Vincigrip Forte 10 Sachets Granules for Oral Solution (Orange Flavour)

Vincigrip Forte (10 Envelopes Granules For Oral Solution (Cocoa Flavor))

ACTION AND MECHANISM

- Combination of a [ANALGESIC] [ANTIPIRETIC], a [HISTAMINERGIC ANTAGONIST (H-1)] and a [NASUS / PHARYNX DECONGESTANT]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of prostaglandin synthesis at the central level. For its part, pseudoephedrine is an alpha-1 adrenergic agonist, which leads to vasoconstriction, reducing nasal congestion. Finally, chlorphenamine antagonizes H1 and cholinergic receptors, eliminating catarrhal symptoms such as sneezing, whining or rhinorrhea.

INDICATIONS

- Symptomatic treatment of processes such as [COMMON COLD] and [FLU] that present with fever, moderate pain, headache and nasal congestion.

POSOLOGY

- Adults, oral: 1 capsule / 6-8 hours or 1 sachet / 6-8 hours (Vincigrip) or 1 sachet / 8 hours (Vincigrip Forte). The maximum daily dose is 8 sachets / 24 hours or 8 capsules / 24 hours (Vincigrip) or 6 sachets / 24 hours (Vincigrip Forte).

- Children, oral:

* Children 12 years or older: 1 capsule / 6-8 hours or 1 sachet / 6-8 hours (Vincigrip) or 1 sachet / 8 hours (Vincigrip Forte). The maximum daily dose is 8 sachets / 24 hours or 8 capsules / 24 hours (Vincigrip) or 6 sachets / 24 hours (Vincigrip Forte).

* Children under 12 years of age: The safety and efficacy of this medicine have not been evaluated.

RULES FOR CORRECT ADMINISTRATION

The sachets should be dissolved in half a glass of water. The capsules should be swallowed whole with a glass of water. The administration of this medicine should be started when the first symptoms appear. As these disappear, this medication should be discontinued.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug, including cases of [ALLERGY TO PARACETAMOL].
- [HEPATOPATIA], such as [HEPATIC INSUFFICIENCY] or [HEPATITIS]. Paracetamol can lead to hepatotoxicity.
- [PORFIRIA]. H1 antihistamines are not considered safe in these patients.
- Severe heart disease or uncontrolled diabetes mellitus. There is a risk of serious decompensation.
- Patients in treatment with antidepressants of the MAOI type in the 14 days before starting therapy with pseudoephedrine (See Interactions).

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Accumulation of active ingredients could occur. In these patients, the appearance of renal adverse reactions to paracetamol is more frequent.

- Patients with [DIABETES], [GLAUCOMA], [CORONARY INSUFFICIENCY], [ISCHEMIC CARDIOPATIA], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [HYPERTHYROIDISM], [PHEOCROMOCITOMA], [URGENT HYPERTRUCTIONAL OJECTOMA, [PROSTRUCTIONAL OJTERPLAS] ], [MYASTENIA GRAVE], [PEPTIC ULCER] stenosing or [INTESTINAL OBSTRUCTION]. Both pseudoephedrine and chlorphenamine may aggravate symptoms. In severe cases, it may be advisable to avoid administration.

- [ASTHMA], [PULMONARY EMPHYSEMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Chlorphenamine could worsen these processes due to its anticholinergic effects. Bronchospastic reactions have been described when paracetamol is administered to asthmatic patients with [SALICYLATE ALLERGY], so special caution is recommended in these patients.

- [EPILEPSY]. Some H1 antihistamines have been associated with the occurrence of seizures.

- [DYSCRASIAS SANGUINEAS]. Paracetamol could occasionally lead to [ANEMIA], [LEUCOPENIA] or [THROMBOCYTOPENIA]. It is recommended to take extreme precautions, avoiding prolonged treatments, and perform periodic hematological counts in these cases.

- Hepatotoxicity. The metabolism of paracetamol could give rise to hepatotoxic substances. It is recommended to avoid its use in patients with previous liver damage (See Contraindications), as well as to exercise extreme caution in those with [CHRONIC ALCOHOLISM] or other factors that could trigger hepatotoxicity phenomena. It is advisable to avoid prolonged treatments and not exceed doses of 2 g / 24 hours in these patients. Similarly, it is recommended to monitor transaminase levels, suspending treatment in the event of a significant increase in them.

