INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CIPLATON (Capsules).

CIPLATON (Capsules)
Western herbal medicine –Combination product.
CIPLATON capsules have not been evaluated by the Medicines Control Council. CIPLATON capsules are not intended to diagnose, treat, cure or prevent any disease.
SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

CIPLATON (Capsules).

COMPOSITION:
Each CIPLATON capsule contains:


ACTIVE INGREDIENT QUANTITY % NRV
Panax ginsengroot extract equivalent to 40 mg *
Panax ginseng root powder 200 mg *
Lecithin 92 mg *
Rutin 20 mg *
Vitamin A 1200 micrograms RE (4000 IU) 133
Vitamin B1 2 mg 167
Vitamin B2 2 mg 154
Nicotinamide 10 mg 63
Vitamin B6 1 mg 59
Folic acid 400 micrograms 100
Vitamin B12 1 microgram 42
Pantothenic acid 9,2 mg 184
Vitamin C 60 mg 60
Vitamin D 10 micrograms (400 IU) 67
Vitamin E 10 mg á-TE 67
Calcium 103,5 mg 8
Copper 1 mg 111
Iron 10 mg 56
Magnesium 5 mg 1
Manganese 1 mg 44
Phosphorus 80 mg 6
Zinc 1 mg 9
Potassium 4 mg *
* NRV (Nutrient reference values for individuals 4 years and older) not established.
Preservatives:
Methyl parahydroxybenzoate 0,04% w/w.
Propyl parahydroxybenzoate 0,02% w/w.
Inactive ingredients are beeswax, butylated hydroxyanisole, castor oil, cochineal red, gelatine, glycerine, hardened unsaturated oil, iron oxide black, iron oxide red, purified water, sunflower seed oil / canola oil.
CIPLATON capsules are free from sugar and lactose.

PHARMACOLOGICAL CLASSIFICATION:
D 22.2 Vitamins. Other.

PHARMACOLOGICAL ACTION:
Pharmacodynamic properties:
The combination of the active ingredients contained in this formulation exerts a stimulant effect at both physical and psychological levels through its action on the body’s basic metabolic processes.
The ginseng extract raises the overall level of cellular activity, which is evident from a pronounced increase in mental and physical capacity. More than 200 constituents in ginseng root have been identified to date.
In situations of increased demands, the vitamins, minerals and trace elements rectify and prevent impairment of cell metabolism. Insufficient dietary intake of vitamins, minerals, and trace elements can cause disturbances, such as weakness, tiredness, decrease in vitality, reduced force of resistance, and slow recovery.
Lecithin, providing choline, inositol, linoleic acid and linolenic acid, improves energy production and lipid metabolism.
Pharmacokinetic properties:
The active ingredients in this formulation are well known. Pharmacokinetic studies have not been conducted due to its complex composition and the small quantities of the active ingredients it contains.

INDICATIONS:
CIPLATON
capsules are indicated to support energy levels, relieve short-term tiredness and exhaustion, and to improve general health. Panax ginseng has been used in traditional Chinese medicine for more than 2000 years amongst others to enhance physical performance, reduce fatigue and to improve overall quality of life.

CONTRAINDICATIONS:
CIPLATON
capsules are contraindicated in patients with: A hypersensitivity to any of the ingredients in
CIPLATON capsules. A hypersensitivity to peanut oil and soya.
Disturbances of calcium metabolism (e.g. hypercalcaemia and hypercalciuria).
Hypervitaminosis A or D.
Renal insufficiency.
Concomitant therapy with retinoids (e.g. against acne) or vitamin D (see “INTERACTIONS”).
Haemochromatosis or iron overload syndrome (see “WARNINGS AND SPECIAL PRECAUTIONS”).

WARNINGS AND SPECIAL PRECAUTIONS:
CIPLATON
capsules should be used with care in patients with a family history of haemochromatosis (see “CONTRAINDICATIONS”).
CIPLATON capsules should be used with care in patients suffering from insomnia or hypertension (see “SIDE-EFFECTS”).
CIPLATON capsules contain iron. Keep out of the reach and sight of children, as overdose can be fatal (see “KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT”).
When starting or stopping treatment with ginseng containing products, including CIPLATON capsules, patients taking warfarin (or other coumarin anticoagulants) should have increased monitoring of their INR (International Normalised Ratio) levels (see “INTERACTIONS”).
The use of Panax ginseng, as in CIPLATON 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”).
Vitamins or minerals obtained from other sources should be taken into consideration when taking CIPLATON capsules.
Effects on the ability to drive or use machinery:
No studies on the effect of CIPLATON capsules on the ability to drive or operate machines have been performed. It is unlikely that CIPLATON capsules will affect the ability to drive or operate machines.

