Tachifludec

Package leaflet: Information for the user

TACHIFLUDEC effervescent powder for oral solution orange flavour

Paracetamol, ascorbic acid, phenylephrine hydrochloride
Read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What TACHIFLUDEC is and what it is used for
2. What you need to know before taking TACHIFLUDEC
3. How to take TACHIFLUDEC
4. Possible side effects
5. How to store TACHIFLUDEC
6. Contents of the pack and other information

1. What TACHIFLUDEC is and what it is used for

TACHIFLUDEC is a medicine containing the active substances 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 to moderate pain and fever, when associated with nasal congestion.
TACHIFLUDEC oral solution powder is indicated for use in adults and children above 12 years of age.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking TACHIFLUDEC

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 within the last two weeks;
• if you have bronchial asthma;
• if you have phaeochromocytoma (a tumour of the adrenal glands);
• if you have glaucoma (an eye condition often associated with increased intraocular pressure);
• if you are taking other sympathomimetic medicines (such as decongestants, appetite suppressants, and amphetamine-like psychostimulants);
• if you have severe liver failure;
• if you have liver or kidney problems;
• if you have 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 condition leading to a drop in red blood cell count);
• if you suffer from severe haemolytic anaemia (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 (blockage of arteries, e.g. Raynaud's syndrome);
• if you have reduced kidney function (TACHIFLUDEC contains sodium).

During treatment with TACHIFLUDEC, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their
toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also
taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.
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 medicines, the use of TACHIFLUDEC is not recommended (see section 2 “Other medicines and TACHIFLUDEC”).
Do not take together with other medicines containing paracetamol. If paracetamol is taken in high doses, serious adverse reactions may occur, including severe liver damage and kidney and blood disorders.
Paracetamol may interfere with tests measuring blood sugar levels (in people with diabetes) and uric acid levels (in people with gout). Ascorbic acid may interfere with the measurement of serum and urinary parameters (e.g. urates, glucose, bilirubin, haemoglobin).
Other medicines and TACHIFLUDEC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, it is important to inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines that may alter liver function, such as zidovudine or isoniazid, which may increase the harmful effect of paracetamol on the liver;
• medicines that may alter urinary excretion of paracetamol, such as probenecid;
• medicines containing rifampicin (used in the treatment of tuberculosis), cimetidine (used in the treatment of stomach ulcers), or medicines such as glutethimide, phenobarbital, carbamazepine (used in the treatment of epilepsy); when taken together with paracetamol, these medicines should be used with extreme caution and under strict medical supervision;
• medicines used to treat eye infections such as chloramphenicol;
• medicines used to delay or prevent blood clotting, e.g. warfarin, since high-dose paracetamol may increase the risk of bleeding;
• medicines that may speed up (e.g. metoclopramide, domperidone) or reduce/delay (e.g. colestyramine, anticholinergics) the absorption of paracetamol;
• medicines used to treat high blood pressure containing beta-blockers;
• medicines containing monoamine oxidase inhibitors (see also section “Do not take TACHIFLUDEC”);
• medicines containing tricyclic antidepressants or sympathomimetic amines;
• medicines prescribed for heart failure (digoxin);
• medicines used to treat migraine such as ergotamine and methysergide;
• anti-inflammatory medicines;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorders (called metabolic acidosis with high anion gap) which require urgent treatment;
• ascorbic acid (vitamin C) may increase the absorption of iron and oestrogens;
• ascorbic acid (vitamin C) may promote kidney stone formation in patients prone to calcium stones.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of TACHIFLUDEC is not recommended during pregnancy and breastfeeding; use TACHIFLUDEC only after consulting your doctor.
If necessary, TACHIFLUDEC may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible duration. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Driving and using machines
TACHIFLUDEC does not impair your ability to drive or operate machinery.
However, if you experience dizziness, you should not drive or operate machinery.
TACHIFLUDEC contains sucrose, glucose, and sodium
Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 2 g of sucrose (sugar) per sachet. This should be considered in patients with diabetes mellitus who take more than 2 sachets per day (more than 5 g of sucrose).
Glucose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Sodium: this medicine contains 135.82 mg of sodium (the main component of table salt) per sachet. This corresponds to 6.79% of the maximum daily dietary intake recommended for an adult. This should be considered if you have reduced kidney function or are on a low-sodium diet.

