INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BARALGAN® Tablets
BARALGAN® Ampoules

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

BARALGAN® Tablets
BARALGAN® Ampoules

COMPOSITION:
  BARALGAN®Tablet: 
  Sodium metamizol 500 mg
  Pitofenone hydrochloride 5 mg
  Fenpiverinium bromide 0,1 mg
  BARALGAN®Ampoule for Injection (per 1 mL): 
  Sodium metamizol 500 mg
  Pitofenone hydrochloride 2 mg
  Fenpiverinium bromide 0,02 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8: Analgesic Combinations

PHARMACOLOGICAL ACTION:
Sodium metamizol exerts both an analgesic and antispasmodic action. This spasmolytic action is re-inforced by a papaverine analogue, pitofenone hydrochloride, and a component with parasympatholytic action, fenpiverinium bromide.

INDICATIONS:
Colic of the biliary, urinary and gastro-intestinal tract. Spastic conditions of the female genital system.

CONTRA-INDICATIONS:
BARALGAN® should not be administered to patients with a known history of sensitivity to pyrazolone derivatives. It is further contra-indicated in patients suffering from hepatic porphyria, congenital glucose-6-phosphate dehydrogenase deficiency, tachyarrythmias, narrow-angle glaucoma, prostatic hypertrophy with a tendency to urine retention, mechanical obstruction of the gastro-intestinal tract, megacolon.

WARNINGS:
Patients who suffer from bronchial asthma or chronic respiratory infections and patients with a history of other hypersensitivity reactions, also to substances other than medicines, belong to a risk group which, on using any analgesic or antirheumatic, may develop shock (analgesic intolerance). Such predisposition may also exist in patients who react to small amounts of alcoholic beverages with sneezing, running eyes and severe facial flushing.

The risk of shock is comparatively higher after parenteral than after oral administration. Before starting BARALGAN® treatment the patient should be questioned about a history of hypersensitivity reactions.

DOSAGE AND DIRECTIONS FOR USE:
The stated doses are given three times a day:
BARALGAN®Tablets:
Adults and adolescents of 15 years and older: 1 - 2 tablets
Children 7 - 14 years ½ - 1 tablet
Tablets should be swallowed whole with some liquid

BARALGAN®Ampoule:
During intravenous injection, which must be performed slowly (not more than 1 mL per minute) with the patient lying down, blood pressure, heart rate and respiration must be checked.

If analgesic intolerance is suspected, a test should be performed at the start of the injection: stop the injection after 0,1 mL to 0,2 mL and observe the patient’s reaction for one to two minutes.
The solution should be warmed to body temperature prior to injection. BARALGAN® ampoules must not be mixed with other medicines for injections.

  BARALGAN® Ampoules
Smallest Single Dose
(i.m. or i.v.)
BARALGAN® Ampoules
Maximum Daily Dose
(i.m. or i.v.)
Adults and adolescents
of 15 years or older
2 mL to 5 mL but the total amount injected should
not exceed 10 mL (i.e. 2 x 5 mL) per day.

Note: A red colouration of the urine may occasionally be seen. It disappears after the end of treatment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects may include hypersensitivity reactions of the skin and mucosa of the eyes, nose and throat.
Granulocytopenia progressing to agranulocytosis, and shock may also occur. These are always serious.
The symptoms of agranulocytosis are: high fever, chills, sore-throat, dysphagia, inflammation in the regions of mouth, nose, throat and in the anogenital region. If this condition is suspected, blood counts must be performed and BARALGAN® treatment discontinued immediately. If the suspicion is confirmed, appropriate countermeasures must be initiated without delay.
The symptoms of shock (more common with parenteral administration) are pruritus, cold sweat, dizziness, stupor, nausea, flushing or pallor of the skin and dyspnoea.
At the first signs of shock, the preparation must be discontinued immediately, the patient must be put into a supine position with legs raised and airways patent and standard emergency measures must be initiated for the treatment of anaphylactic shock.
Other allergic reactions may include that of the skin and the mucosa of the eyes, nose and throat.
If BARALGAN® causes any type of hypersensitivity reaction, the patient must be warned against the future use of any pyrazolone-containing preparation.
Anticholinergic side-effects such as dry mouth, tachycardia, disturbances in visual accommodation, micturition difficulties and constipation may occur.
If quinidine is administered concomitantly with BARALGAN® potentiation of the anticholinergic effects may occur.
Abstinence from alcohol is recommended during BARALGAN® therapy since mutual influence cannot be excluded.
In patients treated with BARALGAN®, enzymatic blood sugar determinations using the glucose-oxydase method may yield incorrectly low values.
Safety in pregnancy has not been established. Because of its long duration of action BARALGAN® should not be used during childbirth and for the dilation of the cervical canal for curettage. In infants and small children, and in patients with pre-existing dyshaematopoiesis or with unstable circulatory conditions e.g. RR systolic < 100 mm/Hg), BARALGAN® must only be used under medical supervision.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of accidental poisoning or overdosage treatment of any toxic effects is symptomatic and supportive.

IDENTIFICATION:
BARALGAN®Tablets : White, round, flat tablet, bevel-edged with the code OKF on one side and the Hoechst logo on the other side.
BARALGAN®Ampoules : 5 mL clear liquid, sealed into a single dose amber glass ampoule and coded with a white colour band.

PRESENTATION:
BARALGAN® Tablets : 20' and 100'.
BARALGAN® Ampoules : Cartons of 5 x 5 mL.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place in well-closed containers.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBERS:
BARALGAN® Tablets: B984 (Act 101/1965).
BARALGAN® Ampoules: B983 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Noristan Limited
326 Marks Street, Waltloo, Pretoria

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11-08-1989.

Albert Pharmaceuticals
Division of
Hoechst Pharmaceuticals
Division of
Noristan Limited

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