Skip to Content

SEPTRIN FORTE 160MG/800MG TABLETS

Active substance(s): SULFAMETHOXAZOLE / TRIMETHOPRIM

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet
®

Septrin 160 mg/800 mg Forte Tablets

Revision Date: 01.02.2016
Ref. SEPTFOR

(co-trimoxazole)
• if you have developed Stevens-Johnson syndrome or toxic
epidermal necrolysis with the use of Septrin® you must not be restarted 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.

The name of your medicine is Septrin® 160 mg/800 mg Forte Tablets,
but will be referred to as Septrin® throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine
• 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.
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®

If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before taking Septrin®.

6. Further information

Taking other medicines

1. WHAT SEPTRIN® IS AND WHAT IT IS USED FOR

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.

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.

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®.

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.

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®.

If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before taking Septrin®.

Pregnancy and breast-feeding

Take special care with Septrin®

Talk to your doctor before taking this medicine if you are pregnant,
planning to get pregnant, or breast-feeding.

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.

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.

1

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.

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)
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.

Reporting of side effects
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.

If you have taken too much Septrin® you may
• feel or be sick
• feel dizzy or confused.

By reporting side effects, you can help provide more information on the
safety of this medicine.

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.

5. HOW TO STORE SEPTRIN®
Keep out of the sight and reach of children.

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.

Do not take the tablets after the expiry date shown on the bottle label
and carton.

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

Store in the original package with the leaflet.

®

Do not store above 25°C.
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

6. FURTHER INFORMATION






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

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 co-trimoxazole.
Also contains: povidone, sodium starch glycollate, magnesium stearate
and docusate sodium.

Very Common (more than 1 in 10 people)
• High levels of potassium in your blood, which can cause abnormal
heart beats (palpitations).

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.

Common (less than 1 in 10 people)

Septrin® 160 mg/800 mg Forte Tablets are available in blister packs of
50 and 100 tablets.

• 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.

Who manufactured your medicine

• Being sick (vomiting).

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.

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

PL 16378/0570

Uncommon (less than 1 in 100)

• 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

POM

Revision Date: 01.02.2016
Ref. SEPTFOR
Septrin® is a registered trademark of Aspen Global Incorporated.

2

Expand view ⇕

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.

Hide