DOSAGE FORM DESCRIPTION
Each amber glass bottle contains 100ml flavoured BASELINE PARACETAMOL SYRUP.
ACTIVE INGREDIENTS, STRENGTH AND SPECIFICATION
Each 5mls contains Paracetamol BP 120mg.
EXCIPIENTS
PHARMACOLOGICAL ACTION
The action of paracetamol may be by the inhibition of arachidonate cyclo-oxygenase and thus the inhibition of the production of prostaglandins and thromboxanes. The analgesic effect may also be related to the elevation of pain threshold. The antipyretic effect may be by direct action on the hypothalamic heat regulating centre to block the effects of endogenous pyrogens.
PHARMACOKINETICS
After oral administration of paracetamol peak blood concentration are usually reached in 10–60 minutes. It is slightly bound to plasma proteins and partially metabolized by hepatic enzymes. It is converted to acetaminophen sulphate and glucuronide, which is pharmacologically inactive. Less than 5% is excreted unchanged: N-acetyl-P-benzoquinone, a minor but highly active metabolite, is important in high doses — because of its toxicity to the liver and kidney.
DOSAGE
- 3–12 months: 2.5 to 5ml, 6–8 hourly
- 1–6 years: 5 to 10ml, 6–8 hourly
- 6–12 years: 10 to 20ml, 6–8 hourly
Can be given before, during or after meals.
CONTRAINDICATIONS
BASELINE PARACETAMOL SYRUP is contraindicated in patients who are hypersensitive or allergic to paracetamol and/or any ingredient in the formulation.
WARNINGS AND PRECAUTIONS
Patients with impaired kidney or liver function should take BASELINE PARACETAMOL SYRUP only under medical supervision. It should also be given with care to patients with alcohol dependence. If fever or pain persists for more than 2 days, consult your doctor.
POSSIBLE SIDE EFFECTS
Side effects are rare and usually mild at recommended doses.
If your child has an allergic reaction to the medicine, see a doctor straight away. An allergic reaction may include swelling of face, tongue or throat, difficulty swallowing, unexplained wheezing, shortness of breath, rash or hives.
SYMPTOMS AND TREATMENT OF OVERDOSE
Early symptoms of overdose may include nausea, abdominal pain, sweating and liver failure. Seek immediate medical attention if a dose more than what is recommended is taken, even if symptoms are not present.
POSSIBLE INTERACTIONS WITH FOOD OR DRUGS
Do not take any other paracetamol-containing medicine when taking BASELINE PARACETAMOL SYRUP due to the risk of liver toxicity.
PREGNANCY AND LACTATION
Paracetamol within the recommended doses is generally considered safe during the first 3 months of pregnancy and lactation. Despite this, consult your doctor if pregnant especially.
PRESENTATION
BASELINE PARACETAMOL SYRUP is presented in 100ml amber glass bottles.
STORAGE CONDITIONS
BASELINE PARACETAMOL SYRUP should be stored in a dry place below 30°C and away from moisture and light. Keep bottle tightly sealed always.
Keep out of reach of children.
MANUFACTURER
BASELINE PHARMACEUTICALS LTD.
P.O. Box 16977, Accra North, Ghana