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1111111 RELICALM (Tablets)
Western herbal medicine. RELICALM has not been evaluated by the Medicines Control Council. RELICALM is not intended to diagnose, treat, cure or prevent any disease.
SCHEDULING STATUS; Not scheduled. PROPRIETARY NAME (AND DOSAGE FORM): RELICALM (Tablets) COMPOSIJION: Each REUCALM tablet contains 150 mg L-theanine. Inactive ingredients are colloidal anhydrous silica, croscannellose sodium, dibasic calcium phosphate (dihydrate), hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and simethicone. RELICALM is free from lactose and sugar. PHARMACOLOGICAL CLASSIFICATION· D 23 Amino acids PHARMACOLOGICAL ACTION: Pharmacodynamlc properties: L-theanine is the major amino acid found in green tea. Historically, L-theanine has been used for its relaxing effects and to reduce anxiousness. It may cause an effect of wakeful relaxation in healthy people, and some studies suggest a positive contribution to cognitive perfonnance. Pharmacokinetic properties: L-theanine is able to cross the blood-brain barrier. Studies show the effects of L-theanine are evident within 30 minutes and are measurable up to 5 hours after administration. L-theanine is metabolised by the kidneys to glutamic acid and ethylamine. INDICATIONS: RELICALM is a nutritional supplement that may help to relieve feelings of stress by inducing a relaxing effect without drowsiness. Historically, L-theanine has been used for its relaxing effects and to reduce anxiousness. CONTRAINDICATIONS; REUCALM is contraindicated in:
• Patients with hypersensitivity to L-theanine or to any of the inactive ingredients of REUCALM. WARNINGS AND SPECIAL PRECAUTIONS: RELICALM may enhance the effects of antihypertensive medicines. In patients with hypertension or hypotension, the patient's blood pressure may need to be monitored more frequently while he/she is taking REUCALM (see "INTERACTIONS"). RELICALM is a nutritional supplement and should not replace any medicines prescribed by a doctor. Effects on the ability to drive or use machinery: It is unlikely that RELtCALM will affect the ability to drive or operate machines. INTERACTIONS: Antlhypertenslve medicines: Theoretically, the activity of antihypertensive medicines may be potentiated by concurrent use with REUCALM. It is, therefore, recommended that a patient's blood pressure be monitored while he/she is taking RELICALM (see "WARNINGS AND SPECIAL PRECAUTIONS"). Herbs and supplements with hypotenslve effects: Combining RELICALM with other herbs or supplements with hypotensive effects may theoretically increase the risk of hypotension. Examples of such herbs include Andrographis, casein peptides, cat's claw, coenzyme 010, fish oil, L-arginine, lycium, stinging nettle, or other theanine containing products (see "WARNINGS AND SPECIAL PRECAUTIONS"). PREGNANCY AND LACTATION· Safety and efficacy in pregnancy and lactation have not been established. DOSAGE AND PIRECTIONS FOR USE· Adult dose: Take 1 or 2 tablets with a glass of water when required to reduce feelings of anxiousness, in anticipation of stressful situations or 1 hour before bedtime. It takes approximately 30 minutes for RELICALM's effect to become evident. RELICALM may be taken without regard to meals. SIDE-EFFECTS; RELICALM can have side-effects. However, no side-effects have been reported with the use of L-theanine, as in REUCALM. KNOWN SYMPTOMS OF OYERPOSAGE ANP PARTICULARS OF ITS TREATMENT; No side-effects have been reported with the use of L-theanine, as in RELICALM. In the event of overdose, symptomatic and supportive treatment is suggested. IDENTIFICATION· White to off-white circular, flat, bevelled, uncoated tablets with central breakline on one side and plain on the other side. PRESENTATION· Outer carton containing blister strips of 10 tablets each packed in 20's, 40's or a blister strip of 4's. STORAGE INSTRUCTIONS; Store in a cool, dry place at or below 25 °C. 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 THE CERTIFICATE OF REGISTRATION· CIPLA MEDPRO (PTY) LTD Building 9, Pare du Cap, Mispel Street, Bellville, 7530, RSA DATE OF PUBLICATION OF THIS PACKAGE INSERT: May 2014. Cl CIPLA MED PRO (PTY) LTD 2014
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Western herbal medicine.