INTERACTIONS:
The vitamins and minerals in CIPLATON capsules are known to interact with the following medicines:
Bisphosphonates: iron, magnesium and calcium can decrease absorption.
Levodopa: iron can decrease absorption. Vitamin B6 can enhance metabolism.
Levothyroxine: iron and calcium can decrease absorption.
Methyldopa: iron can decrease absorption.
Penicillamine: iron, zinc and copper can decrease absorption.
Quinolone antibiotics: iron, magnesium, calcium, zinc and manganese can decrease absorption.
Tetracycline antibiotics: iron, magnesium, calcium, zinc and manganese can decrease absorption.
Advise patients to take any of the above mentioned medicines at least 2 hours before or after CIPLATON capsules.
Calcium, as in CIPLATON capsules, can decrease absorption of sotalol. Advise patients to take sotalol at least 2 hours before or 4 to 6 hours after CIPLATON capsules.
Iron, as in CIPLATON capsules, can decrease absorption of mycophenolate mofetil and patients should be advised to take it 4 to 6 hours before or 2 hours after CIPLATON capsules.
Folic acid, as in CIPLATON capsules, may reduce the efficacy of methotrexate in the treatment of acute lymphoblastic leukemia and other cancers. Advise cancer patients to consult their oncologist before using CIPLATON capsules. Panax ginseng, as in CIPLATON capsules, may have immune system stimulating properties. Patients taking immunosuppressive medicines should use CIPLATON capsules with caution. Folic acid, as in CIPLATON capsules, can have direct convulsant activity in some people. Patients taking phenobarbital or primidone should be monitored closely for increased seizure activity. Folic acid, as in CIPLATON capsules, can antagonise the antiparasitic effects of pyrimethamine against toxoplasmosis and Pneumocystis carinii pneumonia. Patients taking pyrimethamine should avoid taking CIPLATON capsules. Vitamin D, as in CIPLATON capsules, may induce the cytochrome P450 3A4 (CYP3A4) enzymes, resulting in a reduced bioavailability of atorvastatin and other CYP3A4 substrates. Advise patients to use CIPLATON capsules cautiously if they take medicines metabolised by CYP3A4. Some medicines metabolised by CYP3A4 include lovastatin, clarithromycin, ciclosporin, diltiazem, oestrogens, indinavir and triazolam. There is some evidence that Panax ginseng, as in CIPLATON capsules, can inhibit the cytochrome P450 2D6 (CYP2D6) enzyme. Patients taking medicines metabolised by these enzymes should use CIPLATON capsules cautiously. Some of these medicines include amitriptyline, clozapine, codeine, desipramine, donepezil, fentanyl, flecainide, fluoxetine, meperidine (pethidine), methadone, metoprolol, olanzapine, ondansetron, tramadol and trazodone. Thiazide diuretics decrease urinary calcium excretion, which could lead to hypercalcemia if vitamin D, as in CIPLATON capsules, are taken concurrently. Advise patients to use CIPLATON capsules cautiously and monitor serum calcium levels if they take thiazides. Panax ginseng, as in CIPLATON capsules, may potentially reduce the effect of oral anticoagulants (e.g. warfarin) when taken in conjunction. Patients taking anticoagulants or antiplatelet medicines should have their INR levels monitored more frequently when taking CIPLATON capsules (see “WARNINGS AND SPECIAL PRECAUTIONS”). Theoretically, Panax ginseng, as in CIPLATON capsules, may enhance the blood glucose lowering effects of antidiabetic medicines. Patients on antidiabetic medicines should monitor their glucose levels closely when taking CIPLATON capsules. Theoretically, Panax ginseng, as in CIPLATON capsules, can interfere with MAOI therapy. Patients taking MAOI’s should use CIPLATON capsules with caution. Panax ginseng, as in CIPLATON capsules, can have an additive effect when used in combination with other stimulants. Patients taking stimulants should use CIPLATON capsules with caution. Taking CIPLATON capsules with retinoids, vitamin A or vitamin D can contribute to the development of hypervitaminosis A or D (see “CONTRAINDICATIONS”).

