Desenfriol C 10 Sachets

ACTION AND MECHANISM

- Combination of an [ANALGESICO] [ANTIPIRETICO] and a [HISTAMINERGIC ANTAGONIST (H-1)]. Acetylsalicylic acid exerts analgesic and antipyretic effects 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.

INDICATIONS

- [COMMON COLD]. Symptomatic treatment of the common cold and flu conditions, chills, colds that show symptoms, such as a runny nose, eye congestion, malaise, decay, headache and muscle aches.

POSOLOGY

DOSAGE: - Adults, oral: 1 about / 4-6 hours. - Children, oral: * Children 16 years or older: 1 about / 4-6 hours. * Children under 16 years: The safety and efficacy of this medicine have not been evaluated. - Renal, hepatic or cardiac insufficiency: consider a dose reduction. Maximum dose: 7 envelopes / 24 hours. If the pain persists for more than 10 days, the fever for more than 3 days, or worsen or other symptoms appear, the clinical situation should be evaluated.

RULES FOR THE CORRECT ADMINISTRATION

The contents of the envelope should be dissolved in half a glass of water, then ingested, preferably with meals (especially if digestive discomfort is noticed).

CONTRAINDICATIONS

- Hypersensitivity to any component of the medicine, such as [ALLERGY TO SALICILATOS] or [ALLERGY TO NSAIDs].
- [PEPTIC ULCERA], [GASTROINTESTINAL HEMORRAGY]. Erosion of the gastric mucosa can be increased.
- [COAGULATION CHANGES], such as [HEMOPHILIA], [HYPOPROTHROMBINEMIA] or [VITAMIN K DEFICIT]. ASA increases the risk of bleeding due to its antiplatelet effects.
- [PORPHYRIA]. H1 antihistamines do not consider safe in patients with porphyria.
- Children under 16 with febrile processes, flu or chickenpox. There is a risk of Reye's syndrome.

WARNINGS ON EXCIPIENTS:

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

PRECAUTIONS

- [RENAL INSUFFICIENCY], [HEPATIC INSUFFICIENCY]. An accumulation of the active substances in this medicine may occur.
- Patients suffering from [GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [CARDIAC ARRITMIA], [SERIOUS MIASTENIA] or [INTESTINAL OBSTRUCTION]. Chlorphenamine may worsen these conditions due to its anticholinergic effects.
- [ASTHMA] chronic. There is an increased risk of hypersensitivity reactions and bronchospasm. In addition, in these patients, as well as in those with [PULMONARY DISEASE] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE], chlorphenamine may worsen the disease due to its anticholinergic effects.
- [DIABETES]. ASA could lead to high dose hypoglycemia, so it is recommended to check blood glucose levels periodically.
- [DEFICIENCY OF GLUCOSE-6-PHOSPHATE DEHYDROGENASE]. ASA could induce the onset of hemolytic anemia.
- [ARTERIAL HYPERTENSION] or [HEART INSUFFICIENCY] not controlled. ASA can lead to fluid retention, making these diseases worse.
- [GOUT]. The AAS can compete with the urates in their elimination, and can increase their levels. Caution is recommended in patients with gout.
- [SURGERY]. It is recommended to suspend the administration of influenza products with ASA at least 5-7 days before surgery, due to the risk of bleeding during the operation.
- [EPILEPSY]. Some H1 antihistamines have been associated with the onset of seizures.
- [ANXIETY] and other conditions such as [HYPERTIROIDISM] or cardiac arrhythmias, in which the administration of caffeine could make symptoms worse.
- History of [RENAL CALCULATIONS]. Ascorbic acid may favor the formation of kidney stones.
- [HEMOCROMATOSIS]. Vitamin C could lead to iron poisoning. Avoid prolonged treatments.
- History of peptic ulcer. It can cause a reactivation of the ulcer. In case of active ulcer, it is recommended to avoid administration (See Contraindications).

WARNINGS ON EXCIPIENTS:

- This medicine contains yellow orange S as an excipient. It can cause allergic reactions including asthma, especially in patients with [SALICILATE ALLERGY].

PATIENT ADVICE

- This medicine should be administered after meals.
- 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 longer than ten days without optional prescription.
- If the symptoms continue or worsen after five days, it is recommended to consult the doctor.
- Before starting treatment, the doctor should be notified of any illness suffered by the patient or any drug he is taking.
- It is advisable to see a doctor if blood appears in stool or vomit, stomach pain, general weakness, dizziness or perception of sounds such as beeps or whistles.
- 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.
- The use of products with acetylsalicylic acid is not recommended in children under 16 years.
- It is advised to suspend the treatment several days before a surgical intervention.

SPECIAL WARNINGS

- It may be necessary to perform dose adjustments when products with acetylsalicylic acid are administered to patients treated with anticoagulants, phenytoin, digoxin or methotrexate among others.