PATIENT INFORMATION LEAFLET lotorma)lon tor the Patient about
RELICALM (Tablets)
RELICALM has not been evaluated by the Medicines Control Council. RELICALM is not Intended to diagnose, treat, cure or prevent any disease. SCHEDULING STATUS; Not scheduled. PROPRIETARY NAME STRENGTH AND PHARMACEUTICAL FORMRELICALM containing L·theanlne 150 mg Q'ablets). Read all of this leaflet carefully because It contains Important Information for you. RELtCALM Is available without a doctor's prescription, for you to treat a mild Illness. Nevertheless you still need to use REUCALM carefully to get the best results from It.
• Keep this leaflat, 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 RELICALM CONTAINS; Each RELICALM tablet contains 150 mg L-theanine. Inactive Ingredients are colloidal anhydrous silica, croscannellose sodium, dibasic calcium phosphate (dihydrate), hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and simethicone. RELICALM is free from lactose and sugar. WHAT REUCALM IS USED FOR· RELICALM contains L-theanine, the major amino acid found in green tea. Historically, L-theanine has been used for its relaxing effects and to reduce anxiousness. RELICALM is a nutritional supplement that may help to relieve feelings of stress by inducing a relaxing effect without drowsiness. BEFORE YOU TAKE REUCALM· Do NOT take RELtCALM:
• If you are allergic (hypersensitive) to L-theanine or any of the inactive ingredients of RELICALM.
Take special care with RELICALM: RELICALM may lower I reduce blood pressure. RELICALM may also enhance the effects of blood pressure-lowering medicines (see "Taking other medicines with RELICALM"). If you have high or low blood pressure, you may have to mon�or your blood pressure more regulariy, especially if you feel dizzy or light-headed after standing up. Taking REUCALM with food and drink: RELICALM may be taken without regard to meals. Pregnancy and breastfeeding: Avoid taking RELICALM if you are pregnant or breastleeding your baby, as safety has not been established. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking RELi CALM. _ __ _ _
Driving and using machinery: It is unlikely that RELICALM will Influence your ability to drive or operate machinery. Taking other medicines with RELICALM: I Always tell your healthcare profeaslonal if you are taking any other medicine. :::J RELICALM is a nutritional supplement and should not replace any medicines prescribed by your doctor. If you are taking medicines to reduce your blood pressure, you may have to monitor your blood pressure more often if you take RELICALM on a regular basis. RELICALM may enhanca the effects of blood pressure-lowering medicines, herbs and supplements (see "Take special care with RELICALM"). Examples of such herbs include Andrographis, casein peptides, cat's claw, coenzyme 010, fish oil, L-arginine, lycium, stinging nettle, or other theanine containing products. HOW TO TAKE RELICALM: Always take RELtCALM exactly as directed. You should check with your pharmacist If you are unsure.
Adulfdose: Take 1 or 2 tablets with a glass of water when required to reduce feelings of anxiousness, in anticipation of stressful situations or 1 hour before bedtime. It takes approximately 30 minutes for RELICALM's effect to become evident. ff you take more REUCALM than you should: In the event of overdoaage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. POSSIBLE SIPE-EFFECTS; Not all sldlHlffects reported for RELICALM are Included In this leaflet. Should your general health worsen or If you experience any untoward effects while taking REUCALM, please consult your doctor, pharmacist or other healthcare professional for advice.
RELICALM can have side-effects. However, no side-effects have been reported with the use of L-theanine, as in RELICALM. If you notice any side-effects not mentioned in this leaflet, please inlonn your doctor or phannacist. STORING AND DISPOSING OF REUCALM: Store in a cool, dry place at or below 25 •c. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Keep the blisters in the outer carton until required for use. Do not use after the expiry date stated on the packaging material. Return all unused medicine to your phannacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). PRESENTATION OF RELICALM; Outer carton containing blister strips of 1 O tablets each packed In 20's, 40's or a blister strip of 4's. IPENTIFJCAJION OF REUCALM; White to off-white circular, flat, bevelled, uncoated tablets with central breakllne on one side and plain on the other side. NAME AND BUSINESS ADDRESS OF REGISTRATION HOLDER· CIPLA MEDPRO (PTY) LTD Building 9, Pare du Cap, Mlspel Street, Bellville, 7530, RSA PATE OF PUBUCATION OF THIS PATIENT INFORMATION LEAFLET: � May 2014. i! C CIPLA MEDPRO (PTY) LTD 2014
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Product Name: Relicalm 150mg Tablets J Material No. 21048594 I item: Leaflet I Date: 20-07-2015
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