Hederix Plan

Patient Information Leaflet

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

codeine hydrobromide dihydrate + Hedera helix fluid extract
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking 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 leaf extract (Hedera helix).
HEDERIX PLAN is indicated for the relief of cough.

2. What you need to know before taking HEDERIX PLAN

Do not use HEDERIX PLAN

• if you are allergic to codeine and ivy helix or to other opium-derived substances (opium alkaloids) or to any of the other ingredients of this medicine (listed in section 6);
• if you have liver disease (severe hepatic insufficiency);
• if you have respiratory disorders (respiratory insufficiency);
• if you have had constipation for several days (persistent constipation);
• if you are under 12 years of age;
• if you know that you metabolize codeine very rapidly into morphine;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking HEDERIX PLAN.
Contact your doctor if you experience severe pain in the upper abdomen possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) or bile ducts.
Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for codeine's effects. Some individuals have variations in this enzyme, which may affect people differently. In some individuals, morphine is not produced or is produced in very low amounts, thus having no effect on cough symptoms. Others may be at higher risk of serious adverse effects because very high levels of morphine are produced. If you notice any of the following adverse effects, stop taking the medicine immediately and contact your doctor without delay: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, malaise or feeling unwell, constipation, loss of appetite.

Tolerance, physical and psychological dependence
Repeated use of opioids may reduce the effectiveness of the medicine (you become accustomed to it, a phenomenon known as tolerance). Repeated use of HEDERIX PLAN may also lead to physical and psychological dependence and abuse, potentially resulting in fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Physical or psychological dependence may make you feel that you have lost control over the amount of medicine you take or how often you take it.
The risk of developing dependence varies from person to person. You may have a higher risk of becoming dependent on HEDERIX PLAN if:

• you or a family member has previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence ("addiction");
• you are a smoker;
• you have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking HEDERIX PLAN, this could indicate that you have become dependent:

• you need to take the medicine for a longer period than prescribed by your doctor;
• you need to take a higher dose than recommended;
• you feel a need to continue taking the medicine even though it does not help relieve your cough;
• you use the medicine for reasons other than those prescribed, for example, "to stay calm" or "to help sleep";
• you have repeatedly tried to stop or control your use of this medicine without success;
• you feel unwell when you stop taking the medicine and feel better when you restart it ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including whether it is appropriate to stop treatment and how to do so safely (see section 3 “If you stop taking HEDERIX PLAN”).
In case of dependence, withdrawal symptoms such as irritability, agitation, insomnia, anxiety, and palpitations (awareness of heartbeat) may occur when treatment is discontinued.

Sleep-related breathing disorders
HEDERIX PLAN may cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Your doctor may consider reducing the dose.
Dose.
Inform your doctor before using this medicine:

• if your body converts codeine into morphine (a potent painkiller) more rapidly than normal. Part of the codeine contained in this medicine is metabolized by the human body into morphine. Approximately 5.5% of the population in Western Europe metabolizes codeine into morphine very rapidly. In these individuals, known as “ultra-rapid metabolizers,” cases of morphine poisoning have been reported even after taking normal doses of codeine (therapeutic doses). The risk of poisoning is higher in individuals with kidney problems.

Children and adolescents
HEDERIX PLAN is contraindicated in children and adolescents under 12 years of age.
Adolescents over 12 years of age
HEDERIX PLAN is not recommended for adolescents over 12 years of age with compromised 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:

• concomitant use of HEDERIX PLAN with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
• gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain). However, if your doctor prescribes HEDERIX PLAN together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Please inform your doctor about all sedative medicines you are taking and follow carefully the dose recommended by your doctor. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

Do not take HEDERIX PLAN
If you are taking medicines called "monoamine oxidase inhibitors" (MAOIs), used to treat depression, or if you have stopped taking them less than two weeks ago; or if you are already taking opium-derived substances.
The effects of HEDERIX PLAN may be enhanced if taken together with:

• medicines used to treat anxiety (sedatives or tranquilizers, including benzodiazepines);
• medicines used to treat allergies (antihistamines);
• alcohol (see section “HEDERIX PLAN with alcohol”).

HEDERIX PLAN with alcohol
Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Your doctor will prescribe HEDERIX PLAN only if clearly necessary.
Breastfeeding
Do not take HEDERIX PLAN while breastfeeding. Codeine and morphine pass into breast milk (see “Do not take HEDERIX PLAN”).

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

HEDERIX PLAN contains methyl 4-hydroxybenzoate.
It may cause allergic reactions (including delayed reactions).

3. How to take HEDERIX PLAN

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 6–15 drops, up to 4 times daily if needed, with an interval of 6 hours
between each administration.
The maximum daily dose is 60 drops.
Do not exceed the maximum daily dose.
Do not exceed 3 days of treatment.
HEDERIX PLAN should be used for the shortest duration necessary to relieve symptoms.
Adolescents over 12 years of age
The recommended dose is 4–10 drops, up to 4 times daily if needed, with an interval of 6 hours
between each administration.
The maximum daily dose is 40 drops.
Do not exceed the maximum daily dose.
Do not exceed 3 days of treatment.
HEDERIX PLAN should be used for the shortest duration necessary to relieve symptoms.
Method of administration and instructions for use

HEDERIX PLAN is for oral use.

