Bronchenolo cough, influenza and cold

PATIENT LEAFLET: INFORMATION FOR THE USER

Bronchenolo Cough, Flu and Cold

500 mg + 200 mg + 10 mg powder for oral solution
Paracetamol / Guaifenesin / Phenylephrine Hydrochloride
Please read all of this leaflet carefully before you start 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.

• Keep this leaflet. You may need to read it again.
• If you need more 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 improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What Bronchenolo Cough, Flu and Cold is and what it is used for

2. What you need to know before taking Bronchenolo Cough, Flu and Cold

3. How to take Bronchenolo Cough, Flu and Cold

4. Possible side effects

5. How to store Bronchenolo Cough, Flu and Cold

6. Contents of the pack and other information

1. What Bronchenolo Cough, Flu and Cold is and what it is used for
Bronchenolo Cough, Flu and Cold contains:

• paracetamol, a medicine for pain relief (analgesic) which also helps reduce body temperature when you have a fever;
• guaifenesin, an expectorant that helps loosen mucus;
• phenylephrine, a decongestant that reduces 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, headache, nasal congestion, sore throat, chills and fever, as well as relief of bronchial cough.
This medicine should only be recommended when all of these 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.

2. What you should know before taking Bronchenolo Cough, Flu and Cold

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 disorders such as hemolytic anemia (abnormal breakdown of red blood cells that may cause weakness or paleness of the skin)
• you have high blood pressure (hypertension)
• you have an overactive thyroid
• you have diabetes
• you suffer from phaeochromocytoma (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 due to impaired fluid drainage)
• 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 within the last 14 days – these include medicines such as phenelzine and isocarboxazide
• 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 known as cough suppressants.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bronchenolo Cough, Flu and Cold:

• if you have severe cough or cough accompanied by fever, rash, or persistent headache. See your doctor if the cough lasts more than 3 days or recurs,
• 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 have kidney disease
• if you have an enlarged prostate, as this medicine may cause increased 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 (hereditary non-haemolytic jaundice)
• if you have myasthenia gravis, an autoimmune disease
• if you are elderly, an adult, or an adolescent weighing less than 50 kg
• if you suffer from glutathione deficiency (a disorder that prevents glutathione production)
• if you have glucose-6-phosphate dehydrogenase deficiency (lack of an enzyme 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:

• you suffer from serious illnesses, 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.

Children
Do not give this medicine to children under 12 years of age.
Other medicines and Bronchenolo Cough, Flu and Cold
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Bronchenolo Cough, Flu and Cold may interact with certain medicines:

• those used to treat high cholesterol that reduce fat levels in the blood, such as cholestyramine
• those used to control nausea or vomiting, such as metoclopramide or domperidone
• anticoagulants, used to thin the blood, such as warfarin and other coumarins – occasional doses of paracetamol may be taken, but consult your doctor if regular use is needed
• barbiturates (for epilepsy or to help you sleep), such as phenobarbital
• tricyclic antidepressants such as imipramine, amitriptyline
• monoamine oxidase inhibitors (including moclobemide)
• medicines used to treat heart and circulatory problems, or to lower blood pressure (e.g. cardiac glycosides such as digoxin, detritiazine, guanethidine, reserpine, methyldopa)
• beta-blockers (e.g. atenolol)
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)
• medicines used to treat migraine (e.g. ergotamine and methylergometrine)
• zidovudine, as it may cause blood problems (low white blood cell count)
• phenothiazines used as sedatives (e.g. chlorpromazine, periciazine, fluphenazine)
• probenecid (a medicine used to treat gout and hyperuricaemia)
• chloramphenicol (an antibiotic)
• sympathomimetic amines (e.g. phenylephrine)

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment. (See section 2)

Inform your doctor:

• if you are scheduled for blood or urine tests, as this medicine may affect the results
• if you are scheduled for general anaesthesia, as this may cause changes in heart rhythm.

Other important information:

• Do not use this medicine for more than 3 days unless advised by your doctor.
• This medicine should only be used if you have all the following symptoms – pain and/or fever, nasal congestion, and bronchial cough.
• Use medicines only for the symptoms you are experiencing.
• Do not take this medicine with other products for flu or cold, or with other decongestant products.
• Prolonged use of any type of painkiller for headache may worsen it. If this occurs or is suspected, consult a doctor and stop treatment.
• Do not take with other products containing paracetamol.

