FLORA FORCE® DANDELION capsules traditionally used to support the body’s elimination functions.
Vege caps. Free from additives, sugar and lactose.
PATIENT INFORMATION LEAFLET
Information for the Patient about FLORA FORCE® DANDELION Capsules
Complementary medicine.
Western herbal medicine.
This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety and intended use.
SCHEDULING STATUS:
Not Scheduled
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
FLORA FORCE® DANDELION Capsules
- Keep this leaflet. You may need to read it again.
- Do not share FLORA FORCE® DANDELION 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® DANDELION CAPSULES CONTAIN:
Each FLORA FORCE® DANDELION capsule contains:
| ACTIVE INGREDIENT | QUANTITY |
|---|---|
| Taraxacum officinale root & leaf powder | 300 mg |
Inactive ingredients are vegetable capsules.
FLORA FORCE® DANDELION capsules are free from sugar and lactose.
WHAT FLORA FORCE® DANDELION CAPSULES ARE USED FOR:
FLORA FORCE® DANDELION capsules traditionally used to support the body’s elimination functions.
BEFORE YOU TAKE FLORA FORCE® DANDELION CAPSULES:
Do NOT take FLORA FORCE® DANDELION capsules:
- If you have a hypersensitivity plants from the Asteraceae family (see “Take special care with FLORA FORCE® DANDELION capsules“).
- If you have a bile duct obstruction or gallstones (see “Take special care with FLORA FORCE® DANDELION capsules“).
- If you have a bleeding disorder (see “Take special care with FLORA FORCE® DANDELION capsules“).
- If you have diabetes (see “Take special care with FLORA FORCE® DANDELION capsules“).
- If you have a renal impairment or chronic liver disease (CLD) (see “Take special care with FLORA FORCE® DANDELION capsules“).
- Surgery (see “Take special care with FLORA FORCE® DANDELION capsules“).
- Pregnancy and lactation (see “Pregnancy and breastfeeding“).
Take special care with FLORA FORCE® DANDELION capsules:
Please discuss the use of FLORA FORCE® DANDELION capsules with your pharmacist or registered healthcare practitioner if you:
- Have a hypersensitivity to plants from the Asteraceae family. Members of this family include sunflowers, chrysanthemum, marigolds, daisies and other herbs (see “Do NOT take FLORA FORCE® DANDELION capsules“).
- Suffer from a bile duct obstruction or gallstones (see “Do NOT take FLORA FORCE® DANDELION capsules“).
- Suffer from a bleeding disorder. You may have to arrange increased monitoring of your blood levels when starting or stopping treatment with FLORA FORCE® DANDELION capsules (see “Do NOT take FLORA FORCE® DANDELION capsules“).
- Suffer from Diabetes. You may have to arrange increased monitoring of your blood sugar levels (see “Do NOT take FLORA FORCE® DANDELION capsules“).
- Suffer from renal impairment CLD. You may have to arrange increased monitoring of your oxalate and potassium levels (see “Do NOT take FLORA FORCE® DANDELION capsules“).
- Are undergoing surgery, discontinue use at least 2 weeks prior to the procedure (see “Do NOT take FLORA FORCE® DANDELION 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® DANDELION capsules (see “Taking other medicines with FLORA FORCE® DANDELION capsules“).
The use of FLORA FORCE® DANDELION 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® DANDELION capsules“).
Taking FLORA FORCE® DANDELION capsules with food and drink:
FLORA FORCE® DANDELION capsules should be taken after meals with water.
Pregnancy and breastfeeding:
Safety of FLORA FORCE® DANDELION capsules during pregnancy and breastfeeding has not been established. Avoid taking FLORA FORCE® DANDELION capsules if you are pregnant or breastfeeding.
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® DANDELION 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® DANDELION capsules affects you.
Important information about some of the ingredients of FLORA FORCE® DANDELION capsules:
FLORA FORCE® DANDELION capsules are sugar free.
Taking other medicines with FLORA FORCE® DANDELION capsules:
Discuss the use of the following medicines in combination with FLORA FORCE® DANDELION capsules with your pharmacist or registered healthcare practitioner
- Lithium for the treatment of bipolar disorder.
The dose of the above medications may need to be adjusted when taken in conjunction with FLORA FORCE® DANDELION capsules.
Also, discuss the use of the following medicines in combination with FLORA FORCE® DANDELION capsules with your pharmacist or registered healthcare practitioner:
- Warfarin, other blood thinning or anti-platelet medicines. FLORA FORCE® DANDELION capsules may potentially increase the effect of blood thinning medicines (see “Take special care with FLORA FORCE® DANDELION capsules).
- Anti-diabetic medicines as FLORA FORCE® DANDELION may further lower blood sugar levels. Monitor you blood sugar levels regularly if you are using FLORA FORCE® DANDELION capsules and anti-diabetic medicines in combination.