3. How to take TACHIFLUDEC oral solution powder

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults and children over 12 years: 1 sachet every 4–6 hours, up to a maximum of 3 sachets in 24 hours.
Use in children
This medicine is contraindicated in children under 12 years of age.
Do not take more than the recommended dose without consulting your doctor.

Instructions for use

Dissolve one sachet in a glass of water, hot or cold, and sweeten to taste.
Warning: This product is intended for short-term treatment only.
Do not take for more than 3 consecutive days without consulting your doctor.
Consult your doctor if symptoms persist or if you notice any new changes in their characteristics.
If you take more TACHIFLUDEC than you should
If you or someone else takes more TACHIFLUDEC than prescribed, or if you suspect that a child has swallowed the contents of a sachet, go immediately to the nearest hospital or see a doctor, even if you feel well, and bring this leaflet, any remaining sachets, and the pack with you.
In case of accidental ingestion of high doses of this medicine, symptoms may include pallor, nausea, vomiting, loss of appetite (anorexia), abdominal pain, changes in blood sugar levels (glucose metabolism abnormalities), and accumulation of acids in the body (metabolic acidosis).
In severe poisoning, liver failure may be complicated by brain damage (encephalopathy, cerebral edema), bleeding, low blood sugar (hypoglycemia), and death. Even in the absence of severe liver damage, a reduction in kidney function (acute renal failure) may occur, manifested by kidney injury (acute tubular necrosis), blood in the urine (hematuria), and protein in the urine (proteinuria). Changes in heart rhythm (cardiac arrhythmias) and inflammation of the pancreas (pancreatitis) may also occur.
Other possible symptoms include irritability, headache (cephalalgia), and increased blood pressure. In more severe cases, confusion, hallucinations, and seizures may develop. High doses of the medicine may cause a brief episode of watery diarrhea (transient osmotic diarrhea).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The list below includes the side effects of paracetamol and phenylephrine.
Side effects are listed 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 1,000 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
immediately to hospital if you notice any of the following side effects:

• Allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing difficulty in breathing or dizziness);
• Very rare cases of serious skin reactions have been reported: severe rash, skin 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, consult 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 1,000 people):

• Blood disorders that may appear as unexplained bruising, paleness, or reduced resistance to infection; reduction in specific blood cells (agranulocytosis, leukopenia, thrombocytopenia);
• Tachycardia (increased heart rate), palpitations (awareness of heartbeat in the chest);
• Abnormal liver function (elevated 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 (trembling), dizziness, headache;
• Following prolonged use of high doses of paracetamol, interstitial nephritis (inflammation of the kidneys) and adverse effects on the kidneys may occur.

Not known (frequency cannot be estimated from the available data):

• Anaemia (reduced haemoglobin levels in the blood);
• Mydriasis (pupil dilation), acute angle-closure glaucoma (an eye condition often associated with increased fluid pressure in the eye);
• Laryngeal oedema (swelling of the throat);
• Diarrhoea, gastrointestinal discomfort;
• Liver disorders, hepatitis (yellowing of the skin and/or eyes);
• Kidney disorders (worsening of renal failure), blood in the urine (haematuria), difficulty urinating (anuria, urinary retention);
• Increased blood pressure (hypertension);
• Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious illness using paracetamol (see section 2).

