Rhinathiol

Rhinathiol

carbocisteine

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Carbocisteine.
Description
Adult syrup: Carbocisteine 5.00 g for 100 ml of syrup.
One 15 ml measuring cup contains 750 mg carbocisteine, 6 g sucrose, 0.2 g ethanol and 97 mg sodium.
Children syrup: The active substance is: Carbocisteine 2 g for 100 ml.
One 5 ml measuring spoon contains 100 mg of carbocisteine.
Excipients with known effect: Adult syrup: sucrose, sodium, methyl parahydroxybenzoate (E218), ethanol (Alcohol content (v/v): 1.64°).
Excipients/Inactive Ingredients: Adult syrup: Sucrose, methyl parahydroxybenzoate (E 218), caramel coloring agent (E 150) (glucose, fructose, dextrose, inverted sugar, sucrose, ammonium hydroxide), cinnamon essential oil, aromatic elixir (concentrated rum extract, rum distillate, ethyl, propyl, butyl and amyl alcohol esters; acetic, propionic and butyric acid), sodium hydroxide, purified water.
Children syrup: Sucrose, methyl parahydroxybenzoate (E218), vanillin, cochineal red A (E124), raspberry flavoring, cherry flavoring, sodium hydroxide, purified water.
Action
Pharmacotherapeutic group: MUCOLYTICS. ATC Code: R05CB03. (R: Respiratory System).
Adult syrup: Pharmacology: Pharmacodynamics: Carbocisteine has a mucolytic effect on bronchial secretions. It acts on the gel phase of mucus production, most likely by breaking down the disulfide bonds in the glycoproteins, thus promoting expectoration.
Pharmacokinetics: Absorption: Orally administered carbocisteine is rapidly absorbed; peak plasma concentrations are reached in 2 hours.
Biotransformation: Bioavailability is low (less than 10% of the administered dose), probably as a result of intraluminal metabolism and a marked liver first-pass effect.
Elimination: Elimination half-life is approximately 2 hours.
Carbocisteine and its metabolites are eliminated primarily in the urine.
Toxicology: Preclinical safety data: Not applicable.
Indications/Uses
Adult syrup: This medicine is intended in adults (aged over 15 years) who have had a recent respiratory disorder with difficulty expectorating i.e. difficulty coughing up phlegm.
Children syrup: This medicine thins bronchial secretions (mucus), and makes them easier to cough up (expectorate).
It is intended for use in patients with congestion of lung airways, particularly during acute bronchitis.
Dosage/Direction for Use
Adult syrup: Oral use.
FOR USE IN ADULTS ONLY.
One 15 ml measuring cup contains 750 mg of carbocisteine.
One 15 ml measuring cup to be taken 3 times daily, preferably not during mealtimes.
Duration of treatment: Treatment duration should be short and not exceed 5 days.
Children syrup: A 5 ml measuring spoon is supplied with this medicine. The patient can also use a teaspoon.
Use in children: Dosage for children aged 2 to 5 years: The usual dose is one 5 ml measuring spoon 2 times a day (i.e. 200 mg per day, divided into 2 doses).
Dosage for children aged over 5 years: The usual dose is one 5 ml measuring spoon 3 times a day (i.e. 300 mg per day, divided into 3 doses).
Method of administration: This medicine should be taken by mouth.
Use the measuring spoon provided to measure the quantity of syrup for one dose (5 ml).
Rinse the measuring spoon thoroughly after each use.
Close the bottle tightly after use.
Duration of treatment: Do not use for more than 8 to 10 days. Talk to a doctor if symptoms worsen or persist after 10 days of treatment.
If the patient forgets to take Rhinathiol 2% Children syrup: Do not take a double dose to make up for a forgotten dose.
Overdosage
Adult syrup: Not applicable.
Children syrup: If the patient takes more Rhinathiol 2% Children syrup than they should: Stop the treatment and contact the doctor or pharmacist immediately.
Contraindications
Adult syrup: Children under 2 years of age.
Hypersensitivity to the active substance or to any of the excipients (particularly methyl parahydroxybenzoate) listed in Description.
In case of active gastroduodenal ulcer.
Children syrup: Do not take Rhinathiol 2% Children syrup: If the patient (or a child) is allergic to carbocisteine or any of the other ingredients of this medicine (particularly methyl parahydroxybenzoate), listed in Description.
If the patient (or a child) has a stomach or intestinal ulcer.
If a child is under 2 years of age, as bronchial congestion may become worse.
Warnings
Adult syrup: THE ALCOHOL CONTENT OF THIS MEDICINE IS 1.64° OR 0.2 GRAMS OF ALCOHOL PER 15 ml MEASURING CUP, equivalent to 4.92 ml of beer or 2.05 ml of wine per 15 ml dose.
Special Precautions
Adult syrup: Special warnings: Use of this medicinal product is dangerous in alcoholics and use must be considered carefully in pregnant or breast-feeding women and high-risk groups such as patients with hepatic impairment or epilepsy.
Productive cough, which is a fundamental bronchopulmonary defense mechanism, should not be suppressed.
Combining drugs that affect bronchial secretions with cough suppressants and/or substances that dry up secretions (atropine-like agents) is irrational.
This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Precautions for use: Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding.
If gastrointestinal bleeding occurs, patients should discontinue medication.
This medicine contains 6 g of sucrose per 15 ml measuring cup. This should be taken into account in patients following low-sugar diets or with diabetes mellitus.
This medicine contains sodium. This medicine contains 97 mg sodium in each 15ml measuring cup. This should be taken into account in patients following a strict low-sodium diet.
This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions (possibly delayed).
Effects on ability to drive and use machines: Not applicable.
Children syrup: The patient (or a child) must not use medicines which suppress cough (cough suppressants) or which dry out bronchial secretions when taking Rhinathiol 2% Children syrup. This is because Rhinathiol 2% Children syrup thins secretions, making them easier to cough up. Coughing is a useful mechanism for expectoration.
Talk to a doctor or pharmacist before using Rhinathiol 2% Children syrup: If the patient (or a child) has a fever or are coughing up "greenish" mucus.
