PROFESSIONAL INFORMATION

Scheduling status S0

​

1. Name of medicine: Tala Health & Wellness  
FLEME COUGH  Syrup

 

2. Qualitative and Quantitative Composition: 
Each 5 ml dose contains Ananas comosus bromelain [pineapple stem: standardized to 80 GDU/g* (Gelatin Digesting Units) equivalent to 360 000 FCC PU enzyme activity] 300 mg; Hedera Helix (Ivy leaf)[ [leaf, as 8.33 mg of a 6:1

ex-tract providing 50 mg of dried herb  equivalent] 50 mg; Ascorbic acid (Vitamin C) 100 mg.
See 6.1 for full list of ingredients.

 

3.    Pharmaceutical form:
Clear syrup. 
 
4.    Clinical Particulars:

4.1  Therapeutic Indications: 
The ingredients in FLEME COUGH syrup act as an expectorant in the case of productive cough, sooths minor inflam-mation and contains antioxidant for the maintenance of the immune system and relieve tiredness and fatigue.

4.2   Posology and method of administration: 
Take 5 ml three times per day as needed.

 

Elderly populations:
No studies have been performed in elderly populations, but no dose adjustment is expected to be required. 
    
Paediatric populations: 
Not suitable for children unless under the care of a relevant health care provider.

Babies and children 1 – 5 years old: Give 2.5 ml three times per day.
Children over 6 years old: Give 5 ml three times per day.

4.3     Contraindications: 
Do not take FLEME COUGH Syrup if you are allergic to any of the ingredients. 
Persistent or recurrent cough in children between 2- 4 years of age requires medical diagnosis before treatment.

Special warnings and precautions for use
If symptoms persist longer than one week during the use of FLEME COUGH Syrup, a doctor or pharmacist should be consulted. 
o    Hypersensitivity (e.g. allergy) has been known to occur. In such cases,                   discontinue use and consult a relevant health care provider.
o    Caution is recommended in patients with gastritis or gastric ulcer
o    Consult a relevant health care provider before use if you:
   Have malabsorption or other GIT ailments or are having surgery or
   Are taking blood thinners, antibiotics, or anti-inflammatory medication 
 

Interactions with other medicines and other forms of interaction:
   None known

 

Fertility, pregnancy, and lactation: 
   Safety of FLEME COUGH Syrup in pregnancy and lactation has not been             established. 
   Consult a physician prior to use if you are pregnant or breastfeeding.

 

Undesirable effects: 
   Gastrointestinal reactions (nausea, vomiting, diarrhoea) and allergic                    reactions (urticaria, skin rash, dyspnoea, ana-phylactic reaction) can occur.

 

Overdose:
   Overdose can provoke nausea, vomiting, diarrhoea, and agitation.

 

5.    Pharmacological properties: 
Ivy leaf extract has a well-established use as an expectorant in case of productive cough. Bromelain is a digestive enzyme which assists in the relief of minor inflammation. Vitamin C is an antioxidant for the maintenance of the mucus membranes, assisting in the normal function of the immune system and relieving tiredness and fatigue. 

    

Pharmaceutical properties: 
List of excipients:
Other ingredients: Purified Water, Colour, Flavour, Xanthum Gum, Sodium Metabisulphite.
Preservative: [Methyl Paraben (0,1% m/v) and Propyl Paraben (0,01% m/v)].
Contains alcohol sugar: (Glycerine) 0,2 ml/5 ml.
Contains non-nutritive sweetener: (Sucralose) 0.5 mg/5 ml.

Incompatibilities
In the absence of studies FLEME COUGH Syrup should not be given with other medicines. 

 

Shelf Life:
24 months

 

Special precautions for storage:
Keep out of reach of children. 
Store at or below 25 ˚C

 

Presentation:
200 ml amber glass bottle 

 

6.    Applicant:
   Johannes J Snyman CC 
   454 Koedoesnek Street, 
   Waterkloof Ridge
   Pretoria

 

7.    Date of revision of the text:
   March 2024 

    

 

References:
1.     EMA/HMPC/325716/2017 n Herbal Medicinal Products (HMPC) European Union herbal monograph on Hedera helix L., folium 21         November 2017
2.    SAHPRA guideline 7.04_CM_SE_Health_Supplements_Mar22_v4_3