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SEPTRIN 40 MG/200 MG PER 5 ML PAEDIATRIC SUSPENSION

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

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Septrin® 40 mg/200 mg per 5 ml
Paediatric Suspension

2998
06.04.17[4]

(Co-trimoxazole)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before your child starts taking this
medicine because it contains important information for them.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your child’s doctor or pharmacist.
- This medicine has been prescribed for your child only. Do not pass it on
to others. It may harm them, even if their signs of illness are the same as
your child.
- If your child gets any side effects, talk to your child’s doctor or
pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
Your medicine is available using the above name but will be referred as
Septrin throughout the leaflet.
What is in this leaflet
1. What Septrin is and what it is used for
2. What you need to know before your child takes Septrin
3. How to give Septrin
4. Possible side effects
5. How to store Septrin
6. Contents of the pack and other information
1. WHAT SEPTRIN IS AND WHAT IT IS USED FOR
Septrin 40 mg/200 mg per 5 ml Paediatric Suspension (called ‘Septrin’ in
this leaflet) is a combination of two different antibiotics called
sulfamethoxazole and trimethoprim, which is used to treat infections
caused by bacteria. Like all antibiotics, Septrin only works against some
types of bacteria. This means that it is only suitable for treating some types
of infections.
Septrin 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).
Septrin 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 YOUR CHILD TAKES
SEPTRIN
Your child should not take Septrin:
- If they are allergic (hypersensitive) to sulfamethoxazole, trimethoprim or
co-trimoxazole or any of the other ingredients of Septrin (see section 6:
Contents of the pack and other information).
- If they are allergic to sulphonamide medicines. Examples include
sulphonylureas (such as gliclazide and glibenclamide) or thiazide
diuretics (such as bendroflumethiazide - a water tablet).
- If they have severe liver or kidney problems.
- If they have ever had a problem with their blood causing bruises or
bleeding (thrombocytopenia).
- If you have been told that your child have a rare blood problem called
porphyria, which can affect their skin or nervous system.
Septrin should not be given to your child 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 your child, talk to their doctor
or pharmacist before they take Septrin.
Warnings and precautions
Talk to your child’s doctor or pharmacist before taking Septrin:
- If they have severe allergies or asthma.
- Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported with the use of Septrin
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 your child has developed Stevens-Johnson syndrome or toxic
epidermal necrolysis with the use of Septrin your child must not be restarted on Septrin at any time.

- If your child develops a rash or these skin symptoms, stop giving Septrin,
seek urgent advice from a doctor and tell him that your child is taking this
medicine.
- If you have been told that your child is at risk for a rare blood disorder
called porphyria.
- If they don’t have enough folic acid (a vitamin) in their body - which can
make their skin pale and make them feel tired, weak and breathless. This
is known as anaemia.
- If they have a disease called glucose-6-phosphate dehydrogenase
deficiency, which can cause jaundice or spontaneous destruction of red
blood cells.
- If they have a problem with their metabolism called phenylketonuria and
are not on a special diet to help their condition.
- If they are underweight or malnourished.
- If you have been told by your child’s doctor that your child has a lot of
potassium in their blood.
- If they have a kidney disease.
- If they have severe allergy or bronchial asthma.
- If your child has 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 Septrin
Tell your child’s doctor or pharmacist if your child is taking, has recently
taken or might take any other medicines .This is because Septrin can affect
the way some medicines work. Also some other medicines can affect the
way Septrin works.
In particular tell your child’s doctor or pharmacist if your child is taking any
of the following medicines:
- Diuretics (water tablets), which help increase the amount of urine
produced.
- Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea.
- Ciclosporin, used after 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 the 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 the blood, such
as diuretics (water tablets, which help increase the amount of urine
produced), steroids (like prednisolone) and digoxin.
- Methotrexate, a medicine used to treat certain cancers or certain
diseases affecting the immune system.
- Folinic acid.
- Rifampicin, an antibiotic.
- Contraceptive medicines.
Septrin with food and drink
Your child should take Septrin with some food or drink. This will stop them
feeling sick (nausea) or having diarrhoea. Although it is better to take it with
food, they can still take it on an empty stomach. Make sure your child drink
plenty of fluid such as water while they are taking Septrin.
Septrin contains
3.25 g sorbitol in every 5 ml spoonful. If you have been told by your child’s
doctor that they cannot tolerate or digest some sugars (has an intolerance
to some sugars), contact your child’s doctor before giving this medicinal
product to your child.
- A small amount of ethanol (alcohol), less than 100 mg per 5 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 GIVE SEPTRIN
Always ensure your child takes Septrin exactly as their doctor or
pharmacist has told you. Check with their doctor or pharmacist if you are
not sure.
Usual dose
The dose to be given will depend on the age of your child:
- 6 to 12 years old: two 5 ml spoonfuls in a morning and two 5 ml spoonfuls
in an evening.
- 6 months to 5 years: one 5 ml spoonful in a morning and one 5 ml
spoonful in an evening.
- 6 weeks to 5 months: one 2.5 ml spoonful in a morning and one 2.5 ml
spoonful in an evening.
- Septrin should be taken for at least five days
- Make sure that your child finishes the course of Septrin which their doctor
has prescribed.

