|Read all of this leaflet carefully before you start using UZAPLEX, because it contains important information for you. |
This product is available without a doctors prescription.
Nevertheless you still need to use UZAPLEX carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Do not share UZAPLEX with any other person.
Ask your doctor or pharmacist if you need more information or advice.
You must see a doctor if your symptoms worsen or do not improve.
This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.
|Xysmalobium undulatum radix(uzara root) extract (4 6 : 1, extracting agent 60% (v/v) methanol)||75,6 mg|
|0,035% m/v |
0,045 % m/v
|Consult your doctor in the case of diarrhoea persisting for more than 2 days, if you have a fever (rise in body temperature) or if blood is present in the stool.|
It is important to ensure that fluids and electrolytes are replaced during diarrhoea. Speak to your healthcare professional for advice and information on oral rehydration therapy.
|||you are allergic (hypersensitive) to any of the active or inactive ingredients (see WHAT UZAPLEX CONTAINS).|
|||you are pregnant or breastfeeding your baby (see Pregnancy and breastfeeding).|
|||you have one of the following conditions: heart disease, hypokalaemia (low blood levels of potassium) or hypomagnesaemia (low blood levels of magnesium).|
|||you are currently receiving treatment with cardiac glycosides.|
|UZAPLEX is contra-indicated in patients with heart disease. The uzara root contains cardiac glycosides which can worsen current heart disease or may interfere with existing drug therapy for the treatment of heart disease.|
|||if you have glucose-galactose malabsorption because UZAPLEX contains invert sugar (see Important information about some of the ingredients of UZAPLEX).|
|||UZAPLEX must not be given to children under the age of 2 years.|
|||if you have been diagnosed with conduction disturbances or if you are on intravenous (injection administered directly into the blood stream) calcium therapy due to the presence of cardiac glycosides contained within the uzara root. Side-effects are not expected due to the low absorption of the uzara glycosides from the stomach into the blood; however, special precautions should be taken. Speak to your healthcare professional before taking UZAPLEX.|
|||if you are going for an immunoassay to determine the digoxin blood concentration, as false-positive results have been reported. If you have taken UZAPLEX, results obtained from such tests cannot be interpreted for either digitalis glycosides or uzara glycosides. Speak to your healthcare professional before undergoing blood tests to determine blood concentrations of digitoxin or digoxin.|
|||if you have been diagnosed with diabetes mellitus because UZAPLEX contains invert sugar (see Important information about some of the ingredients of UZAPLEX).|
|||Care should be taken to not exceed the maximum daily dose of UZAPLEX as side-effects typical of cardiac glycosides may occur.|
|||UZAPLEX is for oral administration only. Administration by any other route must be avoided.|
|If you are pregnant or breastfeeding your baby while taking UZAPLEX, please consult your doctor or pharmacist or other healthcare professional for advice.|
|||Invert sugar contains glucose; therefore if you have glucose-galactose malabsorption, you should not take UZAPLEX.|
|||Patients diagnosed with diabetes mellitus should note that the use of UZAPLEX can their blood sugar control due to the presence of invert sugar.|
|If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of UZAPLEX with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.|
|||Cardiac glycoside-containing herbs including black hellebore, Canadian hemp roots, digitalis leaf, hedge mustard, lily of the valley roots, motherwort, oleander leaf, pheasants eye plant, pleurisy root, squill bulb leaf scales and strophanthus seeds. UZAPLEX in combination with these herbs must be avoided because it can increase the risk of cardiac glycoside toxicity.|
|||Horsetail and liquorice, as the use of UZAPLEX in combination with either herbs may cause an increase in the risk of toxicity to the heart.|
|||Stimulant laxative herbs including aloe, alder buckthorn, black root, blue butternut bark, colocynth, European buckthorn, fo-ti, gamboge, gossypol, greater bindweed, jalap, manna, Mexican scammony root, rhubarb, senna and yellow dock. The use of UZAPLEX in combination with one of the above mentioned laxative herbs, may cause an increase in the risk of toxicity to the heart.|
|||Digoxin (also known as Lanoxin). The use of UZAPLEX in combination with digoxin is contra-indicated and must be avoided, as both have the same effect on the heart and the combined use of UZAPLEX with digoxin increases the risk of toxicity to the heart. Refer to Do NOT take UZAPLEX.|
|Calcium, quinidine and long-term cortisone treatment, as the concurrent use with UZAPLEX may cause an increase in the occurrence of adverse effects to the heart including irregular pulse and arrhythmias (irregular heart rhythm).|
|||Macrolide antibiotics, tetracycline and quinine and stimulant laxatives, as the use of UZAPLEX in combination with such medicines may cause an increase in the risk of toxicity to the heart.|
|||Potassium-depleting diuretic medicines including, but not limited to, chlorothiazide (Diuril), chlorthalidone (Thalitone), furosemide (Lasix), hydrochlorothiazide (HCTZ, Hydrodiuril, Microzide). The use of UZAPLEX in combination with one of the above mentioned diuretic drugs, may cause an increase in the risk of toxicity to the heart due to potassium depletion. Caution should also be exercised with all other diuretic agents|
|In the event of overdosage, consult your doctor or pharmacist. If neither is available, immediately seek help at the nearest hospital or poison control centre.|
|||Gastrointestinal disorders, including nausea and vomiting.|
|||Immune system disorders including allergic reactions and hypersensitivity reactions with skin erythema and facial swelling. These side-effects are rare.|
|UZAPLEX should be discontinued and you must consult your doctor at the onset of undesirable effects, particularly allergic (hypersensitive) reactions. If you experience side-effects not listed in this leaflet, you should consult your doctor|