PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
VITAMINME MAGNESIUM GLYCINATE (film-coated tablets)
Magnesium Glycinate
Sugar free
Complementary Medicine: Health Supplement
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
Read all of this leaflet carefully because it contains important information for you.
VITAMINME MAGNESIUM GLYCINATE is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use VITAMINME MAGNESIUM GLYCINATE carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Do not share VITAMINME MAGNESIUM GLYCINATE with any other person.
- Ask your healthcare provider or pharmacist if you need more information or advice.
What is in this leaflet
- What VITAMINME MAGNESIUM GLYCINATE is and what it is used for
- What you need to know before you use VITAMINME MAGNESIUM GLYCINATE
- How to use VITAMINME MAGNESIUM GLYCINATE
- Possible side effects
- How to store VITAMINME MAGNESIUM GLYCINATE
- Contents of the pack and other information
1. What VITAMINME MAGNESIUM GLYCINATE is and what it is used for
VITAMINME MAGNESIUM GLYCINATE is a health supplement that contributes to normal muscle function and protein synthesis, helps with normal nervous system, psychological function and sleep.
2. What you need to know before you use VITAMINME MAGNESIUM GLYCINATE
A varied diet is the most effective and safe way to achieve good nutrition, health, body composition as well as mental and physical performance.
Do not use VITAMINME MAGNESIUM GLYCINATE:
- If you are hypersensitive (allergic) to magnesium glycinate or any of the other ingredients of VITAMINME MAGNESIUM GLYCINATE (listed in section 6).
Warnings and precautions
Take special care:
- If you have a medical condition or if you are currently taking any other medicine.
- If you have a kidney disease or reduced kidney function, as you may be at increased risk of developing hypermagnesemia (high level of magnesium in the blood).
Children and adolescents
VITAMINME MAGNESIUM GLYCINATE is not recommended for individuals below the age of 18 years.
Other medicines and VITAMINME MAGNESIUM GLYCINATE
Always tell your healthcare provider if you are taking any other medicine. This includes all complementary or traditional medicines.
The following medicines may cause an interaction with VITAMINME MAGNESIUM GLYCINATE:
- Aminoglycoside antibiotics: Concomitant use of aminoglycoside antibiotics and magnesium can increase the risk for neuromuscular weakness.
- Bisphosphonates: Magnesium can decrease absorption of bisphosphonates.
- Calcium channel blockers: Magnesium can have additive effects with calcium channel blockers.
- Levodopa/carbidopa: Magnesium can reduce the bioavailability of levodopa/carbidopa.
- Potassium-sparing diuretics: Potassium-sparing diuretics decrease excretion of magnesium, possibly increasing magnesium levels.
- Quinolone antibiotics: Magnesium decreases absorption of quinolones.
- Tetracycline antibiotics: Magnesium decreases absorption of tetracyclines.
VITAMINME MAGNESIUM GLYCINATE with food and drink
VITAMINME MAGNESIUM GLYCINATE has no known interaction with food and drink (see section 3).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before using VITAMINME MAGNESIUM GLYCINATE.
Safety for use during pregnancy and lactation has not been established.
Driving and using machinery
VITAMINME MAGNESIUM GLYCINATE is unlikely to have an effect on your ability to drive a vehicle and operate machinery.
Patients should exercise caution before driving or using machinery until they are reasonably certain that VITAMINME MAGNESIUM GLYCINATE does not adversely affect their performance.
3. How to use VITAMINME MAGNESIUM GLYCINATE
Do not share medicines with any other person.
Always use VITAMINME MAGNESIUM GLYCINATE exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults 18 years and older
Take 1 – 2 tablets daily after food, or as recommended by a healthcare provider.
Swallow the tablet whole and do not chew or crush.
Do not exceed the recommended dose.
If you take more VITAMINME MAGNESIUM GLYCINATE than you should
In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the remaining capsules with you so the doctor will know what you have taken.
If you forget to take VITAMINME MAGNESIUM GLYCINATE
Do not take a double dose to make up for individual forgotten doses.
4. Possible side effects
VITAMINME MAGNESIUM GLYCINATE can have side effects.
Not all side effects reported for VITAMINME MAGNESIUM GLYCINATE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VITAMINME MAGNESIUM GLYCINATE, please consult your healthcare provider for advice.
If any of the following happens, stop using VITAMINME MAGNESIUM GLYCINATE and tell your doctor immediately, or go to the casualty department at your nearest hospital:
- swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing; rash or itching; fainting.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to VITAMINME MAGNESIUM GLYCINATE. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
Side effects occurring with an unknown frequency:
- gastrointestinal irritation; nausea; vomiting; diarrhoea.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, inform your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VITAMINME MAGNESIUM GLYCINATE.
5. How to store VITAMINME MAGNESIUM GLYCINATE.
- Store at or below 25 °C in a dry place away from moisture and direct sunlight.
- Store all medicines out of reach of children.
- Store in the original container until required for use.
- Do not use after the expiry date stated on thelabel.
- Return all unused medicine to your pharmacist.
- Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
6. Contents of the pack and other information
What VITAMINME MAGNESIUM GLYCINATE contains
Each tablet contains: Magnesium Glycinate Providing 125,00 mg Magnesium (elemental) | 625,00 mg |
The other ingredients are microcrystalline cellulose, magnesium stearate, maize starch, silicon dioxide, red film-coating.
Sugar free
What VITAMINME MAGNESIUM GLYCINATE looks like and contents of the pack
Red, oval-shaped film-coated tablets. The tablets are packed in a clear, amber glass jar with a pressure seal and a white, ribbed screwcap lid.
Pack size: 30 tablets.
Holder of Certificate of Registration
VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196
This leaflet was last revised in
Will be allocated by SAHPRA upon registration.
Registration number
Will be allocated by SAHPRA upon registration
.
PASIËNTINLIGTINGSBLAD
SKEDULERINGSTATUS: S0
VITAMINME MAGNESIUM GLYCINATE (filmbedekte tablette)
Magnesiumglisinaat
Suikervry
Komplementêre Medisyne: Gesondheidsaanvulling
Hierdie ongeregistreerde medisyne is nie deur SAHPRA vir gehalte, veiligheid of beoogde gebruik geëvalueer nie.
Lees hierdie inligtingsblad noukeurig deur want dit bevat inligting wat belangrik is vir u.
VITAMINME MAGNESIUM GLYCINATE is beskikbaar sonder ‘n dokter se voorskrif, om jou gesondheid te handhaaf. Nietemin moet VITAMINME MAGNESIUM GLYCINATE versigtig gebruik word ten einde die beste resultate te verkry.
- Hou hierdie inligtingsblad. Dit kan nodig wees dat jy dit weer lees.
- Moenie VITAMINME MAGNESIUM GLYCINATE met enige ander persoon deel nie.
- Vra jou gesondheidsorgverskaffer of apteker indien jy meer inligting of advies nodig het.
Wat is in hierdie inligtingsblad
- Wat is VITAMINME MAGNESIUM GLYCINATE en warvoor word dit gebruik
- Wat jy moet weet voordat jy VITAMINME MAGNESIUM GLYCINATE gebruik
- Hoe om VITAMINME MAGNESIUM GLYCINATE te gebruik
- Moontlike newe-effekte
- Hoe om VITAMINME MAGNESIUM GLYCINATE te bêre
- Inhoud van die pak en ander inligting
1. Wat is VITAMINME MAGNESIUM GLYCINATE en waarvoor word dit gebruik
VITAMIEN MAGNESIUM GLISINAAT is ‘n gesondheidsaanvulling wat bydra tot normale spierfunksie en proteïensintese, help met normale senuweestelsel, sielkundige funksie en slaap.
2. Wat jy moet weet voordat jy VITAMINME MAGNESIUM GLYCINATE gebruik
‘n Gevarieerde dieet is die doeltreffendste en veiligste manier om goeie voeding, gesondheid, liggaamsamestelling, sowel as geestelike en fisiese prestasie te behaal.
