SOPALGIN

SOPALGIN
29 May

SOPALGIN

Analgesics, Antipyretics, Anti-Inflammatory drugs

-Paracetamol is a para-aminophenol derivative, it is a non-Opioid
  non-salicylate. It has analgesic, antipyretic properties and weak
  anti-inflammatory Activity.
-Paracetamol produces  central  and peripheral analgesia by
 elevation of the pain threshold and inhibition of prostaglandin
 biosynthesis, and antipyretic action through the effect on the
 hypothalamic heat-regulating center, resulting in peripheral
 vasodilatation, increased blood flow through the skin, sweating
 and heat loss. 
-Paracetamol is readily absorbed from the gastro-intestinal tract
 with beak plasma concentration occurring about 10 to 60 minutes
 after oral administration.
-Paracetamol is distributed into most body tissues. It crosses the  
 placenta and  is presents in breast milk .
-Paracetamol is metabolised predominantly in the liver and
 excreted  in the urine mainly as the glucuronide and sulphate
 conjugates. Less than 5% is excreted as unchanged Paracetamol 
-The elimination half-life of Paracetamol varies form about
 1to3 hours.
-Caffeine is absorbed readily after oral does and is widely 
  distributed in the body. It is also absorbed through the skin.
-Caffeine passes really in to the CNS. Appears in low 
  concentration in breast milk and it crosses the placenta.
-Caffeine is metabolised almost Completely in the liver and 
  excreted  in urine.
-The elimination half- life of Caffeine are about 3 to 7 hours. 
-Codeine phosphate is absorbed from the gastrointestinal tract,
  ingestion of Codeine phosphate produces peak plasma- codeine
  concentrations in about one hour ,crosses the placenta and is 
  present in breast milk.
- The elimination half life of Codeine phosphate about 3- 7hours. 
 Codeine phosphate is metabolised by O- and N-demethylation in
 the liver to morphine, nor-codeine, and other metabolites including
 normorphine and hydrocodone. Codeine and its metabolites are 
 excreted almost entirely by the kidney, mainly as conjugates with
 glucuronic acid. 

Indecation

- Sopalgin®  Tablets are indicated for the relief of mild to moderate
  pain and fever from: Headache, migraine, neuralgia, toothache, 
  sore throat ,menstrual pain, rheumatic, muscular pain, 
  feverishness cold symptoms, and influenza.

Dosage & Administration

- Sopalgin® Tablets are suitable for adults and children over 12
  years of age : two tablets up to four times a day. 
- Sopalgin® tablets Not recommended for children under 12 years.
- If necessary the dose may be repeated every four hours, but do not
  take  more than four doses in 24 hours.

* Each  Tablet of  Sopalgin® Contains:
Paracetamol                         500 mg
Caffeine                               30    mg
Codeine phosphate               8     mg

- Sopalgin® Tablets are contra-indicated in patients with known hypersensitivity to Paracetamol or codeine and in those patients with G6PD deficiency (hemolytic anemia).

- Sopalgin® Tablets may interact with anticoagulant agents
  prothrombin time.
-The effects of Sopalgin® Tablets in the liver may be increased by
  the use of alcohol and the concomitant use of certain drugs which
  enhance the metabolism of Sopalgin® Tablets in the liver as
  compound  (ie. barbiturates, tri-cyclic antidepressants).

- Although there is epidemiological evidence of the safety of
  Paracetamol in pregnancy and lactation, medical advice should
  be sought before using this product.
- Don’t use this Sopalgin® or any  drugs containing codeine during
  breast feeding unless under supervision of your doctor. 
-Use of these products may harm your baby.

- Sopalgin® Tablet is usually free  from side-effects When taken in
  recommended doses, .However skin reactions such as urticaria 
  have been  reported rarely.
Over dose:-
-In massive over dosage exceeding 10g,of Sopalgin® Tablets may
 cause liver damage. Early symptoms may cause pallor, nausea,
 vomiting, diaphoresis and malaise.
-Clinical and laboratory evidence of liver damage may not be 
 apparent until 48 to 72 hours post-ingestion. Overdose Should be
 promptly treated by gastric lavage followed by intravenous
 acetylcysteine or methionine without waiting for the results of
 plasma Paracetamol levels .
-Additional antidote therapy is normally considered in light of
 further plasma Paracetamol levels and the time elapsed since
 ingestion. 
-Nausea and vomiting are prominent symptoms of codeine toxicity
 and there is evidence circulatory and respiratory depression 
.suggested treatment is gastric lavage and catharsis. If CNS
 depression is sever, artificial respiration, oxygen and parenteral 
 naloxone may be needed.    
In all cases of suspected overdose, prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

-This preparation contains Paracetamol. Do not take other 
  medication containing  Paracetamol at the same time.
- Sopalgin® Tablets should be used with caution in cases of severe
  liver or kidney damage.
- Do not take this product for pain for more than 10 days or for 
  fever for more than 3 days unless directed by a doctor .
- If pain or  fever persists or gets worse, If new symptoms occur, or
  if redness and swelling is present, consult a doctor because these
  could be  signs of a serious condition.
- If sore throat is severe and persists for more than 2 days, 
  accompanied by fever, headache, rash, nausea or vomiting , 
  consult a doctor  promptly.

- Blister of 10 tablets, Pack contains of 2 blisters.
- Blister of 10 tablets, Pack contains of 10 blisters.
- Hospital packs with different sizes.

Store below 25 o C in a well closed container.