FLORA FORCE® BILBERRY capsules

R199,55

FLORA FORCE® BILBERRY capsules support vision and eye health, and help to relieve symptoms related to non-complicated venous insufficiency. Free from additives, sugar and lactose.

The capsules are from additives, sugar and lactose.

(Pregnant or breastfeeding women should consult their healthcare practitioners before taking bilberry.)

PATIENT INFORMATION LEAFLET

Information for the Patient about FLORA FORCE® BILBERRY 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® BILBERRY Capsules

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

  • Keep this leaflet. You may need to read it again.
  • Do not share FLORA FORCE® BILBERRY 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® BILBERRY CAPSULES CONTAIN:
Each FLORA FORCE® BILBERRY capsule contains:

ACTIVE INGREDIENT QUANTITY
Vaccinium myrtillus berry powder 500 mg

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

WHAT FLORA FORCE® BILBERRY CAPSULES ARE USED FOR:
FLORA FORCE® BILBERRY capsules supports vision and eye health, and helps to relieve symptoms related to non-complicated venous insufficiency.

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

  • If you have are allergic to any of the ingredients in FLORA FORCE® BILBERRY
  • If you have a bleeding disorder (see “Take special care with FLORA FORCE® BILBERRY capsules”).
  • If you have diabetes (see “Take special care with FLORA FORCE® BILBERRY capsules”).
  • Surgery (see “Take special care with FLORA FORCE® BILBERRYcapsules”).
  • Pregnancy and lactation (see “Pregnancy and breastfeeding”).

Take special care with FLORA FORCE® BILBERRY capsules:
Please discuss the use of FLORA FORCE® BILBERRY 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® BILBERRY capsules (see “Do NOT take FLORA FORCE® BILBERRY capsules”).
  • Suffer from diabetes. You may have to arrange increased monitoring of your blood sugar levels (see “Do NOT take FLORA FORCE® BILBERRY capsules”).
  • Are undergoing surgery, discontinue use at least 2 weeks prior to the procedure (see “Do NOT take FLORA FORCE® BILBERRY 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® BILBERRY capsules (see “Taking other medicines with FLORA FORCE® BILBERRY capsules”).

The use of FLORA FORCE® BILBERRY 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® BILBERRY CAPSULES”).

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

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

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

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

Taking other medicines with FLORA FORCE® BILBERRY capsules:

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

Discuss the use of the following medicines in combination with FLORA FORCE® BILBERRY capsules with your pharmacist or registered healthcare practitioner:

  • Warfarin, other blood thinning or anti-platelet medicines. FLORA FORCE® BILBERRY capsules may potentially increase the effect of blood thinning medicines (see “Take special care with FLORA FORCE® BILBERRY capsules”).
  • Anti-diabetic medicines as FLORA FORCE® BILBERRY capsules may further lower blood sugar levels. Monitor you blood sugar levels regularly if you are using FLORA FORCE® BILBERRY capsules and anti-diabetic medicines in combination.

HOW TO TAKE FLORA FORCE® BILBERRY CAPSULES:

Do not share medicines prescribed to you with any other person.
Always take FLORA FORCE® BILBERRY 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 twice daily with meals or as directed by your pharmacist or registered healthcare practitioner.

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

FLORA FORCE® BILBERRY 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 healthcare practitioner.

If you take more FLORA FORCE® BILBERRY 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® BILBERRY capsules:
Always take FLORA FORCE® BILBERRY 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 1-2 capsules twice daily.  Do not take a double dose to make up for forgotten individual doses.

POSSIBLE SIDE-EFFECTS:
FLORA FORCE® BILBERRY capsules can have side-effects.
Not all side-effects reported for FLORA FORCE® BILBERRY capsules are included in this leaflet.  Should your general health worsen or if you experience any untoward effects while taking FLORA FORCE® BILBERRY 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:

  • An allergic reaction which may present with shortness of breath, difficulty breathing, wheezing, hives, or itching, swelling of the face, tongue or whole body.
  • Signs of decreased blood sugar or blood pressure such as light headedness, blurred vision and confusion.

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

  • Gastrointestinal disturbances, such as:
    • Increased frequency of bowel movements, constipation, stomach discomfort, nausea and heartburn.

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® BILBERRY 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 REACH OF CHILDREN.

PRESENTATION OF FLORA FORCE® BILBERRY capsules:
90 Capsules packed into 125ml amber glass bottle with light green screw cap and safety seal insert, packed in box.

