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SEPTRIN FORTE 160MG/800MG TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Septrin® 160 mg/800 mg Forte Tablets

Revision Date: 20.04.2017
Ref. SEPTFOR

(co-trimoxazole)
• 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.
• If you have been told that you are at risk for a rare blood disorder called
porphyria.
• If you have a kidney disease.
• 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 elderly.
• 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 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).

The name of your medicine is Septrin® 160 mg/800 mg Forte Tablets, but
will be referred to as Septrin® throughout this leaflet.
This medicine is also available in another strength.
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 Septrin® is and what it is used for
2. What you need to know before you take Septrin®
3. How to take 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® 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
Septrin®. 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 or
PCP).
• 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.

Other medicines and SEPTRIN®
Tell your doctor or pharmacist if you are taking, have recently taken or
may 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 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.
• Rifampicin, an antibiotic.
• 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.
• Folinic acid.
• Contraceptive medicines.

2. WHAT YOU NEED TO KNOW 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: Contents of the pack and other 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 severe liver or kidney problems.
• You have ever had a problem with your blood causing bruises or
bleeding (thrombocytopenia).
• 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, Septrin® 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, Septrin® 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 Septrin®.

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®.

Warnings and precautions
Talk to your doctor or pharmacist before taking Septrin®:
• 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.

4

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.

1

Driving and using machines

Uncommon (less than 1 in 100)

Effects on the ability to drive and operate machinery in patients taking this
medicine have not been studied.

• Being sick (vomiting).

®

3. HOW TO TAKE SEPTRIN
Always take this medicine exactly as your doctor has told you. 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® is not usually given to children under 12 years old. If they have
been given to your child under 12 years 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.

Very Rare (less than 1 in 10,000 people)

Who manufactured your medicine

• 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
(stools)
• 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.

Septrin® 160 mg/800 mg Forte Tablets are manufactured by Alcalá
Farma, S.L, Avenida de Madrid, 82, Alcalá de Henares 28802, Madrid,
Spain and is procured from within the EU and repackaged by Product
Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road,
London W3 0RB.
PL 16378/0570
POM
Revision Date: 20.04.2017
Ref. SEPTFOR
Septrin® is a registered trademark of Aspen Global Incorporated.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Beachcourse,
Tel: 020 8896 9054
for help.

Reporting of side effects

If you forget to take Septrin®

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

• 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

5. HOW TO STORE SEPTRIN®
Keep out of the sight and reach of children.
Do not take the tablets after the expiry date shown on the bottle label and
carton.
Do not store above 25°C.
Store in the original package with the 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.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Very Common (more than 1 in 10 people)

Each tablet contains 800 mg sulfamethoxazole and 160 mg trimethoprim.
Septrin® is made up of two different medicines called sulfamethoxazole
and trimethoprim.
These medicines are sometimes given the combined name cotrimoxazole.
Also contains: povidone, sodium starch glycollate, magnesium stearate
and docusate sodium.
Septrin® 160 mg/800 mg Forte Tablets are white, elongated tablets, plain
on one side. They are biconvex and are scored along the shorter axis.
Septrin® 160 mg/800 mg Forte Tablets are available in blister packs of 50
and 100 tablets.

• 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

2

3

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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