Robitussin Expectorans

Leaflet attached to the packaging: patient information

Robitussin Expectorans, 100 mg/5 ml, syrup
Guaifenesin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days in adults (3 days in children) there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

Robitussin Expectorans contains the active substance guaifenesin. It increases the production of mucus in the bronchi and thins the accumulated secretion, helping to cough it up. Robitussin Expectorans is indicated for use in coughs with excessive amounts of difficult-to-cough-up secretions in the bronchi in adults and children over 6 years of age. If after 7 days in adults (3 days in children) there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Robitussin Expectorans

When not to take 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 taking Robitussin Expectorans, patients should discuss with their doctor or pharmacist if they have a chronic cough, such as one that occurs with smoking or with chronic lung disease, such as asthma or chronic bronchitis.
• If the patient is pregnant or breastfeeding, they should consult their doctor.
• Patients should stop taking Robitussin Expectorans and consult their doctor if their 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.
• Taking this medicine may cause positive doping test results.

Robitussin Expectorans with other medicines

Patients should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Robitussin Expectorans with food, drink, and alcohol

While taking Robitussin Expectorans, patients should avoid alcoholic beverages and medicines containing alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. This medicine should not be taken during pregnancy and breastfeeding without consulting a doctor. This medicine contains 228 mg of alcohol (ethanol) in 10 ml of syrup.

Driving and using machines

The medicine may affect the ability to drive and use machines. Patients who drive or use machines should take into account that the medicine contains alcohol. Robitussin Expectorans contains sodium benzoate, sorbitol, maltitol, ethanol, propylene glycol, glucose, fructose, sodium
The medicine contains 12.0 mg of sodium benzoate in 10 ml of syrup, which is equivalent to 1.2 mg/ml.
The medicine contains 2.1 g of sorbitol in 10 ml of syrup, which is equivalent to 209.4 mg/ml.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their 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 some sugars, they should consult their doctor before taking the medicine. This medicine contains 228 mg of alcohol (ethanol) in 10 ml of syrup, which is 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 have an effect on adults and adolescents, and its effect on children is unlikely to be noticeable. However, it may cause some effect in younger children, such as drowsiness. The alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist. If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before taking this medicine. If the patient is addicted to alcohol, they should consult their doctor or pharmacist before taking this medicine. The medicine contains 22.2 mg of sodium (the main component of common salt) in 10 ml of syrup. This is equivalent to 1.1% of the maximum recommended daily intake of sodium in the diet for adults. The medicine contains 15.8 mg of propylene glycol in 10 ml of syrup. The medicine contains 0.03 mg of fructose in 5 ml of syrup. The medicine contains 1.0 mg of glucose in 10 ml of syrup. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. This should be taken into account in patients with diabetes.

3. How to take Robitussin Expectorans

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, patients should consult their doctor or pharmacist. Recommended dose: Adults and adolescents over 12 years: 10 ml of syrup 4 times a day. Children from 6 to 12 years: 5 ml of syrup 4 times a day. Before taking the medicine, patients should consult their doctor. Oral administration. Robitussin Expectorans is contraindicated in children under 6 years of age (see "When not to take Robitussin Expectorans"). Do not take higher doses than recommended. Patients should stop taking Robitussin Expectorans and consult their doctor if their 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.

Taking a higher dose of Robitussin Expectorans than recommended

In case of overdose, patients should stop taking the medicine and consult their doctor. After an overdose, nausea and vomiting may occur.

Missing a dose of Robitussin Expectorans

Patients should not take a double dose to make up for a missed dose. If patients have any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Robitussin Expectorans can cause side effects, although not everybody gets them. While taking Robitussin Expectorans, the following side effects may occur: Rare(may affect up to 1 in 1000 people): hypersensitivity, nausea, vomiting. Frequency not known(cannot be estimated from the available data): dizziness, headache, dyspnea, rash, urticaria, anaphylactic reactions (severe allergic reactions causing difficulty breathing and usually a significant drop in blood pressure), angioedema (a severe allergic reaction with swelling of the skin and/or mucous membranes, e.g., in the face, throat, limbs, joints), diarrhea, stomach pain.

Reporting side effects

If patients experience any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, patients can help provide more information on the safety of the medicine.

5. How to store Robitussin Expectorans

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label or carton after "Expiry date". The expiry date refers to the last day of the month stated. Store in a temperature 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 should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack 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, liquid maltitol (E 965), natural cherry flavor, sorbitol (70% solution) (E 420), sodium cyclamate, potassium acesulfame, purified water.

What Robitussin Expectorans looks like and what the pack contains

Robitussin Expectorans is a brown syrup with a cherry flavor and aroma. The bottle is made of orange glass with a PE/PP cap and a PP measuring cup.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer:

Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe 1
29016 Cortemaggiore (Piacenza)
Italy

Date of last revision of the leaflet: