Sal Vihi factitium

Leaflet included in the packaging: patient information

Sal Vichy factitium, 600 mg, effervescent tablets

(Sodium hydrogen carbonate + Sodium chloride + Anhydrous sodium phosphate + Anhydrous sodium sulfate
+ Potassium hydrogen carbonate)
Read the leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sal Vichy factitium and what is it used for
• 2. Important information before taking Sal Vichy factitium
• 3. How to take Sal Vichy factitium
• 4. Possible side effects
• 5. How to store Sal Vichy factitium
• 6. Package contents and other information

1. What is Sal Vichy factitium and what is it used for

Sal Vichy factitium - artificial Vichy salt is a mixture of alkaline salts that neutralize stomach acid, increase the alkaline reserve of the blood, and have a choleretic and cholagogic effect. It prevents the formation of gallstones.
A solution of 6 g of artificial Vichy salt (10 tablets) in 1 liter of water has a composition similar to that of natural Vichy water.
Indications for the use of Sal Vichy factitium are auxiliary treatment in hyperacidity of the stomach contents, chronic cholecystitis, and cholelithiasis.

2. Important information before taking Sal Vichy factitium

When not to take Sal Vichy factitium:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Before starting to take Sal Vichy factitium, consult a doctor or pharmacist.
Due to the sodium content, it should be used with caution in patients on a low-sodium diet. The medicine contains 221 mg of sodium (the main component of table salt) in each effervescent tablet, which should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake. This corresponds to 11.1% of the maximum recommended daily sodium intake in adults.
In case of taking 1 or more effervescent tablets per day for a long time, patients, especially those controlling their sodium intake, should contact a doctor or pharmacist.
The medicine contains 45 mg of benzoic acid salt in 1 tablet.
The preparation contains sugar - it should be used with caution in diabetic patients. If intolerance to some sugars has been detected in the patient, the patient should consult a doctor before taking the medicine.

Children

There are no data on the use of the medicine in children.

Sal Vichy factitium and other medicines

It increases the excretion of drugs with weak acid properties and decreases the excretion of drugs with weak base properties, as a result of urine alkalization.
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Sal Vichy factitium with food and drink

The medicine should be taken before meals.

Pregnancy and breastfeeding

The medicine may be used during pregnancy only in cases where the benefit to the mother outweighs the potential risk to the fetus.
The medicine may be used during breastfeeding only in cases where the benefit to the mother outweighs the potential risk to the child.

Driving and using machines

The medicine does not affect psychophysical fitness, the ability to drive vehicles, and operate machinery.

3. How to take Sal Vichy factitium

Orally: dissolve 1 or 2 tablets in a glass of boiled, warm water. Drink 3 times a day before meals.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.
This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, consult a doctor or pharmacist.

Missing a dose of Sal Vichy factitium

Do not take a double dose to make up for a missed dose.

Stopping the use of Sal Vichy factitium

In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequent use of large doses of salt can cause constant alkalization of the urine. Due to the sodium content, it may cause an increase in blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sal Vichy factitium

Keep the medicine out of the sight and reach of children.
Store the container tightly closed to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sal Vichy factitium contains

1 effervescent tablet contains:

• active substance: 600 mg, including: sodium hydrogen carbonate, sodium chloride, anhydrous sodium phosphate, anhydrous sodium sulfate, potassium hydrogen carbonate;
• excipients: sodium hydrogen carbonate, sucrose 38 mg, sodium benzoate, tartaric acid;
• ions: Na 220 mg, K 8 mg, CO 492 mg, Cl 27 mg, SO 16 mg, HPO 8 mg. A solution of 6 g of artificial Vichy salt (10 tablets) in 1 liter of water has a composition similar to that of natural Vichy water.

What Sal Vichy factitium looks like and what the package contains

40 effervescent tablets in a container with a hygroscopic seal, in a cardboard box.

Marketing authorization holder and manufacturer

Ziołolek Pharmaceutical Company Ltd.
ul. Starołęcka 189
61-341 Poznań
tel. 61 8352363
fax 61 8352363
e-mail: [email protected]

Date of the last update of the leaflet: