- 1 Important to know about Biocalyptol Syrup ?
- 2 Biocalyptol Syrup indication and Uses :
- 3 Biocalyptol Syrup Dosage :
- 4 How it works Biocalyptol Syrup :
- 5 Biocalyptol Syrup Side Effects :
- 6 Biocalyptol Syrup Interactions :
- 7 Biocalyptol Syrup Warnings and Precautions :
- 8 Drive and use machines:
- 9 Biocalyptol Syrup and PREGNANCY / BREAST FEEDING / FERTILITY:
- 10 Pregnancy :
- 11 Breastfeeding:
- 12 What should I do if I miss a dose?
- 13 What happens if I overdose from Biocalyptol Syrup ?
- 14 What is Forms and Composition Biocalyptol Syrup?
Important to know about Biocalyptol Syrup ?
This medicine is a central cough suppressant. It is indicated to calm dry coughs and irritation coughs.
Biocalyptol Syrup indication and Uses :
Symptomatic treatment of uncompromising coughs.
Biocalyptol Syrup Dosage :
Reserved for adults and children over 30 months.
1 measuring cup (15 ml) contains 19.65 mg of pholcodine. Each graduation of 2.5 ml corresponds to 3,275 mg of pholcodine.
– Symptomatic treatment should be short (a few days) and limited to the times when coughing occurs.
– The therapeutic dose maximum pholcodine is:
. adults : 90 mg per day
. in children aged 6 to 15 years : 1 mg / kg per day
,. in children from 30 months to 6 years : 0.5 mg / kg per day.
– In all cases, the catch should be spaced at least 4 hours apart.
– In the absence of other drug intake bringing codeine or any other central antitussive the usual dose of Biocalyptol Syrup syrup is:
. In adults : 15 ml (1 measuring cup) per dose to be renewed if necessary, without exceeding 4 doses per day.
. In children from 35 to 50 kg (12 to 15 years) : 5 ml (2 graduations of measuring cup) per intake, to renew if necessary, without exceeding 6 taken per day.
. In children from 20 to 35 kg (6 to 12 years) : 2.5 ml (1 graduation of measuring cup) per dose, to be renewed if necessary, without exceeding 6 doses per day.
. In children from 15 to 20 kg (30 months to 6 years): 2,5 ml (1 measuring cup graduation) per dose, repeat if necessary, 2 to 3 times daily. The maximum daily dose is 5 to 7.5 ml depending on weight.
How it works Biocalyptol Syrup :
ATC Code: R05DA08.
Pholcodine : antitussive morphine derivative of central action. Its depressive action on the respiratory centers is less than that of codeine.
Biocalyptol Syrup Side Effects :
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Nausea, vomiting, constipation,
· Breathing difficulty, asthma attack,
· Allergic reactions: symptoms may include itching, hives, swelling of the face and possible severe allergic reactions,
Due to the presence of yellow-orange S in excipients, risk of allergic reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
Biocalyptol Syrup Interactions :
ASSOCIATION DISCONTINUED :
Increase by alcohol of the sedative effect of the central antitussifs. Impairment of alertness can make driving and using machines dangerous.
Avoid taking alcoholic drinks and drugs containing alcohol.
ASSOCIATIONS TO BE TAKEN INTO ACCOUNT :
Other central nervous system depressants :
morphine derivatives (analgesics and substitution treatments), benzodiazepines, barbiturates, anxiolytics other than benzodiazepines, hypnotics, neuroleptics, sedative antihistamines H1, sedative antidepressants, central antihypertensives, baclofen, thalidomide .
Increase of the central depression. Impairment of alertness can make driving and using machines dangerous.
In addition, for morphine derivatives (analgesics and substitution treatments), barbiturates, benzodiazepines: risk of respiratory depression, which can be fatal in case of overdose.
Biocalyptol Syrup Warnings and Precautions :
· The productive coughs which are a fundamental element of the broncho-pulmonary defense must be respected.
· It is illogical to associate an expectorant or mucolytic to an antitussive.
· Before delivering antitussive therapy, it should be ensured that cough causes that require specific treatment have been sought.
· If the cough is resistant to an antitussive given at a usual dosage, the dose should not be increased, but the clinical situation should be reconsidered.
· This specialty contains, as an excipient, a terpene derivative (cineole), which can lower the epileptogenic threshold. In excessive doses, risk of neurological accidents such as convulsions in infants and children. Respect the recommended dosages and duration of treatment.
· This medicine contains an azo coloring agent (E110) and may cause allergic reactions.
· This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase / isomaltase deficiency. This medicine contains 12.52 g of sucrose per 15 ml measuring cup, which must be taken into account in the daily ration in case of low sugar diet or diabetes.
· This medicine contains low amounts of ethanol (alcohol), less than 100 mg per 15 ml measuring cup.
Precautions for use
· Elderly / hepatic insufficiency The initial dosage will be halved relative to the recommended dosage in adults, and may be increased depending on tolerance and need.
· Taking alcoholic beverages and medicines containing alcohol (see section 4.5) during treatment is not recommended.
· If there is a history of epilepsy, consider the presence, as an excipient, of a terpene derivative, cineole.
Drive and use machines:
Attention is drawn to the risk of drowsiness associated with the use of this medication, particularly for vehicle drivers and machine users.
Biocalyptol Syrup and PREGNANCY / BREAST FEEDING / FERTILITY:
There is no teratogenesis study available in animals.Clinically, no malformative or fetotoxic effect has emerged to date. However, the monitoring of pregnancies exposed to this drug is insufficient to exclude any risk.
During the last three months of pregnancy, the mother’s chronic use of pholcodine, irrespective of the dose, may be the cause of withdrawal syndrome in the newborn.
In late pregnancy, high doses, even in short treatment, are likely to cause respiratory depression in the newborn.
Therefore, as a precaution, it is best not to use pholcodine during pregnancy.
What should I do if I miss a dose?
do not take a double dose to make up for the dose you forgot to take.
What happens if I overdose from Biocalyptol Syrup ?
in case of accidental overdose, STOP THE TREATMENT AND CONSULT YOUR DOCTOR QUICKLY.
What is Forms and Composition Biocalyptol Syrup?
|FORMS and PRESENTATIONS|
Syrup: 200 ml bottle, with 15 ml measuring cup, graduated to 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml.
|2.5 ml||15 ml|
|pholcodine||3,275 mg||19.65 mg|
Excipients: cineole, mint green (patent blue V [E 131], orange yellow S [E 110], quinoline yellow [E 104], sodium chloride), ethanol 96%, sucrose solution, purified water.
Excipients with known effect: yellow orange S (E110), ethanol 96% (<100 mg / scoop 15 ml), sucrose solution (12.52 g / scoop 15 ml).