S2 TALK:
Codeine phosphate,
doxylamine succinate,
paracetamol, caffeine
This feature explains medical terms encountered in S0, S1 and S2 package inserts to pharmacist’s assistants.
This is a combination product and it should not be
used in combination with other flu medication
containing anti-histamines or other products containing
paracetamol and codeine.
Antipyretics
Used to treat fever.
Cyanosis
Blue colouring of the skin and mucosa due to low
oxygen levels in the blood. There must be a high
enough blood count in order to see cyanosis.
Biliary tract
This is the gall bladder and bile ducts.
Codeine
This is an opioid and it is a common ingredient of
combination pain medication. It may cause constipation
in some patients and it has very little analgesic potential
at this dosage. See warnings included in the package
insert.
Thrombocytopenia
Low platelet count
Neutropenia (rare)
This is a depletion of neutrophils, which are white
cells.
Pancytopenia
This is a decrease in all the circulating blood cells
including white and red blood cells, inflammatory
cells and platelets.
Leucopenia
Depletion of white blood cells.
Erythematous
This is redness of the skin due to inflammation.
Urticarial
This is an allergic reaction of the skin. Almost like
tiny mosquito bites.
* Other causes of these rashes should also be excluded.
Tinnitus
A noise in the ears, such as ringing, buzzing, roaring
or clicking.
Anorexia
This is the medical term for a loss of appetite and is
not the eating disorder - anorexia nervosa.
Micturition
Passing urine
Acute tubular necrosis
Dead kidney cells that are supposed to preserve water
and produce concentrated urine. If the kidney fails
to do this, the body retains water and urine excretion
is low.
Cardiac arrhythmias
Rhythm disturbances of the heart.
Transaminases and lactic dehydrogenases
Enzymes of the liver. Their levels can be determined
by a blood test to give an indication of what the liver’s
function is.
Bilirubin
Bilirubin is one of the breakdown products of red
blood cells. The liver helps to excrete bilirubin into
the gall bladder. The bile contains a lot of bilirubin
that is released into the small intestine. If bilirubin is
not excreted a patient develops jaundice.
Prothrombin time
This is the time blood takes to clot. The liver produces
clotting factors and if liver’s function is impaired,
patients may develop bleeding tendencies.
SCHEDULING STATUS: S2
PROPRIETARY NAME (AND DOSAGE FORM):
PYNSTOP® Tablets
COMPOSITION:
Each tablet contains: Codeine phosphate10 mg, doxylamine succinate 5 mg, paracetamol 450 mg, caffeine 45 mg. Sugar
free.
PHARMACOLOGICAL CLASSIFICATION:
A. 2.8 Analgesic combination
PHARMACOLOGICAL ACTION:
PYNSTOP® tablets have analgesic, antipyretic and antihistaminic properties.
INDICATIONS:
PYNSTOP® tablets for adults are indicated for the symptomatic relief of mild to moderate pain and pain associated with
tension and fever.
CONTRA-INDICATIONS:
PYNSTOP® tablets are contra-indicated in:
1.
Sensitivity (allergy) to the active ingredients.
2.
Severe liver function impairment.
3.
Respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion.
4.
During an attack of bronchial asthma.
5.
Heart failure secondary to lung disease.
6.
Head injuries and conditions in which intracranial pressure is raised.
7.
The presence of acute alcoholism.
8.
After operations on the biliary tract.
WARNINGS:
1.
Codeine: Exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead
to dependence and addiction.
2.
Patients should be warned against taking charge of vehicles or machinery performing potentially hazardous tasks
where loss of concentration may lead to accidents.
3.
Consult a doctor if no relief is obtained from the recommended dosage.
4.
Do not use continuously for more than 10 days without consulting your doctor.
5.
Dosage in excess of those recommended may cause severe liver damage.
6.
PYNSTOP® tablets should not be given to children under 12 years of age.
7.
Patients suffering from liver of kidney disease should only take paracetamol under medical supervision.
