Rhinathiol

Rhinathiol

carbocisteine

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Carbocisteine.
Description
Adult syr: Carbocisteine 5.00 g.
For 100 ml of syrup: 1 measuring cup (15 ml) contains 750 mg of carbocisteine, 6 g of sucrose, 0.2 g of ethanol and 97 mg of sodium.
Alcohol content (v/v): 1.64°.
Childn syr: The active substance is: Carbocisteine 2 g for 100 ml.
One 5 ml measuring spoon contains 100 mg of carbocisteine.
Excipients/Inactive Ingredients: Adult syr: 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.
Childn syr: 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 syr: Pharmacology: Pharmacodynamics: Carbocisteine is a mucus modifying agent with a mucolytic effect on bronchial secretions. It acts on the gel phase of mucus production, probably by breaking down the disulfide bonds in mucus glycoproteins, thus promoting expectoration.
Pharmacokinetics: Orally administered carbocisteine is rapidly absorbed; peak plasma concentrations are reached within two hours.
The drug is poorly bioavailable (less than 10% of the administered dose), probably as a result of intraluminal metabolism and a marked hepatic first‐pass effect.
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 syr: This medicine is intended in adults (aged over 15 years) who have had a recent respiratory disorder with difficulty expectorating ie. difficulty coughing up phlegm.
Childn syr: This medicine thins bronchial secretions (mucus), and makes them easier to cough up (expectorate). It is intended for use in patients with difficulty expectorating ie. difficulty coughing up phlegm.
Dosage/Direction for Use
Adult syr: 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.
Childn syr: How much Rhinatiol 2% Children syrup be given: A 5 ml measuring spoon is supplied with this medicine. The patient can also use a teaspoon.
Dosage for children aged 2 to 5 years: The usual dose is one 5 ml measuring spoon twice 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 three 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 the 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 syr: Not applicable.
Childn syr: If the patient takes more Rhinathiol 2% Children syrup than they should: Stop the treatment and contact the doctor or pharmacist immediately.
Contraindications
Adult syr: Children under 2 years of age.
Hypersensitivity to any of the ingredients.
Childn syr: Do not take Rhinathiol 2% Children syrup: If the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine listed in Description.
If the child is under 2 years of age, as bronchial congestion may become worse.
Warnings
Adult syr: THE ALCOHOL CONTENT OF THIS MEDICINAL PRODUCT IS 1.64° i.e. 0.2 g OF ALCOHOL PER 15 ml MEASURING CUP, which is equivalent to 4.92 ml of beer or 2.05 ml of wine per 15 ml dose.
Special Precautions
Adult syr: Special warnings: Use of this medicinal product is dangerous in alcoholics and the alcohol content should be taken into account in pregnant or breast‐feeding women, in children or high‐risk populations such as patients with liver failure or epilepsy.
Productive cough, which is a fundamental bronchopulmonary defense mechanism, should not be suppressed.
Using drugs that affect bronchial secretions in combination with antitussives and/or substances that dry up secretions (atropine‐like agents) is not logical.
This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose and galactose malabsorption syndrome or sucrose/isomaltase deficiency.
Precautions for Use: Caution should be exercised in patients with peptic ulcers.
This medicine contains 6 g of sucrose per 15 ml measuring cup; this must be taken into account in the daily allowance in patients on a low‐sugar diet or with diabetes.
This medicinal product contains 97 mg of sodium per 15ml measuring cup. This should be taken into account in patients following a strict low‐salt diet.
This medicinal product contains methyl parahydroxybenzoate (E218) and can cause (possibly delayed) allergic reactions.
Effects on ability to drive and use machines: Not applicable.
Childn syr: 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 the doctor before using Rhinathiol 2% Children syrup: If the patient or child have a fever or are coughing up "greenish" mucus.
If the patient or child suffers from chronic bronchial or pulmonary disease.
If the patient or child has a gastroduodenal ulcer (affecting the stomach or intestine).
If the patient is 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.
Other medicines and Rhinathiol 2% Children syrup: Tell the doctor or pharmacist if the patient or child is taking or have recently taken any other medicines, including medicines obtained without a prescription.
Rhinathiol 2% Children syrup contains sodium, methyl parahydroxybenzoate (E218), cochineal red A (E124) and sucrose: This medicine contains 13 mg of sodium per 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: It is therefore not recommended for use in patients with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase‐isomaltase deficiency (rare hereditary diseases).
If the patient has an intolerance to some sugars, contact the doctor before taking this medicinal product.
Each measuring spoon contains 3.5 g of sucrose. This should be taken into account if the patient are on a no-sugar or low-sugar diet.
Use In Pregnancy & Lactation
Adult syr: Pregnancy: Animal studies have revealed no evidence of teratogenic effects, therefore the drug is not expected to have a malformative effect in humans. To date, substances causing malformation in humans have been shown to be teratogenic in animals during well‐conducted studies in two species.
No particular malformative or fetotoxic effects have been reported to date in clinical practice. Nevertheless, there are insufficient data on pregnancies exposed to carbocisteine to completely rule out a risk.
Therefore, use of carbocisteine should only be considered during pregnancy if necessary.
Lactation: There are no data available on the excretion of carbocisteine in breast milk. However, in view of its mild toxicity, potential risks to infants appear to be negligible during treatment with this medicine. Breast‐feeding is therefore possible.
Childn syr: Pregnancy: This medicine should only be used during pregnancy on the doctor's advice. If the patient is pregnant during treatment, talk to the doctor. Only the doctor can decide whether it is necessary to continue treatment.
Ask the doctor or pharmacist for advice before taking any medicine.
Lactation: The patient may breastfeed the child while being treated with this medicine.
Ask the doctor or pharmacist for advice before taking any medicine.
Adverse Reactions
Adult syr: Possible gastrointestinal disorders (stomach pain, nausea, diarrhea). Is these occur, the dose should be reduced.
Possible allergic skin reactions such as urticaria, angioedema, pruritus, erythematous eruption.
A few cases of fixed drug eruption have been reported.
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.
Childn syr: 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 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 the doctor immediately.
Brown or purple plaques which can cause skin discoloration (fixed drug eruption). In this case, the patient should see the 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 the doctor or pharmacist.
Drug Interactions
Adult syr: Combinations to be taken into account: Combinations to be taken into account due to the alcohol content of this medicinal product: Medicines causing an antabuse reaction with alcohol (heat sensation, redness, vomiting, tachycardia): disulfiram, cefamandole, cefoperazone, latamoxef (cephalosporin antibacterials), chloramphenicol (phenicol antibacterial), chlorpropamide, glibenclamide, glipizide, tolbutamide (antidiabetic sulfonylureas), griseofulvin (antifungal agent), 5‐nitroimidazoles (metronidazole, ornidazole, secnidazole, tinidazole), ketoconazole, procarbazine (cytostatic agent).
Central nervous system depressants.
Caution For Usage
Adult syr: Incompatibilities: Not applicable.
Childn syr: 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
Store at a temperature below 25°C.
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 (raspberry/cherry flavour) 100 mg/5 mL x 125 mL.
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