Tachifluactiv for influenza and cold

Patient Information Leaflet

TACHIFLUACTIV COLD AND FLU 500 mg/60 mg effervescent tablets

paracetamol/hydrochloride pseudoephedrine
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 you.

• 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 those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days in adults and 3 days in adolescents.

Contents of this leaflet:

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

1. What TACHIFLUACTIV INFLUENZA E RAFFREDDORE is and what it is used for

TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains the active substances paracetamol and pseudoephedrine, which act against pain, fever, and nasal congestion.
TACHIFLUACTIV INFLUENZA E RAFFREDDORE is indicated for the treatment of symptoms of cold and flu.
Consult your doctor if you do not feel better or if you feel worse after 5 days of treatment if you are an adult, or after 3 days if the medicine is being taken by an adolescent, if the condition occurs repeatedly, or if you have noticed any recent change in its characteristics.

2. What you need to know before taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE

Do not use TACHIFLUACTIV INFLUENZA E RAFFREDDORE

• if you are allergic to paracetamol, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if the patient is a child under 12 years of age (see section “Children”);
• if you have a deficiency of an enzyme known as glucose-6-phosphate dehydrogenase;
• if you have a severe form of any of the following conditions:
  • coronary artery disease (chest pain (angina), previous heart attack);
  • asthma;
  • very high blood pressure (severe hypertension) or uncontrolled hypertension with medication;
  • heart rhythm disorders (arrhythmias);
  • liver failure;
  • severe acute (sudden) or chronic (long-term) kidney disease or renal failure;
  • diabetes;
  • urinary problems caused by an enlarged prostate (prostatic hypertrophy) or other diseases;
• reduced number of red blood cells due to their destruction (haemolytic anaemia);
  • if your thyroid gland is overactive (hyperthyroidism);
  • if you have a condition characterized by high pressure inside the eye (closed-angle glaucoma);
  • if you have a tumour of the adrenal gland known as phaeochromocytoma;
  • if you are taking the following medicines:
• antidepressants belonging to the tricyclic antidepressants class
• heart or high blood pressure medicines belonging to the beta-blockers class
• sympathomimetic medicines used to treat low blood pressure or nasal congestion (see section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”);
  • if you are currently taking or have taken within the last 14 days medicines for depression and Parkinson’s disease belonging to the class of monoamine oxidase inhibitors. See section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”.

Warnings and precautions
Talk to your doctor or pharmacist before taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE.
Talk to your doctor before taking this medicine:

• if you are elderly;
• if you have kidney problems;
• if you have liver problems, including liver failure and acute hepatitis;
• if you have a deficiency of an enzyme known as glucose-6-phosphate dehydrogenase (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”);
• if you have a reduced number of red blood cells due to their destruction (haemolytic anaemia);
• if you suffer from chronic malnutrition and dehydration;
• if you have heart and/or blood vessel problems, such as chest pain (angina), palpitations or other heart rhythm disorders;
• if you have diabetes mellitus;
• if you have an enlarged prostate (prostatic hypertrophy) causing urinary problems;
• if you have mental health problems (psychosis);
• if your thyroid gland is overactive (hyperthyroidism);
• if you have asthma;
• if you have a condition characterized by high pressure inside the eye (glaucoma);
• if you have high blood pressure (hypertension);
• if you are alcohol-dependent (alcoholism) (see section “TACHIFLUACTIV INFLUENZA E RAFFREDDORE and alcohol”);
• if you are taking any other medicine (see section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”), particularly:
  • other medicines that affect the liver (consult your doctor if you are unsure whether this applies to you)
  • if you are taking oral anticoagulants (medicines that reduce blood clotting), as your doctor will assess whether the dose of the anticoagulant needs to be reduced.

Talk to your doctor if, during treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE:

• pain or nasal congestion worsen or last longer than 5 days, or if symptoms do not improve within 5 days;
• fever worsens or lasts more than 3 days;
• you develop redness or swelling;
• you develop new symptoms.

During treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE, contact 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 over a prolonged period 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.

