Purbac double strength Side Effects

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Explain possible side effects and interaction/safety considerations for purbac double strength without overstating causality or efficacy.

What is Purbac double strength?

Purbac-Double-Strength contains the active ingredient Trimethoprim; Sulphamethoxazole.

• Active ingredient — Trimethoprim; Sulphamethoxazole
• Registration number — 28/20.2/0417
• Registration holder — Shanur Healthcare (Pty) Ltd

It is approved for:

• Upper and lower lung infections
• Urinary bladder or urinary tract infections
• Gastrointestinal tract (your mouth, oesophagus (gullet), stomach and intestines) infections
• Genital tract (reproductive track including sexually transferred diseases) infections
• Skin infections
• Other infections with bacteria sensitive to ILVITRIM SUSPENSION

Possible side effects of Purbac double strength

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• a fungal infection called thrush or candidiasis which can affect your child’s mouth or vagina
• high levels of potassium in your blood, which can cause abnormal heart beats (palpitations)
• headache
• feeling sick (nausea)
• diarrhoea
• skin rashes

Less frequent side effects

• pseudomembranous colitis (infection of the colon resulting in watery and sometimes bloody stools)
• changes in the blood cells, resulting in feeling weak, tired or listless, pale skin, and more frequent infections
• cyanosis (bluish or greyish colour of the skin, nails, lips or around the eyes)
• hypothyroidism where the thyroid doesn’t create and release enough thyroid hormone into your bloodstream. This makes you feel tired, gain weight and unable to tolerate cold temperatures
• low blood sugar
• low sodium concentration in your blood
• decreased appetite
• build-up of acid in your body (metabolic acidosis)
• depression
• seeing strange or unusual sights (hallucination)
• fits (convulsions or seizures)
• tingling or numbness in your hands and feet
• loss of balance and coordination (ataxia)
• dizziness
• feeling tired
• difficulty to sleep
• vision disorders, seeing flickering or flashing lights
• short-sighted for a short period
• inflammation of the eye which causes pain and redness
• feeling unsteady or giddy
• ringing or other unusual sounds in your ears
• inflammation of blood vessels
• vomiting
• swollen and inflamed tongue
• inflammation of the pancreas with severe upper stomach pain, often with nausea and vomiting (pancreatitis)
• the appearance of a rash or sunburn when your child has been outside (even on a cloudy day)
• arthralgia (pains in the joints)
• myalgia (pains in the muscles)
• problems with your urine, difficulty passing urine, passing more or less urine than usual
• blood or cloudiness in your urine
• kidney problems
• muscle pain and/or muscle weakness in HIV patients
• problems controlling movements. Side effects with frequency unknown:
• psychotic disorder (a mental state in which you may lose touch with reality)(changes in behaviour)
• plum coloured, raised, painful sores on the limbs and sometimes on the face and neck with a fever (Sweets syndrome)
• drug reaction with eosinophilia and systemic symptoms (an allergic type of reaction in which you may develop fever, skin rash, and abnormalities in blood and liver function tests – these may be signs of a multi-organ sensitivity disorder)

Interactions and medicines to check

The approved leaflet names these interactions.

• Zidovudine used in the treatment of HIV, as it can increase your risk of developing less blood cells
• Ciclosporin, used after organ transplant surgeries
• Rifampicin (an antibiotic)
• Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea, as you can develop side effects, e.g. anaemia
• If you/your child is taking any of the following, as the effect of these medicines can become stronger, and your doctor might monitor you more closely:
• Blood thinners such as warfarin
• Phenytoin, used to treat epilepsy (fits)
• Methotrexate, a medicine used to treat certain cancers or certain diseases affecting the immune system
• Medicines to treat problems with the way the heart beats such as digoxin or procainamide
• Medicines used to treat diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylureas) and repaglinide
• Lamivudine used in the treatment of HIV (Human Immunodeficiency Virus), as ILVITRIM SUSPENSION at high dosages can increase the effect of lamivudine
• Medicines that can increase the amount of potassium in the blood, such as diuretics (water tablets, which help increase the amount of urine produced, such as spironolactone), steroids (like prednisolone) and digoxin or ACE inhibitors (may be used to treat high blood pressure or some heart problems). These medicines can increase the amount of potassium to dangerously high levels in your blood
• Folinic acid, a supplement can lower the effect of ILVITRIM SUSPENSION
• Contraceptives can become less effective when taking with ILVITRIM SUSPENSION. You should use additional protection while on ILVITRIM SUSPENSION treatment
• Azathioprine may be used in patients following organ transplant or to treat immune system disorders or inflammatory bowel disease. Your doctor might monitor your blood cells more closely
• Amantadine, used to treat Parkinson’s disease, multiple sclerosis, flu or shingles. ILVITRIM SUSPENSION with food and drink Your child should take ILVITRIM SUSPENSION with some food or drink

Who should use extra caution?

