Tablets for indigestion labofarm

Patient Information Leaflet
LABOFARM ANTI-DYSPEPSIA TABLETS
tablets
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as
advised by the doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7–14 days, or if you feel worse, consult your doctor.

Table of Contents

1. What are Labofarm Anti-Dyspepsia Tablets and what are they used for?
2. Important information before taking Labofarm Anti-Dyspepsia Tablets
3. How to take Labofarm Anti-Dyspepsia Tablets
4. Possible side effects
5. How to store Labofarm Anti-Dyspepsia Tablets
6. Contents of the pack and other information

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

Labofarm Anti-Dyspepsia Tablets are a herbal medicinal product with mild antispasmodic and carminative effects. It is believed that the product enhances secretion of digestive juices and bile (by stimulating liver function).
It is traditionally used for digestive disturbances such as bloating, flatulence, insufficient gastric juice and bile secretion.
Traditional herbal medicinal product for use in specific indications solely based on long-standing use.
If there is no improvement after 7–14 days, or if you feel worse, consult your doctor.

2. Important information before using Labofarm Indigestion Tablets

When not to use Labofarm Indigestion Tablets

• if the patient is allergic to any of the ingredients of this medicine (listed in section 6) or to other plants from the daisy family ( Asteraceae , formerly Compositae), the carrot family ( Apiaceae , formerly Umbelliferae), fennel, birch, or menthol.
• if the patient has intestinal obstruction, narrowing or atony (stagnation) of the intestine, appendicitis, inflammatory bowel diseases (e.g. Crohn's disease,
  ulcerative colitis), abdominal pain of unknown origin, severe
  dehydration associated with loss of electrolytes; during pregnancy and breastfeeding, in children
  under 12 years of age.

Warnings and precautions

The product is intended for immediate or short-term use only. Do not use for longer than 7–14 days. Daily use over a prolonged period may lead to impaired intestinal function and difficulty with defecation after discontinuation of the medicine. The product has a cholagogue effect, facilitating bowel movements. Due to the presence of rhubarb root, in patients particularly sensitive to anthranoid compounds, use at maximum doses may cause a laxative effect. In such cases, lower doses should be used. Patients with renal insufficiency should be aware of possible electrolyte imbalance. Because of its cholagogue effect, use is not recommended in cases of biliary tract obstruction, biliary inflammation, liver disease, gallstones, or other biliary diseases. Use is not recommended in cases of achlorhydria (lack of hydrochloric acid in gastric juice). Due to the presence of peppermint leaf, heartburn may worsen in patients with gastroesophageal reflux.

Children

Do not use in children under 12 years of age.

Labofarm Indigestion Tablets and other medicines

Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

Chronic overuse of the medicine may lead to low blood potassium levels, which may enhance the effects of concurrently used cardiac glycosides and cause interactions with antiarrhythmic drugs. Concurrent use with diuretics, corticosteroids, or liquorice root may worsen potassium deficiency.

Pregnancy and breastfeeding

Use during pregnancy and lactation is contraindicated due to experimental data indicating genotoxicity risk of certain anthranoids, including emodin and frangulin, and due to the passage of small amounts of active anthranoid metabolites, such as rhein, into breast milk.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Not studied.

3. How to use Tabletki przeciw niestrawności Labofarm

This medicine should always be taken exactly as described in this patient leaflet, or
as directed by a doctor or pharmacist. If in doubt, consult a doctor or
pharmacist.
Orally. Adults, elderly patients, and adolescents over 12 years of age: 2 tablets up to
3 times daily.
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Take tablets after meals, with water. If symptoms persist, consult a
doctor.
For any questions regarding the use of this medicine, consult a doctor or pharmacist.
Use of a higher than recommended dose of Tabletki przeciw niestrawności Labofarm
Overdose may cause diarrhoea, possibly leading to electrolyte loss, particularly
potassium ions. In case of overdose, fluid and electrolyte replacement should be administered.
Missed dose of Tabletki przeciw niestrawności Labofarm
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
During treatment, yellow or red-brown (depending on pH) discoloration of urine may occur, which has no clinical significance. The medicine may exacerbate symptoms of gastroesophageal reflux and heartburn. Allergic reactions and hypersensitivity, abdominal cramps and pain, and diarrhoea (especially in patients with irritable bowel syndrome) may occur. These symptoms may also indicate an overdose of the product. Chronic abuse of the medicine may lead to disturbances in water and electrolyte balance, proteinuria, haematuria, and deposition of pigment in the mucosa of the large intestine (pseudomelanosis coli), which usually resolves after discontinuation of the medicine.

Reporting of adverse effects:
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 can also be reported to the marketing authorisation holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Tabletki przeciwniestrawnosci Labofarm

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

6. Contents of the packaging and other information

What Tabletki przeciw niestrawności Labofarm contain
The active substances are dandelion root with caraway fruit (2:1), powdered;
powdered peppermint leaf; powdered buckthorn bark; and dry extract from milk thistle fruit.
The excipients are: potato starch, colloidal anhydrous 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.,
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folium (powdered peppermint leaf); 60 mg of Rhamnus frangula L. (Frangula alnus Miller),
cortex (powdered buckthorn bark), equivalent to 3.8 mg of glucofrangulin calculated as
glucofranguline A; 7 mg of purified and standardized dry extract from Silybum marianum L.,
fructus (milk thistle fruit) (22–27:1), extraction solvent: 95% (V/V) acetone, content of silymarin
calculated as silybinin 58%.

What Tabletki przeciw niestrawności Labofarm look like and contents of the packaging
20, 60 or 90 tablets in a polypropylene tablet container with LDPE cap.
20, 60 or 90 tablets in a polypropylene tablet container with LDPE cap, 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]
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