Take special care:

• TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains paracetamol; before taking any other medicine, check that it does not contain paracetamol, as taking high doses of paracetamol may cause serious adverse effects, such as liver damage;
• do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE with other medicines used to treat pain and fever, as serious adverse effects may occur;
• if you are due to undergo surgery, inform your doctor that you are taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE, because treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE should be stopped several days before surgery.

One of the active substances in TACHIFLUACTIV INFLUENZA E RAFFREDDORE, pseudoephedrine, may lead to abuse, and high doses of pseudoephedrine can be toxic. Continuous use may lead to taking more TACHIFLUACTIV INFLUENZA E RAFFREDDORE than the recommended dose to achieve the desired effect, increasing the risk of overdose. The maximum recommended dose and duration of treatment must not be exceeded (see section 3).
Abdominal pain or rectal bleeding may occur with TACHIFLUACTIV INFLUENZA E RAFFREDDORE due to inflammation of the colon (ischaemic colitis). If you experience these gastrointestinal symptoms, stop using TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contact your doctor or seek immediate medical assistance. See section 4.
Reduced blood flow to the optic nerve may occur with TACHIFLUACTIV INFLUENZA E RAFFREDDORE. If sudden vision loss occurs, stop taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contact your doctor or a healthcare facility immediately. See section 4.
Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may lead to reduced blood supply to the brain. Stop using TACHIFLUACTIV INFLUENZA E RAFFREDDORE immediately and seek immediate medical help if you develop symptoms that could indicate PRES or RCVS (see section 4 “Possible side effects” for symptoms).
If you develop a generalized feverish erythema associated with pustules, stop taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contact your doctor or seek immediate medical assistance. See section 4.

Children
TACHIFLUACTIV INFLUENZA E RAFFREDDORE must not be given to children under 12 years of age (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”).

Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE with the following medicines:

• monoamine oxidase inhibitors (medicines used to treat depression and Parkinson’s disease), even if treatment has been stopped less than 14 days ago;
• other sympathomimetics (medicines used to treat low blood pressure or nasal congestion);
• heart or high blood pressure medicines belonging to the beta-blockers class;
• antidepressants belonging to the tricyclic antidepressants class. See also section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”.

Take particular care and inform your doctor before taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you are already using or need to use one or more of the following medicines:

• medicines for tuberculosis: rifampicin, isoniazid;
• antibiotics: chloramphenicol, linezolid;
• antacids: cimetidine, ranitidine;
• medicines for epilepsy and/or mental disorders: glutethimide, phenobarbital, carbamazepine, phenytoin, lamotrigine;
• medicines used for high blood pressure, for example: debrisoquine, guanethidine, reserpine, methyldopa;
• midodrine (a medicine used for low blood pressure);
• medicines used to reduce blood clotting, e.g. warfarin;
• metoclopramide (a medicine used for stomach and/or intestinal problems and to treat nausea and vomiting);
• domperidone (a medicine used to treat nausea and vomiting or digestive problems);
• cholestyramine (a medicine to lower cholesterol); cholestyramine should be taken at least one hour after taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE;
• zidovudine (a medicine used for AIDS);
• probenecid (a medicine for gout);
• medicines used to induce anaesthesia (see also section “Warnings and precautions”);
• medicines for heart problems: digoxin, cardiac glycosides;
• medicines for migraine: ergotamine, methysergide;
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that requires urgent treatment (see section 2).

Laboratory tests
The paracetamol contained in this medicine may interfere with certain laboratory tests used to determine blood uric acid levels (uricemia) or blood sugar levels (glycaemia).

TACHIFLUACTIV INFLUENZA E RAFFREDDORE and alcohol
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE with alcoholic drinks because alcohol increases the risk of liver damage.
Inform your doctor if you are alcohol-dependent, as your doctor will pay particular attention when prescribing TACHIFLUACTIV INFLUENZA E RAFFREDDORE (see section “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you are pregnant, think you may be pregnant, or are planning a pregnancy (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”).

Breastfeeding
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you are breastfeeding (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”).

Driving and using machines
TACHIFLUACTIV INFLUENZA E RAFFREDDORE may cause dizziness. If this occurs, you must not drive or operate machinery.

TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains sodium, sorbitol, aspartame and benzoic acid (contained in simeticone emulsion).
Sodium: This medicine contains 324 mg of sodium (the main component of table salt) per tablet. This is approximately 16% of the maximum recommended daily dietary intake for an adult.
Sorbitol: This medicine contains 296 mg of sorbitol per tablet, equivalent to 98.7 mg/g. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, talk to your doctor before you (or your child) take this medicine.
Aspartame: This medicine contains 20 mg of aspartame per tablet, equivalent to 6.7 mg/g. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
Benzoic acid: This medicine contains 0.06 mg of benzoic acid per tablet, equivalent to 0.06 mg/3 g.

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take TACHIFLUACTIV INFLUENZA E RAFFREDDORE

Always use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Use in adults
The recommended dose is 1 effervescent tablet, 2–3 times a day, for a maximum of 5 days of treatment.
Use in adolescents over 12 years of age
The recommended dose is 1 effervescent tablet, 2–3 times a day, for a maximum of 3 days of treatment.
Use in children under 12 years of age
TACHIFLUACTIV INFLUENZA E RAFFREDDORE must not be administered to children under 12 years of age.
How to take TACHIFLUACTIV INFLUENZA E RAFFREDDORE
Dissolve the tablet in a glass of water and drink the resulting solution immediately.
Be careful not to exceed the recommended doses without medical advice and take this medicine only for short periods of time.
Consult your doctor if you do not feel better or if you feel worse after the maximum recommended treatment period, if the condition recurs repeatedly, or if you have noticed any recent changes in its characteristics.
If you take more TACHIFLUACTIV INFLUENZA E RAFFREDDORE than you should
In case of accidental ingestion of an excessive dose of TACHIFLUACTIV INFLUENZA E RAFFREDDORE, contact your doctor immediately or go to the nearest hospital.
The risk is higher in elderly patients, children, patients with liver problems, chronic alcohol users, malnourished individuals, and patients taking medicines that affect the liver.
The first symptoms caused by taking an excessive dose are:

• pallor
• nausea, vomiting, reduced or loss of appetite
• abdominal pain

Ingestion of an excessive dose may also cause:

• changes in heart rhythm (palpitations, arrhythmias)
• inflammation of the pancreas (pancreatitis)
• irritability, restlessness, excitement
• tremors
• seizures
• increased blood pressure
• difficulty urinating
• severe liver toxicity
• severe kidney failure
• brain damage (encephalopathy)
• coma
• death

Your doctor will treat the ingestion of an excessive dose of TACHIFLUACTIV INFLUENZA E RAFFREDDORE according to your condition.
If you forget to take TACHIFLUACTIV INFLUENZA E RAFFREDDORE
Do not take a double dose to make up for the missed dose.
If you stop treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE
If you have any doubts about using 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.
Very serious side effects:
Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Severe conditions affecting the brain's blood vessels, known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE immediately and seek urgent medical advice if you develop symptoms that could indicate reversible posterior encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• Severe headache with sudden onset
• Nausea
• Vomiting
• Confusion
• Seizures
• Changes in vision.

Other possible side effects are:
Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions, including swelling of the skin or mucous membranes (angioedema)
• Nervousness, insomnia, anxiety, agitation, hallucinations, particularly in children
• Dizziness
• Headache
• Tremors
• Changes in heart rhythm (tachycardia, palpitations)
• Increased blood pressure
• Vomiting, nausea, dry mouth
• Increased levels of certain liver enzymes, detectable by laboratory tests
• Skin rash, erythema, urticaria, itching
• Difficulty urinating, particularly in patients with enlarged prostate volume (prostatic hypertrophy).

Very rare side effects (may affect up to 1 in 10,000 people)

• Reduction in the number of platelets in the blood (thrombocytopenia)
• Reduction in the number of white blood cells (leucopenia, agranulocytosis)
• Reduction in all blood cells (pancytopenia)
• Severe skin reactions

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Severe and sudden allergic reaction (anaphylactic shock)
• Severe skin reaction (Stevens-Johnson syndrome)
• Severe allergic reaction affecting the skin and mucous membranes, which may also be life-threatening (toxic epidermal necrolysis)
• Sudden onset of fever, skin redness, or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP), which may occur within the first 2 days of treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE. See section 2. Stop using TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you develop these symptoms and contact your doctor or seek immediate medical help.
• Inflammation of the colon due to insufficient blood supply (ischaemic colitis)
• Reduced blood flow to the optic nerve (ischaemic optic neuropathy)
• Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2).

