Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using TRIMETHOPRIM VIATRIS?
TRIMETHOPRIM VIATRIS contains the active ingredient Trimethoprim. TRIMETHOPRIM VIATRIS
is used to treat urinary tract infections caused by bacteria.
For more information, see Section
1. Why am I using TRIMETHOPRIM VIATRIS? in the full CMI.
2. What should I know before I use TRIMETHOPRIM VIATRIS?
Do not use if you have ever had an allergic reaction to trimethoprim or any of the
ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist 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 use TRIMETHOPRIM VIATRIS? in the full CMI.
3. What if I am taking other medicines?
4. How do I use TRIMETHOPRIM VIATRIS?
For adults and children over 12 years, the usual dose is one tablet daily. Elderly
patients may need smaller doses.
For children 6 to 12 years, the usual dose is half a tablet daily.
5. What should I know while using TRIMETHOPRIM VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TRIMETHOPRIM
VIATRIS.
Immediately stop taking TRIMETHOPRIM VIATRIS if a skin rash or any other allergic
reaction occurs.
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Things you should not do
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Do not take any other medicines while you are taking TRIMETHOPRIM VIATRIS without
first telling your doctor.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
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Driving or using machines
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Do not drive or operate machinery or tools until you know how TRIMETHOPRIM VIATRIS
affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your tablets in the original container they were provided in until it is time
to take them.
Keep TRIMETHOPRIM VIATRIS below 30°C and protect from light.
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6. Are there any side effects?
Speak to your doctor or pharmacist if you have any of these less serious side effects:
nausea (feeling sick), vomiting, diarrhoea, sore tongue, stomach upset, dizziness,
fainting, ringing, hissing, whistling, buzzing, or persisting noise in the ears, joint
or muscle pain, nosebleeds, urticaria, skin rashes.
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: any type of skin rash which includes redness and itching, unusual bruising or bleeding,
tiredness which may occur with headache, weight loss and yellowing of the eyes or
skin, signs of frequent infections such as fever, chills, sore throat or mouth ulcers,
swelling of the face, lips, mouth, tongue and throat, shortness of breath, wheezing
or difficulty breathing, depression, hallucinations, confusion, nervousness, feeling
anxious, blurred vision, redness of the eye, eye pain, increased sensitivity to light.
This is not a complete list of all 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.
Active ingredient(s):
trimethoprim
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking TRIMETHOPRIM VIATRIS. 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 TRIMETHOPRIM VIATRIS.
Where to find information in this leaflet:
1. Why am I taking TRIMETHOPRIM VIATRIS?
TRIMETHOPRIM VIATRIS contains the active ingredient trimethoprim. TRIMETHOPRIM VIATRIS is an antibiotic.
TRIMETHOPRIM VIATRIS is used to treat urinary tract infections caused by bacteria.
It works by stopping the growth of bacteria that are causing your infection.
Use TRIMETHOPRIM VIATRIS only as directed and consult a
health care professional if pain or symptoms persist.
TRIMETHOPRIM VIATRIS will not work against infections caused by viruses, such as colds
or flu.
Ask your doctor if you have any questions about why TRIMETHOPRIM VIATRIS has been
prescribed for you.
Your doctor may have prescribed TRIMETHOPRIM VIATRIS for another reason.
2. What should I know before I take TRIMETHOPRIM VIATRIS?
Warnings
Do not use TRIMETHOPRIM VIATRIS if:
You are allergic to trimethoprim, any other antibiotics, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction to TRIMETHOPRIM VIATRIS may include red,
itchy skin rashes, difficulty in breathing, swelling of the face, lips or throat or
faintness.
It passed the expiry date (EXP.) printed on the pack.
The packaging is torn or shows signs of tampering.
Check with your doctor or pharmacist if you:
are allergic to any other medicines or any foods, dyes or preservatives.
have or have had, any medical conditions, especially the following:
folate deficiency.
kidney problems
liver problems.
porphyria.
any type of blood disorder.
take any medicines for any other condition.
If you have not told your doctor about any of the above, tell them before you start
taking TRIMETHOPRIM VIATRIS.
