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SEPTRIN Tablets, SEPTRIN Forte Tablets & SEPTRIN Sugar-Free ...201042322540


SEPTRIN Tablets, SEPTRIN Forte Tablets & SEPTRIN Sugar-Free ...201042322540

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									SEPTRIN Tablets, SEPTRIN Forte Tablets & SEPTRIN Sugar-Free Paediatric Suspension
Trimethoprim and Sulfamethoxazole
Consumer Medicine Information
What is in this leaflet?                            People with AIDS may not tolerate or respond to        How to take SEPTRIN
                                                    SEPTRIN in the same manner as someone who
This leaflet answers some common questions          does not have AIDS. There may be an increase in        SEPTRIN Tablets and SEPTRIN Forte
about SEPTRIN. It does not contain all of the       the number and severity of side effects.               Tablets should be taken with a glass of water.
available information.                              12. You are taking any medicines, including:           Do not crush or chew the tablets.
Reading this leaflet does not take the place of     • Any malaria medicines (eg. pyrimethamine)            SEPTRIN Sugar-Free Paediatric Suspension
talking to your doctor or pharmacist.                                                                      should be shaken before use. The correct
                                                    • Any diabetes medicines                               amount of the suspension should be measured
Taking any medicine involves some risk. It is
possible that all risks associated with this        • Any diuretics                                        before being given by mouth.
medicine might not have been detected, despite      • Any epilepsy (fits) medicines (eg. phenytoin,        If you forget to take your dose
proper testing.                                          primidone and some barbiturates)
                                                                                                           If it is almost time for your next dose, skip the
Only your doctor or pharmacist is able to           • Rifampicin, methotrexate, cyclosporin,               dose that you have missed and take your next
weigh up all of the relevant facts, and you              warfarin, digoxin, procainamide or                dose when you are supposed to. Otherwise take
should consult them if you have any queries.             amantadine                                        the dose that you have missed as soon as you
If you have any concerns about taking               13. You are taking any other medicines,                remember, then go back to your normal schedule.
SEPTRIN, ask your doctor or pharmacist.                  including medicines that you buy without a        If you have forgotten to take more than one
                                                         prescription from a pharmacy, supermarket         dose, contact your doctor or pharmacist.
Keep this information.                                   or health food shop.
You may want to read it again.                                                                             Do not take a double dose to make up for the
                                                    Your doctor will have a complete list of the           dose that you have missed.
This leaflet provides information about             medicines that may cause problems when taken
SEPTRIN. The statements that are made in this       with SEPTRIN.                                          If you have trouble remembering when to take
leaflet cannot be applied to any other medicine,                                                           your medicine, ask your pharmacist for some
even those that are similar or appear to contain    SEPTRIN and very young children                        hints.
the same ingredients.                               SEPTRIN should not be used in premature                In case of overdose
                                                    babies or in children younger than 2 months
                                                    old.                                                   Immediately contact your doctor or Poisons
What SEPTRIN is used for
                                                                                                           Information Centre for advice, or go to
SEPTRIN is used for the treatment of a variety of   SEPTRIN and the elderly                                Casualty at your nearest hospital, if you think
bacterial infections, including bronchitis and      The use of SEPTRIN in elderly patients,                that you or anyone else may have taken too
infections of the ear, sinus, kidney, bladder,      particularly those with a liver or kidney disease or   much SEPTRIN. Do this even if there are no
stomach, bowel, skin and wounds.                    those taking certain other medicines, carries an       signs of discomfort or poisoning.
                                                    increased risk of severe adverse reactions.            You may need urgent medical attention.
How does SEPTRIN work?
                                                    When you must not take SEPTRIN                         Keep telephone numbers for these places
Trimethoprim and sulfamethoxazole (the active
ingredients in SEPTRIN) belong to a group of        Do not take SEPTRIN after the expiry date
medicines called "anti-infectives". They work in    printed on the pack or bottle.                         If too much SEPTRIN has been taken signs and