Moenie VITAMINME MAGNESIUM GLYCINATE neem nie:
- Indien jy hipersensitief (allergies) is magnesiumglisinaat of vir enige van die ander bestanddele van VITAMINME MAGNESIUM GLYCINATE (gelys in afdeling 6).
Waarskuwings en voorsorgmaatreëls
Neem spesiale sorg:
- Indien jy ‘n mediese toestand het of as jy tans enige ander medisyne gebruik.
- Indien jy ‘n niersiekte of verminderde nierfuksie het, aangesien jy ‘n groter risiko het om hipermagnesemie (hoë vlak van magnesium in die bloed) te ontwikkel.
Kinders en adolessente
VITAMINME MAGNESIUM GLYCINATE word nie aanbeveel vir individue onder die ouderdom van 18 jaar nie.
Ander medisyne en VITAMINME MAGNESIUM GLYCINATE
Lig altyd jou gesondheidsorgverskaffer in indien jy enige ander medisyne neem. Dit sluit aanvullende of tradisionele medisyne in.
Die volgende medisynes mag interaksie met VITAMINME MAGNESIUM GLYCINATE hê:
- Aminoglikosied antibioktika: gelyktydige gebruik van aminoglikosied antibiotika en magnesium kan die risiko vir neuromuskulêre swakheid verhoog.
- Bisfosfonate: Magnesium kan absorpsie van bisfosfonate verminder.
- Kalsiumkanaalblokkeerders: Magnesium kan bykomende effekte hê met kalsiumkanaalblokkeerders.
- Levodopa/carbidopa: Magnesium kan die beskikbaarheid van levodopa/carbidopa verminder.
- Kaliumbesparende diuretika: Kaliumbesparende diuretika verminder die uitskeding van magnesium, wat moontlik magnesiumvlakke verhoog.
- Kinoloon antibiotika: Magnesium verminder absorpsie van kinolone.
- Tetrasiklien antibiotika: Magnesium verminder die absorpsie van tetrasikliene.
VITAMINME MAGNESIUM GLYCINATE met kos en drinkgoed
VITAMINME MAGNESIUM GLYCINATE het geen bekende interaksie met kos of drinkgoed nie (sien afdeling 3).
Swangerskap, borsvoeding en vrugbaarheid
Indien jy swanger is of jou baba borsvoed, vermoed dat jy swanger mag wees of beplan om swanger te raak, raadpleeg asseblief jou dokter, apteker of ander gesondheidsorgverskaffer voordat jy VITAMINME MAGNESIUM GLYCINATE neem.
Veiligheid vir gebruik tydens swangerskap en laktasie is nie vasgestel nie.
Bestuur en die gebruik van masjinerie
Dit is onwaarskynlik dat VITAMINME MAGNESIUM GLYCINATE jou vermoë om ‘n voertuig te bestuur en masjinerie te gebruik sal affekteer.
Pasiënte moet versigtig wees voordat hulle bestuur of masjinerie gebruik, totdat hulle redelik seker is dat VITAMINME MAGNESIUM GLYCINATE nie hul werkverrigting nadelig beïnvloed nie.
3. Hoe om VITAMINME MAGNESIUM GLYCINATE te gebruik
Moenie medisyne met enige ander persoon deel nie.
Gebruik VITAMINME MAGNESIUM GLYCINATE altyd presies soos wat in hierdie inligtingsblad aangedui word, of soos wat jou dokter of apteker vir jou aangewys het. Vra gerus jou dokter of apteker indien jy onseker is.
Volwassenes 18 jaar en ouer
Neem 1 – 2 tablette daagliks na ete, of soos aanbeveel deur jou gesondheidsorgverskaffer.
Sluk die tablet heel in en moet dit nie kou of opbreek nie.
Moenie die aanbevole dosis oorskry nie.
Wat om te doen indien jy meer VITAMINME MAGNESIUM GLYCINATE geneem het as wat jy moet
In die geval van ‘n oordosis, raadpleeg jou dokter of apteker. Indien nie een van hulle beskikbaar is nie, kontak die naaste hospitaal of gifsentrum. Neem hierdie inligtingsblad en die res van die kapsules saam sodat die dokter weet wat jy geneem het.
