Tachifludec adults - analgesic antipyretic 10 orange flavour bags

Product Description

A paracetamol-based medicine, useful in cases of fever and various types of pain, formulated in powder form for oral solution.

Indications

Tachifludec Adults is an analgesic and antipyretic medicine used in the short-term treatment of cold and flu symptoms, including mild and moderate pain and fever, when associated with nasal congestion.

Dosage

Adults: 1 sachet every 4-6 hours and up to a maximum of 3 sachets in 24 hours.
Children and adolescents: the use of the medicine is not recommended in children and adolescents under 18 years of age.
The medicine should not be used for more than 3 consecutive days without consulting your doctor.

Directions for use

Dissolve the contents of one sachet in a glass of hot or cold water and sweeten to taste.
Once dissolved, the medicine gives rise to an opalescent, orange-colored solution, free of foreign particles and with an orange flavor.

Composition

Active ingredients: paracetamol 600 mg, ascorbic acid 40 mg and phenylephrine hydrochloride 10 mg (equivalent to phenylephrine 8.2 mg).
Excipients: sucrose, anhydrous citric acid, sodium citrate, maize starch, sodium cyclamate, sodium saccharin, colloidal anhydrous silica, blood orange flavour, sunset yellow (E110).

Contraindications

Tachifludec Adults should not be administered:

• in children and adolescents under 18 years;
• in patients with hypersensitivity to the active substances or to any of the excipients;
• in patients taking beta-blockers;
• in patients taking tricyclic antidepressants, or who are taking or have taken in the last 2 weeks monoamine oxidase inhibitors;
• in patients with bronchial asthma, pheochromocytoma, narrow-angle glaucoma, or who are taking other sympathomimetic drugs at the same time (such as decongestants, appetite suppressants and amphetamine-like psychostimulants);
• in patients with hepatic or renal insufficiency, diabetes, hyperthyroidism, hypertension and cardiovascular disease.

Paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase insufficiency, in those with severe hemolytic anemia and with severe hepatocellular insufficiency.

Storage

Store below 25 degrees.
Store in the original container to protect the product from moisture.

Warnings and precautions

Do not take other medicines containing paracetamol while taking Tachifludec Adulti, as high doses of paracetamol can cause serious adverse reactions.
Avoid alcohol consumption during treatment.
The risk of overdose is greater in patients with liver problems.
Contact your doctor before combining warfarin or any other drug.
Use of the product is not recommended if the patient is being treated with anti-inflammatory drugs.
Consult your doctor before using the product in patients with enlarged prostate gland or occlusive vascular diseases (e.g. Raynaud's syndrome).
Do not exceed the recommended dose and do not administer for more than 3 consecutive days without consulting your doctor.
The medicine contains 5.9 mmol (135.8 mg) of sodium per sachet: to be taken into consideration by patients with reduced kidney function or on a low-sodium diet.
Tachifludec adults contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Patients with diabetes should take into account the sucrose content of the product when taking more than 2 sachets per day (sucrose > 5g), azo dyes and sunset yellow (E110) which may cause allergic reactions.

Interactions

Paracetamol: the hepatotoxic effect of paracetamol can be enhanced by the intake of other drugs that act on the liver, such as zidovudine and isoniazid, which can inhibit the metabolism of paracetamol.
The administration of probenecid before paracetamol decreases the clearance of paracetamol and the urinary elimination of paracetamol sulphate and paracetamol glucuronide, and increases the half-life of paracetamol itself.
Use with extreme caution and under close monitoring during chronic treatment with drugs that can induce hepatic monooxygenases or in case of exposure to substances that can have this effect (for example, rifampicin, cimetidine and antiepileptics such as glutethimide, phenobarbital, carbamazepine).
Paracetamol increases the half-life of chloramphenicol.
The product taken in high doses can enhance the effect of coumarin anticoagulants (warfarin).
Metoclopramide and domperidone can increase the absorption of paracetamol, while it is reduced or delayed by cholestyramine and anticholinergics, respectively.
Phenylephrine: phenylephrine can increase the half-life of chloramphenicol. Phenylephrine may antagonize the effect of beta-blockers and antihypertensive drugs (including debrisoquine, guanethidine, reserpine, and methyldopa) and may enhance the action of monoamine oxidase inhibitors.
Concomitant use of phenylephrine with tricyclic antidepressants or sympathomimetic amines may increase the risk of cardiovascular effects.
Phenylephrine may interact with digoxin and cardiac glycosides, increasing the risk of arrhythmia or heart attack, and with alkaloids (ergotamine and methysergide), increasing the risk of ergotism.
Ascorbic acid: Ascorbic acid may increase the absorption of iron and estrogen.
Ascorbic acid is metabolized to oxalate and may increase the risk of estrogen toxicity. potentially cause hyperoxaluria and kidney stones, through the crystallization of calcium oxalate in patients who tend to form calcium stones.
Interference with some laboratory tests: Paracetamol administration may interfere with the determination of uric acid (by the phosphotungstic acid method) and blood glucose (by the glucose-oxidase-peroxidase method).
Ascorbic acid may interfere with the measurement of blood and urinary parameters (e.g. urate, glucose, bilirubin, hemoglobin).

