BRONCHENOLO TOSS INFL RAF 500 MG + 200 MG + 10 MG POWDER FOR ORAL SOLUTION 10 SACHETS IN IN/ALU/LDPE/PAPER

Name
Bronchenolo Cough, Flu and Cold 500 mg+200 mg+10 mg powder for oral solution
Paracetamol/Guaifenesin/Phenylephrine Hydrochloride


What it is and what it is used for
Bronchenolo Cough, Flu and Cold contains: • paracetamol which is a pain relief medicine (analgesic) and helps reduce your temperature when you have a fever;
• guaifenesin which is an expectorant that helps loosen mucus;
• phenylephrine which is a decongestant to reduce swelling in your nasal passages to help you breathe more easily.

These sachets are used for the short-term relief of cold and flu symptoms including aches, headaches, stuffy nose and sore throat, chills and fever, and for the relief of bronchial cough.

This medicine should only be recommended if all symptoms are present (pain and/or fever, nasal congestion and bronchial cough).

Contact your doctor if you do not feel better or if you feel worse after 3 days.


What you need to know before taking the medicine
Do not take Bronchenolo Cough, Flu and Cold if:
• are allergic to paracetamol, guaifenesin, phenylephrine or any of the other ingredients of this medicine (listed in section 6);
• is pregnant or breastfeeding;
• have liver problems or severe kidney problems, including alcoholic liver disease;
• have a serious heart condition or cardiovascular disorder or blood problems such as haemolytic anaemia (abnormal breakdown of red blood cells which can cause weakness or pale skin);
• has high blood pressure (hypertension);
• has an overactive thyroid;
• has diabetes;
• have pheochromocytoma (a rare tumor of the adrenal gland tissue);
• have glaucoma, including narrow-angle glaucoma (damage to the eye nerve caused by rapidly increasing pressure inside the eye because fluid cannot drain out);
• have difficulty passing urine or are unable to empty their bladder completely;
• you are taking antidepressant medicines called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days – these are medicines such as phenelzine and isocarboxazid;
• is taking tricyclic antidepressants (e.g. amitriptyline);
• is taking beta-blocker drugs;
• is taking other products containing paracetamol;
• are taking other decongestant medicines (e.g. ephedrine, xylometazoline), appetite suppressants or stimulants (e.g. amphetamines);
• is taking cough medicines called cough suppressants.


Warnings and precautions
Talk to your doctor or pharmacist before taking Bronchenolo Cough, Flu and Cold:
• if you have a severe cough or cough accompanied by fever, rash or persistent headache. See your doctor if the cough lasts more than 3 days or if it comes back;
• if you have asthma and are sensitive to aspirin;
• if you suffer from circulatory disorders such as Raynaud's phenomenon, which causes poor circulation in the fingers and toes;
• if you suffer from angina;
• if you suffer from kidney disease;
• if you have an enlarged prostate, as this medicine may cause greater difficulty in passing urine;
• if you have serious stomach or intestinal problems;
• if you suffer from cardiovascular disease;
• if you suffer from chronic alcoholism, malnutrition or dehydration;
• if you have Gilbert's syndrome (familial non-haemolytic jaundice);
• if you have myasthenia gravis, an autoimmune disease;
• if you are elderly, an adult or a teenager weighing less than 50 kg;
• if you suffer from glutathione deficiency (a disorder that prevents the production of glutathione);
• if you have glucose-6-phosphatase dehydrogenase deficiency (deficiency of an enzyme (chemical) present in red blood cells);
• if you are taking concomitant treatment with medicines that affect liver function.

During treatment with Bronchenolo Cough Flu and Cold, inform your doctor immediately if:
• have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or 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 in these situations when paracetamol is used at regular doses over a long 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.

Children
Do not give this medicine to children under 12 years of age.


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

Serious side effects
• Allergic reactions which may be sudden and severe with difficulty breathing, swelling, dizziness, sweating and loss of consciousness;
• Very rare cases of serious skin reactions have been reported. For example, life-threatening reaction with flu-like effects and painful or blistering rash on the skin, mouth, eyes and genitals. Sudden blistering of large areas of skin. Inflammation of the skin;
• Shortness of breath;
• Reduction of platelets in the blood, which increases the risk of bleeding or bruising;
• Severe decrease in white blood cells which can lead to serious infections;
• Sudden inflammation of the pancreas causing severe pain in the stomach and back;
• Damage to the eye nerve caused by rapidly increasing pressure inside the eye because fluid cannot drain away.

Other side effects
Rare (may affect up to 1 in 1,000 people):
• stomach pain or upset stomach;
• diarrhea;
• a faster heartbeat;
• an increased awareness of your heartbeat (palpitations);
• eye disorders such as dilation/widening of the pupils;
• problems passing urine or inability to completely empty the bladder;
• feeling of malaise;
• vomit;
• urticaria;
• skin rash.

Very rare: (may affect up to 1 in 10,000 people):
• liver problems;
• itching;
• sweating;
• skin rash with raised red or purple spots, the spots look like small bruises or blood spots;
• cloudy urine

Not known: cannot be estimated based on available data
• nervousness, irritability, restlessness or excitability;
• difficulty sleeping (insomnia);
• heachache;
• high blood pressure;
• serious condition which can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.