Bronchogrip powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bronchogrip powder for oral solution

Paracetamol, Guaifenesin, Phenylephrine hydrochloride

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

Contents of the leaflet

1. What Bronchogrip is and what it is used for
2. What you need to know before taking Bronchogrip
3. How to take Bronchogrip
4. Possible adverse effects
5. Storage of Bronchogrip
6. Contents of the pack and other information

1. What Bronchogrip is and what it is used for

Bronchogrip contains the following active substances:

• Paracetamol, which relieves pain (analgesic) and is effective against pain and discomfort, including headache and sore throat, and also helps reduce body temperature if you have a fever (antipyretic).
• Guaifenesin, which is an expectorant that helps loosen mucus (phlegm) when you have a productive cough.
• Phenylephrine hydrochloride, which is a decongestant used to reduce swelling in the nasal passages, thereby making breathing easier.

Bronchogrip is used for the short-term relief of cold and flu symptoms, including pain and discomfort such as headache, sore throat, nasal congestion, chills, and fever. It helps loosen persistent mucus (phlegm) and provides relief from productive cough in adults and adolescents aged 15 years and over.

This medicine should only be used if you have all of the following symptoms: pain and/or fever, nasal congestion, and productive cough.

Consult your doctor if you do not improve or feel worse after 3 days.

2. What you need to know before taking Bronchogrip

If you take a painkiller for headache for more than 3 days, it may worsen your symptoms.

Do not take Bronchogrip if you:

• Are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• Have severe liver or kidney disease.
• Have a heart condition or cardiovascular disorder, or blood problems such as anaemia (low red blood cell count).
• Have high blood pressure (hypertension).
• Have overactive thyroid (hyperthyroidism).
• Have diabetes.
• Have phaeochromocytoma (a rare tumour of the adrenal gland tissue).
• Are taking tricyclic antidepressants such as imipramine or amitriptyline.
• Are taking beta-blockers (e.g. atenolol) or vasodilators (e.g. hydralazine), used to treat high blood pressure (hypertension).
• Are taking other products containing paracetamol.
• Are taking antidepressant medicines called monoamine oxidase inhibitors (MAOIs), or have taken them within the last 14 days (medicines such as moclobemide, phenelzine, isocarboxazide, and tranylcypromine).
• Have closed-angle glaucoma (high pressure in the eyes).
• Have difficulty urinating, an enlarged prostate, or other prostate problems.
• Are currently taking other decongestants (e.g. ephedrine and xylometazoline) or stimulants (e.g. dexamphetamine).

Warnings and precautions

Consult your doctor or pharmacist before taking Bronchogrip if you:

• Have a severe cough or asthma and are sensitive to aspirin. Consult your doctor if your cough lasts more than 5 days or returns.
• Have circulatory disorders, such as Raynaud's phenomenon, which involves poor circulation in fingers and toes.
• Have angina or other cardiovascular diseases.
• Have an autoimmune disorder called myasthenia gravis, in which muscles become easily fatigued and weak.
• Have an enlarged prostate gland, as this may cause further difficulty in urination.
• Have serious stomach or intestinal problems.
• Have liver or kidney disease.
• Are taking a cough suppressant.
• Have trouble sleeping (insomnia), nervousness, fever, tremors, and/or seizures.
• Have intolerance to certain sugars.
• Have phenylketonuria, a rare inherited metabolic disorder.
• Have chronic alcoholism, malnutrition, or dehydration.
• Have Gilbert's syndrome (familial non-haemolytic jaundice).
• Are elderly, or an adult or adolescent weighing less than 50 kg.

You should consult your doctor if:

• You develop high fever, rash, or persistent headache.
• You develop signs of another infection such as feeling unwell, night sweats, fatigue, pain, or swelling.
• Your symptoms do not improve after three days.
• You suffer from serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance in blood and body fluids) has been reported in patients in these situations 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 rapid and deep breathing, drowsiness, nausea, and vomiting.

Children and adolescents

Do not give this medicine to children under 15 years of age.

Taking Bronchogrip with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

If you are taking any of the following medicines, consult your doctor before taking Bronchogrip:

• If you are taking probenecid, talk to your doctor, as the dose of Bronchogrip may need to be reduced.
• Medicines to treat high cholesterol levels that reduce fat in the blood, such as cholestyramine.
• Medicines to control nausea and vomiting, such as metoclopramide or domperidone.
• Medicines called anticoagulants, used to thin the blood, such as warfarin or 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 phenobarbitones.
• Tricyclic antidepressants such as imipramine and amitriptyline.
• Monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, isocarboxazide, and tranylcypromine, used to treat depression.
• Medicines to treat heart or circulatory problems, or to lower blood pressure (e.g. digoxin, guanethidine, reserpine, methyldopa).
• Aspirin or other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
• Medicines to treat migraine (e.g. ergotamine and methysergide).
• Zidovudine, as this could cause blood problems (low white blood cell count).
• Phenothiazines used as sedatives (e.g. chlorpromazine, periciazine, and fluphenazine).
• Other cold or flu remedies, or decongestants containing sympathomimetic amines.
• If you are due to have blood or urine tests, as taking this medicine may affect the results.
• If you are undergoing general anaesthesia, as this may cause changes in heart rhythm.
• If you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Bronchogrip and alcohol

Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This product should not be used during pregnancy.

This product should not be used during breastfeeding without medical advice.

Driving and using machines

This product may cause dizziness. If you feel dizzy, do not drive or operate machinery.

