NOTICE
ANSM - Updated: 22/10/2018
Name of the drug
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution
acetylcysteine
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, whether or not mentioned in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
· You should talk to your doctor if you do not feel better or feel worse after 8-10 days.
What does this booklet contain ?
1. What is FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution and in which cases is it used?
2. What you need to know before using FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?
3. How to use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?
4. What are the possible side effects?
5. How to store FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?
6. Contents of the package and other information.
1. WHAT IS FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic class - ATC code: R05C B01.
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, contains acetylcysteine which is the active substance. This medicine is a mucolytic. It degrades and thins the thick mucus, making it more liquid and easier to remove by coughing. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, is used in adults for the treatment of bronchial affections in which a reduction in viscosity is necessary to facilitate expectoration, especially during episodes of acute bronchitis.
You should talk to your doctor if you do not feel better or feel worse after 8-10 days.
2. BEFORE YOU USE ACETYLCYSTEINE ALPEX 600 mg granules for oral solution?
Do not use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution:
· if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6).
This medication should not be used (contraindicated) in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS granules for oral solution in the situations described below.
· If breathing difficulties, such as shortness of breath that may be associated with coughing and / or increased bronchial secretions, occur after taking this medication. It may be bronchospasm (sudden decrease in the size of the bronchi). In this case, you should immediately stop treatment with FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, and seek medical attention.
· If you have a peptic ulcer or if you have had a peptic ulcer in the past. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, may irritate the stomach lining, especially if you are taking other medicines known to irritate the lining of the stomach.
· Rare cases of severe hypersensitivity reactions with fever (high), redness of the skin, joint pain and / or eye damage (Stevens-Johnson syndrome) or sudden hypersensitivity reactions with fever and vesicles on skin or skin detachment have been reported during treatment with acetylcysteine. If any abnormalities occur in the skin or mucous membranes, you should immediately stop using acetylcysteine and consult a doctor.
· When the thick bronchial mucus becomes more liquid, its volume increases, especially at the beginning of the treatment. If you have difficulty expectorating and evacuating fluid mucus while coughing, you should consult a doctor who will take the appropriate measures.
A slight smell of sulfur (smell of rotten egg) can be released when opening the package. This odor is normal and characteristic of the active substance. It does not indicate an alteration of the drug.
Consult your doctor if you are concerned with any of the situations described above.
Children and adolescents
Medications, such as FLUIMUCIL EXPECTORANT ACETYLCYSTEINE, that thin mucus (mucolytics) can cause airway obstruction in children under 2 years of age due to airway features in these patients. As a result, the ability to remove bronchial secretions by sputum (spitting) can be reduced. Also, FLUIMUCIL EXPECTORANT ACETYLCYSTEINE should not be used (contraindicated) in children under 2 years of age.
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution should not be used in children and adolescents. Other pharmaceutical forms suitable for children and adolescents are available. Ask your doctor or pharmacist.
Consult your doctor if you are concerned with any of the situations described above.
Other medicines and FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you use other medicines, you should not dissolve them in the solution of FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution.
If you are taking antibiotics (medicines prescribed for the treatment or prevention of infections), you should take these medicines 2 hours before or after taking FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution.
You should not use antitussive drugs (cough-reducing medications) at the same time as FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, because coughing helps you to expectorate (spit) bronchial secretions (mucus) whose fluidity is increased by the treatment.
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, may increase the antihypertensive effect (decreases blood pressure) of nitroglycerin which is a drug used to treat angina pectoris (feeling of oppression of cardiac origin in the thorax). Caution is required.
Taking activated charcoal (a drug used to treat traveler's diarrhea) may decrease the effect of FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution.
This medicine does not contain sodium or sugar.
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution with food, beverages and alcohol
Not applicable.
Pregnancy and breast feeding
There is limited data on the use of acetylcysteine in pregnant women. Studies in animals have not shown any direct or indirect harmful effect on the pregnancy or development of the child before, during or after birth. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, should be used during pregnancy only if necessary, after a careful evaluation of the risks and benefits.
It is not known if acetylcysteine is excreted in breast milk. FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, should be used during breastfeeding only if necessary, after a careful evaluation of the risks and benefits.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No data on the effect of acetylcysteine on the ability to drive and use machines are available. An effect of acetylcysteine is unlikely, however.
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution contains:
Not applicable.
3. HOW TO USE FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
adults
The recommended dose is 1 sachet once a day.
Patients who have difficulty expectorating mucus (elderly patients or debilitated patients) should take the medicine in the morning.