Indien jy vergeet het om VITAMINME MAGNESIUM GLYCINATE te neem
Moenie ‘n dubbele dosis neem om op te maak vir die individuele dosisse wat oorgeslaan is nie.
4. Moontlike newe-effekte
VITAMINME MAGNESIUM GLYCINATE kan newe-effekte hê.
Nie alle newe-effekte wat vir VITAMINME MAGNESIUM GLYCINATE gerapporteer is, word in hierdie inligtingsblad ingesluit nie. Indien jou algemene gesondheid verswak of indien jy enige ongunstige effekte onderwind terwyl VITAMINME MAGNESIUM GLYCINATE geneem word, raadpleeg asseblief jour gesondheidsverskaffer.
Indien jy enige van die volgende ervaar, hou op om VITAMINME MAGNESIUM GLYCINATE te neem en sê dadelik vir jou dokter of gaan na die ongevalle-afdeling by jouse naase hospitaal:
- swelling van jou hande, voete, enkels, gesig, lippe en mond of keel, wat probleme kan veroorsaak met sluk en asemhaling; uitslag of gejeuk; floute.
Hierdie is baie ernstige newe-effekte. Indien jy dit het, mag jy ’n ernstige allergiese reaksie op VITAMINME MAGNESIUM GLYCINATE gehad het. Jy mag dringende mediese bystand of hospitalisasie benodig.
Sê vir jou dokter indien jy enige van die volgende opmerk:
Newe-effekte wat met onbekende frekwensie voorkom:
- gastroïntestinale irritasie; naarheid; braking; diarree.
Indien jy enige newe-effekte opmerk wat nie in hierdie inligtingsblad genome word nie, lig asseblief jou dokter of apteker in.
Rapportering van newe-effekte
Indien jy newe-effekte ondervind, bespreek dit met jou dokter of apteker. Jy kan ook newe-effekte aan SAHPRA rapporteer via die “6.04 Adverse Drug Reactions Reporting Form”, wat aanlyn by SAHPRA se publikasies beskikbaar is: http://www.sahpra.org.za/Publications/Index/8. Deur newe-effekte te rapporteer kan jy help om meer inligting rakende die veiligheid van VITAMINME MAGNESIUM GLYCINATE te verskaf.
5. Hoe omVITAMINME MAGNESIUM GLYCINATE te bêre
- Bêre by of onder 25 °C in ‘n droë plek weg van vog en direkte sonlig.
- Bêre alle medisyne buite bereik van kinders.
- Bêre in die oorspronklike houer tot benodig word vir gebruik.
- Moenie gebruik na die vervaldatum op dieetiketnie.
- Neem alle ongebruikte medisyne na u apteker terug.
- Moenie ongebruikte medisyne in afvoerpype of rioolsisteme (bv. toilette) weggooi nie.
6. Inhoud van die verpakking en ander inligting
Wat VITAMINME MAGNESIUM GLYCINATE bevat
Elke tablet bevat: Magnesiumglisinaat Verskaf 125,00 mg Magnesium (elementale) | 625,00 mg |
Die ander bestanddele is mikrokristallyne sellulose, magnesiumstearaat, mieliestysel, silikondioksied, rooi film-bedekking.
Suikervry
Hoe VITAMINME MAGNESIUM GLYCINATE lyk en inhoud van die verpakking
Rooi, ovaalvormige filmbedekte tablette. Die tablette word verpak in ‘n deursigtige, bruinkleurige glasfles met ‘n drukseël en ‘n wit, geribde skroefdop deksel.
Verpakkingsgrootte: 30 tablette.
Houer van Registrasiesertifikaat
VitaminMe (Edms.) Bpk.
Frickerpad 32
Illovo
Johannesburg
Suid-Afrika
2196
Hierdie inligtingsblad is laas hersien in
Sal met registrasie deur SAHPRA toegeken word.
Registrasienommer
Sal met registrasie deur SAHPRA toegeken word.
PROFESSIONAL INFORMATION
COMPLEMENTARY MEDICINE: HEALTH SUPPLEMENT
This unregistered medicine has not been evaluated by SAHPRA for its quality, safety or intended use.