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

5. How to store TACHIFLUDEC

Store below 25°C.
Keep in the original container to protect the medicine from moisture and light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
It is important to always keep the product information available. Keep the outer box and the leaflet.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TACHIFLUDEC contains
Each sachet contains:
The active substances are: paracetamol 600 mg, ascorbic acid 40 mg and phenylephrine hydrochloride 10 mg (equivalent to
phenylephrine 8.2 mg).
The other components are: sucrose, anhydrous citric acid, sodium citrate, maize starch, sodium cyclamate,
sodium saccharin, anhydrous colloidal silica, bitter orange flavour, curcumin (E100), dried glucose syrup. See also section 2 "TACHIFLUDEC contains sucrose, sodium, glucose".
Description of the appearance of TACHIFLUDEC and the pack contents
TACHIFLUDEC is presented in sachets containing a yellow, heterogeneous, free-flowing powder for oral solution with an orange odour.
TACHIFLUDEC is available in cardboard packs containing 10 and 16 sachets.
Marketing Authorisation Holder and Manufacturer
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A. – Via Vecchia del Pinocchio, 22 - 60131 Ancona.

Package leaflet: information for the user

TACHIFLUDEC effervescent powder for oral solution, lemon flavour

TACHIFLUDEC effervescent powder for oral solution, lemon and honey flavour
Paracetamol, ascorbic acid, phenylephrine hydrochloride
Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What TACHIFLUDEC is and what it is used for
2. What you need to know before taking TACHIFLUDEC
3. How to take TACHIFLUDEC
4. Possible side effects
5. How to store TACHIFLUDEC
6. Contents of the pack and other information

1. What TACHIFLUDEC is and what it is used for

TACHIFLUDEC is a medicine containing the active substances paracetamol, ascorbic acid, and
phenylephrine hydrochloride, used for the treatment of pain, fever, and congestion.
TACHIFLUDEC is used for the short-term treatment of symptoms of cold and
influenza, including mild to moderate pain and fever, when associated with nasal
congestion.
TACHIFLUDEC powder for oral solution is indicated for use in 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.

2. What you need to know before taking TACHIFLUDEC

Do not take TACHIFLUDEC

• if you are allergic to paracetamol, ascorbic acid, hydrochloride phenylephrine, 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 within the last two weeks;
• if you have bronchial asthma;
• if you have phaeochromocytoma (a tumour of the adrenal glands);
• if you have glaucoma (an eye condition often associated with increased intraocular pressure);
• if you are taking other sympathomimetic medicines (such as decongestants, appetite suppressants, and amphetamine-like psychostimulants);
• if you have severe liver failure;
• if you have liver or kidney problems;
• if you have 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 condition leading to a decrease in red blood cell count);
• if you suffer from severe haemolytic anaemia (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 (blockage of arteries, e.g. Raynaud's syndrome);
• if you have reduced kidney function (TACHIFLUDEC contains sodium).

During treatment with TACHIFLUDEC, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their
toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also
taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, nausea, and vomiting.
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 medicines, 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 may occur, including severe liver damage and kidney and blood disorders.
Paracetamol may interfere with tests for blood sugar levels (in people with diabetes) and uric acid levels (in people with gout). Ascorbic acid may interfere with the measurement of serum and urinary parameters (e.g. urates, glucose, bilirubin, haemoglobin).
Other medicines and TACHIFLUDEC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, it is important to inform your doctor or pharmacist if you are taking any of the following
medicines:

