RESPRIM® & RESPRIM FORTE®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
RESPRIM contains the active ingredients trimethoprim and sulfamethoxazole. RESPRIM
is used to treat infections in different parts of the body caused by bacteria.
For more information, see Section 1. Why am I taking RESPRIM? in the full CMI.
Do not take if you have ever had an allergic reaction to trimethoprim or sulfamethoxazole,
or any other sulfonamide (sulfur) antibiotic or any of the ingredients listed at the
end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take RESPRIM? in the full CMI.
Some medicines may interfere with RESPRIM and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
The dose and length of time you have to take RESPRIM will depend on the type of infection
you have.
Your doctor will tell you how much RESPRIM to take each day.
More instructions can be found in Section 4. How do I take RESPRIM? in the full CMI.
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking RESPRIM.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Tell your doctor or pharmacist immediately if you get severe diarrhoea, even if it
occurs several weeks after stopping RESPRIM.
If you become pregnant while taking RESPRIM, tell your doctor.
|
|---|---|
|
Things you should not do
|
Do not stop taking RESPRIM or change the dose without first checking with your doctor.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take RESPRIM to treat any other complaints unless your doctor tells you to.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how RESPRIM affects you.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol. They may suggest you avoid alcohol while being
treated with RESPRIM.
|
|
Looking after your medicine
|
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the pack until it is time to take them.
|
For more information, see Section 5. What should I know while taking RESPRIM? in the full CMI.
Less serious side effects: nausea (with or without vomiting), abdominal or stomach discomfort, oral or vaginal
thrush. Serious side effects: severe or watery diarrhoea, jaundice (yellowing of the eyes or skin), renal stones,
increased or decreased urine production and discolouration, depression, imagined sensations,
weakness, increased sensitivity to light, any type of skin rash, peeling of the skin,
severe itching or hives, unsteadiness, eye inflammation, swelling of the face and
throat, shortness of breath or lumps in the neck. This is not a complete list of possible side effects.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
RESPRIM® & RESPRIM FORTE®
Active ingredient(s):
trimethoprim and sulfamethoxazole
Consumer Medicine Information (CMI)
This leaflet provides important information about taking RESPRIM. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking RESPRIM.
Where to find information in this leaflet:
RESPRIM contains the active ingredients trimethoprim and sulfamethoxazole , also known
as co-trimoxazole. RESPRIM belongs to a group of medicines called antibiotics. There are many different
types of medicines used to treat bacterial infections. Sulfamethoxazole in RESPRIM
belongs to a group of medicines known as sulfonamides. Trimethoprim belongs to a group
of medicines known as the benzylpyrimidines.
RESPRIM is used to treat infections in different parts of the body caused by bacteria.
RESPRIM works by stopping the growth of the bacteria that is causing your infection.
RESPRIM will not work against infections caused by viruses, such as colds or flu.
RESPRIM has been prescribed for your current infection. Another infection later on
may require a different medicine.
Your doctor may have prescribed RESPRIM for another reason. Ask your doctor if you have any questions about why RESPRIM has been prescribed for
you.
Do not take RESPRIM if:
you are allergic to trimethoprim, sulfamethoxazole or any other sulfonamide (sulfur)
antibiotic, or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue which may cause difficulty in swallowing or breathing
rash, itching or hives, peeling of the skin.
Always check the ingredients to make sure you can take this medicine.
you have severe liver or kidney disease, any blood disorder or megaloblastic anaemia
the child you are treating is under 3 months of age
you have streptococcal pharyngitis
you are taking dofetilide, a medicine used to treat irregular heartbeats
the expiry date printed on the pack has passed or if the packaging is torn of shows
signs of tampering.
Check with your doctor if you:
are allergic to:
diuretics (fluid tablets)
medicines used to treat diabetes
medicines for an overactive thyroid.
You may have an increased chance of being allergic to RESPRIM if you are allergic
to these medicines.
have any medical conditions, especially the following:
any type of blood disorder (including porphyria and glucose-6-phosphate dehydrogenase
deficiency)
liver or kidney disease
a hereditary disease called phenylketonuria
epilepsy (fits or convulsions)
asthma
allergic disorders
rheumatoid arthritis
urinary obstruction
folic acid deficiency.
are allergic to any other medicines, foods, dyes or preservatives.
