Tabletki pzheciv niestravnoshci Labofarm

Patient Information

LABOFARM ANTI-INDIGESTION TABLETS

tablets

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7-14 days there is no improvement or the patient feels worse, they should consult a doctor.

Table of Contents of the Leaflet

• 1. What are Labofarm Anti-Indigestion Tablets and what are they used for
• 2. Important information before taking Labofarm Anti-Indigestion Tablets
• 3. How to take Labofarm Anti-Indigestion Tablets
• 4. Possible side effects
• 5. How to store Labofarm Anti-Indigestion Tablets
• 6. Package contents and other information

1. What are Labofarm Anti-Indigestion Tablets and what are they used for

Labofarm Anti-Indigestion Tablets are a herbal medicine with mild antispasmodic and carminative effects. It is assumed that the product increases the secretion of digestive juices and bile (by stimulating liver function). It is traditionally used for disorders related to digestive process disturbances, such as a feeling of fullness in the stomach, bloating, insufficient bile and gastric juice secretion. Traditional herbal medicinal product for use in specified indications, resulting solely from its long-term use. If after 7-14 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Labofarm Anti-Indigestion Tablets

When not to take Labofarm Anti-Indigestion Tablets

• if the patient is allergic to any of the ingredients of this medicine (listed in section 6) or other plants of the Asteraceae family (formerly Compositae), Apiaceae family (formerly Umbelliferae), peppermint, birch, or menthol.
• if the patient has intestinal obstruction, narrowing or atony (stagnation), appendicitis, inflammatory bowel disease (e.g., Crohn's disease,

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ulcerative colitis), abdominal pain of unknown etiology, severe dehydration with electrolyte loss; during pregnancy and breastfeeding, in children under 12 years of age.

Warnings and precautions

The product is intended for short-term or occasional use. Do not use for more than 7-14 days. Using the product daily for a longer period may lead to bowel function disorders and difficulties with bowel movements after stopping the medication. The product has a choleretic effect, which facilitates bowel movements. Due to the content of buckthorn bark, in particularly sensitive patients to the action of anthranoid compounds, the product used in maximum doses may cause a laxative effect. In such cases, lower doses should be used. Patients with renal insufficiency must be aware of possible electrolyte balance disorders. Due to the choleretic effect, it is not recommended to use in cases of bile duct obstruction, bile duct inflammation, liver disease, gallstones, and other bile duct diseases. It is not recommended to use in cases of achlorhydria (lack of hydrochloric acid in gastric juice). Due to the content of peppermint leaf, it may exacerbate heartburn in patients with gastroesophageal reflux.

Children

Do not use in children under 12 years of age.

Labofarm Anti-Indigestion Tablets and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Chronic abuse of the medicine may lead to low potassium levels in the blood, which may enhance the effect of concurrently taken cardiac glycosides, cause interactions with antiarrhythmic medicines. Concurrent use of the medicine with diuretics, adrenal cortex steroids, or licorice root may exacerbate potassium deficiency.

Pregnancy and breastfeeding

Use during pregnancy and lactation is contraindicated due to experimental data on the risk of genotoxicity of some anthranoids, including emodin and frangulin, and because small amounts of active anthranoid metabolites, such as rhein, pass into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

Driving and operating machinery

Not investigated.

3. How to take Labofarm Anti-Indigestion Tablets

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Orally. Adults, elderly, and adolescents over 12 years: 2 tablets 3 times a day.
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Take the tablets after a meal, with water. If symptoms persist, consult a doctor.
To clarify the use of the medicine, consult a doctor or pharmacist.

Taking a higher dose of Labofarm Anti-Indigestion Tablets than recommended

Overdose causes diarrhea with possible electrolyte loss, particularly potassium ions. In case of overdose, replenish fluid and electrolyte losses.

Missing a dose of Labofarm Anti-Indigestion Tablets

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. During treatment, urine may turn yellow or reddish-brown (depending on pH), which is clinically insignificant. The medicine may exacerbate symptoms of gastroesophageal reflux and heartburn. Allergic reactions and hypersensitivity, abdominal cramps, and pain, liquid stools (especially in patients with irritable bowel syndrome) may occur. Such symptoms may also indicate an overdose of the product. Chronic abuse of the medicine may lead to water-electrolyte balance disorders, proteinuria, hematuria, and pigment deposition in the colon mucosa (pseudomelanosis coli), which usually resolves after stopping the medicine.

Reporting side effects:

If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel. 22 49 21 301, fax 22 49 21 309. Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Labofarm Anti-Indigestion Tablets

Keep the medicine out of sight and reach of children. Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging.

6. Package contents and other information

What Labofarm Anti-Indigestion Tablets contain

The active substances of the medicine are dandelion root with caraway fruit (2:1), powdered; peppermint leaf, powdered; buckthorn bark, powdered; and dry extract of milk thistle fruit.
The excipients are potato starch, anhydrous colloidal silica.
Each tablet contains 150 mg of Taraxacum officinale F.H. Wigg., radix cum Carum carvi L. fructu (dandelion root with caraway fruit (2:1), powdered); 60 mg of Mentha x piperita L., folium (peppermint leaf, powdered); 60 mg of Rhamnus frangula L. (Frangula alnus Miller), cortex (buckthorn bark, powdered), equivalent to 3.8 mg of glucofrangulin, calculated as glucofrangulin A; 7 mg of dry extract of Silybum marianum L., fructus (milk thistle fruit) (22-27:1), extraction solvent: aceton 95% (V/V), silymarin content, calculated as silybin, 58%.

What Labofarm Anti-Indigestion Tablets look like and what the package contains

20, 60, or 90 tablets in a polypropylene tablet container with an LDPE lid.
20, 60, or 90 tablets in a polypropylene tablet container with an LDPE lid, in a cardboard box.
10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 tablets in PVC/Aluminum blisters (each blister contains 10 tablets), in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Labofarm sp. z o.o.
ul. Lubichowska 176B
83-200 Starogard Gdański
tel. 58 561 20 08
e-mail: [email protected]

Date of last revision of the leaflet:

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