• medicines that may alter liver function, such as zidovudine or isoniazid, which may increase the harmful effect of paracetamol on the liver;
• medicines that may alter urinary excretion of paracetamol, such as probenecid;
• medicines containing rifampicin (used to treat tuberculosis), cimetidine (used to treat stomach ulcers), or medicines such as glutethimide, phenobarbital, carbamazepine (used to treat epilepsy); when taken together with paracetamol, these medicines should be used with extreme caution and under strict medical supervision;
• medicines used to treat eye infections such as chloramphenicol;
• medicines used to delay or prevent blood clotting, e.g. warfarin, since high-dose paracetamol may lead to an increased risk of bleeding;
• medicines that may accelerate (e.g. metoclopramide, domperidone) or reduce/delay (e.g. colestyramine, anticholinergics) the absorption of paracetamol;
• medicines used to treat high blood pressure that contain beta-blockers;
• medicines containing monoamine oxidase inhibitors (see also section “Do not take TACHIFLUDEC”);
• medicines containing tricyclic antidepressants or sympathomimetic amines;
• medicines prescribed for heart failure (digoxin);
• medicines used to treat migraine such as ergotamine and methysergide;
• anti-inflammatory medicines;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalances (called high anion gap metabolic acidosis) which require urgent treatment;
• ascorbic acid (vitamin C), which may increase the absorption of iron and oestrogens;
• ascorbic acid (vitamin C), which may promote the formation of kidney stones in patients prone to calcium stone formation.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of TACHIFLUDEC is not recommended during pregnancy and breastfeeding; use TACHIFLUDEC
only after consulting your doctor.
If necessary, TACHIFLUDEC may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible duration. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Driving and using machines
TACHIFLUDEC does not affect your ability to drive or use machines.
However, if you experience dizziness, you should not drive or operate machinery.
TACHIFLUDEC lemon flavour contains sucrose, glucose and sodium:
Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 1.817 g of sucrose per sachet. This should be considered in patients with diabetes mellitus who take more than 2 sachets per day (more than 5 g of sucrose).
Glucose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Sodium: this medicine contains 112.86 mg of sodium (the main component of table salt) per sachet. This corresponds to 5.64% of the maximum daily dietary intake recommended for an adult. This should be considered if you have reduced kidney function or are on a low-sodium diet.
TACHIFLUDEC lemon and honey flavour contains sucrose and sodium:
Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 1.892 g of sucrose per sachet. This should be considered in patients with diabetes mellitus who take more than 2 sachets per day (more than 5 g of sucrose).
Sodium: this medicine contains 135.79 mg of sodium (the main component of table salt) per sachet. This corresponds to 6.79% of the maximum daily dietary intake recommended for an adult. This should be considered if you have reduced kidney function or are on a low-sodium diet.

3. How to take TACHIFLUDEC oral solution powder

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults and children over 12 years: 1 sachet every 4-6 hours, up to a maximum of 3 sachets in 24 hours.
Use in children
This medicine is contraindicated in children under 12 years of age.
Do not take more than the recommended dose without medical advice.
Instructions for use
Dissolve one sachet in half a glass of very hot water; if desired, dilute with cold water to cool down and sweeten to taste.
Warning: This product is intended for short-term treatment only.
Do not take for more than 3 consecutive days without consulting a doctor.
Consult your doctor if symptoms persist or if you notice any new changes in their characteristics.
If you take more TACHIFLUDEC than you should
If you or someone else takes more TACHIFLUDEC than recommended, or if you suspect that a child has swallowed the contents of a sachet, go immediately to the nearest hospital or see a doctor, even if you feel well, and bring this leaflet, any remaining sachets, and the pack with you. In case of accidental ingestion of high doses of this medicine, symptoms such as pallor, nausea, vomiting, loss of appetite (anorexia), abdominal pain, disturbances in blood sugar levels (glucose metabolism abnormalities), and accumulation of acids in the body (metabolic acidosis) may occur.
In severe poisoning, liver failure may progress to brain damage (encephalopathy, cerebral edema), bleeding, low blood sugar (hypoglycemia), and death. Even in the absence of severe liver damage, a reduction in kidney function (acute renal failure) may occur, manifesting as kidney injury (acute tubular necrosis), blood in the urine (hematuria), and protein loss in the urine (proteinuria).
Changes in heart rhythm (cardiac arrhythmias) and inflammation of the pancreas (pancreatitis) may also occur.
Irritability, headache (cephalalgia), and increased blood pressure may also occur. In more severe cases, confusion, hallucinations, and seizures may develop. High doses of the medicine may cause a brief episode of watery diarrhea (transient osmotic diarrhea).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following list includes the adverse effects of paracetamol and phenylephrine.
Adverse effects are listed 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 1,000 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 hospital immediately if you experience any of the following adverse effects:

• allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing difficulty in breathing or dizziness);
• very rare cases of serious skin reactions have been reported: severe rash, skin exfoliation, or mouth ulcers (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or polymorphous erythema);
• breathing problems (bronchospasm).