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
Check with your doctor if you are pregnant or intend to become pregnant.
TRIMETHOPRIM VIATRIS is rated in Australia as a Category B3 drug for the use in pregnancy.
Ask your doctor about the risks and benefits involved when using TRIMETHOPRIM VIATRIS
during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
TRIMETHOPRIM VIATRIS is able to pass into breast milk. There is a possibility that
the breast-fed baby may be affected. Therefore, do not take TRIMETHOPRIM VIATRIS if you are breast-feeding or plan to breastfeed.
Paediatric use
TRIMETHOPRIM VIATRIS should not be administered to premature babies or infants under
4 months of age.
TRIMETHOPRIM VIATRIS is not recommended for use in children under the age of 6 years.
The safety and effectiveness of TRIMETHOPRIM VIATRIS in children under the age of
6 years has not been established.
3. What if I am taking other medicines?
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 be affected by TRIMETHOPRIM VIATRIS, or may affect how it works.
These include:
pyrimethamine, a medicine used to prevent malaria
warfarin, a medicine used to prevent blood clots
coumarins
methotrexate, a medicine used to treat arthritis and some types of cancer
phenytoin, a medicine used to control epilepsy (fits or seizures)
digoxin, a medicine used to treat heart failure or to control a fast irregular heart
beat
procainamide, a medicine used to correct an irregular heart beat or to slow an over
active heart
zidovudine, zalcitabine or lamivudine; medicines used for certain viral infections
dapsone, a medicine used for leprosy or dermatitis herpetiformis
rifampicin, an antibiotic
ciclosporin, a medicine used to help prevent organ transplant rejection or to treat
certain problems with the immune system
folate antagonists and anticonvulsants
repaglinide, used to treat diabetes
diuretics, also known as fluid or water tablets
bone marrow depressants
ACE inhibitors, medicines used to treat high blood pressure and some heart conditions
certain blood pressure medications that can increase potassium levels in the blood
The above medicines may either reduce the effectiveness of TRIMETHOPRIM VIATRIS, reduce
its own effectiveness and/or react with TRIMETHOPRIM VIATRIS resulting in untoward
or sometimes dangerous side effects.
This list is not exhaustive. Your doctor or pharmacist has more information on medicines
to be careful with or avoid while taking TRIMETHOPRIM VIATRIS.
Talk to your doctor about the need for additional contraception while taking TRIMETHOPRIM
VIATRIS.
Some antibiotics may decrease the effectiveness of some birth control pills.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TRIMETHOPRIM VIATRIS.
4. How do I take TRIMETHOPRIM VIATRIS?
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.
How much to take
Adults and children over 12 years:
The usual dose is 1 tablet daily. Elderly patients and people with kidney problems
may need smaller doses.
Children 6-12 years:
The usual dose is ½ tablet daily.
Do not give TRIMETHOPRIM VIATRIS to children under the age of 6 years.
There is no information concerning the right dose for children under the age of 6
years.
Different people may respond differently to TRIMETHOPRIM VIATRIS, so your doctor may
tell you to take a different dose.
Some people may need to take folate supplements while taking TRIMETHOPRIM VIATRIS.
These people may include the elderly, people with folate deficiency and people taking
certain medicines. Your doctor will tell you if this is necessary.
How to take TRIMETHOPRIM VIATRIS
Swallow the tablets whole with a glass of water.
TRIMETHOPRIM VIATRIS can be taken with or without food. Taking TRIMETHOPRIM VIATRIS
with food will help reduce the chance of a stomach upset.
When to take TRIMETHOPRIM VIATRIS
TRIMETHOPRIM VIATRIS tablets are best taken before bedtime.
Keep taking TRIMETHOPRIM VIATRIS until you finish the pack, or for as long as your
doctor recommends.
For most infections, TRIMETHOPRIM VIATRIS is usually taken for 7 days.
Do not stop taking TRIMETHOPRIM VIATRIS, 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 you forget to take TRIMETHOPRIM VIATRIS
TRIMETHOPRIM VIATRIS should be used regularly at the same time each day. If you miss
your dose at the usual time, take your dose as soon as you remember, and then go back
to taking it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you have taken too much TRIMETHOPRIM VIATRIS
If you think that you have taken too much TRIMETHOPRIM VIATRIS, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(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.
Also, report any other medicine or alcohol which has been taken.
If you take too much TRIMETHOPRIM VIATRIS you may have the following symptoms: nausea,
vomiting, dizziness, headaches, confusion, and mental depression.
5. What should I know while using TRIMETHOPRIM VIATRIS?
Things you should do
Immediately stop taking TRIMETHOPRIM VIATRIS if a skin rash or any other allergic
reaction occurs.
Use this medicine exactly as directed or as your doctor has prescribed.
Before starting any new medicine, tell your doctor or pharmacist that you are taking
TRIMETHOPRIM.
If your symptoms do not improve within a few days or if they become worse, tell your
doctor
If you have been taking TRIMETHOPRIM for a long time, visit your doctor regularly
so that they can check on your progress.
You may need to have regular blood tests.
Always discuss with your doctor any problems or difficulties during or after taking
TRIMETHOPRIM.
If you have been taking TRIMETHOPRIM VIATRIS for a long time, visit your doctor regularly
so that they can check on your progress.
You may need to have regular blood tests.
Call your doctor straight away:
If you become pregnant while taking TRIMETHOPRIM VIATRIS, tell your doctor immediately.
Remind any doctor, dentist or pharmacist you visit that you are using TRIMETHOPRIM
VIATRIS.
Things you should not do
Do not take any other medicines while you are taking TRIMETHOPRIM VIATRIS without
first telling your doctor.
Do not use TRIMETHOPRIM to treat any other conditions unless your doctor tells you
to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TRIMETHOPRIM
VIATRIS affects you.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
Keep your medicine in the original container until it is time to take it.
Keep TRIMETHOPRIM VIATRIS below 30°C and protect from light. Follow the instructions
in the carton on how to take care of your medicine properly.
Do not take TRIMETHOPRIM VIATRIS if the tablets do not look quite right.
Store TRIMETHOPRIM VIATRIS 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 and 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 use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take TRIMETHOPRIM VIATRIS after the expiry date printed on the pack.
If you take this medicine after the expiry date, it may not work as well.
6. Are there any side effects?
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.
Less serious side effects
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Less serious side effects
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What to do
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headache
nausea (feeling sick), vomiting
diarrhoea
sore tongue
stomach upset
cough
dizziness, sleepiness, drowsiness
fainting
ringing, hissing, whistling, buzzing, or persisting noise in the ears
joint or muscle pain
nosebleeds
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Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
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Serious side effects
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Serious side effects
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What to do
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any type of skin rash which includes itching and redness
unusual bruising or bleeding
tiredness which may occur together with headaches, sore mouth or tongue, weight loss
or yellowing of the eyes or skin
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
depression, hallucinations, confusion, nervousness, feeling anxious
signs of an allergic reaction such as itching or hives; swelling of the face, lips
or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness
of breath
blurred vision, redness of the eye, eye pain, increased sensitivity to light, uveitis
(eye inflammation).
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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.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Check with your doctor as soon as possible if you have any problems while taking TRIMETHOPRIM
VIATRIS even if you do not think the problems are connected with the medicine or are
not listed in this leaflet.
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.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What TRIMETHOPRIM VIATRIS contains
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Active ingredient
(main ingredient)
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Trimethoprim 300 mg each tablet
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Other ingredients
(inactive ingredients)
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Lactose monohydrate, povidone, sodium starch glycollate, purified talc, magnesium
stearate.
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Potential allergens
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Lactose and traces of sulfites and galactose
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Do not take this medicine if you are allergic to any of these ingredients.
What TRIMETHOPRIM VIATRIS looks like
TRIMETHOPRIM VIATRIS 300mg is a 9.5 mm white normal convex tablet marked "TM/300"
on one side, "G" on the other (AUST R 338350).
Each pack contains 7 tablets.
Who distributes TRIMETHOPRIM VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in May 2024
TRIMETHOPRIM VIATRIS_cmi\May24/01