Active ingredients: Opium alkaloids and its derivatives
CARDIAZOL-PARACODINA 20 mg / ml + 100 mg / ml oral drops, solution
Why is Cardiazol Paracodina used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Alkaloids of opium and its derivatives
THERAPEUTIC INDICATIONS
Cough suppressant.
Contraindications When Cardiazol Paracodina should not be used
Hypersensitivity to the active substances or to any of the excipients. Severe hepato-cellular insufficiency, respiratory insufficiency, obstinate constipation.
Do not administer during or in the two weeks following treatment with monoamine oxidase inhibitors, nor simultaneously with other drugs belonging to the analgesic-narcotic group. The medicine must not be administered to patients with epilepsy, including anamnestic, or patients with seizure-type disorders.
The product is contraindicated in children under 2 years and during lactation
Precautions for use What you need to know before taking Cardiazol Paracodina
Follow the recommended doses scrupulously.
During the therapy it is not advisable to consume alcohol at the same time.
Interactions Which drugs or foods can modify the effect of Cardiazol Paracodina
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The effects of opium alkaloids on the central nervous system are enhanced by other depressant drugs such as sedatives, tranquilizers, antihistamines and alcohol.
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician to avoid unexpected and unwanted effects from interaction
Warnings It is important to know that:
CARDIAZOL-PARACODINA can be addictive.
Caution requires the use of the preparation especially at high doses and / or for long periods of time in the elderly as the opium alkaloids can cause an aggravation of a pre-existing symptomatology (brain disorders, difficulty in urination, etc.).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
As opiates cross the placental barrier, neonatal respiratory depression is possible.
During pregnancy and infancy the product should be used only in case of real need and under direct medical supervision.
CARDIAZOL-PARACODINA must not be administered during lactation (see section "Contraindications").
For those who play sports:
The use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Effects on ability to drive and use machines
Since drowsiness is not uncommon during treatment, those who may be driving vehicles or attending to operations requiring integrity of vigilance should be warned of this.
Dose, Method and Time of Administration How to use Cardiazol Paracodina: Posology
Average doses (unless otherwise prescribed):
Adults: 10-15-20 drops 2-3 times a day
Boys: 1 drop for each year of age 2-3 times a day
Children over 2 years: 2-5 drops 2-3 times a day
CARDIAZOL-PARACODINA should preferably be taken after meals and not on an empty stomach; for delicate people and children, the preparation is more appreciated if diluted in sugared water or fruit juices.
In the treatment of elderly patients the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
Overdose What to do if you have taken an overdose of Cardiazol Paracodina
The most important symptoms of opioid poisoning reported are: deep coma, decreased respiratory rate, drop in blood pressure, miosis, decreased diuresis, drop in body temperature, pulmonary edema.
Emergency treatment provides, as a first step, an adequate restoration of the respiratory function.
The antidote of choice is considered naloxone which must be administered i.v. at a dose of 0.4 mg. This dose can be repeated after 2-3 minutes. For children the recommended dose is 0.01 mg / kg.
Concerning the symptoms of pentetrazole overdose the following are reported: respiratory depression and seizures of the epileptic type.
Treatment in case of poisoning involves immediate gastric emptying; to control possible convulsive states, administer diazepam or a short-acting barbiturate (eg sodium thiopental) intravenously.
In case of accidental ingestion / intake of an excessive dose of CARDIAZOLPARACODINE, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of CARDIAZOL-PARACODINA, ask your doctor or pharmacist.
Side Effects What are the side effects of Cardiazol Paracodina
Like all medicines, CARDIAZOL-PARACODINE can cause side effects, although not everybody gets them.
