Robitussin expectorans

Patient Information Leaflet

Robitussin Expectorans, 100 mg/5 ml, syrup
Guaifenesinum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has directed.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days in adults (3 days in children), or if symptoms worsen, consult your doctor.

Contents of the leaflet

1. What Robitussin Expectorans is and what it is used for
2. Important information before taking Robitussin Expectorans
3. How to take Robitussin Expectorans
4. Possible side effects
5. How to store Robitussin Expectorans
6. Contents of the pack and other information

1. What Robitussin Expectorans is and what it is used for

Robitussin Expectorans contains the active substance guaifenesin. It increases mucus secretion in the bronchi and liquefies retained secretions, helping to expel them by coughing.
Robitussin Expectorans is indicated for the treatment of productive cough with excessive, difficult-to-expectorate mucus in the bronchi in adults and children over 6 years of age.
If there is no improvement after 7 days in adults (3 days in children), or if symptoms worsen, consult your doctor.

2. Important information before using Robitussin Expectorans

When not to use Robitussin Expectorans:

• If the patient is allergic to guaifenesin or any of the other ingredients of this medicine (listed in section 6).
• Do not use in children under 6 years of age.

Warnings and precautions

• Before starting to use Robitussin Expectorans, consult a doctor or pharmacist if there is a chronic cough associated with smoking or chronic lung disease such as asthma or emphysema.
• If the patient is pregnant or breastfeeding, she should consult a doctor.
• Discontinue use of Robitussin Expectorans and consult a doctor if cough persists for more than 7 days in adults (3 days in children), recurs, or is accompanied by fever, rash, or persistent headache. These may be symptoms of a serious illness.
• Do not exceed the recommended dose.
• Use of this medicine may result in positive doping test results.

Robitussin Expectorans and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Robitussin Expectorans with food, drink, and alcohol
Avoid alcoholic beverages and medications containing alcohol while taking Robitussin Expectorans.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. Do not use this medicine during pregnancy or breastfeeding without consulting a doctor.
This medicine contains 228 mg of alcohol (ethanol) per 10 ml of syrup.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery.
Patients who drive or operate machinery should be aware that this medicine contains alcohol.
Robitussin Expectorans contains sodium benzoate, sorbitol, maltitol, ethanol, propylene glycol,
glucose, fructose, and sodium
The medicine contains 12.0 mg of sodium benzoate per 10 ml of syrup, equivalent to 1.2 mg/ml.
The medicine contains 2.1 g of sorbitol per 10 ml of syrup, equivalent to 209.4 mg/ml.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
This medicine contains 228 mg of alcohol (ethanol) per 10 ml of syrup, equivalent to 23 mg/ml (2.06% v/v). The amount of alcohol in 10 ml of syrup is equivalent to 6 ml of beer or 3 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents, and its effect in children is likely to be negligible. However, it may cause some effects in younger children, such as drowsiness.
Alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, he or she should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, he or she should consult a doctor or pharmacist before using this medicine.
The medicine contains 22.2 mg of sodium (a main component of table salt) per 10 ml of syrup. This corresponds to 1.1% of the maximum recommended daily dietary sodium intake for adults.
The medicine contains 15.8 mg of propylene glycol per 10 ml of syrup.
The medicine contains 0.03 mg of fructose per 5 ml of syrup.
The medicine contains 1.0 mg of glucose per 10 ml of syrup. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine. This should be taken into account in patients with diabetes.

3. How to use Robitussin Expectorans

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and adolescents over 12 years of age: 10 ml of syrup 4 times daily.
Children aged 6 to 12 years: 5 ml of syrup 4 times daily.
Consult a doctor before use.
For oral use.
Robitussin Expectorans is contraindicated in children under 6 years of age (see section “When not to use Robitussin Expectorans”).
Do not use doses larger than those recommended.
Stop using Robitussin Expectorans and consult a doctor if cough persists for more than 7 days in adults (3 days in children), recurs, or is accompanied by fever, rash, or persistent headache. These may be symptoms of a serious illness.
Use of a higher than recommended dose of Robitussin Expectorans
If a higher than recommended dose is used, stop taking the medicine and seek medical advice. Nausea and vomiting may occur after overdose.
Missed dose of Robitussin Expectorans
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Robitussin Expectorant:
Rare (may occur in fewer than 1 in 1,000 patients):
hypersensitivity, nausea, vomiting.
Frequency unknown (cannot be estimated from the available data):
dizziness, headache, dyspnea, rash, urticaria, anaphylactic reactions (severe allergic reactions causing difficulty in breathing and usually associated with a significant drop in blood pressure), angioedema (severe allergic reaction with swelling of the skin and/or mucous membranes, e.g. in the face, throat, limbs, joints), diarrhea, stomach pain.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Robitussin Expectorans

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or cardboard box after: "Expiry date". The expiry date refers to the last day of the stated month.
Store below 25°C in the original packaging.
The shelf life of the medicine after first opening is 6 months.
Do not use this medicine if the cap is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Robitussin Expectorans contains

• The active substance is guaifenesin. 5 ml of syrup contains 100 mg of guaifenesin.
• The other ingredients are: glycerol, sodium carboxymethylcellulose, sodium benzoate, ethanol 96%, levomenthol, anhydrous citric acid, caramel, maltitol liquid (E 965), natural cherry flavor, sorbitol (70% solution) (E 420), sodium cyclamate, potassium acesulfame, purified water.

What Robitussin Expectorans looks like and contents of the pack
Robitussin Expectorans is a brown-colored syrup with a cherry flavor and aroma.
Packaged in an amber glass bottle with a PE/PP cap, tamper-evident seal, and a PP measuring cup.
Marketing Authorisation Holder:
Haleon Poland Sp. z o.o.
Rzymowskiego 53 Street
02-697 Warsaw
tel. 800 702 849
Manufacturer:
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe 1
29016 Cortemaggiore (Piacenza)
Italy
Date of the latest revision of the leaflet: