TACHIFLUDEC*10SACHETS LEMON

TACHIFLUDEC powder for oral solution, lemon flavor
TACHIFLUDEC powder for oral solution, lemon and honey flavor
Paracetamol, ascorbic acid, phenylephrine hydrochloride

What it is and what it is used for
TACHIFLUDEC is a medicine containing the active ingredients paracetamol, ascorbic acid, and phenylephrine hydrochloride, used for the treatment of pain, fever, and congestion.

TACHIFLUDEC is used for the short-term treatment of cold and flu symptoms, including mild/moderate pain and fever, when associated with nasal congestion.
TACHIFLUDEC powder for oral solution is indicated for adults and children over 12 years of age.

Consult 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 TACHIFLUDEC
- if you are allergic to paracetamol, ascorbic acid, 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 conditions);
- 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 suffer from pheochromocytoma (a tumor of the adrenal glands);
- if you suffer from glaucoma (an eye condition often associated with increased intraocular pressure);
- if you are taking other sympathomimetic medicines (such as decongestants, appetite suppressants, and psychostimulants similar to amphetamines);
- 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 decrease in red blood cell count);
- if you suffer from severe hemolytic anemia (abnormal breakdown of blood cells).

Do not use this medicine in children under 12 years of age.

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

Do not use TACHIFLUDEC for more than 3 consecutive days without consulting your doctor.

Do not drink alcohol during treatment with TACHIFLUDEC.

If you are taking anti-inflammatory drugs, the use of TACHIFLUDEC is not recommended (see section 2 Other medicines and TACHIFLUDEC).

Do not take in combination with other medicines containing paracetamol. If paracetamol is taken in high doses, serious adverse reactions can occur, including severe liver disease and alterations to the kidneys and blood.

Paracetamol can interfere with tests for determining blood sugar levels (in people with diabetes) and uric acid levels (in people with gout). Ascorbic acid can interfere with the measurement of serum and urine parameters (e.g., urates, glucose, bilirubin, hemoglobin).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following list includes the side effects of paracetamol and phenylephrine.
Side effects are presented in order of decreasing 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 TACHIFLUDEC immediately and contact your doctor or go to the hospital immediately if you notice any of the following side effects:
- allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing breathing difficulties or dizziness);
- very rare cases of severe skin reactions have been reported: severe rash or exfoliation or mouth ulcers (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or polymorphic);
- respiratory 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, pallor or poor resistance to infection; decrease in specific blood cells (agranulocytosis, leukopenia, thrombocytopenia);
- tachycardia (increased heart rate), palpitations (sensation of heart beating in the chest);
- abnormal liver function (increased hepatic 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;
- after prolonged use of high doses of paracetamol, interstitial nephrosis (inflammation of the kidneys) and kidney side effects may occur.

Not known (frequency cannot be estimated from the available data):
- anemia (decrease in hemoglobin levels in the blood);
- mydriasis (pupil dilation), 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 diseases, hepatitis (yellowing of the skin and/or eyes);
- kidney disorders (aggravated kidney failure), blood in the urine (hematuria), difficulty urinating (anuria, urinary retention);
- increased blood pressure (hypertension).

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.