FLORA FORCE® GINGER capsules

R87,35

FLORA FORCE® GINGER capsules are traditionally used to relieve digestive disturbances and nausea.

Vege caps. Free from additives, sugar and lactose.

PATIENT INFORMATION LEAFLET

Information for the Patient about FLORA FORCE® GINGER Capsules

Western herbal medicine
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, STRENGTH AND PHARMACEUTICAL FORM:
FLORA FORCE® GINGER Capsules

Read all of this leaflet carefully because it contains important information for you. FLORA FORCE® GINGER capsules are available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use FLORA FORCE® GINGER capsules carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Do not share FLORA FORCE® GINGER capsules with any other person.
  • Ask your pharmacist if you need more information or advice.
  • You must see a registered healthcare practitioner if your symptoms worsen or do not improve.

WHAT FLORA FORCE® GINGER CAPSULES CONTAIN:
Each FLORA FORCE® GINGER capsule contains:

ACTIVE INGREDIENT QUANTITY
Zingiber officinale rhizome powder 500 mg

Inactive ingredients are vegetable capsules.
FLORA FORCE® GINGER capsules are free from sugar and lactose.

WHAT FLORA FORCE® GINGER CAPSULES ARE USED FOR:
FLORA FORCE® GINGER capsules are traditionally used to relieve digestive disturbances and nausea.

BEFORE YOU TAKE FLORA FORCE® GINGER CAPSULES:
Do NOT take FLORA FORCE® GINGER capsules:

  • If you have a bleeding disorder (see “Take special care with FLORA FORCE® GINGER capsules”).
  • If you have diabetes (see “Take special care with FLORA FORCE® GINGER capsules”)
  • If you have a heart condition (see “Take special care with FLORA FORCE® GINGER capsules”).
  • Surgery (see “Take special care with FLORA FORCE® GINGER capsules”).
  • Pregnancy and lactation (see “Pregnancy and breastfeeding”)

Take special care with FLORA FORCE® GINGER capsules:

Please discuss the use of FLORA FORCE® GINGER capsules with your pharmacist or registered healthcare practitioner if you:

  • Suffer from a bleeding disorder. You may have to arrange increased monitoring of your blood levels when starting or stopping treatment with FLORA FORCE® GINGER capsules (see “Do NOT take FLORA FORCE® GINGER capsules”).
  • Suffer from diabetes. You may have to arrange increased monitoring of your blood sugar levels (see “Do NOT take FLORA FORCE® GINGER capsules”).
  • Suffer from a heart condition. (see “Do NOT take FLORA FORCE® GINGER capsules”).
  • Are undergoing surgery, discontinue use at least 2 weeks prior to the procedure (see “Do NOT take FLORA FORCE® GINGER capsules”).
  • Take warfarin, other blood thinning or anti-platelet medicines.  You may have to arrange increased monitoring or your INR (International Normalised Ratio) levels when starting or stopping treatment with FLORA FORCE® GINGER capsules (see “Taking other medicines with FLORA FORCE® GINGER capsules”).

The use of FLORA FORCE® GINGER capsules in children and adolescents under 18 years of age is not recommended due to lack of adequate data (see “HOW TO TAKE FLORA FORCE® GINGER capsules”).

Taking FLORA FORCE® GINGER capsules with food and drink:
FLORA FORCE® GINGER capsules should be taken after meals with water.

Pregnancy and breastfeeding:
Safety of FLORA FORCE® GINGER capsules during pregnancy and breastfeeding has not been established.  Avoid taking FLORA FORCE® GINGER capsules if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or registered healthcare practitioner for advice before taking FLORA FORCE® GINGER capsules.

Driving and using machinery:
No studies on the effect on the ability to drive and use machinery have been performed. It is unlikely that FLORA FORCE® GINGER capsules will impair your ability to drive or use machines. However, please exercise care when driving or operating machinery until you know how FLORA FORCE® GINGER capsules affects you.

Important information about some of the ingredients of FLORA FORCE® GINGER capsules:
FLORA FORCE® GINGER capsules are sugar free.

Taking other medicines with FLORA FORCE® GINGER capsules:

Always tell your pharmacist or registered healthcare practitioner if you are taking any other medicine (this includes complementary or traditional medicines).

Please discuss the use of the following medicines in combination with FLORA FORCE® GINGER capsules with your pharmacist or registered healthcare practitioner.

  • Metronidazole for the treatment of bipolar disorder.

The dose of the above medications may need to be adjusted when taken in conjunction with FLORA FORCE® GINGER capsules.

Also, discuss the use of the following medicines in combination with FLORA FORCE® GINGER capsules with your pharmacist or registered healthcare practitioner:

  • Warfarin, other blood thinning or anti-platelet medicines. FLORA FORCE® GINGER capsules may potentially increase the effect of blood thinning medicines.  You may have to arrange increased monitoring of your INR levels when taking FLORA FORCE® GINGER capsules (see “Take special care with FLORA FORCE® GINGER capsules”).
  • Anti-diabetic medicines as FLORA FORCE® GINGER may further lower blood sugar levels. Monitor your blood glucose / sugar levels regularly if you are using FLORA FORCE® GINGER capsules and anti-diabetic medicines in combination.
  • Cyclosporine as FLORA FORCE® GINGER may decrease the absorption of these medicines. Please discuss the use of FLORA FORCE® GINGER capsules in combination with any other medicines with your doctor or pharmacist.
  • Calcium channel blockers as FLORA FORCE® GINGER may have hypotensive and calcium channel-blocking effectsThis might cause an additive effect with calcium channel blockers.  Please discuss the use of FLORA FORCE® GINGER capsules in combination with any other medicines with your pharmacist or registered healthcare practitioner.

HOW TO TAKE FLORA FORCE® GINGER CAPSULES:
Do not share medicines prescribed to you with any other person.
Always take FLORA FORCE® GINGER capsules exactly as directed. You should check with your pharmacist or registered healthcare practitioner if you are unsure.
DO NOT EXCEED THE RECOMMENDED DAILY DOSAGE.

Adults (18 years and older):
Take 1 – 2 capsules daily with meals or as directed by your pharmacist or registered healthcare professional.

Children (under 18 years of age):
Not recommended for use (see “Take special care with FLORA FORCE® GINGER capsules”).

FLORA FORCE® GINGER capsules may be taken for a period of up to 12 weeks followed by an interval of 1 week after which the next 12-week cycle can commence.  However, should you experience any adverse effects or any of the side effects indicated below please consult your pharmacist or registered healthcare practitioner.

If you take more FLORA FORCE® GINGER capsules than you should:
In the event of over dosage, consult your pharmacist or registered healthcare practitioner.  If neither is available, contact the nearest hospital or poison control centre.

 If you forget to take FLORA FORCE® GINGER capsules:
Always take FLORA FORCE® GINGER capsules as directed.  If you miss a dose, take it as soon as you remember.  If you do not remember the missed dose till the next dose is due, skip the missed dose and go back to your regular dosing schedule of 2 capsules twice daily.  Do not take a double dose to make up for forgotten individual doses.

POSSIBLE SIDE-EFFECTS:
FLORA FORCE® GINGER capsules may have side-effects.
Not all side-effects reported for FLORA FORCE® GINGER capsules are included in this leaflet.  Should your general health worsen or if you experience any untoward effects while taking FLORA FORCE® GINGER capsules, please consult your pharmacist or registered healthcare practitioner for advice.

Serious side-effects that you (or a family member if you are unable to) should report to your pharmacist or registered healthcare practitioner immediately include:

  • Irregular heartbeat.
  • Increased urge to urinate.
  • State of sleep or calm, sleepy, lethargic and dizziness.

Side-effects that you should report to your pharmacist or registered healthcare practitioner as soon as possible:

  • Skin rash, bruising and skin redness.
  • Increased menstrual bleeding.

Side-effects that you should report to your pharmacist or registered healthcare practitioner if they continue or become bothersome include:

  • Gastrointestinal disturbances, such as:
    • Stomach discomfort, diarrhoea, constipation, nausea, vomiting and heartburn.
    • Burning, irritation and numbness in mouth, tongue and throat.

If you notice any side-effects not mentioned in this leaflet, please inform your pharmacist or registered healthcare practitioner.

