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CO-TRIMOXAZOLE 960MG TABLETS

Active substance(s): SULFAMETHOXAZOLE / TRIMETHOPRIM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-trimoxazole 960 mg tablets
(Sulfamethoxazole and Trimethoprim)
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. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Co-trimoxazole tablet is and what it is used for
2. What you need to know before you take Co-trimoxazole tablets
3. How to take Co-trimoxazole tablets
4. Possible side effects
5. How to store Co-trimoxazole tablets
6. Contents of the pack and other information
1. What Co-trimoxazole tablet is and what it is used for
Co-trimoxazole tablets are made up of two different medicines called
sulfamethoxazole & trimethoprim. These medicines are sometimes given the
combined name Co-trimoxazole. Both belong to the group of medicine called
antibiotics. They are used to treat infections caused by Specific bacteria.
This means that it is only suitable for treating some type of infections.
Co-trimoxazole tablets are used to treat or prevent:
- Lung infections (Pneumonia or Pneumocystis pneumonia) caused by a
bacteria called Pneumocystis jiroveci (previously known as Pneumocystis
carinii)
- Infection caused by a bacterium called Toxoplasma (toxoplasmosis)
Co-trimoxazole tablets are used to treat:
- Bladder or urinary tract infections (water infection)
- Acute worsening of chronic bronchitis due to bacterial infection.
- Ear infections such as otitis media
- An infection called nocardiosis, which can affect the lungs, skin and brain.
2. What you need to know before you take Co-trimoxazole tablets
Do not take Co-trimoxazole tablets:
- You are allergic to sulfamethoxazole, trimethoprim or any of the other
ingredient of Co-trimoxazole tablets (listed in section 6).
- You are allergic to other sulphonamide medicines.These include
sulphonylurea (such as gliclazide and glibenclamide used to treat diabetes)
or thiazide diuretics (such as bendroflumethiazide – a water tablet)
- You have liver problems like marked liver damage.
- You have severe renal insufficiency.
- You suffer from porphyria, a genetic disease which can affect your skin or
nervous system.
- Co-trimoxazole 160 mg/800 mg tablets are not suitable for children under
12 years old.
Warnings and precautions
Before you take Co-trimoxazole tablets, tell your doctor or pharmacist if:
- You have severe allergies or asthma.
- You have ever had an allergic skin reaction such as Stevens – Johnson
syndrome, toxic epidermal necrolysis (TEN) or Lyell’s syndrome.
- If you have previously developed Stevens-Johnson syndrome or toxic
epidermal necrolysis with the use of Co-trimoxazole tablets you must not
be re-started on Co-trimoxazole tablets at any time.
- If you develop a rash or these skin symptoms, stop taking Co-trimoxazole
tablets, seek urgent advice from a doctor and tell him that you are taking
this medicine.
- You have a rare disease called porphyria, you should not take
Co-trimoxazole tablets as it can lead to acute worsening of your condition.
- If you have a serious disease affecting your blood.
Co-trimoxazole tablets can affect the bone marrow and stop it from
producing red or white blood cells.
- If you suffer from an abnormality called 6 GDP deficiency- taking
Co-trimoxazole tablets may lead to destruction of red blood cells.
- If you are dehydrated, as the risk of kidney damage or kidney stones while
taking Co-trimoxazole tablets is increased. You should take plenty of fluids
while taking Co-trimoxazole tablets unless otherwise advised by your doctor.
- 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 and
cause a particular type of anaemia. You may have to take folic acid
supplements, particularly if you are elderly.
- You have problem with metabolism called phenylketonuria and are not on
special diet to help your condition.

- You are elderly.
- You are underweight or malnourished.
- You have high levels of potassium in your blood.
- You have had severe diarrhoea whilst taking antibiotics in the past
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Co-trimoxazole tablets.
Other medicines and Co-trimoxazole tablets
Tell your doctor if you are taking or have recently taken or might take any
other medicines, including medicines obtained without a prescription. This
includes herbal medicines. This is because Co-trimoxazole tablets can affect
the way some medicine work. Also some medicine can affect the way
Co-trimoxazole tablets works:
In particular, tell your doctor or pharmacist if you are taking any of following
medicines
- Diuretics (water tablets), which help increase the amount of urine you
produce.
- Pyrimethamine, used to treat and prevent malaria, and to treat
toxoplasmosis.
- Ciclosporin, used after kidney transplants
- Warfarin used to the thin blood.
- Phenytoin used to treat epilepsy (fits)
- Medicine for diabetes, such as glibenclamide, glipizide or tolbutamide
(Sulphonylureas)
- Medicine 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.
- Medicine to treat HIV (Human Immunodeficiency Virus) such as
zidovudine or lamivudine.
- Medicine that can increase amount of potassium in your blood, such as
potassium sparing diuretics (water tablets)
- Methotrexate, a medicine used to treat cancer for or diseases involving
your immune system.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Co-trimoxazole tablets.
Use in children
Co-trimoxazole tablets are not suitable for children aged 12 or under.
Co-trimoxazole tablets with food and drink
You should take Co-trimoxazole tablets with some food or drink. This will
stop you feeling sick (nausea) or having diarrhea. 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 Co-trimoxazole
tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine.
Driving and using machines
While taking Co-trimoxazole tablets you may feel sleepy, dizzy, confused,
see or hear things that are not there (hallucinations), have fits (convulsions)
and vertigo. If this happens, do not drive or use any machinery.
3. How to take Co-trimoxazole tablets
Always take Co-trimoxazole tablets 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.
Check with your doctor or pharmacist if you are not sure.
Usual Dose:
Adults and adolescents above the age of 12 years
- The usual dose is one tablet in morning and one tablet in an evening.
- Co-trimoxazole tablets should be taken for at least 5 days.
- Make sure that you finish the course of Co-trimoxazole tablets which your
doctor has prescribed.
Special Dose
The dose of Co-trimoxazole tablets 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 Co-trimoxazole tablets to
- Treat urinary tract (water) infections
- Treat and prevent lung infection caused by bacteria Pneumocystis jiroveci
- Treat infection caused by bacteria toxoplasma (Toxoplasmosis) or
Nocardia (nocardiosis).
If you have kidney problem your doctor may
- Prescribe lower dose of Co-trimoxazole tablets.
- Take blood test whether medicine is working properly.

