TACHIFLUACTIV INFL RAFFR 500 MG/60 MG EFFERVESCENT TABLETS 10 TABLETS IN PP TUBE

Name
TACHIFLUACTIV FLU AND COLD 500 mg/60 mg effervescent tablets
Paracetamol/pseudoephedrine hydrochloride


What is it and what is it used for?
TACHIFLUACTIV FLU AND COLD contains the active ingredients paracetamol and pseudoephedrine which act against pain, fever and stuffy nose.

TACHIFLUACTIV INFLUENZA E RAFFREDDORE is indicated for the treatment of cold and flu symptoms.

Contact your doctor if you do not feel better or if you feel worse after 5 days of treatment if you are an adult and after 3 days if the person taking the medicine is a teenager, if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.


What you need to know before taking the medicine
Do not use TACHIFLUACTIV FLU AND COLD
- 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 diseases:
• coronary artery disease (chest pain (angina), previous heart attack);
• asthma;
• very high blood pressure (severe hypertension) or hypertension not controlled by medications;
• heart rhythm disturbances (arrhythmias);
• liver failure;
• severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• diabetes;
• urinary problems caused by an increase in the volume of the prostate (prostatic hypertrophy) and other diseases;
• reduction in the number of red blood cells in the blood due to their destruction (hemolytic anemia);
- if your thyroid gland is overactive (hyperthyroidism);
- if you have a disease characterized by high pressure inside the eye (closed-angle glaucoma);
- if you have an adrenal tumor known as pheochromocytoma;
- if you are using the following medicines:
• medicines against depression belonging to the class of tricyclic antidepressants;
• heart or high blood pressure medicines belonging to the beta-blocker class;
• sympathomimetic medicines, used to treat low blood pressure or a blocked nose (see section "Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE");
- if you are using or have used in the last 14 days medicines for the treatment of depression and Parkinson's disease belonging to the class of monoamine oxidase inhibitors. See the section "Other medicines and TACHIFLUACTIV FLU AND COLD".


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

Talk to your doctor before taking this medicine :
- if he is 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 reduction in the number of red blood cells in your blood due to their destruction (haemolytic anaemia);
- if you suffer from a chronic form of malnutrition and dehydration;
- if you have problems with your heart and/or blood vessels, such as chest pain (angina), palpitations or other heart rhythm disturbances;
- if you have diabetes mellitus;
- if you have an enlarged prostate (prostatic hypertrophy) that causes problems when urinating;
- if you have mental problems (psychosis);
- if your thyroid gland is overactive (hyperthyroidism);
- if you have asthma;
- if you have a disease characterized by high pressure inside the eye (glaucoma);
- if you have high blood pressure (hypertension);
- if you have an alcohol dependence (alcoholism) (see paragraph "TACHIFLUACTIV INFLUENZA E RAFFREDDORE and alcohol");
- if you are using any other medicines (see section "Other medicines and TACHIFLUACTIV INFLUENZA E RAFFREDDORE"), in particular:
• other medicines that affect the liver (talk to your doctor if you are not sure if this applies to you);
• if you are using medicines that reduce blood clotting (anticoagulants) taken by mouth, because your doctor will assess whether to reduce the dose of the medicine.

Contact your doctor if during treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE :
• pain or stuffy nose gets worse or lasts more than 5 days or if symptoms do not improve within 5 days;
• fever worsens or lasts more than 3 days;
• has redness or swelling;
• shows new symptoms.

During treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE, inform your doctor immediately if:
If you have serious illnesses, including severe kidney failure 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). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.

Pay particular attention :
• TACHIFLUACTIV FLU AND COLD contains paracetamol; before using any other medicine, check that it does not contain paracetamol as the use of high doses of paracetamol could cause serious side effects, such as liver damage;
• do not take TACHIFLUACTIV INFLUENZA E RAFFREDDORE with other medicines used to treat pain and fever because serious side effects could occur;
• if you have to undergo surgery, tell your doctor that you are taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE, because treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE should be stopped a few days before the operation.

One of the active ingredients in TACHIFLUACTIV FLU AND COLD, pseudoephedrine, can be abused, and high doses of pseudoephedrine can be toxic. Continued use may result in taking more TACHIFLUACTIV FLU AND COLD than the recommended dose to achieve the desired effect, thus increasing the risk of overdose. The maximum recommended dose and duration of treatment should not be exceeded (see section 3).

Sudden abdominal pain or rectal bleeding may occur with TACHIFLUACTIV FLU AND COLD due to inflammation of the colon (ischaemic colitis). If you experience these gastrointestinal symptoms, stop using TACHIFLUACTIV FLU AND COLD and contact your doctor or seek immediate medical attention. See section 4.

TACHIFLUACTIV FLU AND COLD may cause a reduction in blood flow to the optic nerve. If you experience sudden vision loss, stop taking TACHIFLUACTIV FLU AND COLD and contact your doctor or healthcare provider immediately. See section 4.

Cases of posterior reversible 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 can lead to reduced blood flow to the brain. Stop using TACHIFLUACTIV FLU AND COLD immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms).

If you develop a generalized feverish rash associated with pustules, stop taking TACHIFLUACTIV FLU AND COLD and contact your doctor or seek medical help immediately. See section 4.

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


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

Very serious side effects: Side effects with unknown frequency (frequency cannot be estimated from the available data)
• serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop treatment with TACHIFLUACTIV INFLUENZA E RAFFREDDORE immediately and contact your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
These include:
• severe headache with sudden onset;
• nausea;
• vomit;
• confusion;
• convulsions;
• 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, especially in children;
• dizziness;
• heachache;
• tremors;
• alterations in heart rhythm (tachycardia, palpitations);
• increased blood pressure;
• vomiting, nausea, dry mouth;
• increased levels of some liver enzymes, visible through laboratory tests;
• skin rash, erythema, urticaria, itching;
• difficulty urinating, particularly in patients with an increased 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 (leukopenia, agranulocytosis);
• reduction in the number of 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 involving the skin and mucous membranes, which can even be fatal (toxic epidermal necrolysis);
• sudden onset of fever, redness of the skin or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with TACHIFLUACTIV FLU AND COLD. See section 2. Stop using TACHIFLUACTIV FLU AND COLD if you develop these symptoms and contact your doctor or seek medical help immediately;
• inflammation of the colon due to insufficient blood supply (ischemic colitis);
• reduction of blood flow to the optic nerve (ischemic optic neuropathy);
• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Other side effects that may occur after taking TACHIFLUACTIV INFLUENZA E RAFFREDDORE:
• sweating;
• thirst;
• chest pain over the heart (precordial pain);
• difficulty urinating;
• muscle weakness;
• dilation of the pupils;
• stomach problems;
• severe alteration of the heart rhythm (ventricular arrhythmia);
• allergic reaction involving the skin and mucous membranes (erythema multiforme);
• swelling of the throat (larynx);
• severe and sudden allergic reaction causing collapse and which can be fatal (anaphylactic shock);
• anemia;
• changes in liver function, inflammation of the liver (hepatitis);
• alteration of kidney function:
- severe kidney failure;
- severe inflammation of the kidney (interstitial nephritis);
- presence of blood in the urine (hematuria);
- failure to pass urine (anuria).