TACHIFLUTASK*10 SACHETS 600MG+10MG

TACHIFLUTASK 600 mg/10 mg granules in sachet
Paracetamol/phenylephrine hydrochloride

What it is and what it is used for
Short-term treatment of cold and flu symptoms, including mild/moderate pain and fever, when associated with nasal congestion.

What you need to know before taking the medicine
- Children under 12 years of age.
- Hypersensitivity to the active ingredients or to any of the excipients (listed in section 6.1).
- Patients taking beta-blockers.
- Patients taking tricyclic antidepressants and those taking or who have taken monoamine oxidase inhibitors in the last 2 weeks.
- Patients with bronchial asthma, pheochromocytoma, closed-angle glaucoma, or who are concurrently taking other sympathomimetic medicines (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).
Patients suffering from liver or kidney failure, diabetes, hyperthyroidism, hypertension and cardiovascular diseases.
- Paracetamol-based products are contraindicated in patients with overt glucose-6-phosphate dehydrogenase deficiency and in those suffering from severe haemolytic anaemia.
- Severe hepatocellular insufficiency.

Warnings and precautions
Patients should be advised not to take other paracetamol-containing medicines while taking TACHIFLUTASK as high doses of paracetamol can cause serious adverse reactions.
Avoid alcohol consumption during treatment with TACHIFLUTASK. The risk of overdose is indeed greater in patients with liver problems.
Advise the patient to contact their doctor before combining with warfarin or any other medication (see also section 4.5).
The use of the product is not recommended if the patient is being treated with anti-inflammatory drugs.
Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the maximum daily doses of paracetamol. Close monitoring is recommended, including measurement of urinary 5-oxoproline.
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.
TACHIFLUTASK contains aspartame: this substance can be harmful to individuals suffering from phenylketonuria.
TACHIFLUTASK contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially sodium-free.

Possible side effects
The side effects listed below are organised according to the MedDRA System Organ Class classification.

Frequency is defined as follows: 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).

System Organ Class	Frequency	Side effect
Blood and lymphatic system disorders	Rare	Agranulocytosis1, leucopenia1, thrombocytopenia1
	Not known	Anaemia1
Immune system disorders	Rare	Allergic reactions1,2, hypersensitivity reactions1,2, anaphylaxis1,2
	Not known	Anaphylactic shock1,2
Metabolism and nutrition disorders	Common	Anorexia2
Psychiatric disorders	Very rare	Insomnia2, nervousness2, anxiety2, restlessness2, confusion2, irritability2
Nervous system disorders	Very rare	Tremor2, dizziness2, headache2
Eye disorders	Not known	Mydriasis2, acute angle-closure glaucoma2
Cardiac disorders	Rare	Tachycardia2, palpitations2
Vascular disorders	Not known	Hypertension2
Respiratory, thoracic and mediastinal disorders	Rare	Bronchospasm1,2
	Not known	Laryngeal oedema1
Gastrointestinal disorders	Common	Nausea2, vomiting2
	Not known	Diarrhoea1, gastrointestinal disorder1
Hepatobiliary disorders	Rare	Abnormal liver function1
	Not known	Hepatic disorder1, hepatitis1
Skin and subcutaneous tissue disorders	Rare	Rash1,2, angioedema2
	Not known	Toxic epidermal necrolysis1, Stevens-Johnson Syndrome1, erythema multiforme or polymorphic erythema1
Renal and urinary disorders	Very rare	Tubulointerstitial nephritis (after prolonged use of paracetamol at high doses)1
	Not known	Aggravated renal failure1, haematuria1, anuria1, urinary retention

¹ Side effects associated with paracetamol
² Side effects associated with phenylephrine

Very rare cases of severe skin reactions have been reported.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.