Take this medicine with a full stomach.
Shake the bottle before use.
The bottle is equipped with a child-resistant safety cap:

• To open, press down and at the same time unscrew:
• To close, screw tightly and press down:

If you use more HEDERIX PLAN than you should
If you take a higher dose of HEDERIX PLAN than prescribed, contact your doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine’s packaging with you, even if it is empty.
Symptoms of overdose may include nervous depression, breathing problems (respiratory depression), and reduced heart activity leading to decreased blood flow to organs (cardiocirculatory depression).

If you forget to take HEDERIX PLAN
Do not take a double dose to make up for the missed dose.

If you stop using HEDERIX PLAN
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur during treatment:

Common side effects (affect fewer than 1 in 10 patients):

• sedation,
• drowsiness,
• nausea,
• vomiting,
• constipation (stipsis).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• headache (cephalalgia),
• dizziness,
• weakness (asthenia),
• agitation, particularly in elderly patients,
• symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts (a condition affecting an intestinal valve known as sphincter of Oddi dysfunction), for example severe upper abdominal pain possibly radiating to the back, nausea, vomiting, or fever.

Withdrawal syndrome
Following discontinuation of medicines containing dihydrocodeine after prolonged use, cases of withdrawal symptoms such as irritability, agitation, insomnia, anxiety, and palpitations (awareness of heartbeat) have been reported (see "Warnings and precautions").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 sight and reach of children.
Store this medicine in a safe and secure place, inaccessible to other people. It may cause
serious harm or be fatal to individuals for whom it is not intended.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after “Expiry”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What HEDERIX PLAN contains

• The active substances are codeine phosphate dihydrate and Hedera helix fluid extract. 1 ml of solution contains 6 mg of codeine phosphate dihydrate and 45 mg of Hedera helix fluid extract.
• The other components 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 amber glass bottle with a child-resistant cap.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Patient Information Leaflet

HEDERIX PLAN 40 mg + 360 mg suppositories

Adults
HEDERIX PLAN 10 mg + 180 mg suppositories
Adolescents from 12 years of age
codeine hydrobromide dihydrate + Hedera helix fluid extract
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 HEDERIX PLAN is and what it is used for

HEDERIX PLAN contains codeine and Hedera helix.
HEDERIX PLAN is indicated for the relief of cough.

2. What you need to know before using 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 have liver disease (severe hepatic insufficiency);
• if you have respiratory disorders (respiratory insufficiency);
• if you have had constipation for several days (persistent constipation);
• if you are under 12 years of age;
• if you know that you metabolize codeine into morphine very rapidly;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using HEDERIX PLAN.
Contact your doctor if you experience severe pain in the upper abdomen possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts.
Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for codeine's effects. Some people have variations in this enzyme, which may affect individuals differently. In some people, morphine is not produced or is produced in very small amounts, thus having no effect on cough symptoms. Other people are more likely to experience serious adverse effects because a very high amount of morphine is produced. If you notice any of the following adverse effects, you must stop taking the medicine and contact your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, malaise or feeling unwell, constipation, loss of appetite.

Tolerance, physical and psychological dependence
Repeated use of opioids may make the medicine less effective (you become accustomed to it, a phenomenon known as tolerance). Repeated use of HEDERIX PLAN may also lead to physical and psychological dependence and abuse, potentially resulting in fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Physical or psychological dependence may make you feel that you no longer have control over how much medicine you take or how often you take it.
The risk of developing dependence varies from person to person. You may have a higher risk of becoming dependent on HEDERIX PLAN if:

• you or a family member have previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence ("addiction");
• you are a smoker;
• you have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking HEDERIX PLAN, this may indicate that you have become dependent:

• you need to take the medicine for a longer period than indicated by your doctor;
• you need to take a higher dose than recommended;
• you feel the need to continue taking the medicine, even if it does not help relieve your cough;
• you use the medicine for reasons other than prescribed, for example, "to stay calm" or "to help sleep";
• you have tried several times to stop or control the use of this medicine without success;
• when you stop taking the medicine you feel unwell, and when you restart it you feel better ("withdrawal effects").

If you notice any of these signs, consult your doctor to discuss the best treatment approach for you, including whether treatment should be discontinued and how to do so safely (see section 3 "If you stop taking HEDERIX PLAN").
In case of dependence, withdrawal symptoms such as irritability, agitation, insomnia, anxiety, and palpitations (awareness of heartbeat) may occur when treatment is stopped.

Sleep-related breathing disorders
HEDERIX PLAN may cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Inform your doctor before using this medicine:

• if your body metabolizes codeine into morphine (a potent painkiller) more quickly than normal.

