Frenadol Forte 10 Sachets

Frenadol Forte 10 Sachets (English)

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Frenadol® Forte is an association of paracetamol, which reduces fever and relieves pain, chlorphenamine, which helps to reduce nasal secretion, and dextromethorphan, which has an antitussive action.

Symptoms That Relieve
This medicine is indicated to help adults and adolescents from the age of 14 to reduce the symptoms of colds and flu that cause mild or moderate headache, in addition to fever, unproductive cough (irritative and nervous), and nasal discharge.

ACTIVE PRINCIPLES

• Paracetamol

A drug with analgesic properties that relieves pain.

• Dextromethorphan

Indicated for reducing and suppressing irritative or nervous cough by temporarily exerting an antitussive action.

• Chlorphenamine

Considered a first-generation antihistamine, chlorphenamine is an active ingredient that helps alleviate the discomfort caused by allergies and colds, as well as nasal secretion.

DOSAGE

• In adults and teenagers from 14 years of age, 1 is recommended every 6 or 8 hours, about 3 or 4 times a day, depending on the need. It is recommended to take one sachet before going to bed and not to exceed 4 a day.
• Patients with hepatic insufficiency: take 1 sachet every 8 hours, with a limit of 3 times a day. It is always recommended to consult a doctor.
• Patients with renal insufficiency: this medicine cannot be taken by this type of patients as it contains a dose of 650 mg of paracetamol.
• Do not consume alcoholic beverages, or drive or perform dangerous activities while taking this medicine. It may cause drowsiness. Do not take in case of respiratory failure and asthma.

OTHER BENEFITS

• Anti-flu indicated to alleviate the most intense symptoms of the flu and the cold.
• It contains an active principle for each symptom that relieves.
• Pleasant lemon flavour.

ACTION AND MECHANISM

Frenadol Forte is a combination of an [ANALGESIC] [ANTIPIRETICO], a [ANTAGONIST HISTAMINERGICO (H-1)] and an [ANTITUSIVO]. 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 symptoms of the cold such as sneezing, whining or rhinorrhea. Finally, dextromethorphan produces depression of the cough center.

FRENADOL FORTE INDICATIONS

- [COMMON COLD]. Symptomatic treatment of catarrh and [FLU] processes that cause fever, moderate pain, headache, unproductive cough and runny nose.

FRENADOL FORTE POSOLOGY

DOSAGE:
- Adults, oral: 1 tablet / 6-8 hours or 1 envelope / 6-8 hours.
- Children, oral:
* Children 12 years old 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 6 tablets / 24 hours, with a distance of at least 6 hours.

RULES FOR THE CORRECT ADMINISTRATION OF FRENADOL FORTE

The effervescent tablets should be dissolved in half a glass of water, then ingested when the bubbling has ceased. The envelopes will dissolve in half a glass or cup of hot water, sweetening then if desired. It is advised to administer the last dose before going to bed. The administration of this medicine should be initiated when the first symptoms appear. As these disappear, this medication should be discontinued.

FRENADOL FORTE CONTRAINDICATIONS

- Hypersensitivity to any component of the medication, including cases of [ALLERGY TO PARACETAMOL] or [ALLERGY TO OPIOIDS].
- [HEPATOPATIA], as [HEPATIC INSUFFICIENCY] or [HEPATITIS]. Paracetamol can lead to hepatotoxicity.
- [PORFIRIA]. H1 antihistamines are not considered safe in patients with porphyria.
- Patients on treatment with antidepressants of the MAOI or SSRI type (See Interactions).

WARNINGS ON EXCIPIENTS:

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

FRENADOL FORTE PRECAUTIONS

- [RENAL INSUFFICIENCY]. Accumulation of the active ingredients could occur. In these patients, the appearance of renal adverse reactions to paracetamol is more frequent.
- Patients afflicted with [GLAUCOMA], [PROSTATIC HYPERPLASIA] or [OBSTRUCTION OF THE URINARY BLADDER], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [GRAY MIASTENIA], [SENSOROUS PEPTICISM] stenosing or [INTESTINAL OBSTRUCTION]. Chlorphenamine could worsen these symptoms due to its anticholinergic effects.
- Persistent or chronic cough, as in that associated with [ASTHMA], [PULMONARY ENFYSTMENT] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Chlorphenamine and dextromethorphan may worsen such processes due to increased viscosity of secretions, and inhibition of cough. Bronchospastic reactions have been described when administering acetaminophen to asthmatic patients with [SALICYLATE ALLERGY], so special caution is recommended in these patients.
- [EPILEPSY]. Some antihistamines H1 have been associated with the onset of seizures.
- [BLOOD DISCUSSIONS]. Paracetamol could sometimes give rise to [ANEMIA], [LEUCOPENIA] or [TROMBOPENIA]. Extreme caution is recommended, avoiding prolonged treatments, and performing periodic hematological counts in these cases.
- Hepatotoxicity. The metabolism of paracetamol could lead to hepatotoxic substances. It is recommended to avoid its use in patients with previous hepatic damage (See Contraindications), as well as to exercise extreme caution in those with [CHRONIC ALCOHOL] 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 if there is 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 extreme precautions and monitor the patient, especially children, in case of symptoms of abuse.

WARNINGS ON EXCIPIENTS:

- Frenadol Forte contains orange yellow S as excipient. It can cause allergic-type reactions including asthma, especially in patients with [SALICYLATE ALLERGY].

PATIENT TIPS

- It is advisable to drink plenty of water during the treatment, avoiding as much as possible the intake of alcoholic beverages.
- The doctor should 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 over ten days without 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 careful when driving, and not combine it with drugs or other sedative substances such as alcohol.

SPECIAL WARNINGS

- It is recommended to monitor the patient in case signs of abuse appear.
- In patients treated with anticoagulants, it is recommended to follow short treatments with low doses, controlling the coagulation parameters.
- The association between products with dextromethorphan and antidepressants should be avoided, allowing at least 14 days 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 the levels of transaminases in patients with prolonged treatments or at risk of presenting hepatotoxicity.
- In case of overdose, the specific antidote for paracetamol is N-acetylcysteine.

FRENADOL FORTE INTERACTIONS

- Ethyl alcohol. The ingestion of alcoholic beverages together with acetaminophen could cause liver damage. In addition, the sedative effects of chlorpheniramine 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 reported when combined with certain antiarrhythmics.
- Oral anticoagulants. Very rarely, normally 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 treatment duration as low as possible, and to control the INR.
- Anticholinergics (antiparkinsonians, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine may potentiate anticholinergic effects, so it is recommended to avoid association.
- Oral contraceptives. They could increase the plasma clearance of paracetamol, decreasing its effects.
- Antidepressants (MAOIs, SSRIs). The joint administration of dextromethorphan products together with MAOIs or SSRIs could lead to serious adverse reactions, even fatal. It is recommended to avoid the association and not to administer dextromethorphan until at least 14 days after treatment with the antidepressant.
- Active carbon. It can produce an adsorption of paracetamol, decreasing its absorption and pharmacological effects.
- Chloramphenicol. The toxicity of paracetamol could be enhanced, probably by inhibiting its metabolism.
- Coxibes. Coxibes may increase plasma concentrations of dextromethorphan.
- Expectorants and mucolytics. The inhibition of cough by dextromethorphan could lead to a pulmonary obstruction in case of increased volume or fluidity of bronchial secretions.
- Enzymatic inducers. Medications such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin or sulfinpyrazone could induce the metabolism of paracetamol, decreasing its effects and increasing the risk of hepatotoxicity.
- Lamotrigine. Paracetamol could reduce serum concentrations of lamotrigine, producing a decrease in therapeutic effect.
- Propranolol. Propranolol could inhibit the metabolism of paracetamol, leading to toxic effects.
- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The co-administration of chlorpheniramine together with a sedative drug could potentiate the hypnotic action.
- Zidovudine. Paracetamol may increase the elimination of zidovudine, decreasing its effects.

