Ilvico Granules for oral solution 10 Sachets

Ilvico (10 Envelopes Granules For Oral Solution)

Paracetamol / Caffeine / Brompheniramine Maleate

ACTION AND MECHANISM

- Combination of a [ANALGESIC] [ANTIPIRETIC] and a [HISTAMINERGIC ANTAGONIST (H-1)]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of prostaglandin synthesis at the central level. For its part, brompheniramine acts as a histaminergic and muscarinic antagonist, eliminating cold symptoms such as sneezing, whining or rhinorrhea.

INDICATIONS

- Symptomatic relief of [COMMON COLD] and [FLU] that present with fever, mild or moderate pain and runny nose.

POSOLOGY

- Adults: 2 tablets / 8 h or 1 sachet / 6-8 h. Maximum dose: 6 tablets / 24 h or 4 sachets / 24 h.

- Children 12 years or older: 1 tablet / 8 h or 1 sachet / 6-8 h. Maximum dose: 6 tablets / 24 h or 3 sachets / 24 h.

- Children under 12 years: contraindicated use.

Duration of treatment: If the symptomatology worsens or if it persists for more than 5 days of treatment, the clinical situation should be evaluated.

Suspension of treatment: once the symptoms have disappeared.

RULES FOR CORRECT ADMINISTRATION

- Tablets: should be swallowed with a little water.

- Envelopes: must be dissolved in half a glass of water, shaking until completely dissolved, then swallowed.

Administration with food: taking this medicine with food and drink does not affect its effectiveness.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug: [ALLERGY TO PARACETAMOL], to caffeine or [ALLERGY TO XANTHINES], to brompheniramine or to any of the excipients.

- Concomitant administration or in the previous 14 days of monoamine oxidase inhibitors (MAOI) (see Interactions).

- Asthmatic patients who have previously experienced severe antihistamine-induced bronchopulmonary adverse effects.

- Focal lesions of the CNS.

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

- [PORFIRIA]. H1 antihistamines are not considered safe in patients with porphyria.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Accumulation of active ingredients could occur. In these patients, the appearance of renal adverse reactions to paracetamol is more frequent.
- Patients afflicted with [CLOSED ANGLE GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [GRAVE MYASTENIA], Stenosing [PEPTIC ULCER] or [OBSTRUCTION INTESTINAL]. Brompheniramine could worsen these conditions due to its anticholinergic effects.
- [ASTHMA], [PULMONARY EMPHYSEMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Brompheniramine could worsen these processes due to its anticholinergic effects. Bronchospastic reactions have been described when paracetamol is administered to asthmatic patients with [SALICYLATE ALLERGY], therefore special caution is recommended in these patients.
- [EPILEPSY]. Some H1 antihistamines have been associated with the occurrence of seizures. On the other hand, treatment with anticonvulsants can enhance the hepatotoxicity of paracetamol and decrease the bioavailability of paracetamol, especially in high dose treatments.
- [DYSCRASIAS SANGUINEAS]. Acetaminophen may 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.
- [ANXIETY] and other conditions such as [HYPERTHYROIDISM] or cardiac arrhythmias, in which the administration of caffeine could worsen the symptoms.
- 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.

PRECAUTIONS RELATING TO EXCIPIENTS

- This medicine contains sorbitol. Patients with hereditary [FRUCTOSE INTOLERANCE] should not take this medicine.

- This medicine contains orange yellow S as an excipient. May cause allergic-type reactions including [ASTHMA], especially in patients with [SALICYLATE ALLERGY].

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

- This medicine contains sucrose. Its use in oral liquids and pharmaceutical forms that remain in contact with the mouth for a while can damage the teeth.

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 physician should be notified of any drug the patient is taking.
- Patients with glaucoma or urinary retention should notify the doctor before starting treatment.
- 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 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 ingestion of alcoholic beverages together with paracetamol could cause liver damage. In addition, the sedative effects of brompheniramine 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.
- Oral anticoagulants. On very rare occasions, usually with high doses, the anticoagulant effects could be potentiated by inhibition of the hepatic synthesis of coagulation factors by paracetamol. It is recommended to administer the minimum dose, with a duration of treatment as low as possible, and to control the INR.
- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Brompheniramine 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.
- 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.
- 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.
- Propranolol. Propranolol could inhibit the metabolism of paracetamol, leading to toxic effects.
- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). Co-administration of brompheniramine with a sedative drug could enhance the hypnotic action.
- 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 the sachets have not been evaluated in children under 12 years of age, so their use is not recommended.
Children treated with brompheniramine may experience paradoxical arousal, characterized by agitation, insomnia, tremors, euphoria, nervousness, delirium, palpitations, and even seizures.

SENIORS

Older people are more susceptible to adverse reactions from brompheniramine, such as dizziness, sedation, and hypotension. It is recommended to use with caution, and to 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 automobiles, until they are reasonably certain that drug treatment does not adversely affect them.

ADVERSE REACTIONS

The most reported adverse reactions during the period of use of paracetamol, caffeine and brompheniramine are: hepatotoxicity, renal toxicity, alterations in the blood formula, hypoglycemia and allergic dermatitis, stimulation of the CNS, gastrointestinal and nervous system disorders.

Adverse reactions are described according to each frequency range, being considered very common (> 10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%) , very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive. Common: [NAUSEA], [VOMITING], [DRY MOUTH] and gastrointestinal upset.

- Hepatic. Rare: [INCREASED TRANSAMINASES]. Very rare: [HEPATOPATIA] with or without [JAUNDICE].

- Neurological / psychological. Very common: [NERVIOSISM], [INSOMNIA], [AGITATION], [DELUSION] moderate. Common: [Drowsiness], paradoxical stimulation, [HEADACHE], psychomotor disturbance. Rare: [EXTRAPYRAMIDAL DISORDERS], [SEIZURES], [TREMOR].

- Genitourinary. Common: [URINARY RETENTION]. Very rare: [PIURIA] sterile (cloudy urine).

- Allergic / dermatological. Very rare: [HYPERSENSITIVITY REACTIONS],], ranging from a simple [URTICARIA] or [SKIN ERUPTIONS], and [ANAPHYLAXIA]. Unknown frequency: [PHOTOSENSITIVITY REACTIONS].

- Ophthalmological. Common: [BLURRED VISION].

- Hematological. Very rare: [ANEMIA], [HEMOLYTIC ANEMIA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCITOPENIA], and [THROMBOCYTOPENIA].

- Metabolic. Very rare: [HYPOGLYCAEMIA].

- Respiratory. Common: increased respiratory secretions ([BRONCHIAL HYPER-SECRETION]).

- Cardiovascular. Rare: [HYPOTENSION], [CARDIAC ARRHYTHMIA], [PALPITATIONS]. Treatment should be discontinued if dizziness or palpitations are experienced.

- Generals. Rare: [GENERAL DISASTER].

ADVERSE REACTIONS RELATING TO EXCIPIENTS

- Because it contains orange yellow (E-110), it may cause [HYPERSENSITIVITY REACTIONS].

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, death of the patient may occur due to liver necrosis or acute renal 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 brompheniramine overdose (deep sedation, anticholinergic symptoms) 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 will be initially carried out, preferably within four hours of ingestion. The 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) in 1000 ml of 5% dextrose will be administered 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.

Prospectus Ilvico Granules for oral solution 10 Sachets