Bronchogrip contains sucrose

This medicine contains 2.1 g of sucrose (sugar) per sachet. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine. This should be considered in patients with diabetes.

Bronchogrip contains aspartame (E951)

This medicine contains 12 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Bronchogrip contains sodium

This medicine contains 129 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 6.5% of the maximum daily sodium intake recommended for an adult.

3. How to take Bronchogrip

Follow exactly the administration instructions described in this leaflet or as directed by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

Oral use.

Adults, elderly patients, and adolescents aged 15 years and over

The recommended dose is 1 sachet every 4 to 6 hours, as needed. Do not take more than 4 sachets (4 doses) within a 24-hour period. Do not take it more frequently than every 4 hours.

Use in children and adolescents

Do not administer to children under 15 years of age.

Elderly patients

Elderly, debilitated, and immobile patients may require a reduced dose.

Empty the contents of 1 sachet into a standard cup. Fill the cup to just below the rim with approximately 250 ml of hot, non-boiling water. Stir until dissolved and allow to cool to a drinkable temperature. Drink the entire yellow solution within one and a half hours.

Do not exceed the recommended dose. If symptoms persist for more than 3 days or worsen, consult your doctor or pharmacist.

If you take more Bronchogrip than you should

In case of overdose or accidental poisoning, contact the Toxicology Information Service at telephone number 91 562 04 20.

Immediate medical advice should be sought in case of overdose due to the risk of irreversible liver damage. Speak to a doctor immediately if you take too much medicine, even if you feel well. This is because excessive paracetamol can cause serious and delayed liver damage.

Go to the nearest hospital emergency department. Take the medicine and this leaflet with you.

If you forget to take Bronchogrip

Do not take a double dose to make up for a missed dose.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Most people do not experience any side effects while taking this medicine. However, if you experience any of the following side effects, or if anything unusual occurs, stop taking the medicine immediately and consult your doctor or pharmacist.

The following adverse reactions represent the most commonly reported adverse reactions, although the actual frequencies are not available:

• Difficulty sleeping (insomnia)
• Diarrhea, nausea
• Nervousness, tremors, irritability, restlessness or excitability
• Increased blood pressure with headache, dizziness, vomiting and irregular heartbeat (palpitations)
• Serious illness that may cause the blood to become more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2)

The frequency of the following reactions is unknown, but they are considered rare:

• Allergic reactions, which may be severe, such as skin rash, skin peeling, itching, red and swollen areas of skin, sometimes with difficulty breathing or swelling of the mouth, lips, tongue, throat or face
• Breathing problems, which are more likely if you have previously experienced them when taking other painkillers such as aspirin or ibuprofen
• Stomach disturbances (pain or discomfort), nausea, vomiting, diarrhea
• Tingling or cold skin
• Liver problems
• Faster or irregular heartbeat
• Acute increase in pressure inside the eye, enlarged pupil
• Problems or pain when swallowing water

The frequency of the following reaction is rare:

• Cloudy urine

The frequency of the following reactions is unknown but considered very rare:

• Increased tendency to bleed, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood

Very rare cases of serious skin reactions have been reported.

If you have previously experienced an allergic reaction (hypersensitivity) when taking decongestants, appetite suppressants or stimulants, you may have an increased risk of developing an allergic reaction when taking this product.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bronchogrip

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container and sachet. The expiry date refers to the last day of the stated month.

Do not store above 25°C.

After reconstitution with warm water, the solution is stable for one and a half hours.

Medicines should not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Bronchogrip contains

Each sachet contains the active substances: 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), powdered menthol flavour [contains natural menthol, corn maltodextrin and gum arabic (E414)], lemon flavour [contains flavouring preparation, natural flavouring substance, corn maltodextrin, gum arabic E414, sodium citrate E331, citric acid E330 and butylated hydroxyanisole E320 (0.01%)], lemon juice flavour [contains flavouring preparation, natural flavouring substance(s), maltodextrin, modified starch E1450 and butylated hydroxyanisole E320 (0.03%)], quinoline yellow (E104).

What Bronchogrip looks like and contents of the pack

Bronchogrip is a white to off-white powder for oral solution with a characteristic citrus/menthol odour, supplied in sachets.

The reconstituted solution is opalescent yellow in colour with a characteristic citrus/menthol odour.

Bronchogrip is available in packs of 5, 6, 10, 14, 15 or 20 sachets, although not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Perrigo España, S.A.

Pza. Xavier Cugat, 2 - Edif. D, Pl. 1ª

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer:

Omega Pharma International NV

Venecoweg 26, Nazareth

9810 Belgium

Perrigo Supply Chain International DAC

The Sharp Building

10-12 Hogan Place

Dublin 2

Ireland

This medicinal product is authorised in the European Economic Area member states under the following names:

Croatia Coldrex ComboGrip 500mg/200mg/10mg prašak za oralnu otopinu

Estonia Coldrex Lemon & Menthol

Hungary Coldrex Plus köhögés elleni por belsoleges oldathoz

Latvia Hotex 500 mg/200 mg/10 mg pulveris iekškigi lietojama škiduma pagatavošanai

Lithuania Coldrex Lemon & Menthol

Portugal Antigrippine Trieffect Tosse 500mg+10mg+200mg Pó para solução oral

Slovenia Paracetamol/gvaifenezin/fenilefrin Adriatic BST 500 mg/200 mg/10 mg prašek za peroralno raztopino

Spain Bronchogrip powder for oral solution

Date of the most recent review of this leaflet: April 2025