A portion of the codeine contained in this medicine is converted by the human body into morphine. Approximately 5.5% of the population in Western Europe metabolizes codeine into morphine very rapidly. In these individuals, known as "ultra-rapid metabolizers," cases of morphine poisoning have been reported even after taking normal doses of codeine (therapeutic doses).
The risk of poisoning is higher in individuals with kidney problems.

Children and adolescents
HEDERIX PLAN is contraindicated in children and adolescents under 12 years of age.

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

Other medicines and HEDERIX PLAN
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
In particular:

• the concomitant use of HEDERIX PLAN with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible;
• gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain). However, if your doctor prescribes HEDERIX PLAN together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Please inform your doctor about all sedative medicines 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 listed above. Contact your doctor if such symptoms occur.

Do not take HEDERIX PLAN
If you are taking medicines called "monoamine oxidase inhibitors" (MAOIs), used to treat depression, or if you have stopped taking them less than two weeks ago; or if you are already taking substances derived from opium.
The effects of HEDERIX PLAN may be enhanced if taken with:

• medicines used to treat anxiety (sedatives or tranquilizers, including benzodiazepines);
• medicines used to treat allergies (antihistamines);
• alcohol (see section "HEDERIX PLAN with alcohol").

HEDERIX PLAN with alcohol
Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.

Pregnancy
Your doctor will prescribe HEDERIX PLAN only if clearly necessary.

Breastfeeding
Do not take HEDERIX PLAN while breastfeeding. Codeine and morphine pass into breast milk (see "Do not use HEDERIX PLAN").

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

3. How to use HEDERIX PLAN

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
HEDERIX PLAN 40 mg + 360 mg suppositories
Adults
The recommended dose is 1 - 2 suppositories per day, if necessary, with an interval of 12 hours between
one dose and the next.
The maximum daily dose is 2 suppositories.
Do not exceed the maximum daily dose.
Treatment must not last longer than 3 days.
HEDERIX PLAN should be used for the shortest duration necessary to relieve symptoms.
HEDERIX PLAN 10 mg + 180 mg suppositories
Adolescents over 12 years of age
The recommended dose is 1 - 2 suppositories per day, if necessary, with an interval of 12 hours between
one dose and the next.
The maximum daily dose is 2 suppositories.
Do not exceed the maximum daily dose.
Treatment must not last longer than 3 days.
HEDERIX PLAN should be used for the shortest duration necessary to relieve symptoms.
Method of administration
HEDERIX PLAN is for rectal use.
If you use more HEDERIX PLAN than you should
If you use a dose of HEDERIX PLAN higher than prescribed, contact your doctor immediately
or go to the nearest hospital. Take this leaflet and the medicine package with you, even if it is
empty.
Symptoms of overdose may include nervous depression, breathing problems (respiratory depression), and reduced heart activity leading to decreased blood flow to organs (cardiocirculatory depression).
If you forget to use HEDERIX PLAN
Do not use a double dose to make up for the missed dose.
If you stop treatment with HEDERIX PLAN
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur during treatment:

Common side effects (affect fewer than 1 in 10 patients):

• sedation,
• drowsiness,
• nausea,
• vomiting,
• constipation (stipsis).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• headache (cephalalgia),
• dizziness,
• weakness (asthenia),
• agitation, particularly in elderly patients,
• symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts (a condition affecting an intestinal valve known as sphincter of Oddi dysfunction), such as severe upper abdominal pain possibly radiating to the back, nausea, vomiting, or fever.

Withdrawal syndrome
Cases of withdrawal symptoms have been reported after discontinuation of medicines containing dihydrocodeine following prolonged use, including symptoms such as irritability, agitation, insomnia, anxiety, and palpitations (awareness of heartbeat) (see "Warnings and precautions").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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.
Store this medicine in a safe and secure place, inaccessible to other people. It may cause
serious harm or even be fatal to individuals for whom it is not intended.
Protect the medicine from sources of heat.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

• The active substances are: codeine hydrobromide dihydrate, Hedera helix fluid extract. Each suppository contains 40 mg of codeine hydrobromide dihydrate and 360 mg of Hedera helix fluid extract.
• The other components are medium-chain saturated triglycerides.

HEDERIX PLAN 10 mg + 180 mg suppositories

• The active substances are: codeine hydrobromide dihydrate, Hedera helix fluid extract. Each suppository contains 10 mg of codeine hydrobromide dihydrate and 180 mg of Hedera helix fluid extract.
• The other components are medium-chain saturated triglycerides.

Description of the appearance of HEDERIX PLAN and contents of the pack
HEDERIX PLAN 40 mg + 360 mg suppositories are supplied in packs of 10 suppositories.
HEDERIX PLAN 10 mg + 180 mg suppositories are supplied in packs of 10 suppositories.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Provinciale per Lecco, 78 – 22038 Tavernerio (CO)