NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
ALPRIM
trimethoprim
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Trimethoprim Mylan.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Trimethoprim Mylan against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What Trimethoprim Mylan is used for
Trimethoprim Mylan is used to treat infections of the urinary tract caused by bacteria.
Trimethoprim Mylan belongs to a group of medicines called antibiotics. It works by stopping the growth of the bacteria that is causing your infection.
Use Trimethoprim Mylan only as directed and consult a health care professional if pain or symptoms persist.
Trimethoprim Mylan will not work against infections caused by viruses, such as colds or flu.
Ask your doctor if you have any questions about why Trimethoprim Mylan has been prescribed for you.
Your doctor may have prescribed Trimethoprim Mylan for another reason.
Trimethoprim Mylan is available only with a doctor’s prescription.
Trimethoprim Mylan is not recommended for use in children under 6 years of age, as the safety and effectiveness of Trimethoprim Mylan in this age group has not been established.
Before you take Trimethoprim Mylan
When you must not take it
Do not take Trimethoprim Mylan if you are allergic to any other medicines containing trimethoprim or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include red, itchy skin rashes, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.
Do not take Trimethoprim Mylan if you have:
a severe blood disorder or anaemia
severe kidney problems.
Do not take Trimethoprim Mylan after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date, it may not work as well.
Do not take Trimethoprim Mylan if the packaging is torn or shows signs of tampering or the tablets do not look quite right.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you are pregnant or plan to become pregnant.
Trimethoprim Mylan is rated in Australia as a Category B3 drug for use in pregnancy. Ask your doctor about the risks and benefits of taking Trimethoprim Mylan during pregnancy.
Tell your doctor if you are breastfeeding or wish to breastfeed.
Trimethoprim Mylan passes into breast milk and may affect your baby. Trimethoprim Mylan is not recommended during breastfeeding.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
folate deficiency
kidney problems
liver problems
porphyria
any type of blood disorder.
Your doctor may want to take special care if you have any of these conditions.
If you have not told your doctor about any of the above, tell him/her before you start taking Trimethoprim Mylan.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by Trimethoprim Mylan, or may affect how well it works. These include:
pyrimethamine, a medicine used to prevent malaria
warfarin, a medicine used to prevent blood clots
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
diuretics, also known as fluid or water tablets
ACE inhibitors, medicines used to treat high blood pressure and some heart conditions.
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.
This list is not exhaustive. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Trimethoprim Mylan.
Talk to your doctor about the need for additional contraception while taking Trimethoprim Mylan.
Some antibiotics may decrease the effectiveness of some birth control pills.
Tell your doctor or pharmacist that you are taking Trimethoprim Mylan before you start taking any other medicine.
How to take Trimethoprim Mylan
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
For adults and children over 12 years, the usual dose is one tablet daily.
For children 6 to 12 years, the usual dose is half a tablet daily.
Do not give Trimethoprim Mylan to children under the age of 6 years.
There is no information concerning the right dose for children under the age of 6 years.
The elderly and people with kidney problems may need smaller doses.
Different people may respond differently to Trimethoprim Mylan, so your doctor may tell you to take a different dose.
Some people may need to take folate supplements while taking Trimethoprim Mylan. 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 Mylan
Swallow the tablets whole with a glass of water.
When to take Trimethoprim Mylan
Trimethoprim Mylan can be taken with or without food. Taking Trimethoprim Mylan with food will help reduce the chance of a stomach upset.
Trimethoprim Mylan tablets are best taken before bedtime.
How long to take Trimethoprim Mylan for
Keep taking Trimethoprim Mylan until you finish the pack, or for as long as your doctor recommends.
For most infections, Trimethoprim Mylan is usually taken for 7 days.
Do not stop taking Trimethoprim Mylan, 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 Mylan
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 tablets 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 or have any questions, ask your doctor or pharmacist.
If you take too much Trimethoprim Mylan (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Trimethoprim Mylan.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much Trimethoprim Mylan, you may experience the following: nausea, vomiting, dizziness, headaches, confusion or mental depression.
While you are taking Trimethoprim Mylan
Things you must do
Immediately stop taking Trimethoprim Mylan if skin rash or any other allergic reaction occurs.
Before starting any new medicine, tell your doctor or pharmacist that you are taking Trimethoprim Mylan.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Trimethoprim Mylan.
If you become pregnant while taking Trimethoprim Mylan, tell your doctor immediately.
If your symptoms do not improve within a few days, or if they become worse, tell your doctor.
If you are taking Trimethoprim Mylan 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 Mylan.
Things you must not do
Do not take any other medicines while you are taking Trimethoprim Mylan without first telling your doctor.
Do not drive or operate machinery until you know how Trimethoprim Mylan affects you.
Do not use Trimethoprim Mylan to treat any other conditions unless your doctor tells you to.
Do not give Trimethoprim Mylan to anyone else, even if they have the same condition as you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Trimethoprim Mylan.
Trimethoprim Mylan helps most people with urinary tract infections, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
stomach upset
nausea (feeling sick), vomiting
sore tongue.
The above list includes the milder side effects of your medicine.
See your doctor immediately if you notice any of the following:
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.
The above list includes serious side effects which may require medical attention.
See your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:
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
pink or red itchy spots on the skin which may blister and progress to form raised, red, pale-centred marks
redness, blistering, peeling or loosening of skin; bleeding of the lips, eyes, mouth, nose and genitals
severe rash with skin peeling, fever, chills and aching muscles.
The side effects listed above are rare but serious and require urgent medical attention or hospitalisation.
Tell your doctor if you notice anything that is making you feel unwell.
This is not a complete list of all possible side effects.
Other side effects not listed above may also occur in some people.
Check with your doctor as soon as possible if you have any problems while taking Trimethoprim Mylan even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
After taking Trimethoprim Mylan
Storage
Keep Trimethoprim Mylan where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep your tablets in a cool dry place where the temperature stays below 30°C and protect from light.
Do not store Trimethoprim Mylan or any other medicine in the bathroom or near a sink.
Do not leave Trimethoprim Mylan in the car or on window sills.
Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking Trimethoprim Mylan, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Trimethoprim Mylan is a round white tablet marked “TM/300” on one side and “G” on the other.
Each pack contains 7 tablets.
Ingredients
The active ingredient in Trimethoprim Mylan is trimethoprim.
Each Trimethoprim Mylan tablet contains 300 mg of trimethoprim.
The tablets also contain the following inactive ingredients:
lactose monohydrate
povidone
sodium starch glycollate
purified talc
magnesium stearate.
Trimethoprim Mylan tablets contain lactose and traces of galactose and sulfites. The tablets are gluten free.
Manufacturer
Trimethoprim Mylan is made in Australia by:
Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
Australian Registration Number:
Trimethoprim Mylan 300 mg – AUST R 338350
This leaflet was prepared in November 2020.
Trimethoprim Mylan_cmi\Nov20/00
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