Active ingredients: Codeine (Neutral Codeine hydrobromide dihydrate), Ivy (Ivy helix fluid extract)
HEDERIX PLAN 6 mg / ml + 45 mg / ml oral drops, solution
Hederix Plan package inserts are available for pack sizes:- HEDERIX PLAN 6 mg / ml + 45 mg / ml oral drops, solution
- HEDERIX PLAN adults 40 mg + 360 mg suppositories HEDERIX PLAN children 10 mg + 180 mg suppositories
Indications Why is Hederix Plan used? What is it for?
HEDERIX PLAN contains codeine and helix ivy.
HEDERIX PLAN is used to calm coughs.
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Hederix Plan should not be used
Do not use HEDERIX PLAN
- if you are allergic to codeine and helix ivy or other substances derived from opium (opium alkaloids) or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from liver disease (severe hepatocellular insufficiency);
- if you suffer from respiratory diseases (respiratory failure);
- if you have been suffering from constipation for several days (stubborn constipation);
- if you are under 12 years old;
- if you know that it metabolizes codeine into morphine very quickly;
- if you are breast-feeding.
Teenagers over the age of 12
HEDERIX PLAN is not recommended for adolescents with impaired respiratory function for the treatment of cough.
Precautions for use What you need to know before taking Hederix Plan
Talk to your doctor or pharmacist before taking HEDERIX PLAN.
Codeine is transformed into morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is either not produced or produced in very small quantities, and therefore has no effect on cough symptoms. Other people are more likely to experience serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you should stop taking the medicine and consult your doctor immediately: slow or shallow breathing, confusion, sleepiness, narrowing of the pupils, feeling unwell or unwell, constipation, lack of appetite.
Tell your doctor before using this medicine:
- if your body converts codeine to morphine (a powerful pain reliever) faster than normal.
Some of the codeine contained in this medicine is transformed by the human body into morphine. About 5.5% of the population of Western Europe transforms codeine into morphine very rapidly. Cases of morphine intoxication even after taking normal doses of codeine (therapeutic doses) have been reported among these subjects, called "ultra-rapid metabolisers".
The risk of intoxication is higher in people with kidney problems.
Children
HEDERIX PLAN is contraindicated in children under 12 years of age. In infancy, the product should be administered only in case of real need and under the direct supervision of the doctor.
Interactions Which drugs or foods may change the effect of Hederix Plan
Other medicines and HEDERIX PLAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Do not take HEDERIX PLAN: if you are taking medicines called "monoamine oxidase inhibitors" used to treat depression, or if you have stopped taking them less than two weeks ago; if you are already taking opium-derived substances;
The effects of HEDERIX PLAN can be enhanced if you take it with:
- medicines used to treat anxiety (sedatives or tranquilizers);
- drugs used to treat allergies (antihistamines);
- alcohol (see section "HEDERIX PLAN with alcohol")
HEDERIX PLAN with alcohol
It is not recommended to use this medicine with alcohol because it increases the sedative effect of morphine analgesics.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take HEDERIX PLAN while breastfeeding. Codeine and morphine pass into breast milk.
Pregnancy
This medicine should not be used during pregnancy unless strictly necessary and under medical supervision.
Driving and using machines
This medicine may affect your ability to drive and use machines. Do not drive or use machines if you feel drowsy.
HEDERIX PLAN contains methyl para-hydroxybenzoate. It can cause allergic reactions (even delayed).
Dose, Method and Time of Administration How to use Hederix Plan: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist. NEVER exceed the dose prescribed by your doctor.
Adults
The recommended dose is 6 to 15 drops 4 times a day or as prescribed by the doctor.
Children
The recommended dose in children over 12 years of age is 4 to 10 drops 4 times a day or as prescribed by the pediatrician.
Method of administration and instructions for use
HEDERIX PLAN must be taken orally. Take this medicine on a full stomach. Shake the bottle before use. The bottle is equipped with a cap with a child resistant safety closure:
- To open, press and unscrew at the same time:
- To close, screw fully and press:
Overdose What to do if you have taken too much Hederix Plan
If you take more HEDERIX PLAN than prescribed, tell your doctor immediately or go to the nearest hospital. Take this leaflet and the pack of this medicine with you even if it is empty.
Symptoms of overdosing can be nervous depression, respiratory problems (depression of the respiratory function) and disorders of the heart and blood circulation (depression of the cardiovascular function).
Side Effects What are the side effects of Hederix Plan
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are:
- an excessive state of "calm" (sedation), sleepiness;
- nausea, vomiting, constipation (constipation).
Occasional side effects are:
- headache (headache), dizziness, feeling of lack of strength and energy (asthenia);
- agitation, which occurs mainly in the elderly.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. .agenziafarmaco.gov.it / it / responsible. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after "Expiry". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What HEDERIX PLAN contains
- The active ingredients are neutral hydrobromide of codeine dihydrate and ivy helix fluid extract. 1 ml of solution contains 6 mg of neutral codeine hydrobromide dihydrate and 45 mg of ivy helix fluid extract.
- The other ingredients are: polysorbate 20, methyl para-hydroxybenzoate, purified water.
Description of what HEDERIX PLAN looks like and contents of the pack
HEDERIX PLAN comes as a solution in a 30ml yellow glass bottle with a child resistant cap.
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
HEDERIX PLAN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
HEDERIX PLAN 6 mg / ml + 45 mg / ml oral drops, solution
1 ml contains:
neutral hydrobromide of codeine dihydrate 6 mg (equal to 5.48 mg as anhydrous salt), ivy helix fluid extract 1: 1 (titre expressed in ederagenina ≥ 4 mg / g) 45 mg.
Excipient with known effects: methyl para-hydroxybenzoate.
HEDERIX PLAN adults 40 mg + 360 mg suppositories
1 suppository of 2.60 g contains:
neutral hydrobromide of codeine dihydrate 40 mg (equal to 36.54 mg as anhydrous salt), ivy helix fluid extract 1: 1 (titre expressed in ederagenina ≥ 4 mg / g) 360 mg.
HEDERIX PLAN children 10 mg + 180 mg suppositories
1 suppository of 1.60 g contains:
neutral hydrobromide of codeine dihydrate 10 mg (equal to 9.13 mg as anhydrous salt), ivy helix fluid extract 1: 1 (titre expressed in ederagenina ≥ 4 mg / g) 180 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral drops, solution.
Suppositories.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cough suppressant.
04.2 Posology and method of administration
HEDERIX PLAN oral drops, solution:
Dosage
Adults: 6 to 15 drops, four times a day or as prescribed by a doctor.
Pediatric population
Children under the age of 12:
HEDERIX PLAN is contraindicated in children below 12 years of age (see section 4.3).
Children between the ages of 12 and 18:
Children over 12 years: 4 to 10 drops, four times a day, according to age or as prescribed by the doctor.
HEDERIX PLAN is not recommended for use in children 12 to 18 years of age with impaired respiratory function (see section 4.4).
HEDERIX PLAN adult suppositories: 1 to 2 suppositories a day or as prescribed by the doctor.
HEDERIX PLAN children suppositories: over 12 years, 1 to 2 suppositories a day or as prescribed by the doctor.
Children under the age of 12:
HEDERIX PLAN is contraindicated in children below 12 years of age (see section 4.3).
Children between the ages of 12 and 18:
HEDERIX PLAN is not recommended for use in children 12 to 18 years of age with impaired respiratory function (see section 4.4).
04.3 Contraindications
• Hypersensitivity to the active substances, to opium alkaloids or to any of the excipients listed in section 6.1;
• Severe hepatocellular insufficiency;
• Respiratory failure;
• Stubborn constipation;
• In children under the age of 12, due to an increased risk of developing serious and life-threatening adverse reactions;
• In women during lactation (see section 4.6);
• In patients known to be CYP2D6 ultra-rapid metabolisers.
04.4 Special warnings and appropriate precautions for use
Follow the recommended doses scrupulously. Alcohol is not recommended during therapy. Do not administer on an empty stomach.
CYP2D6 metabolism
Codeine is metabolised by the hepatic enzyme CYP2D6 to morphine, its active metabolite. If a patient has a deficiency or complete lack of this enzyme, an adequate therapeutic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser, there is an increased risk of developing side effects of opioid toxicity, even at commonly prescribed doses. higher than expected serum morphine levels.
General symptoms of opioid toxicity include confusion, sleepiness, shallow breathing, miotic pupil, nausea, vomiting, constipation, and loss of appetite. In severe cases, symptoms of respiratory and circulatory depression may occur, which can be life-threatening and, very rarely, fatal.
Estimates of the prevalence of ultra-rapid metabolisers in different populations are summarized below:
Children with impaired respiratory function
Codeine is not recommended for use in children in whom there is potential for compromised respiratory function, including neuromuscular disorders, severe respiratory or heart conditions, liver or upper respiratory tract infections, multiple trauma, or extensive surgical procedures. These factors may worsen the symptoms of morphine toxicity.
HEDERIX PLAN oral drops, solution, contains methyl para-hydroxybenzoate. It can cause allergic reactions (even delayed).
04.5 Interactions with other medicinal products and other forms of interaction
Do not administer during or in the two weeks following treatment with monoamine oxidase inhibitors. The effects of opium alkaloids on the central nervous system are enhanced by other depressant drugs such as sedatives, tranquilizers, antihistamines and alcohol.
04.6 Pregnancy and lactation
During pregnancy, the product should be used only in case of real need and under direct medical supervision.
HEDERIX PLAN is contraindicated in lactating women (see section 4.3).
At normal therapeutic doses, codeine and its active metabolite may be present in breast milk at very low doses and are unlikely to adversely affect the infant. However, if the patient is an ultra-rapid metabolizer of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk, which very rarely can cause symptoms of opioid toxicity in the newborn that can be fatal.
04.7 Effects on ability to drive and use machines
HEDERIX PLAN can cause drowsiness, of which those who have to drive vehicles or attend to operations requiring integrity of the degree of vigilance must be warned.
04.8 Undesirable effects
The most common effects can be represented by sedation and somnolence, by gastrointestinal disturbances such as nausea, vomiting and constipation. Headache, dizziness, asthenia, agitation, especially in the elderly, have occasionally been described.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
In the event of an overdose, signs of nervous depression and respiratory and cardiovascular function may appear. In this case, take the appropriate general measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: cough suppressant (opium alkaloids and its derivatives).
ATC code: R05DA04.
Mechanism of action
The medicinal specialty HEDERIX PLAN bases its therapeutic action on the presence of two active ingredients: neutral hydrobromide of codeine dihydrate and fluid extract of ivy helix, titrated in ederagenina.
Codeine: natural alkaloid of opium, it interacts with the opiate receptors of the CNS and the nervous periphery.
The antitussive action is the most therapeutically interesting pharmacodynamic characteristic of codeine and is implemented by intervention on the central (bulbar) neuronal pathways of the cough reflex. For its antitussive efficacy, codeine is the reference drug for the study of any other drug tested for this purpose.
Helix ivy in the form of a fluid extract, obtained from leaves and branches, has a complementary antitussive action. This association does not modify the toxicity of codeine, but enhances its antitussive activity.
05.2 "Pharmacokinetic properties
Codeine is rapidly absorbed from the gastrointestinal tract, the therapeutically active blood peak is reached two hours after administration and lasts for 4 - 6 hours. It has a plasma half-life of approximately 2 hours and is almost completely excreted by the kidney within 4 hours.
Special patient groups
Slow and ultra-rapid metabolisers of the CYP2D6 enzyme
Codeine is metabolised primarily via glucuroconjugation, but through a minor metabolic pathway, such as O-demethylation, it is converted to morphine. This metabolic transformation is catalyzed by the CYP2D6 enzyme. About 7% of the Caucasian population 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 codeine into its active metabolite morphine.
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 morphine 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 morphine-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
The low acute toxicity of codeine is clearly evident in the experimental animal. The oral administration in mice of doses up to 75 mg / kg of codeine hydrobromide did not cause any toxic symptoms. The LD50 of codeine hydrobromide is about 300mg / Kg in mice orally.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
HEDERIX PLAN oral drops, solution
Polysorbate 20, methyl para-hydroxybenzoate, purified water.
HEDERIX PLAN adult suppositories
Medium-chain saturated triglycerides.
HEDERIX PLAN children suppositories
Medium-chain saturated triglycerides.
06.2 Incompatibility
There are no known chemical-physical incompatibilities of HEDERIX PLAN towards other compounds.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
HEDERIX PLAN oral drops, solution
This medicine does not require any special storage conditions.
HEDERIX PLAN adult suppositories and HEDERIX PLAN children suppositories
Protect from heat sources.
06.5 Nature of the immediate packaging and contents of the package
HEDERIX PLAN oral drops, solution
Pharmaceutical yellow glass bottle of 30 ml, with child resistant closure.
HEDERIX PLAN adult suppositories
N ° 10 alveoli in opaque white PVC.
HEDERIX PLAN children suppositories
N ° 10 alveoli in opaque white PVC.
06.6 Instructions for use and handling
HEDERIX PLAN oral drops, solution
Shake before using.
HEDERIX PLAN adult suppositories and HEDERIX PLAN children suppositories
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Pharmaceutical Laboratory SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV).
08.0 MARKETING AUTHORIZATION NUMBER
HEDERIX PLAN oral drops, solution: A.I.C. 007645056
HEDERIX PLAN adult suppositories: A.I.C. 007645082
HEDERIX PLAN children suppositories: A.I.C. 007645070
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 01/10/1991
Date of most recent renewal: 01/06/2010
10.0 DATE OF REVISION OF THE TEXT
08/11/2015
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