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Active substance: TRIMETHOPRIM

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Package Leaflet: Information for the User

Septrin® 160 mg/800 mg Forte Tablets
Read all of this leaflet carefully before you start taking this medicine
• you have been told that you have a rare blood problem called
• Keep this leaflet. You may need to read it again.
porphyria, which can affect your skin or nervous system
• If you have any further questions, ask your doctor or pharmacist.
• you don’t have enough folic acid (a vitamin) in your body • This medicine has been prescribed for you. Do not pass it on to
which can make your skin pale and make you feel tired, weak
others. It may harm them, even if their symptoms are the same
and breathless. This is known as anaemia
as yours.
• you have ever had jaundice which can cause yellowing of your
• If any of the side effects gets serious, or if you notice any
skin or the whites of your eyes
side effects not listed in this leaflet, please tell your doctor or
• you have a problem with your metabolism called
phenylketonuria and are not on a special diet to help your
In this leaflet:
1. What Septrin is and what it is used for
• you are elderly
2. Before you take Septrin
• you are underweight or malnourished
3. How to take Septrin 160 mg/800 mg Forte Tablets
• you have been told by your doctor that you have a lot of
4. Possible side effects
potassium in your blood.
5. How to store Septrin
If you are not sure if any of the above apply to you, talk to your
6. Further information
doctor or pharmacist before taking Septrin.
1 What Septrin is and what it is used for
Taking other medicines
Septrin 160 mg/800 mg Forte Tablets (called ‘Septrin’ in this leaflet)
Please tell your doctor or pharmacist if you are taking or have
are made up of two different medicines called sulfamethoxazole
recently taken any other medicines, including medicines obtained
and trimethoprim. These medicines are sometimes given the
without a prescription. This includes herbal medicines. This is
combined name co-trimoxazole. Both belong to a group of
because Septrin can affect the way some medicines work. Also
medicines called antibiotics. They are used to treat infections
some other medicines can affect the way Septrin works.
caused by bacteria. Like all antibiotics, Septrin only works against
In particular tell your doctor or pharmacist if you are taking any of
some types of bacteria. This means that it is only suitable for
the following medicines:
treating some types of infections.
• Diuretics (water tablets), which help increase the amount of
Septrin can be used to treat or prevent:
urine you produce
• lung infections (pneumonia or PCP) caused by a bacteria called
• Pyrimethamine, used to treat and prevent malaria, and to treat
Pneumocystis jiroveci (previously known as Pneumocystis
• Ciclosporin, used after transplant operations or for your immune
• infections caused by a bacteria called Toxoplasma
• Medicines used to thin the blood such as warfarin
Septrin can be used to treat:
• Phenytoin, used to treat epilepsy (fits)
• bladder or urinary tract infections (water infections)
• Medicines for diabetes, such as glibenclamide, glipizide or
• lung infections such as bronchitis
tolbutamide (sulphonylureas)
• ear infections such as otitis media
• Medicines to treat problems with the way your heart beats such
• an infection called nocardiosis, it can affect the lungs, skin and
as digoxin or procainamide
• Amantadine, used to treat Parkinson’s disease, multiple
2 Before you take Septrin
sclerosis, ‘flu or shingles
• Medicines to treat HIV (Human Immunodeficiency Virus), called
Do not take Septrin if:
zidovudine or lamivudine
• you are allergic (hypersensitive) to sulfamethoxazole,
• Medicines that can increase the amount of potassium in your
trimethoprim or co-trimoxazole or any of the other ingredients
blood, such as diuretics (water tablets, which help increase the
of Septrin (see section 6: Further information)
amount of urine you produce), steroids (like prednisolone) and
• you are allergic to sulphonamide medicines.
Examples include sulphonylureas (such as gliclazide
• Methotrexate, a medicine used to treat cancer or for your
and glibenclamide) or thiazide diuretics (such as
immune system.
bendroflumethiazide – a water tablet)
If you are not sure if any of the above apply to you, talk to your
• you have liver or kidney problems
doctor or pharmacist before taking Septrin.
• you have ever had a problem with your blood
• it is for your child and they are less than 6 weeks old or were
Taking Septrin with food and drink
premature. Unless it is for the treatment or prevention of PCP. In
You should take Septrin with some food or drink. This will stop you
this case, babies should be at least 4 weeks old.
feeling sick (nausea) or having diarrhoea. Although it is better to
• If you are not sure if any of the above apply to you, talk to your
take it with food, you can still take it on an
doctor or pharmacist before taking Septrin.
empty stomach.
Drink plenty of fluid such as water while you are taking Septrin.
Take special care with Septrin
Before you take Septrin, tell your doctor or pharmacist if:
Pregnancy and breast-feeding
• you have severe allergies or asthma
Talk to your doctor before taking this medicine if you are
• potentially life-threatening skin rashes (Stevens-Johnson
pregnant, planning to get pregnant, or breast-feeding.
syndrome, toxic epidermal necrolysis) have been reported with
3 How to take Septrin 160 mg/800 mg Forte Tablets
the use of Septrin appearing initially as reddish target-like spots
Always take Septrin exactly as your doctor has told you.
or circular patches often with central blisters on the trunk.
The label on your pack will tell you how much to take and
• additional signs to look for include ulcers in the mouth, throat,
how often to take it. You should check with your doctor or
nose, genitals and conjunctivitis (red and swollen eyes).
pharmacist if you are not sure.
• 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 Septrin you must not be
re-started on Septrin at any time.
• if you develop a rash or these skin symptoms, stop taking
Septrin, seek urgent advice from a doctor and tell him that you
are taking this medicine.

Usual Dose
Adults and children over 12 years
• The usual dose is one tablet in a morning and one tablet in an
• Septrin should be taken for at least five days.
• Make sure that you finish the course of Septrin which your
doctor has prescribed.
Septrin 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 Septrin 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 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 you have kidney problems your doctor may
• prescribe a lower dose of Septrin
• take blood to test whether the medicine is working properly.
If you take Septrin 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 Septrin.
If you take more Septrin than you should
If you take more Septrin 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 Septrin you may
• feel or be sick
• feel dizzy or confused.
If you forget to take Septrin
• 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 Septrin can cause side effects, although not
everybody gets them. You 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
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 Septrin).
• 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
• 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)
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.

5 How to store Septrin
• 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.
6 Further information
What Septrin contains
Septrin is made up of two different medicines called
sulfamethoxazole and t rimethoprim. These medicines are
sometimes given the combined name co-trimoxazole.
Each Septrin 160 mg/800 mg Forte Tablet contains 800 mg
sulfamethoxazole and 160 mg trimethoprim.
The other ingredients of Septrin 160 mg/800 mg Forte Tablets are:
povidone, sodium starch glycollate, magnesium stearate and
docusate sodium.
What Septrin looks like and contents of the pack
Septrin 160 mg/800 mg Forte Tablets are white elongated tablets,
coded GX 02C on one side. They are biconvex and are scored along
the shorter axis.
Septrin 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.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Aspen Pharma Trading Limited
12/13 Exchange Place, I.F.S.C, Dublin 1, Ireland
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 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: 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.