If the patient (or a child) suffers from chronic (long term) bronchial or pulmonary disease.
If the patient (or a child) has a history of gastroduodenal ulcers (affecting the stomach or intestine).
If the patient is an elderly.
If the patient is also taking medicines that are likely to cause bleeding in the stomach or intestine.
Treatment should be stopped if bleeding in the stomach or intestine occurs.
Rhinathiol 2% Children syrup contains sodium, methyl parahydroxybenzoate (E218), cochineal red A (E124) and sucrose: This medicine contains 13 mg sodium in each measuring spoon (5 ml). This should be taken into account if the patient is on a no-sodium or low-sodium diet.
This medicine contains methyl parahydroxybenzoate (E218) and cochineal red A (E124). These can cause allergic reactions.
This medicine contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
If the patient has been told by a doctor that the patient has an intolerance to some sugars, contact a doctor before taking this medicinal product.
Each measuring spoon contains 3.5 g sucrose. This should be taken into account if the patient is on a no-sugar or low-sugar diet.
Use In Pregnancy & Lactation
Pregnancy: There are no available data on carbocisteine use in pregnant women.
The use of carbocisteine in pregnant women is therefore not recommended.
Adult syrup: Animal studies do not indicate any teratogenic effects.
Children syrup: If the patient is pregnant or breast-feeding, think the patient may be pregnant or are planning to have a baby, ask a doctor or pharmacist for advice before taking this medicine.
This medicine should only be used during pregnancy on a doctor's advice.
If the patient discovers that they are pregnant during treatment, talk to a doctor. Only a doctor can decide whether it is necessary to continue treatment.
Ask a doctor or pharmacist for advice before taking any medicine.
Breast-feeding: There are no available data on the presence of carbocisteine in human milk.
Adult syrup:
Therefore, the use of carbocisteine in breast-feeding women is not recommended.
Children syrup: Breast-feeding a child is not recommended if the patient is taking this medicine.
Ask a doctor or pharmacist for advice before taking any medicine.
Adverse Reactions
Adult syrup: Possibility of cases of digestive intolerance gastric pain, nausea, vomiting, and diarrhea).
If these occur, the dose should be reduced.
Gastrointestinal bleeding. Treatment should be discontinued.
Allergic skin eruption and anaphylactic reactions such as urticaria, angioedema, pruritus and erythematous rash.
Some cases of fixed drug eruption have been reported.
Isolated cases of dermatitis bullous, such as Stevens-Johnson syndrome and erythema multiforme.
Skin and subcutaneous tissue disorders: Severe cutaneous adverse reactions (SCAR) e.g. erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In most of these cases reported at least one other drug was administered at the same time, which may have possibly enhanced the described mucocutaneous effects.
Immune system disorders: Anaphylactic/anaphylactoid reaction.
Children syrup: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible worsening of bronchial congestion in infants.
Gastrointestinal disorders, such as stomach pain, nausea, vomiting and diarrhea. If these occur, the dosage should be reduced.
Bleeding in the stomach or intestine. Treatment should be stopped.
Allergic skin eruption and anaphylactic reactions, such as hives, itching, appearance of plaques or spots on the skin, and swelling of the face and/or neck that can lead to difficulty breathing and be life-threatening (angioedema). In this case, the patient should stop treatment and see a doctor immediately.
Brown or purple plaques which can cause skin discoloration (fixed drug eruption). In this case, the patient should see a doctor immediately.
Appearance of spots, sometimes with blisters, on the skin that can also affect the mouth (erythema multiforme), appearance of blisters with detachment of the skin that can spread over the whole body and may be life-threatening (Stevens-Johnson syndrome).
Rhinathiol 2% Children syrup may cause severe allergy and serious skin reactions. Stop using Rhinathiol 2% Children syrup and seek medical assistance immediately if the patient experiences any of the following symptoms: Severe allergy: breathing difficulties, light headedness, skin swellings or rash.
Severe skin reaction: skin reddening, blisters, rash, fever, sore throat or eye irritation.
If the patient gets any side effects, talk to a doctor or pharmacist.
Drug Interactions
Adult syrup: Combinations to be taken into account: Due to the alcohol content of this medicine: Medicinal products that cause an antabuse-type reaction with alcohol (hot flushes, redness, vomiting, tachycardia): disulfiram, cefamandole, cefoperazone, latamoxef (cephalosporins, i.e. antibacterial agents), chloramphenicol (phenicol, i.e. antibacterial agent), chlorpropamide, glibenclamide, glipizide, tolbutamide (sulfonylureas, i.e. antidiabetic agents), griseofulvin (antifungal agent), 5-nitroimidazoles (metronidazole, ornidazole, secnidazole, tinidazole), ketoconazole, procarbazine (cytostatic agent).
Central nervous system depressants.
Children syrup: Other medicines and Rhinathiol 2% Children syrup: Tell a doctor or pharmacist if the patient (or a child) is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Caution For Usage
Adult syrup: Incompatibilities: Not applicable.
Special precautions for disposal and handling: No particular instructions.
Children syrup:
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away of medicines of no longer use. These measures will help to protect the environment.
Storage
Adult syrup: Store below 25°C.
Children syrup: Do not store above 25°C.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05CB03 - carbocisteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Adult syr (rum/cinnamon flavour) 750 mg/15 mL x 125 mL. Childn syr (red syrup with raspberry/cherry flavour) 100 mg/5 mL x 125 mL.
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