FLORA FORCE® CAYENNE capsules

R99,02

FLORA FORCE® CAYENNE capsules contain Capsicum minimum fruit powder. Cayenne has been used in traditional Western herbal medicine to support the circulatory system. Vege caps. Free from sugar and lactose. No additives or extracts.


PATIENT INFORMATION LEAFLET

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

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

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

ACTIVE INGREDIENT QUANTITY
Capsicum minimum fruit powder 500 mg

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

WHAT FLORA FORCE® CAYENNE CAPSULES ARE USED FOR:
FLORA FORCE® CAYENNE capsules capsules are indicated to support circulatory health.  Capsicum spp. has been used traditionally to improve peripheral circulation.

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

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

Take special care with FLORA FORCE® CAYENNE capsules:
Please discuss the use of FLORA FORCE® CAYENNE capsules with your your doctor 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® CAYENNE capsules (see “Do NOT take FLORA FORCE® CAYENNE capsules”).
  • Suffer from Diabetes. You may have to arrange increased monitoring of your blood sugar levels (see “Do NOT take FLORA FORCE® CAYENNE capsules”).
  • Suffer from Hypertension. You may have to arrange increased monitoring of your blood pressure (see “Do NOT take FLORA FORCE® CAYENNE capsules”).
  • If you are undergoing surgery discontinue use at least 2 weeks prior to the procedure (see “Do NOT take FLORA FORCE® CAYENNE capsules”).
  • Take iron, as it may decrease the bio-availability of iron. You may have to arrange increased monitoring of your iron levels when starting or stopping treatment with FLORA FORCE® CAYENNE capsules” (see “Taking other medicines with FLORA FORCE® CAYENNE capsules”).
  • Take warfarin or other blood thinning medicines.  You may have to arrange increased monitoring of your INR (International Normalised Ratio) levels when starting or stopping treatment with FLORA FORCE® CAYENNE capsules” (see “Taking other medicines with FLORA FORCE® CAYENNE capsules”).

The use of FLORA FORCE® CAYENNE 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® CAYENNE capsules”).

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

Pregnancy and breastfeeding:
Safety of FLORA FORCE® CAYENNE capsules during pregnancy and breastfeeding has not been established.  Avoid taking FLORA FORCE® CAYENNE 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® CAYENNE 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® CAYENNE 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® CAYENNE capsules affects you.

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

Taking other medicines with FLORA FORCE® CAYENNE 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® CAYENNE capsules with your doctor or pharmacist.

  • Theophylline for the treatment of respiratory diseases such as COPD (chronic obstructive pulmonary disease) and asthma.
  • Cefazolin for the treatment of bacterial infections.
  • Ciprofloxacin for the treatment of bacterial infections.

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

Also, discuss the use of the following medicines in combination with FLORA FORCE® CAYENNE capsules with your doctor or pharmacist:

  • Warfarin or other blood thinning medicines. FLORA FORCE® CAYENNE capsules may potentially increase the effect of blood thinning medicines (see “Take special care with FLORA FORCE® CAYENNE capsules”).
  • Antidiabetic medicines as FLORA FORCE® CAYENNE capsules may further lower blood sugar levels. Monitor your blood sugar levels regularly if you are using FLORA FORCE® CAYENNE capsules and antidiabetic medicines in combination.
  • Cytochrome P450 substrates (CYP2C9, CYP2E1 and CYP3A4) which inhibit certain liver enzymes as these can increase capsaicinoid levels and increase the risk of adverse effects.
  • Iron as FLORA FORCE® CAYENNE capsules may decrease the absorption of iron (see “Take special care with FLORA FORCE® CAYENNE capsules”).

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

Adults (18 years and older):
Take 2 capsules twice daily with meals or as directed by your doctor, pharmacist or healthcare professional.

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

FLORA FORCE® CAYENNE 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 period 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® CAYENNE capsules than you should:
If you take more FLORA FORCE® CAYENNE capsules than you should, you may experience increased heart rate, high blood pressure and chest pain.
In the event of over dosage, consult your doctor or pharmacist.  If neither is available, contact the nearest hospital or poison control centre.

If you forget to take FLORA FORCE® CAYENNE capsules:
Always take FLORA FORCE® CAYENNE 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 two capsule twice daily.  Do not take a double dose to make up for forgotten individual doses.

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

Serious side-effects that you (or a family member if you are unable to) should report to your doctor 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.
  • Increased bleeding, heart attack and increased heart rate.
  • Signs of decreased blood sugar such as light headedness, blurred vision and confusion.

Side-effects that you should report to your doctor as soon as possible:

  • Less urine than is normal for you.
  • Swollen feet and ankles.

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

  • Gastrointestinal disturbances, such as:
    • Stomach discomfort, stomach pain, indigestion, diarrhoea, bloated stomach, heartburn, flatulence, ulcer aggravation, nausea and vomiting.
  • An intense feeling of well-being.
  • Sensitivity to light and itching.
  • Dizziness, light-headedness or increased sensitivity to pain.
  • Increased menstrual bleeding.

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

STORING AND DISPOSING OF FLORA FORCE® CAYENNE 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® CAYENNE capsules:
90 Capsules in 125ml amber glass bottle with light green screw cap and safety seal insert, packed in a box.