If you experience any of the following adverse effects, consult 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 1,000 people):

• blood disorders that may present as unexplained bruising, paleness, or reduced resistance to infection; reduction in specific blood cells (agranulocytosis, leukopenia, thrombocytopenia);
• tachycardia (increased heart rate), palpitations (awareness of heartbeats in the chest);
• abnormal liver function (elevated 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 (trembling), dizziness, headache;
• following prolonged use of high doses of paracetamol, interstitial nephritis (inflammation of the kidneys) and other adverse kidney effects may occur.

Not known (frequency cannot be estimated from the available data):

• anaemia (reduction in haemoglobin levels in the blood);
• mydriasis (pupil dilation), acute angle-closure glaucoma (an eye condition often associated with increased pressure of eye fluids);
• laryngeal oedema (swelling of the throat);
• diarrhoea, gastrointestinal discomfort;
• liver disorders, hepatitis (yellowing of the skin and/or eyes);
• kidney disorders (worsening of renal failure), blood in the urine (haematuria), difficulty urinating (anuria, urinary retention);
• increased blood pressure (hypertension);
• severe condition leading to increased acidity of the blood (called metabolic acidosis) in patients with serious underlying illness using paracetamol (see section 2).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report adverse effects directly via the national reporting system at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store TACHIFLUDEC

Store below 25°C.
Keep in the original container to protect the medicine from moisture and light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
It is important to always keep the product information available. Keep the outer packaging and the package leaflet.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TACHIFLUDEC contains
TACHIFLUDEC effervescent powder for oral solution, lemon flavour
Each sachet contains:
The active substances are: paracetamol 600 mg, ascorbic acid 40 mg and phenylephrine hydrochloride 10 mg (equivalent
to phenylephrine 8.2 mg).
The other components are: sucrose, anhydrous citric acid, sodium citrate, maize starch, sodium
cyclamate, sodium saccharin, anhydrous colloidal silica, lemon flavour, curcumin (E100), dried
glucose syrup. See also paragraph 2 “TACHIFLUDEC lemon flavour contains sucrose,
glucose and sodium”.
TACHIFLUDEC effervescent powder for oral solution, lemon and honey flavour
Each sachet contains:
The active substances are: paracetamol 600 mg, ascorbic acid 40 mg and phenylephrine hydrochloride 10 mg (equivalent
to phenylephrine 8.2 mg).
The other components are: sucrose, anhydrous citric acid, sodium citrate, maize starch, sodium
cyclamate, sodium saccharin, anhydrous colloidal silica, lemon flavour, honey flavour, caramel (E150).
See also paragraph 2 “TACHIFLUDEC lemon and honey flavour contains sucrose and sodium”.

Description of the appearance of TACHIFLUDEC and contents of the pack
TACHIFLUDEC lemon flavour comes as sachets containing a light yellow, heterogeneous and free-flowing powder for oral solution with a lemon odour.
TACHIFLUDEC lemon and honey flavour comes as sachets containing a light beige, heterogeneous and free-flowing powder with a lemon and honey odour.
TACHIFLUDEC is available in cartons containing 10 and 16 sachets.

Marketing Authorisation Holder
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy

Manufacturer
A.C.R.A.F. S.p.A. – Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy.

Patient Information Leaflet: Information for the User

TACHIFLUDEC mint-flavored oral solution powder

Paracetamol, ascorbic acid, phenylephrine hydrochloride
Please read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What TACHIFLUDEC is and what it is used for
2. What you need to know before taking TACHIFLUDEC
3. How to take TACHIFLUDEC
4. Possible side effects
5. How to store TACHIFLUDEC
6. Contents of the pack and other information

TACHIFLUDEC is a medicine containing the active substances paracetamol, ascorbic acid, and phenylephrine hydrochloride, used for the treatment of pain, fever, and nasal congestion.
TACHIFLUDEC is used for the short-term treatment of cold and flu symptoms, including mild to moderate pain and fever, when associated with nasal congestion.
TACHIFLUDEC oral solution powder 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.

