what is Prontalgine tablet medication used for and indication?
Treatment in adults of pain of moderate to severe intensity or which is not relieved by aspirin or paracetamol alone.
PRESENTATION (S) AVAILABLE FOR PRONTALGINE
5 presentations are available for this drug:
- 2 blister (s) PVC aluminum of 5 tablet (s)
- 2 blister pack (s) PVC aluminum of 6 tablet (s)
- 2 PVC aluminum blister pack (s) of 18 tablet (s)
- 4 blister pack (s) PVC aluminum of 5 tablet (s)
- PVC aluminum blister pack (s) of 6 tablet (s)
|Pharmaceutical class||not communicated|
|Active substance (s)||for one tablet: caffeine (50.0 mg), paracetamol (400.0 mg), codeine (phosphate) hemihydrate (20.0 mg)|
|Route (s) of administration||oral|
|Selling price||unregulated price|
|Social security reimbursement rate||0%|
|Laboratory (s)||Laboratory (s) manufacturer Prontalgine|
|Conditions of issue||available by simple prescription|
Prontalgine tablet Dosage
RESERVED FOR ADULTS.
1 tablet to be taken with a glass of water, to be renewed if necessary after 4 hours, possibly 2 tablets per dose in the event of severe pain, without exceeding 6 tablets per day.
THIS MEDICINE HAS BEEN DELIVERED TO YOU PERSONALLY IN A SPECIFIC SITUATION:
- IT MAY NOT BE SUITABLE FOR ANOTHER CASE.
- DO NOT ADVISE IT TO ANOTHER PERSON.
Prontalgine tablet Contraindications
How To Take Prontalgine tablet ?
Frequency of administration
- Systematic catches prevent pain peaks.
- They must be spaced at least 4 hours apart.
- In the event of severe kidney disease (renal failure), the catches should be spaced at least 8 hours apart.
Duration of the treatment
- If the pain persists for more than 5 days, consult your doctor.
how does Prontalgine tablet work?
Pharmacotherapeutic group: OTHER ANALGESICS AND ANTIPYRETICS, ATC code: N02BE51.
Association of three active ingredients:
- · Paracetamol analgesic, antipyretic. Paracetamol has a central and peripheral mechanism of action,
- · Codeine phosphate hemihydrate: central opioid analgesic,
- · Caffeine: central stimulant.
The combination of paracetamol and codeine phosphate has an analgesic activity significantly greater than that of its components taken alone, with a more prolonged effect over time.
- Codeine is a weak centrally acting analgesic. It exerts its effect through its action on µ opioid receptors although its affinity for these receptors is low. Its analgesic effect is due to its conversion to morphine.
- Codeine, in particular when it is combined with other analgesics such as paracetamol, has shown its effectiveness in the treatment of nociceptive pain.
How To Store Prontalgine tablet ?
- Keep this medication out of the sight and reach of children.
- Do not use PRONTALGINE, tablet after the expiry date stated on the box.
- No special storage conditions.
- Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
Prontalgine tablet Side Effects
Like all medicines, PRONTALGINE, tablet can cause side effects, although not everybody gets them.
Linked to the presence of paracetamol
- A few rare hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, extensive skin rash have been reported. Their occurrence requires the definitive discontinuation of this drug and related drugs.
- Very exceptional cases of decrease in platelets (important blood elements in blood clotting) have been reported.
Linked to the presence of codeine
Possibility of :
- constipation, nausea, vomiting,
- drowsiness, dizziness,
- hypersensitivity reactions (pruritus, hives and, in rare cases, extensive rash),
- respiratory problems,
- abdominal pain especially in cholecystectomized patients (without gallbladder).
Linked to the presence of caffeine
- Possibility of excitement, insomnia, palpitations.
If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Prontalgine tablet Interactions
RELATED TO PARACETAMOL
Combinations subject to precautions for use
- Risk of an increase in the effect of the antivitamin K and of the risk of bleeding if paracetamol is taken at maximum doses (4 g / d) for at least 4 days.
- More frequent control of the INR. Possible adjustment of the dose of the antivitamin K during treatment with paracetamol and after its discontinuation.
Interactions with paraclinical examinations
- Taking paracetamol can falsify the determination of blood glucose by the glucose oxidase-peroxidase method in the event of abnormally high concentrations.
- Taking paracetamol can interfere with the dosage of uric acid in the blood by the phosphotungstic acid method.
RELATED TO CODEINE
Not recommended associations
- Alcohol enhancement of the sedative effect of codeine.
- Impaired vigilance can make driving and using machines dangerous.
- Avoid taking alcoholic drinks or drugs containing alcohol.
