1. Product Name Oxyboldine effervescent tablets
2. Ingredients Per tablet: Boldine: 0.5 mg Anhydrous sodium sulphate: 54.0 mg Monosodium phosphate: 132.0 mg 1 tablet contains 470 mg of sodium. For a full list of excipients, see section 6.1. 3. Dosage Form Effervescent tablet
4. Product Information
4.1. Therapeutic IndicationsAdjuvant treatment for ingestion-like problems (dyspepsia; also known as heartburn), symptoms of which include slow digestion and bloating.
4.2. Directions for Use and DosageFor adult use only. To be taken orally. Take 1 tablet before each of the 3 daily main meals, or whenever you experience digestive discomfort. Dissolve in a glass of water.
4.3. Contra-indicationsDo NOT use if you are allergic to oxyboldine or any of its ingredients.
4.4. Warnings and Precautions– Do NOT use if you have blocked bile ducts or severe hepatic insufficiency (liver failure). – Contains sodium (470 mg per tablet). Use with caution if you are on a strict low-salt diet. – Do NOT use if you have diarrhoea or abdominal pain.
4.5. If you are pregnant or breast-feedingPregnancyNo reliable data exists concerning the possibility of teratogenesis in animals, nor have any malformative or foetotoxic effects been reported during clinical testing. However, use of this product may still pose a risk to an unborn baby. Consequently, use of this product during pregnancy is NOT recommended. Breast-feedingThe potential for this product to pass naturally into breast milk has not yet been determined. Consequently, use of this product while breast-feeding is NOT recommended, except when necessary (in which case, all feeding must be suspended).
4.6.Possible Side Effects– Diarrhoea (if taken in excessive doses). – Skin reaction (in rare cases).
5. Pharmacological Properties Pharmacotherapeutic Group: cholagogues and choleretics (A: digestive system and metabolism)
6. Pharmaceutical Information
6.1. ExcipientsSodium benzoate, anise essential oil, tartaic acid, anhydrous citric acid, sodium bicarbonate.
6.2. Shelf Life4 years
6.3. Storage Instructions Store in a dry place.
6.4. Packaging2 x tubes (polypropylene), sealed by a cap (polyethylene), with a desiccant silica gel pack. Pack of 2 tubes.
7. Marketing Authorisation Holder COOPERATION PHARMACEUTIQUE FRANCAISE PLACE LUCIEN-AUVERT 77020 MELUN CEDEXFRANCE 8. Marketing Authorisation No. 361 710-3: polypropylene tubes containing 24 tablets This pack is comprised of 2 tubes containing 12 tablets each.
9. Prescription and Delivery Conditions Non-prescription medicine
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