BRONCHENOLO COUGH INFL RAF*10SACH

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 reliever (analgesic) and helps reduce temperature when you have a fever
• guaifenesin, which is an expectorant that helps loosen mucus
• phenylephrine, which is a decongestant to reduce swelling in the 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).

Consult 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:
• you are allergic to paracetamol, guaifenesin, phenylephrine or any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or breastfeeding;
• you have liver problems or severe kidney problems, including alcoholic liver disease;
• you have a serious heart condition or cardiovascular disorder or blood problems such as hemolytic anemia (abnormal breakdown of red blood cells that can cause weakness or pale skin);
• you have high blood pressure (hypertension);
• you have an overactive thyroid;
• you have diabetes;
• you suffer from pheochromocytoma (a rare tumor of the adrenal gland tissue);
• you suffer from glaucoma, including narrow-angle glaucoma (damage to the optic nerve caused by a rapid increase in pressure inside the eye because fluid cannot drain);
• you have difficulty passing urine or are unable to completely empty your bladder;
• you are taking antidepressant medicines called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days - these include medicines such as phenelzine and isocarboxazid;
• you are taking tricyclic antidepressants (e.g. amitriptyline);
• you are taking beta-blockers;
• you are taking other products containing paracetamol;
• you are taking other decongestant medicines (e.g. ephedrine, xylometazoline), appetite suppressants or stimulants (e.g. amphetamines);
• you are 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 a cough accompanied by fever, rash or persistent headache. See a doctor if the cough lasts more than 3 days or if it recurs;
• you have asthma and are sensitive to aspirin;
• you suffer from circulatory disorders such as Raynaud's phenomenon, which causes poor circulation in the fingers and toes;
• you suffer from angina;
• you suffer from kidney disease;
• you have an enlarged prostate, as this medicine may cause increased difficulty in passing urine;
• you have severe stomach or intestinal problems;
• you suffer from cardiovascular disease;
• you suffer from chronic alcoholism, malnutrition or dehydration;
• you have Gilbert's syndrome (non-hemolytic familial jaundice);
• you have myasthenia gravis, an autoimmune disease;
• you are elderly, an adult or adolescent weighing less than 50 kg;
• you suffer from glutathione deficiency (a disorder that prevents glutathione production);
• you have glucose-6-phosphatase dehydrogenase deficiency (deficiency of an enzyme (chemical) present in red blood cells);
• you are concomitantly taking medicines that affect liver function.

Children
Do not administer 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 that can be sudden and severe with difficulty breathing, swelling, lightheadedness, sweating and loss of consciousness;
• Very rare cases of severe skin reactions have been reported. For example, life-threatening reaction with flu-like effects and a painful rash or blistering on the skin, mouth, eyes and genitals. Sudden blistering over large areas of the skin. Skin inflammation;
• Wheezing;
• Reduction in blood platelets, which increases the risk of bleeding or bruising;
• Severe decrease in white blood cells that can lead to severe infections;
• Sudden inflammation of the pancreas causing severe abdominal and back pain;
• Damage to the optic nerve caused by the rapid increase in pressure inside the eye because fluid cannot drain.

Other side effects

Rare (may affect up to 1 in 1,000 people):
• stomach ache or stomach upset;
• diarrhoea;
• a faster heartbeat;
• an increased awareness of the heartbeat (palpitations);
• eye disorders such as pupil dilation/enlargement;
• problems passing urine or inability to completely empty the bladder;
• feeling unwell;
• vomiting;
• hives;
• rash.

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

Not known (cannot be estimated from the available data):
• nervousness, irritability, restlessness or excitability;
• difficulty sleeping (insomnia);
• headache;
• high blood pressure.

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.