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SEPTRIN 800MG/160MG FORTE TABLETS

Active substance: TRIMETHOPRIM

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Package Leaflet: Information for the User

Septrin® 160 mg/800 mg Forte Tablets
co-trimoxazole
Read all of this leaflet carefully before you start taking this medicine

PHARMA CODE N° 809

In this leaflet:
1. What Septrin is and what it is used for
2. Before you take Septrin
3. How to take Septrin 160 mg/800 mg Forte Tablets
4. Possible side effects
5. How to store Septrin
6. Further information
1 What Septrin is and what it is used for
Septrin 160 mg/800 mg Forte Tablets (called ‘Septrin’ in this leaflet)
are 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 you take Septrin
Do not take Septrin if:
• you are allergic (hypersensitive) to sulfamethoxazole,
trimethoprim or co-trimoxazole or any of the other ingredients
of Septrin (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 Septrin.
Take special care with Septrin
Before you take Septrin, 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 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 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.

• 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 Septrin.
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 Septrin can affect the way some medicines work. Also
some other medicines can affect the way Septrin 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 Septrin.
Taking Septrin with food and drink
You should take Septrin 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 Septrin.
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 Septrin 160 mg/800 mg Forte Tablets
Always take Septrin 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.
Usual Dose
Adults and children over 12 years
• The usual dose is one tablet in a morning and one tablet in an
evening.
• 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.

PHARMA CODE N° 809

• 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.

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.

PHARMA CODE N° 809

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
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 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
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).

• 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.
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 trimethoprim. 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 S3 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:
UK:
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)
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: February 2015
Septrin is a registered trademark of Aspen

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
12000000106239

PHARMA CODE N° 809

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

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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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