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SODIUM BICARBONATE 500MG CAPSULES

Active substance(s): SODIUM BICARBONATE

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REVISED ARTWORK FOR MHRA APPROVAL
VERSION: 4 (TEVA)
DRAFT ISSUE: 2

Braille reads:
sodium bicarbonate #500
mg capsules

Braille reads:
sodium bicarbonate #500
mg capsules

sodium Bicarbonate #500
mg capsules

sodium Bicarbonate #500
mg capsules

REASON FOR CHANGE: CUTTER PROFILE DIMENSIONS CHANGE

Base label (Selfadhesive) – Digital print

Total of label / Braille placement only – CCL work area

76 mm

56 Capsules
PL 00289/1423

P

SSDB 500
00
A0429/4

27 mm

3

01077-C

MA Holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Almus ® is a registered trademark

Base label (Selfadhesive) – Flexo print – CCL work area

56 Capsules
PL 00289/1423

P

SDB 500
A0429/4

11 mm
Tab/Glue

27 mm

3

01077-C

27 mm

84 mm

11 mm
Tab

27 mm

Sodium
00
Bicarbonate
carbona um
sodiu
u500
m BicarCapsules
apsules
bonate
te
t
e #500
56
mg c
capsules
ules
u
l
01077-C
01077
0
C

5 060057 404294

Sodium
500
Bicarbonate
mg
Capsules

11 mm
Tab

For proofreading of Braille

76 mm

Each capsule contains Sodium
Bicarbonate 500 mg.
DOSAGE:
For oral use. Please peel and read the
leaflet before you start to take your
medicine. Swallow the capsules
or empty the contents into water and
swallow. As an antacid: 1 g to 5 g
(2 to 10 capsules) in water as required.
Metabolic acidosis: as directed by
the doctor.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN.
Store in a cool, dry place.
Store in the original container.

3 8 mm
Glue

84 mm

sodium Bicarbonate #500
mg capsules

5 060057 404294

Sodium
500
Bicarbonate
mg
Capsules

11 mm
Tab/Glue

Each capsule contains Sodium
Bicarbonate 500 mg.
DOSAGE:
For oral use. Please peel and read the
leaflet before you start to take your
medicine. Swallow the capsules
or empty the contents into water and
swallow. As an antacid: 1 g to 5 g
(2 to 10 capsules) in water as required.
Metabolic acidosis: as directed by
the doctor.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN.
Store in a cool, dry place.
Store in the original container.

3 8 mm
Glue

MA Holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Almus ® is a registered trademark

mg
m

Caps
Capsules

PL 00289/1
00289/1423

P

SDB 500

A0429
A0429/4

Each
ach capsule
sule contai
contains Sodium
odiumm
Bica
ca ate 500 mg
Bicarbonate
mg.
DOS
DOSAGE:
For ooral use.
se. Please
se peel and read
rea
the leaflet
l t before
fore yo
you startrt to takee
your medicine.
icine. Swal
he capsules
Swallow the
orr em
empty the conten
contents intoo water an
and
sswallow. As ann antacid:
swal
antac 1 g to 5 g
((2 to 10 capsules)
sule iin water
er as
requ
equ Metabolic
abolic acidosis:
osis: as
required.
direc
rec by the
he doct
directed
doctor.
R H
KEEP OUTT OF THE REACH
N.
AND SIGHT OF CHILDREN.
Store in a cool, dry place..
ainer.
ain
Store in the original container.

SUPPLIER ISSUE DATE: 21.10.2015

MA Holder: TEVA UK Limited, Eastbourne, BN22 9A
9AG.
Almus ® is
Al
i a registered
i t d trademark
t d
k

Leaflet outside (Prima)
84 mm
Page 9

If you forget to take Sodium Bicarbonate
If you have been prescribed regular doses of this medicine, and you forget to take your
dose at the correct time, take your dose as soon as you remember, unless it is nearly time
to take the next one. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Sodium Bicarbonate can cause side effects, although not everybody
gets them.
If the following happens, stop taking the capsules and tell your doctor immediately or go to
the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.
Tell your doctor if you suffer from any of the following for more than a few days:
• stomach pains

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• feeling bloated
• belching
• wind.
The following effects may also occur:
• if you use Sodium Bicarbonate for a long time, your body tissues and fluids may
become too alkaline. This is called alkalosis and you may notice muscle weakness and
cramps.
• Sodium Bicarbonate capsules contain a lot of sodium, which could make your blood
pressure go up or cause fluid accumulation in your body and lungs.
• if you already have a low level of potassium in your blood (hypokalaemia), Sodium
Bicarbonate capsules may make this worse.
If you experience these effects, or if you are worried about them, you should contact your
doctor or pharmacist.

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 leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

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Page 12

5. HOW TO STORE SODIUM BICARBONATE
Keep out of the reach and sight of children.
You should keep your capsules in a cool, dry place. Store in the original container.
Do not use Sodium Bicarbonate after the expiry date that is stated on the outer packaging.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your

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pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Sodium Bicarbonate capsules contain:
• The active ingredient is sodium bicarbonate
• The other ingredients are syrup, colloidal silicon dioxide, and magnesium stearate. The
capsule shell contains gelatin, water, and titanium dioxide (E171). The printing ink
contains shellac, black iron oxide (E172) and propylene glycol (E1520).

8 mm
Glue

84 mm
Front page outside

Not all pack sizes may be marketed.

Sodium
500
Bicarbonate
mg
Capsules

Marketing Authorisation Holder and Manufacturer
Your capsules are made by Teva Pharmaceutical Works Private Limited Company,
4042 Debrecen, Pallagi út 13, Hungary.
The marketing authorisation holder is TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised: June 2015
PL 00289/1423

56 Capsules

What Sodium Bicarbonate capsules look like and contents of the pack:
• The Sodium Bicarbonate capsules are white capsules. They are printed ‘SDB 500’ and
‘Twin Triangle Logo’ or unmarked.
• They come in packs of 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250, 500, or 1000 capsules.

PL 00289/1423

P

SDB 500
A0429/4

11 mm
Tab

Each capsule contains Sodium
Bicarbonate 500 mg.
DOSAGE:
For oral use. Please peel and read the
leaflet before you start to take your
medicine. Swallow the capsules
or empty the contents into water and
swallow. As an antacid: 1 g to 5 g
(2 to 10 capsules) in water as required.
Metabolic acidosis: as directed by
the doctor.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN.
Store in a cool, dry place.
Store in the original container.

84 mm
Page 8
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.
Please take this leaflet, any remaining capsules, and the container with you to the hospital
or doctor so that they know which capsules were consumed.

01077-C

MA Holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Almus ® is a registered trademark

Leaflet inside (Sekunda)
11 mm
Tab/Glue

84 mm
Page 1 (Front page inside)

84 mm
Page 2

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.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 24 hours.
• 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.

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SODIUM BICARBONATE 500 mg CAPSULES
1.
2.
3.
4.
5.
6.

What Sodium Bicarbonate is and what it is used for
Before you take Sodium Bicarbonate
How to take Sodium Bicarbonate
Possible side effects
How to store Sodium Bicarbonate
Further 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 capsules are used to treat:
• indigestion

REG0151746

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

2. 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.

Version 2.4

Taking other medicines
Talk to your doctor if you are taking any of the following:
• antibiotics or antifungals (to treat an infection) e.g. rifampicin, ketoconazole,
tetracycline
• phenothiazines (to treat anxiety or depression)
• corticosteroids (to treat swelling and inflammation or for allergic reactions)
• lithium (for mental illness)
• aspirin
• methotrexate (for certain types of tumours, 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)

Approved

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• penicillamine (for rheumatism)
• dipyridamole (to prevent blood clots associated with heart problems).
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
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
for advice before taking this medicine.

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Driving and using machines
Sodium Bicarbonate is not known to affect your ability to drive or operate machinery.

3. HOW TO TAKE SODIUM BICARBONATE
If your doctor has prescribed this medicine, always take Sodium Bicarbonate capsules
exactly as your doctor has told you. Otherwise, follow the instructions below. If you are not
sure how to take this medicine, talk to your doctor or pharmacist.
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:

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Adults
• Indigestion
Between 1 g and 5 g (2 to 10 capsules) when needed.
• Acidosis
Your doctor will calculate the appropriate dose for you.
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.
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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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