Friolgrip Antitussive - Powder for Oral Solution

Friolgrip Antitussive (10 Envelopes Granules Oral Solution)

ACTION AND MECHANISM

- Combination of an [ANALGESICO] [ANTIPIRETICO], a [HISTAMINERGIC ANTAGONIST (H-1)] and a [ANTITUSIVE]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of prostaglandin synthesis at the central level. For its part, chlorphenamine acts as a histaminergic and muscarinic antagonist, eliminating cold symptoms such as sneezing, whining or rhinorrhea. Finally, dextromethorphan causes depression of the cough center.

INDICATIONS

- [COMMON COLD]. Symptomatic treatment of catarrhal processes and [GRIPE] that present fever, moderate pain, headache, unproductive cough and rhinorrhea.

POSOLOGY

- Adults: 1 tablet / 6-8 hours or 1 envelope / 6-8 hours.

- Children:

* Children 12 years or older: 1 tablet / 6-8 hours or 1 envelope / 6-8 hours.

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

The maximum daily dose is 4 tablets or sachets, taking the shots at least 6 hours.

Always use the lowest dose that is effective. The administration of the preparation is subject to the appearance of the first symptoms, as they disappear, this medication should be discontinued.

If the patient worsens or symptoms persist after 5 days of treatment in adults or 3 days in adolescents, or if the fever persists for more than 3 days, the clinical situation should be evaluated.

RULES FOR THE CORRECT ADMINISTRATION

Dissolve in half a glass of water, then swallowed.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication, including cases of [PARACETAMOL ALLERGY] or [OPIOID ALLERGY].

- [HEPATOPATIA], such as [HEPATIC INSUFFICIENCY] or [HEPATITIS]. Paracetamol can lead to hepatotoxicity.

- [PORPHYRIA]. H1 antihistamines do not consider safe in patients with porphyria.

- Patients in treatments with antidepressants of the IMAO or SSRI type (See Interactions).

PRECAUTIONS

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

- Patients suffering from [GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [ARTERIAL HYPERTENSION], [CARDIAC ARRITHMIA], [SERIOUS MYASTENIA], [SEPTIC ULCERA] stenosis or [INTESTINAL OBSTRUCTION] Chlorphenamine may worsen these conditions due to its anticholinergic effects.

- Persistent or chronic cough, as in the one associated with [ASTHMA], [PULMONARY DISEASE] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Chlorphenamine and dextromethorphan could worsen these processes due to the increased viscosity of secretions, and the inhibition of cough. Bronchospastic reactions have been described when administering acetaminophen to asthmatic patients with [SALICILATE ALLERGY], so special caution is recommended in these patients.

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

- [BLOOD DISCRASIAS]. Paracetamol may occasionally lead to [ANEMIA], [LEUCOPENIA] or [TROMBOCITOPENIA]. Extreme precautions are recommended, avoiding prolonged treatments, and performing periodic hematological counts in these cases.

- Hepatotoxicity. Paracetamol metabolism could lead to hepatotoxic substances. It is recommended to avoid its use in patients with previous liver damage (See Contraindications), as well as to take precautions in those with [CHRONIC ALCOHOLISM] or other factors that could trigger hepatotoxicity phenomena. It is advisable to avoid prolonged treatments and not exceed the 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.

- Dependency Although they are very rare, there have been cases of dependence on products with dextromethorphan. It is recommended to take precautions and monitor the patient, especially children, in case symptoms of abuse appear.

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains sucrose. Patients with hereditary [INTRODUCTION TO FRUCTOSE], glucose or galactose malabsorption, or sucrose-isomaltase insufficiency should not take this medication.

- This medicine contains sucrose. The administration of amounts greater than 5 g daily should be taken into account in patients with [DIABETES].

- This medicine contains sucrose. Its use in oral fluids and pharmaceutical forms that remain in contact with the mouth for some time can harm the teeth.

PATIENT ADVICE

- It is advisable to drink plenty of water during the treatment, avoiding as much as possible the intake of alcoholic beverages.

- The doctor must be notified of any changes in the patient's behavior or mood.

- It is recommended not to exceed the recommended daily doses and avoid treatments longer than ten days without optional prescription.

- If the symptoms continue or worsen after five days, it is recommended to consult the doctor.

- The doctor should be notified of any drug the patient is taking, especially in the case of antidepressants.

- Patients with glaucoma or urinary retention should notify the doctor before starting treatment.

- It can cause drowsiness, so it is recommended to be cautious when driving, and not combine it with drugs or other sedative substances such as alcohol.

SPECIAL WARNINGS

- It is recommended to monitor the patient for signs of abuse.

- In patients treated with anticoagulants, it is recommended to follow short treatments with low doses, controlling coagulation parameters.

- The association between products with dextromethorphan and antidepressants should be avoided, allowing at least 14 days of rest between the administration of both drugs.

- It is recommended to perform hematological counts in patients treated with high doses or for prolonged periods of time.

- It is advisable to control transaminase levels in patients with prolonged treatment or in danger of presenting hepatotoxicity.

- In case of overdose, the specific antidote for paracetamol is N-acetylcysteine.

INTERACTIONS

- Ethyl alcohol. The intake of alcoholic beverages along with paracetamol could cause liver damage. In addition, the sedative effects of chlorphenamine could be enhanced. It is recommended to avoid alcohol intake during treatment. In chronic alcoholics, no more than 2 g / 24 hours of paracetamol should be administered.

