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In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting or blood in stool, medical advice should immediately be sought.
To prevent overdosing, it should be ensured that any other drugs taken concurrently do not contain Acetaminophen, one of the active components of this product.
Liver damage may result if the recommended dosage for Acetaminophen is exceeded (see Overdosage).
This product should be used with caution in: Glucose-6-phosphate-dehydrogenase deficiency, Hepatic dysfunction (e.g. due to chronic alcohol abuse, hepatitis); Impaired renal function; Gilbert's syndrome; Hepatocellular insufficiency (Child-Pugh A/B).
Hyoscine Butylbromide may cause drowsiness and patients should not drive or operate machinery.
Do not exceed recommended dosage, it may cause hepatic impairment.
In such case, this product should only be used under medical supervision and, if necessary, the dose reduced of the intervals between the individual administrations prolonged.
The blood count and renal and liver function should be monitored after prolonged use.
Extensive use of analgesics, especially at high doses, may induce headaches that must not be treated with increased dose of the drug.
Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are very infrequently observed. Treatment must be discontinued at the first signs of a hypersensitivity reaction following the administration of this product.
Abrupt discontinuation of analgesics after a prolonged use at high doses may induce withdrawal symptoms (e.g. headache, tiredness, nervousness), that typically resolve within few days. Reintake of analgetics should depend upon physician's advice, and withdrawal symptoms abated.
This product should not be taken for more than 3 days unless directed by a physician. The patients should be instructed to seek medical advice, if pain persist or get worse, if new symptoms occur, or if redness or swelling is present, because these could be signs of a serious condition.
Because of potential risk of anticholinergic complication caution should be used in patients prone to narrow angle glaucoma as well as in patients susceptible to intestinal or urinary outlet obstructions and in those inclined to tachyarrhythmia.
This product contain 4.32 mg sodium per unit resulting in 25.92 mg sodium per maximum recommended daily dose, to be taken into consideration for patients on a controlled sodium diet.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Pregnancy: There are no adequate data on use this product during pregnancy.
Long experience with the mono substances has shown insufficient evidence of adverse effects during human pregnancy.
Under normal conditions of use, Acetaminophen can be used throughout pregnancy after careful review of the risk-benefit ratio.
During pregnancy, Acetaminophen should not be taken for prolonged periods, in high doses, or in combination with other medicinal products as the safety has not been confirmed in such cases.
Therefore, this product is not recommended during pregnancy.
Fertility: No studies on the effects on human fertility have been conducted.
Use in Lactation: For Hyoscine Butylbromide safety during lactation has not yet been established. However, adverse effects on the newborn have not been reported. Acetaminophen enters breast milk, but is not likely to affect the infant when therapeutic doses are used.
