FECTRIM PAEDIATRIC TABLETS
Active substance(s): SULPHAMETHOXAZOLE / TRIMETHOPRIM / SULPHAMETHOXAZOLE / TRIMETHOPRIM / SULPHAMETHOXAZOLE / TRIMETHOPRIM
FECTRIM PAEDIATRIC TABLETS
(Trimethoprim and Sulphamethoxazole)
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
What is in your medicine?
The name of this medicine is FECTRIM
which contains a combination of Trim ethoprim and Sulphamethoxazole in three
20mg Trimethoprim with 100mg Sulphamethoxazole (FECTRIM Paediatric).
FECTRIM and Forte tablets also contain povidone, crospovidone and magnesium stearate.
FECTRIM Paediatric tablets also contain povidone, crospovidone, magnesium stearate and microcrystalline cellulose.
FECTRIM Paediatric and FECTRIM Forte tablets are available in containers of 100 tablets, and FECTRIM is available in pack
sizes of 100 and 500 tablets, and in blister packs of 10, 28 and 30 tablets.
How does FECTRIM work?
FECTRIM is an antibacterial drug which is
helpful in the prevention and treatment of bacterial infections sensitive to
FECTRIM, affecting the lungs and genito-urinary tract. It is also used for treatment of middle ear inflammation in children.
If you are not sure why you have been prescribed FECTRIM then please ask your doctor.
The Manufacturer is: DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE.
The Product Licence Holder of FECTRIM is: Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor,
Nicosia, P.C. 1060, Cyprus
What are FECTRIM tablets for?
FECTRIM tablets are used for the preventi on and treatment of inflammation of the lungs in adults and children, and for the
treatment of urinary tract infections, and for acute attacks of bronchitis in patients who suffer from chronic bronchitis.
FECTRIM is also used for the treatment of middle ear inflammation in children.
Check before you take these tablets
Before taking this medicine, tell your doctor if you have ever had any unusual or allergic reactions to Sulphamethoxazole or
Trimethoprim, or any of the other ingredients of FECTRIM, or other sulphonami de medicines or medicines used in the
treatment of diabetes.
Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes. Also tell
them if you are taking any medicines known as blood thinners,
any antimalarial drugs (particularly pyrimethamine), or
medicines for the treatment of diabetes such as tolbutamide or glibenclamide.
It is important that you tell your doctor if you are pregnant, or likely to become pregnant, or if you are breast feeding.
This medicine should not be used during pregnancy, or when you are breast feeding.
Can you take FECTRIM with other medicines?
You can take these tablets with other medicines, but there are some medicines that can interfere with FECTRIM tablets.
It is very important to tell your doctor or pharmacist about all the medicines which you are taki ng, whether prescribed by your
doctor or bought without a prescription from the pharmacy or elsewhere. This incl udes medicines such as antimalarials
(particularly pyrimethamine), medicines for the treatment of diabetes such as tolbutamide and glibenclamide and medicines
used as blood thinners. Medicines used for Rheumatoid arthri tis such as Cyclosporin; medicines used for heart problems
such as Digoxin; medicines used for tuberculosis, such as Rifampicin.
The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor or
pharmacist if you have other medical pr oblems such as liver problems, kidney problems, anaemia, diabetes, lung disease,
malaria, infection of the urinary tract (including sexually transmitted diseases such as gonorrhoea).
Also tell your doctor or pharmacist is you are taking drugs known as sulphonamides.
When and how to take FECTRIM tablets.
FECTRIM tablets are taken by mouth and only in the doses prescribed by your docto r. Do not take more of them, and do
not take them more often or for a longer time than your doctor ordered.
Do not stop taking your medicine or change the dose unless your doctor tells you to.
You will be prescribed the lowest dose necessary to control your symptoms.
Adults and children over 12 years:
2 FECTRIM tablets (or one FECTRIM Forte tablet) twice daily.
For treatment exceeding 14 days and for a minimum dosage 1 FECTRIM tablet (or ½ a FECTRIM Forte tablet) twice daily.
In severe infections and for septicaemia (infection in the blood stream) 3 FECTRIM Standard t ablets (or 1½ FECTRIM Forte
tablets) twice daily.
For gonorrhoeal infections (uncomplicated) 4 FECTRIM tablets (or 2 FECTRIM Fo rte tablets) 12 hourly during a 48 hour
period (over 2 days).
Children (6 to 12 years): 1 FECTRIM tablet twice daily (or 4 paediatric tablets twice daily)
Children (2 to 5 years): 2 paediatric tablets twice daily.
Elderly: Treatment should commence with one FECTRIM tablet twice daily and increased, if necessary, to the adult dosage.
Treatment in all acute infections shoul d be continued for a minimum of 5 days or until you are symptom-free for two days or
whichever is the longer.
What to do if too many tablets are taken at the same time.
If you accidentally take more tablets than recommended, contact your doctor or local hospital Casualty Department at once.
What if you miss a dose?
If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose.
If you feel that this medicine is not working as well after y ou have taken it for a short time , do not increase the dose, inste ad
check with your doctor.
What side effects can FECTRIM have?
FECTRIM can cause various blood disorders, and the elderly are most susceptible to these disorders of the blood. If you
notice a sore throat, fever and bruising tell your doctor immediately.
A blood count should be measured if treatment is continued for 4 weeks or longer.
Side-effects include: skin rashes and sensitivity to light. O ccasionally, serious skin reactions can develop. If changes start to
affect your skin, contact a doctor immediately.
Allergic reactions may occur, rarely fluid under the skin and mucous membranes, allergic shock and allergic inflammation of
the heart and of the arteries.
In patients with a condition known as glucose-6-phosphate dehydrogenase deficiency, a destruction of blood cells may occur.
Increased secretions of the liver such as bilirubin (bile) and rarely jaundice and liver poisoning.
A feeling of sickness, vomiting, diarrhoea, inflammation of the tongue and mouth and loss of appetite.
Non-infectious meningitis which returns to normal when the drug is withdrawn, convulsions.
Inflammation of the nerves of the arms and legs, walking diffi culty (ataxia), dizziness and a spinning sensation, ringing noise s
in the ears (tinnitus), headache, depression, hallucinations.
Kidney function may be reduced with rarely inflammation of the kidney.
Cough, difficulty in breathing.
Increase of potassium in the blood and a decrease of sodium in the blood.
Painful joints and muscles.
Most people do not develop serious side effects. However, should any of the above occur or if you notice any other problems,
report to your doctor.
Storing your medicine
You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.
Keep your medicine in a dry place, below 25C in a well-closed container.
If your doctor tells you to stop the treatment, return any remain ing tablets to the pharmacist. Only keep the medicine if the
doctor tells you to.
On the label you will find the words "Expiry Date" followed by numbers indicating the day, mont h and year. This is the date
when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist who have access to additional information.
PL No: 28444/0171
This leaflet was last revised in 10/2016
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.