COMPOSITION: Each caplet contains:
Active ingredients: Paracetamol ………………………….. 500mg
Pamabrom ………………………………………. 25 mg
Pyrilamine maleate ……………………. 15 mg
Other ingredients: Pregelatinized starch, maize starch, crospovidone, povidone K30, colloidal anhydrous silica, stearic acid, magnesium stearate, opadry II pink.
DESCRIPTION OF PRODUCT:
Pink film coated caplet, printed “TYDOL WOMEN” on both sides.
PHARMACODYNAMICS:
Paracetamol is the active metabolite of phenacetin, exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre.
Pamabrom, a xanthine derivative, is a safe and effective diuretic in relieving the water-accumulation symptoms of water-weight gain, bloating, swelling, and/or full feeling associated with the premenstrual and menstrual periods.
Pyrilamine is an antihistamine, H1 receptor blocking agent belonging to the ethylenediamine class of antihistamines. H1-blocking drugs inhibit the actions of histamine on smooth muscle, capillary permeability, and can both stimulate and depress the central nervous system. Pyrilamine also possesses anticholinergic and sedative properties.
PHARMACOKINETICS:
Paracetamol (acetaminophen) is rapidly and almost completely absorbed from the gastrointestinal tract. The plasma concentration peaks in 30 to 50 minutes after therapeutic dose. Paracetamol is rapidly and uniformly distributed into most body tissues. About 25% of paracetamol is bond to plasma protein. The plasma half-life is from 1.25 to 3 hours at therapeutic doses. The main route of elimination is via the urine.
Pamabrom is well absorbed from the gastrointestinal tract. Its diuretic action begins approximately two hours, reaching its peak plasma levels between 3 and 6 hours after administration. Once absorbed combined with plasma proteins partially excreted in bile into the intestine, but mostly excreted in the urine as unchanged drug.
Pyrilamine is well absorbed from the gastrointestinal tract. After oral administration with peak plasma concentrations within 2 to 3 hours and the effects commonly last for 4 to 6 hours. The drug is widely distributed in the body, including the central nervous system (CNS). Little or nothing is excreted unchanged in the urine, the majority appears there as metabolites.
INDICATIONS:
For the temporary relief of symptoms associated with premenstrual syndrome and menstrual periods such as bloating, water-weight gain, cramps, breast tenderness, headache, backache.
ADMINISTRATION AND DOSAGE:
Adults and children 12 years and over:
Take 2 caplets every 4 to 6 hours. Do not exceed 8 caplets in 24 hours.
CONTRAINDICATIONS:
- Hypersensitivity to any ingredients of this product.
- In those with asthma, glaucoma, bladder-neck obstruction, peptic ulcer or pyloroduodenal obstruction, emphysema, chronic pulmonary disease.
- Pregnancy and Lactation.
- Children under 12 years of age.
WARNINGS AND PRECAUTIONS:
– Special precaution and warning when using medication containing Paracetamol: The doctor must warn the patients about the symptoms of serious skin reactions including: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or Lyell Syndrome, acute generalized exanthematous pustulosis (AGEP).
– Paracetamol poisoning can result in hepatic damage
– Do not use with other products containing Paracetamol.
– This product may cause drowsiness. Use caution when driving a motor vehicle or operating machinery
SIDE EFFECTS:
– Side effects include drowsiness and lethargy.
– Hypersensitivity reactions are rare but may include urticaria, skin eruptions, pruritus or anaphylaxis.
In case of an unexpected reaction, consult your physician.
INTERACTIONS:
– The combination of isoniazid, phenytoin, barbiturate, carbamazepine and acetaminophen has caused severe hepatotoxicity.
-Alcohol, sedatives and tranquilizers may increase the drowsiness effect.
OVERDOSE AND TREATMENT:
Paracetamol
Symptoms of Paracetamol overdosage in the first 24 hours are nausea, vomitting, anoresia, pallor, abdominal pain.
Paracetamol overdose can lead to liver failure. Overdose, Paracetamol 10g or more in a single admistration in adults and 150 mg/kg of bodyweighht in a single administration in children, cause hepatic cytolysis to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma or death.
Treatment:
Immediate treatment is essential in the management of Paracetamol overdose. When infected with severe poisoning, it is important to treat actively support. Gastric lavage is used in all cases, the best within 4 hours after drinking. In most cases, N-acetylcysteine, will be given by mouth or IV (through the vein) as an antidote
Pyrilamine maleate
Symptoms: hallucinations, agitation and seizures, dilated pupils, urinary retention and dry mouth.
Treatment: symptomatic and supportive measures.
PRESENTATION:
Box of 1 blisters x 10 film coated caplets.
Box of 2 blisters x 10 film coated caplets.
Box of 10 blisters x 10 film coated caplets.
STORAGE: Store at temperature below 300C, in a dry place, protect from light.
SHELF-LIFE: 36 months from manufacturing date. Do not use after expiry date.
DATE OF REVISON OF PACKAGE INSERT