If you take Co-trimoxazole tablets for long time your doctor may
Take blood test whether medicine is working properly.
Prescribe folic acid (a vitamin) for you to take at the same time as Cotrimoxazole tablets.
If you take more Co-trimoxazole tablets than you should
If you take more Co-trimoxazole tablets than you should, talk to your doctor
or go to hospital straight away. Take the medicine pack with you.
If you have taken too much Co-trimoxazole tablets, you may feel or be
sick and feel dizzy or confused.
If you forget to take Co-trimoxazole tablets
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 a forgotten dose.
4. Possible side effects
Like all medicines, Co-trimoxazole tablets can cause side effects, although
not everybody gets them.
You may experience the following side effects with this medicine.
Stop taking Co-trimoxazole tablets and tell your doctor immediately if you
have allergic reaction. Chance of an allergic reaction is very rare (fewer than
1 in 10,000 people are affected), signs of 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 skin
Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS) and
toxic epidermal necrolysis (TEN)) have been reported with the use of Cotrimoxazole tablets. There appear 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 develop
a rash or these skin symptoms, stop taking Co-trimoxazole tablets, seek
urgent advice from a doctor and tell him that you are taking this medicine.
If you develop watery and severe diarrhoea, which may also be bloody, stop
taking Co-trimoxazole tablets and speak to your doctor straight away.
Very Common (more than 1 in 10 people)
- High level of potassium in your blood, which can cause abnormal heart
beats (palpitations).
Common (less than 1 in 10 people)
- An infection caused by candida called thrush or candidiasis which can
affect your mouth or vagina.
- Headache
- Feeling sick (nausea)
- Diarrhoea
- Skin rashes.
Uncommon (less than 1 in 100 people)
- Being sick (vomiting)
Very rare (less than 1 in 10,000 people)
- Abnormalities affecting the blood such as Reduced formation of red and
white blood cells or destruction of red blood cells (haemolytic anaemia)
- A decrease in the number of white cells in your blood (leucopenia,
neutropenia), which increases your risk of infection. The signs may
include high temperature (fever), shivering and a sore throat.
- Feeling weak, short of breath, tired or listless, pale skin (anaemia)
- Bleeding or bruising more than usual. This may be because the level of
platelets in your blood has dropped (thrombocytopenia).
- Fever (high temperature)
- Sudden wheeziness or difficulty breathing
- 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 eye which causes pain and redness.
- The appearance of a rash or sunburn when you have been outside (even
on cloudy day)
- Low levels of sodium in your blood
- High levels of potassium in you blood
- Heart problems (inflammation of the heart muscle).
- Narrowing or blockage of blood vessels (vasculitis), unusual bleeding or
bruising under the skin.

- Abnormal liver function tests, liver damage
- Jaundice (the skin and whites of your eyes turn yellow). This can occur at
same time as unexpected bleeding or bruising
- Pains in your stomach, which can be caused by an inflammation of the
pancreas.
- Inflammation of the large bowel which can cause stomach pains & fever
with diarrhoea, usually with blood & mucus
- Pains in your chest, muscles or joints and muscle weakness, arthritis
- Abnormal kidney function, inflammation of the kidney
- Sudden headache or stiffness of your neck, accompanied by fever (high
temperature)
- Problems controlling your movement.
- Fits (convulsion 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 and muscle damage , which may
be accompanied by darkening of your urine and worsening of your kidney
function
If you get any side effects 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 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:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Co-trimoxazole tablets
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Co-trimoxazole tablets after the expiry date stated on the label
and carton. The expiry date refers to the last day of that month.
Store in the original package with this leaflet.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to dispose of medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Co-trimoxazole tablets contains
Co-trimoxazole tablets are made up of two different medicines called
Sulfamethoxazole & Trimethoprim. These medicines are sometimes given
the combined name Co-trimoxazole.
- The active substances are Sulfamethoxazole 800 mg and Trimethoprim
160 mg.
- The other ingredients are docusate sodium, magnesium stearate, sodium
starch glycolate (type A), and povidone (PVP K 30).
What Co-trimoxazole tablets looks like and contents of the pack
Co-trimoxazole tablets are white, uncoated, standard curvature with one side
breakline, capsule shaped tablets.
Co-trimoxazole tablets are supplied to you in:
Blister pack: PVC and Aluminum foil
Pack sizes are10, 14 (with and without calendar pack), 28 (with and without
calendar pack), 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DAWA Limited, 5 Sandridge close, Harrow, Middlesex HA1 1XD, UK
Manufacturer
DRUGSRUS Limited, 5 Sandridge close, Harrow Middlesex, HA1 1XD, UK
This leaflet was last revised in 03/2015

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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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