SEPTRIN 40 MG/200 MG PER 5 ML PAEDIATRIC SUSPENSION

Active substance: TRIMETHOPRIM

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Package Leaflet: Information for User

Septrin® 40 mg/200 per 5ml Paediatric Suspension
co-trimoxazole
Read all of this leaflet carefully before your child starts taking this medicine
• 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. Do not pass it
on to others. It may harm them, even if their symptoms are the
same as your child’s.
• 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.
In this leaflet:
1. What Septrin is and what it is used for
2. Before your child takes Septrin
3. How to give Septrin 40 mg/200 mg per 5 ml Paediatric
Suspension
4. Possible side effects
5. How to store Septrin
6. Further 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 made up of two different medicines
called sulfamethoxazole and trimethoprim. These medicines are
sometimes given the combined name co-trimoxazole.
Both belong to a group of medicines called antibiotics. They are
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 PCP) 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:
• 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 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: Further information)
• they are allergic to sulphonamide medicines. Examples include
sulphonylureas (such as gliclazide and glibenclamide) or thiazide
diuretics (such as bendroflumethiazide – a water tablet)
• they have liver or kidney problems
• they have ever had a problem with their blood
• 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 your child, talk to
their doctor or pharmacist before they take Septrin.
Take special care with Septrin
Before your child takes Septrin, tell their doctor or pharmacist 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 re-started on Septrin at any time.
• if your child develops a rash or these skin symptoms, stop taking
Septrin, seek urgent advice from a doctor and tell him that your
child is taking this medicine.
• you have been told that your child has a rare blood problem
called porphyria, which can affect the skin or nervous system
• 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
• they have ever had jaundice which can cause yellowing of their
skin or the whites of their eyes
• they have a problem with their metabolism called
phenylketonuria and are not on a special diet to help their
condition
• they are underweight or malnourished
• you have been told by your child’s doctor that your child has a lot
of potassium in their blood.
If you are not sure if any of the above apply to your child, talk to
their doctor or pharmacist before they take Septrin.
Taking other medicines
Please tell your child’s doctor or pharmacist if your child is taking
or has recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal 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 operations or for the 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 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 cancer or for the immune
system.
If you are not sure if any of the above apply to your child, talk to
their doctor or pharmacist before they take Septrin.
Taking 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 drinks plenty of fluid such as water while they
are taking Septrin.
Important information about some of the ingredients of
Septrin 40 mg/200 mg per 5 ml Paediatric Suspension
Septrin 40 mg/200 mg per 5 ml Paediatric Suspension contains:
• 3.25 g sorbitol 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 5 ml
spoonful.
• Methyl hydroxybenzoate, which may cause allergic reactions
(possibly delayed).
• Benzoate, which may increase the risk of jaundice in newborn
babies.
• Less than 1 mmol sodium (23 mg) per 5 ml, i.e. essentially
‘sodium free’.
3 How to give Septrin 40 mg/200 mg per 5 ml
Paediatric Suspension
Always ensure your child takes Septrin exactly as their doctor has
told you. The label on the pack will tell you how much they should
take and how often to take it. You should 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 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.
• A double dose should not be taken 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 taking Septrin 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 the blood, which can cause abnormal
heart beats (palpitations).
Common (less than 1 in 10 people)
• An infection called thrush or candidiasis which can affect the
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 Septrin).
• 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.
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.
5 How to store Septrin
• Keep out of the reach and sight of children.
• Keep away from direct heat or sunlight.
• Do not store above 25ºC.
• Do not use 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 Further information
What Septrin contains
Septrin is made up of two different medicines called
sulfamethoxazole and trimethoprim. These medicines are
sometimes given the combined name co-trimoxazole.
The other ingredients of Septrin 40 mg/200 mg per 5 ml
Paediatric Suspension are:
sorbitol solution (E420 ii), glycerol (E422), dispersible
cellulose (E460), sodium carmellose, methyl hydroxybenzoate
(E218), sodium benzoate (E211), saccharin sodium (E954), ethanol
(alcohol), vanilla flavour, banana flavour, polysorbate 80 (E433) and
purified water.
What Septrin looks like and contents of the pack
Septrin 40 mg/200 mg per 5 ml Paediatric Suspension is supplied
to you in an amber-coloured glass bottle, containing 100 ml or 30
ml of an off-white liquid, which smells of banana and vanilla. 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 Septrin 40 mg/200 mg per 5 ml Paediatric Suspension
contains 200 mg sulfamethoxazole and 40 mg trimethoprim.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
UK:
Aspen Pharma Trading Limited
12/13 Exchange Place, I.F.S.C,
Dublin 1, 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 Septrin 40 mg/200 mg per 5 ml
Paediatric Suspension
Reference number PL 39699/0037
This is a service provided by the Royal National Institute
of Blind People.
Leaflet date: May 2013
Septrin is a registered trademark of Aspen

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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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