TACHIFLUTASK 600 MG/10 MG GRANULES IN SACHET 10 PET/AL/PE SACHETS

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


What it is and what it is used for
TACHIFLUTASK is a medicine containing the active substances paracetamol and phenylephrine hydrochloride which is used to treat pain, fever and congestion.
TACHIFLUTASK is used for the short-term treatment of cold and flu symptoms, including mild/moderate pain and fever, when associated with nasal congestion.
TACHIFLUTASK is indicated for adult patients and children over 12 years of age .
Contact your doctor if you do not feel better or if you feel worse after 3 days.


What you need to know before taking the medicine
Do not take TACHIFLUTASK:
- if you are allergic to paracetamol, phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- if you are taking beta-blockers (used to treat high blood pressure or heart disease);
- if you are taking tricyclic antidepressants (medicines used to treat depression);
- if you are taking monoamine oxidase inhibitors (medicines used to treat depression) or have taken them in the last two weeks;
- if you suffer from bronchial asthma;
- if you have pheochromocytoma (tumor of the adrenal glands);
- if you suffer from glaucoma (an eye disease often associated with increased intraocular pressure);
- if you are taking other sympathomimetic medicines (such as decongestants, appetite suppressants and amphetamine-like psychostimulants);
- if you suffer from severe liver failure;
- if you have liver or kidney problems;
- if you suffer from diabetes;
- if you have an overactive thyroid (hyperthyroidism);
- if you have high blood pressure or heart or circulatory problems;
- if you have glucose-6-phosphate dehydrogenase deficiency (an inherited disease that leads to a lowering of the red blood cell count);
- if you suffer from severe haemolytic anaemia (abnormal breakdown of blood cells).
Do not use the medicine in children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking TACHIFLUTASK:
• if you are taking other medicines (see also "Other medicines and TACHIFLUTASK");
• if you have an enlarged prostate gland;
• if you have occlusive vascular disease (blockage of the arteries, e.g. Raynaud's syndrome);
• if you have reduced kidney function (TACHIFLUTASK contains sodium).

During treatment with TACHIFLUTASK, tell your doctor immediately if: If you suffer from serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid deep breathing, drowsiness, nausea and vomiting.

Do not use TACHIFLUTASK for more than 3 consecutive days without consulting your doctor.
Do not drink alcohol during treatment with TACHIFLUTASK.
If you are taking anti-inflammatory drugs, the use of TACHIFLUTASK is not recommended (see section 2 "Other medicines and TACHIFLUTASK").
Do not take in combination with other medicines containing paracetamol. If paracetamol is taken in high doses, serious adverse reactions may occur, including severe liver disease and changes in the kidneys and blood.
Paracetamol may interfere with tests to determine blood sugar levels (in people with diabetes) and uric acid levels (in people with gout).


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following list includes side effects of paracetamol and phenylephrine.
Undesirable effects are presented in decreasing order of frequency:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known: Frequency cannot be estimated from the available data.
Stop taking TACHIFLUTASK immediately and contact your doctor or go to hospital immediately if you notice any of the following side effects:
- allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing difficulty breathing or dizziness);
- very rare cases of serious skin reactions have been reported: severe skin rash or peeling or mouth ulcers (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or polymorphous);
- breathing problems (bronchospasm).
If you experience any of the following side effects, talk to your doctor or pharmacist.
Common (may affect up to 1 in 10 people):
- loss of appetite;
- nausea and vomiting.
Rare (may affect up to 1 in 1000 people):
- blood disorders that may appear as unexplained bruising, paleness or poor resistance to infection; decrease in specific blood cells (agranulocytosis, leukopenia, thrombocytopenia);
- tachycardia (increased heart rate), palpitations (sensation of beatings in the chest);
- abnormal liver function (increased liver transaminases);
- hypersensitivity, including skin rashes, angioedema (sudden swelling of the skin and mucous membranes).
Very rare (may affect up to 1 in 10,000 people):
- insomnia (difficulty falling asleep), nervousness, anxiety, agitation, confusion, irritability;
- tremor (shaking), dizziness, headache;
- following prolonged use of high doses of paracetamol, interstitial nephrosis (inflammation of the kidneys) and adverse effects on the kidneys may occur.
Not known (frequency cannot be estimated from the available data):
- anemia (decrease in the level of hemoglobin in the blood);
- mydriasis (dilation of the pupil), acute angle-closure glaucoma (an eye disease often associated with increased fluid pressure in the eye);
- laryngeal edema (swelling of the throat);
- diarrhea, gastrointestinal discomfort;
- liver disease, hepatitis (yellowing of the skin and/or eyes);
- kidney problems (worsened renal failure), blood in the urine (hematuria);
- difficulty urinating (anuria, urinary retention);
- increased blood pressure (hypertension);
- a serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.