Other side effects that may occur after taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE:

• Sweating

• Thirst

• Chest pain near the heart (precordial pain)

• Difficulty urinating

• Muscle weakness

• Dilatation of the pupils

• Stomach problems

• Severe disturbance of heart rhythm (ventricular arrhythmia)

• Allergic reaction affecting the skin and mucous membranes (erythema multiforme)

• Swelling of the throat (larynx)

• Severe and sudden allergic reaction causing collapse, which may be fatal (anaphylactic shock)

• Anaemia

• Liver function abnormalities, inflammation of the liver (hepatitis)

• Kidney function abnormalities:

  o Severe kidney failure
  o Severe inflammation of the kidney (interstitial nephritis)
  o Presence of blood in the urine (haematuria)
  o Failure to produce urine (anuria)

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 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 TACHIFLUACTIV INFLUENZA E RAFFREDDORE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Scad.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original container and keep the tube tightly closed to protect the medicine from moisture.
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 TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains

• The active substances are paracetamol and pseudoephedrine hydrochloride. Each effervescent tablet contains 500 mg of paracetamol and 60 mg of pseudoephedrine hydrochloride.
• The other components are: citric acid, sodium bicarbonate, anhydrous sodium carbonate, sorbitol (E420), lemon flavour, aspartame (E951), sodium saccharin, simethicone emulsion, leucine, sodium docusate.

Description of the appearance of TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contents of the
pack
Pack containing 8 or 10 effervescent tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Angelini Pharma S.p.A., Viale Amelia, 70 – 00181 ROME
Manufacturer
E-Pharma Trento S.p.A. - Ravina hamlet - Via Provina, 2 – 38123 Trento (TN)

Patient information leaflet

TACHIFLUACTIV FLU AND COLD 500 mg/60 mg effervescent tablets

paracetamol/hydrochloride pseudoephedrine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TACHIFLUACTIV INFLUENZA E RAFFREDDORE is and what it is used for

TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains the active substances paracetamol and
pseudoephedrine, which act against pain, fever and nasal congestion.
TACHIFLUACTIV INFLUENZA E RAFFREDDORE is indicated for the treatment of symptoms of
cold and flu.
Consult your doctor if you do not feel better or if you feel worse after 5 days of treatment if you are an adult, or after 3 days if the patient is an adolescent, if the condition occurs repeatedly, or if you have noticed any recent change in its characteristics.

2. What you need to know before taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE

Do not use Paracetamol or TACHIFLUACTIV INFLUENZA E RAFFREDDORE:

• if you are allergic to paracetamol, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if the patient is a child under 12 years of age (see section “Children”);
• if you have a deficiency of an enzyme known as glucose-6-phosphate dehydrogenase;
• if you have a severe form of the following conditions:
  • coronary artery disease (chest pain (angina), previous heart attack); asthma;
  • very high blood pressure (severe hypertension) or uncontrolled hypertension due to medication;
  • heart rhythm disorders (arrhythmias); liver failure;
  • severe acute (sudden) or chronic (long-term) kidney disease or renal failure;
  • diabetes;
  • urinary problems caused by an enlarged prostate (prostatic hypertrophy) or other diseases;
• reduced number of red blood cells in the blood due to their destruction (haemolytic anaemia);
  • if your thyroid gland is overactive (hyperthyroidism);
  • if you have a condition characterised by high pressure inside the eye (closed-angle glaucoma);
  • if you have a tumour of the adrenal gland known as phaeochromocytoma; if you are taking the following medicines:
  • antidepressant medicines belonging to the class of tricyclic antidepressants;
  • medicines for heart conditions or high blood pressure belonging to the class of beta-blockers;
  • sympathomimetic medicines used to treat low blood pressure or nasal congestion (see section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”);
  • if you are currently taking or have taken within the last 14 days medicines for depression and Parkinson’s disease belonging to the class of monoamine oxidase inhibitors. See section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”.

