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RENNIE SPEARMINT - patient leaflet, side effects, dosage

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Patient leaflet - RENNIE SPEARMINT

4. possible side effects

I

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are unlikely at the recommended dose. If you experience the following side effects stop treatment immediately and seek medical advice. Rarely allergic reactions to ingredients have been reported, e.g. rashes, itching, difficulty in breathing and swelling of the face, mouth or throat and anaphylactic shock (anaphylactic shock is a severe sudden allergic reaction, symptoms of which are low blood pressure, shock, palpitations, difficulty in breathing, bronchospasm, skin reactions, abdominal pain or cramps, vomiting and diarrhoea).

Long term use of high doses can cause high blood levels of calcium and magnesium, especially in people with kidney conditions. Symptoms of this may include nausea, vomiting, upset stomach, constipation, diarrhoea, tiredness, muscular weakness, headache, kidney problems and impaired sense of taste.

In exceptional cases, long term use of high doses can lead to milk alkali syndrome, which can cause high blood levels of calcium.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA 1 Yellow Card in the Google Play or Apple App Store. | By reporting side effects you can help provide more information on the safety of this medicine.

  • 5. HOWTOSTORE­RENNIE®SPEARMINT

Keep this medicine out of the sight and reach of children. Store below 25°C and keep in the original pack. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  • 6. CONTENTSOF­THEPACKANDOTHER

INFORMATION

I

What Rennie Spearmint contains:

The active substances are: calcium carbonate 680mg and heavy magnesium carbonate 80mg.

The other ingredients are sucrose, glucose, spearmint flavour, talc, povidone, saccharin sodium, magnesium stearate.

  • _ JWhatRennte_Spe­arminttooks1i­ke_andcontents_----

of the pack :

Rennie Spearmint are cream white square tablets, engraved „RENNIE“ on both faces.

Rennie Spearmint are available in packs of 12, 24, 36, 48, 72, 96, 120 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturer:

  • _ ■MarketingAutho­risationHotde­rrBayerplc;-----1----

400 South Oak Way, Reading, RG2 6AD, UK. 1

Manufacturer: Delpharm Gaillard, 74240 Gaillard, i France.

I

This leaflet was last revised in: January 2021 1

Bayer;

FONT SIZE PANEL


Main Text (body copy):

8pt

Height (based on lower case x):

1.4 mm


ARTWORK APPROVAL PANEL


Packaging Site Approval:


Name:

Date:

Action:


Country Approval:


Name:

Date:

Action:



DELPHARM GAILLARD TRYPTIC NUMBER:

DELPHARM N/A


MOCKUP

not for production


BAYER ARTWORK PANEL


Bayer Ref No:

BAY451374

Reference No:

TR2065364

Brand:

Rennie

Range:

Chew Tablets

Product:

Spearmint

Pack Type:

Leaflet

Pack Size:

24/36/48/72/96 Pack

Action:

B

Date:

21/12/20

Country:

UK

Finished Goods Code:

Synaps Request Code:

Component Code:

6567946

AW.CSA/MUP-36681–01

000000

CAD Ref No:

PIL 170X210 [SB768B]

Printer:

Packaging Site:

Delpharm Gaillard France [FR]

Substrate:

White Paper

Barcode 1 Type:

Code 128

Barcode 1 Mag:

33.7%

Barcode 2 Type:

N/A

Barcode 2 Mag:

N/A

Pharmacode No/NE:

N/A

Technical & Non Printing Items | Cutter Guides


Rennie!


170 mm


Colours

Process Black


FONT SIZE PANEL


Main Text (body copy): 10 pt

Height (based on lower case x): 1.8 mm


ARTWORK APPROVAL PANEL


Packaging Site Approval:

Name:

Date:

Action:


Calcium Carbonate, Magnesium Carbonate

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. – 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

  • – You must contact a doctor if you do not feel better or if you feel worse after 14 days.

WHAT IS IN THIS LEAFLET

  • 1. What Rennie Spearmint is and what it is used for

  • 2. What you need to know before you take Rennie Spearmint

  • 3. How to take Rennie Spearmint

  • 4. Possible side effects

  • 5. How to store Rennie Spearmint

  • 6. Contents of the pack and information

1. what rennie® spearmint is and what itis used forrennie spearmint fast-acting tablets get to work within minutes to provide effective relief from heartburn, indigestion and acid reflux.

