Sal vichy factitium

Package leaflet: Information for the patient

Sal Vichy factitium, 600 mg, effervescent tablets
(Sodium hydrogen carbonate + Sodium chloride + Anhydrous sodium hydrogen phosphate + Anhydrous sodium sulfate + Potassium bicarbonate)
Please read carefully all of this leaflet before using this medicine, because it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Sal Vichy factitium is and what it is 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. Contents of the package and other information

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

Sal Vichy factitium – artificial Vichy salt – is a mixture of alkaline salts that neutralize the acidic contents of the stomach, increase blood alkaline reserve, and have cholagogue and choleretic effects. It helps prevent the formation of gallstones.
A solution of 6 g of artificial Vichy salt (10 tablets) in 1 litre of water has a composition similar to that of natural Vichy water.
The indications for use of Sal Vichy factitium include adjunctive treatment of gastric hyperacidity, chronic cholecystitis, and cholelithiasis.

2. Important information before using Sal Vichy factitium

When not to use Sal Vichy factitium:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• in cases of inflammatory conditions of the urinary tract, renal pelvis, or urinary bladder.

Warnings and precautions
Before starting treatment with Sal Vichy factitium, consult your doctor or pharmacist.
Due to its sodium content, use with caution in patients on a low-sodium diet. The medicine contains 221 mg of sodium (main component of table salt) in each effervescent tablet, which should be taken into account in patients with impaired kidney function and in patients monitoring sodium intake. This corresponds to 11.1% of the maximum recommended daily dietary sodium intake for adults.
If taking 1 or more effervescent tablets daily over a prolonged period, patients—especially those monitoring sodium intake—should consult their doctor or pharmacist.
The medicine contains 45 mg of benzoic acid salt in 1 tablet.
This preparation contains sugar – use with caution in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Children
There is no data available regarding the use of this medicine in children.

Sal Vichy factitium and other medicines
Increases the excretion of weakly acidic drugs and decreases the excretion of weakly basic drugs due to urine alkalization.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

Food and drink
This medicine should be taken before meals.

Pregnancy and breastfeeding
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
This medicine may be used during breastfeeding only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the infant.

Driving and operating machinery
This medicine does not impair psycho-physical performance and does not affect the ability to drive mechanical vehicles or operate machinery in motion.

3. How to use Sal Vichy factitium

Orally: dissolve 1 or 2 tablets in a glass of boiled, warm water. Drink 3 times daily before meals.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
This medicine should always be used exactly as described in the patient leaflet or according to the instructions of a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Missed dose of Sal Vichy factitium
Do not take a double dose to make up for a missed dose.
Stopping Sal Vichy factitium
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not in everyone.
Frequent use of high doses of salt may cause persistent urine alkalization. Due to its sodium content,
it may lead to increased blood pressure.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect further information on the safety of using this medicine.

5. How to store Sal Vichy factitium

Keep the medicine out of 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Sal Vichy factitium contains
One effervescent tablet contains:

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

What Sal Vichy factitium looks like and contents of the pack
40 effervescent tablets in a container with hygroscopic protection, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Pharmaceutical Company "Ziołolek" Sp. z o.o.
ul. Starołęcka 189
61-341 Poznań
tel. 61 8352363
fax 61 8352363
e-mail: [email protected]