Warnings and precautions
Talk to your doctor or pharmacist before taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE.
Talk to your doctor before taking this medicine:

• if you are elderly;
• if you have kidney problems;
• if you have liver problems, including liver failure and acute hepatitis;
• if you have a deficiency of an enzyme known as glucose-6-phosphate dehydrogenase (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”);
• if you have a reduced number of red blood cells in the blood due to their destruction (haemolytic anaemia);
• if you suffer from chronic malnutrition and dehydration;
• if you have heart and/or blood vessel problems, for example chest pain (angina), palpitations or other heart rhythm disorders;
• if you have diabetes mellitus;
• if you have an enlarged prostate (prostatic hypertrophy) causing urinary problems;
• if you have mental health problems (psychosis);
• if your thyroid gland is overactive (hyperthyroidism);
• if you have asthma;
• if you have a disease characterised by high pressure inside the eye (glaucoma);
• if you have high blood pressure (hypertension);
• if you are alcohol-dependent (alcoholism) (see section “TACHIFLUACTIV INFLUENZA E RAFFREDDORE and alcohol”);
• if you are taking any other medicine (see section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”), in particular:
  • other medicines that affect the liver (consult your doctor if you are unsure whether this applies to you);
  • if you are taking oral anticoagulants (medicines that reduce blood clotting), as your doctor may need to adjust the dose.

Talk to your doctor if, during treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE:

• pain or nasal congestion worsen or last longer than 5 days, or if symptoms do not improve within 5 days;
• fever worsens or lasts more than 3 days;
• you develop redness or swelling;
• you experience new symptoms.

During treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE, inform your doctor immediately if:
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 together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Take special care:

• TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains paracetamol; before using any other medicine, check that it does not contain paracetamol, as taking high doses of paracetamol may cause serious adverse effects, such as liver damage;
• do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE with other medicines used to treat pain and fever, as serious adverse effects may occur;
• if you are scheduled for surgery, inform your doctor that you are taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE, as treatment should be stopped several days before the procedure.

One of the active ingredients in TACHIFLUACTIV INFLUENZA E RAFFREDDORE, pseudoephedrine, may lead to abuse, and high doses of pseudoephedrine can be toxic. Continued use may lead to taking more TACHIFLUACTIV INFLUENZA E RAFFREDDORE than the recommended dose to achieve the desired effect, increasing the risk of overdose. The maximum recommended dose and duration of treatment must not be exceeded (see section 3).
Sudden abdominal pain or rectal bleeding may occur with TACHIFLUACTIV INFLUENZA E RAFFREDDORE due to inflammation of the colon (ischaemic colitis). If you experience these gastrointestinal symptoms, stop using TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contact your doctor or seek immediate medical assistance. See section 4.
Reduced blood flow to the optic nerve may occur with TACHIFLUACTIV INFLUENZA E RAFFREDDORE. If sudden vision loss occurs, stop taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contact your doctor or seek immediate medical attention. See section 4.
Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may result in reduced blood flow to the brain. Stop using TACHIFLUACTIV INFLUENZA E RAFFREDDORE immediately and seek urgent medical attention if you develop symptoms that could indicate PRES or RCVS (see section 4 “Possible side effects” for symptoms).
If you develop a febrile generalised erythema associated with pustules, stop taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contact your doctor or seek immediate medical assistance. See section 4.

Children
TACHIFLUACTIV INFLUENZA E RAFFREDDORE must not be given to children under 12 years of age (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”).

Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicine.
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE with the following medicines:

• monoamine oxidase inhibitors (medicines used to treat depression and Parkinson’s disease), even if treatment has been discontinued less than 14 days ago;
• other sympathomimetic medicines (used to treat low blood pressure or nasal congestion);
• medicines for heart conditions or high blood pressure belonging to the class of beta-blockers;
• antidepressant medicines belonging to the class of tricyclic antidepressants. See also section “Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE”.