- Medications which are changed and broken down by die liver (glucuronidated drugs) as FLORA FORCE® DANDELION capsules can influence the absorption and effectiveness of these medicines.
- Medicines which are changed and broken down by the liver (Cytochrome P450 1A2 (CYP1A2) substrates) as FLORA FORCE® DANDELION capsules could decrease effectiveness of these medicines.
- Quinolone Antibiotics as FLORA FORCE® DANDELION may decrease the absorption of these antibiotics.
- Water pills (potassium-sparing diuretics) as FLORA FORCE® DANDELION contains significant amounts of potassium and some of these medications can also increase potassium levels in the body. This might cause too much potassium in the body.
HOW TO TAKE FLORA FORCE® DANDELION CAPSULES:
Do not share medicines prescribed to you with any other person.
Always take FLORA FORCE® DANDELION 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® DANDELION capsules”).
FLORA FORCE® DANDELION 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® DANDELION 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® DANDELION capsules:
Always take FLORA FORCE® DANDELION 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 2-3 times daily. Do not take a double dose to make up for forgotten individual doses.
POSSIBLE SIDE-EFFECTS:
FLORA FORCE® DANDELION capsules may have side-effects.
Not all side-effects reported for FLORA FORCE® DANDELION capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLORA FORCE® DANDELION 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 shock such as low blood pressure, rapid shallow breathing, cold and clammy skin, rapid weak pulse, dizziness, fainting or weakness.
- Increased bleeding.
- Rapid or irregular heartbeat, loss of consciousness.
- Signs of decreased blood sugar such as light headedness, blurred vision and confusion.
- Signs of kidney stones such as severe or sudden abdominal or flank pain, blood in the urine, frequent urge to urinate, pain when urinating and fever and chills.
- Blood in urine, painful urination and more urine than is normal for you.
Side-effects that you should report to your pharmacist or registered healthcare practitioner as soon as possible:
- Skin becoming cold, pale, red or swelling. A loss of sensation or severe pain.
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 and heartburn.
- Nasal congestion, runny nose, post-nasal drip, sneezing, red eyes, itching of nose and eyes.
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® DANDELION 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® DANDELION capsules:
60 Capsules in 125ml amber glass bottle with screw cap and safety seal insert.
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:
08/04/2021
FLORA FORCE® DANDELION Capsules
Complementary medicine.
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® DANDELION Capsules
COMPOSITION:
Each FLORA FORCE® DANDELION capsule contains:
| ACTIVE INGREDIENT | QUANTITY |
|---|---|
| Taraxacum officinale leaf & root powder | 300 mg |
Inactive ingredients: vegetable capsules
FLORA FORCE® DANDELION 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:
Taraxacum officinale contains sesquiterpene lactones which appears to be responsible for its diuretic activity. The high potassium content of the herb ensures replacement of potassium eliminated in the urine.
The principal bitter constituents of the leaf are the sesquiterpene lactones, taraxinic acid glucoside and its 11, 13-dihydro derivative which may produce the choleretic actions.
The root contains bitter substances which are beneficial to the digestive process, increases bile secretions and has an aperient effect1.
The root contains high concentrations of inulin. Oligo-fructans, such as inulin, are used as food sources by beneficial intestinal bacteria. Taraxacum officinale root enhances the growth of bifidobacterial and may be useful as a “prebiotic”.
INDICATIONS:
FLORA FORCE® DANDELION capsules are used traditionally to support the body’s elimination functions.
CONTRA-INDICATIONS:
FLORA FORCE® DANDELION capsules are contra-indicated in patients with:
- A hypersensitivity to plants from the Asteraceae family (see “WARNINGS AND SPECIAL PRECAUTIONS“).
- Biliary obstruction (bile duct obstruction and gallstones) (see “WARNINGS AND SPECIAL PRECAUTIONS“)
- Bleeding disorders (see “WARNINGS AND SPECIAL PRECAUTIONS“).
- Diabetes (see “WARNINGS AND SPECIAL PRECAUTIONS“).
- Renal impairment & chronic liver disease (CLD) (see “WARNINGS AND SPECIAL PRECAUTIONS“).
- Surgery (see “WARNINGS AND SPECIAL PRECAUTIONS“).
- Pregnancy and lactation (see “PREGNANCY AND LACTATION“).
WARNINGS AND SPECIAL PRECAUTIONS:
Taraxacum officinale may cause an allergic reaction in individuals sensitive to plants from the Asteraceae family. Members of this family include sunflowers, chrysanthemums, marigolds, daisies and other herbs (see “CONTRA-INDICATIONS”).
FLORA FORCE® DANDELION capsules should be used with care in patients with biliary obstruction (bile duct obstruction and gallstones) and should only be used after consultation with a physician (see “CONTRA-INDICATIONS”).