INTERACTIONS

- Acetazolamide. There is a risk of acetazolamide poisoning, so it is recommended to avoid the association.
- Urinary acidifiers (ascorbic acid, ammonium chloride, methionine) or urinary alkalinizers (absorbable antacids). They could decrease or increase the elimination of ASA respectively.
- Tiludronic acid. The ASA could greatly decrease the absorption of tiludronate, so it is recommended to distance administrations of these medications at least 2 hours.
- Valproic acid. Possibility of toxicity by valproate. A dose adjustment may be necessary.
- NSAID. Increases the risk of peptic ulcer and gastric hemorrhage.
- Ethyl alcohol. There is an increased risk of gastric damage. In addition, alcohol may enhance sedation by chlorphenamine. It is recommended to avoid alcohol consumption during treatment.
- Algeldrato. Ascorbic acid could increase the absorption of aluminum. It is suggested to distance the administration of both medications.
- Antacids. They could delay and decrease the absorption of ASA. Absorbables could also increase their elimination.
- Platelet antiaggregants. Possible potentiation of antiaggregant effects, so it is recommended to exercise caution.
- Oral anticoagulants. Possible potentiation of anticoagulant effects, with the risk of bleeding. It is recommended to avoid the association, and if it is not possible, extreme precautions 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. Ascorbic acid may favor the accumulation of drugs such as ethinyl estradiol.
- Antiulcer. The increase in gastric pH could increase the absorption of ASA, with the possible risk of poisoning.
- Barbiturates. The ASA could increase barbiturate concentrations, with the consequent risk of poisoning.
- Cyclosporine. NSAIDs may increase cyclosporine nephrotoxicity. It is recommended to periodically evaluate renal functionality, especially in the elderly.
- Corticosteroids. There is an increased risk of damage to the gastric mucosa.
- Deferoxamine. Iron may accumulate in tissues, so it may be necessary to reduce doses of vitamin C.
- Digoxin. ASA may increase digoxin concentrations, increasing the risk of poisoning.
- Diuretics ASA could slightly reduce the effects of diuretics, with the occurrence of acute renal failure being more frequent.
- Ototoxic drugs. ASA may increase the ototoxicity of drugs such as aminoglycosides, cisplatin, erythromycin, furosemide or vancomycin, especially at high doses.
- Phenytoin. Possible adverse effects of phenytoin due to increased levels. It is recommended to monitor the patient.
- Griseofulvin. The absorption of ASA may be greatly reduced, so it is recommended to avoid association.
- Heparin. Possible potentiation of anticoagulant effects. It is advised to assess the risk in each patient, and control their clotting parameters.
- IECA. Possible antagonism of antihypertensive effects. Periodic monitoring of blood pressure is recommended.
- SSRI. There is an increased risk of bleeding in general, and gastric in particular, so it is recommended to avoid association.
- Lithium The AAS could decrease the clearance of lithium, increasing the risk of poisoning. A dose adjustment may be necessary.
- Methotrexate. ASA may increase the effects of methotrexate. Extreme precautions are recommended, given the risk of severe pancytopenia.
- Nitroglycerin. ASA could increase plasma nitroglycerin levels.
- Pentazocine. A case of reversible renal toxicity of ASA has been described by adding pentazocine. It is recommended to evaluate the patient's renal functionality.
- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). Co-administration of chlorphenamine together with a sedative drug could potentiate the hypnotic action.
- Uricosuric. The ASA antagonizes the effects of probenecid or sulfinpyrazone at a low dose.
- Verapamil. Possible potentiation of the platelet antiaggregant effects of ASA by verapamil.
- Zafirlukast. ASA could increase zafirlukast levels, with the possible risk of toxicity.
- Foods. The administration of ASA after meals may reduce its absorption, but reduce the risk of gastric irritation.

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 use of ASA in children under 16 years with fever associated with viral infections such as influenza or chickenpox has been associated with the appearance of a potentially fatal Reye syndrome. It is therefore recommended to avoid the administration of products with acetylsalicylic acid in children under 16 years.

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 [GASTRIC HYPERACIDEZ] and anticholinergic phenomena such as [NAUSEAS], [VOMITES], [MOUTH DROUGHT], [DIARRHY] and [CONSTIPATION] may appear. More rare is the appearance of [ANOREXIA] or [PEPTIC ULCERA].
- Neurological / psychological. Cases of [SOMNOLENCE], [NERVIOSISM], [INSOMNIUM] or [CEPHALEA] may occur.
- Genitourinary. [URINARY RETENTION].
- Allergic / dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [URTICARY], [EXANTEMATIC ERUPTIONS], [ANGIOEDEMA], [DISNEA], [BRONCHIAL SPASM] and [PHOTOSENSITIVITY REACTIONS].
- Ophthalmological. [MIDRIASIS], [CLEAR VISION], [EYE HYPERTENSION].
- Blood. [ANEMIA], [HEMOLITICAL ANEMIA], especially in patients with glucose-6-phosphate dehydrogenase deficiency, [LEUCOPENIA] and / or [TROMBOPENIA].

OVERDOSE

Symptoms: The main symptoms associated with overdose by this medicine are due to acetylsalicylic acid. Nausea and vomiting, diarrhea, abdominal pain, headache, deafness and ringing in the ears, blurred vision, hyperthermia, seizures, hyperventilation with respiratory alkalosis and metabolic acidosis may occur. In more severe cases delirium, respiratory depression, collapse and coma may occur.
In addition to the symptoms of salicylate overdose, symptoms of chlorfenamine overdose (deep sedation, anticholinergic symptoms) may occur.
Treatment: No antidote is available in case of salicylate poisoning. It is recommended to proceed with the usual elimination measures, with stomach lavage and administration of active carbon in the period of the next 2 hours. Before 30 minutes of ingestion, you can add syrup of ipecac.
If absorption has already occurred, it is recommended to control salicylate levels, acid-base balance and electrolyte balance. It is recommended to properly hydrate the patient, for which an infusion of 5% dextrose in saline will be added. In case of acid-basic imbalance, bicarbonate will be administered and mechanical ventilation maintained.
Seizures will be treated with diazepam, and possible hypoprothrombinemia with vitamin K.
Forced diuresis, with alkalization of urine, is very effective in promoting the elimination of ASA.

See leaflet Desenfriol C 10 Envelopes

See Technical Data Sheet Desenfriol C 10 Envelopes