Important Safety Information: Nitrofurantoin (generic Macrobid)

Important Safety Information – Macrobid (Nitrofurantoin)

Important safety information and consumer warnings you should know about nitrofurantoin.

Overview

The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch .

MacroBID 100mg Capsules (nitrofurantoin) Read all of this leaflet carefully before you start using this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The product is known by the name above but will be referred to as MacroBID throughout the rest of this leaflet.

In this leaflet: What MacroBID is and what it is used for Before you take MacroBID How to take MacroBID Possible side effects How to store MacroBID Further information

WHAT MacroBID IS AND WHAT IT IS USED FOR

Nitrofurantoin (the active substance in MacroBID) is an antibiotic.

It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.

BEFORE YOU TAKE MacroBID

DO NOT TAKE MacroBID and talk to your doctor if: you are allergic (causing itching, reddening of the skin or difficulty in breathing) to Nitrofurantoin or any of the ingredients of MacroBID (see Section 6 below) or other medicines containing nitrofurantoin you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure) you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby you have porphyria (blood disorder) in patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency in infants under three months of age you are breastfeeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate dehydrogenase). Tell your doctor if you are not sure about any of the above.

TAKE SPECIAL CARE with MacroBID and speak to your doctor or pharmacist before taking the capsules if: you have diabetes you are suffering from any illness causing severe weakness you have anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness); a lack of vitamin B or abnormal levels of salts in your blood (your doctor will be able to advise you). The above conditions may increase the chance of developing a side effect which causes damage to the nerves, altered sense of feeling, like pins and needles.

you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Middle Eastern or Asian origin.Your doctor will know) you have any disease of the lungs, liver or nervous system. If you need to take MacroBID for a number of months, your doctor may want to regularly check how your lungs and liver are working you have false positive results on testing your urine for glucose you have urine coloured yellow or brown. Taking other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If they are taken with MacroBID their effect or the effect of MacroBID may be changed.

Antacids for indigestion (e.g. magnesium trisilicate) Medicines for gout (e.g. probenecid or sulfinpyrazone) Medicines for raised pressure in the eye (glaucoma), such as carbonic anhydrase inhibitors (e.g. acetazolamide) Medicines which make the urine less acidic (e.g. potassium citrate mixture) Medicines for infections, known as quinolones Oral contraceptive “the pill”. You will need to use extra contraceptive precautions such as using a condom, as antibiotics can make the contraceptive pill less effective Typhoid vaccine, which is given for the prevention of typhoid. If you are in doubt about any of these medicines ask your doctor or pharmacist.

Taking MacroBID with food and drink: MacroBID capsules should be taken at meal times with food or milk. This will help to avoid stomach upset and also to help the absorption.

Pregnancy and breast-feeding: Ask your doctor or pharmacist for advice before taking any medicine. As far as it is known MacroBID may be used in pregnancy. However it should not be used during labour or delivery because there is a possibility that use at this stage may affect the baby. If you want to breastfeed, please consult with your doctor first.

Driving and using machines: MacroBID may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.

Important information about some of the ingredients in MacroBID: This medicine contains lactose and sucrose (sugars). If you have been told by your doctor that you are intolerant to some sugars and have to avoid them, contact your doctor before taking this medicine.

HOW TO TAKE MacroBID

Follow your doctor’s instructions exactly and complete the course of treatment even if you feel better. You should check with your doctor or pharmacist if you are not sure. Do not forget to take your medicine. Capsules should be swallowed whole.

Adults and children over 12 years old: The normal dosage depends on the type of infection you have and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions are not clear.

The usual doses are:

For treatment of bladder infections: One capsule twice a day for seven days For prevention of bladder infections during surgery: One capsule twice a day on the day of the operation and three days thereafter. MacroBID is not recommended for children under 12 years of age.

MacroBID should be taken with food or milk.

Medical Checks: Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system. MacroBID may interfere with the results of some tests for glucose in the urine.

If you TAKE MORE MacroBID than you should: Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over capsules with you, as well as the container and label, so that the medical staff know what you have taken.

If you FORGET TO TAKE MacroBID: Do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose take the normal dose the next day. Do not take a double dose to make up for a forgotten capsule. If you are not sure, ask your doctor or pharmacist.

If you STOP TAKING MacroBID: Your doctor will tell you how long to take the treatment. Do not stop earlier than you are told, even if you feel better.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, MacroBID can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking MacroBID. If you experience any of the side effects detailed below or any other side effects, stop taking MacroBID and consult your doctor.

All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any sudden wheezing, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately.