slightly different ways to stop the growth of       SEPTRIN may have no effect if you take it after        symptoms may include nausea, vomiting,
bacteria causing the infection.                     the expiry date.                                       dizziness, headache, depression and confusion. It
                                                                                                           is also possible that you will feel drowsy and you
If you have any questions about why you are         Do not take SEPTRIN if the packaging
                                                                                                           may lose consciousness.
taking SEPTRIN, ask your doctor or                  appears to have been tampered with.
pharmacist.                                         Do not take SEPTRIN to treat any other                 When to stop taking SEPTRIN
Before taking SEPTRIN                               conditions unless advised by your doctor.              Do not stop taking SEPTRIN just because you
                                                    Do not give SEPTRIN to anyone else, even if            feel better.
Read this section carefully. If you have any
                                                    their symptoms seem similar to yours.                  It is important that you take the full course of
concerns about the use of SEPTRIN, please
                                                                                                           SEPTRIN prescribed by your doctor. This will
discuss them with your doctor.
                                                                                                           reduce the risk of your infection recurring.
SEPTRIN is not suitable for everyone.               Using SEPTRIN
                                                                                                           Your doctor will advise you when to stop taking
Before taking SEPTRIN you must tell your
                                                    Take SEPTRIN as directed by your doctor or             SEPTRIN.
doctor if:
                                                    pharmacist. Never change the dose yourself. If         If you are unsure whether you should stop
1. You are allergic to:
                                                    you have any questions about the dose that you         taking SEPTRIN, talk to your doctor or
• trimethoprim, sulfamethoxazole or any other       have been prescribed, ask your doctor or
    ingredient listed at the end of this                                                                   pharmacist.
                                                    Your doctor or pharmacist will be able to tell
• any other sulphonamide type antibiotics, any                                                             While you are taking SEPTRIN
    diuretics (medicines that increase the volume   • how much SEPTRIN to take at each dose.               It is important that you drink plenty of fluids
    of your urine), or medicines for diabetes or                                                           (water) while you are taking SEPTRIN.
    an overactive thyroid gland.                    • how many doses to take each day.
                                                    • when to take each dose.                              Tell your doctor that you are taking SEPTRIN
2. You are pregnant or breastfeeding or become                                                             before you have any blood tests.
    pregnant, while taking SEPTRIN.                 The label on the container that your SEPTRIN           If you are taking SEPTRIN over a long period, or
3. You have ever had any type of liver, kidney      was supplied in will give the same information.        you have kidney problems, your doctor may ask
    or bladder complaint or disease (eg.            For adults and children over 12 years old the          you to undergo regular blood and urine tests.
    hepatitis).                                     usual dose is one SEPTRIN Forte Tablet, or two         Your doctor or pharmacist will be able to tell you
4. You have ever had any type of blood              SEPTRIN Tablets, twice a day.                          whether there are any other special instructions
    disorder (including porphyria and glucose-6-    The dose of SEPTRIN Sugar-Free Paediatric              while you are taking SEPTRIN.
    phosphate dehydrogenase deficiency).            Suspension for children under 12 years old             There is no evidence that SEPTRIN is addictive.
5. You have asthma or an allergic disorder.         depends on your child's weight and age. Your
6. You have a folic acid vitamin deficiency.        doctor or pharmacist will be able to tell you how
                                                    much your child should be given.                       Side Effects
7. You have phenylketonuria.
8. You suffer from alcoholism.                      Depending on the type of infection, and your           All medicines have side effects. Sometimes they
                                                    overall health, your doctor may prescribe a            are serious. Most of the time they are not.
9. You suffer from rheumatoid arthritis.
                                                    different dose of SEPTRIN.
10. You are being treated for epilepsy (fits).
                                                    Always take the full course of SEPTRIN
11. You have been diagnosed with AIDS.              prescribed by your doctor.