Special dose
The dose of Septrin and how long your child needs to take it depends on
the infection they have and how bad it is. Your child’s doctor may prescribe
you a different dose or length of course of Septrin 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 your child takes Septrin for a long time their doctor may
- Take blood to test whether the medicine is working properly.
- Prescribe folic acid (a vitamin) for your child to take at the same time as
Septrin.
If your child takes more Septrin than they should
If your child takes more Septrin than they should, talk to their doctor or go
to a hospital straight away. Take the medicine pack with you.
If your child has taken too much Septrin they may
- Feel or be sick.
- Feel dizzy or confused.
If you forget to give your child Septrin
- If a dose is forgotten, your child should take it as soon as possible.
- Do not give your child a double dose to make up for the forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Septrin can cause side effects, although not everybody
gets them.
Your child may experience the following side effects with this medicine.
Stop giving your child Septrin and tell your child’s doctor immediately if your
child has 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 the 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
child’s 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 the tongue.
- Skin lumps or hives (raised, red or white, itchy patches of skin).
- Blisters on the skin or inside the mouth, nose, vagina or bottom.
- Inflammation of the eye which causes pain and redness.
- The appearance of a rash or sunburn when your child has been outside
(even on a cloudy day).
- Low levels of sodium in the blood.
- Changes in blood tests.
- Feeling weak, tired or listless, pale skin (anaemia).
- Heart problems.
- Jaundice (the skin and the whites of the eyes turn yellow). This can occur
at the same time as unexpected bleeding or bruising.
- Pains in the stomach, which can occur with blood in the faeces (poo).
- Pains in the chest, muscles or joints and muscle weakness.
- Arthritis.
- Problems with the urine. Difficulty passing urine. Passing more or less
urine than usual. Blood or cloudiness in the urine.
- Kidney problems.

- Sudden headache or stiffness of the neck, accompanied by fever (high
temperature).
- Problems controlling movements.
- Fits (convulsions or seizures).
- Feeling unsteady or giddy.
- Ringing or other unusual sounds in the ears.
- Tingling or numbness in the 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 child’s 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 SEPTRIN
- Keep out of the sight and reach of children.
- Do not use the suspension after the expiry date shown on the bottle label
and carton.
- Do not store above 25˚C.
- Store in the original package in order to protect from light
- If the solution 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Septrin contains
Each 5 ml contains 40 mg trimethoprim and 200 mg sulfamethoxazole.
The other components are: sorbitol (70%), glycerol (E-422), dispersible
cellulose, carmellose sodium, polysorbate 80, methyl parahydroxybenzoate
(E-218), sodium benzoate (E-211), sodium saccharin, Banana flavour
(propylene glycol E-1520, sodium citrate E-331), ethanol 96%, vanilla
flavour (benzyl alcohol, caramel colour E-150d, propylene glycol E-1520,
glycerol E-422, water) and purified water.
What Septrin looks like and contents of the pack
Septrin is an off-white suspension with characteristic banana and vanilla
odour.
Available as 1 bottle containing 100ml suspension supplied in a ambercoloured glass bottle with metal screw cap.
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.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Alcalá Farma, S.L., Avenida de Madrid 82, Alcalá de
Henares, 28802 Madrid, Spain.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2998