Please note that while taking MacroBID your urine may become coloured dark yellow or brown. This is quite normal and not a reason to stop taking the medicine.

If you notice any of the following side effects consult you doctor immediately:

Your lungs may react to MacroBID. This may develop quickly, within a week of starting treatment or very slowly, especially in elderly patients. This may produce fever, chills, cough and shortness of breath MacroBID may cause the liver to become inflamed, producing jaundice (yellowing of the skin or whites of the eyes). Other side effects are: Feeling sick (nausea) and headache Loose stools Loss of appetite, stomach ache, and being sick (vomiting) Dizziness, drowsiness Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anaemia, and a susceptibility to colds or persistent cold The nerves outside the spinal cord may be affected causing changes to the sense of feeling and the use of muscles. In addition headache, extreme changes of mood or mental state, confusion, weakness, blurred vision may occur. These effects may be severe and in some instances permanent A variety of skin rashes or reactions have occurred in some patients. These may appear as flaking skin, a red rash or fever accompanied by rapid heart rate and severe rash with blistering. Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas gland (causing severe abdominal pain) and joint pains. Short-term hair loss Raised pressure in the skull (causing severe headaches) Urinary infection by germs which are not sensitive to MacroBID. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Remember: This medicine is only for you. Only a doctor can prescribe it for you. Never give this medicine to someone else. It could harm them, even if their symptoms seem the same as yours.

HOW TO STORE MacroBID

Keep this medicine out of sight and reach of children.

Do not store above 30°C (aluminium/aluminium). Do not store above 25°C (For PVC/polyethylene/aclar/aluminium blisters).

Store in the original package to protect from light and moisture.

Do not use MacroBID after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What MacroBID contains: The active substance is 100mg nitrofurantoin in each capsule.

The other ingredients are talc, corn starch, lactose, carbopol, povidone, sugar and magnesium stearate. The capsule shell contains gelatin, quinoline yellow (E104), titanium dioxide (E171) and FD&C Blue No.2 (E132). The printing ink contains shellac, propylene glycol (E1520), titanium dioxide (E171) black iron oxide (E172), ammonium hydroxide (E527) and simethicone.

What MacroBID looks like and contents of the pack: Appearance: The 100mg capsule has an opaque blue cap and opaque yellow body and bears the monogram “GS 100”.

Packaging: The capsules are available in blister strips of 14.

The views expressed in this article intend to highlight alternative studies and induce conversation. They are the views of the author and do not necessarily represent the views of Revelry Care, and are for informational purposes only, even if and to the extent that this article features the advice of physicians and medical practitioners. This article is not, nor is it intended to be, a substitute for professional medical advice, diagnosis, or treatment, and should never be relied upon for specific medical advice.

 

Important Safety Information: Cephalexin (generic Keflex)

Important Safety Information – Cephalexin

Important safety information and consumer warnings you should know about cephalexin.

Overview

The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch.

KEFLEX 500mg Tablets (cephalexin anhydrous – as monohydrate)

Read all of this leaflet carefully before you start taking this medicine. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet What Keflex is and what it is used for What you need to know before you take Keflex How to take Keflex Possible side effects How to store Keflex Contents of the pack and other information

What Keflex is and what it is used for

Keflex contains the active ingredient cefalexin, which is an antibiotic.

Keflex is used to treat the following infections caused by bacteria that can be killed by cefalexin:

Respiratory tract (lung and airways) infections e.g. tonsillitis, pharyngitis and bronchitis Middle ear infection (otitis media) Skin and soft tissue (e.g. muscle) infections Bone and joint infections Infections of the reproductive organs and urinary tract (e.g. cystitis), including acute inflammation of the prostate (prostatitis) Dental infections 2. What you need to know before you take Keflex Do not take Keflex if You are allergic (hypersensitive) to cephalexin, other cephalosporins (similar antibiotics) or any of the other ingredients (these are listed in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. Warnings and precautions Talk to your doctor or pharmacist if you

have had an allergic reaction to cephalexin, cephalosporins, penicillins, or other drugs in the past develop severe or prolonged diarrhoea during or after taking Keflex have a severe kidney disorder (you may need a reduced dose). Tell your doctor if you are having blood or urine tests. Keflex may interfere with these tests.

Long term use of Keflex may lead to interaction with resistant bacteria and fungi.

Other medicines and Keflex Please tell your doctor or pharmacist if you are taking any other medicines. This is especially important of the following, as they may interact with your Keflex:

Any other antibiotics (e.g. gentamicin, tobramycin, cefuroxime) Potent diuretics e.g. furosemide (water tablets used to treat high blood pressure or water retention) Probenecid (a treatment for gout) Metformin (a treatment for diabetes) Drugs used to treat leukaemia It may still be alright for you to be given Keflex and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding You should tell your doctor if you are pregnant or breast- feeding. Ask your doctor or pharmacist before taking any medicine.

Driving and using machines Keflex should not affect your ability to drive or use machines.

How to take Keflex

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage Adults and the elderly The usual total daily dose is 1-4g orally daily, in divided doses.

Most infections can be treated by 500mg every 8 hours. For skin and soft tissue infections, sore throat (streptococcal pharyngitis), and mild infections of the urinary tract (e.g. cystitis), the usual dose is 250mg every 6 hours, or 500mg every 12 hours. For more severe infections, larger doses may be needed. A reduced dose is needed for patients with severe kidney disorders. The usual total daily dose for children is 25-50mg/kg (body weight) in divided doses.

For skin and soft tissue infections, sore throat (streptococcal pharyngitis), and mild infections of the urinary tract (e.g. cystitis), the total daily dose may be divided and administered every 12 hours. For most infections the following schedule is suggested:

Children under 5 years: 125mg every 8 hours Children 5 years and over: 250mg every 8 hours.

In severe infections, the dose may be doubled. In the treatment of middle ear infections, a total daily dose of 75 to 100mg/kg in 4 doses is required.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Keflex can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor immediately if you get any sudden wheezing, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Serious side effects The following side effects are serious. You should stop taking this medicine and contact your doctor immediately if you experience them:

Serious peeling or blistering of the skin Severe or prolonged diarrhoea during or after taking Keflex. This could be a symptom of a more serious condition e.g. pseudomembranous colitis. The following side effects have been reported Diarrhoea Feeling sick (nausea) Vomiting Indigestion Stomach pains Measle-like rash, (alone) Itching Red wheals on the skin (urticaria) (alone) Rash with widespread joint pain and / or stiffness, swollen lymph glands, fever and, possibly, cloudy urine Changes in blood counts, which may show up as bruising or a very tired feeling. You will need a blood test to confirm this. Damage to your liver or kidneys which can only be detected by a blood and / or urine test Jaundice (yellow skin and eyes) Weakness Fainting Abnormally excitable behaviour Agitation Tiredness Headache Confusion Dizziness Seeing or hearing things (hallucinations) Itching of the vagina or anus caused by thrush (candidiasis) If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to Store Keflex

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP and on the blister after Use Before. The expiry date refers to the first day of that month.

Do not store above 30° C.

Keep in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and further information

What Keflex contains The active substance in Keflex 500 mg tablets is: 500mg cephalexin anhydrous (as monohydrate).

The other ingredients are: sodium starch glycolate, magnesium stearate and povidone.

The tablet coating contains: methylhydroxypropylcellulose, glycerol and talc and are coloured with titanium dioxide (E171) and red and yellow oxide (E172).

What Keflex looks like and contents of the pack Keflex 500mg tablets are peach coloured and pillow- shaped, marked GP4.

Pack size: Keflex 500mg tablets are available in blister packs of 21.

The views expressed in this article intend to highlight alternative studies and induce conversation. They are the views of the author and do not necessarily represent the views of Revelry Care, and are for informational purposes only, even if and to the extent that this article features the advice of physicians and medical practitioners. This article is not, nor is it intended to be, a substitute for professional medical advice, diagnosis, or treatment, and should never be relied upon for specific medical advice.

Important Safety Information: Sulfamethoxazole / Trimethoprim (generic Bactrim)

Important Safety Information – Sulfamethoxazole and Trimethoprim

Important safety information and consumer warnings you should know about sulfamethoxazole and trimethoprim.

Overview

The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch.

BACTRIM DS Tablets and Bactrim Oral Suspension What is in this leaflet This leaflet answers some common questions about BACTRIM DS tablets and BACTRIM oral suspension (mixture is another name that can be used instead of oral suspension). It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking BACTRIM against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What BACTRIM is used for BACTRIM contains the active ingredients sulfamethoxazole and trimethoprim, also known as co-trimoxazole.

BACTRIM is used to treat bacterial infections in different parts of the body. BACTRIM belongs to a group of medicines called antibiotics. There are many different types of medicines used to treat bacterial infections. Sulfamethoxazole in BACTRIM belongs to a group of medicines known as sulfonamides.

Trimethoprim belongs to a group of medicines known as the benzyl pyrimidines.

BACTRIM works by stopping the growth of the bacteria causing the infection.

BACTRIM does not work against infections caused by viruses, such as colds and flu.