When starting, or stopping treatment with Taraxacum officinale containing products, including FLORA FORCE® DANDELION capsules, patients with bleeding disorders should have increased monitoring of their INR (International Normalised Ratio) levels (see “CONTRA-INDICATIONS”).
FLORA FORCE® DANDELION capsules should be used with care in patients with diabetes as Taraxacum officinale may decrease blood sugar levels. Diabetic patients should monitor their blood sugar levels when taking FLORA FORCE® DANDELION capsules (see “CONTRA-INDICATIONS”).
FLORA FORCE® DANDELION capsules should be used with care in patients with renal impairment and CLD. You may have to arrange increased monitoring of your oxalate and potassium levels. Theoretically, Taraxacum officinale may reduce oxalate clearance and increase the risk of hyperoxalaemia in patients with renal impairment. Taraxacum officinale contains potassium and could theoretically increase the risk of hyperkalemia in CLD (see “CONTRA-INDICATIONS”).
FLORA FORCE® DANDELION 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 Taraxacum officinale containing products, including FLORA FORCE® DANDELION 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® DANDELION 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® DANDELION capsules on the ability to drive or operate machines have been performed. It is unlikely that FLORA FORCE® DANDELION capsules will affect the ability to drive or operate machines.
INTERACTIONS:
The herbs in FLORA FORCE® DANDELION capsules may interact with the following medicines:
- Lithium: Taraxacum officinale may increase levels of lithium.
The dose of the above medications may need to be adjusted when taken in conjunction with FLORA FORCE® DANDELION capsules.
Taraxacum officinale, as in FLORA FORCE® DANDELION capsules, may potentially increase the effect of oral anti-coagulants and anti-platelet drugs (e.g. warfarin, heparin, aspirin, clopidogrel, NSAID’s, diclofenac, dalteparin, ibuprofen, naproxen, enoxaparin, heparin) when taken concomitantly (see “WARNINGS AND SPECIAL PRECAUTIONS”).
Theoretically, Taraxacum officinale, as in FLORA FORCE® DANDELION 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® DANDELION capsules.
There is preliminary evidence that Taraxacum officinale might inhibit CYP1A2 enzymes and increase bio-availability of medicines metabolised by cytochrome P450 1A2 (CYP1A2). Patients taking medicines metabolised by these enzymes should use FLORA FORCE® DANDELION capsules cautiously or avoid. These medicines include amitriptyline, haloperidol, ondansetron, propranolol, theophylline, verapamil and others.
There is preliminary evidence that Taraxacum officinale might induce UDP-glucuronosyltransferase, a phase II enzyme. Theoretically, Taraxacum officinale might increase the clearance of drugs that are UDP-glucuronosyltransferase substrates. Patients taking medicines that are UDP-glucuronosyltransferase substrates should use FLORA FORCE® DANDELION capsules cautiously. These medicines include acetaminophen, estrogens and oral contraceptives, entacapone, irinotecan and others.
Taraxacum officinale contains significant amounts of potassium. Theoretically, concomitant use of potassium-sparing diuretics with Taraxacum officinale, as in FLORA FORCE® DANDELION capsules, might increase the risk of hyperkalemia. These medicines include amiloride, spironolactone and triamterene.
Theoretically, Taraxacum officinale, might lower fluoroquinolone levels. Preliminary research suggests that a related species, Taraxacum mongolicum, reduces absorption of ciprofloxacin and can lower levels by 73%. Patients taking Quinolones should use FLORA FORCE® DANDELION capsules with care. Quinolones include ciprofloxacin, enoxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifoxacin, norfloxacin, ofloxacin, sparfloxacin and trovafloxacin.
PREGNANCY AND LACTATION:
The safety and efficacy of FLORA FORCE® DANDELIONcapsules 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 1-2 capsules tow to three times 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® DANDELION capsules.
Endocrine disorders:
Frequency unknown: Hyper-oxalaemia and hypo-glycaemia.
Vascular disorders:
Frequency unknown: Increased bleeding, palpitations, tachycardia, syncope and peripheral gangrene.
Gastrointestinal disorders:
Frequency unknown: Stomach discomfort, diarrhoea, heartburn, and intestinal blockage.
Skin and subcutaneous disorders:
Frequency unknown: Contact dermatitis, erythema multiforme and skin allergy.
Respiratory, thoracic and mediastinal disorders:
Frequency unknown: Allergy, anaphylaxis, rhino-conjunctivitis and asthma.
Renal and urinary disorders:
Frequency unknown: Haemorrhagic cystitis.
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 green herbal powder.
PRESENTATION:
60 Capsules packed into 125ml amber glass bottle with lscrew 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:
08/04/2021
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- Patient Information Leaflet – English (pdf)
- Pasiënt Inligtingstuk – Afrikaans (pdf)
- Professional Information Leaflet (pdf)
