Leaflet: information for the user

Bronchogrip powder for oral solution

Paracetamol, Guaifenesina, Fenilefrina hydrochloride

Read this leaflet carefully before you start taking 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 not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

1. What isBronchogripand for what it is used

2. What you need to know before starting to takeBronchogrip

3. How to takeBronchogrip

4. Possible adverse effects

5. Conservation ofBronchogrip

6. Contents of the package and additional information

Bronchogrip contains the following active ingredients:

• Paracetamol, which relieves pain (analgesic) and is effective against pains and discomforts, including headache and sore throat, and also helps to reduce temperature if you have a fever (antipyretic).
• Guaifenesina, which is an expectorant to help fluidify mucus (phlegm) when you have productive cough.
• Phenylephrine hydrochloride, which is a decongestant used to reduce nasal passages inflammation, thus facilitating breathing.

Bronchogrip is used for short-term relief of symptoms of the common cold and flu, including pains and discomforts, such as headache, sore throat, nasal congestion, chills, and fever. It thins persistent mucus (phlegm) and provides relief against productive cough in adults and adolescents 15 years or older.

This medication should only be used if you present all the following symptoms: pain and/or fever, stuffy nose, and productive cough.

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

If you take a pain reliever for a headache for more than 3 days, it may worsen them.

Do not takeBronchogrip if you:

• You are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride, or any of the other components of this medication (listed in section 6).
• You have severe liver or kidney disease.
• You have a heart condition or cardiovascular disorder or blood problems, such as anemia (low red blood cell count).
• You have high blood pressure (hypertension).
• You have hyperthyroidism (an overactive thyroid gland).
• You have diabetes.
• You have pheochromocytoma (a rare tumor of the adrenal gland tissue).
• You are taking tricyclic antidepressants such as imipramine or amitriptyline.
• You are taking beta-blockers (e.g. atenolol) or vasodilators (e.g. hydralazine), which are used to treat high blood pressure (hypertension).
• You are taking other products containing paracetamol.
• You are taking monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days (medications such as moclobemide, phenelzine, isocarboxazid, and tranylcypromine).
• You have angle-closure glaucoma (high eye pressure).
• You have difficulty urinating, an enlarged prostate, or other prostate problems.
• You are currently taking other decongestants (e.g. ephedrine and xylometazoline) or stimulants (e.g. dextroamphetamine).

Warnings and precautions

Consult your doctor or pharmacist before takingBronchogrip if you:

• You have a lot of coughing or asthma and are sensitive to aspirin. Consult your doctor if your cough lasts more than 5 days or returns.
• You have circulatory disorders, such as a condition called Raynaud's phenomenon, which consists of poor circulation in the fingers of the hands and feet.
• You have angina or other cardiovascular diseases.
• You have myasthenia gravis, a type of autoimmune disorder in which muscles become easily fatigued and weakened.
• You have an enlarged prostate, as this may cause more difficulty urinating.
• You have severe gastrointestinal or intestinal problems.
• You have liver or kidney disease.
• You are taking a cough suppressant.
• You have difficulty sleeping (insomnia), nervousness, fever, tremors, and/or convulsions.
• You have intolerance to some sugars.
• You have phenylketonuria, a rare inherited metabolic disorder.
• You have chronic alcoholism, malnutrition, or dehydration.
• You have Gilbert's syndrome (familial non-hemolytic jaundice).
• You are an elderly, adult, or adolescent weighing less than 50 kg.

You must 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.
• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe condition called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when paracetamol is used in regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulties with rapid and deep breathing, drowsiness, feeling of dizziness (nausea), and vomiting.

Children and adolescents

Do not give this medication to children under 15 years old.

Use of Bronchogrip with other medications

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

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

• If you are taking probenecid, speak with your doctor as it may be necessary to reduce the dose of Bronchogrip.
• Medications to treat high cholesterol levels that reduce the amount of fat in the blood, such as cholestyramine.
• Medications to control nausea and vomiting, such as metoclopramide or domperidone.
• Medications called anticoagulants, which are used to thin the blood, such as warfarin or other coumarins - you can take occasional doses of paracetamol but consult your doctor if you need to take it regularly.
• Barbiturates (for epilepsy or to help you sleep), such as phenobarbitones.
• Tricyclic antidepressants such as imipramine and amitriptyline.
• MAOIs such as moclobemide, phenelzine, isocarboxazid, and tranylcypromine, which are used to treat depression.
• Medications to treat heart or circulatory problems, or to lower blood pressure (e.g. digoxin, guanetidine, reserpine, metildopa).
• Aspirin or other NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
• Medications to treat migraines (e.g. ergotamine and methysergide).
• Zidovudine, as this may cause blood problems (low white blood cell count).
• Phenothiazines used as sedatives (e.g. chlorpromazine, perphenazine, and fluphenazine).
• Other cold or flu products, or decongestants containing sympathomimetic amines.
• If you are having blood or urine tests, as taking this medication may affect the results.
• If you are undergoing general anesthesia, 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 must be treated urgently (see section 2).

Bronchogrip with alcohol

Do not drink alcohol while taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

This product should not be used during pregnancy.

This product should not be used duringbreastfeeding without medical advice.

Driving and operating machinery

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

Bronchogrip contains saccharose

This medication contains 2.1g of saccharose (sugar) per tablet. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication. This should be taken into account in patients with diabetes.

Bronchogrip contains aspartame (E951)

This medication contains 12 mg of aspartame per tablet. 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 correctly.

Bronchogrip contains sodium

This medication contains 129 mg of sodium (main component of table salt/for cooking) per tablet. This is equivalent to 6.5% of the maximum daily sodium intake recommended for an adult..

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

Oral administration.

Adults, elderly patients, and adolescents 15 years or older

The recommended dose is 1 tablet every 4 to 6 hours as needed. Do not take more than 4 tablets (4 doses) in 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.

Elderly patients

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

Empty the contents of 1 tablet into a standard cup. Fill the cup to just below the rim with approximately 250 ml of hot water that does not boil. Stir until dissolved and let cool to a temperature that can be consumed. Drink all the yellow solution in 1.5 hours.

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

If you take more Bronchogrip than you should

In case of overdose or accidental poisoning, consult the Toxicological Information Service, telephone 91 562 04 20.

Seek immediate medical advice in case of overdose, due to the risk of irreversible liver damage.Talk to a doctor immediately if you take too much medication even if you feel well. This is because too much paracetamol can cause severe and late liver damage.

Go to the nearest hospital emergency department. Bring the medication and this leaflet with you.

If you forgot to takeBronchogrip

Do not take a double dose to compensate for the missed dose.

If you have any doubts about the use of this medication, ask your doctor or pharmacist..

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

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

The following adverse reactions represent the most common 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 heartbeats (palpitations).
• Severe disease that can make the blood acidic (designated metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

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

• Allergic reactions that can be severe, such as skin rash, skin peeling, itching, red and swollen areas of the skin, sometimes with difficulty breathing or swelling of the mouth, lips, tongue, throat, or face
• Respiratory problems, these are more likely if you have experienced them before taking other pain relievers such as aspirin or ibuprofen
• Stomach problems (pain or discomfort), nausea, vomiting, diarrhea
• Tickling or cold skin
• Liver problems
• Heartbeats that are faster or irregular
• Acute increase in pressure within the eye, dilated pupil of the eye
• Problems or pain swallowing water.

The frequency of the following reaction is rare:

• Cloudy urine.

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

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

Very rare cases of severe skin reactions have been reported.

If you have previously experienced an allergic reaction (hypersensitivity) when taking decongestants, appetite suppressants, and stimulants, you may have a higher 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date indicated on the packaging and on the overwrap. The expiration date refers to the last day of the month.

Do not store at a temperature above 25°C.

After reconstitution with warm water, the solution is stable for 1 hour and 30 minutes.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

What it containsBronchogrip

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

Appearance of Bronchogrip and packaging contents

Bronchogrip is an oral powder, white in color and has a characteristic citrus/menthol odor, in sachets.

The reconstituted solution is a yellowish opalescent color with a characteristic citrus/menthol odor.

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

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Perrigo España, S.A.

Xavier Cugat Square, 2 - Edif. D, 1st Floor

08174 Sant Cugat del Vallès (Barcelona)

Spain

Responsible 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 medicine is authorized in the Member States of the European Economic Area with the following names:

CroatiaColdrex ComboGrip 500mg/200mg/10mg powder for oral solution

EstoniaColdrex Lemon & Menthol

HungaryColdrex Plus cough relieving powder for oral solution

LithuaniaColdrex Lemon & Menthol

PortugalAntigrippine Trieffect Cough 500mg+10mg+200mg Powder for oral solution

SloveniaParacetamol/guaifenezin/fenilefrin Adriatic BST 500 mg/200 mg/10 mg powder for oral solution

SpainBronchogrip powder for oral solution

Last review date of this leaflet:April 2025