Kamol Paracetamol Syrup 120 mg/5 ml

 

Summary of Product Characteristics

1. NAME OF MEDICINAL PRODUCT: Kamol Syrup.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

Kamol syrup contains 120mg Paracetamol in each 5 ml Excipients: For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Oral syrup. A pink syrup with a mixed fruit odor.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications
Kamol is indicated for the treatment of pain (including teething pain) and as an antipyretic Kamol is indicated for the relief of headache, migraine, toothache and teething pains, sore throat, rheumatic aches and pains, influenza, feverishness and feverish colds.

Dosage:

(Take in every 6 hours)

• 3 months-1 yr.
• 2.5ml 3 to 4 times daily Over 6 yrs.
• 10ml-20ml 3 times daily.

4.2 Caution

• Consult your doctor if symptoms persist.
• Do not give more than 4 doses in any 24-hour period.
• Leave at least 4 hours between doses.
• Do not give this medicine to your child for more than 3 days.
• without speaking to your pharmacist.

The Elderly

In the elderly, the rate and extent of Paracetamol absorption is normal, but plasma half-life is longer and Paracetamol clearance is lower than in young adults.
Hepatic/renal dysfunction.
Caution should be exercised when administering the product to patients with hepatic or renal impairment.

4.3 Contraindications

Kamol is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.

4.4 Special warnings and precautions for use

Kamol should be used with caution in moderate to severe renal impairment or severe hepatic impairment The label contains the following statements.
Store below 30 degrees Celsius. Protect from light. Contains Paracetamol.

The following precautions should be followed when taking this medicine

• Do not take with any other Paracetamol-containing products.
• Never give more medicine than shown in the table.
• Do not over fill the spoon.
• Always use the spoon supplied with the pack.
• Do not give babies less than two months of age.
• For Infants 2-3 months not more than two dose should be given.
• Do not give more than four dose in any 24-hour period.
• Leave at least four hours between doses.
• Immediate medical advice should be sought in the event of an overdose, even if u feel well because of the risk of irreversible liver damage.
• Do not give this medicine to your child for more than three days without speaking to your doctor or pharmacist.
• As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.
• If symptoms persist consult your doctor.
• Keep out of reach and sight of children.

4.5 Interactions with other medical products and other forms of interaction

Chronic alcohol intake can increase the hepatotoxicity of Paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who have an overdose of Paracetamol, Acute alcohol intake may diminish an individual's ability to metabolize large doses of Paracetamol, the plasma life of which can be prolonged.

The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of Paracetamol, resulting in reduced plasma concentrations of the reduced plasma concentrations of the drug and faster elimination rate.
The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulants effect of warfarin and other coumarins may be enhanced by prolonged regular use of Paracetamol with increases risk of bleeding, occasional doses have no significant effects.

4.6 Fertility, pregnancy and lactation

The safe use of Kamal during pregnancy has not been established. There is epidemiological evidence of the safety of Paracetamol in human pregnancy.
A pharmacokinetic study in 12 nursing mothers revealed that less than 1% of the dose ingested by a nursing mother appears in human breast milk, therefore maternal ingestion of therapeutic doses does not present risk to the infant.

4.7 Effects on ability to drive and use machines

No special comment-unlike to produce.

4.8 Undesirable effects

Paracetamol has been widely used and when taken at the usual recommended dosage, side effects are mild and infrequent, and reports of adverse reaction are rear. Skin rash and other allergic reactions occur rarely. Most reports of adverse reactions to Paracetamol relate to over dosage with the drug Isolated cases of thrombocytes purpura, hemolytic anemia and agranulocytosis have been reported Chronic hepatic necrosis has been reported in patient who took daily therapeutic doses of Paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amount for such periods.

A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long term users of Paracetamol nor was the control of the disease improved after Paracetamol withdrawal.
Nephrotoxic effects following therapeutic doses of Paracetamol are uncommon. Papillary necrosis been reported after prolonged administration.

4.3 Overdose

Symptoms and signs:

Pallor anorexia, nausea and vomiting are frequent early symptoms of Paracetamol over dosage, although in many cases there are no symptoms for many hours.

Hepatic necrosis is a dose-related complication of Paracetamol overdose. Hepatic enzymes may become elevated and prothrombin time prolonged within 12 to 48 hours, but clinical symptoms may be apparent for 1 to 6 days after ingestion. Toxicity is likely in subjects who have taken single dose of 10g.