Leaflet revision and issue date (Ref.) 06.04.17[4]
Septrin is a trademark of Aspen Global Incorporated.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Co-Trimoxazole®

40 mg/200 mg
per 5 ml Paediatric Suspension

2998
06.04.17[4]

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before your child starts taking this
medicine because it contains important information for them.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your child’s doctor or pharmacist.
- This medicine has been prescribed for your child only. Do not pass it on
to others. It may harm them, even if their signs of illness are the same as
your child.
- If your child gets any side effects, talk to your child’s doctor or
pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
Your medicine is available using the above name but will be referred as CoTrimoxazole throughout the leaflet.
What is in this leaflet
1. What Co-Trimoxazole is and what it is used for
2. What you need to know before your child takes Co-Trimoxazole
3. How to give 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 40 mg/200 mg per 5 ml Paediatric Suspension (called ‘CoTrimoxazole’ in this leaflet) is a combination of two different antibiotics
called sulfamethoxazole and trimethoprim, which is 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 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 YOUR CHILD TAKES COTRIMOXAZOLE
Your child should not take Co-Trimoxazole:
- If they are allergic (hypersensitive) to sulfamethoxazole, trimethoprim or
co-trimoxazole or any of the other ingredients of Co-Trimoxazole (see
section 6: Contents of the pack and other information).
- If they are allergic to sulphonamide medicines. Examples include
sulphonylureas (such as gliclazide and glibenclamide) or thiazide
diuretics (such as bendroflumethiazide - a water tablet).
- If they have severe liver or kidney problems.
- If they have ever had a problem with their blood causing bruises or
bleeding (thrombocytopenia).
- If you have been told that your child have a rare blood problem called
porphyria, which can affect their skin or nervous system.
Co-Trimoxazole should not be given to your child 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 your child, talk to their doctor
or pharmacist before they take Co-Trimoxazole.
Warnings and precautions
Talk to your child’s doctor or pharmacist before taking Co-Trimoxazole:
- If they 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 your child has developed Stevens-Johnson syndrome or toxic
epidermal necrolysis with the use of Co-Trimoxazole your child must not
be re-started on Co-Trimoxazole at any time.

- If your child develops a rash or these skin symptoms, stop giving CoTrimoxazole, seek urgent advice from a doctor and tell him that your child
is taking this medicine.
- If you have been told that your child is at risk for a rare blood disorder
called porphyria.
- If they don’t have enough folic acid (a vitamin) in their body - which can
make their skin pale and make them feel tired, weak and breathless. This
is known as anaemia.
- If they have a disease called glucose-6-phosphate dehydrogenase
deficiency, which can cause jaundice or spontaneous destruction of red
blood cells.
- If they have a problem with their metabolism called phenylketonuria and
are not on a special diet to help their condition.
- If they are underweight or malnourished.
- If you have been told by your child’s doctor that your child has a lot of
potassium in their blood.
- If they have a kidney disease.
- If they have severe allergy or bronchial asthma.
- If your child has 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 child’s doctor or pharmacist if your child is taking, has recently
taken or might 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 child’s doctor or pharmacist if your child is taking any
of the following medicines:
- Diuretics (water tablets), which help increase the amount of urine
produced.
- Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea.
- Ciclosporin, used after 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 the 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 the blood, such
as diuretics (water tablets, which help increase the amount of urine
produced), steroids (like prednisolone) and digoxin.
- Methotrexate, a medicine used to treat certain cancers or certain
diseases affecting the immune system.
- Folinic acid.
- Rifampicin, an antibiotic.
- Contraceptive medicines.
Co-Trimoxazole with food and drink
Your child should take Co-Trimoxazole with some food or drink. This will
stop them feeling sick (nausea) or having diarrhoea. Although it is better to
take it with food, they can still take it on an empty stomach. Make sure your
child drink plenty of fluid such as water while they are taking CoTrimoxazole.
Co-Trimoxazole contains
3.25 g sorbitol in every 5 ml spoonful. If you have been told by your child’s
doctor that they cannot tolerate or digest some sugars (has an intolerance
to some sugars), contact your child’s doctor before giving this medicinal
product to your child.
- A small amount of ethanol (alcohol), less than 100 mg per 5 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 GIVE CO-TRIMOXAZOLE
Always ensure your child takes Co-Trimoxazole exactly as their doctor or
pharmacist has told you. Check with their doctor or pharmacist if you are
not sure.
Usual dose
The dose to be given will depend on the age of your child:
- 6 to 12 years old: two 5 ml spoonfuls in a morning and two 5 ml spoonfuls
in an evening.
- 6 months to 5 years: one 5 ml spoonful in a morning and one 5 ml
spoonful in an evening.
- 6 weeks to 5 months: one 2.5 ml spoonful in a morning and one 2.5 ml
spoonful in an evening.
- Co-Trimoxazole should be taken for at least five days
- Make sure that your child finishes the course of Co-Trimoxazole which
their doctor has prescribed.

