TC Health Acid Sooth 195 mg/170 mg Oral Suspension

PATIENT INFORMATION LEAFLET:

TC HEALTH ACID SOOTH^® 195 mg/170 mg Oral Suspension

Magnesium hydroxide 195 mg/5 ml

Aluminium hydroxide 170 mg/5 ml

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has recommended.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice
• If you get any side effects, talk to your doctor, pharmacist or health care practitioner. This includes any possible side effects not listed in this leaflet (see section 4).
• You must talk to a doctor if you do not feel better or if you feel worse

What is in this patient information leaflet:

1. What TC Health Acid Sooth Suspension is and what it is used for
   2. What you need to know before you take TC Health Acid Sooth Suspension
   3. How to take TC Health Acid Sooth Suspension
   4. Possible side effects
   5. How to store TC Health Acid Sooth Suspension
   6. Contents of the pack and other information
2. What TC Health Acid Sooth Suspension is and what it is used for

TC Health Acid Sooth Suspension contains two different minerals. They are called aluminium hydroxide and magnesium hydroxide. They belong to a group of medicines called anti-acids.

TC Health Acid Sooth Suspension is used for:

• Heartburn or when your stomach has too much acid (indigestion)
• Inflammation of the stomach (gastritis), and
• When prescribed by a doctor it may also be used for lowering the amount of acid in your stomach or gut (intestine) for when you have an ulcer

TC Health Acid Sooth Suspension works by lowering the amount of acid in your stomach.

2. What you need to know before you take TC Health Acid Sooth Suspension

Do not take TC Health Acid Sooth Suspension if:

• You are allergic to aluminium hydroxide or magnesium hydroxide or any of the other ingredients in TC Health Acid Sooth Suspension (listed in section 6).
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You are feeling very weak and have no energy (lethargic)
• You have kidney problems. Long term exposure to high doses of TC Health Acid Sooth Suspension can lead to dementia.
• You have severe stomach pain
• Your bowel is partially or fully blocked

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking TC Health Acid Sooth Suspension.

Warnings and precautions

Take special care with TC Health Acid Sooth Suspension. Check with your doctor or pharmacist before taking this medicine:

If you are on a low-phosphorous diet

Other medicines and TC Health Acid Sooth Suspension

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines.

TC Health Acid Sooth Suspension should not be taken at the same time as other medicines. This is because TC Health Acid Sooth Suspension can affect the way other medicines work.

Some medicines may be affected by magnesium hydroxide or they may affect how well magnesium hydroxide will work. Tell your doctor or pharmacist if you are already taking: Salicylates.

In particular, TC Health Acid Sooth Suspension can affect the following medicines:

• Some medicines used to treat infections such as Ciprofloxacin, Tetracycline, Rifampicin & Ketoconazole
• Medicines for malaria such as Hydroxychloroquine and Chloroquine
• Vitamins or Iron supplements
• Chlorpromazine – used for mental illness
• Polystyrene sulphonate – used to treat high levels of potassium in the blood

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking this medicine if:

• You are pregnant, might become pregnant, or think you may be pregnant. You should not take TC Health Acid Sooth Suspension during the first three months of pregnancy
• You are breast-feeding or planning to breast-feed

TC Health Acid Sooth Suspension contains sorbitol (E420).

This medicine contains sorbitol

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

3. How to take TC Health Acid Sooth Suspension

Always take this medicine exactly as described in this patient information leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Shake well before use to ensure the product is mixed properly
• Take this medicine by mouth
• If necessary, TC Health Acid Sooth Suspension may be taken with water or milk

Adults, the elderly and children aged 14 years or older

• Take two to four 5ml teaspoonfuls
• Take 15 minutes to 1 hour after meals and at bedtime
• Alternatively, take as directed by your doctor

If the symptoms do not go away, talk to your doctor

Children less than 14 years old

• TC Health Acid Sooth Suspension is not recommended for children less than 14 years of age

If you take more TC Health Acid Sooth Suspension than you should

Talk to your doctor or go to a hospital immediately. Remember to take any medicine that is left with you, so the doctor knows what you have taken.

The following effects may occur: stomach pain, diarrhoea, or you may get a bloated feeling and cramping pain in the abdomen (stomach), be sick (vomit), have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the bowel (ileus).

4. Possible side effects

Like all medicines, TC Health Acid Sooth Suspension can cause side effects, although not everybody gets them.

Stop taking TC Health Acid Sooth Suspension and see a doctor or go to a hospital immediately if:

• You have a red and lumpy skin rash, swollen eyelids, lips, face, mouth or tongue, itching and difficulty breathing and/or swallowing. This could be an allergic reaction.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:

• Constipation
• Diarrhoea

• Hypermagnesemia, including observations after prolonged administration to patients with renal impairment.

