Medine.co.uk

Sodium Bicarbonate 500mg Capsules

Document: label-leaflet MAH GENERIC_PL 13931-0021 change

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Please take this leaflet, any remaining capsules, and the container with you to

4. POSSIBLE SIDE EFFECTS

• feeling bloated

If you experience these effects, or if you are worried about them, you should

5. HOW TO STORE SODIUM BICARBONATE

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Marketing Authorisation Holder and Manufacturer

the hospital or doctor so that they know which capsules were consumed.

Like all medicines, Sodium Bicarbonate can cause side effects, although not

• belching.

contact your doctor or pharmacist.

Keep this medicine out of the sight and reach of children.

What Sodium Bicarbonate capsules contain:

Chanelle Medical

everybody gets them.

• wind

This medicinal product does not require any special storage conditions.

• The active ingredient is sodium bicarbonate. Each capsule contains 500 mg

Loughrea

If you forget to take Sodium Bicarbonate

Reporting of side effects

Do not use Sodium Bicarbonate after the expiry date which is stated on the

of sodium bicarbonate.

Co. Galway

If you have been prescribed regular doses of this medicine, and you forget to

If the following happens, stop taking the capsules and tell your doctor

The following effects may also occur:

If you get any side effects, talk to your doctor or pharmacist. This includes

label. The expiry date refers to the last day of that month.

• The other ingredient is magnesium stearate. The capsule shells contain

Ireland

take your dose at the correct time, take it as soon as you remember, unless it

immediately or go to the casualty department at your nearest hospital:

• If you use Sodium Bicarbonate for a long time, your body tissues and

any possible side effects not listed in this leaflet. You can also report side

gelatin and titanium dioxide (E171).

is nearly time to take the next one. Do not take a double dose to make up for

• an allergic reaction (swelling of the lips, face or neck leading to severe

fluids may become too alkaline. This is known as alkalosis and you may

effects directly via Yellow Card Scheme, website:

Medicines should not be disposed of via wastewater or household waste.

The distributor is Chanelle Medical U.K. Ltd.

a forgotten dose.

difficulty in breathing; skin rash or hives).

notice muscle weakness and cramps.

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide

Ask your pharmacist how to dispose of medicines no longer required. These

What Sodium Bicarbonate looks like and the contents of the pack

This is a very serious but rare side effect. You may need urgent medical

• Sodium Bicarbonate capsules contain a lot of sodium, which could make

more information on the safety of this medicine.

measures will help to protect the environment.

Sodium Bicarbonate capsules are white to off white capsules containing a

This leaflet was last revised in 01/2016

If you have any further questions on the use of this product, ask your doctor

attention or hospitalisation.

your blood pressure go up or cause fluid accumulation in your body and

white crystalline powder.

or pharmacist.

lungs.

Sodium Bicarbonate is available in the following pack sizes: 56 and 100

Tell your doctor if you suffer from any of the following for more than a few days:

• If you already have a low level of potassium in your blood (hypokalaemia),

capsules.

• stomach pains

Sodium Bicarbonate capsules may make this worse.

Not all pack sizes may be marketed.


56 Sodium Bicarbonate Capsules 500mg Capsules


Each capsule contains 500 mg Sodium Bicarbonate Please read the attached leaflet carefully-KEEP OUT OF THE SIGHT AHD REACH OF CHILDREN. Uiughrn Co. Galway.

Swallow the capsules or empty the contents into water and swallow. Maximum sodium content per capsule is 144.0 mg.

Dosage

As an antacid: 1 g to 5 g (2 to 10 capsules) in water or as directed by your doctor.

Metabolic acidosis: as directed by your doctor.

CHANELLE

MEDICAL U.K. LTD.


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PACKAGE LEAFLET: INFORMATION FOR THE USER

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. However, you still need to take Sodium Bicarbonate capsules carefully to get the best results from them.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    You must contact a doctor if your symptoms worsen or do not improve after 24 hours.

•    This medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

•    If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.


What is in this leaflet:

1.    What Sodium Bicarbonate is and what it is used for

2.    What you need to know before you take Sodium Bicarbonate

3.    How to take Sodium Bicarbonate

4.    Possible side effects

5.    How to store Sodium Bicarbonate

6.    Contents of the pack and other information

1. WHAT SODIUM BICARBONATE IS AND WHAT IT IS USED FOR

Sodium Bicarbonate belongs to a group of drugs known as antacids.