ADVICE TO THE PATIENT

- It is advisable to drink plenty of water during the treatment, avoiding as much as possible the intake of alcoholic beverages.
- It is recommended not to exceed the recommended daily doses and avoid treatments for more than ten days without a medical prescription.
- If the symptoms continue or worsen after five days, it is recommended to consult a doctor.
- The doctor or pharmacist should be notified of any illness that the patient suffers or any medication that he is taking.
- It can cause drowsiness, so it is recommended to exercise caution when driving, and not to combine it with drugs or other sedative substances such as alcohol.

SPECIAL WARNINGS

- In patients treated with anticoagulants, it is recommended to follow short treatments with low doses, controlling the coagulation parameters.
- It is recommended to perform hematological counts in patients treated with high doses or for prolonged periods of time.
- It is advisable to control the levels of transaminases in patients with prolonged treatments or in danger of presenting hepatotoxicity.
- In case of overdose, the specific antidote for paracetamol is N-acetylcysteine.

INTERACTIONS

- Ethyl alcohol. Ethyl alcohol might enhance the sedative effects of this medicine. In addition, the intake of alcoholic beverages together with paracetamol could cause liver damage. It is recommended to avoid alcohol intake during treatment. In chronic alcoholics, no more than 2 g / 24 hours of paracetamol should be administered.
- Oral anticoagulants. On very rare occasions, usually with high doses, the anticoagulant effects could be potentiated by inhibiting the hepatic synthesis of coagulation factors by paracetamol. It is recommended to administer the minimum dose, with a treatment duration as low as possible, and to control the INR.
- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine could potentiate anticholinergic effects, so it is recommended to avoid the association.
- Oral contraceptives. They could increase the plasma clearance of paracetamol, reducing its effects.
- Antihypertensives (beta-blockers, diuretics, guanethidine, methyl-dopa). Pseudoephedrine could antagonize the antihypertensive effects, and even lead to hypertensive crisis, so it is recommended to monitor blood pressure. Propranolol could inhibit the metabolism of paracetamol, leading to toxic effects.
- Active carbon. It can produce an adsorption of paracetamol, reducing its absorption and pharmacological effects.
- Chloramphenicol. The toxicity of paracetamol could be enhanced, probably by inhibiting its metabolism.
- Digoxin. The risk of cardiac arrhythmias associated with pseudoephedrine could be increased.
- Nerve stimulants (amphetamines, cocaine, xanthines). Nerve stimulation could be enhanced, leading to intense excitability.
- Thyroid hormones. There could be a potentiation of the effects of both drugs, with a risk of arterial hypertension and coronary insufficiency.
- MAOI. MAOIs could potentiate the effects of pseudoephedrine by inhibiting norepinephrine metabolism, increasing the risk of hypertensive crisis and other cardiac events. It is recommended to avoid the administration of this medicine in patients treated with MAOIs in the previous 14 days.
- Enzyme inducers. Medications such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin or sulfinpyrazone, could induce the metabolism of paracetamol, reducing its effects and increasing the risk of hepatotoxicity.
- Lamotrigine. Paracetamol could reduce the serum concentrations of lamotrigine, reducing the therapeutic effect.
- Levodopa. The administration of levodopa together with sympathomimetics increases the risk of cardiac arrhythmias, so a decrease in the dose of the adrenergic agonist might be necessary.
- Nitrates. Pseudoephedrine could antagonize the antianginal effects of nitrates, so it is recommended to avoid the association.
- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The sedative effects could be enhanced.
- Sympathomimetics. It can produce a potentiation of side effects, both of nervous and cardiovascular origin.
- Zidovudine. Paracetamol could increase the elimination of zidovudine, decreasing its effects.

PREGNANCY

Some active principles of this specialty are capable of crossing the placental barrier. The safety and efficacy of this drug have not been evaluated in pregnant women, so it is recommended to avoid its administration, unless there are no safer therapeutic alternatives, and provided that the benefits outweigh the possible risks.

LACTATION

Some of the active principles of this medicine are excreted with milk, so it is recommended to stop breastfeeding or avoid the use of this medicine in pregnant women.

KIDS

The safety and efficacy of this medicine have not been evaluated in children under 12 years of age, so its use is not recommended.

SENIORS

Elderly patients may be more susceptible to the adverse effects of this drug, so it is recommended to use it with caution, and to suspend its administration if the adverse reactions are not tolerable.

EFFECTS ON DRIVING

This medicine can substantially affect the ability to drive and / or operate machinery. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that drug treatment does not adversely affect them.

ADVERSE REACTIONS

- Digestive. Anticholinergic phenomena such as [DRY MOUTH] and [CONSTIPATION] may appear. Rarer is the appearance of [ANOREXIA].