• Hypophosphatemia is an electrolyte disturbance in which there is an abnormally low level of phosphate in the body. This may occur at high doses of the product or even at normal doses especially in patients with low phosphorous diets
• Hyperaluminemia is an electrolyte disturbance in which there is an abnormally elevated level of aluminium in the body
• Abdominal pain

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this patient information leaflet.

5. How to store TC Health Acid Sooth Suspension

Keep this medicine out of reach of children.

Do not use TC Health Acid Sooth Suspension after the expiry date which is stated on the bottle after “EXP”. The expiry date refers to the last day of that month.

Throw away any medicine remaining 6 months after opening the bottle.

Store below 25°C.

Do not throw away medicines into wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. Contents of the pack and other information

What TC Health Acid Sooth Suspension contains

• Each 5ml of suspension contains 195mg of Magnesium hydroxide and 170mg of Aluminium hydroxide as the active ingredients.
• The other ingredients (excipients) are: Purified water, Sodium Benzoate, Potassium Sorbate, Peppermint flavour, Carboxymethylcellulose, Methyl paraben, Sucralose, Saccharin sodium, Sorbitol liquid (E420).

What TC Health Acid Sooth Suspension looks like and contents of the pack

TC Health Acid Sooth Suspension is a white, mint flavoured suspension and is available in a 250ml white plastic bottle, with a white plastic lid. The product must have a clear plastic tamper sleeve over it when initially purchased.

Manufacturer:

Microbel Laboratories (Pty) Ltd, 86 Gazelle Avenue, Corporate Park South, Midrand, 1685.

This patient information leaflet may not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This unregistered medicine has not been evaluated by the SAHPRA or BOMRA for its quality, safety or intended use. The medicine is not intended to diagnose, treat, cure, or prevent any disease.

This leaflet was last revised in July 2022

© Microbel Laboratories

TC Health Acid Sooth 195 mg/170 mg Orale Suspensie

Skeduleringstatus: S0

PASIËNTINLIGTINGSPAMFLET:

TC HEALTH ACID SOOTH^® 195mg/170mg Orale Suspensie

Magnesiumhidroksied 195 mg/5 ml

Aluminiumhidroksied 170mg/5 ml

Lees hierdie hele pamflet aandagtig deur voordat jy dié medikasie gebruik; dit bevat belangrike inligting.

Hierdie medikasie is beskikbaar sonder ‘n voorskrif van ‘n dokter. Neem altyd die medikasie presies soos dit in die pamflet aangedui word, of soos aanbeveel deur jou dokter of apteker.

• Moenie hierdie pamflet weggooi nie. Jy mag dit moontlik weer moet lees.
• Vra jou gesondheidsorgverskaffer of apteker indien jy meer inligting of advies benodig.
• Indien jy newe-effekte ervaar terwyl jy hierdie produk gebruik, moet jy jou dokter, apteker of ander gesondheidskundige vir advies raadpleeg. Dit sluit enige moontlike newe-effekte in, wat nie in die pamflet gelys is nie (verwys na afdeling 4).
• Jy moet jou dokter in kennis stel indien jou simptome vererger of nie verbeter nie.

Wat is in hierdie pamflet:

1. Wat TC HEALTH ACID SOOTH^®Suspensie is en waarvoor dit gebruik word.
   2. Wat jy moet weet voordat jy TC HEALTH ACID SOOTH^®Suspensie gebruik.
   3. Hoe om TC HEALTH ACID SOOTH^® Suspensie te gebruik.
   4. Moontlike newe-effekte.
   5. Bergingsaanwysings vir TC HEALTH ACID SOOTH^® Suspensie.
   6. Inhoud van die verpakking en ander inligting.
2. WAT TC HEALTH ACID SOOTH^®SUSPENSIE IS EN WAARVOOR DIT GEBRUIK WORD:

TC HEALTH ACID SOOTH^® SUSPENSIE bevat twee verskillende minerale, naamlik aluminiumhidroksied en magnesiumhidroksied. Hierdie minerale behoort aan die medisynegroep, wat teensuurmiddels genoem word.

TC HEALTH ACID SOOTH^® SUSPENSIE word gebruik vir:

• Sooibrand of wanneer jou maag ‘n hoë suurinhoud het (spysverteringsprobleme),
• Inflammasie van die maag (gastritis), en
• Wanneer dit deur ‘n dokter voorgeskryf word kan dit ook gebruik word om die suurinhoud in die maag of derms te verlaag, vir die behandeling van swere.

TC HEALTH ACID SOOTH^® SUSPENSIE werk deur die suurinhoud in die maag te verlaag.