Sodium Bicarbonate is used to treat:

•    indigestion

•    acidosis (a condition where the body fluids and tissues are unusually acidic).


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM BICARBONATE

Take special care with Sodium Bicarbonate

Talk to your doctor before you start to take this medicine if you:

•    have kidney problems

•    have liver problems

•    suffer from high blood pressure or heart failure

•    are elderly

•    are on a low sodium (salt) diet (see also 'important information about some of the ingredients of Sodium Bicarbonate' below).

Please talk to your doctor if your symptoms remain the same after taking this medicine.


Warning and precautions

Talk to your doctor or pharmacist before taking Sodium Bicarbonate

Other medicines and Sodium Bicarbonate

Talk to your doctor if you are taking any of the following:

•    antibiotics or antifungals (to treat infections) e.g. rifampicin, ketoconazole, tetracycline

•    phenothiazines (to treat anxiety or depression)

•    corticosteroids (to treat swelling and inflammation or for allergic reactions)

•    lithium (for depressive illness)

•    aspirin

•    methotrexate (for certain types of tumors, psoriasis or rheumatoid arthritis)

•    quinidine or dipyridamole (to treat heart rhythm disorders)


•    ephedrine (to treat breathing problems)

•    phenytoin (for epilepsy)

•    chloroquine (to prevent or treat malaria)

•    penicillamine (for rheumatism)

•    dipyridamole (to prevent blood clots associated with heart problems).

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

Sodium Bicarbonate with food and drink

Important information about some of the ingredients of Sodium Bicarbonate

•    Patients who are intolerant to sucrose should note that Sodium Bicarbonate capsules contain a small amount of sucrose. If you have been told by your


doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• This capsule contains a significant amount of sodium. This should be taken into account if you are on a low sodium diet.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Sodium Bicarbonate is not known to affect your ability to drive or operate machinery.


3. HOW TO TAKE SODIUM BICARBONATE

Always take Sodium Bicarbonate capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Do not take more than prescribed dose.

Do not take the capsules for too long without seeing your doctor. If your indigestion does not get any better after taking the capsules, go and see your doctor.

The capsules should be swallowed with a drink of water. The usual dose is: Adults

   Indigestion Between 1g and 5 g (2 to 10 capsules) when needed.

   Acidosis Your doctor will calculate the appropriate dose for you.


MA Holder: Chanelle Medical,

Distributed in die U.K. by: Chanelle Medical U.K. Ltd.


PL13931/0021    LE1228


Elderly

If you are elderly, you should consult your doctor before taking this medicine, and must be particularly careful to follow your doctor's instructions.

Use in children

Sodium Bicarbonate is not recommended for use in children.

If you take more Sodium Bicarbonate than you should

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. A severe overdose is likely to cause shortness of breath, muscle weakness, uncontrolled shaking of body and prolonged unconsciousness.


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%EEP At A THE SIGHT AND REACH OF CHILDREN. Uwghnn. Co. Galway,

Swa How the c apsule#r9np0th e co rrtents into wate rand Ireland.

swallow. Maximum sodium content per capsule is 144.0 mg. Debuted in the U K by

Iftaciff 1 g to (2 to 1 ftapsul^ in watoT (ftis ^ directed by your doct# # #    #    #

Metabolic acidosis: directed byyou0octor. 0

CHANELLE    m

MEDICAL U.K. LTD.


Sodium Bicarbonate 500mg Capsules


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MA Holder Chanelle Medicel,

Chaney Mgical U.K. Ltd. • • •

PL13931/0021    LE1228


LC 84251 KEYLINE.art 19/12/2012 SIZE BASE LABEL: 110X35mm LEAFLET SIZE:617X35mm

GUIDES


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Linkassociates

The Studio, Abbeytown House, Caherlistrane, Galway, Ireland. T: +353 93 31060 E: raydes@iol.ie

Client

Chanelle

Colours used:

Date

27.1.16

Black

Product

Sodium Bicarbonate

280

Pack Code

341

Scale / Size

1:1 / 110x35mm (617x35mm total)

Software

Illustrator CS5

Proof No

5

Contact

Ray McDonnell

Minimum font size: 7pt