
sulfamethoxazole and trimethoprim.
These medicines are sometimes given the combined name
co-trimoxazole.
- The other ingredients Co-Trimoxazole 80 mg/400 mg per 5 ml Adult
Suspension are: sucrose, glycerol (E422), cellulose (E460), sodium
carmellose, methyl hydroxybenzoate (E218), saccharin sodium
(E954), ammonium glycyrrhizinate, star anise oil, ethanol (alcohol),
vanilla flavour, polysorbate 80 (E433) and purified water.
What Co-Trimoxazole looks like and contents of the pack
Co-Trimoxazole 80 mg/400 mg per 5 ml Adult Suspension is supplied
to you in an amber-coloured glass bottle, containing 100 ml of an
off-white liquid. The medicine comes with a double-ended measuring
spoon. One end of the spoon will give you 5 ml of the suspension and
the other will give you 2.5 ml.
Each 5 ml of Co-Trimoxazole 80 mg/400 mg per 5 ml Adult Suspension
contains 400 mg sulfamethoxazole and 80 mg trimethoprim.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
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)
This leaflet was last revised in December 2016.
Other source of information:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:

Braille RNIB Helpline 0800 198 5000 (UK only).

Please be ready to give the following information:
Product name Co-Trimoxazole 80 mg/400 mg per 5 ml Adult
Suspension
Reference number PL 39699/0038
This is a service provided by the Royal National Institute of
Blind People.

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PHARMA CODE N° xxxx

PHARMA CODE N° xxxx

Usual dose
Adults and children over 12 years
• The usual dose is two 5 ml spoonfuls in a morning and two 5 ml
spoonfuls 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 80 mg/400 mg per 5 ml Adult Suspension is not usually
given to children under 12 years old. If this has been given to your
child under 12 years 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
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.

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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