If you have not told your doctor about any of the above, tell them before you start
taking RESPRIM.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or intend to become pregnant.
If RESPRIM is taken during pregnancy, it may harm the baby. Your doctor will discuss
the risks and benefits of taking RESPRIM during pregnancy.
Tell your doctor if you are breastfeeding or intend to breastfeed.
RESPRIM passes into breast milk. Your doctor will discuss the risks and benefits of
taking RESPRIM when breastfeeding.
Use in very young children
RESPRIM should not be given to children under 12 years of age. Alternative dosage
form of trimethoprim and sulfamethoxazole is available from other brands for children
from 3 months to 12 years of age.
Use in people over 65 years
People over 65 years are at more risk of severe side effects when taking RESPRIM.
The risk is greater if you have kidney or liver disease or are taking other medicines,
such as diuretics.
Use in people with HIV infection
People with HIV infection may not respond to RESPRIM in the same way as people without
HIV. People with HIV infection have been reported to get more side effects while being
treated with RESPRIM than people without HIV.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with RESPRIM and affect how it works. These include:
medicines used to treat diabetes such as repaglinide, rosiglitazone, pioglitazone,
glibenclamide, gliclazide, glipizide, chlorpropamide and tolbutamide
diuretics (fluid tablets)
phenytoin, a medicine used to treat epilepsy
pyrimethamine, a medicine used to prevent malaria
other medicines used to treat infections such as rifampicin, dapsone and polymyxin
zidovudine, a medicine used to treat HIV infection
ciclosporin, a medicine used to prevent organ transplant rejections or to treat certain
problems with the immune system
warfarin, acenocoumarol, phenprocoumon, medicines used to thin the blood
medicines used to treat some heart conditions such as digoxin and amiodarone
amantadine, a medicine commonly used to treat the influenza virus and Parkinson's
disease
memantine, a medicine used to treat Parkinson's disease
lamivudine, an antiretroviral medicine used to treat HIV/AIDS
urinary acidifiers (for kidney conditions)
oral contraceptives ('the pill')
sulfinpyrazone, a medicine used to treat gout
salicylates, medicines to treat conditions such as psoriasis or warts
medicines used to treat cancer such as paclitaxel, mercaptopurine and methotrexate
clozapine, a medicine used to treat schizophrenia
medicines used to treat overactive thyroid conditions
medicines used to treat depression such as imipramine, clomipramine, amitriptyline,
dosulepin (dothiepin), doxepin, nortriptyline and trimipramine
immunosuppressant medicines such as azathioprine and methotrexate
medicines used to treat high blood pressure as well as a variety of heart and kidney
conditions such as captopril, enalapril, lisinopril, fosinopril, perindopril, quinapril,
ramipril, trandolapril, valsartan, telmisartan, irbesartan, candesartan, eprosartan,
losartan, dofetilide and olmesartan.
These medicines may be affected by RESPRIM or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking RESPRIM.
If you have not told your doctor about any of the above, tell them before you start
taking RESPRIM.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect RESPRIM.
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
How much to take
The dose and length of time you have to take RESPRIM will depend on the type of infection
you have.
Your doctor will tell you how much RESPRIM to take each day.
Take RESPRIM exactly as your doctor has prescribed.
The usual dose for adults and children over 12 years is one RESPRIM FORTE tablet (or
two RESPRIM tablets) twice a day.
How to take RESPRIM
Swallow the tablets whole with a glass of water.
Take RESPRIM after food. This will lessen the chance of a stomach upset.
How to long to take RESPRIM for
Continue taking RESPRIM for as long as your doctor recommends.
Do not stop taking RESPRIM, even if you feel better after a few days, unless advised
by your doctor.
Your infection may not clear completely if you stop taking your medicine too soon.
If your symptoms do not improve within a few days, or if they become worse, let your
doctor know.
