CrampAway has not been evaluated by the Medicine Control Council. CrampAway is not intended to diagnose, treat, cure or prevent any disease.
To be allocated by Council upon registration.
PROPRIETARY NAME (and dosage form)
CrampAway- (hard gelatine capsules)
Each daily dosage contains:Active ingredients:
Magnesium Oxide 74.13mg
Magnesium Citrate 88mg
Magnesium Gluconate 25mg
Di-Potassium Phosphate 30mg
Di Sodium Phosphate 90mg
Calcium Carbonate 50mg
L-Aspartic Acid 20mg
Vitamin B6 5mg
Vitamin D3 6mcg
Vitamin B12 12.5mcg
Methylsulfonylmethane (MSM) 50mg
Other ingredients include Magnesium Stearate, Talc, Aerosil and Microcrystalline cellulose.
D34.12 Multiple Substance Formulation, Complementary Medicine: Health Supplement
Pharmacodynamic and Pharmacokinetic properties
Electrolyte deficiency can be the cause of cramping, especially if the body is deficient duringexercise. Nutrients also play a role in preventing muscle cramps. L-Glutamine assists with muscle cell repair after exercise and restores plasma glutamine levels depleted after periods of prolonged exhaustive exercise. L-Aspartic acid transport minerals to the cells which assists in cramp prevention, therefore increasing stamina and endurance levels in athlete. The beneficial effect of MSM is due in part to its ability to improve cell permeability, allowing harmful substances (lactic acid, toxins) to flow out while permitting nutrients to flow in, thereby preventing a pressure buildup in cells that causes inflammation in the joints. Betaine (trimethylglycine), the trimethylated compound of the amino acid glycine, is an essential biochemical component of the methionine/homocysteine cycle.
The 4 main electrolyte minerals are sodium, potassium, magnesium, and calcium. These minerals play a direct role in muscle activity. Deficiency in one or more of these can lead to cramping, especially if the body is deficient during exercise.
Absorption: Glutamine absorption occurs by an active transport mechanism.
Distribution: Glutamine enters the portal circulation and is transported to the liver, followed by systemic circulation for remaining amino acid.
Elimination: Glutamine is eliminated by glomerular filtration but is almost completely reabsorbed by renal tubules. Glutamine dipeptides are mainly absorbed intact and then metabolised to individual amino acids in body cells.
Distribution: MSM crosses the blood-brain barrier and is distributed throughout the brain and brainstem, with equal concentrations in grey and white matter.
Metabolism: Studies shows the metabolism and excretion of Dimethylsulfoxide (DMSO) and Methylsulfonylmethane (MSM) found that both were detectable in serum two hours after ingestion. MSM reached steady state after four days of treatment and was cleared from the blood approximately 120 hours after DMSO administration was stopped. Half-life was calculated to be 38 hours.
Excretion: MSM were excreted in urine, and neither was detected in the faeces.
CrampAway is indicated for the prevention of cramps due to strenuous exercise or deficiency of magnesium and other components.
CrampAway is contraindicated in:
Known hypersensitivity to any ingredients in CrampAway.
Known or suspected pregnancy (see PREGNANCY AND LACTATION).
Breastfeeding (see PREGNANCY AND LACTATION).
Patients with liver conditions.
Children under 12 years of age.
WARNINGS AND SPECIAL PRECAUTIONS:
Use with caution in patients with pre-existing gastritis or gastro-oesophageal reflux disease
(GERD). Use with caution in patients with abnormal liver function and using Gingko Biloba.
CrampAway can increase bleeding potential when taking warfarin anticoagulant therapy and frequent blood monitoring is therefore recommended. It is also advised to ensure that blood profiles are checked within 10 days after starting CrampAway to confirm safety Patients should be advised to take special care if taking other supplement, since this supplement can contain the same or similar ingredients. Herbs that have anticoagulant or antiplatelet activity are angelica, clove, red clover, turmeric, ginseng and others.
PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation have not been established and the administration of CrampAway during pregnancy is therefore contraindicated. If pregnancy occurs during the use of CrampAway, further intake should be stopped. CrampAway should not be used during breastfeeding.
DOSAGE AND DIRECTIONS FOR USE:
Take 1-2 capsules daily, after meals or as prescribed by a healthcare practitioner. Do not exceed the recommended dosage.
Use not recommended.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Nervous system disorders: Less frequent: Headache
Gastrointestinal disorders: Frequent: Gastrointestinal or abdominal discomfort, diarrhoea and nausea.
Skin and subcutaneous tissue disorders: Less frequent: Skin irritation or rash.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
Treatment is symptomatic and supportive. There is no specific antidote.
White capsule that contains white powder.
The capsules are packed into white bottles containing 30 capsules. The cap is an induction seal.
Store below 25 ˚C, in a dry, dark place. Keep in original packaging.
KEEP OUT OF REACH OF CHILDREN
To be allocated by Council upon registration.
NAME AND BUSINESS ADDRESS FOR THE HOLDER OF THE CERTIFICATE OF
California Pharmaceuticals (Pty) Ltd, 179 Edison Crescent, Hennopspark X7, Centurion, 0157
DATE OF PUBLICATION OF PACKAGE INSERT:
Will be allocated by Council upon registration
Company Reg No: 2002/023566/07