Undesirable effects

The following undesirable effects are listed below, organized according to the MedDRA System Organ Class.
The frequency is as follows: defined: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
Blood and lymphatic system disorders: (rare) agranulocytosis, leukopenia, thrombocytopenia, (not known) anaemia.
Immune system disorders: (rare) allergic reactions, hypersensitivity reactions, anaphylaxis, (not known) anaphylactic shock.
Metabolism and nutrition disorders: (common) anorexia.
Psychiatric disorders: (very rare) insomnia, nervousness, anxiety, restlessness, confusion, irritability.
Nervous system disorders: (very rare) tremor, dizziness, headache.
Eye disorders: (not known) mydriasis, acute angle-closure glaucoma.
Cardiac disorders: (rare) tachycardia, palpitations.
Vascular disorders (not known).
Hypertension.
Respiratory, thoracic and mediastinal disorders: (rare) bronchospasm, (not known) laryngeal oedema.
Gastrointestinal disorders: (common) nausea, vomiting, (not known) diarrhoea, gastrointestinal disorder.
Hepatobiliary disorders: (rare) abnormal liver function, (not known) liver disorder, hepatitis.
Skin and subcutaneous tissue disorders: (rare) rash, angioedema, (not known) toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or polymorphous.
Renal and urinary disorders: (very rare) tubulointerstitial nephritis (after prolonged use of paracetamol at high doses), (not known) aggravated renal failure, haematuria, anuria, urinary retention.
Report any suspected adverse reactions via the Italian Medicines Agency.

Pregnancy and breastfeeding

Pregnancy
Paracetamol: Epidemiological studies in pregnant women have shown that there are no contraindications to the use of paracetamol when used in the recommended doses, but the administration of the preparation during pregnancy and breastfeeding must take place under the direct supervision of a doctor.
Phenylephrine: Data on the use of phenylephrine during pregnancy are limited. Vasoconstriction of the uterine vessels and reduction of blood flow to the uterus associated with the use of phenylephrine can result in fetal hypoxia. The use of phenylephrine during pregnancy should be avoided as further information is needed.
Ascorbic Acid: There are no controlled data on use during pregnancy. The use of ascorbic acid during pregnancy is recommended only when the benefit outweighs the risk.
Breastfeeding
Paracetamol: Paracetamol is excreted in breast milk, but in clinically insignificant quantities. Available published data do not contraindicate its use during breastfeeding.
Phenylephrine: There are no data available regarding the excretion of phenylephrine in breast milk, nor are there any information regarding the effects of phenylephrine on breastfed children. In the absence of available data, the use of phenylephrine should be avoided during breastfeeding.
Ascorbic Acid: Ascorbic acid is excreted in breast milk. The effects on breastfed children are unknown. In summary, use is not recommended during pregnancy and breastfeeding.
Fertility
There is no evidence in non-clinical studies to indicate an effect of paracetamol on male and female fertility at doses commonly used in clinical practice.
The effect of phenylephrine on male and female fertility has not been studied.
There is sufficient evidence to indicate the importance of ascorbic acid at various levels in the reproductive process.
However, no definitive data in humans on the clinical potential of vitamin C are available.

Format

Pack of 10 sachets