Take special care and inform your doctor before taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you are currently using or need to use one or more of the following medicines:

• medicines for the treatment of tuberculosis: rifampicin, isoniazid;
• antibiotics: chloramphenicol, linezolid;
• antacids: cimetidine, ranitidine;
• medicines for epilepsy and/or mental disorders: glutethimide, phenobarbital, carbamazepine, phenytoin, lamotrigine;
• medicines used for high blood pressure, for example: debrisoquine, guanethidine, reserpine, methyldopa;
• midodrine (a medicine used for low blood pressure);
• medicines used to reduce blood clotting, for example warfarin;
• metoclopramide (a medicine used for stomach and/or intestinal problems and to treat nausea and vomiting);
• domperidone (a medicine used to treat nausea and vomiting or digestive problems);
• colestyramine (a medicine to lower cholesterol); colestyramine should be taken at least one hour after taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE;
• zidovudine (a medicine used for AIDS);
• probenecid (a medicine for gout);
• medicines used to induce anaesthesia (see also section “Warnings and precautions”);
• medicines for heart problems: digoxin, cardiac glycosides;
• medicines for migraine treatment: ergotamine, methysergide;
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

Laboratory tests
The paracetamol contained in this medicine may interfere with certain laboratory tests used to determine blood levels of uric acid (uricaemia) or blood sugar (glycaemia).

TACHIFLUACTIV INFLUENZA E RAFFREDDORE and alcohol
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE with alcoholic beverages, as alcohol increases the risk of liver damage.
Inform your doctor if you are alcohol-dependent, as your doctor will pay particular attention when prescribing TACHIFLUACTIV INFLUENZA E RAFFREDDORE (see section “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you are pregnant, think you may be pregnant, or are planning a pregnancy (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”).

Breastfeeding
Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you are breastfeeding (see section “Do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE”).

Driving and using machines
TACHIFLUACTIV INFLUENZA E RAFFREDDORE may cause dizziness; if this occurs, do not drive or operate machinery.

TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains sodium, sorbitol, aspartame and benzoic acid (contained in simeticone emulsion).
Sodium: This medicine contains 324 mg of sodium (main component of table salt) per tablet. This corresponds to approximately 16% of the maximum daily dietary intake recommended for an adult.
Sorbitol: This medicine contains 296 mg of sorbitol per tablet, equivalent to 98.7 mg/g. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolise fructose, speak with your doctor before you (or the child) take this medicine.
Aspartame: This medicine contains 20 mg of aspartame per tablet, equivalent to 6.7 mg/g. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body’s inability to properly eliminate it.
Benzoic acid: This medicine contains 0.06 mg of benzoic acid per tablet, equivalent to 0.06 mg/3 g.

For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take TACHIFLUACTIV INFLUENZA E RAFFREDDORE

Take this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults
The recommended dose is 1 effervescent tablet, 2–3 times daily, for a maximum treatment duration of 5 days.

Use in adolescents over 12 years of age
The recommended dose is 1 effervescent tablet, 2–3 times daily, for a maximum treatment duration of 3 days.

Use in children under 12 years of age
TACHIFLUACTIV INFLUENZA E RAFFREDDORE must not be administered to children under 12 years of age.

How to take TACHIFLUACTIV INFLUENZA E RAFFREDDORE
Dissolve the tablet in a glass of water and drink the resulting solution immediately.
Be careful not to exceed the recommended doses without medical advice and take this medicine only for short periods of time.
Consult your doctor if you do not feel better or if you feel worse after the maximum recommended treatment period, if symptoms recur repeatedly, or if you have noticed any recent changes in their characteristics.

