Galoxin Plus

Hyoscine butylbromide, acetaminophen.

Each film-coated caplet contains Hyoscine Butylbromide 10 mg; Acetaminophen 500 mg.

Pharmacotherapeutic group: Antispasmodics in combination with analgesics.
PHARMACOLOGY: Hyoscine Butylbromide exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genitourinary tract. As a quaternary ammonium derivative, Hyoscine Butylbromide does not enter the central nervous system. Therefore, anticholinergic side effects at the central nervous system do not occur. Peripheral anticholinergic action results from a ganglion blocking action within the visceral wall as well as from an antimuscarinic activity.
Acetaminophen has analgesic and antipyretic actions, together with a very weak anti-inflammatory effect. Its mechanism of action is not fully understood. It strongly inhibits central prostaglandin synthesis but only weakly inhibits peripheral prostaglandin synthesis. It also inhibits the effect of endogenous pyrogens on the temperature regulation centre in the hypothalamus.

Paroxysmal pain in decrease of the stomach or intestine spastic pain and functional disorders in the biliary and urinary tracts and female genital organs (e.g. dysmenorrhea).

GALOXIN PLUS should not be taken over prolonged period of time (for more than 3 days) without a prescription from the physician. The following doses are recommended: Adults: 1-2 caplets 3 time daily.
The total daily dose should not exceed 6 caplets.
The caplets should not be chewed, but swallowed in whole with a sufficient amount water.
Children: GALOXIN PLUS is not suitable for children under 10 years of age.

Due to overdosage of Acetaminophen in elderly persons, small children, patients with liver disorder, chronic alcohol consumption or chronic malnutrition, as well as patients co-administered with enzyme-inducing drugs are at an increased risk intoxication, including fatal outcomes.
Symptoms: Hyoscine Butylbromide: In the case of overdose, anticholinergic effects have been observed.
Acetaminophen: Symptoms normally occur during the first 24 hours and include pallor, nausea, vomiting, anorexia and abdominal pain. Patients may then experience a temporary subjective improvement but mild abdominal pain possibly indicative of liver damage may persist.
A single dose of Acetaminophen approximately 6 g or more in adults or 140 mg/kg in children may cause hepatocellular necrosis. This may lead to complete irreversible necrosis and subsequently to hepatocellular insufficiency, metabolic acidosis and encephalopathy, which may turn progress to coma and death. Concurrent rises in liver transaminases (AST, ALT), lactate dehydrogenase and bilirubin and an increase in prothrombin time, occurring 12-48 hours after ingestion have been observed. Clinical symptoms of liver damage are normally apparent after 2 days and reach a maximum after 4-6 days.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe damage. Other non-hepatic symptoms such as myocardial abnormalities and pancreatitis have also been reported to occur after Acetaminophen overdosage.
Therapy: Hyoscine Butylbromide: If required, parasympathomimetic drugs should be administered. Ophtalmological advice should be sought urgently in cases of glaucoma.
Cardiovascular complications should be treated according to usual therapeutic principles.
In case of respiratory paralysis: intubation, artificial respiration should be considered. Catheterization may be required for urinary retention. In addition, appropriate supportive measures should be used as required.
Acetaminophen: Where Acetaminophen intoxication is suspected, intravenous administration of SH group donators such as N-Acetylcysteine within the first 10 hours after ingestion is indicated. Although N-Acetylcysteine is most effective if initiated within this period, it can still offer some degree of protection if given as late as 48 hours after ingestion; in this case, it is taken for longer. The plasma concentration of Acetaminophen can be decreased by dialysis. Determinations of the plasma concentration of Acetaminophen are recommended.
Further measures will depend on the severity, nature and course of clinical symptoms of Acetaminophen intoxication and should follow standard.

This product must not be used in cases: Mechanical-stenosis of gastrointestinal tract, achalasia, paralytic ileus, intestinal atony, prostatic hypertrophy with urinary retention, myasthenia gravis, glaucoma, pathological tachyarrhythmia, mega colon and known hypersensitivity to Hyoscine Butylbromide, or Acetaminophen; Patients with porphyria, exacerbate the disease; Patient with hepatic dysfunction; Severe hepatocellular insufficiency (Child-Pugh C).
In case of rare hereditary conditions that may be incompatible with an excipient of the product (see Precautions) the use of this product is contraindicated.

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.

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.
Fertility: No studies on the effects on human fertility have been conducted.
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.

Blood and lymphatic system disorders: Pancytopenia, agranulocytosis, thrombocytopenia, leucopenia.
Immune system disorders, skin and subcutaneous tissue disorders: Anaphylactic shock, anaphylactic reactions, drug eruption, dyspnoea, abnormal sweating, pruritus, skin reactions, hypersensitivity (angioderma, rash, urticaria, exanthema, erythema, nausea, blood pressure decreased including shock).
Very rare cases of serious skin reactions (such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported for Acetaminophen.
Cardiac disorders: Tachycardia.
Respiratory, thoracic and mediastinal disorders: Bronchospasm (especially in patients with a history of bronchial asthma or allergy).
Gastrointestinal disorders: Dry mouth.
Hepatobiliary disorders: Transaminases increased.
Renal and urinary disorders: Urinary retention.

Otherwise harmless doses of Acetaminophen may cause liver damage if taken together with drugs leading to enzyme induction such as certain hypnotics and anti-epileptics (e.g. Gluthetimide, Phenobarbital, Phenytoin, Carbamazepine) as well as Rifampicin.
The same applies to potentially hepatotoxic substances and alcohol abuse.
Combination with Chloramphenicol can prolong the half life of Chloramphenicol with the risk of increased toxicity.
The clinical relevance of interactions between Acetaminophen and Warfarin as well as coumarin derivates cannot yet be assessed. Therefore, longterm use of Acetaminophen in patients being treated with anti-coagulants is only advisable under medical supervision.
Concomitant use of Acetaminophen and Zidovudine (AZT or Retovir) enhances the tendency towards reducing leucocytes (neutropenia). Therefore, this product should only be taken together with Zidovudine following medical advice.
Intake of Probenecid inhibits the binding of Acetaminophen to Glucoronic Acid, thereby reducing Acetaminophen clearance roughly by a factor of 2. The Acetaminophen dose should therefore be reduced during concurrent administration with Probenecid.
Cholestyramine reduces the absorption of Acetaminophen.
Intake of Acetaminophen may impact the lab determination of uric acid by phosphotungstic acid and of blood glucose by glucose oxidase-peroxidase.
The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, Quinidine, Amantadine, Disopyramide and other anti-cholinergics (e.g. Tiotropium, Ipratropium, Atropine-like compounds) may be intensified by this product.
Concomitant treatment with dopamine antagonist such as Metoclopramide Hydrochloride may result in diminution of the effects of both drugs on the gastrointestinal tract.
The tachycardic effects of beta-adrenergic agents may be enhanced by this product.
For oral applications in addition: Where gastric emptying is slowed down, as for instance with Propantheline, the absorption rate of Acetaminophen may be reduced with the results that onset of action delayed. Acceleration of gastric emptying, e.g. after administration of Metoclopramide, leads to an increase in the absorption rate of Acetaminophen.

Store below 30°C.

Antispasmodics

A03DB04 - butylscopolamine and analgesics ; Belongs to the class of belladonna and derivatives antispasmodics in combination with analgesics. Used in the treatment of functional gastrointestinal disorders.

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