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Package leaflet: Information for the Patient

(Trimethoprim and Sulphamethoxazole)

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
- 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
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet
1. What Fectrim is and what it is used for
2. What you need to know before you take
3. How to take Fectrim
4. Possible side effects
5. How to store Fectrim
6. Contents of the pack and other information

1. What Fectrim is and what it is
used for
The name of your medicine is Fectrim Tablets or Fectrim
Forte Tablets (called Fectrim in this leaflet) which contains
two active substances called trimethoprim and
sulphamethoxazole in three strengths:
 Fectrim Tablets (80 mg of Trimethoprim and 400 mg of
 Fectrim Forte Tablets (160 mg of Trimethoprim and
800 mg of Sulphamethoxazole)
Both the active substances belong to a group of medicines
called antibiotics. Antibiotics are used to treat infections
caused by bacteria. Fectrim works against some types of
bacteria, therefore it is only suitable for treating some
types of infections.
Fectrim can be used to treat:
 or prevent lung infections (pneumonia) caused by the
bacteria Pneumocystis jirovecii
 or prevent infections such as toxoplasmosis
 bladder or urinary tract infections
 infections of the chest (chronic bronchitis)
 ear infections (otitis media) in children
 infections such as nocardiosis (bacterial infection
affecting the lungs, skin and brain).
Fectrim Tablets and Fectrim Forte Tablets are used in
adults and children over 12 years of age.
You must talk to a doctor if you do not feel better or if you
feel worse.

2. What you need to know before
you take Fectrim
Do not take Fectrim tablets if:
 you are allergic to trimethoprim, sulphamethoxazole or
any other ingredients of this medicine (listed in
section 6)
 you have severe liver or kidney problems
 you have or ever had any blood disorder or anaemia
or porphyria (a rare blood problem affecting your skin
or nervous system)
 you have reduced amount of the enzyme
glucose-6-phosphate dehydrogenase (G6PD)
Fectrim should not be given to infants during the first 6
weeks of life.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fectrim
tablets, if:
 potentially life-threatening skin rashes (StevensJohnson syndrome, toxic epidermal necrolysis) have
been reported with the use of Fectrim, 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
 the highest risk for occurrence of serious skin
reactions is within the first weeks of treatment.
 you have developed Stevens-Johnson syndrome or
toxic epidermal necrolysis with the use of Fectrim, you
must not be re-started on Fectrim at any time.
 you develop a rash or these skin symptoms, seek
immediate advice from a doctor and tell that you are
taking this medicine.
 you have severe allergies or asthma.
 you develop blood related problems.
 you do not 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
 you have any liver diseases (such as jaundice) or
kidney problems (lower doses are prescribed).
 you have a problem with your metabolism called
phenylketonuria and are on a special diet.
 you have high potassium levels in blood
(hyperkalemia) and close monitoring is necessary.
 you are elderly.
Regular blood and urine tests are recommended for
patients on long term treatment.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Fectrim.
Other medicines and Fectrim tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including medicines obtained without a prescription. This
is because Fectrim can affect the way some medicines
work. Also some other medicines can affect the way
Fectrim works.
In particular tell your doctor or pharmacist if you are taking
any of the following medicines:
 medicines to thin the blood (warfarin)
 pyrimethamine, used to treat and prevent malaria
 medicines to treat diabetes (glibenclamide or
tolbutamide, repaglinide, rosiglitazone)
 medicines used after organ transplants or for your
immune system (cyclosporin, azathioprine)
 medicines used to treat heart failure or heart rhythm
problems (digoxin, amiodarone, procainamide)
 medicines used to treat bacterial infections (such as
rifampicin and dapsone)
 methotrexate, used to treat cancer or for your immune
 phenytoin, used to treat seizures
 medicines that can increase the amount of potassium
in your blood, such as diuretics (water tablets such as
spironolactone, amiloride) or angiotensin-converting
enzyme inhibitors (enalapril, quinapril)
 medicines to treat HIV or AIDS (lamivudine,
zidovudine or didanosine)
 amantadine, used to treat Parkinson’s disease
 clozapine, used to treat mental problems
 lidocaine/prilocaine (in infants)
 loperamide, used to treat diarrhoea
Fectrim tablets with food and drink
You should take Fectrim with some food and drink.
This will stop you feeling sick (nausea) or having
diarrhea. Drink plenty of water while you are taking
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.
This medicine should not be used during pregnancy, or
when you are breast feeding. Fectrim is excreted in breast
milk causing problems in breast-fed infants.

3. How to take Fectrim
Always take Fectrim 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.

 The usual dose for acute infections depends on either
your age or weight. The recommended dose is:
Patient Group
Age 12 years and
above including elderly
Body weight 53 kg or

Recommended dose
960 mg (160 mg
trimethoprim and
800 mg sulphamethoxazole)
twice daily.

Your doctor may prescribed you the dose to treat or
prevent lung infections (Pneumonia or PCP). The dose
and frequency will depend on:
- the type and severity of infection you have
- your weight
- your age
 The doses should be reduced in patients with kidney
problems and your doctor shall decide the dose
depending on your condition.
If you take more Fectrim tablets than you should
If you (or someone else) swallow a lot of tablets at the
same time, or you think a child may have swallowed any,
contact your nearest hospital casualty department or tell
your doctor immediately. Signs of an overdose include
vomiting, blurred vision, confusion, skin discolouration or
If you forget to take Fectrim tablets
If you forget to take a dose, take it as soon as
you remember it and then take the next dose at the right
time. Do not take a double dose to make up for a forgotten
If you stop taking Fectrim tablets
Do not stop taking Fectrim tablets because you feel better.
Take the tablets for as long as your doctor has told you or
your problem may come back.

4. Possible side effects
Like all medicines, Fectrim tablets can cause side-effects,
although not everybody gets them.
Stop taking the tablets immediately and seek urgent
medical advice if the following occur:
 allergic reactions: skin rashes which may be itchy, skin
flushing, swelling of the face, lips, tongue or throat,
difficulty breathing, extreme tiredness, joint stiffness,
fever, wheezing, abdominal pain, feeling or being sick
 inflamed heart muscle (chest pain, fever, a fast
heartbeat, tiredness), systemic lupus erythematosus
(SLE-skin rash, hair loss, difficulty breathing and joint
 aseptic meningitis (headache, fever, stiff neck,
tiredness, feeling ill and sensitivity of eyes to bright light)
 Very rare, potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported (see section 2).
Tell your doctor if the following side effects occur:
 effects on blood: changes in the numbers and types of
your blood cells. If you notice increased bruising,
nosebleeds, sore throats, infections, excessive
tiredness, breathlessness on exertion or abnormal
paleness of the skin, you should tell your doctor who
may want you to have a blood test.
 feeling or being sick, diarrhoea, inflammation of
tongue/intestines (difficulty in swallowing, swelling or
ulceration of the gullet), inflammation of the pancreas
(abdominal pain, being sick, fever unwell);
pseudomembranous colitis (causing severe and
painful diarrhoea)
 loss of appetite, decreased levels of sodium, low blood
glucose, increased levels of potassium
 Muscle/joint pain or muscle weakness
 liver failure or jaundice (yellowing of the skin or whites
of the eyes), changes in levels of liver enzymes
 kidney problems, abdominal pain, difficulty passing
urine, blood in urine, crystals in the urine (this can be
avoided by drinking plenty of water)
 headache, depression, dizziness, seeing strange or
unusual sights (hallucinations), fits, lack of
co-ordination (ataxia), drowsiness
 other effects: cough, shortness of breath, swollen
skin (angioedema), sensitivity to light, painful red eyes
with blurred vision (uveitis), inflammation of blood
vessels, colour change of skin (pupura), spinning

sensation, ringing in the ears, fungal infections
Most commonly, high frequency of side effects are
reported in elderly patients.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at By reporting side effects
you can help provide more information on the safety of this

5. How to store Fectrim
Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date (EXP.)
which is stated on the label or carton.
Do not store above 25°C. Store it in a dry place, in
well-closed container.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other
What Fectrim tablets contain
Fectrim tablet contains the active ingredients,
trimethoprim and sulphamethoxazole.
Fectrim tablets: 80 mg of trimethoprim and 400 mg of
Fectrim Forte tablets: 160 mg of trimethoprim and
800 mg of sulphamethoxazole.
Fectrim tablets and Fectrim Forte tablets contain povidone
K25, crospovidone and magnesium stearate.
What Fectrim tablets look like and contents of the
Fectrim tablets: Flat, white, bevelled tablets, engraved
‘80’ and ‘400’ on the scored side.
Fectrim Forte tablets: White, capsule shaped tablets,
engraved ‘160’ and ‘800’ on the scored side.
Fectrim tablets are available in containers of 100 tablets.
Fectrim Forte tablets are available in containers of 100,
500 tablets and in blisters of 10, 28, 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited
11 Boumpoulinas, 3rd floor
1060 Nicosia, Cyprus
DDSA Pharmaceuticals Limited
84 Pembroke Road
London, W8 6NX, UK
For any information about this medicine, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 08/2017.


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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.