FLORA FORCE® Turmerynne® capsules

R108,05

FLORA FORCE® TURMERYNNE® capsules with turmeric, cayenne and black pepper, provide antioxidants for the maintenance of good health, and may reduce inflammation. Preliminary research suggests that turmeric (Curcuma longa) and its active constituent, curcumin, may have antioxidant effects. These help to scavenge free radicals. Curcumin also has an anti-inflammatory action.

The major active constituent in Cayenne (Capsicum minimum) is capsaicin. Various studies suggest that Capsicum minimum and capsaicin have antioxidant effects and decrease inflammation.

Piperine, the active constituent found in Black Pepper (Piper nigrum) increases the oral absorption and bio-availability of other substances.

Avoid taking TURMERYNNE® capsules if you are pregnant or breastfeeding.

Vege caps. Free from additives, sugar and lactose.

PATIENT INFORMATION LEAFLET

Information for the Patient about FLORA FORCE® TURMERYNNE® 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:
TURMERYNNE® Capsules

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

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

ACTIVE INGREDIENT QUANTITY
Curcuma longa rhizome powder 332 mg
Capsicum minimum fruit powder 108 mg
Piper nigrum fruit powder 10 mg

Inactive ingredients are vegetable capsules.
TURMERYNNE® capsules are free from sugar and lactose.

WHAT TURMERYNNE® CAPSULES ARE USED FOR:
TURMERYNNE® capsules provide anti-oxidants for the maintenance of good health, and may reduce inflammation.

BEFORE YOU TAKE TURMERYNNE® CAPSULES:
Do NOT take TURMERYNNE® capsules:

  • If you are allergic to any of the ingredients in TURMERYNNE® capsules.
  • If you have a bile duct obstruction or gallstones.
  • If you have a bleeding disorder (see “Take special care with TURMERYNNE® capsules”).
  • If you have diabetes (see “Take special care with TURMERYNNE® capsules”).
  • If you have gastro-oesophageal reflux disease.
  • If you struggle with infertility.
  • If you have low iron levels (see “Take special care with TURMERYNNE® capsules”).
  • Surgery (see “Take special care with TURMERYNNE® capsules”).
  • Pregnancy and lactation (see “Pregnancy and breastfeeding”).

Take special care with TURMERYNNE® capsules:
Please discuss the use of TURMERYNNE® 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 TURMERYNNE® capsules (see “Do NOT take TURMERYNNE® capsules”).
  • Suffer from Diabetes. You may have to arrange increased monitoring of your blood sugar levels (see “Do NOT take TURMERYNNE® capsules”).
  • Suffer from iron deficiency. You may have to arrange increased monitoring of your iron levels (see “Do NOT take TURMERYNNE® capsules”).
  • If you are undergoing surgery, discontinue use at least 2 weeks prior to the procedure (see “Do NOT take TURMERYNNE® capsules”).
  • Suffer from a hormone-sensitive cancer. Theoretically, turmeric might have mild estrogenic effects. Until more is known, women with hormone-sensitive conditions should use turmeric cautiously.
  • Take warfarin or other blood thinning medicines. You may have to arrange increased monitoring or your INR (International Normalised Ratio) levels when starting or stopping treatment with TURMERYNNE® capsules (see “Taking other medicines with TURMERYNNE® capsules”).

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

Taking TURMERYNNE® capsules with food and drink:
TURMERYNNE® capsules should be taken after meals with water.

Pregnancy and breastfeeding:
Safety of TURMERYNNE® capsules during pregnancy and breastfeeding has not been established. Avoid taking TURMERYNNE® 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 TURMERYNNE® 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 TURMERYNNE® capsules will impair your ability to drive or use machines. However, please exercise care when driving or operating machinery until you know how TURMERYNNE® capsules affects you.

Important information about some of the ingredients of TURMERYNNE® capsules:
TURMERYNNE® capsules are sugar free.

Taking other medicines with TURMERYNNE® 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 TURMERYNNE® capsules with your pharmacist or registered healthcare practitioner.

  • Theophylline for the treatment of respiratory diseases such as COPD (chronic obstructive pulmonary disease) and asthma.
  • Beta blockers such as propranolol for the treatment of heart conditions such as angina and high blood pressure.
  • Sulfasalazine for rheumatoid arthritis and inflammatory bowel disease such as ulcerative colitis and Crohn’s disease.
  • Oestrogen for the treatment of female hormonal imbalances or menopause.
  • Lithium for the treatment of bipolar disorder.
  • Rifampin, an anti-biotic, for the treatment of tuberculosis.
  • Norfloxacin for the treatment of urinary tract infections.

