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 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you personally. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 the patient is allergic to morphine or any of the other ingredients of this medicine (listed in section 6)
• If the patient has respiratory disease or breathing disorders for other reasons
• In case of retention of mucus in the airways
• If the patient has seizure disorders or head injuries
• If the patient has paralytic ileus
• In case of sudden abdominal pain (acute abdomen) or gastroparesis (delayed gastric emptying)
• In case of liver disease
• If the patient is taking monoamine oxidase inhibitors (drugs used to treat depression) or has stopped taking them within the last two weeks
• After consuming alcohol or sedatives

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, 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 fall asleep"
• 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 to stop the treatment and how to do it safely (see section 3 "Stopping Vendal retard").

Warnings and precautions

Before starting Vendal retard, the patient should consult a doctor, pharmacist, or nurse.
Special caution is required 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.
The patient should consult a doctor if they experience 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 patients taking Vendal retard. Symptoms usually occur within the first 10 days of treatment. The patient should tell their doctor if they have ever had a severe skin rash or exfoliation after taking Vendal retard or other opioids, or if they have had blisters and (or) ulcers in the mouth. The patient should stop taking Vendal retard and consult a doctor immediately if they notice any of the following symptoms: blisters, widespread exfoliation, or pustular rash with fever.

The patient should not take Vendal retard during pregnancy, breastfeeding, or before surgery and within the first 24 hours after surgery.

Respiratory disorders during sleep

Vendal retard may cause respiratory disorders during sleep, such as sleep apnea (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 the medicine.
Consuming alcohol while taking Vendal retard may cause increased sleepiness 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.

Long-term 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. Long-term use of Vendal retard may lead to physical dependence, and sudden cessation of treatment may cause withdrawal syndrome (see section 3 of this leaflet).
Proper administration of the medicine to patients with chronic pain reduces the risk of physical and psychological dependence and is not a fundamental problem in the treatment of patients with severe pain. Cross-tolerance occurs with other opioids (drugs similar to morphine). Proper administration of the medicine to patients with chronic pain reduces the risk of physical and psychological dependence (see Tolerance, dependence, and addictive use).
In patients over 65 years old, 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 children under 12 years of age.

Vendal retard with other medicines

The patient should inform their doctor or pharmacist about all medicines taken recently, including those available without a prescription.
Concomitant use of Vendal retard and other medicines may enhance or reduce their effectiveness.
Vendal retard enhances the effect of medicines that depress the central nervous system, such as:

• Painkillers (in oral and maxillofacial surgery and general surgery)
• Sedatives and tranquilizers
• Neuroleptics (drugs used to treat mental disorders, such as depression and psychosis)
• Some anti-emetic and anti-nausea drugs
• Some antihistamines
• Other strong painkillers (opioids)
• Gabapentin or pregabalin used to treat epilepsy or neuropathic pain
• Alcohol

Vendal retard enhances the effect of:

• Painkillers
• Sedatives, anesthetics, and sleep aids
• Alcohol
• Muscle relaxants
• Antihypertensive drugs

Concomitant use of Vendal retard and sedatives, such as benzodiazepines or derivatives, increases the risk of sleepiness, respiratory depression, or sedation, which can be life-threatening. Therefore, combined treatment 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 taken and strictly follow the prescribed dose.

The following medicines may affect the action of Vendal retard:

• Drugs used to neutralize stomach acid (antacids). The patient should maintain a 2-hour interval 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)

Vendal retard should not be taken with other painkillers with a similar effect to morphine but with 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

The patient should 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 the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medicine.
Vendal retard should not be taken during pregnancy. Due to the mutagenic properties of morphine, it may cause fetal harm. Therefore, patients of childbearing age who take Vendal retard should use appropriate methods of contraception.
If Vendal retard was taken during pregnancy for a long time, there is a risk of neonatal withdrawal syndrome (abstinence syndrome), which should be treated by a doctor.

