PATIENT INFORMATION LEAFLET
Information for the Patient about FLORA FORCE® West Coast Kelp Capsules
Complementary medicine.
Health Supplement.
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® WEST COAST KELP Capsules
Read all of this leaflet carefully because it contains important information for you. FLORA FORCE® WEST COAST KELP capsules are available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use FLORA FORCE® WEST COAST KELP capsules carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Do not share FLORA FORCE® WEST COAST KELP 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® WEST COAST KELP CAPSULES CONTAIN:
Each FLORA FORCE® WEST COAST KELP capsule contains:
| ACTIVE INGREDIENT |
QUANTITY |
| Ecklonia maxima fronds powder |
480 mg |
Inactive ingredients are vegetable capsules.
FLORA FORCE® WEST COAST KELP capsules are free from sugar and lactose.
WHAT FLORA FORCE® WEST COAST KELP CAPSULES ARE USED FOR:
FLORA FORCE® WEST COAST KELP capsules provide anti-oxidants for the maintenance of good health, and may reduce inflammation.
BEFORE YOU TAKE FLORA FORCE® WEST COAST KELP CAPSULES:
Do NOT take FLORA FORCE® WEST COAST KELP capsules:
- If you are allergic to iodine or any of the ingredients in FLORA FORCE® WEST COAST KELP capsules (see “Take special care with FLORA FORCE® WEST COAST KELP capsules”).
- If you have a kidney problem (see “Take special care with FLORA FORCE® WEST COAST KELP capsules”).
- If you have a thyroid disease (“Take special care with FLORA FORCE® WEST COAST KELP capsules”).
- If you are undergoing surgery (see “Take special care with FLORA FORCE® WEST COAST KELP capsules”).
- If you are pregnant and breastfeeding (see “Pregnancy and breastfeeding”).
Take special care with FLORA FORCE® WEST COAST KELP capsules:
Please discuss the use of FLORA FORCE® WEST COAST KELP capsules with your pharmacist or registered healthcare practitioner if you:
- Suffer from an allergy to iodine or seaweed/kelp. Patients should avoid using FLORA FORCE® WEST COAST KELP capsules if you are allergic to iodine or seaweed/kelp (see “Do NOT take FLORA FORCE® WEST COAST KELP capsules”).
- Suffer from kidney problems. You may have to arrange increased monitoring of your potassium levels (see “Do NOT take FLORA FORCE® WEST COAST KELP capsules”).
- Suffer from a thyroid disease. You may have to arrange increased monitoring of your thyroid hormones (see “Do NOT take FLORA FORCE® WEST COAST KELP capsules”).
- If you are undergoing surgery discontinue use at least 2 weeks prior to the procedure (see “Do NOT take FLORA FORCE® WEST COAST KELP capsules”).
- Take heart medication (ACE-inhibitors and digoxin), potassium supplements and water pills (potassium sparing diuretics). Patients should use FLORA FORCE® WEST COAST KELP capsules and these medications with caution (see “Taking other medicines with FLORA FORCE® WEST COAST KELP capsules”).
- Take thyroid medication, lithium carbonate or other iodine containing medication. Patients should avoid using FLORA FORCE® WEST COAST KELP capsules and thyroid medication in combination (see “Taking other medicines with FLORA FORCE® WEST COAST KELP capsules”).
The use of FLORA FORCE® WEST COAST KELP 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® WEST COAST KELP capsules”).
Taking FLORA FORCE® WEST COAST KELP capsules with food and drink:
FLORA FORCE® WEST COAST KELP capsules should be taken after meals with water.
Pregnancy and breastfeeding:
Safety of FLORA FORCE® WEST COAST KELP capsules during pregnancy and breastfeeding has not been established. Avoid taking FLORA FORCE® WEST COAST KELP 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 FLORA FORCE® WEST COAST KELP 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® WEST COAST KELP 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® WEST COAST KELP capsules affects you.
Important information about some of the ingredients of FLORA FORCE® WEST COAST KELP capsules:
FLORA FORCE® WEST COAST KELP capsules are sugar free.
Taking other medicines with FLORA FORCE® WEST COAST KELP capsules:
Always tell your pharmacist or registered healthcare practitioner if you are taking any other medicine (this includes complementary or traditional medicines).
Discuss the use of the following medicines in combination with FLORA FORCE® WEST COAST KELP capsules with your pharmacist or registered healthcare practitioner.
- Heart medication (ACE-inhibitors and digoxin), potassium supplements and water pills (potassium sparing diuretics). FLORA FORCE® WEST COAST KELP capsules may potentially cause higher than normal potassium levels (hyperkalemia) when taking these medications. It may also increase the effects and adverse effects of digoxin (see “Take special care with FLORA FORCE® WEST COAST KELP capsules”).
- Thyroid medication, as FLORA FORCE® WEST COAST KELP capsules may interact with medication for hyper-or hypothyroidism (see “Take special care with FLORA FORCE® WEST COAST KELP capsules”).
- Bipolar medication (lithium carbonate) and iodine containing medication, as FLORA FORCE® WEST COAST KELP capsules contain iodine and may increase their effects (see “Take special care with FLORA FORCE® WEST COAST KELP capsules”).
Avoid taking the above medications in conjunction with FLORA FORCE® WEST COAST KELP capsules.
HOW TO TAKE FLORA FORCE® WEST COAST KELP CAPSULES:
Do not share medicines prescribed to you with any other person.
Always take FLORA FORCE® WEST COAST KELP 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 capsule 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 FLORA FORCE® WEST COAST KELP capsules”).
FLORA FORCE® WEST COAST KELP 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® WEST COAST KELP capsules than you should:
If you take more FLORA FORCE® WEST COAST KELP 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 FLORA FORCE® WEST COAST KELP capsules:
Always take FLORA FORCE® WEST COAST KELP 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 one capsule twice daily. Do not take a double dose to make up for forgotten individual doses.
POSSIBLE SIDE-EFFECTS:
FLORA FORCE® WEST COAST KELP capsules may have side-effects.
Not all side-effects reported for FLORA FORCE® WEST COAST KELP capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLORA FORCE® WEST COAST KELP 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:
- Signs of arsenic poisoning such headache, weakness, fatigue, worsening memory loss, rash, nail damage, diarrhoea and vomiting.
- An allergic reaction which may present with nasal congestion, hoarseness, persistent coughing, wheezing, swelling of the face, tongue or whole bod
- Signs of hypo- and hyperthyroidism which may present with fatigue, depression, cold sensitivity, constipation, dry skin, unexplained weight gain or loss, rapid or irregular heartbeat, sweating and irritability.
Side-effects that you should report to your pharmacist or registered healthcare practitioner if they continue or become bothersome include:
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® WEST COAST KELP 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® WEST COAST KELP capsules:
60 Capsules in a 125ml amber glass bottle with safety seal and screw cap, packed in a box.
IDENTIFICATION:
Clear size 0 vegetable capsule containing light brown, speckled 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:
08/11/2022