BACTRIM has been prescribed for your current infection. Another infection later on may require a different medicine.

Your doctor may have prescribed BACTRIM for another purpose.

Ask your doctor if you have any questions why BACTRIM has been prescribed for you.

This medicine is available only with a doctor’s prescription.

Before you take BACTRIM When you must not take it Do not take BACTRIM if:

you have had an allergic reaction to sulfamethoxazole, trimethoprim, any other sulfonamide, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include:

skin rash peeling of the skin itching or hives swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing wheezing or shortness of breath. you have severe liver or kidney disease, any blood disorder or megaloblastic anaemia the child you are treating is less than 3 months of age you have streptococcal pharyngitis the package is torn or shows signs of tampering you are taking dofetilide, a medicine used to treat irregular heartbeats the expiry date (EXP) printed on the pack has passed If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be taking BACTRIM, talk to your doctor.

Before you start to take it Your doctor must know about all the following before you can start to take BACTRIM.

Tell your doctor if:

you are pregnant or intend to become pregnant If BACTRIM is taken during pregnancy, it may harm the baby. Your doctor will discuss the risks and benefits of taking BACTRIM during pregnancy.

you are breast-feeding or plan to breast-feed BACTRIM passes into breast milk. Your doctor will discuss the risks and benefits of taking

BACTRIM while breast-feeding.

you have any other health problems including: an allergic reaction to any diuretic (fluid) tablet or medicines for diabetes or overactive thyroid. This may increase your chances of an allergic reaction to BACTRIM any type of blood disorder (including porphyria and glucose-6-phosphate dehydrogenase deficiency) kidney or liver disease a hereditary disorder called phenylketonuria epilepsy (fits or convulsions) asthma allergic disorders rheumatoid arthritis urinary obstruction folic acid deficiency you are allergic to any other medicines, foods, dyes or preservatives Taking other medicines Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food shop.

Some medicines may interfere with BACTRIM. These medicines include:

medicines used to treat diabetes such as repaglinide, rosiglitazone, pioglitazone, glibenclamide, gliclazide, glipizide, chlorpropamide and tolbutamide fluid tablets (diuretics) phenytoin, a medicine for epilepsy pyrimethamine, a medicine for malaria other medicines used to treat infections such as rifampicin, dapsone and polymyxin zidovudine, a medicine to treat HIV infection cyclosporin, a medicine used to treat organ transplant patients warfarin, acenocoumarol, phenprocoumon, medicines used to thin the blood medicines used to treat certain heart conditions such as digoxin and amiodarone amantadine, a medicine used to treat the influenza virus and Parkinson’s Disease memantine, a medicine used to treat Parkinson’s disease 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, 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 BACTRIM or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking BACTRIM.

If you have not told your doctor about any of the above, tell them before you start taking BACTRIM.

Use in very young children BACTRIM should not be given to premature babies or children younger than 3 months of age.

Use in People Over 65 Years People over 65 years are more at risk of severe side effects when taking BACTRIM. The risk is greater if you have kidney or liver disease or are taking some types of other medicines, such as diuretics.

Use in People with HIV infection People with HIV infection have been reported to get more side effects while being treated with BACTRIM than people without HIV.

How to take BACTRIM 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 Take BACTRIM exactly as your doctor has prescribed. Your doctor will tell you how much BACTRIM to take each day.

The dose and length of time you have to take BACTRIM will depend on the type of infection you have.

For adults and children over 12 years, the usual dose of BACTRIM DS is one tablet twice per day.

For children under 12 years of age, the dose of BACTRIM oral suspension depends on the age and weight of your child. Your doctor or pharmacist will tell you how much your child should be given.

How to take it Swallow BACTRIM DS tablets whole (or halve them if necessary) with a glass of water. The correct amount of BACTRIM oral suspension should be measured, using a metric measure, before being given by mouth.

When to take it Take BACTRIM DS tablets or oral suspension after a meal.

How long to take BACTRIM Continue taking BACTRIM until your doctor tells you to stop. The full course of BACTRIM prescribed by your doctor should be taken, even if you feel better after a few days. This will help clear your infection completely.

If your symptoms do not improve within a few days, or if they become worse, let your doctor know.

If you forget to take BACTRIM Do not take an extra dose. Wait until the next dose and take your normal dose then.

Do not try to make up for the dose that you missed by taking more than one dose at a time.

If you are not sure what to do, ask your doctor or pharmacist.

