Therapeutic indications
Acetylcysteine contained in this medicine is a mucolytic. It liquefies mucous secretions from the bronchial tubes to make them easier to cough up.
This medicine is indicated in adults for the treatment of secretion disorders in the airways, when a reduction in the viscosity of bronchial secretions is necessary to facilitate expectoration, particularly during episodes of acute bronchitis.
2. WHAT YOU SHOULD KNOW BEFORE TAKING MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose
List of information needed before taking the medicine
Not applicable.
Contraindications
Never take MUCODRILL 600 mg SUGAR-FREE, sucralose-sweetened effervescent tablet in the following cases:
- ·if you have a history of hypersensitivity to acetylcysteine or any of the excipients.
- ·do not give this medicine to children under two years of age
Precautions for use; special warnings
Warnings and precautions for use
If you are asthmatic or if you experience more or less intermittent breathing difficulties due to muscularcontraction of the bronchial muscles or swelling ofthe mucous membrane of theairways, often associated withcoughing andhypersecretion of bronchial mucus, the administration of this medicine may increase breathing difficulties due to a contraction of the bronchial muscles around the airways (bronchospasm). In this case, you shouldimmediately stop treatment with thismedicine and consult a doctor.
If youhave apepticulcerorhavehad one in thepast, this medicine maycausestomachirritation, especially if you are also taking other medicines known to irritatethestomach.
Severe hypersensitivity reactions with(high )fever, skin rash ,joint pain and/oreyeinfection(Stevens-Johnson syndrome) orsudden onset hypersensitivity reactions with fever associated with blistering orpeeling of the skin (Lyellsyndrome) have been reported rarely in association with this drug. However,in most of these cases, patientsweretaking at least one other drugthat may have causedthese reactions.
If you notice a change in the appearance ofyour skinor mucous membranes, you should seek medical advice immediately and stoptaking acetylcysteineimmediately .
When thethick mucusbecomes more fluid, itsvolume increases, especially at the beginning of treatment. If you are unable to expectorate these fluid mucus secretions effectivelyyou should consult adoctor toto determine the appropriate measuresto clear it up.
Bronchial mucus thinners (mucolytics) such as this medication may cause airway obstruction in children under two years of age, due to the characteristics of the airways in this age group. The ability to expectorate mucus secretions may be limited. Therefore , this drug should not be given to children under two yearsof age.
This medicine should not begiven to children between 2 and18 years of age.
Youyou may notice a slight smellsulphur (rotten egg smell) whenyou open the package. This odour is a normal characteristic of the of the active substance. It does not indicate a change in the medicine.
Consult your doctor ifany of the above warningsabove applies toàyou or has been applied to you to you in the you in the past.
Interactions with other medicines
Other drugs and MUCODRILL 600 mg SUGAR-FREE, sucralose-sweetened effervescent tablet :
If you are taking other medicines, do not dissolve them at the same time as this medicine.
If you need to take medicines to treat or prevent infection (antibiotics), it is advisable to take them two hours before or after this medicine. Do not take medicines that inhibit the cough reflex, called cough suppressants, at the same time as this medicine, as you need to be able to cough up the thinned mucus effectively.
This drug may potentiate the antihypertensive activity of nitrate derivatives (such as nitroglycerin) which are drugs used for angina (painful tightness in the chest). Caution is recommended.
Taking activated charcoal (a drug usually used for infectious diarrhea) may decrease the effect of this medicine.
If you are takingorhave recently takena other medicines than this medication, includinganon-prescription medication, talk to your your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and lactation
Pregnancy
Limited data are available on the use of acetylcysteine in pregnant women Animal studies have not shown any direct or indirect deleterious effects on pregnancy or on the development of the offspring before, during or after birth. The use of this drug during pregnancy should be considered only after careful weighing of the benefits and risks.
Lactation
The passage of acetylcysteine into breast milk is not known. The use of this drug during lactation should be considered only after careful weighing of the benefits and risks. If you are planning to have a child, are pregnant or breastfeeding, ask your doctor or pharmacist before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and 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 a known effect
MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose contains sodium.
This medicine acetylcysteine contains 115 mg of sodium per effervescent tablet. The recommended adult daily dosage provides 411 mg of sodium. Caution should be exercised in patients on a low salt diet
3. HOW TO TAKE MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Adults:
1 tablet effervescent oncea day.
In patients with difficulty incoughing up bronchial mucus(elderly or debilitatedpatients ), it is preferable totake the tabletin the morning.
Method of administration
Dissolve the tablet inhalf a glass ofwater. Drink thesolution immediately.
Always follow your doctor's instructions for using this medicineAsk your doctor orpharmacistfor advice if youhave any doubts.
Do not use this medication formore than 8-10 days without medical advice.
Symptoms and instructions in case of overdose
If you have taken more MUCODRILL 600 mg SUGAR-FREE, sucralose-sweetened effervescent tablets than you should have:
The symptomsthat may occurare as follows:nausea, vomiting anddiarrhea.
If you have taken more than of this medicinethanyou should have,contact yourdoctor or pharmacistimmediately.
Instructions in case of missed doses
If you forget to take MUCODRILL 600 mg SUGAR-FREE, sucralose-sweetened effervescent tablet :
If you miss adose andit is almosttime for your next dose,do not takethemisseddose, but continuetreatment as instructed in " How to take MUCODRILL600 mg SUGAR-FREE, sucralose-sweetened effervescent tablets ".
Do not double the dose toto make up for themissed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, this medicine may cause side effects, but they do not always occur in everyone.
If any of the following side effects occur, stop taking this medicine immediately and contact your doctor or the nearest hospital emergency room.
Shock (severe drop in blood pressure, pallor, restlessness, weak pulse, clammy skin, reduced consciousness) due to sudden dilation of blood vessels caused by severe hypersensitivity to certain substances (anaphylactic shock).
Swelling due to sudden onset edema (sudden accumulation of fluid in the skin or mucous membranes) of the throat or tongue, difficulty breathing and/or itching and skin rash, most often due to an allergic reaction (angioedema).
These reactions are very serious side effects. If they occur, you may have developed a serious allergic reaction to this medicine, requiring emergency medical attention and possibly hospitalization.
These very serious side effects are very rare (less than 1 in 10,000 patients).
Bleeding 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 the bronchial muscles (bronchospasm)
Difficulty breathing, shortness of breath (dyspnea)
Digestive problems with a feeling of fullness in the abdomen, pain in the stomach area, belching, nausea and heartburn (dyspepsia)
The following side effects are rare (1 to 10 in 10,000 users):
Hypersensitivity (allergy)
May include bronchospasm and dyspnea (see above), increased heart rate (tachycardia), itching (pruritus), itchy skin rash and papules (urticaria), angioedema.
Headaches
Ringing in the ears (tinnitus)
Inflammation of the oral mucosa (stomatitis)
Diarrhea
Fever
Low blood pressure
Abdominal pain
Nausea
Vomiting
The following side effects are rare (1 to 10 in 1000 users):
If you have a peptic ulcer, or have had one in the past, acetylcysteine may cause irritation of your gastric mucosa.
If you experience any side effects, including those not mentioned in this leaflet, talk to your doctor or pharmacist.
Reporting 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr. By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.
5. HOW TO USE MUCODRILL 600 mg SUGAR-FREE, effervescent tablet sweetened with sucralose?
Keep this medicine out of the sight and reach of children.
Expiry date
Do not use this after the expiry dateexpiry dateon theboxafter« Do not use after "or " Exp". The expiry date refers to the last day of that month.
Storage conditions
After first opening, the medicine should be stored for a maximum of 10 days.
Store in the original packaging in a dry place.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of any medication in the sewage system or in your household waste. Ask your pharmacist to dispose of any medication you no longer use. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What MUCODRILL 600 mg SUGAR-FREE effervescent tablet sweetened with sucralose contains
The active substance is :
Acetylcysteine................................................................................................................ 600 mg
For one effervescent tablet
The other components are :
The other components (excipients) are sodium bicarbonate (E500) (equivalent to 115 mg sodium), citric acid (E330), sucralose (E955), orange flavour (gum arabic (E414), butylated hydroxyanisole (E320), citric acid monohydrate (E330), maltodextrin).
Pharmaceutical form and content
Aspect of MUCODRILL 600 mg SUGAR-FREE, sucralose-sweetened effervescent tablet and contents of packaging
Carton containing 6, 10, 12, 20 or 30 effervescent tablets.
The tablets are packaged in aluminium-aluminium blister packs or in a tube (propylene) with a polyethylene cap and desiccant.
An odor ofsulphur is sometimes perceptible when opening the of the package. It is normaland safe.
Name and address of the marketing authorisation holder and manufacturing authorisation holder responsible for batch release, if different
Marketing authorisation holder and manufacturer
Holder
ALPEX PHARMA (UK) LIMITED
PO BOX 849
HAYNES, BEDFORD
MK45 9EG
UNITED KINGDOM
Operator
PIERRE FABRE MEDICAMENT
45 PLACE ABEL GANCE
92100 BOULOGNE
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