- Antiarrhythmics (amiodarone, quinidine). Cases of dextromethorphan toxicity have been described when combined with certain antiarrhythmics.

- Oral anticoagulants. Very rarely, normally with high doses, anticoagulant effects could be enhanced by inhibition of hepatic synthesis of coagulation factors by paracetamol. It is recommended to administer the minimum dose, with the treatment duration as low as possible, and control the INR.

- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine may potentiate the anticholinergic effects, so it is recommended to avoid the association.

- Oral contraceptives. They could increase the plasma clearance of paracetamol, reducing its effects.

- Antidepressants (IMAO, SSRI). Co-administration of products with dextromethorphan together with MAOI or SSRI could lead to serious adverse reactions, even fatal ones. It is recommended to avoid association and not administer dextromethorphan until at least 14 days after treatment with the antidepressant.

- 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 inhibition of its metabolism.

- Coxibes. Coxibes could increase plasma dextromethorphan concentrations.

- Expectorants and mucolytics. The inhibition of cough by dextromethorphan could lead to pulmonary obstruction in case of increased volume or fluidity of bronchial secretions.

- Enzymatic inductors. Medicines such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin or sulfinpyrazone, could induce paracetamol metabolism, reducing its effects and increasing the risk of hepatotoxicity.

- Lamotrigine. Paracetamol could reduce serum concentrations of lamotrigine, causing a decrease in therapeutic effect.

- Propranolol. Propranolol could inhibit the metabolism of paracetamol, resulting in toxic effects.

- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). Co-administration of chlorphenamine together with a sedative drug could potentiate the hypnotic action.

- Zidovudine. Paracetamol could increase the elimination of zidovudine, reducing its effects.

PREGNANCY

Some active ingredients of this specialty are capable of crossing the placental barrier. The safety and efficacy of this medicine in pregnant women have not been evaluated, 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 substances in this medicine are excreted with milk, so it is recommended to stop breastfeeding or avoid using this medicine in pregnant women.

CHILDREN

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

ELDERLY

Elderly patients may be more susceptible to the adverse effects of this medicine, so it is recommended to use with caution, and suspend its administration in case the adverse reactions were 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 cars, until they are reasonably certain that drug treatment does not adversely affect them.

ADVERSE REACTIONS

The adverse reactions described are:

- Digestive Anticholinergic phenomena may appear such as [NAUSEAS], [VOMITOS], [MOUTH DROUGHT], [DIARRHEA] and [CONDENSATION] More rare is the appearance of [ANOREXIA].

- Hepatic. Occasionally [HEPATOPATIA] may occur with or without [ICTERICIA].

- Cardiovascular. [HYPOTENSION] in the elderly and [TAQUICARDIA].

- Neurological / psychological. The most common adverse reaction is the appearance of [SOMNOLENCE]. There may also be paradoxical reactions of [EXCITABILITY], with [NERVIOSISM] and [INSOMNIUM], being especially frequent in children and the elderly.

- Genitourinary. [URINARY RETENTION].

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

- Ophthalmological. [MIDRIASIS], [CLEAR VISION], [EYE HYPERTENSION].

- Blood. [ANEMIA], [HEMOLITIC ANEMIA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCITOPENIA], and [TROMBOCITOPENIA].

- Metabolic Rarely [HYPOGLUCEMIA].

OVERDOSE

Symptoms: Overdose by products with paracetamol is a very serious and potentially fatal poisoning. Symptoms may not manifest immediately, and 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 after 48-72 hours with nausea, vomiting, anorexia, malaise, diaphoresis, jaundice, abdominal pain, diarrhea and liver failure.

In children there are also states of drowsiness and alterations in the way of walking.

In the most severe cases, the death of the patient due to liver necrosis or acute renal failure may occur.

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 chlorfenamine overdose (deep sedation, anticholinergic symptoms) may occur. Dextromethorphan overdose does not usually cause serious symptoms, although an increase in sedation is expected.

Treatment: In case of overdose, you should immediately go 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, the gastric lavage and aspiration of the stomach contents will proceed initially, preferably within four hours after ingestion. The administration of active carbon 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 hours. minutes, according to the following scheme:

- Adults. Initially, a shock dose with 150 mg / kg (0.75 ml / kg of 20% solution) will be administered slowly intravenously, for 15 minutes, either directly or diluted in 200 ml of 5% dextrose.

A maintenance dose with 50 mg / kg (0.25 ml / kg of 20% solution) in 500 ml of 5% dextrose in slow intravenous infusion for 4 hours will then be established.

Finally, 100 mg / kg (0.50 ml / kg of 20% solution) in 1000 ml of 5% dextrose will be administered in a slow intravenous infusion for 20 hours.

- Children. The same amounts will be administered per unit of weight as in the adult, but dextrose volumes 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 before 8 hours of ingestion. The effectiveness decreases progressively thereafter and is ineffective after 15 hours.

The administration of 20% N-acetylcysteine ​​may be interrupted when blood paracetamol levels are below 200 µg / ml.

In addition to the administration of the antidote, symptomatic treatment will be instituted, keeping the patient under clinical surveillance.

In the event that hepatotoxicity occurs, it is advisable to conduct a study of liver function and repeat the study at 24-hour intervals.

Friolgrip Antitussive Leaflet - Powder For Oral Solution