Vendal retard is not recommended during labor and delivery

Due to the risk of respiratory depression in newborns. If Vendal retard was taken during pregnancy, the newborn may experience withdrawal syndrome.
Vendal retard is not recommended for breastfeeding women, as it passes into breast milk.

Driving and using machines

Vendal retard may impair the ability to drive and use machines.
The patient should expect this, especially during the initial treatment phase, when changing the dose, and when combined with alcohol or sedatives.

The patient should consult their doctor to determine if they are fit to drive and use machines

Vendal retard contains lactose

The medicine contains lactose; if the patient has been diagnosed with intolerance to some sugars, they should consult their 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 the doctor. In case of doubts, the patient should consult their doctor again.
Vendal retard tablets should be swallowed 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 during treatment, the doctor will discuss with the patient what to expect from taking Vendal retard, when and how long 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 individualized 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 old

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). The patient should strictly follow the 12-hour interval between doses. If the pain worsens or tolerance to morphine develops, the doctor will increase the dose of the medicine.

• The patient should take the medicine as directed by the doctor, usually 1-3 tablets of 10 mg Vendal retard (equivalent to 10-30 mg of morphine hydrochloride) twice a day (morning and evening).

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

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 children under 12 years of age.

Elderly patients and patients with renal or hepatic impairment

The doctor will prescribe a lower initial dose.

Taking a higher dose of Vendal retard than recommended

The patient should consult a doctor immediately if they have taken too many tablets.
The greatest risk of Vendal retard overdose is respiratory depression. If the patient has taken a higher dose of Vendal retard than recommended, they may experience respiratory failure due to inhalation of vomit or foreign bodies. Symptoms may include shortness of breath, cough, and fever.
Additionally, overdose symptoms may include respiratory depression leading to loss of consciousness and even death, pinpoint pupils, and low blood pressure. In severe cases, circulatory failure and deepening sedation occur. In children, generalized seizures have been observed. If it is suspected that a child has accidentally taken Vendal retard, the patient should consult a doctor immediatelyand not wait for side effects to occur.

Missing a dose of Vendal retard

If a dose is missed, the patient should take it as soon as possible. If it is almost time for the next dose, the patient should not take the missed dose, but take the next one at the usual time. The next dose should be taken 12 hours later.
The patient should not increase the dose of the medicine on their own.
The patient should not take a double dose to make up for the missed dose.

Stopping Vendal retard

The patient should not stop taking Vendal retard unless their doctor advises them to do so. To stop taking Vendal retard, the patient should consult their 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.
In case of questions or doubts, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• Severe skin reaction with blisters, widespread exfoliation, and pustular rash with fever, which may be a condition called acute generalized exanthematous pustulosis (AGEP).

The patient should consult a doctor immediately if they 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 disorders; rare); pulmonary edema (fluid accumulation in the lungs) in patients under intensive medical care (very rare)
• Sleepiness (common), confusion (uncommon), general weakness up to fainting (rare)
• The patient may experience physical or psychological dependence (symptoms, see section 3 of this leaflet) or withdrawal symptoms or dependence (information on symptoms - see section 3: Stopping Vendal retard) (frequency not known)

Other side effects:

• Common (affecting 1 to 10 in 100 patients): pinpoint pupils
• Nausea, vomiting, constipation. If nausea, vomiting, and (or) constipation occur, the patient should consult a doctor, who will prescribe appropriate medicines

Uncommon (affecting 1 to 10 in 1,000 patients):

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

Rare (affecting 1 to 10 in 10,000 patients):

• 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 twitching
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the:
Department of Drug Safety Monitoring, 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.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Vendal retard

The medicine should be kept out of sight and reach of children.
Vendal retard should not be taken after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the specified month.
The medicine should be stored at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This 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 coating of the tablet)

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 coating of the tablet)

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 coating of the tablet)

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 coating of the tablet)

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 coating of the tablet)

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: yellow-orange, 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, please contact the representative of 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 protected]

Date of last revision of the leaflet