Do not drink alcohol while taking Bronchenolo Cough, Flu and Cold
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Bronchenolo Cough, Flu and Cold must not be taken during pregnancy or breastfeeding.
Driving and using machines
This medicine may cause dizziness. If affected, do not drive or operate machinery.
Bronchenolo Cough, Flu and Cold contains sugar, aspartame and sodium.
Bronchenolo Cough, Flu and Cold:

• Contains 2.1 g of sucrose (sugar) per sachet. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. This should be considered in people with diabetes.
• Contains 12 mg of aspartame (E951) per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing phenylalanine to accumulate because the body cannot eliminate it properly.
• Contains 129.5 mg of sodium (the main component of table salt) per sachet. This corresponds to 6.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to take Bronchenolo Cough, Flu and Cold

Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Pour the contents of one sachet into a standard cup. Fill the cup up to just below the rim with approximately 250 ml (8 fl. oz.) of warm, but not boiling, water. Stir until the product dissolves completely, and allow the solution to cool to a drinkable temperature. Drink the entire solution within one and a half hours.

The recommended dose is:
Adults, elderly and adolescents aged 12 years and over:
One sachet every four hours as needed. Do not use more than 4 sachets (4 doses) within 24 hours. Take the product at intervals of at least 4 hours.

If symptoms persist for more than 3 days or worsen, consult a doctor or pharmacist.
Do not give to children under 12 years of age.

If you take more Bronchenolo Cough, Flu and Cold than you should
Bronchenolo Cough, Flu and Cold contains paracetamol.
Seek immediate medical help, even if you feel well, due to the risk of delayed, severe liver damage. Go to the nearest hospital emergency department. Take the medicine and this leaflet with you.

If you forget to take Bronchenolo Cough, Flu and Cold
Do not exceed the stated dose.
Do not take a double dose to make up for a forgotten dose.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

• Allergic reactions which may be sudden and severe, with breathing difficulties, swelling, mental confusion, sweating and loss of consciousness
• Very rare cases of serious skin reactions have been reported. For example, life-threatening reactions with flu-like symptoms and painful rash or blisters on the skin, mouth, eyes and genitals. Sudden blisters over large areas of skin. Skin inflammation.
• Shortness of breath
• Reduction in blood platelets, increasing the risk of bleeding or bruising
• Severe decrease in white blood cells which may lead to serious infections
• Sudden inflammation of the pancreas causing severe stomach and back pain
• Eye nerve damage caused by rapid increase in pressure inside the eye due to fluid not being able to drain properly

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

• Stomach ache or stomach discomfort
• Diarrhoea
• Faster heartbeat
• Increased awareness of heartbeat (palpitations)
• Eye disorders such as dilation/enlargement of the pupils
• Problems passing urine or inability to completely empty the bladder
• Feeling unwell
• Vomiting
• Urticaria (hives)
• Rash

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

• Liver problems
• Itching
• Sweating
• Rash with raised red or purple spots, which 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
• Severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness using paracetamol (see section 2).

Reporting of side effects
If you experience any side effects, 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 Bronchenolo Cough, Flu and Cold

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bronchenolo Cough, Flu and Cold contains
The active substances are: paracetamol 500 mg, guaifenesin 200 mg and phenylephrine hydrochloride 10 mg.
The other components are: sucrose, citric acid (E330), tartaric acid (E334), sodium cyclamate (E952), sodium citrate (E331), acesulfame potassium (E950), aspartame (E951), menthol flavouring powder, lemon flavour, lemon juice flavour, quinoline yellow (E104).
Description of the appearance of Bronchenolo Cough, Flu and Cold and contents of the pack
The medicine is an almost white powder with a characteristic citrus/menthol odour, supplied in sachets of 4.4 g.
This medicine is available in packs of 5, 6 and 10 sachets, although not all pack sizes may be marketed.
Marketing Authorisation Holder
Perrigo Italia S.r.l.
Viale dell’Arte, 25 – 00144 Rome
Manufacturer
Perrigo Supply Chain International DAC,
The Sharp Building, Hogan Place,
Dublin 2,
Dublin, D02
TY74, Ireland
This medicine is authorised in the Member States of the European Economic Area under the
following names:
Italy: Bronchenolo Cough, Flu and Cold
Poland: Coldrex Complex Grip