French pharmacy
MUCODRILL COUGH BOLD TASTE ORANGE 10 EFFERVESCENT TABLETS, effervescent tablet sweetened with sucralose is indicated in adults for treatment of secretory disorders of the respiratory tract, where reducing the viscosity of bronchial secretions is needed to facilitate expectoration , particularly during acute bronchitis.
Oily cough is a natural body mechanism used to purify the airways of inhaled impurities. It is usually due to irritation which can be found throughout the respiratory tree: the trachea, the bronchi.
In bronchitis , the cough is usually first "dry" and then becomes oily within a few days. But during a winter respiratory condition, the cough can be "mixed": sometimes dry, sometimes oily, depending on the moment. After such a viral episode, the cough continues for 3 to 8 weeks while the disease is cured, because the mucosa of the respiratory tree has been weakened: it is called "post-infectious" and "sub-acute".
MucoDrill 600 mg is a medicine used to treat disorders of the respiratory tract in adults. MucoDrill effervescent tablet is a mucolytic drug. It thins the mucous secretions of the bronchi to make them easier to evacuate by coughing.
This medication is indicated in adults for the treatment of secretion disorders in the respiratory tract, when a reduction in the viscosity of bronchial secretions is necessary to facilitate sputum , especially during episodes of acute bronchitis .
The active substance is :
Acetylcysteine 600 mg. For an effervescent tablet.
The other ingredients (excipients) are :
Sodium bicarbonate (E500) (equivalent to 115 mg of sodium), citric acid (E330), sucralose (E955) orange flavor (gum arabic (E414), butylhydroxyanisole (E320), citric acid monohydrate (E330), maltodextrin).
Known hypersensitivity (allergy) to acetylcysteine or to any of the excipients.
Children under 2 years old.
Box of 10 effervescent tablets. 10 days of treatment.
No official price in pharmacies, the price is freely set for each pharmacist.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 08/02/2016
MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose
acetylcysteine
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.
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.
Pharmacotherapeutic group: Mucolytics
ATC code: R05C B01
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
· 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
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
Interactions with Herbal Medicines or Alternative Therapies
Use during pregnancy and lactation
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.
Effects on ability to drive or use 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?
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
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.
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.
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
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
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.
Marketing Authorization Holder and Manufacturer
PO BOX 849
HAYNES, BEDFORD
MK45 9EG
UK
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
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
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
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Bronchial Fluidifier
acetylcysteine
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
MUCODRILL 600 mg without sugar: effervescent tablet (orange flavoring); box of 10.
-
Laboratory Pierre Fabre Medicine
| p cp | |
| acetylcysteine | 600 mg |
| Sodium | 115 mg |
Usual dosage:
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