PATIENT INFORMATION LEAFLET
Information for the Patient about FLORA FORCE® BUCHU 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® BUCHU Capsules- Keep this leaflet. You may need to read it again.
- Do not share FLORA FORCE® BUCHU 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.
| ACTIVE INGREDIENT | QUANTITY |
|---|---|
| Agathosma betulina leaf powder | 370 mg |
- If you have are allergic to any of the ingredients in FLORA FORCE® BUCHU
- If you have a bleeding disorder (see “Take special care with FLORA FORCE® BUCHU capsules”).
- If you have a kidney infection.
- Surgery (see “Take special care with FLORA FORCE® BUCHU capsules”).
- Pregnancy and lactation (see “Pregnancy and breastfeeding”).
- Suffer from a bleeding disorder. You may have to arrange increased monitoring of your INR (International Normalised Ratio) levels when starting or stopping treatment with FLORA FORCE® BUCHU capsules (see “Do NOT take FLORA FORCE® BUCHU capsules”).
- Are undergoing surgery, discontinue use at least 2 weeks prior to the procedure (see “Do NOT take FLORA FORCE® BUCHU capsules”).
- Are pregnant. FLORA FORCE® BUCHU capsules might act as an abortifacient and are not recommended during pregnancy (see “Pregnancy and breastfeeding”).
- 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® BUCHU capsules (see “Taking other medicines with FLORA FORCE® BUCHU capsules”).
- Warfarin, other blood thinning or anti-platelet medicines. FLORA FORCE® BUCHU capsules may potentially increase the effect of blood thinning medicines (see “Take special care with FLORA FORCE® BUCHU capsules”).
- Lithium, as FLORA FORCE® BUCHU capsules may increase lithium levels.
- An allergic reaction which may present with shortness of breath, difficulty breathing, wheezing, hives, or itching, swelling of the face, tongue or whole body.
- Flank pain and painful urination.
- Stomach pain, nausea, unusual tiredness, dark coloured urine, light coloured stools, yellow skin and eyes, loss of appetite and fever.
- Fainting, blackouts, dizziness, chest pain, shortness of breath, palpitations or vomiting.
- Muscle spasms or weakness.
- Gastrointestinal disturbances, such as:
- Stomach discomfort and diarrhoea.
- Increased menstrual bleeding.
| ACTIVE INGREDIENT | QUANTITY |
|---|---|
| Agathosma betulina leaf powder | 370 mg |
Agathosma betulina contains diosmin and has known anti-inflammatory activity. Anti-bacterial activity may be due to diosphenol, while flavonoids may contribute to the diuretic activity.
INDICATIONS:FLORA FORCE® BUCHU capsules are used traditionally to assist with symptoms related to urinary tract infections.
CONTRA-INDICATIONS:FLORA FORCE® BUCHU capsules are contra-indicated in patients with:
- A hypersensitivity to tany of the ingredients in FLORA FORCE® BUCHU capsules.
- Bleeding disorders (see "WARNINGS AND SPECIAL PRECAUTIONS")
- Diabetes (see "WARNINGS AND SPECIAL PRECAUTIONS").
- Kidney infection.
- Surgery (see <"strong>WARNING AND SPECIAL PRECAUTIONS").
- Pregnancy and lactation (see "PREGNANCY AND LACTATION").
When starting, or stopping treatment with Agathosma betulina containing products, including FLORA FORCE® BUCHU capsules, patients with bleeding disorders should have increased monitoring of their INR (International Normalised Ratio) levels (see “CONTRA-INDICATIONS”).
FLORA FORCE® BUCHU 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 Agathosma betulina containing products, including FLORA FORCE® BUCHU capsules, patients taking warfarin (or other coumarin anti-coagulants) should have increased monitoring of their INR (International Normalised Ratio) levels (see “INTERACTIONS”).
The use of FLORA FORCE® BUCHU 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”).
Agathosma betulina, as in FLORA FORCE® BUCHU capsules, might act as an abortifacient. FLORA FORCE® BUCHU capsules are not recommended during pregnancy (see“PREGNANCY AND LACTATION”).
Effects on the ability to drive or use machinery: No studies on the effect of FLORA FORCE® BUCHU capsules on the ability to drive or operate machines have been performed. It is unlikely that FLORA FORCE® BUCHU capsules will affect the ability to drive or operate machines
INTERACTIONS:Agathosma betulina, as in FLORA FORCE® BUCHU capsules, might reduce excretion of lithium and increase levels in the blood. The dose of lithium may need to be adjusted.
Agathosma betulina, as in FLORA FORCE® BUCHU 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® BUCHU capsules (see “WARNINGS AND SPECIAL PRECAUTIONS”).
PREGNANCY AND LACTATION:The safety and efficacy of FLORA FORCE® BUCHU capsules during pregnancy and lactation have not been established. Agathosma betulina, as in FLORA FORCE® BUCHU capsules, might act as an abortifacient. 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® BUCHU capsules.
Vascular disorders: Frequency unknown: Cardiac arrest
Gastrointestinal disorders: Frequency unknown: Gastro-intestinal irritation, diarrhoea.
Hepatobiliary disorders: Frequency unknown: Hepatotoxicity
Renal and urinary disorders: Frequency unknown: Kidney irritation
Musculoskeletal, connective tissue and bone disorders: Frequency unknown: Smooth muscle spasms or relaxation
Reproductive system and breast disorders: Frequency unknown: Increased menstrual flow.
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 light green screw cap and safety seal insert, packed into 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
DATE OF PUBLICATION:27/11/2017
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