Vendal retard

Leaflet included in the packaging: patient information

Vendal retard, 10 mg, prolonged-release tablets

Vendal retard, 30 mg, prolonged-release tablets

Vendal retard, 60 mg, prolonged-release tablets

Vendal retard, 100 mg, prolonged-release tablets

Vendal retard, 200 mg, prolonged-release tablets

Morphine hydrochloride
Read this leaflet carefully before taking the medicine, as it contains important information for you.

• 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Vendal retard and what is it used for

Vendal retard is a very potent and effective pain reliever.
It is used for long-term relief of severe and very severe pain(such as pain associated with cancer), which is resistant to weaker painkillers.
Vendal retard tablets contain a special system for controlled release of morphine, so that they work effectively when taken at 12-hour intervals.

2. Important information before taking Vendal retard

When not to take Vendal retard

• If you are allergic to morphine or any of the other ingredients of this medicine (listed in section 6)
• If you have respiratory disease or breathing disorders for other reasons
• In case of retention of mucus in the airways
• If you have seizure disorders or head injuries
• If you have paralytic ileus
• In case of sudden abdominal pain (acute abdomen) or gastrointestinal disorders (delayed gastric emptying)
• In case of liver disease
• If you are taking monoamine oxidase inhibitors (drugs used to treat depression) or have stopped taking them within the last two weeks
• After consuming alcohol or sleeping pills

Tolerance, dependence, and addictive use

This medicine contains morphine, which is an opioid. Repeated use of opioids can lead to decreased effectiveness of the medicine (the patient gets used to it, which is known as tolerance). Repeated use of Vendal retard can also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and duration of use.
Dependence or addictive use can cause the patient to feel a loss of control over how much medicine to take or how often to take it.
The risk of dependence or addictive use varies from person to person. The risk of dependence on Vendal retard or its addictive use may be higher if:

• The patient or any of their relatives have ever abused or been dependent on alcohol, prescription drugs, or narcotics ("dependence")
• The patient smokes
• The patient has ever had mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses

If any of the following symptoms occur while taking Vendal retard, it may indicate dependence or addictive use

• The patient needs to take the medicine for a longer period than prescribed by the doctor
• The patient needs to take a higher dose than prescribed
• The patient uses the medicine for reasons other than those for which the doctor prescribed it, such as "to calm down" or "to be able to sleep"
• The patient has repeatedly tried to stop or control the use of the medicine but failed
• After stopping the medicine, the patient feels unwell and feels better when they take it again ("withdrawal effect")

If any of these symptoms are noticed, the patient should discuss the best treatment strategy with their doctor, including when it is appropriate to stop the treatment and how to do it safely (see section 3 "Stopping Vendal retard")

Warnings and precautions

Before starting Vendal retard, consult your doctor, pharmacist, or nurse.
Particular care is needed in the following cases

• Patients dependent on opioids (see Tolerance, dependence, and addictive use)
• High intracranial pressure or low blood pressure
• Disorders of consciousness
• Bile duct disease
• Ureteral colic
• Pancreatitis or intestinal obstruction, constipation
• Prostate enlargement
• Adrenal insufficiency (e.g., Addison's disease)

If paralytic ileus is suspected or occurs, the medicine should be stopped immediately.
Consult a doctor if the patient experiences severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these may be symptoms related to pancreatitis and bile duct disease.
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Vendal retard treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever had a severe skin rash or skin peeling after taking Vendal retard or other opioids, or if you have had blisters and (or) ulcers in the mouth. Stop taking Vendal retard and consult a doctor immediately if you notice any of the following symptoms: blisters, widespread skin peeling, or pustular rash with fever.

Vendal retard should not be used during pregnancy, childbirth, or breastfeeding (see "Pregnancy, breastfeeding, and fertility"), or before surgery and during the first 24 hours after surgery.

Sleep apnea syndrome

Vendal retard may cause sleep apnea syndrome, such as pauses in breathing during sleep and hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness.
If the patient or someone else notices these symptoms, they should consult a doctor. The doctor may consider reducing the dose of Vendal retard.
Consuming alcohol while taking Vendal retard may cause increased drowsiness or increase the risk of serious side effects such as respiratory depression and loss of consciousness. It is recommended not to consume alcohol while taking Vendal retard.
Prolonged use of Vendal retard may lead to the development of tolerance to the medicine, making it necessary to use increasingly higher doses of morphine to maintain pain control. Prolonged use of Vendal retard may lead to physical dependence, and sudden cessation of treatment may cause withdrawal syndrome (see section 3 of this leaflet).
Appropriate use of the medicine in patients with chronic pain reduces the risk of physical and psychological dependence and is not a major problem in the treatment of patients with severe pain. Cross-tolerance occurs with other opioids (drugs similar to morphine). Appropriate use of the medicine in patients with chronic pain reduces the risk of physical and psychological dependence (see Tolerance, dependence, and addictive use).
In patients over 65 years of age, with hypothyroidism, or with significant renal or hepatic impairment, a lower dose may be recommended.
In patients of childbearing age, appropriate contraception should be used during Vendal retard treatment (see "Pregnancy, breastfeeding, and fertility").
Vendal retard may cause positive results in doping tests.
The tablets are not intended to be dissolved and injected. This can cause tissue death at the injection site and granulomatous pneumonia. Overdose can also cause serious side effects, including death.

Children

Vendal retard should not be given to children under 1 year of age.
Due to the lack of sufficient data, Vendal retard is not recommended for use in children under 12 years of age.

Vendal retard with other medicines

Tell your doctor or pharmacist about all the medicines you have taken recently, including those available without a prescription.
Concomitant use of Vendal retard and other medicines may cause increased or decreased effectiveness.
Vendal retard enhances the effects of medicines that depress the central nervous system, such as sedation and respiratory depression (breathing disorders), including

• Painkillers (in dental and general surgery)
• Sleeping pills and sedatives
• Neuroleptics - drugs used to treat mental disorders (e.g., depression and psychosis)
• Some anti-nausea and anti-vomiting drugs
• Some antihistamines
• Other strong painkillers (opioids)
• Gabapentin or pregabalin used to treat epilepsy or pain caused by nerve disorders (neuropathic pain)
• Alcohol

Vendal retard enhances the effects of

• Painkillers
• Sedatives, anesthetics, and sleeping pills
• Alcohol
• Muscle relaxants
• Antihypertensive drugs

Concomitant use of Vendal retard and sedatives, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), or sleep apnea, which can be life-threatening. Therefore, combination therapy should only be considered when other treatment options are not available. If Vendal retard is used with sedatives, the doctor should limit the dose and duration of concomitant use. The patient should tell their doctor about all sedatives they are taking and strictly follow the prescribed dose.
It may be helpful to inform a relative or close friend of the patient about the possibility of these symptoms. If these symptoms occur, the patient should consult a doctor.
The following medicines may affect the action of Vendal retard

• Drugs used to neutralize stomach acid (antacids). A minimum interval of 2 hours should be maintained between taking the two medicines.
• Cimetidine (a drug that inhibits stomach acid secretion)
• Monoamine oxidase inhibitors (some drugs used to treat depression) - see "When not to take Vendal retard"
• Rifampicin (used to treat tuberculosis)
• Clomipramine and amitriptyline (some drugs used to treat depression)

Do not take Vendal retard with other painkillers with similar effects to morphine but partially opposing effects, such as

buprenorphine, nalbuphine, pentazocine, due to the risk of reduced analgesic effect of morphine.

Vendal retard with food, drink, and alcohol

Avoid consuming alcohol while taking Vendal retard, as it may enhance its effects. High doses of Vendal retard combined with alcohol may lead to serious side effects, including death.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.
Vendal retard should not be used during pregnancy. Due to the mutagenic properties of morphine, it may cause fetal damage. Therefore, patients of childbearing age who are taking Vendal retard should use appropriate methods of contraception.
If Vendal retard was taken during pregnancy for a long time, there is a risk of withdrawal symptoms in the newborn (abstinence syndrome), which should be treated by a doctor.

Do not use morphine during childbirth

Due to the risk of respiratory depression in newborns. If Vendal retard was used during pregnancy, the newborn may experience withdrawal syndrome.
Morphine should not be used in breastfeeding women, as it passes into breast milk.

Driving and using machines

Vendal retard may impair the ability to drive and use machines.
This should be expected, especially during the initial treatment phase, when changing the dose, and when combined with alcohol or sedatives.

Consult a doctor to determine if you are fit to drive or operate machinery.

Vendal retard contains lactose

The medicine contains lactose; if you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Vendal retard 60/100 mg contains sunset yellow FCF (E110)

The medicine contains sunset yellow FCF (E110), a colorant that may cause allergic reactions.

Vendal retard 200 mg contains Ponceau 4R (E124) and sunset yellow FCF (E110)

The medicine contains Ponceau 4R (E124) and sunset yellow FCF (E110), colorants that may cause allergic reactions.

3. How to take Vendal retard

Vendal retard should be taken as directed by your doctor. If you are unsure, consult your doctor again.
Take the tablets whole, without chewing, with a sufficient amount of liquid. Breaking or dissolving the tablet will destroy the prolonged-release system and cause a rapid release of a large amount of the medicine, which can lead to serious side effects.
Before and regularly during treatment, your doctor will discuss with you what to expect from taking Vendal retard, when and how to take it, when to consult a doctor, and when to stop taking the medicine (see also "Stopping Vendal retard" in this section).

Dosage

The dose of Vendal retard depends on the severity of the disease, age, and should be determined individually for each patient. The appropriate dose of the medicine will control the pain for 12 hours without causing significant side effects.
The doctor will decide on the duration of treatment.
To determine the appropriate dose of Vendal retard, the following strengths are available: 10 mg, 30 mg, 60 mg, 100 mg, and 200 mg.

Adults and adolescents over 12 years of age

Typically, the initial dose should be 1-3 tablets of 10 mg Vendal retard (equivalent to 10-30 mg of morphine hydrochloride) twice a day (morning and evening). It is essential to maintain 12-hour intervals between doses. If the pain worsens or tolerance to morphine develops, the doctor will increase the dose of the medicine.

• Do not exceed the prescribed dose

It is not recommended to use tablets with prolonged release of 60, 100, and 200 mg in the initial treatment phase.

Children

Do not use Vendal retard in children under 1 year of age.
Due to the lack of sufficient data, Vendal retard is not recommended for use in children under 12 years of age.

Elderly patients and patients with renal or hepatic impairment

The doctor will recommend a lower initial dose.

Taking a higher dose of Vendal retard than recommended

Consult a doctor immediately if you have taken too many tablets.
The greatest risk with Vendal retard overdose is respiratory depression.
If you have taken more than the recommended dose of Vendal retard, you may experience respiratory failure, which can be life-threatening.
Additionally, overdose symptoms may include difficulty breathing leading to loss of consciousness and even death, constricted pupils, and decreased blood pressure.
In severe cases, circulatory failure and deepening coma can occur. In children, generalized seizures have been observed. If it is suspected that a child has accidentally taken Vendal retard, consult a doctor immediately. Do not wait for side effects to occur.

Missing a dose of Vendal retard

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, do not take the missed dose, only take the next dose at the usual time. The next dose should be taken after 12 hours.
Do not increase the dose of the medicine yourself.
Do not take a double dose to make up for a missed dose.

Stopping Vendal retard treatment

Do not stop taking Vendal retard unless your doctor tells you to. To stop taking Vendal retard, consult your doctor, who will decide how to gradually reduce the dose to avoid withdrawal symptoms. Withdrawal symptoms may include body aches, seizures, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms include intense dissatisfaction, anxiety, and irritability.
If you have any questions or concerns, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vendal retard can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking Vendal retard and consult a doctor immediately

• Severe skin reaction with blisters, widespread skin peeling, and pustular rash with fever. This may be a condition known as acute generalized exanthematous pustulosis (AGEP)

Consult a doctor immediately if you experience any of the following side effects

• Severe allergic reactions (frequency not known) causing difficulty breathing or dizziness; swelling of the eyelids, face, or lips; rash or itching (especially affecting the whole body)
• Breathing difficulties in the following cases: bronchospasm, respiratory depression, asthma attacks in susceptible patients (rare), overdose (may lead to respiratory depression; uncommon); pulmonary edema (fluid accumulation in the lungs) in patients under intensive medical care (very rare)
• Drowsiness (common), confusion (uncommon), general weakness, and fainting (rare)
• Physical or psychological dependence may occur (symptoms, see section 3 of this leaflet) withdrawal symptoms or dependence (information on symptoms - see section 3: If you stop taking Vendal retard) (frequency not known)

Other side effects

• Common (affects 1 to 10 users in 100): constricted pupils, nausea, vomiting, constipation. If nausea, vomiting, and (or) constipation occur, consult a doctor, who will prescribe appropriate medication

Uncommon (affects 1 to 10 users in 1,000)

• Palpitations, excessive sweating, dizziness, headache, mood changes
• Colic, dry mouth
• Urination problems, ureteral spasm
• Flushing
• Bile duct spasm
• Hallucinations

Rare (affects 1 to 10 users in 10,000)

• Accelerated or slowed heart rate
• Double vision or nystagmus (involuntary eye movements)
• Hives or itching
• Increased or decreased blood pressure
• Fluid accumulation in tissues (edema), photosensitivity, chills
• Insomnia

Frequency not known (cannot be estimated from the available data)

• Cognitive disorders, muscle cramps
• Increased sensitivity to pain
• Sleep apnea (pauses in breathing during sleep)
• Symptoms related to pancreatitis and bile duct disease, such as severe abdominal pain radiating to the back, nausea, vomiting, or fever

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland, phone: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vendal retard

Keep the medicine out of the sight and reach of children.
Do not use Vendal retard after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store the medicine at a temperature below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What does Vendal retard 10 mg contain

The active substance is morphine hydrochloride.
One prolonged-release tablet contains 10 mg of morphine hydrochloride, equivalent to 7.6 mg of morphine, and
excipients

• lactose monohydrate, polyacrylate dispersion 30%, methacrylic acid, and ethyl acrylate copolymer (1:1), ammonio methacrylate copolymer (type B), hypromellose, magnesium stearate (in the core of the tablet)
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30% (in the tablet coating)

What does Vendal retard 30 mg contain

The active substance is morphine hydrochloride.
One prolonged-release tablet contains 30 mg of morphine hydrochloride, equivalent to 22.8 mg of morphine, and
excipients

• lactose monohydrate, polyacrylate dispersion 30%, methacrylic acid, and ethyl acrylate copolymer (1:1), ammonio methacrylate copolymer (type B), hypromellose, magnesium stearate (in the core of the tablet)
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30%, indigo carmine (E 132), quinoline yellow (E 104)/indigo carmine (E 132) (in the tablet coating)

What does Vendal retard 60 mg contain

The active substance is morphine hydrochloride.
One prolonged-release tablet contains 60 mg of morphine hydrochloride, equivalent to 45.6 mg of morphine, and
excipients

• lactose monohydrate, polyacrylate dispersion 30%, methacrylic acid, and ethyl acrylate copolymer (1:1), ammonio methacrylate copolymer (type B), hypromellose, magnesium stearate (in the core of the tablet)
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30%, quinoline yellow (E 104)/sunset yellow FCF (E 110) (in the tablet coating)

What does Vendal retard 100 mg contain

The active substance is morphine hydrochloride.
One prolonged-release tablet contains 100 mg of morphine hydrochloride, equivalent to 76 mg of morphine, and
excipients

• lactose monohydrate, polyacrylate dispersion 30%, methacrylic acid, and ethyl acrylate copolymer (1:1), ammonio methacrylate copolymer (type B), hypromellose, magnesium stearate (in the core of the tablet)
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30%, quinoline yellow (E 104)/sunset yellow FCF (E 110), sunset yellow FCF (E 110) (in the tablet coating)

What does Vendal retard 200 mg contain

The active substance is morphine hydrochloride.
One prolonged-release tablet contains 200 mg of morphine hydrochloride, equivalent to 152 mg of morphine, and
excipients

• lactose monohydrate, polyacrylate dispersion 30%, methacrylic acid, and ethyl acrylate copolymer (1:1), ammonio methacrylate copolymer (type B), hypromellose, magnesium stearate (in the core of the tablet)
• macrogol 6000, talc, hypromellose, polyacrylate dispersion 30%, Ponceau 4R (E 124), sunset yellow FCF (E 110) (in the tablet coating)

What Vendal retard looks like and contents of the pack

Vendal retard 10 mg: white, round, biconvex tablets

Vendal retard 30 mg: blue-green, round, biconvex tablets

Vendal retard 60 mg: yellow, round, biconvex tablets

Vendal retard 100 mg: orange-yellow, round, biconvex tablets

Vendal retard 200 mg: red, round, biconvex tablets

Available in packs of 10 and 30 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH, Schlossplatz 1, A-8502 Lannach, Austria

For more information, contact the marketing authorization holder

G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland, phone: 022/ 636 52 23; 636 53 02, email: [email protected]

Date of last revision of the leaflet