Each tablet contains two antacids – calcium carbonate and magnesium carbonate – that work quickly and powerfully to neutralise excess acid in the stomach.

2. what you need to know before you take rennie® spearmint

Do not take Rennie Spearmint if you:

  • Have severe kidney disease.
  • Have high calcium in the urine or kidney stones.
  • Have high calcium or low phosphate levels in the blood.
  • Are allergic (hypersensitive) to any of the ingredients (listed in Section 6).

Warnings and precautions:

Do not exceed the stated dose.

Rennie Spearmint should not be used for more


SB768 B – Notice Bobine Dimensions : 210 × 170 mm



than 14 days without consulting a doctor.

Please consult your doctor or pharmacist if you have mild or moderate kidney problems as regular blood tests should be carried out.

Other medicines and Rennie Spearmint:

  • Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
  • If you are taking any of the following medicines speak to your doctor or pharmacist before taking Rennie Spearmint because it can affect how these medicines work.

– Tetracyclines and quinolones (antibiotics) – Bisphosphonates (used for the treatment of osteoporosis)

– Dolutegravir (an anti-retroviral medicine used for the treatment of HIV infection)

  • – Levothyroxine (a thyroid hormone)

  • – Eltrombopag (used to increase the number of platelets)

  • – Digoxin (used for some heart conditions)

  • – Thiazide diuretics (water tablets to treat fluid retention and high blood pressure)

  • – Fluorides (for preventing dental caries)

  • – Phosphates (for clearing the bowel before a surgical procedure)

  • – Iron supplements

  • To maximise the benefit of all medicines being used, take Rennie Spearmint at least 4 hours before or after taking eltrombopag and 1 to 2 hours after taking any other medicines.

Taking Rennie Spearmint with food and drink Avoid taking Rennie Spearmint with large amounts of milk or dairy products.

Pregnancy and breastfeeding:

Rennie Spearmint can be used during pregnancy and breastfeeding if taken as instructed. As Rennie Spearmint provides a substantial amount of calcium in addition to dietary calcium intake, pregnant women should strictly limit their use of Rennie Spearmint to the maximum recommended daily dose and avoid concomitant, excessive intake of milk (1 litre contains upto 1.2 g elemental calcium) and dairy products.

000000


Rennie Spearmint contains glucose, sucrose and sodium

This product contains sucrose (250mg) and glucose (250mg). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to teeth. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially ‘sodium-free’.

3. how to take rennie® spearmint

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are unlikely at the recommended dose. If you experience the following side effects stop treatment immediately and seek medical advice.

Rarely allergic reactions to ingredients have been reported, e.g. rashes, itching, difficulty in breathing and swelling of the face, mouth or throat and anaphylactic shock (anaphylactic shock is a severe sudden allergic reaction, symptoms of which are low blood pressure, shock, palpitations, difficulty in breathing, bronchospasm, skin reactions, abdominal pain or cramps, vomiting and diarrhoea).

Long term use of high doses can cause high blood levels of calcium and magnesium, especially in people with kidney conditions. Symptoms of this may include nausea, vomiting, upset stomach, constipation, diarrhoea, tiredness, muscular weakness, headache, kidney problems and impaired


sense of taste. In exceptional cases, long term use of high doses can lead to milk alkali syndrome, which can cause high blood levels of calcium.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rennie® spearmint

Keep this medicine out of the sight and reach of children. Store below 25°C and keep in the original pack. Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Rennie Spearmint contains:

The active substances are: calcium carbonate 680mg and heavy magnesium carbonate 80mg.

The other ingredients are sucrose, glucose, spearmint flavour, talc, povidone, saccharin sodium, magnesium stearate.

What Rennie Spearmint looks like and contents of the pack

:

Rennie Spearmint are cream white square tablets, engraved „RENNIE“ on both faces.

Rennie Spearmint are available in packs of 12, 24, 36, 48, 72, 96, 120 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder: Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK.

Manufacturer: Delpharm Gaillard, 74240 Gaillard, France.

This leaflet was last revised in: January 2021 ggygp





Country Approval:

Name:

Date:

Action:




DELPHARM


DELPHARM GAILLARD TRYPTIC NUMBER: N/A


MOCKUP

not for production