MIXANAL Caplet Ref.[115699] Active ingredients: Caffeine Paracetamol

Source: Registered Drug Product Database (NG)  Publisher: Applicant (MAH): ORANGE DRUGS LIMITED, 66/68 Town Planning Way, Ilupeju, Lagos, Nigeria, Phone.: +2348036005454, Email: eojukwu@orangegroups.com Manufactured by: PT. Dankos Farma, Jl. Rawa Gatel Blok III S, Kav. 36-38, Kawasan Industri Pulo Gadung, Jakarta 13930 - Indonesia

4.1. Therapeutic indications

To reduce and relieve the symptoms of headache, dizziness, fever, toothache, pain during menstruation, muscle pain and joint ache.

Information of medicine:

  • Mixanal is indicated for headache and tootache
  • Mixanal relieves headache and dizziness
  • Mixanal is also effective to reduce fever and relieve other pains such as: Toothache, pain during menstruation, muscle pain, and joint ache.
  • Mixanal act fast and the effect appears in a few minutes
  • Mixanal has a long duration of action
  • Mixanal is safe because it does not contain metamizol, acetyl salicylic acid or salicylamide
  • Mixanal does not cause pain in the stomach, does not have the potency to cause impairment on red blood cells, and does not cause sleepiness

Pharmacology:

Act as analgesic for acute painful and antipyretic. Caffeine enhances the analgesic efficacy of acetaminophen.

For oral administration.

4.2. Posology and method of administration

Adults: 1-2 caplets, 3-4 times daily.

4.9. Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes or

b) Regularly consumes ethanol in excess of recommended amounts or

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral odema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside of hospital.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Protect from light. Store below 30°C.

Keep all medicines out of reach of children.

6.5. Nature and contents of container

Primary packaging: Polycellonium foil strip.

Secondary packaging: Catch cover: Artpaper 85 g/m². Box: Duplex coated 270 g/m² + Water Based. Packing : Box, 25 Catch cover @ 1 strip @ 4 caplets (envelope containing 4 caplets in alumunium strip).

6.6. Special precautions for disposal and other handling

None.

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