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you or your child are hypersensitive (allergic) to sulphamethoxazole, sulphonamide or trimethoprim or any of the other ingredients of ILVITRIM SUSPENSION (listed in section 6)
• if you/your child have been told that you have or are at risk for a rare blood disorder called porphyria
• if you/your child have severe liver or severe kidney problems
• if you/your child have been told that you have an anaemia due to not having enough folic acid or vitamin B12
• if you are pregnant or breastfeeding
• ILVITRIM SUSPENSION should not be given to infants during the first 6 weeks of life

Use with care, and tell your doctor, if

• If you/your child has skin rashes, often accompanied by flu-like symptoms after taking ILVITRIM SUSPENSION. The rash may progress to widespread blistering or peeling of the skin. This can be a serious skin reaction to ILVITRIM SUSPENSION
• Stop taking ILVITRIM SUSPENSION and seek urgent advice from your doctor
• There have been very rare reports about excessive immune reactions due to a dysregulated activation of white blood cells resulting in inflammations (haemophagocytic lymphohistiocytosis), which can be life-threatening if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, feeling weak, lightheaded, shortness of breath, bruising, or skin rash simultaneously or with a slight delay, contact your doctor immediately
• If you develop an unexpected worsening of cough and shortness of breath, inform your doctor immediately
• If you are elderly you may have more severe side effects, e.g. problem with your blood causing bruises or bleeding (thrombocytopenia). This can happen more frequently if you are also taking water tablets, e.g. thiazides
• If you/your child have kidney problems. You/your child should take enough fluids, especially if you are underweight or malnourished
• If you/your child don’t have enough folic acid (a vitamin) in your body, which can make your skin pale and make you feel tired, weak and breathless
• This is known as anaemia. Your doctor might prescribe additional folic acid with your ILVITRIM SUSPENSION treatment
• If they have a disease called glucose-6-phosphate dehydrogenase deficiency, which can cause jaundice or spontaneous destruction of red blood cells
• If they have severe allergies or asthma
• If they have a problem with their metabolism called phenylketonuria and are not on a special diet to help their condition
• If you have been told by your child’s doctor that your child has a lot of potassium in their blood. Concomitant administration of ILVITRIM SUSPENSION with certain medicines, potassium supplements and food rich in potassium may lead to severe hyperkalaemia (increased potassium blood level). The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache
• If your child has a severe blood disorder, such as a low number of red blood cells (anaemia), a low number of white blood cells (leucopenia) or a low number of platelets, which may cause bleeding and bruising (thrombocytopenia)
• If you/your child are suffering from AIDS or are having special treatment that lowers your immune system, e.g. after an organ transplant. You can experience more severe side-effects
• If you/your child are allergic to sulfonamides. Examples include sulfonylurea (such as gliclazide and glibenclamide) or acetazolamide and thiazide diuretics (water tablets). You might be allergic to ILVITRIM SUSPENSION as well. Children Do not give ILVITRIM SUSPENSION to premature or new-born infants during the first 6 weeks of life

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking ILVITRIM SUSPENSION
• You should not take ILVITRIM SUSPENSION while you are pregnant or breastfeeding your baby

Dose, timing and other factors that can affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you or your child are hypersensitive (allergic) to sulphamethoxazole, sulphonamide or trimethoprim or any of the other ingredients of ILVITRIM SUSPENSION (listed in section 6)
• if you/your child have been told that you have or are at risk for a rare blood disorder called porphyria
• if you/your child have severe liver or severe kidney problems
• if you/your child have been told that you have an anaemia due to not having enough folic acid or vitamin B12
• if you are pregnant or breastfeeding
• ILVITRIM SUSPENSION should not be given to infants during the first 6 weeks of life

Use with care, and tell your doctor, if

• If you/your child has skin rashes, often accompanied by flu-like symptoms after taking ILVITRIM SUSPENSION. The rash may progress to widespread blistering or peeling of the skin. This can be a serious skin reaction to ILVITRIM SUSPENSION
• Stop taking ILVITRIM SUSPENSION and seek urgent advice from your doctor
• There have been very rare reports about excessive immune reactions due to a dysregulated activation of white blood cells resulting in inflammations (haemophagocytic lymphohistiocytosis), which can be life-threatening if not diagnosed and treated early. If you experience multiple symptoms such as fever, swollen glands, feeling weak, lightheaded, shortness of breath, bruising, or skin rash simultaneously or with a slight delay, contact your doctor immediately
• If you develop an unexpected worsening of cough and shortness of breath, inform your doctor immediately
• If you are elderly you may have more severe side effects, e.g. problem with your blood causing bruises or bleeding (thrombocytopenia). This can happen more frequently if you are also taking water tablets, e.g. thiazides
• If you/your child have kidney problems. You/your child should take enough fluids, especially if you are underweight or malnourished
• If you/your child don’t have enough folic acid (a vitamin) in your body, which can make your skin pale and make you feel tired, weak and breathless
• This is known as anaemia. Your doctor might prescribe additional folic acid with your ILVITRIM SUSPENSION treatment
• If they have a disease called glucose-6-phosphate dehydrogenase deficiency, which can cause jaundice or spontaneous destruction of red blood cells
• If they have severe allergies or asthma
• If they have a problem with their metabolism called phenylketonuria and are not on a special diet to help their condition
• If you have been told by your child’s doctor that your child has a lot of potassium in their blood. Concomitant administration of ILVITRIM SUSPENSION with certain medicines, potassium supplements and food rich in potassium may lead to severe hyperkalaemia (increased potassium blood level). The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache
• If your child has a severe blood disorder, such as a low number of red blood cells (anaemia), a low number of white blood cells (leucopenia) or a low number of platelets, which may cause bleeding and bruising (thrombocytopenia)
• If you/your child are suffering from AIDS or are having special treatment that lowers your immune system, e.g. after an organ transplant. You can experience more severe side-effects
• If you/your child are allergic to sulfonamides. Examples include sulfonylurea (such as gliclazide and glibenclamide) or acetazolamide and thiazide diuretics (water tablets). You might be allergic to ILVITRIM SUSPENSION as well. Children Do not give ILVITRIM SUSPENSION to premature or new-born infants during the first 6 weeks of life

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking ILVITRIM SUSPENSION
• You should not take ILVITRIM SUSPENSION while you are pregnant or breastfeeding your baby

Serious symptoms and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

What to do if side effects occur

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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