FLORA FORCE® FENUGREEK capsules

R86,58

FLORA FORCE® FENUGREEK capsules are traditionally used to promote lactation and enhance milk secretion. Use fenugreek after birth, or when milk supply slows down – such as when you return to work.

Free from sugar and lactose.

Avoid taking FLORA FORCE® FENUGREEK capsules if you are pregnant.

PATIENT INFORMATION LEAFLET

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

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

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

ACTIVE INGREDIENT QUANTITY
Trigonella foenum-graecum seed powder 500 mg

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

WHAT FLORA FORCE® FENUGREEK CAPSULES ARE USED FOR:
FLORA FORCE® FENUGREEK capsules are traditionally used to promote lactation.

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

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

Take special care with FLORA FORCE® FENUGREEK capsules:
Please discuss the use of FLORA FORCE® FENUGREEK capsules with 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® FENUGREEK capsules (see “Do NOT take FLORA FORCE® FENUGREEK capsules”).
  • Suffer from Diabetes. You may have to arrange increased monitoring of your blood sugar levels (see “Do NOT take FLORA FORCE® FENUGREEK capsules”).
  • If you are undergoing surgery discontinue use at least 2 weeks prior to the procedure (see “Do NOT take FLORA FORCE® FENUGREEK 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® FENUGREEK capsules” (see “Taking other medicines with FLORA FORCE® FENUGREEK 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® FENUGREEK capsules” (see “Taking other medicines with FLORA FORCE® FENUGREEK capsules”).
  • Take anti-diabetic medicines.  You may have to arrange increased monitoring or your blood glucose / sugar levels when starting or stopping treatment with FLORA FORCE® FENUGREEK capsules (see “Taking other medicines with FLORA FORCE® FENUGREEK capsules”).

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

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

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

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

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

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

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

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

Taking the above-mentioned medicines at the same time as FLORA FORCE® FENUGREEK capsules can lower or increase their effectiveness.  These medicines must be taken at least 2 hours before or after FLORA FORCE® FENUGREEK capsules.

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

  • Warfarin or other blood thinning medicines. FLORA FORCE® FENUGREEK 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® FENUGREEK capsules (see “Take special care with FLORA FORCE® FENUGREEK capsules”).Antidiabetic medicines as FLORA FORCE® FENUGREEK may further lower blood sugar levels.  Monitor you blood glucose / sugar levels regularly if you are using FLORA FORCE® FENUGREEK capsules and antidiabetic medicines in combination (see “Take special care with FLORA FORCE® FENUGREEK capsules”).

HOW TO TAKE FLORA FORCE® FENUGREEK CAPSULES:
Do not share medicines prescribed to you with any other person.
Always take FLORA FORCE® FENUGREEK 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® FENUGREEK capsules”).

FLORA FORCE® FENUGREEK 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® FENUGREEK capsules than you should:
If you take more FLORA FORCE® FENUGREEK capsules than you should, you may experience an 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® FENUGREEK capsules:
Always take FLORA FORCE® FENUGREEK 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® FENUGREEK capsules may have side-effects.
Not all side-effects reported for FLORA FORCE® FENUGREEK capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLORA FORCE® FENUGREEK 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 nasal congestion, hoarseness, persistent coughing, wheezing, swelling of the face, tongue or whole body.
  • Signs of shock such as low blood pressure, rapid shallow breathing, cold and clammy skin, rapid weak pulse, dizziness, fainting or weakness.
  • 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:

  • More urine than is normal for you.

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

  • Gastrointestinal disturbances, such as:
    • Heartburn, stomach discomfort and pain, diarrhoea, bloated stomach, flatulence.
  • Sweet urine odour..

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

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

IDENTIFICATION:
Clear size 0 all vegetable capsule containing green 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® FENUGREEK 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® FENUGREEK Capsules

COMPOSITION:
Each FLORA FORCE® FENUGREEK capsule contains:

ACTIVE INGREDIENT QUANTITY
Trigonella foenum-graecum seed powder 500 mg

Inactive ingredients: vegetable capsules
FLORA FORCE® FENUGREEK 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:

Trigonella foenum-graecum seed is thought to act via stimulation of sweat production, thereby enhancing milk secretion (the breast is a modified sweat gland).

INDICATIONS:

FLORA FORCE® FENUGREEK capsules are traditionally used to promote lactation.

CONTRA-INDICATIONS:

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

  • A hypersensitivity to the Fabaceae family including soybeans, peanuts, chick peas and green peas. Theoretically, patients who are allergic to other Fabaceae plants, might also be allergic to fenugreek, as in, FLORA FORCE® FENUGREEK capsules.
  • Bleeding disorders (see “WARNINGS AND SPECIAL PRECAUTIONS“)
  • Diabetes (see “WARNINGS AND SPECIAL PRECAUTIONS“).
  • Surgery (see <“strong>WARNING AND SPECIAL PRECAUTIONS”).
  • Pregnancy (see “PREGNANCY AND LACTATION“)

WARNINGS AND SPECIAL PRECAUTIONS:

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

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

FLORA FORCE® FENUGREEK capsules should be used with caution in patients with iron deficiency. Patient should monitor their iron levels (see “CONTRAINDICATIONS”).