2. What you should know before taking TACHIFLUDEC

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 within the last two weeks;
• if you have bronchial asthma;
• if you have phaeochromocytoma (a tumour of the adrenal glands);
• if you have glaucoma (an eye condition often associated with increased intraocular pressure);
• if you are taking other sympathomimetic medicines (such as decongestants, appetite suppressants, and amphetamine-like psychostimulants);
• if you have severe hepatic insufficiency;
• if you have liver or kidney problems;
• if you have 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 disorder leading to a decrease in red blood cell count);
• if you suffer from severe haemolytic anaemia (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 (blockage of arteries, e.g. Raynaud's syndrome);
• if you have reduced kidney function (TACHIFLUDEC contains sodium).

During treatment with TACHIFLUDEC, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an imbalance in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
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 medicines, 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 may occur, including severe liver damage and effects on the kidneys and blood.
Paracetamol may interfere with tests measuring blood sugar levels (in people with diabetes) and uric acid levels (in people with gout). Ascorbic acid may interfere with the measurement of serum and urinary parameters (e.g. urates, glucose, bilirubin, haemoglobin).
Other medicines and TACHIFLUDEC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, it is important to inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines that may affect liver function, such as zidovudine or isoniazid, which may increase the harmful effects of paracetamol on the liver;
• medicines that may affect the urinary excretion of paracetamol, such as probenecid;
• medicines containing rifampicin (used in the treatment of tuberculosis), cimetidine (used in the treatment of stomach ulcers), or medicines such as glutethimide, phenobarbital, carbamazepine (used in the treatment of epilepsy); when taken together with paracetamol, these medicines should be used with extreme caution and under close medical supervision;
• medicines used to treat eye infections such as chloramphenicol;
• medicines used to delay or prevent blood clotting, e.g. warfarin, since high-dose paracetamol may increase the risk of bleeding;
• medicines that may speed up (e.g. metoclopramide, domperidone) or slow down/reduce (e.g. colestyramine, anticholinergics) the absorption of paracetamol;
• medicines used to treat high blood pressure that contain beta-blockers;
• medicines containing monoamine oxidase inhibitors (see also section “Do not take TACHIFLUDEC”);
• medicines containing tricyclic antidepressants or sympathomimetic amines;
• medicines prescribed for heart failure (digoxin);
• medicines used to treat migraine such as ergotamine and methysergide;
• anti-inflammatory medicines;
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called high anion gap metabolic acidosis) which require urgent treatment;
• ascorbic acid (vitamin C), which may increase the absorption of iron and oestrogens;
• ascorbic acid (vitamin C), which may promote kidney stone formation in patients prone to calcium stones.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of TACHIFLUDEC is not recommended during pregnancy and breastfeeding; use TACHIFLUDEC only after consulting your doctor.
If necessary, TACHIFLUDEC may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible time.
Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Driving and using machines
TACHIFLUDEC does not affect your ability to drive or operate machinery.
However, if you experience dizziness, you should not drive or operate machinery.
TACHIFLUDEC contains sucrose and sodium:
Sodium: this medicine contains 138.47 mg of sodium (the main component of table salt) per sachet. This corresponds to 6.92% of the maximum daily dietary intake recommended for an adult. This should be taken into account if you have reduced kidney function or are on a low-sodium diet.
Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 2.070 g of sucrose per sachet. This should also be considered in patients with diabetes mellitus if more than 2 sachets are taken per day (more than 5 g of sucrose).

