HEDERIX 6 mg /Ml + 45 Mg/Ml Oral Drops, Solution

Зміст інструкції

1. HEDERIX PLAN adults 40 mg + 360 mg suppositories, children 10 mg + 180 mg suppositories
   1. What is HEDERIX PLAN and what is it used for
   2. What you need to know before you use HEDERIX PLAN
   3. How to use HEDERIX PLAN
   4. Possible side effects
   5. How to store HEDERIX PLAN
   6. Contents of the pack and other information
2. HEDERIX PLAN 6 mg/ml + 45 mg/ml oral drops, solution
   1. What HEDERIX PLAN is and what it is used for
   2. What you need to know before you take HEDERIX PLAN
   3. How to take HEDERIX PLAN
   4. Possible side effects
   5. How to store HEDERIX PLAN
   6. Contents of the pack and other information

HEDERIX PLAN adults 40 mg + 360 mg suppositories, children 10 mg + 180 mg suppositories

Codeine hydrobromide dihydrate + Hedera helix fluid extract

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What HEDERIX PLAN is and what it is used for
• 2. What you need to know before using HEDERIX PLAN
• 3. How to use HEDERIX PLAN
• 4. Possible side effects
• 5. How to store HEDERIX PLAN
• 6. Contents of the pack and other information

1. What is HEDERIX PLAN and what is it used for

HEDERIX PLAN contains codeine and ivy helix.
HEDERIX PLAN is used to relieve cough.

2. What you need to know before you use HEDERIX PLAN

Do not use HEDERIX PLAN

• if you are allergic to codeine and ivy helix or to other substances derived from opium (opium alkaloids) or to 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 of age;
• if you know that you metabolize codeine into morphine very quickly;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using HEDERIX PLAN.
Codeine is converted 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
may affect people in different ways. In some people, morphine is not produced or
is produced in very small amounts, and therefore has no effect on cough symptoms. Others
are more likely to experience serious side effects because a large 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, drowsiness, constricted pupils, feeling unwell or sick,
constipation, loss of appetite.

Tell your doctor before using this medicine:

• if your body converts codeine into morphine (a potent pain reliever) faster than normal.

Part of the codeine contained in this medicine is converted by the human body into morphine.
Approximately 5.5% of the population of Western Europe rapidly converts codeine into
morphine. Among these subjects, called “ultrarapid metabolizers”, cases of
morphine intoxication have been reported even after taking normal doses of codeine (therapeutic doses).
The risk of intoxication is higher in subjects with kidney problems.

Children
HEDERIX PLAN is contraindicated in children under 12 years of age.
In childhood, the product should only be administered if absolutely necessary and under the direct supervision of
the doctor.

Adolescents over 12 years of age
HEDERIX PLAN is not recommended for adolescents with impaired respiratory function for
the treatment of cough.

Other medicines and HEDERIX PLAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, the concomitant use of HEDERIX PLAN with sedatives such as benzodiazepines or
related drugs increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma
and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if the doctor prescribes HEDERIX PLAN together with sedatives, the dose and duration of
concomitant treatment must be limited by the doctor. Please tell your doctor about all
sedatives you are taking and carefully follow the dose recommended by the doctor. It may
be helpful to inform friends or relatives about the signs and symptoms indicated above. Contact your doctor
when these symptoms occur.

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 substances
derived from opium.
The effects of HEDERIX PLAN may be enhanced if you take it with:

• medicines used to treat anxiety (sedatives or tranquilizers including benzodiazepines);
• 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-like analgesics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before using this medicine.
Pregnancy
This medicine should not be used during pregnancy unless strictly necessary and
under the control of the doctor.
Breastfeeding
Do not take HEDERIX PLAN while breastfeeding. Codeine and morphine
pass into breast milk.

Driving and using machines
This medicine can alter your ability to drive vehicles and use machines. Do not drive
vehicles or use machines if you feel drowsy.

3. How to use HEDERIX PLAN

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, ask your doctor or pharmacist.
Do not ever exceed the dose prescribed by your doctor.

Adults

HEDERIX PLAN adulti 40 mg + 360 mg suppositories
The recommended dose is 1 to 2 suppositories per day or as prescribed by your doctor.

Children

HEDERIX PLAN bambini 10 mg + 180 mg suppositories
The recommended dose in children over 12 years of age is 1 to 2 suppositories per day or as prescribed
by your doctor.
Method of administration
HEDERIX PLAN must be administered rectally.

If you use more HEDERIX PLAN than you should
If you use a dose of HEDERIX PLAN, higher than that prescribed, immediately inform your
doctoror go to the nearest hospital. Bring this leaflet and the packaging of this
medicine with you, even if it is empty.
Symptoms of overdose may include nervous depression, breathing problems (respiratory depression) and heart and blood circulation disorders (cardiovascular depression).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The more common side effects are:

• an excessive state of “calm” (sedation), drowsiness;
• nausea, vomiting, constipation.

The occasionalside effects are:

• headache, dizziness, feeling of lack of strength and energy (asthenia);
• agitation, which manifests mainly in the elderly.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist or nurse.
You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store HEDERIX PLAN

Keep this medicine out of the sight and reach of children.
Protect the medicine from heat sources.
Do not use this medicine after the expiry date that is reported on the pack after “Scad.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What HEDERIX PLAN contains
HEDERIX PLAN adults 40 mg + 360 mg suppositories

• The active ingredients are: codeine hydrobromide neutral hydrate, ivy helix fluid extract. One suppository contains 40 mg of codeine hydrobromide neutral hydrate and 360 mg of ivy helix fluid extract.
• The other ingredients are medium chain saturated triglycerides.

HEDERIX PLAN children 10 mg + 180 mg suppositories

• The active ingredients are: codeine hydrobromide neutral hydrate, ivy helix fluid extract. One suppository contains 10 mg of codeine hydrobromide neutral hydrate and 180 mg of ivy helix fluid extract.
• The other ingredients are medium chain saturated triglycerides.

Description of the appearance of HEDERIX PLAN and contents of the pack
HEDERIX PLAN adults 40 mg + 360 mg suppositories are available in packs of 10 suppositories.
HEDERIX PLAN children 10 mg + 180 mg suppositories are available in packs of 10 suppositories.

Marketing Authorisation Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)

Manufacturer
DMS Farmaceutici S.p.a. - Via Provinciale per Lecco, 78 – 22038 Tavernerio (CO)

HEDERIX PLAN 6 mg/ml + 45 mg/ml oral drops, solution

Codeine hydrobromide dihydrate + Hedera helix fluid extract

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What HEDERIX PLAN is and what it is used for
• 2. What you need to know before you take HEDERIX PLAN
• 3. How to take HEDERIX PLAN
• 4. Possible side effects
• 5. How to store HEDERIX PLAN
• 6. Contents of the pack and other information

1. What HEDERIX PLAN is and what it is used for

HEDERIX PLAN contains codeine and ivy helix.
HEDERIX PLAN is used to relieve cough.

2. What you need to know before you take HEDERIX PLAN

Do not use HEDERIX PLAN

• if you are allergic to codeine and ivy helix or to other substances derived from opium (opium alkaloids) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from liver diseases (severe hepatocellular insufficiency);
• if you suffer from respiratory system diseases (respiratory insufficiency);
• if you have been suffering from constipation for several days (stubborn constipation);
• if you are under 12 years of age;
• if you know that you metabolize codeine into morphine very quickly;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking HEDERIX PLAN.
Codeine is converted 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
may affect people in different ways. In some people, morphine is not produced or
is produced in very small quantities, and therefore has no effect on cough symptoms. Others
are more likely to experience serious side effects because a large 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, drowsiness, pinpoint pupils, feeling unwell or sick,
constipation, loss of appetite.

Tell your doctor before using this medicine:

• if your body converts codeine to morphine (a potent pain reliever) faster than normal.

Part of the codeine contained in this medicine is converted into morphine by the human body.
Approximately 5.5% of the population of Western Europe converts codeine to
morphine very quickly. Among these subjects, called “ultrarapid metabolizers”, cases of
morphine intoxication have been reported even after taking normal doses of codeine (therapeutic doses).
The risk of intoxication is higher in subjects with kidney problems.

Children
HEDERIX PLAN is contraindicated in children under 12 years of age.
In childhood, the product should only be administered if absolutely necessary and under the direct supervision of
the doctor.

Adolescents over 12 years of age
HEDERIX PLAN is not recommended for adolescents with impaired respiratory function for
the treatment of cough.

Other medicines and HEDERIX PLAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, the concomitant use of HEDERIX PLAN with sedatives such as benzodiazepines or
related drugs increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma
and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes HEDERIX PLAN together with sedatives, the dose and duration of
concomitant treatment must be limited by the doctor. Please tell your doctor about all
sedatives you are taking and carefully follow the dose recommended by your doctor. It may
be helpful to inform friends or relatives about the signs and symptoms indicated above. Contact your doctor
when these symptoms occur.

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 substances derived from opium.
The effects of HEDERIX PLAN may be enhanced if you take it with:

• medicines used to treat anxiety (sedatives or tranquilizers including benzodiazepines);
• 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-like analgesics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
Pregnancy
This medicine should not be used during pregnancy unless strictly necessary and
under the control of the doctor.
Breastfeeding
Do not take HEDERIX PLAN while breastfeeding. Codeine and morphine
pass into breast milk.

Driving and using machines
This medicine can impair your ability to drive and operate machines. Do not drive
vehicles or use machines if you feel drowsy.

HEDERIX PLAN contains methyl para-hydroxybenzoate.It may cause allergic reactions (including
delayed reactions).

3. How to take HEDERIX PLAN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Do not exceed the dose prescribed by your doctor.

Adults
The recommended dose is from 6 to 15 drops 4 times a day as prescribed by your doctor.

Children
The recommended dose in children over 12 years of age is from 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 child-resistant safety closure cap:

• To openpress and simultaneously unscrew:

• To closescrew on tightly and press:

If you take more HEDERIX PLAN than you should
If you take a dose of HEDERIX PLAN, higher than that prescribed, immediately inform your
doctoror go to the nearest hospital. Bring this leaflet and the packaging of this
medicine with you, even if it is empty.
Symptoms of overdose may include nervous depression, breathing problems (respiratory depression) and heart and blood circulation disorders (cardiovascular depression).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonside effects are:

• an excessive state of “calmness” (sedation), drowsiness;
• nausea, vomiting, constipation.

The occasionalside effects are:

• headache, dizziness, feeling of lack of strength and energy (asthenia);
• agitation, which manifests especially in the elderly.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist or nurse.
You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse..
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store HEDERIX PLAN

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 pack after “Expiry”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What HEDERIX PLAN contains

• The active ingredients are codeine neutral bromide dihydrate and ivy helix fluid extract. 1 ml of solution contains 6 mg of codeine neutral bromide dihydrate and 45 mg of ivy helix fluid extract.
• The other ingredients are polysorbate 20, methyl parahydroxybenzoate, purified water.

Description of the appearance of HEDERIX PLAN and contents of the pack
HEDERIX PLAN is presented as a solution in a 30 ml yellow glass bottle with a child-resistant closure cap.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)