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

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

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

  • Warfarin or other blood thinning medicines. TURMERYNNE® capsules may potentially increase the effect of blood thinning medicines (see “Take special care with TURMERYNNE® capsules”).
  • Epilepsy / seizure medication (such as carbamazepine and phenytoin) as TURMERYNNE® capsules may increase the effect these medications. Please consult your doctor in case of increased seizure activity.
  • Anti-diabetic medicines as TURMERYNNE® capsules may further lower blood sugar levels. Monitor you blood glucose / sugar levels regularly if you are using TURMERYNNE® capsules and anti-diabetic medicines in combination.
  • Medications activated by cell plasma membrane systems (P-Glycoprotein Substrates) as TURMERYNNE® capsules may affect the activity of these systems and increase how much of some medications get absorbed.
  • Midazolam as TURMERYNNE® capsules may increase its sedative effects.
  • Medicines which are changed and broken down by the liver (Cytochrome P450 substrates) as TURMERYNNE® capsules can influence the absorption and effectiveness of these medicines.
  • Anti-neoplastic agents (such as docetaxel, paclitaxel, etoposide, vinblastine and vincristine) as TURMERYNNE® capsules may increase their levels.
  • Iron as TURMERYNNE® capsules may decrease the absorption of iron. You may have to arrange increased monitoring of your iron levels when taking TURMERYNNE® capsules.

HOW TO TAKE TURMERYNNE® CAPSULES:
Do not share medicines prescribed to you with any other person.
Always take TURMERYNNE® 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 3 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 TURMERYNNE® capsules”).

TURMERYNNE® 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 TURMERYNNE® capsules than you should:
If you take more TURMERYNNE® 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 pharmacist or registered healthcare practitioner. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take TURMERYNNE® capsules:
Always take TURMERYNNE® 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 three capsules twice daily. Do not take a double dose to make up for forgotten individual doses.

POSSIBLE SIDE-EFFECTS:
TURMERYNNE® capsules may have side-effects.
Not all side-effects reported for TURMERYNNE® capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TURMERYNNE® 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.
  • Increased bleeding
  • Signs of decreased blood sugar such as light headedness, blurred vision and confusion

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

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

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, stomach pain, indigestion, diarrhoea, constipation, hard yellow stools, bloated stomach, heartburn, flatulence, ulcer aggravation, nausea and vomiting.
  • An intense feeling of well-being and giddiness.
  • 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 pharmacist or registered healthcare practitioner.

STORING AND DISPOSING OF TURMERYNNE® 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 TURMERYNNE® capsules:
90 Capsules in a 125ml amber glass bottle with light gold/mustard screw cap and safety seal insert, packed in a box.

IDENTIFICATION:
Clear size 0 all vegetable capsule containing dark orange 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:
28/11/2017

TURMERYNNE® 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):
TURMERYNNE® Capsules

COMPOSITION:
Each TURMERYNNE® capsule contains:

ACTIVE INGREDIENT QUANTITY
Curcuma longa rhizome powder 332 mg
Centella asiatica herb powder 108 mg
Centella asiatica herb powder 10 mg

Inactive ingredients: vegetable capsules
TURMERYNNE® 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 constituents in Curcuma longa are curcuminoids including curcumin. Preliminary research suggests that turmeric and its constituent curcumin may have anti-oxidant effects. Both turmeric and its constituents have been found to scavenge free radicals and phenolic oxidants and decrease levels of reactive oxygen species.
Curcumin has anti-inflammatory activity, possibly by inhibiting cyclooxygenase-2 (COX-s), prostaglandins, leukotrienes and other cytokines involved in pro-inflammatory signalling pathways.
The major active constituent in Capsicum minimum is capsaicin. Various studies suggest that Capsicum minimum and capsaicin have anti-oxidant effects and decrease inflammation.
The active constituent, piperine, found in Piper nigrum increases the oral absorption and bio-availability of other substances.

INDICATIONS:
TURMERYNNE® capsules provide anti-oxidants for the maintenance of good health, and may reduce inflammation.

CONTRA-INDICATIONS:
TURMERYNNE® capsules are contra-indicated in patients with:

  • A hypersensitivity to any of the ingredients in TURMERYNNE® capsules.
  • Biliary obstruction (bile duct obstruction and gallstones) (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Bleeding disorders (see “WARNING AND SPECIAL PRECAUTIONS”).
  • Diabetes (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Hypertension (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Gastro-oesophageal reflux disease.
  • Infertility.
  • Iron deficiency (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Surgery (see “WARNINGS AND SPECIAL PRECAUTIONS”).
  • Pregnancy and lactation (see “PREGNACY AND LACTATION”).

WARNINGS AND SPECIAL PRECAUTIONS:
TURMERYNNE® capsules should be used with care in patients with cholelithiasis (gallstones) and should only be used after consultation with a physician (see “CONTRA-INDICATIONS”).

When starting, or stopping treatment with Capsicum spp. and Curcuma longa containing products, including TURMERYNNE® capsules, patients with bleeding disorders should have increased monitoring of their INR (International Normalised Ratio) levels (see “CONTRA-INDICATIONS”).