FRENADOL FORTE AND PREGNANCY

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

FRENADOL FORTE AND LACTATION

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

FRENADOL FORTE AND CHILDREN

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

ELDERLY

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

FRENADOL FORTE EFFECTS ON DRIVING

Frenadol Forte can substantially affect the ability to drive and / or operate machinery. Patients should avoid handling dangerous machinery, including automobiles, until they have reasonable assurance that drug treatment does not adversely affect them.

ADVERSE REACTIONS

The adverse reactions described are:
- Digestive. Anticholinergic phenomena such as [NAUSEAS], [VOMITOS], [DRYNESS], [DIARRHEA] and [CONSTIPATION] may appear. More rare is the appearance of [ANOREXIA].
- Hepatic. Occasionally, [HEPATOPATHY] with or without [ICTERITY] may occur.
- Cardiovascular. [HYPOTENSION] in the elderly and [TACHYARDARD].
- Neurological / psychological. The most common adverse reaction is the appearance of [SOMNOLENCE]. Paradoxical reactions of [EXCITABILITY] can also appear, with [NERVIOSISM] and [INSOMNIUM], being especially frequent in children and the elderly.
- Genitourinary. [URINARY RETENTION].
- Allergic / dermatological. Rarely [REACTIONS OF HYPERSENSITIVITY], with [URTICARIA], [EXANTEMATIC ERUPTIONS], [EXCESS OF SWEATING] and [PHOTOSENSITIVITY REACTIONS].
- Ophthalmological. [MIDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION].
- Bloodlines. [ANEMIA], [ANEMIA HEMOLITICA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCITOPENIA], and [TROMBOPENIA].
- Metabolic Rarely [HIPOGLUCEMIA].

OVERDOSE

Symptoms: Overdose by products with paracetamol is a very serious and potentially fatal poisoning. The symptoms may not manifest 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 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 changes in the way of walking.
In the most severe cases, the death of the patient can occur due to hepatic 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 chlorphenamine overdose (deep sedation, anticholinergic symptoms) may appear. Dextromethorphan overdose does not usually produce severe symptoms, although an increase in sedation is to be expected.
Treatment: In case of overdose, you should go immediately to a medical center, since paracetamol poisoning can be fatal, although no symptoms appear. In children it is especially important the early identification of overdosage by paracetamol, due to the severity of the picture, as well as the existence of a possible treatment.
In any case, initially proceed with gastric lavage and aspiration of stomach contents, preferably within four hours after ingestion. The administration of activated carbon can reduce the amount absorbed.
There is a specific antidote in case of poisoning by acetaminophen, 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, for a period of 20 hours and 15 minutes. 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 intravenously slowly for 15 minutes, either directly or diluted in 200 ml of 5% dextrose.
Next, a maintenance dose of 50 mg / kg (0.25 ml / kg of 20% solution) in 500 ml of 5% dextrose in a slow intravenous infusion for 4 hours will be instituted.
Finally 100 mg / kg (0.50 ml / kg of 20% solution) in 1000 ml of 5% dextrose in slow intravenous infusion for 20 hours will be administered.
- Children. The same amounts will be administered per unit of weight 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 effectiveness of the antidote is maximum if it is administered before 8 hours after ingestion. Effectiveness decreases progressively thereafter and is ineffective after 3 pm
The administration of N-acetylcysteine ​​at 20% may be interrupted when blood paracetamol levels are lower than 200 μg / ml.
In addition to the administration of the antidote, a symptomatic treatment will be instituted, keeping the patient under clinical supervision.
In the event that hepatotoxicity occurs, it is advisable to perform a study of liver function and repeat the study at 24-hour intervals.

See leaflet Frenadol Forte 10 Envelopes

See Technical File Frenadol Forte 10 Envelopes