Frenadol Junior 10 Sachets

Frenadol Junior 10 Sachets (English)

You can buy Frenadol Junior 10 Sachets online from UK, Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovakia, Slovenia and Sweden.

Especially recommended for children and young people, Frenadol Junior helps to reduce fever and relieve pain. The combination of active ingredients such as paracetamol, dextromethorphan, which is an antitussive, and chlorphenamine, an ally to reduce nasal secretion. Find out about its properties and how it can alleviate those annoying symptoms.

Symptoms it relieves

Frenadol Junior is indicated for the symptomatic relief of colds and flu with mild or moderate headache, as well as fever, unproductive cough, such as irritative and nervous cough, and nasal discharge in children over 6 years and adolescents.

ACTIVE PRINCIPLES

• Paracetamol

A drug with analgesic properties that relieves pain.

• Dextromethorphan

Active ingredient that acts as a temporary cough suppressant (antitussive). It cannot be administered in combination with grapefruit or bitter orange juice or alcohol.

• Chlorphenamine

Chlorphenamine is a first-generation antihistamine active ingredient used to relieve symptoms such as sneezing and runny nose caused by allergies or colds.

DOSAGE

• Children from 6 to 12 years old, between 21.5 kg and 43 kg in weight, 1 is recommended every 6 or 8 hours (3 or 4 times a day) as needed.
• Older than 12 years old, weighing more than 44 kg:
• Administer 2 sachets every 6 or 8 hours (3 or 4 times a day) depending on the need.
• In terms of recommendations, it is preferable to take 1 dose before going to bed and not to exceed 4 daily doses.

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

Infantile multisymptomatic flu.
Covers several symptoms of flu and cold in a single product to make it easier for children to take.
A single medicine that helps relieve fever, irritable cough and runny nose.

ACTION AND MECHANISM

Frenadol Junior 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 at the center of the cough.

FRENADOL JUNIOR INDICATIONS

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

FRENADOL JUNIOR POSOLOGY

DOSAGE:
- Children, oral:
* Children between 6 and 11 years old: 1 on / 6-8 hours.
* Children under 6 years: The safety and efficacy of this medicine have not been evaluated.
The four daily doses should not be exceeded.

RULES FOR THE CORRECT ADMINISTRATION

The envelopes will dissolve in half a glass of cold water, then swallowed. 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 JUNIOR 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]. Antihistamines H1 do not consider safe in patients with porphyria.
- Patients on treatment with antidepressants of the MAOI or SSRI type (See Interactions).

WARNINGS ON EXCIPIENTS:

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

FRENADOL JUNIOR 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], [MIASTENIA GRAVE], [SLEEPING ULCERA] 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 paracetamol 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 liver 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 the treatment in case 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 symptoms of abuse appear.

WARNINGS ON EXCIPIENTS:

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

WARNINGS ON EXCIPIENTS:

- Frenadol Junior contains sodium salts. To know the exact content in sodium, it is recommended to review the composition. Oral and parenteral dosage forms with sodium levels greater than 1 mmol (23 mg) / maximum daily dose should be used with caution in patients with or with low sodium diets.

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 of more than 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 transaminase levels in patients with prolonged treatments or at risk 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 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 described 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 severe adverse reactions, even fatal. It is recommended to avoid 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 the 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 joint 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 JUNIOR 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 JUNIOR 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.

FRENADOR JUNIOR AND CHILDREN

The safety and efficacy of this medicine have not been evaluated in children under 6 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.

EFFECTS ON DRIVING

Frenadol Junior can substantially affect your ability to drive and / or operate machinery. Patients should avoid handling dangerous machinery, including automobiles, until they are reasonably certain that drug treatment does not adversely affect them.

ADVERSE REACTIONS

The adverse reactions described are:
- Digestive. Anticholinergic phenomena such as [NAUSEAS], [VOMITOS], [DRYING OF MOUTH], [DIARRHEA] and [CONSTIPATION] may appear. More rare is the appearance of [ANOREXIA].
- Hepatic. Occasionally [HEPATOPATHY] may occur with or without [ICTERICIA].
- Cardiovascular. [HYPOTENSION] in the elderly and [TACHYCARDY].
- Neurological / psychological. The most common adverse reaction is the appearance of [SOMNOLENCE]. Paradoxical reactions of [EXCITABILITY], with [NERVIOSISM] and [INSOMNIA], may also appear, 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 is also a state 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 chlorpheniramine 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, the 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, 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. An initial shock dose of 150 mg / kg (0.75 ml / kg of 20% solution) will be administered 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) will be established in 500 ml of 5% dextrose in slow intravenous infusion for 4 hours.
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
Administration of 20% N-acetylcysteine ​​may be interrupted when paracetamol blood levels are less 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 Junior 10 Envelopes

See Technical File Frenadol Junior 10 Envelopes