Morphinic agonist-antagonists: buprenorphine, nalbuphine, pentazocine.
- Decrease in the analgesic effect by competitive blocking of receptors, with the risk of the appearance of a withdrawal syndrome.
Partial antagonist morphines
- Risk of reduction of the analgesic effect.
Associations to take into account
Barbiturates, benzodiazepines, other morphine derivatives (analgesics, cough suppressants and substitution treatments)
- Increased risk of respiratory depression which may be fatal in case of overdose.
+ Other CNS depressants: sedative antidepressants, sedating H1 antihistamines, barbiturates, clonidine and related drugs, hypnotics, neuroleptics, anxiolytics.
- Increase in central depression.
- Impaired vigilance can make driving and using machines dangerous.
- Not applicable.
Effects on ability to Drive and use machines
- Attention is drawn especially among vehicle drivers and machine users to the risks of drowsiness due to the presence of codeine in this medication.
- This phenomenon subsides after several intakes, it may be useful to start this treatment in the evening.
- This phenomenon is accentuated by the consumption of alcoholic beverages.
Warnings and Precautions
To avoid a risk of overdose:
- · Check for codeine and paracetamol in the composition of other medications, including whether they are medicines obtained without a prescription,
- · Respect the maximum recommended doses (see Dosage and Administration).
- Prolonged use of codeine can lead to a state of dependence.
- Deafferentation pain (neurogenic pain) does not respond to the codeine paracetamol combination.
- As part of the management of pain in children, the administration of codeine requires a medical prescription .
- Monitoring should focus on the vigilance of the child: before taking this medication, make sure that the child does not have an excessive or abnormal tendency to drowsiness.
Precautions for use
Elderly: reduce the initial dosage by half of the recommended dosage, and possibly increase it secondarily depending on tolerance and needs (see section Dosage and method of administration).
Related to paracetamol:
Paracetamol should be used with caution in the following cases:
- · Weight <50 kg
- · Mild hepatic insufficiency to moderate
- · Severe renal impairment (creatinine clearance ≤ 30 ml / min (see sections Dosage and administration and Pharmacokinetic properties)),
- · Chronic alcoholism,
- · Chronic malnutrition (low reserves of hepatic glutathione)
- · Dehydration (see Dosage and Administration).
If acute viral hepatitis is found, treatment should be stopped.
Related to codeine:
- Alcohol absorption during treatment is not recommended due to the presence of codeine.
- In the event of intracranial hypertension, codeine may increase the extent of this hypertension.
- In productive coughs, codeine can interfere with sputum.
- In cholecystectomized patients, codeine can cause an acute abdominal pain syndrome of the biliary or pancreatic type, most often associated with laboratory abnormalities, suggestive of a spasm of the sphincter of Oddi.
- Codeine is metabolized to morphine by the liver enzyme CYP2D6, its active metabolite. In the event of a deficiency or absence of this enzyme, the expected analgesic effect will not be obtained.
- It is estimated that up to 7% of the Caucasian population may have this deficit.
- However, if the patient is a rapid or ultra-rapid metabolizer, there is an increased risk, even at therapeutic doses, of developing adverse effects due to opioid toxicity. These patients convert codeine to morphine rapidly, therefore their serum morphine level is higher than expected.
- General symptoms of opioid toxicity include confusion, drowsiness, shallow breathing, miosis, nausea, vomiting, constipation, and lack of appetite. In severe cases, patients may present with symptoms of respiratory and circulatory depression, which can be life-threatening and very rarely be fatal.
The estimated prevalences of ultrafast metabolizers in the different populations are summarized below:
|Africans / Ethiopians||29%|
|African Americans||3.4% to 6.5%|
|Asians||1.2% to 2%|
|Caucasians||3.6% to 6.5%|
|Northern Europeans||1 to 2%|
Post-operative use in children
- Cases published in the literature have shown that codeine, used postoperatively in children after tonsillectomy and / or adenoidectomy in the context of obstructive sleep apnea syndrome, causes rare side effects but may cause game the vital prognosis or even lead to death (see section Contraindications). All of these children had received codeine at the recommended doses; however, there was evidence that these children were rapid or ultra-rapid metabolisers of codeine into morphine.
Children with impaired respiratory function
- Codeine is not recommended in children who may have impaired respiratory function due to neuromuscular disorders, severe cardiac or respiratory disorders, upper respiratory or pulmonary infections, multiple trauma or lengthy surgical procedures. These factors can worsen the symptoms of morphine toxicity.
PREGNANCY & BREAST-FEEDING & FERTILITY
- Using point of this drug can be considered during pregnancy, if it is necessary from a clinical point of view. However, it should be used at the lowest effective dose, for the shortest possible time and at the lowest possible frequency. Its chronic use should be avoided.
