SODIUM BICARBONATE 500 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM BICARBONATE

Available from:

REKAH PHARMACEUTICAL INDUSTRY LTD, ISRAEL

ATC code:

B05CB04

Pharmaceutical form:

TABLETS

Composition:

SODIUM BICARBONATE 500 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

REKAH PHARMACEUTICAL INDUSTRY LTD, ISRAEL

Therapeutic group:

SODIUM BICARBONATE

Therapeutic area:

SODIUM BICARBONATE

Therapeutic indications:

Antacid.

Authorization date:

2021-11-30

Patient Information leaflet

Patient package insert according to Pharmacists' Regulations
(Preparations) -1986
This medicine can be sold without a physician’s prescription
SODIUM BICARBONATE 500 mg, Tablets
Composition:
Each tablet contains: Sodium Bicarbonate 500 mg.
Each tablet contains approximately 137 mg Sodium.
Inactive ingredients and allergens in the medicine - see section 6
"Additional information".
Read the entire leaflet carefully before using this medicine. This
leaflet contains concise information about the
medicine. If you have any further questions, ask the doctor or
pharmacist.
Take this medicine according to the instructions in section 3 "How to
use this medicine?" in this leaflet. Consult the
pharmacist if you need additional information. Refer to a doctor if
the symptoms of your illness get worse or if they do
not improve after 14 days.
1. What is the medicine intended for?
The medicine Sodium Bicarbonate 500 mg is intended for relief in cases
of hyperacidity in the stomach.
Therapeutic group: Antacid.
2. Before using this medicine
Do not use this medicine if:
• You are hypersensitive (allergic) to the active ingredient (Sodium
Bicarbonate) or to any of the other ingredients this
medicine contains (see section 6 "Additional information”).
Special warnings regarding the use of this medicine
Before using Sodium Bicarbonate 500 mg, tell the doctor if:
• You have previously suffered from heart failure
• You suffer from liver or kidney problems
• You have high blood pressure
• You are on a low salt diet (each tablet contains approximately
137 mg of Sodium)
• You are elderly
Children and adolescents:
The medicine is not recommended for use in children and infants under
6 years of age.
Drug interactions:
If you are taking or have recently taken other medicines, including
non-prescription medicines and nutritional
supplements, tell the doctor or pharmacist. Especially if you are
taking:
• Drugs containing Lithium (for depression)
• Phenothiazines (to treat anxiety)
• Antibiotics (e.g., Rifampicin or Tetracycl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate 500 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Sodium Bicarbonate 500 mg.
Each tablet contains approximately 137 mg Sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A white, round biconvex tablet, "REKAH" engraved on one size, plain on
the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium Bicarbonate is used for relief in cases of hyperacidity in the
stomach.
4.2 Posology and method of administration
Posology
Adults
1-4 tablets, 4 times daily
_(_
0.5g – 8g), as needed.
Paediatric population
Not recommended for use under 6 years of age.
Method of administration
Oral. To be swallowed with a glass of water.
For ease of swallowing, the tablet may be halved or crushed, for
immediate use.
No information is available regarding the uniformity of split halves
of the tablet.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4 Special warnings and precautions for use
Avoid in patients on salt restricted diets.
Administer with caution in patients suffering from heart failure,
hypertension,
hepatic or renal impairment.
Warning: Do not take more medicine than the label tells you to.
Prolonged use should be avoided.
Caution advised in elderly patients. Although a reduction of the
normal adult
dose is not considered necessary, sodium retention could occur if
there is
concomitant impaired cardiac or renal function.
4.5 Interaction with other medicinal products and other forms of
interaction
Sodium bicarbonate increases the excretion of lithium, resulting in
reduced
plasma lithium concentration.
Antacids reduce the absorption of antibacterials (eg. tetracycline,
rifampicin)
and antifungals (itraconazole and ketoconazole). They also reduce the
absorption of dipyridamole, phenothiazines, chloroquine,
hydroxychloroquine,
phenytoin, gabapentin, bisphosphonates, penicillamine, captopril,
enalapril
and possibly othe