Actigrip cough mucolytic

Package leaflet: Information for the patient

ACTIGRIP COUGH EXPECTORANT "20 mg/ml, oral solution, menthol flavour"

Guaifenesin
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact your pharmacist.
• If any side effects occur, including any not listed in this leaflet, speak to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days of treatment.

Contents of this leaflet:

1. What ACTIGRIP COUGH EXPECTORANT is and what it is used for
2. What you need to know before taking ACTIGRIP COUGH EXPECTORANT
3. How to take ACTIGRIP COUGH EXPECTORANT
4. Possible side effects
5. How to store ACTIGRIP COUGH EXPECTORANT
6. Contents of the pack and other information

1. What ACTIGRIP COUGH EXPECTORANT is and what it is used for

ACTIGRIP COUGH EXPECTORANT contains guaifenesin, a type of medicine called an expectorant. It helps
relieve chesty cough by thinning and loosening mucus (phlegm), making it easier to cough up and thus making the cough more productive.
This medicine is used in adults and adolescents aged 12 years and over.

2. What you need to know before taking ACTIGRIP COUGH EXPECTORANT

Do not take ACTIGRIP COUGH EXPECTORANT

• If you are allergic to guaifenesin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACTIGRIP COUGH EXPECTORANT if:

• your cough has lasted for more than 7 days, or if the cough returns or is accompanied by fever, rash, or persistent headache;
• you have a persistent cough that may be due to asthma;
• you have a cough that produces a large amount of mucus (phlegm);
• you suffer from severe liver or kidney problems;
• you are consuming alcoholic beverages.

Children:
The safety and efficacy of guaifenesin in children under 12 years of age has not yet been established.
Interference with laboratory tests
If you are undergoing urine tests, it is important that you inform your doctor or nurse that you are taking or have recently taken this medicine, as it may affect certain test results.
Other medicines and ACTIGRIP COUGH EXPECTORANT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• It is not recommended to take this medicine together with other medicines intended to suppress cough (antitussives or cough suppressants), as they may interfere with the action of this medicine.

ACTIGRIP COUGH EXPECTORANT with food and drink
This medicine may be taken with or without food and drink.
Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy unless advised by a doctor.
• Do not take this medicine while breastfeeding without first talking to a doctor or pharmacist.

Driving and using machines
ACTIGRIP COUGH EXPECTORANT is not expected to affect your ability to drive or operate machinery. However, if you feel unwell, do not drive or operate machinery.
ACTIGRIP COUGH EXPECTORANT contains

• 381 mg of alcohol (ethanol) in each 10 ml dose, equivalent to 38.1 mg/ml. The amount in 10 ml of this medicine is equivalent to 9.5 ml of beer or 3.8 ml of wine. The small amount of alcohol in this medicine is unlikely to have significant effects.
• Ponceau 4R (E124) – a red dye – which may cause allergic reactions.
• This medicine contains less than 1 mmol of sodium (23 mg) per 10 ml dose, i.e. essentially "sodium-free".
• Glucose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
• This medicine contains 10 mg of sodium benzoate in each 10 ml dose.
• 2003.50 mg of propylene glycol in each 10 ml dose. If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional monitoring during treatment with this medicine. If you have liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional monitoring during treatment with this medicine.
• Macrogol glycerol hydroxystearate 40 may cause stomach upset and diarrhoea.

3. How to take ACTIGRIP COUGH MUCOLYTIC

Take this medicine exactly as stated in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.

• This solution is for oral use only.
• Do not use more than the recommended dose.

Age Dose
Adults and adolescents over 12 years Two 5 ml spoonfuls (total 10 ml), 4 times daily
Elderly As for adults
Children under 12 years Do not administer
Patients with liver or kidney problems Consult a doctor or pharmacist

• DO NOT take more than 4 doses (40 ml) in 24 hours.
• If symptoms worsen or do not improve after 7 days, contact your doctor.

If you take more ACTIGRIP COUGH MUCOLYTIC than you should
If anyone has taken more medicine than recommended, contact a doctor or the nearest emergency department, taking this leaflet and the packaging with you.
Taking more medicine than recommended may cause kidney stones.
Symptoms may include:

• stomach upset, nausea, and drowsiness.

If you forget to take ACTIGRIP COUGH MUCOLYTIC
You should take this medicine only as instructed, carefully following the dosage directions.
If you forget to take a dose, take the next one as needed. Do not take a double dose to make up for the missed dose. Do not take more than 4 doses (40 ml) in 24 hours.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop using this medicine and
seek immediate medical assistance:

• Allergic reactions including skin rashes (which may be severe and include blistering and peeling of the skin) and itching.
• Difficulty breathing, swelling of the face, neck, tongue or throat (anaphylactic reaction).

Other possible side effects (frequency not known) include:

• nausea or vomiting;
• stomach pain and diarrhoea.

Reporting of side effects
If you get 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
http://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 ACTIGRIP COUGH EXPECTORANT

• Keep this medicine out of the sight and reach of children.
• Do not store the medicine at temperatures above 25°C.
• Store the product in its original packaging, protected from light. Do not use the medicine if the bottle seal is broken when you first receive it.
• Do not use this medicine after the expiry date stated on the bottle and outer carton after the words “EXP”. The expiry date refers to the last day of that month.
• Use the medicine within 4 weeks after opening.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ACTIGRIP COUGH EXPECTORANT contains:
The active substance is guaifenesin. Each ml of oral solution contains 20 mg of guaifenesin. 10 ml of oral
solution contain 200 mg of guaifenesin.
The other ingredients are: xanthan gum, sodium chloride, sodium saccharin, glycyrrhizinate ammonium,
citric acid, sodium citrate, macrogol glycerol hydroxystearate 40, levomenthol, raspberry flavour (containing
ethanol), glycerol, macrogol 1500, propylene glycol (E1520), ethanol, purified water, sodium benzoate
(E211), Ponceau 4R (E124), caramel (E150).
(For further information on certain excipients, see section 2).
Description of the appearance of ACTIGRIP COUGH EXPECTORANT and contents of the pack
ACTIGRIP COUGH EXPECTORANT is a red, transparent to opalescent solution for oral use only.
It is available in a 150 ml amber glass bottle with a child-resistant plastic cap.
Marketing Authorization Holder:
Johnson & Johnson S.p.A., Via Ardeatina Km 23,500 – 00071, Santa Palomba - Pomezia (Roma)
Manufacturer:
Delpharm Orleéans, 5 avenue de Concyr, Orleans, Cedex 2, 45071, France.
This medicinal product is authorized in the European Economic Area Member States and in the
United Kingdom (Northern Ireland) under the following names:
Belgium/Luxembourg: Bronchosedal Mucus Menthol 20 mg/ml syrup
Ireland: Benylin Phlegm Cough Menthol 100 mg/5ml Oral Solution
Italy: Actigrip Tosse Mucolitico “Gusto Mentolo 20 mg/ml, Soluzione Orale”
Spain: Iniston Mucosidad 20 mg/ml Solución Oral
United Kingdom (Northern Ireland): Benylin Mucus Cough Max Menthol flavour 100mg/5ml oral
solution