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Logo FLUFIX(Syrup)

PATIENT INFORMATION LEAFLET
Information for the Patient about FLUFIX

Read all of this leaflet carefully before you start using FLUFIX, because it contains important information for you.
This product is available without a doctor's prescription. Nevertheless you still need to use FLUFIX carefully to get the best results from it.
•        Keep this leaflet. You may need to read it again.
•        If you have further questions, please ask your doctor or pharmacist.
•        You must see a doctor if your symptoms worsen or do not improve.
•        Do not share FLUFIX with any other person
•        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):

FLUFIX(Syrup)

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

WHAT FLUFIX CONTAINS:
Each 10 mL of FLUFIX syrup contains:

Active Ingredient Quantity (mg per 10 mL)
Pelargonium sidoides dry extract (4 - 25:1, extracting agent 11% (m/m) ethanol) 20.0 mg
Preservatives:  
Potassium sorbate 0,035% (m/v)
Sodium benzoate 0,045% (m/v)
Other inactive ingredients include carboxymethyl cellulose, citric acid, maltodextrin, microcrystalline cellulose, sodium carboxymethyl cellulose, sorbitol and water.
Each 10 mL of FLUFIX contains 4,18 g sorbitol.
FLUFIX is free from alcohol, artificial colourants and flavourants,aspartame, caffeine, gluten, isomaltulose, lactose, tartrazine and yeast.

WHAT FLUFIX IS USED FOR:
FLUFIX
is a traditional herbal preparation to relieve the symptoms associated with the common cold in adults and children over the age of 6 years. Pelargonium sidoides is a medicinal plant native to South Africa and commonly known as South African Geranium and Umckaloabo. Pelargonium sidoides supports the immune system and aids in the dissolving of mucus, which helps to clear the airways.

BEFORE YOU TAKE FLUFIX:
Do NOT take FLUFIX:
If you are allergic (hypersensitive) to any of the active or inactive ingredients in the formulation.
If you are pregnant or breastfeeding your baby (see "Pregnancy and breastfeeding").
If you have an autoimmune disease such as multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, because FLUFIX may worsen these conditions.

TAKE SPECIAL CARE WITH FLUFIX:
If hepatotoxicity (liver disorder) occurs, the administration of FLUFIX should be discontinued.
Signs of hepatotoxicity include abdominal pain, jaundice (a condition characterised by yellow discolouration of the skin), loss of appetite, nausea and vomiting. Speak to your doctor if you suspect hepatotoxicity.
Consult your doctor prior to using FLUFIX if any of the above precautions are applicable to you.

FLUFIX
should not be used to replace any medicines prescribed by your doctor. Check with your doctor if you are taking prescription medicines (see "Taking FLUFIX with other medicines"). DO NOT TAKE any other nutritional or herbal supplements without first discussing their combined use with FLUFIX with your doctor or pharmacist (see "Taking FLUFIX with other medicines"). Ensure that you stay within the recommended dosage guidelines.

Use in children:
FLUFIX
should not be taken by or given to children under the age of 6 years old, as safety and efficacy have not been evaluated.

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

Pregnancy and breastfeeding:
Do NOT take FLUFIX while you are pregnant or breastfeeding your baby as safety has not been established (see " Do NOT take FLUFIX").
If you are pregnant or breastfeeding your baby while taking FLUFIX, please consult your doctor or pharmacist or other healthcare professional for advice. Avoid use of FLUFIX during pregnancy and breastfeeding.

Driving or using machinery:
It is unlikely that FLUFIX will affect your ability to drive or operate machines. However, if you develop side-effects such as dizziness, light-headedness or blurred vision, you should avoid driving a car or operating machinery.

Important information about some of the ingredients of FLUFIX:
Sorbitol, an inactive ingredient in FLUFIX, is a sugar alcohol and may have a laxative effect.

Taking FLUFIX with other medicines:
If you are taking other medicines on a regular basis, including complementary or traditional medicines the use of FLUFIX 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 medicines or substances in combination with FLUFIX with your doctor or pharmacist:
Immunosuppressant medication, because FLUFIX may have a stimulating effect. These medicines include azathioprine, basiliximab, cyclosporin, daclizumab, mycophenolate, tacrolimus, sirolimus, prednisone and other corticosteroids.

HOW TO TAKE FLUFIX:
AGE DOSAGE INSTRUCTIONS MAXIMUM DAILY DOSE QUANTITY SORBITOL / MAXIMUM DAILY DOSE
Children aged 6 to 12 years. Take 10 mL twice daily. Do not exceed 20 mL. 8,36g sorbitol/20 mL
Adults and children from the age of 12 years. Take 10 mL three times daily. Do not exceed 30 mL. 12,54g sorbitol/30 mL
If symptoms persist for longer than 7 days or return after the use of FLUFIX, you should consult your doctor.
DO NOT EXCEED THE RECOMMENDED DAILY DOSAGE. If you have the impression that the effect of FLUFIX is too strong or too weak, please speak to your doctor or pharmacist.

If you take more FLUFIX than you should:
If you take more FLUFIX than you should, you may experience an increase in the side-effects listed below (see “POSSIBLE SIDE-EFFECTS”).

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 forget to take FLUFIX:
Always take FLUFIX as directed. If you miss 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 to make up for forgotten individual doses.

POSSIBLE SIDE-EFFECTS:
FLUFIX
may have side-effects.
Not all side-effects reported for FLUFIX are included in this leaflet. Should your general health worsen while taking FLUFIX, please consult your doctor, pharmacist or other healthcare professional for advice.
Consult your doctor, pharmacist or healthcare professional if you experience any of the following signs and symptoms:
Mild gastrointestinal side-effects including:
  - Diarrhoea.
  - Dysphagia (difficulty in swallowing)
  - Epigastric discomfort (discomfort in the upper abdomen).
  - Nausea.
  - Vomiting.
Allergic reactions are rare.
Hepatotoxicity (liver damage).
Nasal and gingival bleeding are rare.
Small increase in body temperature and pulse.
Please report/inform your doctor or pharmacist if you notice any side-effects not mentioned in this leaflet.

STORAGE AND DISPOSING OF FLUFIX:
Store at or below 25ºC in a dry place. Keep the container closed. Protect from heat and light. 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 FLUFIX:
150 mL glass amber bottle, with a slow flow dropper bottle cap, packed in an outer carton. A clear plastic measuring cup is included.

IDENTIFICATION OF FLUFIX:
FLUFIX
syrup is a light peach to brown syrup with a sweet fruity flavour.

REGISTRATION NUMBER:
To be allocated.

NAME AND BUSINESS ADDRESS OF THE REGISTRATION HOLDER:
LAMAR INTERNATIONAL (PTY) LTD
P.O. Box 4972
Tygervalley
7530
Email: info@lamar.co.za

DATE OF PUBLICATION OF THIS PATIENT INFORMATION LEAFLET:
March 2015

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

http://www.lamar.co.za/sites/default/files/files/-Flufix%20Syrup%20PIL%20L10063%2013B.pdf

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