PARALMAX® COLD

POSOLOGY AND METHOD OF ADMINISTRATION

DOSAGE

Adults, children aged 12 years and over and elderly: 1 tablet twice daily.

Children from 6 to 12 years: Consult your doctor.

Should be taken with meal or after meal.

ADMINISTRATION

Oral administration only. Do not exceed the stated dose. Should not be used with other paracetamol/ loratadine/ dextromethorphan-containing products, decongestants or cold and flu medicines.

CONTRAINDICATIONS

This product is contraindicated in patients:

Hypersensitivity to any components of the drug. 

Children under 6 years of age.

Patients with severe renal or hepatic impairment or glucose-6-phosphate dehydrogenase deficiency.

Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in the last two weeks.

WARNINGS AND PRECAUTIONS

- Paracetamol should be given with care to patients with alcohol dependence, impaired kidney or liver function.

- Paracetamol may cause liver damage if you consume more alcoholic drinks; it is advised to avoid or reduce alcohol consumption.

- For paracetamol-containing drugs, the physician should warn patients of serious signs of skin reactions such as Steven-Jonhson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).

- During administration of loratadine, risk of dryness of mouth in the elderly and risk of tooth decay have been reported.

- Loratadine is used with caution in patients suffering from sputum cough or chronic cough in alcoholics, asthma or emphysema, risks of respiratory insufficiency; patients with hepatic failure or mild renal insufficiency, hives that do not itch or look unusual (bruised, blistered, or a strange color), elderly people.

- High doses of dextromethorphan can cause drug abuse and dependence.

- Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

- Avoid concurrent administration with the drugs containing paracetamol, loratadine and dextromethorphan.

PREGNANCY AND LACTATION

Pregnancy

The safety of this product used in pregnancy associated with possible adverse effects in the fetus is not established. Human and animal studies with paracetamol have not identified any risk to paracetamol in pregnancy or embryo-foetal development. As a result, this drug should be used in pregnacy only if clearly needed.

Lactation

This product should not be used while breast-feeding without medical advice.

Human studies with paracetamol at the recommended dosed have not identified any risk to lactation or the breastfed offspring. Loratadine may pass into breast milk and affect a nursing baby. Therefore, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Dextromethorphan may cause dizziness and mild drowsiness with consequences on the ability to drive vehicle or use machine, therefore, caution must be observed when driving vehicles and operating machinery.

STORAGE CONDITION

In a dry place, below 30°C, protect from light.

SHELF-LIFE

36 months from the manufacturing date. Do not use it after the expiry date.

Box of 15 blisters x 12 film-coated tablets.

Box of 10 blisters x 10 film-coated tablets.