PREGNANCY AND LACTATION:
The safety and efficacy of CIPLATON capsules during pregnancy and lactation have not been established. CIPLATON capsules should therefore not be taken during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE:
The recommended daily dosage should not be exceeded.
Adults (18 years and older):
Take 1 capsule daily with breakfast.
Children (under 18 years of age):
Not recommended for use (see “WARNINGS AND SPECIAL PRECAUTIONS”). CIPLATON capsules are recommended for a treatment period of 4 weeks to treat short-term tiredness and exhaustion. If symptoms have not improved after 4 weeks, advise patients to consult a healthcare practitioner. CIPLATON capsules may be taken for a period of up to 12 weeks.

SIDE-EFFECTS:
The following side-effects may occur with the use of CIPLATON capsules:
Immune system disorders:
Frequency unknown: Hypersensitivity reactions, including urticaria and pruritus.
Psychiatric disorders:
Frequency unknown: Insomnia, euphoria (see “WARNINGS AND SPECIAL PRECAUTIONS”).
Nervous system disorders:
Frequent: Headache.
Frequency unknown: Dizziness, nervousness.
Vascular disorders:
Frequency unknown: Hypertension, oedema (see “WARNINGS AND SPECIAL PRECAUTIONS”).
Gastrointestinal disorders:
Frequent: Nausea, vomiting.
Less Frequent: Diarrhoea.
Frequency unknown: Abdominal pain, stomach discomfort, constipation.
Skin and subcutaneous tissue disorders:
Frequency unknown: Rash, pruritus.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The following symptoms may be experienced in the event of an overdose:
Nervousness, nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis can also occur.
The toxicity of CIPLATON capsules in large overdoses is caused by the toxicity of the liposoluble vitamins A and D. Prolonged intake of large amounts (corresponding to 25 capsules for Vitamin A and 5 capsules for Vitamin D) can cause symptoms of chronic toxicity, such as vomiting, headache, drowsiness and diarrhoea. Acute toxic symptoms are only seen at even higher doses.
Serious acute iron toxicity has been reported from doses of 168 mg iron (corresponding to 16 capsules) per day and more (see “WARNINGS AND SPECIAL PRECAUTIONS”).
The following treatment is suggested to minimise or prevent further absorption of the active ingredients in CIPLATON capsules:
•        Induce vomiting e.g. by administration of an emetic.
In cases of severe poisoning, shock and/or coma with high iron levels (serum iron >90 micromol/L in children, >142 micromol/L in adults) can occur and can be treated as follows:
•        Immediate supportive measures plus intravenous infusion of desferrioxamine.
In cases of less severe poisoning:
•        Intramuscular desferrioxamine is recommended (1 g, 4 - 6 hourly in children; 50 mg/kg up to a maximum dose of 4 g in adults).

IDENTIFICATION:
An oblong, dark brown, soft gelatine capsule.

PRESENTATION:
Blister strips of 10 capsules each packed in an outer carton of 30 or 60 capsules.

STORAGE INSTRUCTIONS:
Store at or below 25°C in a dry place. Protect from light.

KEEP OUT OF REACH OF CHILDREN.
Keep the blisters in the outer carton until required for use.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Building 9
Parc du Cap
Mispel Street
Bellville
7530
RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 2015


PATIENT INFORMATION LEAFLET
Information for the Patient about CIPLATON (Capsules)

Western herbal medicine –Combination product.
CIPLATON capsules have not been evaluated by the Medicines Control Council. CIPLATON capsules are not intended to diagnose, treat, cure or prevent any disease.

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
CIPLATON
(Capsules).

Read all of this leaflet carefully because it contains important information for you. CIPLATON capsules are available without a doctor’s prescription. Nevertheless you still need to use CIPLATON capsules carefully to get the best results from it.
•        Keep this leaflet, you may need to read it again.
•        Ask your pharmacist if you need more information or advice.
•        You must see a doctor if your symptoms worsen or do not improve

WHAT CIPLATON CAPSULES CONTAIN:
Each CIPLATON capsule contains:
ACTIVE INGREDIENT QUANTITY % NRV
Panax ginseng root extract equivalent to 40 mg *
Panax ginseng root powder 200 mg *
Lecithin 92 mg *
Rutin 20 mg *
Vitamin A 1200 micrograms RE (4000 IU) 133
Vitamin B1 2 mg 167
Vitamin B2 2 mg 154
Nicotinamide 10 mg 63
Vitamin B6 1 mg 59
Folic acid 400 micrograms 100
Vitamin B12 1 microgram 42
Pantothenic acid 9,2 mg 184
Vitamin C 60 mg 60
Vitamin D 10 micrograms (400 IU) 67
Vitamin E 10 mg á-TE 67
Calcium 103,5 mg 8
Copper 1 mg 111
Iron 10 mg 56
Magnesium 5 mg 1
Manganese 1 mg 44
Phosphorus 80 mg 6
Zinc 1 mg 9
Potassium 4 mg *
*NRV (Nutrient reference values for individuals 4 years and older) not established. Preservatives:
Methyl parahydroxybenzoate 0,04% w/w.
Propyl parahydroxybenzoate 0,02% w/w.
Inactive ingredients are beeswax, butylated hydroxyanisole, castor oil, cochineal red, gelatine, glycerine, hardened unsaturated oil, iron oxide black, iron oxide red, purified water, sunflower seed oil / canola oil.
CIPLATON capsules are free from sugar and lactose.