In case of an overdose Immediately telephone your doctor for advice or go to the ER at your nearest hospital if you think that you or anyone else may have taken too much BACTRIM even, if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much BACTRIM, you may feel sick or vomit, feel dizzy, depressed or confused or have a headache. You may also feel drowsy or become unconscious.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking BACTRIM Things you must do Tell all doctors, dentists and pharmacists who are treating you that you are taking BACTRIM.

Tell your doctor if you become pregnant while taking BACTRIM.

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 the tablets or oral suspension is not helping your condition.

Drink plenty of fluids while you are taking BACTRIM.

This will help to flush the medicine through your system.

If you are taking BACTRIM 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.

Tell your doctor you are taking BACTRIM if you have to have any blood tests.

BACTRIM may affect the results of some blood tests.

Contact your doctor immediately if you get severe diarrhoea, even if it develops several weeks after stopping BACTRIM. DO NOT take any diarrhoea medicine without first checking with your doctor.

Diarrhoea medicines may make your diarrhoea worse or make it last longer.

Things you must not do Do not stop taking BACTRIM 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 BACTRIM to anyone else even if their symptoms seem similar to yours.

Do not use BACTRIM to treat other complaints unless your doctor says to.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting with a pharmacist.

Things to be careful of Be careful driving or operating machinery until you know how BACTRIM affects you.

Sometimes use of this medicine allows other bacteria and fungi which are not sensitive to BACTRIM to grow. If other infections such as thrush occur while you are taking BACTRIM, tell your doctor.

If you are going outdoors, wear protective clothing or use a SPF 15+ sunscreen. Your skin may burn more easily while you are taking BACTRIM.

Side Effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking BACTRIM.

BACTRIM helps most people with susceptible infections but it may have unwanted side effects in a few 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.

Ask your doctor or pharmacist to answer any questions you may have.

If side effects do occur, they may be:

nausea, with or without vomiting diarrhoea or other abdominal (gut) or stomach discomfort These side effects are not usually serious or long lasting.

Tell your doctor if you notice these side effects and they worry you:

oral thrush (white, furry sore tongue and mouth) vaginal thrush (sore itchy vagina with vaginal discharge) Your doctor will need to treat the thrush infection separately. Tell your doctor immediately if you notice any of the following:

jaundice (yellowing of the 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 swelling of the face and throat These symptoms are usually rare but may be serious and need urgent medical attention.

Very rarely, people have died from complications due to certain severe skin, liver or blood reactions. Elderly people, people with liver or kidney disease and people taking certain other medicines are more at risk of these severe reactions.

Other rare side effects include:

other allergic reactions pins and needles in the hands and 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. If you experience any of these effects contact your doctor as soon as possible.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking BACTRIM Storage Keep your BACTRIM DS tablets in the blister pack until it is time to take them.

Keep the oral suspension in the bottle until it is time to take it.

If you take the tablets out of the blister pack or the oral suspension out of the bottle before it is time to take them, they may not keep well.

Keep BACTRIM in a cool dry place where the temperature stays below 30°C.

Do not store it, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep BACTRIM 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.

Disposal If your doctor tells you to stop taking BACTRIM, or the tablets or oral suspension has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Product Description Availability BACTRIM is available as tablets (800 mg/ 160 mg) or as an oral suspension (mixture) 200 mg/ 40 mg per 5 mL).

BACTRIM comes in the following pack sizes:

BACTRIM DS – 10 tablets per carton BACTRIM oral suspension – 100 mL per bottle What BACTRIM looks like BACTRIM DS tablets are white to almost white, oblong, with a breakline on one side and “ROCHE 800 + 160” on the other side.

The tablets have a breakline so that they can be broken in half if needed.

BACTRIM oral suspension is lightbeige in colour with a banana flavour.

Ingredients Active ingredient

BACTRIM DS tablets and BACTRIM oral suspension contain the active ingredients trimethoprim and sulfamethoxazole.

each BACTRIM DS tablet contains 160 mg of trimethoprim and 800 mg of sulfamethoxazole. each 5 mL of BACTRIM oral suspension contains 40 mg of trimethoprim and 200 mg of sulfamethoxazole. Inactive ingredients BACTRIM DS tablets also contain:

povidone (1201) docusate sodium (480) sodium starch glycolate magnesium stearate (470) BACTRIM DS tablets are gluten free and lactose free.

BACTRIM oral suspension also contains:

Cellulose – dispersible (460) methyl hydroxybenzoate (218) propyl hydroxybenzoate (216) sorbitol solution (420) polysorbate 80 (433) banana flavour 85509 H vanilla flavour 73690-36 water BACTRIM oral suspension is gluten free and sugar free.

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