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Logo UZAPLEX (SYRUP)

PATIENT INFORMATION LEAFLET
Information for the Patient about UZAPLEX

Read all of this leaflet carefully before you start using UZAPLEX, because it contains important information for you.
This product is available without a doctor’s 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.

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

UZAPLEX (SYRUP)

PHARMACOLOGICAL CLASSIFICATION:
D 32.2 Other. Complementary Medicine –Western Herbal

WHAT UZAPLEX CONTAINS:
Each 10 mL of UZAPLEX syrup contains
uzara root:
Ingredient Quantity
Xysmalobium undulatum radix(uzara root) extract (4 –6 : 1, extracting agent 60% (v/v) methanol) 75,6 mg
Preservatives:
Potassium sorbate
Sodium benzoate
0,035% m/v
0,045 % m/v
The other inactive ingredients include citric acid, agent (cola invert sugar and water.

UZAPLEX is free from added yeast, alcohol, colourants, aspartame, gluten, lactose and tartrazine.
UZAPLEX contains a nature identical flavourant.
UZAPLEX contains invert sugar. Invert sugar is sucrose (sugar) that has been inverted to form dextrose (glucose) and fructose.

WHAT UZAPLEX IS USED FOR:
UZAPLEX
is an herbal supplement for the relief of symptoms of diarrhoea. It acts by reducing bowel motility.
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.

BEFORE YOU TAKE UZAPLEX:
Do NOT take UZAPLEX if:
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.

Take special care with UZAPLEX:
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.

Taking UZAPLEX with food and drink:
UZAPLEX can be taken with or without food.

Use in children:
UZAPLEX should not be taken by or given to children under the age of 2.

Pregnancy and breastfeeding:
Do not take UZAPLEX if you are pregnant or breastfeeding your baby as safety has not been established (see “Do NOT take UZAPLEX”).
If you are pregnant or breastfeeding your baby while taking UZAPLEX, please consult your doctor or pharmacist or other healthcare professional for advice.

Driving or using machinery:
It is unlikely that UZAPLEX will affect your ability to drive or operate machinery. Side-effects as listed under “POSSIBLE SIDE-EFFECTS” may influence your ability to react.

Important information about some of the ingredients of UZAPLEX:
UZAPLEX contains invert sugar as an inactive ingredient.
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.

Taking UZAPLEX with other medicines:
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.

Please discuss the use of the following herbal medicines or supplements in combination with UZAPLEX with your doctor or pharmacist:
Cardiac glycoside-containing herbs including black hellebore, Canadian hemp roots, digitalis leaf, hedge mustard, lily of the valley roots, motherwort, oleander leaf, pheasant’s 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.

Please discuss the use of the following medicines or supplements in combination with UZAPLEX with your doctor or pharmacist:
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

HOW TO TAKE UZAPLEX:
Adults and children, 12 years and older:
First day of treatment: take 25 mL as a single dose.
On the following days: take 5 mL three (3) to six (6) times per day until the symptoms have subsided.
Maximum daily dose is 30 mL.
Children, 6 to 11 years old:
First day of treatment: take 5 to 7 mL as a single dose.
On the following days: take 3 to 4 mL three (3) to six (6) times per day until the symptoms have subsided.
Maximum daily dose is 24 mL.
Children, 2 to 5 years old:
Take 1 to 2 mL three (3) to (5) times per day until the symptoms have subsided. Maximum daily dose is 10 mL.
DO NOT EXCEED THE RECOMMENDED DAILY DOSAGE.

Method of Administration and Duration of Use
UZAPLEX is for oral use only. Do not administer by any other route than oral administration (see “Take special care with UZAPLEX”). UZAPLEX can be taken with or without meals.
Continue with treatment until symptoms have subsided, but not for longer than 7 days. DO NOT EXCEED 7 DAYS OF TREATMENT.

If you take more UZAPLEX than you should:
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.
If you take more UZAPLEX than you should, the various known side-effects associated with digitalis glycosides may occur and include cardiac (heart), gastrointestinal and central nervous system related side-effects. There is no typical sequence in which the symptoms may occur; cardiac (heart) and non-cardiac symptoms may occur together or consecutively, whereby cardiac (heart) signs of digitalis intoxication are much more serious.

If you forget to take UZAPLEX:
Always take UZAPLEX as prescribed (see “HOW TO TAKE UZAPLEX”). If you have missed a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose of UZAPLEX to make up for forgotten individual doses.

POSSIBLE SIDE-EFFECTS:
UZAPLEX may have side-effects.
Not all side-effects reported for UZAPLEX are included in this leaflet. Should your general health worsen while taking UZAPLEX, please consult your doctor, pharmacist or other healthcare professional for advice.
UZAPLEX may have the following side-effects:
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

STORAGE AND DISPOSING OF UZAPLEX:
Store at or below 25ºC in a dry place.
Protect from light.
Store in the original packaging.
Keep the bottle tightly closed.
Do not take the syrup after the expiry date stated on the package.
Return all unused syrup to your pharmacist.
Do not dispose of unused syrup in drains or sewerage systems (e.g. toilets).
KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.

PRESENTATION OF UZAPLEX:
A 100 mL amber glass bottle, with a white tamper evident screw cap and a vertical dropper, packed in an outer carton. A clear plastic measuring cup is included.

IDENTIFICATION OF UZAPLEX:
Sweet cola tasting golden yellow syrup with a bitter after taste.

REGISTRATION NUMBER:
To be allocated.

NAME AND BUSINESS ADDRESS OF THE REGISTRATION HOLDER:
LAMAR INTERNATIONAL (PTY) LTD
P.O. Box 4972
Tygervalley
7536
Email: info@lamar.co.za

DATE OF PUBLICATION OF THIS PATIENT INFORMATION LEAFLET:
October 2013.

New addition to this site: October 2016
Source: Pharmaceutical Industry website

http://www.lamar.co.za/sites/default/files/files/Uzaplex%20Syrup%20PIL.pdf

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