WHAT CIPLATON CAPSULES ARE USED FOR:
CIPLATON
capsules contain Panax ginseng which has been used in traditional Chinese medicine for more than 2000 years amongst others to enhance physical performance, reduce fatigue and to improve overall quality of life. CIPLATON capsules are used to support energy levels, relieve short-term tiredness and exhaustion, and to improve general health.

BEFORE YOU TAKE CIPLATON CAPSULES:
Do NOT take CIPLATON capsules:
If you are allergic to any of the active or inactive ingredients in CIPLATON capsules.
If you are allergic to peanut oil or soya.
If you have any problems with calcium metabolism (e.g. abnormally high or low concentrations of calcium in the blood and urine).
If you suffer from hypervitaminosis A or D (conditions resulting from consuming too much vitamin A or D).
If you have poor kidney function.
In combination with retinoids (vitamin A derived medicines) used for the treatment of acne, such as isotretinoin and tretinoin, or vitamin D (see “Taking other medicines with CIPLATON capsules”).
If you suffer from conditions / disorders in which the body absorbs and stores too much iron (see “Take special care with CIPLATON capsules”).

Take special care with CIPLATON capsules:
Please discuss the use of CIPLATON capsules with your doctor if you:
Have a family history of conditions / disorders in which the body absorbs and stores too much iron (see “Do NOT take CIPLATON capsules”).
Suffer from sleeplessness or high blood pressure (see “POSSIBLE SIDE-EFFECTS”).
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 CIPLATON capsules (see “Taking other medicines with CIPLATON capsules”).

CIPLATON capsules contain iron and must be kept out of the reach and sight of children, as overdose may cause death (see “If you take more CIPLATON capsules than you should”).
The use of Panax ginseng, as in CIPLATON capsules, in children and young people under 18 years of age is not recommended (see “HOW TO TAKE CIPLATON CAPSULES”).
Vitamins or minerals can be obtained from other sources, e.g. daily diet and other supplements. Please take this into consideration when taking CIPLATON capsules.

Taking CIPLATON capsules with food and drink:
CIPLATON
capsules should be taken with meals.

Pregnancy and breastfeeding:
Safety of CIPLATON capsules during pregnancy and breastfeeding has not been established.
Avoid taking CIPLATON capsules if you are pregnant or breastfeeding your baby.

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking CIPLATON 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 CIPLATON capsules will impair your ability to drive or use machines. However, please exercise care when driving or operating machinery until you know how CIPLATON capsules affects you.

Important information about some of the ingredients of CIPLATON capsules:
CIPLATON
capsules may contain peanut oil and soya. You should not take CIPLATON capsules if you are allergic to peanut or soya.

Taking other medicines with CIPLATON capsules:
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)
Please discuss the use of the following medicines in combination with CIPLATON capsules with your doctor or pharmacist:
Bisphosphonates such as alendronate and risedronate, for the treatment of osteoporosis (low bone mineral density resulting in bones that are brittle and easily fracture).
Levodopa for the treatment of Parkinson’s disease.
Levothyroxine for the treatment of under active thyroid gland.
Methyldopa for the treatment of high blood pressure.
Penicillamine for the treatment of rheumatoid arthritis.
Quinolone antibiotics such as ciprofloxacin, levofloxacin and moxifloxacin.
Tetracycline antibiotics such as doxycycline and minocycline.
Taking the above mentioned medicines at the same time as CIPLATON capsules can lower their effectiveness. These medicines must be taken at least 2 hours before or after CIPLATON capsules.