2. WAT JY MOET WEET VOORDAT JY TC HEALTH ACID SOOTH^®SUSPENSIE GEBRUIK:

Moenie TC HEALTH ACID SOOTH^® SUSPENSIE gebruik indien:

• Jy allergies is vir aluminiumhidroksied of magnesiumhidroksied of enige van die ander gelyste bestanddele in TC HEALTH ACID SOOTH^® SUSPENSIE nie (verwys na afdeling 6).
  Tekens van ‘n allergiese reaksie sluit die volgende in: ‘n uitslag, sluk- of asemhalingsprobleme, swelling van lippe, gesig, keel of tong.
• Jy swak voel of geen energie het nie (lusteloos).
• Jy nierprobleme het. Langtermyn blootstelling aan hoë dosisse van TC HEALTH ACID SOOTH^® SUSPENSIE kan na demensie lei.
• Jy erge maagpyn het.
• Jou derms gedeeltelik of heeltemal geblokkeer is.

Moenie hierdie medikasie gebruik indien enige van die bogenoemde punte van toepassing is op jou nie. Indien jy onseker is, raadpleeg jou dokter of apteker voordat jy TC HEALTH ACID SOOTH^® SUSPENSIE gebruik.

WAARSKUWINGS EN VOORSORGMAATREËLS

Neem spesiale sorg met TC HEALTH ACID SOOTH^® SUSPENSIE. Raadpleeg jou dokter of apteker voordat jy die medikasie gebruik:

Indien jy ‘n lae-fosfor dieet volg.

Ander medikasie en TC HEALTH ACID SOOTH^® SUSPENSIE

Stel jou dokter of apteker in kennis indien jy ander medikasie huidiglik gebruik, onlangs gebruik het of van plan is om dit te gebruik. Dit sluit aanvullende- en tradisionele medikasie in.

TC HEALTH ACID SOOTH^® SUSPENSIE moet nie saam met ander medikasie gebruik word nie, omdat dit die werking/effek van ander medikasie kan beïnvloed.

Sommige medikasie se werking kan beïnvloed word deur magnesiumhidroksied of dit kan die effektiewe werking van magnesiumhidroksied beïnvloed. Stel jou dokter of apteker in kennis indien jy reeds die volgende gebruik: Salisilate.

In besonder kan TC TC HEALTH ACID SOOTH^® SUSPENSIE die volgende medikasie beïnvloed:

• Sommige medikasie wat gebruik word vir die behandeling van infeksies: Siprofloksasien, Tetrasiklien, Rifampisien en Ketokonasool.
• Medikasie vir malaria byvoorbeeld Hidroksiechlorokien en Chlorokien.
• Vitamiene of ysteraanvullings.
• Chloorpromasien – aangedui vir geestesongesteldheid.
• Polistireensulfonaat – aangedui vir die behandeling van hoë kaliumvlakke in die bloed.

Swangerskap en borsvoeding

Raadpleeg jou dokter of apteker voordat jy hierdie medikasie gebruik indien:

• Jy swanger is, beplan om swanger te word, of dink dat daar ‘n moontlikheid is dat jy wel swanger is. Jy moet nie TC HEALTH ACID SOOTH^® SUSPENSIE gedurende die eerste drie maande van swangerskap gebruik nie.
• Jy borsvoed of beplan om te borsvoed.

TC HEALTH ACID SOOTH^® SUSPENSIE bevat sorbitol (E420).

Hierdie medikasie bevat sorbitol.

Sorbitol is ‘n bron van fruktose. Indien jou dokter jou in kennis gestel het dat jy (of jou kind) ‘n onverdraagsaamheid het teenoor sekere suikers of indien jy met ‘n oorerflike fruktose-onverdraagsaamheid (‘n genetiese afwyking waar ‘n persoon se liggaam nie fruktose kan afbreek nie) gediagnoseer is, moet jou dokter geraadpleeg word voordat hierdie medikasie gebruik word.

3. HOE OM TC HEALTH ACID SOOTH^®SUSPENSIE TE GEBRUIK:

Neem altyd die medikasie presies soos dit in die pamflet aangedui word, of soos aanbeveel deur jou dokter of apteker. Raadpleeg jou dokter of apteker indien jy onseker is.

Hoe om medikasie te gebruik:

• Skud goed voor gebruik om te verseker dat die produk behoorlik gemeng is.
• Neem oraal.
• Indien nodig kan TC HEALTH ACID SOOTH^® SUSPENSIE saam met water of melk geneem word.

Volwassenes, bejaardes en kinders van 14 jaar en ouer

• Neem twee tot vier teelepels  (5 ml) vol
• Neem die medikasie 15 minute tot 1 uur na etes of voor slaaptyd
• Alternatiewelik, neem soos voorgeskryf deur jou dokter.

Indien die simptome nie verbeter nie, moet jou dokter in kennis gestel word.

Kinders onder 14 jaar

• TC HEALTH ACID SOOTH^® SUSPENSIE word nie aanbeveel vir gebruik in kinders onder die ouderdom van 14 jaar nie.