SEPTRIN Tablets, SEPTRIN Forte Tablets & SEPTRIN Sugar-Free Paediatric Suspension Published by MIMS/myDr August
2002                                                                                                     1
Stop taking SEPTRIN and tell your doctor               SEPTRIN Forte Tablets are elongated, white,
immediately if you notice, or experience, any          scored and marked "SEPTRIN FORTE".
of the following (you may need urgent medical          They are supplied in blister packs of 10 tablets.
• Any form of skin rash.                               SEPTRIN Sugar-Free Suspension is a thick, pink
                                                       cherry flavoured liquid in a 100 mL bottle.
The rash may indicate that you are allergic to
SEPTRIN. In very rare circumstances, patients          Ingredients
have died from complications that may arise from       Each SEPTRIN Tablet contains 80 mg of
certain severe allergic reactions. Your doctor will    trimethoprim and 400 mg sulfamethoxazole.
know what action to take if you develop a severe       Each SEPTRIN Forte Tablet contains 160 mg of
reaction.                                              trimethoprim and 800 mg sulfamethoxazole.
• Severe fever, chills, sore throat, joint pains,      The tablets also contain:
     cough or bruising.
                                                       • povidone
• Difficulty breathing or chest pains.
                                                       • docusate sodium
• Severe, persistent diarrhoea. This is
     particularly important if there is any blood or   • sodium starch glycollate
     mucus present. It is possible for this reaction   • magnesium stearate
     to only become apparent several weeks after       Every 5 mL of Septrin Sugar-Free Paediatric
     taking SEPTRIN.                                   Suspension contains 40 mg trimethoprim and 200
• Jaundice (yellowing of the skin), which is           mg sulfamethoxazole.
     related to the function of your liver.            The suspension also contains:
SEPTRIN may also cause more common side                • carmellose sodium
effects such as nausea, vomiting and
inflammation of the mouth or tongue.                   • saccharin sodium
                                                       • cellulose-dispersible
Other rare side effects include various other
allergic side effects, pins and needles in the hands   • glycerol
and feet, ringing in the ears, diarrhoea, loss of      • polysorbate 80
appetite, kidney damage, fits, headaches,              • citric acid - anhydrous
depression, imagined sensations (hallucinations),
nervousness, an increase or decrease in urine          • sorbitol
production, unsteadiness, dizziness,                   • ethanol
sleeplessness, weakness, tiredness, increased          • water
sensitivity to light and stomach pains.
                                                       • sunset yellow FCF (CI 5985)
If you experience any of these side effects,
                                                       • allura red AC (CI 16035)
please contact your doctor as soon as possible.
Various effects on the blood, particularly in the      • imitation cherry flavour 50001OU
elderly, have been attributed to the use of            • methyl hydroxybenzoate
SEPTRIN. In very rare circumstances, patients          • sodium benzoate
have died from some of these effects. Having a
blood test may be able to detect these effects.        The Australian Registration numbers are:
A small number of patients have had other              Septrin Tablets:
unwanted effects after taking SEPTRIN.                 AUST R 11001
Tell your doctor or pharmacist as soon as              Septrin Forte Tablets:
possible if you think you are experiencing any         AUST R 10998
side effects from taking SEPTRIN.                      Septrin Sugar-Free Paediatric Suspension: AUST
                                                       R 11000
After using SEPTRIN                                    Supplier
If your doctor advises you to stop taking              Sigma Pharmaceuticals Pty Ltd
SEPTRIN, ask your pharmacist what to do with           A.C.N. 004 118 594
any SEPTRIN that you may have left.                    1408 Centre Rd
                                                       Clayton Victoria, 3168
Storage                                                Australia
Keep SEPTRIN Tablets and SEPTRIN Forte                 Telephone: (03) 9839-2800
Tablets in a cool dry place where the
temperature stays below 30°C. Protect the              Date of preparation:
tablets from light.                                    March 2002
Keep SEPTRIN Sugar-Free Suspension in a
cool dry place where the temperature stays
below 30°C. Protect the suspension from light.
Keep your SEPTRIN in the container it was
supplied with.
Do not store SEPTRIN in the bathroom or
near a sink. Heat and dampness may affect
Do not leave SEPTRIN in the car on hot days.
Keep SEPTRIN and all other medicines,
where children cannot reach them.

Product description
What SEPTRIN looks like
SEPTRIN Tablets are round, white, scored and
marked "SEPTRIN".
They are supplied in bottles of 10 tablets.

SEPTRIN Tablets, SEPTRIN Forte Tablets & SEPTRIN Sugar-Free Paediatric Suspension Published by MIMS/myDr August
2002                                                                                                     2

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