If you forget to take RESPRIM
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking
your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you take too much RESPRIM
If you think that you or anyone else has taken too much RESPRIM, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much RESPRIM, you may feel sick, vomit, feel dizzy, depressed or confused
or have a headache. You may also feel drowsy or become unconscious.
Things you should do
Before starting any new medicine, tell your doctor or pharmacist that you are taking
RESPRIM.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking
RESPRIM.
If you become pregnant while taking RESPRIM, tell your doctor.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Tell your doctor if you feel that RESPRIM is not helping your condition.
Drink plenty of fluids while you are taking RESPRIM.
This will help to flush the medicine through your system.
If you are taking RESPRIM for a long time, visit your doctor regularly so your progress
can be checked.
Your doctor may ask you to have regular tests to check your kidneys, liver or blood.
If you have to have any blood tests, tell your doctor that you are taking RESPRIM.
RESPRIM may affect the results of some tests.
Call your doctor or pharmacist straight away if you:
get severe diarrhoea, even if it occurs several weeks after stopping RESPRIM. Do not
take any diarrhoea medicine without checking with your doctor.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care.
Things you should not do
Do not stop taking RESPRIM or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not take RESPRIM to treat any other complaints unless you doctor tells you to.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting with a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how RESPRIM
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Combining RESPRIM and alcohol can make you feel sick, vomit, or have stomach cramps,
headaches and flushing. Your doctor may suggest you avoid alcohol while being treated
with RESPRIM.
Things to be careful of
Sometimes the use of this medicine allows other bacteria and fungi which are not sensitive
to RESPRIM to grow. If other infections such as thrush occur while you are taking
RESPRIM tell your doctor.
Your skin may burn more easily while you are taking RESPRIM. If outdoors, wear protective
clothing or use a SPF 30+ sunscreen.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Store below 30°C.
Keep RESPRIM in a cool dry place away from moisture, heat or sunlight; for example,
do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat or dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Less serious side effects
|
Less serious side effects
|
What to do
|
|---|---|
|
nausea, with or without vomiting
diarrhoea or other abdominal (gut) or stomach discomfort
oral thrush (white, furry sore tongue and mouth)
vaginal thrush (sore and itchy vagina, vaginal discharge)
Your doctor will need to treat the thrush infection separately.
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
These side effects are usually not serious or long lasting.
|
Serious side effects
|
Serious side effects
|
What to do
|
|---|---|
|
jaundice (yellowing of the eyes or skin)
severe or watery diarrhoea
any type of skin rash, peeling of the skin, severe itching or hives
fever, sore throat, lumps in the neck
cough, shortness of breath
severe persistent headache
discolouration of urine
renal stones
swelling of the face and throat
other allergic reactions
pins and needles in the hands & feet
loss of appetite, fits, headaches, depression, imagined sensations or nervousness
increased or decreased urine production
unsteadiness or dizziness
sleeplessness, weakness, tiredness, increased sensitivity to light and stomach pains
uveitis (eye inflammation)
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
These side effects are usually rare but may be serious and need urgent medical attention.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell, even if it is not on this list.
This is not a complete list of all possible side effects. Other side effects not listed
here may occur in some people.
Very rarely, people have died from complications due to certain severe skin, liver
and blood reactions.
Elderly people, people with liver or kidney disease and people taking certain other
medicines are more at risk of these severe reactions.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is only available with a doctor's prescription.
What RESPRIM contains
|
Active ingredient
(main ingredient)
|
RESPRIM
trimethoprim 80 mg sulfamethoxazole 400 mg
RESPRIM FORTE trimethoprim 160 mg sulfamethoxazole 800 mg
|
|---|---|
|
Other ingredients
(inactive ingredients)
|
povidone
docusate sodium
sodium starch glycollate
magnesium stearate
|
|
Potential allergens
|
sulfites
|
Do not take this medicine if you are allergic to any of these ingredients.
What RESPRIM looks like
RESPRIM is an 11 mm flat bevelled edge white tablet, marked "80|400" on one side and
"R" on the other side (AUST R 17681).
RESPRIM FORTE is a 19 mm x 9 mm oblong convex white tablet, marked "160|800" on one
side and "RF" on the other side (AUST R 17682).
Each blister pack contains 10 tablets.