Treatment

To protect the patient against delayed hepatotactic, Paracetamol over dosage should be treated promptly by gastric lavage followed by intravenous N-acetylcysteine or oral methionine. Additional therapy (further methionine or intravenous cystermine or intravenous N-acetylcysteine) is normally considered in the light of blood Paracetamol content and the time elapsed since Ingestion. Fulminant hepatic failure which may follow Paracetamol overdose requires specialized management.

In Paracetamol over dosage with liver cell damage Paracetamol half-life is prolonged from around 2 hours in normal adults to 4 hours or longer.

However, liver cell damage has been found with Paracetamol half-life less than four hours. Diminution of 14C02 excretion after 14C-N aminopyrine has been reported to correlate better with liver cell damage in Paracetamol over dosage than either plasma Paracetamol concentration pr half-life, or conventional liver function a measurement. Renal failure due to acute tubular necrosis may follow Paracetamol anthicid fulminant hepatic failure: the incidence of this is, however, no more frequent in these patients than others with fulminant hepatic failure from other causes.

5.1. Pharmacodynamic properties

Paracetamol has analgesic and anti-pyretic effects similar to those of aspirin arid is useful in the treatment of mild to moderate pain, it has weak anti-inflammatory effects.

5.2. Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose, and the plasma half-life is in the range of 1-3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90400% of the drug is recovered in the urine within 24 hours entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (3%). Small amount of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity of glucoronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic leading to necrosis.

5.3 Preclinical Safety Data

Mutagenicity

There are no studies relating to the mutagenic potential of Kamol.
In vivo mutagenicity tests of Paracetamol in mammal are limited and show conflicting results.

Therefore, there is insufficient information to determine whether Paracetamol poses a mutagenic risk to
man.

Paracetamol has been found to be non-mutagenic assays, although a clear clastogenic effects has been observed in mammalian cells in vitro following exposure to Paracetamol (3 and 10m for 2 hr.).

Carcinogenicity

There are no studies relating to the carcinogenic potential of Kamol.
There is inadequate evidence to determine the carcinogenic potential of Paracetamol in humans.

A positive association between the use of Paracetamol and cancer of the urethra (but not of other site in the urinary tract) was observed in a case control study in which approximate lifetime consumption of Paracetamol whether acute or chronic) was estimated.
However other similar studies have failed to demonstrate a statistically significant association between Paracetamol and cancer of the urinary tract, or Paracetamol and renal cell carcinoma.

There is limited evidence for the carcinogenicity of Paracetamol in experimental animals. liver cell tumors can be detected in mice and liver and bladder carcinomas can be detected in rats following chronic feeding 500mg/kg/day Paracetamol.

Teratogenicity

There is no information relating to the potential of Kamol. In humans, Paracetamol crosses the placenta and attains concentrations in the fetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of Paracetamol are not associated with teratogenic effects in humans.
Paracetamol has been found to be fetotoxic to cultured rat embryo.

Fertility

There is no information relating to the effects of Kamol. A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high dose of Paracetamol (500mg/kg body weight/day) orally for 70 days.

6. PHARMACEUTICAL PARTICULARS

6.1 list of excipients:

• Sucrose
• Para hydroxybenzoate
• Sodium saccharin
• Propylene glycol
• Erythrosine

6.2 Incompatibilities: not applicable.

6.3 Shelf life: 3 years.

6.4 Special precautions for storage: 

Do not store above 30°C. keep in original container.

6.5 Nature and content of container.

• A spoon with 5 ml and 2.5 ml measure is supplied with this pack.
• 100ml amber glass bottle with a tamper evident closure fitted.

6.6 Special precautions of disposal of a used medicinal product or waste materials derived from such. medicinal product and other handling of the product.
No special requirements.

7. MARKETING AUTHORIZATION HOLDER
Kama Industries Ltd, PO Box AN 5347
Plot number 8 Light Industrial Area, Ring Road East, Accra-Ghana.

9. DATE OF AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Date of first authorization; December 2014-10. 

DATE OF REVISED OF THE TEXT: January 2017

Manufactured in Ghana by:
KAMA INDUSTRIES LTD
PO BOX 5437 ACCRA-NORTH, GHANA
number 8 Light Industrial Area, Ring Road East, Nyaniba Estates
info@aspenghana.com/www.aspenghana.com
Telephone 00233-302-782725