IDENTIFICATION:
Clear size 0 all vegetable capsule containing dark red 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:
To be allocated

FLORA FORCE® CAYENNE 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® CAYENNE Capsules

COMPOSITION:
Each FLORA FORCE® CAYENNE capsule contains:

ACTIVE INGREDIENT QUANTITY
Capsicum minimum fruit powder 500 mg

Inactive ingredients: vegetable capsules
FLORA FORCE® CAYENNE 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:
The major active constituent in Capsicum minimum are capsaicinoids including capsaicin.
In human, animal and in vitro studies, consumption of Capsicum minimum and capsaicin decreased the rate of oxidation, increased lag time to lipoprotein oxidation and enhanced blood flow. Capsaicin is also thought to reduce platelet aggregation and related to increased fibrinolytic activity.

INDICATIONS:
FLORA FORCE® CAYENNE capsules are indicated to support circulatory health.  Capsicum minimum has been used traditionally to improve peripheral circulation.

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

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

WARNINGS AND SPECIAL PRECAUTIONS:

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

FLORA FORCE® CAYENNE capsules should be used with care in patients with diabetes as Capsicum spp. may decrease blood sugar levels.  Diabetic patients should monitor their blood sugar levels when taking FLORA FORCE® CAYENNE capsules (see “CONTRA-INDICATIONS”).

 FLORA FORCE® CAYENNE capsules should be used with care in patients with hypertension.  Theoretically Capsicum spp. may increase blood pressure.

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

When starting, or stopping treatment with Capsicum spp. containing products, including FLORA FORCE® CAYENNE, patients taking warfarin (or other coumarin anticoagulants) should have increased monitoring of their INR (International Normalised Ratio) levels (see “INTERACTIONS”).

The use of FLORA FORCE® CAYENNE 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® CAYENNE capsules on the ability to drive or operate machines have been performed. It is unlikely that FLORA FORCE® CAYENNE capsules will affect the ability to drive or operate machines.

Take care when handling capsules.  Exposure to the contents can cause unpleasant symptoms.  It can also cause an allergic reaction characterised by shortness of breath, rash, itching and swelling.

INTERACTIONS:

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

  • Theophylline: Capsicum spp. may enhance theophylline absorption.
  • Cefazolin: Theoretically capsaicin. may enhance absorption.
  • Ciprofloxacin: Theoretically capsaicin may increase bioavailability

Advise patients to take any of the above-mentioned medicines at least 2 hours before or after FLORA FORCE CAYENNE® capsules

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

Theoretically, Capsicum spp., as in FLORA FORCE® CAYENNE capsules, may enhance the blood glucose lowering effects of antidiabetic medicines.  Patients on antidiabetic medicines should monitor their glucose levels closely when taking FLORA FORCE® CAYENNE capsules.

There is some evidence that capsaicinoids, which are components of Capsicum spp., are metabolised by CYP2C9 enzymes.  Theoretically CYP2C9 inhibitors might increase capsaicinoid levels and increase the risk of adverse effects. Patients taking these medicines should use FLORA FORCE® CAYENNE capsules cautiously.  Some CYP2C9 inhibitors include Cordarone, fluconazole, lovastatin, Paxil, Accolate, and many others.

There is some evidence that capsaicinoids, which are components of Capsicum spp., are metabolised by CYP2E1 enzymes.  Theoretically CYP2E1 inhibitors might increase capsaicinoid levels and increase the risk of adverse effects. Patients taking these medicines should use FLORA FORCE® CAYENNE capsules cautiously.  Some of these drugs include diethyldithiocarbamate and disulfiram.

There is some evidence that capsaicinoids, which are components of Capsicum spp., are metabolised by CYP3A4 enzymes.  Theoretically CYP3A4 inhibitors might increase capsaicinoid levels and increase the risk of adverse effects. Patients taking these medicines should use FLORA FORCE® CAYENNE capsules cautiously.  Some of these drugs include amiodarone, clarithromycin, diltiazem, erythromycin, indinavir, ritonavir, saquinavir, and many others.

Theoretically, Capsicum spp may decrease the bioavailability of iron.  Patients taking iron should monitor their iron levels when taking FLORA FORCE® CAYENNE capsules.

PREGNANCY AND LACTATION:
The safety and efficacy of FLORA FORCE® CAYENNE 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 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® CAYENNE capsules.

Endocrine disorders:
Frequency unknown:         Reduced blood glucose, increase plasma insulin

Psychiatric disorders:
Frequency unknown:         Addiction

Nervous system disorders:
Frequency unknown:                           Dizziness, hyperalgesia,

Vascular disorders:
Frequency unknown:                           Increased bleeding, myocardial infarct, hypertension and tachycardia

Gastrointestinal disorders:
Frequency unknown:                           Gastro-intestinal irritation, mouth, throat and oesophageal irritation and pain, stomach discomfort and pain, dyspepsia, diarrhoea, heart burn, rectal hypersensitivity, abdominal distention, gastroesophageal reflux, nausea, flatulence, ulcer aggravation, vomiting and liver damage

Skin and subcutaneous disorders:
Frequency unknown:                           Photosensitivity, pruritus, oedema

Renal and urinary disorders:
Frequency unknown:                           Kidney damage

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

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS:
The following symptoms may be experienced in the event of an overdose:
Tachycardia, hypertension, hypertensive crisis and myocardial infarct.
Contact a poison control centre in area.

IDENTIFICATION:
Clear size 0 all vegetable capsule containing dark red herbal powder.

PRESENTATION:
90 Capsules packed into 125ml amber glass bottle with light gold/mustard screw cap and safety seal insert in a box.

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:
To be allocated.

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Description

FLORA FORCE® CAYENNE capsules contain Capsicum minimum fruit powder. Cayenne has been used in traditional Western herbal medicine to support the circulatory system.

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® CAYENNE capsules are 100% free from:

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