Tachiflutask

Package leaflet: Information for the user

TACHIFLUTASK 600 mg/10 mg granules in sachet

Paracetamol/phenylephrine hydrochloride
Please read all of 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 to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What TACHIFLUTASK is and what it is used for

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

2. What you need to know before taking TACHIFLUTASK

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 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 have 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 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 arteries, e.g. Raynaud's syndrome);
• if you have reduced kidney function (TACHIFLUTASK contains sodium).

During treatment with TACHIFLUTASK, inform your doctor immediately if:
You suffer from serious conditions, including severe kidney 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, rapid 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 medicines, 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 damage and alterations affecting the kidneys and blood.
Paracetamol may interfere with tests for blood sugar levels (in people with diabetes) and uric acid levels (in people with gout).

Other medicines and TACHIFLUTASK
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 effects 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 must 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, as high-dose paracetamol may increase the 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 containing beta-blockers;
• medicines containing monoamine oxidase inhibitors (see also section “Do not take TACHIFLUTASK”);
• 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) that require urgent treatment.

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 TACHIFLUTASK is not recommended during pregnancy and breastfeeding; use TACHIFLUTASK only after consulting your doctor.

Driving and using machines
TACHIFLUTASK does not impair your ability to drive or operate machinery. However, if you experience dizziness, you should not drive or operate machinery.

TACHIFLUTASK contains sorbitol and aspartame:
This medicine contains:

• 42 mg of sorbitol per sachet;
• 25 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take TACHIFLUTASK

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 consulting your doctor.

Instructions for use
Place the granules directly on the tongue and swallow. TACHIFLUTASK dissolves with saliva: this allows it to be taken without water.
Alternatively, you may dissolve the contents of one sachet in a glass of warm water (not boiling), stirring with a teaspoon. If desired, you may dilute it with cold water to cool and sweeten it.
Once prepared, drink the solution within a few minutes.

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 TACHIFLUTASK than you should
If you or someone else takes more TACHIFLUTASK than the recommended dose, 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. Take 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, changes in blood sugar levels (abnormalities in glucose metabolism), 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 (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).
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 diarrhoea (transient osmotic diarrhoea).

If you have any questions 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 experiences 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 TACHIFLUTASK 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 which may present as unexplained bruising, paleness, or reduced resistance to infection; decrease 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 sleeping), nervousness, anxiety, agitation, confusion, irritability;
• Tremor (trembling), dizziness, headache;
• Following prolonged use of high doses of paracetamol, interstitial nephritis (kidney inflammation) and other kidney-related adverse effects 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 diseases, 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 leading to increased acidity of the blood (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, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: 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 TACHIFLUTASK

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

6. Package contents and other information

What TACHIFLUTASK contains
The active substances are: paracetamol 600 mg and phenylephrine hydrochloride 10 mg (equivalent to phenylephrine 8.2 mg).
The other components are: mannitol (E 421), Xylitab 200 (xylitol, carboxymethylcellulose), lemon flavour, sorbitol (E 420), ascorbic acid, citric acid, hydrated colloidal silica, aspartame (E 951), sodium saccharin.

Description of the appearance of TACHIFLUTASK and the contents of the pack
TACHIFLUTASK is presented in sachets containing a granulate ranging in colour from white to ivory.
TACHIFLUTASK is available in cardboard boxes containing 10 and 16 sachets.

Marketing Authorisation Holder
Angelini Pharma S.p.A. - Viale Amelia, 70 – 00181 ROME

Manufacturer
E-Pharma Trento S.p.A. – Via Provina, 2 – 38123 Trento (TN)