Dissolve this medicine in half a glass of water. Drink the solution immediately.
If you have used more FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution than you should:
If you have used more FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, than you should, contact your doctor or pharmacist immediately.
Possible symptoms of overdose are nausea, vomiting and diarrhea.
If you forget to use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution:
If you missed a dose and the next dose is close, do not take the missed dose, but continue with the rate of intake listed under "How to use FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for solution drinkable".
Do not take a double dose to make up for the dose you forgot to take.
If you stop using FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately stop using FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, and contact your doctor or the emergency department of your local hospital if any of the following side effects occur:
· Hypersensitivity reaction manifested by a significant drop in blood pressure, pallor, agitation, slowing of the pulse, moist skin, decreased consciousness (anaphylactic shock causing sudden dilation of the blood vessels).
· Allergic reaction manifested by angioedema (sudden swelling of the skin or mucous membranes, for example in the throat or tongue), difficulty breathing and / or itching and rash
The reactions described above are serious side effects. If you get these reactions, you may have developed a severe allergic reaction to FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution. You must receive urgent medical attention or be hospitalized.
This serious side effect is very rare (seen in less than 1 in 10,000 users).
There is also a very rare risk of bleeding.
You should tell your doctor if you develop any of the following side effects after taking this treatment:
· bronchospasm: difficulty breathing with shortness of breath (dyspnea) or shortness of breath in connection with a sudden narrowing of the size of the bronchi (do not renew the catch)
· feeling of heaviness in the stomach, pain in the stomach, regurgitation, nausea and heartburn (dyspepsia)
These side effects are rare (observed in 1 to 10 users out of 10,000).
· Hypersensitivity (allergic reaction)
may manifest as bronchospasm (abrupt reduction of the size of the bronchi) and dyspnea (feeling of choking, see above), an acceleration of the heart rate (tachycardia), itching (pruritus), a rash with severe itching and plaque formation (urticaria) and angioedema.
· Headache (headache)
· Tinnitus (tinnitus)
· Inflammation of the oral mucosa (stomatitis)
· Diarrhea
· Fever (pyrexia)
· Decreased blood pressure (hypotension)
· Abdominal pain
· nausea
· vomiting
These side effects are uncommon (seen in 1 to 10 users in 1,000).
If you have a stomach ulcer or have had a stomach ulcer in the past, acetylcysteine can have a harmful effect on your gastrointestinal lining.
If you get any side effects, whether or not mentioned in this leaflet, please tell your doctor or pharmacist. Consult your doctor or pharmacist if you notice that the effect of FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, is too strong or too weak.
Declaration of side effects
If you get any side effects, whether or not mentioned in this leaflet, tell your doctor or pharmacist or nurse. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet or carton after "EXP". The expiry date refers to the last day of this month.
Store the medicine in the original package to protect from moisture.
Do not use this medicine if you notice any visible signs of deterioration.
It is possible that you feel a slight smell of sulfur when opening the package. It's normal and harmless.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What FLUIMUCIL EXPECTORANT ACETYLCYSTEINE contains 600 mg ADULTS, granules for oral solution
· The active substance is:
acetylcysteine
· The other excipients are:
maltodextrin (E1542), sucralose (E955), anhydrous colloidal silica (E551) and orange flavor (containing gum arabic (E414), butylated hydroxyanisole (E320), citric acid monohydrate (E330) and maltodextrin).
What FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution and contents of the pack
FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution, is in the form of white to yellowish granules packaged in sachets. Cardboard boxes containing 6, 10, 12, 20 or 30 sachets per box.
Not all presentations may be marketed.
Marketing Authorization Holder
ALPEX PHARMA (UK) LIMITED
PO BOX 849
HAYNES, BEDFORD
MK45 9EG
UNITED KINGDOM
Operator of the marketing authorization
ZAMBON FRANCE SA
13 RENE JACQUES STREET
92138 ISSY-LES-MOULINEAUX CEDEX
LA FRANCE
Maker
KYMOS PHARMA SERVICES, SL
RONOLA OF CAN FATJO, 7B
PARC TECHNOLOGICO DEL VALLES
CERDAYOLA DEL VALLES
BARCELONA
SPAIN
Names of the medicine in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names:.
Netherlands: ACETYLCYSTEINE ALPEX 600 mg, granulaat voor drank
France: FLUIMUCIL EXPECTORANT ACETYLCYSTEINE 600 mg ADULTS, granules for oral solution
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.