Dhc Continus

Leaflet attached to the packaging: patient information

DHC Continus,60 mg, prolonged-release tablets
DHC Continus,90 mg, prolonged-release tablets
Dihydrocodeine tartrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

• 1. What is DHC Continus and what is it used for
• 2. Important information before taking DHC Continus
• 3. How to take DHC Continus
• 4. Possible side effects
• 5. How to store DHC Continus
• 6. Contents of the pack and other information

1. What is DHC Continus and what is it used for

DHC Continus contains the active substance dihydrocodeine tartrate, which belongs to a group of strong painkillers called opioids.
DHC Continus is used to treat severe cancer pain and chronic (long-term) pain of other origins.

2. Important information before taking DHC Continus

When not to take DHC Continus:

• if you are allergic to dihydrocodeine or any of the other ingredients of this medicine (listed in section 6);
• if you have severe chronic obstructive pulmonary disease;
• if you have a condition called acute heart failure;
• if you have severe asthma;
• if you have severe respiratory depression with hypoxia;
• in children under 12 years of age;
• if you have paralytic ileus;
• if you have a head injury or increased intracranial pressure,
• if you suffer from alcoholism (acute phase);
• if you have previously been diagnosed with intolerance to some sugars.

Warnings and precautions

If you are or have been addicted to opioid medicines, other medicines, or alcohol, you should avoid taking DHC Continus. However, if your doctor has prescribed DHC Continus for you with an alcohol problem or drug abuse, they will regularly check your liver function.
DHC Continus should be used with caution in the following cases:

• if you have respiratory depression (shallow breathing, followed by cessation of breathing) with hypoxia;
• if you have chronic obstructive pulmonary disease;
• if you have asthma;
• if you have heart failure;
• if you have sleep apnea;
• if you are taking other medicines that affect the central nervous system (see section 2, DHC Continus and other medicines).
• if you are taking monoamine oxidase inhibitors or have stopped taking them in the last 2 weeks;
• if you have tolerance to the medicine, physical dependence, and withdrawal syndrome
• if you are psychologically dependent on medicines, psychotropic substances, and/or alcohol;
• if you have a head injury, intracranial changes, or increased intracranial pressure,
• if you have consciousness disorders of unknown origin;
• if you have biliary disorders;
• if you have pancreatitis;
• if you have liver function disorders;
• if you have severe renal failure;
• if you have constipation;
• if you have hypothyroidism;
• if you have prostatic hyperplasia;
• if you are elderly;

Respiratory depression
The primary risk of opioid overdose is respiratory depression.
Sleep-related breathing disorders
Opioids can cause sleep-related breathing disorders, including central sleep apnea (CSA) and sleep-related hypoxemia. In some patients, opioid use may increase the risk of CSA in a dose-dependent manner. Opioids can also exacerbate existing sleep apnea (see section 4). The doctor may then consider reducing the total daily dose of opioids.
Concomitant use of DHC Continus with sedative medicines, such as benzodiazepines or related medicines, increases the risk of sedation, respiratory depression, or coma that can be life-threatening. Therefore, combination therapy should only be considered when other treatment options are not available. If dihydrocodeine is used with sedative medicines, the doctor should limit the dose and duration of concomitant use.
You should inform your doctor about all sedative medicines you are taking and strictly follow the prescribed dose.
It may be helpful to inform a relative or close friend about the possibility of the above symptoms.
If the above symptoms occur, you should consult a doctor.
Tolerance, physical dependence, withdrawal syndrome
During long-term use, the patient may develop tolerance to the active substance (increasingly larger doses of the medicine will be needed to achieve a constant analgesic effect). DHC Continus, like other opioids, can cause dependence and may be misused. The medicine can cause physical dependence resulting in withdrawal symptoms. If the doctor decides that treatment with DHC Continus is no longer necessary, they will recommend gradual dose reduction.
You should avoid giving dihydrocodeine to a patient with a high potential for dependence, especially on alcohol or other medicines that may affect liver function. However, if the doctor, after weighing the benefits and risks, decides to prescribe this medicine to a patient, treatment will be carried out under close medical supervision with the need for periodic liver function tests (e.g., AST, ALT, GGTP).
A dose reduction is recommended for patients with hypothyroidism, liver and kidney failure, and elderly patients.
Opioid medicines can affect the hormonal system, disrupting the function of the adrenal glands, ovaries, and testes. These medicines can, among other things, cause an increase in prolactin levels, a decrease in cortisol and testosterone levels in the blood, resulting in clinical symptoms.
This medicine may increase sensitivity to pain, especially when using high doses.
Inform your doctor if this happens. It may be necessary to reduce the dose or change to another medicine.
Prolonged-release tablets should be swallowed whole, without breaking, chewing, or crushing.
Administration of a broken or crushed tablet can cause rapid release and absorption of too large a dose of dihydrocodeine, which can result in symptoms of overdose, even death (see section "Taking a higher dose of DHC Continus than recommended").
During improper use of oral medicines, by administering them through another route, severe side effects can occur, posing a risk to life.

DHC Continus and other medicines

Inform your doctor about all medicines you have taken recently or are taking, as well as any medicines you plan to take.
Do not take DHC Continus at the same time as monoamine oxidase inhibitors (medicines used to treat depression and low blood pressure).

DHC Continus with food, drink, and alcohol

Do not consume alcohol while taking DHC Continus.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist.
Do not take DHC Continus during pregnancy unless your doctor recommends it.
Do not breastfeed while taking DHC Continus.
There is no data on the effect of dihydrocodeine on fertility.

Driving and using machines

Do not drive or operate any machines, as DHC Continus causes drowsiness, which can impair your ability to react.

DHC Continus contains lactose.

One DHC Continus 60 mg tablet contains 58.4 mg of lactose.
One DHC Continus 90 mg tablet contains 40.5 mg of lactose.
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take DHC Continus

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not take in children under 12 years of age.
Adults and adolescents over 12 years of age
the usual starting dose is 60 mg every 12 hours.
Your doctor may increase the dose to a maximum of 120 mg every 12 hours.
DHC Continus 60 mg: 1 or 2 tablets every 12 hours.
DHC Continus 90 mg: 1 tablet every 12 hours.
In elderly patients and patients with liver and kidney failure and hypothyroidism, the doctor may recommend taking smaller doses.
The tablet should be swallowed whole, without dividing, chewing, or crushing. Taking a crushed tablet can cause too rapid absorption of the medicine and lead to symptoms of overdose (see below).
If you feel that the effect of DHC Continus is too strong or too weak, consult your doctor.
Concomitant use of opioid medicines and sedative medicines, such as benzodiazepines or related medicines, increases the risk of excessive sedation, respiratory depression, coma, or death due to additive depressant effects on the central nervous system. The doctor may reduce the daily dose of the medicine and the duration of treatment.

Taking a higher dose of DHC Continus than recommended

If you have taken more than the recommended dose of DHC Continus or suspect that you have taken more than the recommended dose, consult your doctor or pharmacist immediately.
Symptoms of overdose include drowsiness progressing to stupor or coma, pinpoint pupils, vomiting, muscle spasms, muscle breakdown, irregular heartbeat - faster heartbeat (tachycardia) or slower heartbeat (bradycardia), low blood pressure, cardiovascular and respiratory failure, or respiratory arrest, which can be life-threatening in severe cases.
Procedure: Inform your doctor immediately, who will initiate treatment tailored to the nature and severity of the symptoms. Keep the patient conscious and ensure continuous breathing. It may be necessary to transport the patient to the hospital for constant medical care.

Missing a dose of DHC Continus

Do not take a double dose to make up for a missed tablet.

Stopping treatment with DHC Continus

Do not stop taking DHC Continus without consulting your doctor. If you have any doubts about taking the medicine, consult your doctor or pharmacist. Abruptly stopping DHC Continus after long-term therapy may cause withdrawal symptoms, including pain, severe irritability, and restlessness.

4. Possible side effects

Like all medicines, DHC Continus can cause side effects, although not everybody gets them.
The risk of side effects is described by the following categories:
Common(occurring in 1 to 10 in 100 people):
drowsiness, abdominal pain, constipation, dry mouth, nausea, vomiting.
Uncommon(occurring in 1 to 10 in 1000 people):
angioedema, disorientation, drug dependence, hallucinations, mood changes, dysphoria characterized by irritability, outbursts of anger, anxiety, tendency to cry, hypotension, seizures (especially in people with epilepsy or a history of seizures), dizziness, headache, paresthesia, sedation (dose-dependent, drowsiness to impaired consciousness), vertigo of labyrinthine origin, excessive sweating, rash, itching, urticaria, diarrhea, paralytic ileus, biliary colic, biliary spasm, increased liver enzyme activity, urinary retention, dyspnea, asthma attack (especially in patients with asthma), respiratory depression, weakness, fatigue, malaise, physical dependence with withdrawal syndrome.
Rare(occurring in 1 to 10 in 10,000 people):
visual disturbances.
Frequency not known(frequency cannot be estimated from the available data):
increased prolactin levels in the blood (hyperprolactinemia), sleep apnea syndrome, tolerance to the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to: Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store DHC Continus

Store in a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What DHC Continus contains

• The active substance is dihydrocodeine tartrate.
• Tablet core: anhydrous lactose, hydroxyethylcellulose, cetostearyl alcohol, magnesium stearate, talc.

What DHC Continus looks like and contents of the pack

The pack contains 30, 56, or 60 prolonged-release tablets in a polypropylene container in a cardboard box.

Marketing authorization holder:

Ennogen Healthcare (Europe) Ltd
Block B, The Crescent Building,
Northwood, Santry
Dublin 9, D09 C6X8, Ireland.

Manufacturer:

Fidelio Healthcare Limburg GmbH
Mundipharma Strasse 2,
D-65549 Limburg, Germany

Importer:

Mundipharma DC B.V.
Leusderend 16
Leusden, 3832RC, Netherlands

Date of last revision of the leaflet: