Thamicarb 84mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium hydrogen carbonate

Available from:

Syri Pharma Limited t/a Thame Laboratories

ATC code:

A02AH

INN (International Name):

Sodium hydrogen carbonate

Dosage:

84 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Therapeutic area:

Antacids with sodium bicarbonate

Authorization status:

Marketed

Authorization date:

2014-10-17

Patient Information leaflet

VAR/IA-021/RFI-I
1.3.1 Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
THAMICARB™ 84MG/ML ORAL SOLUTION
(sodium hydrogen carbonate) (1mmol/ml)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

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.
The name of your medicine is Thamicarb 84mg/ml Oral Solution but it
will be referred to as
Thamicarb throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Thamicarb is and what it is used for
2. What you need to know before you take Thamicarb
3. How to take Thamicarb
4. Possible side effects
5. How to store Thamicarb
6. Contents of the pack and other information
1. WHAT THAMICARB IS AND WHAT IT IS USED FOR
Thamicarb contains the active substance sodium hydrogen carbonate
which belongs to a
group of medicines called antacids.
Thamicarb is used to treat hyperacidity, dyspepsia (indigestion) and
to provide symptomatic
relief from heartburn and peptic ulceration.
Thamicarb is also used to treat metabolic acidosis in patients with
chronic kidney disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THAMICARB
DO NOT TAKE THAMICARB:

if you are allergic to sodium hydrogen carbonate or any of the other
ingredients of this
medicine (listed in section 6)

if you have reduced stomach acid

if you have low levels of potassium in the blood

if you have low levels of chloride in the blood

if you have low levels of calcium in the blood

if you have a liver problem

if you have toxaemia of pregnancy

if you have problems with urination

if you have excess sodium in the blood

if you are under 12 years old
WARNINGS AND PRECAUTIONS:
Talk to your doctor or

Summary of Product characteristics

Health Products Regulatory Authority
17 September 2019
CRN008JRR
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Thamicarb 84mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 84mg of sodium hydrogen carbonate
(equivalent to 1mmol/ml sodium and hydrogen
carbonate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thamicarb is used to treat hyperacidity, dyspepsia and symptomatic
relief of heartburn and peptic ulceration.
Thamicarb is also indicated for the treatment of metabolic acidosis in
adults with chronic kidney disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For acid indigestion
_Adults and children over 12 years:_
Take 12ml (1g) to 60ml (5g) every 4 to 6 hours.
_Not recommended for use in children under 12 years of age._
For metabolic acidosis in chronic kidney disease
Adults (including elderly)
Metabolic Acidosis: Dosage is calculated on an individual basis and
administered according to the acid-base balance and
electrolyte status.
Children
There is no experience using Thamicarb in the management of metabolic
acidosis in children.
Method of administration
The required dose should be drawn from the container into the
graduated syringe using the syringe adaptor (see section 6.6).
4.3 CONTRAINDICATIONS
Contraindicated in patients with metabolic or respiratory alkalosis,
hypocalcaemia, or hypochlorhydria.
Not to be taken by children under 12 years old.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
17 September 2019
CRN008JRR
Page 2 of 6
Sodium hydrogen carbonate should be given extremely cautiously to
patients with heart failure, oedema, renal impairment,
hypertension, eclampsia, aldosteronism, or other conditions associated
with sodium retention.
Keep all medicines away from children.
Do not take if you are hypersensitive to sodium hydrogen carbonate.
Consult your doctor