FLORA FORCE® FENUGREEK 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 FENUGREEK containing products, including FLORA FORCE® FENUGREEK capsules, patients taking warfarin (or other coumarin anticoagulants) should have increased monitoring of their INR (International Normalised Ratio) levels (see “INTERACTIONS”).

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

Vitamins and minerals obtained from other sources should be taken into consideration when taking FLORA FORCE® FENUGREEK capsules.

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

INTERACTIONS:

FLORA FORCE® FENUGREEK capsules may interact with the following medicines:.

  • Beta blockers: curcumin may decrease the absorption of talinolol and may increase the absorption of celiprolol.
  • Sulfasalazine: Curcuma longa might increase absorption of sulfasalazine.
  • Oestrogen: Curcuma longa might decrease the effects of oestrogen
  • Norfloxacin: Curcuma longa might increase levels

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

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

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

Theoretically, Curcuma longa, as in FLORA FORCE® FENUGREEK 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® FENUGREEK capsules (see “WARNINGS AND SPECIAL PRECAUTIONS”)

`Theoretically, Curcuma longa, as in FLORA FORCE® FENUGREEK capsules, might increase levels of p-glycoprotein substrates. Some of these medicines include chemotherapeutic agents, antifungals, protease inhibitors, H2 agonists, calcium channel blockers, digoxin, corticosteroids, erythromycin, cisapride, fexofenadine, cyclosporine, loperamide and quinidine.

Curcuma longa, as in FLORA FORCE® FENUGREEK capsules, may increase the sedative effects of Midazolam. Patients taking Midazolam should use FLORA FORCE® FENUGREEK capsules with caution (see “WARNINGS AND SPECIAL PRECAUTIONS”).

There is some evidence that Curcuma longa and/or curcumin may interact with CYP3A4 enzymes and increase bioavailability of medicines metabolised by cytochrome P450 isoenzymes CYP3A4. Patients taking medicines metabolised by these enzymes should use FLORA FORCE® FENUGREEK capsules cautiously. Some of these medicines include calcium channel blockers, chemotherapeutic agents, antifungals, glucocorticoids, alfentanil, cisapride, fentanyl, lidocaine, losartan, fluoxetine, omeprazole, ondansetron and fexofenadine.

There is some evidence that Curcuma longa may interact with CYP1A2 enzymes and increase the bioavailability of medicines metabolised by cytochrome P450 1A2 isoenzymes CYP1A2. Patients taking medicines metabolised by these enzymes should use FLORA FORCE® FENUGREEK capsules cautiously. Some of these medicines include clozapine, fluvoxamine, haloperidol, imipramine, olanzapine, pentazocine, propranolol and zolmitriptan.

There is some evidence that Curcuma longa as in FLORA FORCE® FENUGREEK capsules, may increase levels of certain antineoplastic agents. Some of these include docetaxel, paclitaxel, etoposide, vinblastine, vincristine and vindesine.
Theoretically, Curcuma longa may decrease the absorption of iron. Patients taking iron should monitor their iron levels when taking FLORA FORCE® FENUGREEK capsules.

PREGNANCY AND LACTATION:

The safety and efficacy of FLORA FORCE® FENUGREEK capsules during pregnancy and lactation have not been established. FLORA FORCE® FENUGREEK capsules should therefore not be taken during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE:

The recommended daily dose should not be exceeded.

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® FENUGREEKcapsules.

Psychiatric disorders:
Frequency unknown: Giddiness

Nervous system disorders:
Frequency unknown: Vertigo

Gastrointestinal disorders:
Frequency unknown: Constipation, flatulence and yellow, hard stools, nausea and vomiting, diarrhoea or loose stool, dyspepsia, gastritis, distension and gastroesophageal reflux disease, abdominal fullness and pain, epigastric burning and tongue staining.

Skin and subcutaneous disorders:
Frequency unknown: Pruritus, pitting oedema, photosensitivity.

Renal and urinary disorders:
Frequency unknown: Diuresis

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 dark yellow 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

DATE OF PUBLICATION:

21/11/2016

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Description

FLORA FORCE® FENUGREEK capsules contain fenugreek (Trigonella foenum-graecum) seed powder. Fenugreek has been traditionally used to promote lactation and enhance milk secretion. Use fenugreek after birth, or when milk supply slows down – such as when you return to work.

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® FENUGREEK capsules are 100% free from:

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