SCHEDULING STATUS
S0
1. NAME OF THE MEDICINE
VITAMINME MAGNESIUM GLYCINATE (film-coated tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Magnesium Glycinate Providing 125,00 mg Magnesium (elemental) |
625,00 mg |
Sugar free.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
19 mm oval, red film-coated tablets.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
VITAMINME MAGNESIUM GLYCINATE is a health supplement that contributes to normal muscle function and protein synthesis, helps with normal nervous system, psychological function and sleep.
4.2 Posology and method of administration
Posology
Adults 18 years and older: Take 1 – 2 tablets daily after food, or as recommended by a healthcare provider.
Swallow the tablet whole and do not chew or crush.
Do not exceed the recommended dose.
Method of administration
For oral use. To be taken after food.
4.3 Contraindications
- Hypersensitivity to magnesium glycinate or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
- VITAMINME MAGNESIUM GLYCINATE should be used with caution by individuals with kidney disease or reduced kidney function. Kidney disease reduces magnesium excretion and increases the risk for hypermagnesemia.
4.5 Interaction with other medicines and other forms of interaction
- Aminoglycoside antibiotics: Concomitant use of aminoglycoside antibiotics and magnesium can increase the risk for neuromuscular weakness.
- Bisphosphonates: Magnesium can decrease absorption of bisphosphonates.
- Calcium channel blockers: Magnesium can have additive effects with calcium channel blockers.
- Levodopa/carbidopa: Magnesium can reduce the bioavailability of levodopa/carbidopa.
- Tetracyclines antibiotics: Magnesium decreases absorption of tetracyclines.
- Potassium-sparing diuretics: Potassium-sparing diuretics decrease excretion of magnesium, possibly increasing magnesium levels.
- Quinolone antibiotics: Magnesium decreases absorption of quinolones.
- Tetracycline antibiotics: Magnesium decreases absorption of tetracyclines.
4.6 Fertility, pregnancy and lactation
Safety in fertility, pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
Patients should exercise caution before driving or operating machinery until they are reasonably certain that VITAMINME MAGNESIUM GLYCINATE does not adversely affect their performance.
4.8 Undesirable effects
VITAMINME MAGNESIUM GLYCINATE is generally well tolerated.
Gastrointestinal disorders
Frequency unknown: gastrointestinal irritation, nausea, vomiting, diarrhoea.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.
4.9 Overdose
In the event of an overdose, undesirable effects as listed in 4.8 can be precipitated or be of increased severity.
Treatment of overdose is symptomatic and supportive.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Class and category: Category D 34.7 Minerals.
Extracellular magnesium is critical to both maintaining nerve and muscle electrical potentials and transmitting impulses across neuromuscular junctions. Magnesium is important for normal bone structure. Magnesium is required for the formation of cyclic AMP and is involved in ion movements across cell membranes. It is involved in protein synthesis and carbohydrate metabolism.
5.2 Pharmacokinetic properties
Magnesium is absorbed throughout the gastrointestinal tract and about one third of dietary magnesium is absorbed. Magnesium plasma concentrations peak after 4 hours and is excreted primarily via the kidneys. Magnesium excretion is primarily via the kidneys.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core:
Microcrystalline cellulose
Magnesium stearate
Maize starch
Silicon dioxide
Red film-coating:
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months.
6.4 Special precautions for storage
Store at or below 25 °C.
Store in a dry place away from direct sunlight and moisture.
Store in the original packaging until required for use.
6.5 Nature and contents of container
Clear, amber glass jar with a pressure seal and a white, ribbed screwcap lid.
Pack size: 30 tablets.
6.6 Special precautions for disposal
No special requirements.
7. HOLDER OF CERTIFICATE OF REGISTRATION
VitaminMe (Pty) Ltd
32 Fricker Road
Illovo
Johannesburg
South Africa
2196
8. REGISTRATION NUMBER
Will be allocated by SAHPRA upon registration.
9. DATE OF FIRST AUTHORISATION
Will be allocated by SAHPRA upon registration.