Effer Paralmax Extra

INSTRUCTION FOR USE

Administration 

- For oral use, dissolve the tablet with about 200 ml of water, drink after effervescing completely and according to the doctor's instructions.

Dosage 

- Adults and children 12 years and over: 1 tablet/time every 4 - 6 hours as needed, not more than 6 tablets per day.

 CONTRAINDICATIONS 

- Hypersensitivity to any ingredient of the drug.

- Patients with glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency.

- Severe liver failure.

WARNINGS AND PRECAUTIONS

- Paracetamol is relatively non-toxic with therapeutic doses and when used under the guidance of the doctor. However, paracetamol overdose is the main cause of acute liver failure.  Concomitant use of products containing paracetamol (acetaminophen) can lead to side effects (such as paracetamol overdose).

- Caution should be exercised when using paracetamol in patients with hepatic impairment, renal impairment,  chronic alcoholism, chronic malnutrition or dehydration.

-  Use caution in patients with pre-existing anemia because cyanosis may not be evident, despite dangerously high concentrations of methemoglobin in the blood.- Drinking a lot of alcohol when using paracetamol can increase toxicity on the liver, should avoid or limit using alcohol. 

- Doctor should warn the patients about the signs of serious skin reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).

- Each of tablet contains 382.9 mg sodium, needs to pay attention to the daily diet, in case the patient has been appointed on a salt diet.

- Each Effer-Paralmax Extra effervescent tablet contains aspartame which is the source of phenylalanine. Caution should be exercised in patients with phenylketonuria.

PREGNANCY AND LACTATION 

Pregnancy:

- The safety of paracetamol during pregnancy has not been established with possible ADRs on fetal development. Therefore, paracetamol should be used in pregnancy only when needed.

Lactation:

- Studies of lactation, paracetamol did not show any ADRs in breastfed infants.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

Paracetamol has no or negligible influence on the ability to drive and use machines. 

SHELF-LIFE 

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