8.
Contains tartrazine, which may cause allergic type reactions (including bronchial asthma) in certain individuals.
The overall incidence of tartrazine sensitivity is low; it is however, frequently seen in patients who also have aspirin
sensitivity.
INTERACTIONS:
This medicine may lead to drowsiness and impaired concentration, which is aggravated by the simultaneous intake of
alcohol or other central nervous system depressant agents.
Doxylamine succinate may enhance the sedative effects of central nervous system depressant including alcohol, barbiturates,
hypnotics, narcotic analgesics, sedatives and tranquillisers.
The depressant effects of codeine are enhanced by depressant of central nervous system such as alcohol, anesthetics,
hypnotics and sedatives. Codeine should be given with extreme caution to patients taking monoamine oxidase inhibitors
or within 14 days of stopping such treatment.
PREGNANCY AND LACTATION:
Safety of PYNSTOP® in pregnant and lactating women has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: One or two tablets repeated four hourly if necessary. Do not exceed eight tablets
per day. Consult your doctor if no relief is obtained with the recommended dosage.
Do not exceed the stated dose.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol: Side-effects of paracetamol are usually mild though haematological reactions including thrombocytopenia,
leucopenia, pancytopenia, neutropenia and agranulocytosis have been reported. Pancreatitis, skin rashes and other
allergic reactions occur occasionally. The rash is usually erythematous or urticarial but sometimes more serious and
may be accompanied by fever and mucosal lesions.
Doxylamine succinate: Sedation may occur. Other side-effects include gastro-intestinal disturbances, blurred vision,
tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness
of the chest, and tingling, heaviness and weakness of the hands may occur. Symptoms of stimulation include insomnia,
nervousness, tachycardia tremors, muscle twitching and convulsions. Large doses may precipitate fits in epileptics. Use
with care in conditions such as glaucoma and prostatic hypertrophy.
Codeine phosphate: May cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial
flushing, dizziness, slow pulse rate, low blood pressure when standing erect, subnormal body temperature, restlessness
and changes of mood. To be used with caution by patients with impaired thyroid and liver functions, enlarged prostate
and with inflammatory or obstructive bowel disorders.
Caffeine: Can cause the following side-effects: nausea, headache, sleeplessness, irritability and symptoms of anxiety.
Large doses may cause restlessness, excitement, muscle tremor, ringing of the ears, increased pulse rate and gastric
ulceration. To be used with care by patients with a history of peptic ulceration.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol:
In the event of overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage
may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may
occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac
arrhythmia’s have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential
seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver
injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic
dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver
damage may progress to encephalopathy, coma and death. Cerebral oedema and non-specific myocardial depression
have also occurred. In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately.
Specialised treatment is essential as soon as possible. Prompt treatment is essential. Any patient who has ingested 7.5g
of paracetamol in the preceding 4 hours should undergo a gastric lavage. Specific therapy with an antidote such as
acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as
possible.
Acetylcysteine: Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 ml glucose injection, given intravenously over 15 minutes, followed by an
intravenous infusion of 50 mg/kg in 500 ml of glucose injection over the next 4 hours and then 100 mg/kg in 1000ml
over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses.
Acetylcysteine is effective if administered within 8 hours of overdosage.
Doxylamine succinate, codeine phosphate and caffeine: Refer to “Side-effects and Special Precautions. Treatment
is symptomatic and supportive.
IDENTIFICATION:
Green, circular, flat tablet with score line on one side and a diameter of 12.7 mm.
PRESENTATION:
Packaged in push-through blister packs of 18 tablets, and in securitainers of 50 and 100 tablets.
STORAGE INSTRUCTIONS:
Store below 25 °C. Protect from light and moisture. KEEP OUT OF REACH OF CHILDREN>
REGISTRATION NUMBER:
C/2.8/233
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited, Adcock Ingram Park,17 Harrison Avenue, Bryanston Ext. 77, Private Bag X 69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT: October 1955