STORING AND DISPOSING OF FLORA FORCE® GINGER capsules:
Store at or below 25ºC in a dry place.
Protect from light / moisture.
Do not take the capsules after the expiry date stated on the packaging material.
Return all unused capsules to your pharmacist.
Do not dispose of unused capsules in drains or sewerage systems (e.g. toilets).
STORE ALL MEDICINE OUT OF THE REACH OF CHILDREN.

PRESENTATION OF FLORA FORCE® GINGER capsules:
60 Capsules in 125ml amber glass bottle with light green screw cap and safety seal insert.

IDENTIFICATION:
Clear size 0 all vegetable capsule containing a cream coloured herbal powder.

REGISTRATION NUMBER/REFERENCE NUMBER:
To be allocated.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Flora Force Heath Products (Pty) Ltd.
Unit 3 Regent Park
Bell Crescent
Westlake
Cape Town
South Africa

DATE OF PUBLICATION:
13/02/2018

FLORA FORCE® GINGER Capsules

Western herbal medicine
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):
FLORA FORCE® GINGER Capsules

COMPOSITION:
Each FLORA FORCE® GINGER capsule contains:

ACTIVE INGREDIENT QUANTITY
Zingiber officinale rhizome powder 500 mg

Inactive ingredients: vegetable capsules
FLORA FORCE® GINGER capsules are free from sugar and lactose.

PHARMACOLOGICAL CLASSIFICATION:
D 11.10, Gastro-intestinal tract, Other.

PHARMACOLOGICAL ACTION:

Pharmacodynamic properties:
Preliminary research suggests the gastro-intestinal effects of ginger might be due to increases in levels of protective prostaglandins in the gut wall. Gastro-intestinal motility is enhanced by 6-shoagaol.
The anti-nausea activity of Zingiber officinale may be due to the active constituents such as gingerols, shogaols and galano-lactone.  These seem to act primarily on the 5-HT3 receptors of the ileum.  The predominant anti-emetic action of ginger is localized in the GI tract, but there is some evidence that ginger constituents may also have central nervous system (CNS)activity.

INDICATIONS:
FLORA FORCE® GINGER capsules are traditionally used to relieve digestive disturbances and nausea.

CONTRA-INDICATIONS:
FLORA FORCE® GINGER capsules are contra-indicated in patients with:

  • Bleeding disorders (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Diabetes (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Heart conditions (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Surgery (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Pregnancy and lactation (see “PREGNANCY AND LACTATION”).

WARNINGS AND SPECIAL PRECAUTIONS:
When starting, or stopping treatment with Zingiber officinale containing products, including FLORA FORCE® GINGER capsules, patients with bleeding disorders should have increased monitoring of their INR (International Normalised Ratio) levels (see “CONTRA-INDICATIONS”).

FLORA FORCE® GINGER capsules should be used with care in patients with diabetes.  Theoretically, Zingiber officinale may decrease blood sugar levels.  Diabetic patients should monitor their blood sugar levels when taking FLORA FORCE® GINGER capsules (see “CONTRA-INDICATIONS”).

FLORA FORCE® GINGER capsules should be used with care in patients with heart conditions.  Theoretically, excessive doses of ginger might worsen some heart conditions (see “CONTRA-INDICATIONS”).

FLORA FORCE® GINGER capsules should be used with care in patients undergoing surgery.  Patients should discontinue use at least 2 weeks before elective surgical procedures (see “CONTRA-INDICATIONS”).

When starting, or stopping treatment with Zingiber officinale containing products, including FLORA FORCE® GINGER capsules, patients taking oral anti-coagulants or anti-platelet drugs) should have increased monitoring of their INR (International Normalised Ratio) levels (see “INTERACTIONS”).

The use of FLORA FORCE® GINGER capsules in children and adolescents under 18 years of age is not recommended due to lack of adequate data (see “DOSAGE AND DIRECTIONS FOR USE”).

Effects on the ability to drive or use machinery:
No studies on the effect of FLORA FORCE® GINGER capsules on the ability to drive or operate machines have been performed.  It is unlikely that FLORA FORCE® GINGER capsules will affect the ability to drive or operate machines.