IDENTIFICATION:
Clear size 0 all vegetable capsule containing a dark red-brown 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:
23/02/2018

FLORA FORCE® BILBERRY Capsules

Western herbal medicine
FLORA FORCE® BILBERRY capsules 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® BILBERRY Capsules

COMPOSITION:
Each FLORA FORCE® BILBERRY capsule contains:

ACTIVE INGREDIENT QUANTITY
Vaccinium myrtillus berry powder 500 mg

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

PHARMACOLOGICAL CLASSIFICATION:
D 40.1 Complementary medicine not otherwise specified – Discipline specific traditional claim

PHARMACOLOGICAL ACTION:

Pharmacodynamic properties:

Vaccinium myrtillus contains several compounds that have demonstrated biological activity.  The main chemicals have been shown to be anthocyans, anthocyanidins, anthocyanins and anthocyanosides; as well as flavonoids, tannins, quercetin, epicatechin, hydroquinone and many more.  Flavonoids possess a number of biological properties, including reduction of capillary permeability and fragility.  Anthocyanosides have been shown to exert a direct effect on the retina.  Vaccinium myrtillus improves microcirculation which may also play a role in improvement of visual function.

INDICATIONS:

FLORA FORCE® BILBERRY capsules supports vision and eye health, and helps to relieve symptoms related to non-complicated chronic venous insufficiency.

CONTRA-INDICATIONS:

FLORA FORCE® BILBERRY capsules are contra-indicated in patients with:

  • A hypersensitivity to any of the ingredients in FLORA FORCE® BILBERRY
  • Bleeding disorder (see “WARNING AND SPECIAL PRECAUTIONS”).
  • Diabetes (see “WARNING AND SPECIAL PRECAUTIONS”).
  • Surgery (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Pregnancy and lactation (see “PREGNACY AND LACTATION”).

WARNINGS AND SPECIAL PRECAUTIONS:

When starting, or stopping treatment with Vaccinium myrtillus containing products, including FLORA FORCE® BILBERRY capsules, patients with bleeding disorders should have increased monitoring of their INR (International Normalised Ratio) levels (see “CONTRA-INDICATIONS”).

FLORA FORCE® BILBERRY 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”).

FLORA FORCE® BILBERRY 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”).

The use of FLORA FORCE® BILBERRY 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”).

FLORA FORCE® BILBERRY capsules should be used with care in patients taking sedative medications, including Midazolam, as it may increase its sedative effects (see “INTERACTIONS”).

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

INTERACTIONS:

Vaccinium myrtillus, as in FLORA FORCE® BILBERRY capsules, may potentially increase the effect of oral anti-coagulants and anti-platelet drugs (e.g. warfarin, aspirin, clopidogrel, NSAIDs, ibuprofen, dalteparin, 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® BILBERRY capsules (see “WARNINGS AND SPECIAL PRECAUTIONS”)

Theoretically, Vaccinium myrtillus, as in FLORA FORCE® BILBERRY 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® BILBERRY capsules.

 

PREGNANCY AND LACTATION:

The safety and efficacy of FLORA FORCE® BILBERRY capsules during pregnancy and lactation have not been established.  Capsules should therefore not be taken during pregnancy and lactation (see “WARNINGS AND SPECIAL PRECAUTIONS”).

DOSAGE AND DIRECTIONS FOR USE:

The recommended daily dose should not be exceeded.

Do not tamper with capsule.

Adults (18 years and older):
Take 1-2 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® BILBERRY capsules.

Endocrine disorders:
Frequency unknown: Hypoglycaemia

Vascular disorders:
Frequency unknown: Hypotension

Gastrointestinal disorders:
Frequency unknown: Increased frequency of bowel movements, constipation, gastro-intestinal discomfort, nausea and heartburn

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS:

The following symptoms may be experienced in the event of an overdose:
Hydroquinone poisoning, anti-coagulation or gastro-intestinal distress. Contact a poison control centre in area.

IDENTIFICATION:

Clear size 0 all vegetable capsule containing red-brown herbal powder.

PRESENTATION:

90 Capsules packed in a 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

DATE OF PUBLICATION:

21/11/2016

 

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Description

FLORA FORCE® BILBERRY capsules contain Vaccinium myrtillus berry powder. Bilberry support vision and eye health, and help to relieve symptoms related to non-complicated venous insufficiency.

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® BILBERRY capsules are 100% free from:

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