- In the event of administration at the end of pregnancy, take into account the morphino-mimetic properties of this drug (theoretical risk of respiratory depression in the newborn after high doses before childbirth, risk of withdrawal syndrome in the event of administration chronic in late pregnancy).
Linked to paracetamol:
- A large amount of data on pregnant women demonstrate the absence of any malformations or fetal / neonatal toxicity. Epidemiological studies devoted to the neurodevelopment of children exposed to paracetamol in utero produce inconclusive results.
Linked to codeine:
- Clinically, although a few case-control studies show an increased risk of heart defects occurring, most epidemiological studies rule out a malformation risk.
- Studies in animals have shown a teratogenic effect.
Feeding with milk
This medication is contraindicated during breast-feeding (see section Contraindications):
- Paracetamol and codeine pass into breast milk.
- The action to be taken during breastfeeding depends on the presence of codeine.
- At normal therapeutic doses, codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to cause adverse effects in the nursing infant. However, if the patient is an ultra-rapid CYP2D6 metabolizer, a significant amount of the active metabolite, morphine, may be present in maternal blood as well as in breast milk. In very rare cases, these elevated levels can cause symptoms of opioid toxicity in children (drowsiness, difficulty sucking, pauses or even respiratory depression and hypotonia) which can be fatal.
Linked to paracetamol:
- Due to the potential mechanism of action on cyclooxygenase and the synthesis of prostaglandins, paracetamol could impair fertility in women, through an effect on ovulation which is reversible upon discontinuation of treatment.
- Effects on male fertility have been observed in an animal study. The relevance of these effects in humans is not known.
Linked to codeine:
- There are no data in animals regarding male and female fertility.
What happens if I overdose from Prontalgine tablet ?
OVERDOSAGE WITH PARACETAMOL:
- The risk of serious intoxication (therapeutic overdose or accidental intoxication) may be particularly high in the elderly, in young children, in patients with liver damage, in chronic alcoholism, in patients suffering from chronic malnutrition. .
- In these cases, poisoning can be fatal.
- Nausea, vomiting, anorexia, pallor, abdominal pain usually appear within the first 24 hours.
- An overdose, starting from 10 g of paracetamol in a single dose in adults and 150 mg / kg of body weight in a single dose in children, causes hepatic cytolysis which may lead to complete and irreversible necrosis. resulting in hepatocellular insufficiency, metabolic acidosis, encephalopathy which can lead to coma and death.
- At the same time, there is an increase in hepatic transaminases, lactico-dehydrogenase, bilirubin and a decrease in the level of prothrombin which may appear 12 to 48 hours after ingestion.
- Emergency driving
- · Stop the treatment.
- · Immediate transfer to hospital.
- · Take a tube of blood plasma to the initial dosage of paracetamol.
- · Rapid evacuation of the ingested product, by gastric lavage.
- · Treatment of overdose typically includes administration as early as possible of the antidote N-acetylcysteine intravenously or orally if possible before the tenth hour.
- · Symptomatic treatment.
Signs in adults:
- · Acute depression of the respiratory centers (cyanosis, respiratory slowing), drowsiness, rash, vomiting, itching, ataxia, pulmonary edema (rare).
Signs in children (toxic threshold: 2 mg / kg as a single dose):
- · Slowing of respiratory rate, pauses in breathing, miosis, convulsions, signs of histaminoliberation: “facial puffiness”, urticarial rash, collapse, urinary retention.
- · Stop the treatment.
- · Respiratory assistance.
- · Administration of naloxone.
What should I do if I miss a dose?
If you forget to take PRONTALGINE, tablet
- Do not take a double dose to make up for the single dose you forgot to take. Continue treatment as prescribed.
What happens if you stop taking Prontalgine tablet ?
Effects which may appear when treatment with PRONTALGINE, tablet is stopped:
- With prolonged treatment, suddenly stopping this medication may lead to withdrawal syndrome.
What is Forms and Composition ?
SHAPES and PRESENTATIONS
- Tablet (white): Box of 18, in blister packs.
- PRONTALGINE, tablet, box of 12
|Paracetamol * (INN)||400 mg|
|Anhydrous caffeine||50 mg|
|Codeine phosphate hemihydrate||20 mg|
|(corresponding amount of codeine: 15.6 mg / tab)|
- Excipients: crospovidone, sodium carboxymethyl starch, colloidal anhydrous silica, magnesium stearate, povidone, microcrystalline cellulose.
- * in the form of granulated paracetamol with povidone (paracetamol titer: 94.5 to 97.5%).
- The quantity used is adjusted according to the title.
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