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

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

TURMERYNNE® capsule should be used with caution in patients with iron deficiency. Patient should monitor their iron levels (see “CONTRA-INDICATIONS”).

TURMERYNNE® 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”).

TURMERYNNE® capsules should be used with care in patients with hormone-sensitive cancers. Theoretically, turmeric might have mild estrogenic effects. Until more is known, advise women with hormone-sensitive conditions to use turmeric cautiously.

When starting, or stopping treatment with capsicum and turmeric containing products, including TURMERYNNE® capsules, patients taking warfarin (or other coumarin anti-coagulants) should have increased monitoring of their INR (International Normalised Ratio) levels (see “INTERACTIONS”).

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

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

INTERACTIONS:
The herbs in TURMERYNNE® capsules may interact with the following medicines:

  • Theophylline: Capsicum spp. and piperine may enhance theophylline absorption.
  • Beta blockers: curcumin may decrease or increase absorption. Piperine may increase absorption of propranolol.
  • Sulfasalazine: Curcuma longa might increase absorption of sulfasalazine.
  • Oestrogen: Curcuma longa might decrease the effects of oestrogen
  • Lithium: Piper nigrum may increase levels of lithium.
  • Rifampin: piperine might increase absorption.
  • Norfloxacin: Curcuma longa might increase levels

Advise patients to take any of the above-mentioned medicines at least 2 hours before or after TURMERYNNE® capsules (see “DOSAGE AND DIRECTIONS FOR USE”).

Capsicum spp. and Curcuma longa, as in TURMERYNNE® 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 anti-platelet medicines should have their INR levels monitored more frequently when taking TURMERYNNE® capsules (see “WARNINGS AND SPECIAL PRECAUTIONS”).

Piper nigrum, as in TURMERYNNE® capsules, may increase the effect of medications for epilepsy when taken concomitantly. Patients taking these medications should use TURMERYNNE® capsules with caution and be monitored closely. Some of these medications include carbamazepine and phenytoin.

Theoretically, Capsicum spp. and Curcuma longa, as in TURMERYNNE® 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 TURMERYNNE® capsules.

Theoretically, Piper nigrum and Curcuma longa might increase levels of p-glycoprotein substrates. Some of these medicines include chemotherapeutic agents, anti-fungals, protease inhibitors, H2 agonists, calcium channel blockers, digoxin, corticosteroids, erythromycin, cisapride, fexofenadine, cyclosporine, loperamide and quinidine.

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

Piperine increases the bio-availability of curcumin in Turmeric. This may increase the potential of curcumin to interacting with other medicines.

There is some evidence that Curcuma longa and/or curcumin, Capsicum spp. and Piper nigrum 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 TURMERYNNE® capsules cautiously. These medicines include calcium channel blockers, chemotherapeutic agents, anti-fungals, 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 bio-availability of medicines metabolised by cytochrome P450 1A2 isoenzymes CYP1A2. Patients taking medicines metabolised by these enzymes should use TURMERYNNE® capsules cautiously. Some of these medicines include clozapine, fluvoxamine, haloperidol, imipramine, olanzapine, pentazocine, propranolol and zolmitriptan.

There is some evidence that Curcuma longa and Piper nigrum, as in TURMERYNNE® capsules, may increase levels of certain anti-neoplastic agents such as docetaxel, paclitaxel, etoposide, vinblastine and vincristine.

Theoretically, Curcuma longa may decrease the absorption of iron. Patients taking iron should monitor their iron levels when taking TURMERYNNE® capsules.

PREGNANCY AND LACTATION:
The safety and efficacy of TURMERYNNE® 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”).

Theophylline, beta-blockers, sulfasalazine, oestrogen, lithium, rifampicin and norfloxacin must be taken at least 2 hours before or after TURMERYNNE® capsules (see “INTERACTIONS”).

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

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

Psychiatric disorders:
Frequency unknown: Addiction.

Nervous system disorders:
Frequency unknown: Dizziness, hyperalgesia, vertigo.

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

Gastrointestinal disorders:
Frequency unknown: Gastro-intestinal irritation, mouth and throat irritation, stomach discomfort, dyspepsia, diarrhoea, constipation, yellow hard stools, abdominal distention, gastro-oesophageal 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.

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 orange herbal powder.

PRESENTATION:
90 Capsules packed in a 125ml amber glass bottle with light gold/mustard 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:
To be allocated.

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Description

FLORA FORCE® Turmerynne® capsules contain turmeric (Curcuma longa) root powder, cayenne (Capsicum minimum) fruit powder and black pepper (Piper nigrum) fruit powder. Turmeric and cayenne provide the body with anti oxidant and anti inflammatory nutrients while black pepper enhances the absorption of turmeric’s bio-actives.

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® Turmerynne® capsules are 100% free from:

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