NOTICE
ANSM - Last updated: 08/02/2016
Name of the medicinal product
MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose
acetylcysteine
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 14 days.
Review summary
In this notice :
1. What is MUCODRILL 600 mg SUGAR-FREE, sucralose-sweetened effervescent tablet and in which cases is it used?
2. What should I know before taking MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose ?
3. How to take MUCODRILL 600 mg WITHOUT SUGAR, effervescent tablet sweetened with sucralose ?
4. What are the possible side effects?
5. How to store MUCODRILL 600 mg WITHOUT SUGAR, effervescent tablet sweetened with sucralose ?
6. Additional information.
1. WHAT MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
Pharmacotherapeutic group: Mucolytics
ATC code: R05C B01
Therapeutic indications
The acetylcysteine contained in this drug is a mucolytic. It liquefies the mucous secretions of the bronchi to make them easier to evacuate by coughing.
This medication is indicated in adults for the treatment of respiratory secretion disorders, when a reduction in the viscosity of the bronchial secretions is necessary to facilitate sputuming, particularly during episodes of acute bronchitis.
2. BEFORE YOU TAKE MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take MUCODRILL 600 mg WITHOUT SUGAR, effervescent tablet sweetened with sucralose in the following cases:
· if you have a history of hypersensitivity to acetylcysteine or any of the excipients.
· Do not administer this medication to children under two years of age.
Precautions for use; special warnings
Warnings and Precautions
If you are asthmatic or if you experience a more or less intermittent respiratory discomfort due to muscle contraction of the bronchial muscles or swelling of the mucosa of the respiratory tract often associated with coughing and hypersecretion of bronchial mucus , administration of this medication may increase breathing difficulties due to bronchial muscle contraction around the airway ( bronchospasm). In this case , you must immediately cease the treatment with and consult a physician .
Yes you have a peptic ulcer or if you had one in the past , this medication may cause irritation of the wall stomach , especially if you are taking other medicines known to be irritate the wall of the stomach.
Severe hypersensitivity reactions with ( high) fever , redness of the skin, joint pain and or eye infection ( Stevens-Johnson syndrome) or sudden onset of hypersensitivity reactions associated with fever blisters or peeling to the skin (syndrome of Lyell ) have been reported, in rare cases, in relation to the intake of this drug . However, in most of these cases, the patients were taking at least one other which could be the source of these reactions.
If you notice a change in appearance on your skin or mucous membranes , you should immediately seek medical attention and stop taking acetylcysteine immediately .
When the thick mucus becomes more fluid , its volume increases , especially at the beginning of treatment. If you are unable to effectively expectorate these fluid mucus secretions, you should consult a physician that it shall determine the appropriate measures to evacuate them.
Medicines that migrate mucus from the bronchi (mucolytics) such as this medication may cause airway obstruction in children under two years of age, due to respiratory tract characteristics in this age group. The ability to expectorate mucus secretions can then be limited. This is why should not be administered to children under two years of age.
This drug should not be administered to children between 2 and 18 years.
You may perceive a slight odor of sulfur ( smell of rotten eggs) when you will open the package . This odor is a normal characteristic of the active substance. It does not indicate an alteration of the drug.
Consult your doctor if one of the warnings above applies at you or applied to you in the past.
Interaction with other medicines
Other medicines and MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose :
If you are taking other medicines, do not dissolve them together with this medication.
If you need to take medications to treat or prevent an infection (antibiotics), it is advisable to take them two hours before or after this medication. Do not take medicines that inhibit the cough reflex, called cough reflex medications, at the same time as this medication, because you must be able to cough effectively to expectorate the fluidized mucus.
This medication may potentiate the antihypertensive activity of nitro-derivative drugs (such as nitroglycerin) which are medicines used for angina or angina pectoris (painful tightness in the chest). Caution is advised.
The use of activated charcoal (medication usually used against infectious diarrhea) may decrease the effect of this drug.
If you take or you have recently taken a drug other than the drug, including a obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
Available data on the use of acetylcysteine in pregnant women are limited. Animal studies have shown no direct or indirect deleterious effects on gestation or progeny development before, during or after birth. During pregnancy, the use of this medication should be considered only after carefully weighing the benefit and the risks.
feeding
The passage of acetylcysteine in breast milk is not known. The use of this medication during breast-feeding should be considered only after careful consideration of the benefit and the risks. If you are planning to have a baby, are pregnant, or are breast-feeding, seek the advice of your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
There have been no studies on the effect of acetylcysteine on the ability to drive and use machines. However, such an effect is unlikely.
List of excipients with known effect
MUCODRILL 600 mg SUGAR-FREE, sucralose-sweetened effervescent tablet contains sodium.
This medicine contains 115 mg of sodium per effervescent tablet. The recommended daily dosage in adults provides 411 mg of sodium. Caution should be exercised in patients on low salt diets.
3. HOW TO TAKE MUCODRILL 600 mg WITHOUT SUGAR, effervescent tablet sweetened with sucralose?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
adults:
1 tablet effervescent once a day.
In patients with difficulty to expectorate bronchial mucus ( elderly or debilitated patients ), it is preferable to take the tablet in the morning .
Administration mode
D issuing the tablet effervescent in half a glass of water. Drink immediately the solution.
Always follow your doctor's instructions for using this medicine . Seek advice from your doctor or your pharmacist if you have doubts .
Do not use this medication for more than 8-10 days without medical advice .
Symptoms and Instructions for Overdose
If you take more than MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose you should:
Symptoms which may occur are the following : nausea, vomiting and diarrhea.
If you take more of this medication than you should, contact your doctor or pharmacist immediately .
Instructions for omission of one or more doses
If you forget to take MUCODRILL 600 mg WITHOUT SUGAR, effervescent tablet sweetened with sucralose:
If you have forgotten dose and that it is almost time to take the next, do not take the dose you have forgotten , but continue treatment according to the instructions in " How to take MUCODRILL 600 mg WITHOUT SUGAR, effervescent tablet sweetened with sucralose ".
Do not double the dose to offset the forgotten dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
If any of the following side effects occur, stop taking this medication immediately and contact your doctor or emergency department immediately.
· Shock (high blood pressure, paleness, restlessness, weak pulse, sweaty skin, reduced consciousness) due to the sudden dilation of blood vessels caused by severe hypersensitivity to certain substances (anaphylactic shock).
· Swelling due to sudden onset of edema (sudden accumulation of fluid in the skin or mucous membranes) of the throat or tongue, difficulty breathing and / or itching and rash, usually associated with an allergic reaction (angioedema ).
These reactions are very serious side effects. If they occur, you may have developed a serious allergic reaction to this medication, requiring emergency medical attention and possibly hospitalization.
These very serious side effects are very rare (less than 1 in 10,000 patients).
Hemorrhage is another very rare side effect.
Contact your doctor if you develop any of the following side effects:
· Shortness of breath due to contraction of bronchial muscles (bronchospasm)
· Difficulty breathing, shortness of breath (dyspnea)
· Digestive disorders with sensation of fullness in the abdomen, pain in the stomach area, belching, nausea and heartburn (dyspepsia)
The following side effects are rare (1 to 10 users out of 10,000):
· Hypersensitivity (allergy)
· May present with bronchospasm and dyspnea (see above), increased heart rate (tachycardia), itching (pruritus), rash with itching and formation of papules (urticaria), angioedema.
· Headache
· Tinnitus (tinnitus)
· Inflammation of the buccal mucosa (stomatitis)
· Diarrhea
· Fever
· hypotension
· Abdominal pain
· nausea
· vomiting
The following side effects are rare (1 to 10 users in 1000):
If you have a peptic ulcer, or if you have had one in the past, acetylcysteine can cause irritation of your gastric mucosa.
If you have any side effects, including other effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use this medication after expiration date on the box after " Do not use after " or " Exp". The expiry date refers to the last day of that month.
Storage conditions
After first opening, the medication should be stored for a maximum of 10 days.
Store in the original package, away from moisture.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What MUCODRILL contains: 600 mg SUGAR-FREE, sucralose sweetened effervescent tablet
· The active substance is:
Acetylcysteine ................................................. .................................................. ............. 600 mg
For an effervescent tablet
· The other components are:
Other ingredients (excipients) are sodium bicarbonate (E500) (equivalent to 115 mg sodium), citric acid (E330), sucralose (E955), orange flavoring (gum arabic (E414), butylhydroxyanisole (E320), citric acid monohydrate (E330), maltodextrin).
Pharmaceutical form and content
Aspect of MUCODRILL 600 mg WITHOUT SUGAR, effervescent tablet sweetened with sucralose and contents of the pack
Carton box containing 6, 10, 12, 20 or 30 effervescent tablets.
The tablets are packaged in aluminum-aluminum blister packs or in a tube (propylene) with polyethylene cap and dehydrating agent.
A smell of sulfur is sometimes perceptible when the package is opened . It is normal and safe.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Marketing Authorization Holder and Manufacturer
Holder
ALPEX PHARMA (UK) LIMITED
PO BOX 849
HAYNES, BEDFORD
MK45 9EG
UK
exploiting
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
Maker
KYMOS PHARMA SERVICES, SL
RONOLA DE CAN FATJO, 7B
PARQUE TECHNOLOGICO DEL VALLES
CERDANYOLA DEL VALLES
BARCELONA
SPAIN
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.