At therapeutic doses the most common undesirable effects are represented by sedation and / or somnolence, by gastrointestinal disturbances such as nausea, vomiting and constipation. Headache, dizziness, asthenia, agitation, especially in the elderly, have occasionally been described. More severe signs of nervous depression and respiratory and cardiovascular function may appear in hypersensitive people.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package. Store at a temperature not exceeding 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
HOW TO OPEN THE BOTTLE
To open:
- Place the bottle on a flat surface
- Press the capsule onto the bottle and at the same time unscrew
To close:
- Screw the capsule back in completely
COMPOSITION
1 ml of solution contains: Active principles: pentetrazole 100 mg; dihydrocodeine rhodanate 20 mg. Excipients: purified water, mint essence, polysorbate 80.
PHARMACEUTICAL FORM AND CONTENT
Oral drops, solution - 10 ml dropper bottle
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CARDIAZOL-PARACODINA
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains:
Active principles:
Pentetrazole 100 mg
Dihydrocodeine rhodanate 20 rng
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Oral drops, solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cough suppressant.
04.2 Posology and method of administration
Average doses (unless otherwise prescribed):
Adults: 10-15-20 drops 2-3 times a day
Boys: 1 drop for each year of age 2-3 times a day
Children over 2 years: 2-5 drops 2-3 times a day
CARDIAZOL-PARACODINA it should preferably be taken after meals and not on an empty stomach; for delicate people and children, the preparation is more appreciated if diluted in sugared water or fruit juices.
In the treatment of elderly patients the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients. Hepato-cellular insufficiency gravand, respiratory failure, stubborn constipation.
Do not administer during or in the two weeks following treatment with monoamine oxidase inhibitors, nor simultaneously with other drugs belonging to the analgesic-narcotic group. The medicine must not be administered to patients with epilepsy, including anamnestic, or patients with seizure-type disorders.
The product is contraindicated in children under 2 years and during lactation.
04.4 Special warnings and appropriate precautions for use
Ultra-rapid metabolisers and dihydromorphine intoxication
In about 5.5% of the Western European population, even at therapeutic doses, a higher amount of morphine-like active metabolites may be produced due to the high activity of the CYP2D6 enzyme (ultra-rapid metabolism). A case of morphine intoxication at therapeutic doses of codeine in an ultra-rapid metabolizer has been reported. The risk of intoxication is higher in ultra-rapid metabolisers with impaired renal function (see also section 5.2).
Symptoms of opioid overdose and its treatment are described in section 4.9.
A fatal case of morphine intoxication has been reported in a breastfed infant whose mother was an ultra-rapid metaboliser treated with codeine at therapeutic doses (see also section 4.6).
CARDIAZOL-PARACODINA can be addictive.
Caution requires the use of the preparation especially at high doses and / or for long periods of time in the elderly as the opium alkaloids can cause an aggravation of a pre-existing symptomatology (brain disorders, difficulty in urination, etc.).
Follow the recommended doses scrupulously.
During the therapy it is not advisable to consume alcohol at the same time.
For those who carry out sporting activities:
The use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
04.5 Interactions with other medicinal products and other forms of interaction
The effects of opium alkaloids on the central nervous system are enhanced by other depressant drugs such as sedatives, tranquilizers, antihistamines and alcohol.
The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician to avoid unexpected and unwanted effects of interaction.
04.6 Pregnancy and lactation
As opiates cross the placental barrier, neonatal respiratory depression is possible.
During pregnancy and infancy the product should be used only in case of real need and under direct medical supervision.
CARDIAZOL-PARACODINA it must not be administered during lactation (see section 4.3).
04.7 Effects on ability to drive and use machines
Since drowsiness is not uncommon during treatment, those who may be driving vehicles or attending to operations requiring integrity of vigilance should be warned of this.
04.8 Undesirable effects
At therapeutic doses the most common undesirable effects are represented by sedation and / or somnolence, by gastrointestinal disturbances such as nausea, vomiting and constipation. Headache, dizziness, asthenia, agitation, especially in the elderly, have occasionally been described.
More severe signs of nervous depression and respiratory and cardiovascular function may appear in hypersensitive people.
04.9 Overdose
The most important symptoms of opioid poisoning reported are: deep coma, decreased respiratory rate, drop in blood pressure, miosis, decreased diuresis, drop in body temperature, pulmonary edema.
Emergency treatment provides, as a first step, an adequate restoration of the respiratory function.
The antidote of choice is considered naloxone which must be administered i.v. at a dose of 0.4 mg. This dose can be repeated after 2-3 minutes. For children the recommended dose is 0.01 mg / kg.
Concerning the symptoms of pentetrazole overdose the following are reported: respiratory depression and seizures of the epileptic type.
Treatment in case of poisoning involves immediate gastric emptying; to control possible convulsive states, administer diazepam or a short-acting barbiturate (eg sodium thiopental) intravenously.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Opium alkaloids and its derivatives
ATC code: R05DA20
Pentetrazole fights circulatory and respiratory disorders often present in diseases accompanied by persistent and prolonged cough.
Dihydrocodeine rhodanate is a derivative of codeine which exerts a specific sedative action on the cough center located in the brain stem, thus reducing the frequency and intensity of coughing excesses.
Dihydrocodeine exerts a minimal depressive action on the respiratory center. Furthermore, the rhodanic component, which salifies dihydrocodeine, has a secretolytic action.
05.2 "Pharmacokinetic properties
Studies carried out with pentetrazole administered orally in rats, at a dose of 50 mg / kg, showed their rapid absorption with a plasma peak after one "hour after administration. Similar results were obtained in the brain parenchyma. The half-life time. (t ½) was found to be 202 minutes in the blood and 160 minutes in the brain parenchyma Still detectable concentrations of the drug were determined, both in the blood and in the brain parenchyma, 8 hours after administration.
Special patient groups
Slow and ultra-rapid metabolisers of the CYP2D6 enzyme
Dihydrocodeine is metabolised primarily via glucuroconjugation, but via a minor metabolic pathway, such as O-demethylation, it is converted to dihydromorphine. This metabolic transformation is catalyzed by the CYP2D6 enzyme. About 7% of the population of Caucasian origin has a deficiency of the CYP2D6 enzyme due to genetic variation. These subjects are called poor metabolisers and may not benefit from the expected therapeutic effect as they are unable to transform dihydrocodeine into its active metabolite dihydromorphine.
Conversely, about 5.5% of the population in Western Europe is made up of ultra-rapid metabolisers. These subjects have one or more duplicates of the CYP2D6 gene and therefore may have higher concentrations of dihydromorphine in the blood resulting in an increased risk of adverse reactions (see also sections 4.4 and 4.6).
The existence of ultra-rapid metabolisers should be considered with particular attention in the case of patients with renal insufficiency in whom an increase in the concentration of the active metabolite dihydromorphine-6-glucuronide may occur.
The genetic variation related to the CYP2D6 enzyme can be ascertained by the genetic typing test.
05.3 Preclinical safety data
Acute toxicity
Toxicological tests have shown that in the most common laboratory animals,
CARDIAZOL-PARACODINA it is well tolerated (LD50: mouse p.o. 155 mg / kg, rat p.o. 158 mg / kg, with no substantial difference between the two sexes).
Subacute and chronic toxicity
The association CARDIAZOL-PARACODINA, administered to common laboratory animals (Mus musculus, rat, rabbit and dog) has very low subacute and chronic toxicity. Therefore it is well tolerated for the recommended route of administration, even for high doses and several times higher than those used in clinical practice.
CARDIAZOL-PARACODINA it has not shown any harmful effects on the gestating animal, on the embryo-fetal development and on the reproductive cycle of the rabbit and the albino rat.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Purified water, mint essence, polysorbate 80
06.2 Incompatibility
None
06.3 Period of validity
5 years
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Carton containing a glass dropper bottle with a "child resistant" closure, containing 10 ml of solution.
06.6 Instructions for use and handling
To open:
Place the bottle on a flat surface
Press the capsule onto the bottle and at the same time unscrew
To close:
Screw the capsule back in completely
07.0 MARKETING AUTHORIZATION HOLDER
TEOFARMA S.r.l. Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C .: n. 021473018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: 12.08.1969
Authorization renewal: 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
June 2010