Also discuss the use of the following medicines in combination with CIPLATON capsules with your doctor or pharmacist:
Sotalol for the treatment of high blood pressure and heart disease. Sotalol must be taken at least 2 hours before or 4 to 6 hours after CIPLATON capsules.
Mycophenolate mofetil, an immunosuppressant as CIPLATON capsules can oppose its immunosuppressant effect. Mycophenolate mofetil must be taken 4 to 6 hours before or 2 hours after CIPLATON capsules.
Methotrexate for the treatment of certain cancers. Consult your oncologist before taking CIPLATON capsules in combination with methotrexate.
Immunosuppressants (such as azathioprine, ciclosporin, tacrolimus, sirolimus, prednisone and other corticosteroids) as CIPLATON capsules may oppose their immunosuppressant effects.
Phenobarbital or primidone for epilepsy / seizures. Please consult your doctor in case of increased seizure activity.
Pyrimethamine since CIPLATON capsules can oppose its antiparasitic effect.
Thiazide diuretics (“water tablets”) such as hydrochlorthiazide and indapamide since their use in combination with CIPLATON capsules can lead to abnormally high calcium levels.
Warfarin or other blood thinning medicines. CIPLATON capsules may potentially reduce the effect of blood thinning medicines. You may have to arrange increased monitoring of your INR levels when taking CIPLATON capsules (see “Take special care with CIPLATON capsules”).
Antidiabetic medicines (such as insulin, glimepiride and pioglitazone) as CIPLATON capsules may further lower blood sugar levels. Monitor your blood glucose / sugar levels regularly if you are using CIPLATON capsules and antidiabetic medicines in combination.
MAOI’s (monoamine oxidase inhibitors) such as moclobemide.
Medicines with a stimulant effect such as caffeine.
Retinoids (Vitamin A derived medicines) used for the treatment of acne, such as isotretinoin and tretinoin, vitamin A or vitamin D (see “Do NOT take CIPLATON capsules”).
Medicines which are broken down by the liver as CIPLATON capsules can influence the absorption and effectiveness of these medicines. Please discuss the use of CIPLATON capsules in combination with any other medicines with your doctor or pharmacist.

HOW TO TAKE CIPLATON CAPSULES:
Always take CIPLATON 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 1 capsule daily with breakfast.
Children (under 18 years of age):
Not recommended for use (see “Take special care with CIPLATON capsules”).
Take CIPLATON capsules for a period of 4 weeks to treat short-term tiredness and exhaustion. If your symptoms have not improved after 4 weeks, consult a healthcare practitioner.
CIPLATON capsules may be taken for a period of up to 12 weeks.

If you take more CIPLATON capsules than you should:
If you take more CIPLATON capsules than you should, you may experience nervousness, nausea, vomiting, diarrhoea (loose stools), stomach pain and a lack of energy. More severe symptoms may be experienced at very high doses (16 capsules and more) due to the iron content (see “Take special care with CIPLATON capsules”). In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take CIPLATON capsules:
Always take CIPLATON capsules as directed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule of one capsule per day. Do not take a double dose to make up for forgotten individual doses.

POSSIBLE SIDE-EFFECTS:
CIPLATON
capsules may have side-effects.
Not all side-effects reported for CIPLATON capsules are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CIPLATON capsules, please consult your doctor, pharmacist or other healthcare 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 possibly presenting with shortness of breath / difficult breathing, wheezing, hives, or itching, swelling of the face, tongue, or whole body, tightness of the chest.

Side-effects that you should report to your doctor as soon as possible:
High blood pressure (see “Take special care with CIPLATON capsules”).
Swollen feet and ankles.

Side-effects that you should report to your doctor or pharmacist if they continue or become bothersome include:
Headache, dizziness, nervousness, sleeplessness or an intense feeling of well-being (see “Take special care with CIPLATON capsules”).
Gastrointestinal disturbances, such as:
- Stomach discomfort, stomach pain, diarrhoea / loose stools, constipation, nausea and vomiting.
If you notice any side-effects not mentioned in this leaflet, please inform your doctor or pharmacist.

STORING AND DISPOSING OF CIPLATON CAPSULES:
Store at or below 25°C in a dry place.
Protect from light.
Keep the blisters in the outer carton until required for use.
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 MEDICINES OUT OF REACH OF CHILDREN.

PRESENTATION OF CIPLATON CAPSULES:
Blister strips of 10 capsules each packed in an outer carton of 30 or 60 capsules.

IDENTIFICATION OF CIPLATON CAPSULES:
An oblong, dark brown, soft gelatine capsule.

NAME AND BUSINESS ADDRESS OF THE REGISTRATION HOLDER:
CIPLA MEDPRO (PTY) LTD
Building 9
Parc du Cap
Mispel Street
Bellville
7530
RSA

DATE OF PUBLICATION OF THIS PATIENT INFORMATION LEAFLET:
June 2015.

CM366C/SA
905M078

New addition to this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2014/05/ciplaton-caps-PI-2015.pdf

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