If you take more TACHIFLUACTIV INFLUENZA E RAFFREDDORE than you should
In case of accidental overdose of TACHIFLUACTIV INFLUENZA E RAFFREDDORE, contact your doctor immediately or go to the nearest hospital.
The risk is higher in elderly patients, children, patients with liver problems, chronic alcohol users, malnourished individuals, and patients taking medicines that affect the liver.
The first symptoms caused by taking an excessive dose are:

• pallor
• nausea, vomiting, reduced or loss of appetite
• abdominal pain

Taking an excessive dose may also cause:

• changes in heart rhythm (palpitations, arrhythmias)
• inflammation of the pancreas (pancreatitis)
• dilation of the pupils (mydriasis)
• irritation, restlessness, excitement
• tremors
• seizures
• increased blood pressure
• difficulty urinating
• severe liver toxicity
• severe kidney failure
• brain damage (encephalopathy)
• coma
• death

Your doctor will treat an overdose of TACHIFLUACTIV INFLUENZA E RAFFREDDORE according to your condition.

If you forget to take TACHIFLUACTIV INFLUENZA E RAFFREDDORE
Do not take a double dose to make up for the forgotten dose.

If you stop taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very serious side effects:

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Severe conditions affecting the brain's blood vessels, known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Immediately stop treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE and seek urgent medical advice if you develop symptoms that could indicate reversible posterior encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision.

Other possible side effects are:

Rare side effects (may affect up to 1 in 1,000 people)

• allergic reactions, including swelling of the skin or mucous membranes (angioedema)
• nervousness, insomnia, anxiety, agitation, hallucinations, particularly in children
• dizziness
• headache
• tremors
• changes in heart rate (tachycardia, palpitations)
• increased blood pressure
• vomiting, nausea, dry mouth
• increased levels of certain liver enzymes, detectable by laboratory tests
• skin rash, erythema, urticaria, itching
• difficulty urinating, particularly in patients with enlarged prostate volume (prostatic hypertrophy).

Very rare side effects (may affect up to 1 in 10,000 people)

• reduction in the number of platelets in the blood (thrombocytopenia)
• reduction in the number of white blood cells (leucopenia, agranulocytosis)
• reduction in all blood cell counts (pancytopenia)
• severe skin reactions.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• severe and sudden allergic reaction (anaphylactic shock)
• severe skin reaction (Stevens-Johnson syndrome)
• severe allergic reaction affecting the skin and mucous membranes, which may also be fatal (toxic epidermal necrolysis)
• sudden onset of fever, skin redness, or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP), which may occur within the first 2 days of treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE. See section 2. Stop using TACHIFLUACTIV INFLUENZA E RAFFREDDORE if you develop these symptoms and contact your doctor or seek immediate medical help.
• inflammation of the colon due to inadequate blood supply (ischemic colitis)
• reduced blood flow to the optic nerve (ischemic optic neuropathy)
• severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness using paracetamol (see section 2).

Other side effects that may occur after taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE:

• sweating
• thirst
• chest pain in the area of the heart (precordial pain)
• difficulty urinating
• muscle weakness
• dilation of the pupils
• stomach problems
• severe disturbance of heart rhythm (ventricular arrhythmia)
• allergic reaction affecting the skin and mucous membranes (erythema multiforme)
• swelling of the throat (larynx)
• severe and sudden allergic reaction causing collapse, which may be fatal (anaphylactic shock)
• anemia
  • liver function abnormalities, inflammation of the liver (hepatitis)
  • kidney function abnormalities: or severe kidney failure, or severe inflammation of the kidney (interstitial nephritis), or presence of blood in the urine (haematuria), or absence of urine production (anuria)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please inform 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 TACHIFLUACTIV INFLUENZA E RAFFREDDORE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Scad.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original container and keep the tube tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TACHIFLUACTIV INFLUENZA E RAFFREDDORE contains

• The active substances are paracetamol and pseudoephedrine hydrochloride. Each tablet contains 500 mg of paracetamol and 60 mg of pseudoephedrine hydrochloride.
• The other components are: citric acid, sodium bicarbonate, anhydrous sodium carbonate, sorbitol (E420), lemon flavour, aspartame (E951), sodium saccharin, simeticone emulsion, leucine, sodium docusate.

Description of the appearance of TACHIFLUACTIV INFLUENZA E RAFFREDDORE and contents of the
pack
Pack of 16 effervescent tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Angelini Pharma S.p.A. Viale Amelia, 70 – 00181 ROME
Manufacturer
E-Pharma Trento S.p.A. – Ravina district – Via Provina, 2 – 38123 Trento (TN)