Special dose
The dose of Co-Trimoxazole and how long your child needs to take it
depends on the infection they have and how bad it is. Your child’s 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 your child takes Co-Trimoxazole for a long time their doctor may
- Take blood to test whether the medicine is working properly.
- Prescribe folic acid (a vitamin) for your child to take at the same time as
Co-Trimoxazole.
If your child takes more Co-Trimoxazole than they should
If your child takes more Co-Trimoxazole than they should, talk to their
doctor or go to a hospital straight away. Take the medicine pack with you.
If your child has taken too much Co-Trimoxazole they may
- Feel or be sick.
- Feel dizzy or confused.
If you forget to give your child Co-Trimoxazole
- If a dose is forgotten, your child should take it as soon as possible.
- Do not give your child 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.
Your child may experience the following side effects with this medicine.
Stop giving your child Co-Trimoxazole and tell your child’s doctor
immediately if your child has 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 the 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
child’s 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 the tongue.
- Skin lumps or hives (raised, red or white, itchy patches of skin).
- Blisters on the skin or inside the mouth, nose, vagina or bottom.
- Inflammation of the eye which causes pain and redness.
- The appearance of a rash or sunburn when your child has been outside
(even on a cloudy day).
- Low levels of sodium in the blood.
- Changes in blood tests.
- Feeling weak, tired or listless, pale skin (anaemia).
- Heart problems.
- Jaundice (the skin and the whites of the eyes turn yellow). This can occur
at the same time as unexpected bleeding or bruising.
- Pains in the stomach, which can occur with blood in the faeces (poo).
- Pains in the chest, muscles or joints and muscle weakness.
- Arthritis.
- Problems with the urine. Difficulty passing urine. Passing more or less
urine than usual. Blood or cloudiness in the urine.
- Kidney problems.

- Sudden headache or stiffness of the neck, accompanied by fever (high
temperature).
- Problems controlling movements.
- Fits (convulsions or seizures).
- Feeling unsteady or giddy.
- Ringing or other unusual sounds in the ears.
- Tingling or numbness in the 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 child’s 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 out of the sight and reach of children.
- Do not use the suspension after the expiry date shown on the bottle label
and carton.
- Do not store above 25˚C.
- Store in the original package in order to protect from light
- If the solution 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-Trimoxazole contains
Each 5 ml contains 40 mg trimethoprim and 200 mg sulfamethoxazole.
The other components are: sorbitol (70%), glycerol (E-422), dispersible
cellulose, carmellose sodium, polysorbate 80, methyl parahydroxybenzoate
(E-218), sodium benzoate (E-211), sodium saccharin, Banana flavour
(propylene glycol E-1520, sodium citrate E-331), ethanol 96%, vanilla
flavour (benzyl alcohol, caramel colour E-150d, propylene glycol E-1520,
glycerol E-422, water) and purified water.
What Co-Trimoxazole looks like and contents of the pack
Co-Trimoxazole is an off-white suspension with characteristic banana and
vanilla odour.
Available as 1 bottle containing 100ml suspension supplied in a ambercoloured glass bottle with metal screw cap.
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.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Alcalá Farma, S.L., Avenida de Madrid 82, Alcalá de
Henares, 28802 Madrid, Spain.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2998

Leaflet revision and issue date (Ref.) 06.04.17[4]

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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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