Indien jy oordoseer met TC HEALTH ACID SOOTH^® SUSPENSIE:

Kontak jou dokter of gaan onmiddellik na die hospitaal toe. Onthou om enige medikasie wat oor is saam met jou te neem, sodat die dokter weet wat jy geneem het.

Die volgende simptome kan voorkom: maagpyn, diarree, of jy kan ‘n opgeblase gevoel of krampende pyn in die buik (maag) kry, braking, spysverteringsprobleme, sooibrand, omgekrapte maag, hardlywigheid, aptytverlies, droeë mond. Dit kan veroorsaak word deur ‘n obstruksie of blokkasie in die derm (ileus).

4. MOONTLIKE NEWE-EFFEKTE:

Soos alle medikasie kan TC HEALTH ACID SOOTH^® SUSPENSIE newe-effekte veroorsaak, alhoewel nie almal dit ervaar nie.

Staak onmiddellik die gebruik van TC HEALTH ACID SOOTH^® SUSPENSIE en raadpleeg ‘n dokter of gaan onmiddellik na die hospitaal indien:

• Jy ‘n rooi knopperige veluitslag het.
• Jy opgeswelde ooglede, lippe, gesig, mond of tong het.
• Jy jeuk.
• Jy sluk- of asemhalingsprobleme het. Dit kan ‘n allergiese reaksie wees.

Stel jou dokter of apteker in kennis indien enige van die volgende newe-effekte vererger of langer as ‘n paar dae duur. Asook oor enige newe-effekte wat nie in hierdie pamflet gelys in nie.

• Hardlywigheid.
• Diarree.

• Hipermagnesemie, insluitend waarnemings na die langdurige toediening aan pasiënte met nierversaking.
• Hipofosfatemie is ‘n elektrolietwanbalans waar daar abnormale lae vlakke van fosfaat in die liggaam is. Dit kan voorkom waar hoë dosisse van die produk gebruik word of selfs by normale dosisse, veral in pasiënte wat ‘n lae-fosfor dieet volg.
• Hiperaluminemie is ‘n elektrolietwanbalans waar daar abnormale verhoogde vlakke van aluminium in die liggaam is.
• Abdominale pyn.

Aanmelding van newe-effekte

Stel jou dokter of apteker in kennis indien jy enige newe-effekte ervaar. Asook enige newe-effekte wat nie in hierdie pamflet gelys in nie.

5. BERGINGSAANWYSINGS VIR TC HEALTH ACID SOOTH^®SUSPENSIE:

Hou buite bereik van kinders.

Moenie die produk na die vervaldatum, aangedui op die houer, gebruik nie. Die vervaldatum verwys na die laaste dag van die maand.

Gooi enige oorblywende medikasie weg,  6 maande nadat die bottel oopgemaak is.

Bewaar onder 25°C.

Moenie enige ongebruikte medikasie weggooi in die drein of rioolstelsels nie. Vra jou apteker hoe om van medikasie ontslae te raak wat nie meer nodig is nie.

6. INHOUD VAN DIE VERPAKKING EN ANDER INLIGTING:

Wat TC HEALTH ACID SOOTH^® SUSPENSIE bevat

• Elke 5 ml van die suspensie bevat 195 mg Magnesiumhidroksied en 170 mg Aluminiumhidroksied as aktiewe bestanddele.
• Die ander bestanddele (hulpstowwe) is: Gesuiwerde water, Natriumbensoaat, Kaliumsorbaat, Peperment geur, Karboksiemetielsellulose, Metielparabeen, Sukralose, Sakkariennatrium, Sorbitol vloeistof (E420).

Voorkoms van TC HEALTH ACID SOOTH^® SUSPENSIE en inhoud van die verpakking:

TC HEALTH ACID SOOTH^® SUSPENSIE is ‘n wit, peperment-gegeurde suspensie en is beskikbaar in ‘n 250 ml wit plastiekbottel, met ‘n wit plastiek proppie. Die produk moet ‘n deursigtige, plastiek, peuterbestande film oor hê, wanneer dit aanvanklik aangekoop word.

Vervaardiger:

Microbel Laboratories (Pty) Ltd, 86 Gazelle Avenue, Corporate Park South, Midrand, 1685.

Die pasiëntinligtingspamflet mag moontlik nie alle inligting oor die medikasie bevat nie. Indien jy enige vrae het of indien jy onseker is oor enige iets, raadpleeg jou dokter of apteker.

Hierdie ongeregistreerde medikasie is nie deur SAHPRA of BOMRA geëvalueer ten opsigte van kwaliteit, veiligheid of voorgenome gebruik nie. Die doel van hierdie medikasie is nie om enige siekte te diagnoseer, behandel, genees of te voorkom nie.

Datum van laaste hersiening: Julie 2022

© Microbel Laboratories