3. How to take TACHIFLUDEC oral solution powder

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults and children above 12 years of age: 1 sachet every 4-6 hours, up to a maximum of 3 sachets
in 24 hours.
Use in children
This medicine is contraindicated in children under 12 years of age.
Do not exceed the recommended dose without medical advice.
Instructions for use
Dissolve one sachet in a glass of warm or cold water and sweeten to taste, if desired.
Warning: This product is intended for short-term use only.
Do not take for more than 3 consecutive days without consulting your doctor.
Consult your doctor if symptoms persist or if you notice any new changes in their characteristics.
If you take more TACHIFLUDEC than you should
If you or someone else takes more TACHIFLUDEC than recommended, or if you suspect a child
has swallowed the contents of a sachet, go immediately to the nearest hospital or doctor, even
if you feel well, and bring this leaflet, any remaining sachets, and the pack with you.
In case of accidental ingestion of high doses of this medicine, symptoms may include pallor,
nausea, vomiting, loss of appetite (anorexia), abdominal pain, changes in blood sugar levels
(glucose metabolism abnormalities), and accumulation of acids in the body (metabolic acidosis).
In severe poisoning, liver failure may progress to brain damage (encephalopathy, cerebral
edema), bleeding (haemorrhage), low blood sugar (hypoglycaemia), and death. Even in the
absence of severe liver damage, a reduction in kidney function (acute renal failure) may occur,
manifesting as kidney damage (acute tubular necrosis), blood in the urine (haematuria), and
protein in the urine (proteinuria). Cardiac rhythm disturbances (cardiac arrhythmias) and
inflammation of the pancreas (pancreatitis) may also occur.
Other possible symptoms include irritability, headache (cephalalgia), and increased blood
pressure. In more severe cases, confusion, hallucinations, and seizures may develop. High
doses of the medicine may cause a brief episode of watery diarrhoea (transient osmotic diarrhoea).
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following list includes side effects associated with paracetamol and phenylephrine.
Side effects are listed 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 1,000 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
immediately to hospital if you experience any of the following side effects:

• Allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing difficulty in breathing or dizziness);
• Very rare cases of serious skin reactions have been reported: severe rash, skin 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, consult 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 1,000 people):

• Blood disorders that may appear as unexplained bruising, paleness, or reduced resistance to infection; reduction in specific blood cells (agranulocytosis, leucopenia, thrombocytopenia);
• Tachycardia (increased heart rate), palpitations (awareness of heartbeat in the chest);
• Abnormal liver function (elevated 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, dizziness, headache;
• After prolonged use of high doses of paracetamol, interstitial nephritis (inflammation of the kidneys) and adverse effects on the kidneys may occur.

Not known (frequency cannot be estimated from the available data):

• Anaemia (decrease in haemoglobin levels in the blood);
• Mydriasis (pupil dilation), acute angle-closure glaucoma (an eye condition often associated with increased fluid pressure in the eye);
• Laryngeal oedema (swelling of the throat);
• Diarrhoea, gastrointestinal discomfort;
• Liver disorders, hepatitis (yellowing of the skin and/or eyes);
• Kidney disorders (worsening of renal failure), blood in urine (haematuria), difficulty urinating (anuria, urinary retention);
• Increased blood pressure (hypertension);
• Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with serious illness using paracetamol (see section 2).

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

5. How to store TACHIFLUDEC

Store below 25°C.
Keep in the original container to protect the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
It is important to always keep product information available. Keep the outer packaging and the leaflet.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TACHIFLUDEC contains
Each sachet contains:
The active substances are: paracetamol 600 mg, ascorbic acid 40 mg, and phenylephrine hydrochloride 10 mg
(equivalent to phenylephrine 8.2 mg).
The other components are: sucrose, anhydrous citric acid, sodium citrate, maize starch, sodium
cyclamate, mint flavour, sodium saccharin, anhydrous colloidal silica. See also section 2
“TACHIFLUDEC contains sucrose and sodium”.
Description of the appearance of TACHIFLUDEC and contents of the pack
TACHIFLUDEC is presented in sachets containing a white, heterogeneous, free-flowing powder with a mint odour, for oral solution.
TACHIFLUDEC is available in packs containing 10 and 16 sachets.
Marketing Authorisation Holder and Manufacturer
Angelini Pharma S.p.A.
Viale Amelia, 70 - 00181 Rome
Manufacturer
A.C.R.A.F. S.p.A. – Via Vecchia del Pinocchio, 22 - 60131 Ancona.