INTERACTIONS:
The herbs in FLORA FORCE® GINGER capsules may interact with the following medicines:

  • Metronidazole: Zingiber officinale may increase levels of metronidazole.

The dose of the above medications may need to be adjusted when taken in conjunction with FLORA FORCE® GINGER capsules.

Zingiber officinale, as in FLORA FORCE® GINGER capsules, may potentially increase the effect of oral anti-coagulants and anti-platelet drugs (e.g. warfarin, phenprocoumon, heparin, aspirin, clopidogrel, enoxaparin, dalteparin, ticlopidine, enoxaparin, heparin) when taken concomitantly.  Patients taking anti-coagulants or anti-platelet medicines should have their INR levels monitored more frequently when taking FLORA FORCE® GINGER capsules (see “WARNINGS AND SPECIAL PRECAUTIONS”).

Theoretically, Zingiber officinale as in FLORA FORCE® GINGER capsules, may enhance the blood glucose lowering effects of anti-diabetic medicines.  Patients on anti-diabetic medicines should monitor their glucose levels closely when taking FLORA FORCE® GINGER capsules.

In an animal model, Zingiber officinale taken 2 hours prior to cyclosporine administration reduced the maximum concentration.  This effect was not observed when Zingiber officinale and cyclosporine were administered at the same time.  Patients taking cyclosporine should use FLORA FORCE® GINGER capsules with care.

Preliminary research suggests Zinger officinale might have hypotensive and calcium channel-blocking effects.  Theoretically Zingiber officinale might have an additive effect with calcium channel blockers.  These include nifedipine, verapamil, diltiazem, isradipine, felodipine and amlodipine.  Patients taking calcium channel-blockers should use FLORA FORCE® GINGER capsules with care

PREGNANCY AND LACTATION:
The safety and efficacy of FLORA FORCE® GINGER capsules during pregnancy and lactation have not been established.  Capsules should therefore not be taken during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE:
The recommended daily dose should not be exceeded.
Do not tamper with capsule.

Adults (18 years and older):
Take 2 capsules twice daily with meals or as prescribed.

Children (under 18 years of age):
Not recommended for use (see “WARNINGS AND SPECIAL PRECAUTIONS”).

SIDE-EFFECS:
The following side-effects may occur with the use of FLORA FORCE® GINGER capsules.

Nervous system disorders:
Frequency unknown:         Sedation, drowsiness and dizziness.

Vascular disorders:
Frequency unknown:         Mild arrhythmia.

Gastrointestinal disorders:
Frequency unknown:         Abdominal discomfort, heartburn, burning pepper-like irritation in mouth, nausea, belching, dry retching, vomiting, burning sensation in tongue and throat and oral numbness.

Skin and subcutaneous disorders:
Frequency unknown:         Hives, bruising and flushing.

Renal and urinary disorders:
Frequency unknown:         Urinary urgency.

Reproductive system and breast disorders:
Frequency unknown:         Increased menstrual bleeding.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS:
None known. Contact a poison control centre in area.

IDENTIFICATION:
Clear size 0 all vegetable capsule containing cream coloured herbal powder.

PRESENTATION:
60 Capsules packed into 125ml amber glass bottle with light green screw cap and safety seal insert.

STORAGE INSTRUCTIONS:
Store at or below 25 ºC in a dry place.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
To be allocated.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Flora Force Heath Products (Pty) Ltd.
Unit 3 Regent Park
Bell Crescent
Westlake
Cape Town
South Africa

DATE OF PUBLICATION:
13/02/2018

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Description

FLORA FORCE® GINGER capsules contain ginger (Zingiber officinale) rhizome powder. Ginger has been traditionally used to help ease symptoms related to digestive disturbances and nausea.

Our herbal capsules provide the true herb, dried and powdered, not standardised extracts or concentrations of single biochemicals extracted from the herbs.

We use only Vege caps because we believe everyone should have access to true natural products, regardless of their religious requirements or nutritional preferences.

FLORA FORCE® GINGER capsules are 100% free from:

  • Added sugar or lactose
  • Colourants or flavourants
  • Chemical inactives / additives (e.g. flow agents, excipients, fillers, etc.)