- Hepatic. Occasionally, [HEPATOPATHY] may occur with or without [JAUNDICE].

- Neurological / psychological. [Drowsiness], mental [CONFUSION] and [EUPHORIA] may occasionally appear. The appearance of [EXCITABILITY] phenomena is very rare, with [NERVIOSISM] and [INSOMNIA], being especially frequent in children and the elderly.

- Cardiovascular. [ARTERIAL HYPERTENSION], [TACHYCARDIA].

- Genitourinary. [URINARY RETENTION].

- Allergic / dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [DERMATITIS], [SKIN ERUPTIONS], [PHOTOSENSITIVITY REACTIONS] and [HYPERHYDROSIS].

- Ophthalmological. [MIDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION].

- Bloodlines. [ANEMIA], [HEMOLITIC ANEMIA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCITOPENIA], and [THROMBOCYTOPENIA].

- Metabolic. Rarely [HYPOGLYCAEMIA].

OVERDOSE

Symptoms: Overdose from paracetamol products is a very serious and potentially fatal poisoning. Symptoms may not appear immediately, and may even take up to three days to appear. These symptoms include confusion, excitability, restlessness, nervousness and irritability, dizziness, nausea and vomiting, loss of appetite, and liver damage. Hepatotoxicity usually manifests within 48-72 hours with nausea, vomiting, anorexia, malaise, sweating, jaundice, abdominal pain, diarrhea, and liver failure.
In children, states of drowsiness and alterations in the way of walking also appear.
In the most severe cases, the patient may die from liver necrosis or acute kidney failure.
The minimum toxic dose of paracetamol is 6 g in adults and 100 mg / kg in children. Doses greater than 20-25 g of paracetamol are potentially fatal.
In addition to the symptoms of paracetamol overdose, symptoms of chlorphenamine overdose (deep sedation, anticholinergic symptoms) and pseudoephedrine (excitability, seizures, tachycardia, high blood pressure) may appear.
Treatment: In case of overdose, go immediately to a medical center, since paracetamol poisoning can be fatal, even if no symptoms appear. In children, early identification of paracetamol overdose is especially important, due to the severity of the condition, as well as the existence of a possible treatment.
In any case, gastric lavage and aspiration of stomach contents should be initially carried out, preferably within four hours of ingestion. Administration of activated charcoal can reduce the amount absorbed.
There is a specific antidote in case of paracetamol poisoning, N-acetylcysteine. It is recommended to administer a dose of 300 mg / kg of N-acetylcysteine, equivalent to 1.5 ml / kg of 20% aqueous solution, with a pH of 6.5, intravenously, over a period of 20 hours and 15 minutes, according to the following scheme:
- Adults. A shock dose of 150 mg / kg (0.75 ml / kg of 20% solution) will be administered initially by slow intravenous route, over 15 minutes, either directly or diluted in 200 ml of 5% dextrose.
Then a maintenance dose with 50 mg / kg (0.25 ml / kg of 20% solution) in 500 ml of 5% dextrose in slow intravenous infusion over 4 hours will be established.
Finally, 100 mg / kg (0.50 ml / kg of 20% solution) will be administered in 1000 ml of 5% dextrose in slow intravenous infusion over 20 hours.
- Kids. The same amounts per unit of weight will be administered as in the adult, but the volumes of dextrose should be adjusted based on the age and weight of the child in order to avoid vascular congestion.
The efficacy of the antidote is maximum if it is administered within 8 hours of ingestion. The effectiveness decreases progressively thereafter and is ineffective after 15 hours.
The administration of 20% N-acetylcysteine ​​can be interrupted when paracetamol levels in the blood are below 200 µg / ml.
In addition to the administration of the antidote, a symptomatic treatment will be established, keeping the patient under clinical surveillance.
In the event of hepatotoxicity, it is advisable to perform a liver function study and repeat the study at 24-hour intervals.

Doping

Pseudoephedrine is a prohibited substance during competition.

It is prohibited when its administration results in a urine concentration greater than 150 mcg / ml.

The detection in a sample during the competition of any quantity of pseudoephedrine in combination with a diuretic or a masking agent, will be considered an adverse analytical result, unless the athlete has obtained an approved therapeutic use authorization (TUE) for ephedrine, in addition than that granted for the diuretic or masking agent.

It is considered a “specific substance” and, therefore, a violation of the rule in which this substance is involved may lead to a reduction in the penalty as long as the athlete can demonstrate that the use of the specific substance in question was not intended to increase your athletic performance.

Vincigrip Forte 10 Sachets Granules For Oral Solution (Orange Flavor)