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
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform 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 packaging 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 less potent 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 convulsive states or head injuries
• If the patient has paralytic ileus
• In case of sudden abdominal pain (acute abdomen) or nausea (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 sleeping pills

Tolerance, dependence, and addictive use

This medicine contains morphine, which is an opioid. Repeated use of opioids can lead to decreased efficacy 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 made repeated unsuccessful attempts to stop or control the use of the medicine
• After stopping the use of the medicine, the patient feels unwell and experiences improved well-being when taking the medicine again ("withdrawal effect")

If any of these symptoms are observed, 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, the patient should consult a doctor, pharmacist, or nurse.
Special caution should be exercised 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 there is a suspicion of paralytic ileus or its occurrence, the medicine should be discontinued 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 association with Vendal retard treatment. Symptoms usually occur within the first 10 days of treatment. The patient should tell their doctor if they have ever experienced 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.

In case of any of the following symptoms during Vendal retard treatment, the patient should consult a doctor or pharmacist:

• Increased sensitivity to pain, despite increased dose of the medicine (hyperalgesia). The doctor will decide whether a change in dosage or the use of a stronger painkiller is necessary (see section 2).
• Weakness, fatigue, loss of appetite, nausea, vomiting, or low blood pressure. These may be symptoms that the adrenal glands are not producing enough cortisol and hormone supplements may be necessary.
• Loss of sexual desire, impotence, amenorrhea. This may be due to decreased production of sex hormones.
• If the patient has a history of drug or alcohol dependence. The patient should also tell their doctor if they notice that they are becoming dependent on Vendal retard during treatment. For example, when they start thinking about taking the next dose more often, even if they don't need it to relieve pain.
• Withdrawal symptoms or dependence. The most common withdrawal symptoms are listed in section 3. In such cases, the doctor may change the medicine or the time between doses.

Vendal retard is not recommended during pregnancy, breastfeeding, or before surgery and in the first 24 hours after surgical procedures.

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 level 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 another person 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 shallow breathing with the risk of respiratory arrest 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 control pain. 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 of age, with hypothyroidism, or with significant impairment of renal or hepatic function, a lower dose may be recommended.
In patients of childbearing age, during Vendal retard treatment, appropriate contraception should be used (see "Pregnancy, breastfeeding, and fertility").
Vendal retard may cause positive results in doping tests.
The tablets are not intended for dissolution and injection. This can cause tissue death at the injection site and granulomatous pneumonia. Overdose can also cause serious side effects with possible death.

Children

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

Vendal retard and 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 cause mutual enhancement or reduction of their efficacy.
Vendal retard enhances the inhibitory effect on the nervous system, such as sedation and respiratory depression (breathing disorders), in the case of the following medicines and substances:

• Painkillers (in oral and maxillofacial surgery and general surgery)
• Sleeping pills and sedatives
• Neuroleptics - drugs used in mental disorders (e.g., depression and psychoses)
• Some anti-emetic drugs
• Some antihistamines
• Other potent painkillers (opioids)
• Gabapentin or pregabalin used in the treatment of epilepsy or pain caused by nerve disorders (neuropathic pain)
• Alcohol

Vendal retard enhances the effect 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 sleepiness, breathing difficulties (respiratory depression), or sleep apnea, which can be life-threatening. Therefore, combination therapy should only be considered when other treatment methods 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.
It may be helpful to inform a relative or close friend of the patient about the possibility of the above-mentioned 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). The patient should maintain a minimum 2-hour interval between taking both medicines.
• Cimetidine (a drug that inhibits stomach acid production)
• 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 a similar effect to morphine

But partially opposing, e.g., buprenorphine, nalbuphine, pentazocine, due to the reduced analgesic effect of morphine.

Vendal retard with food, drink, and alcohol

While taking Vendal retard, the patient should avoid consuming alcohol, as it may enhance their effect. High doses of Vendal retard combined with alcohol may lead to serious side effects with possible 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 used during pregnancy. Due to the mutagenic properties of morphine, it may cause fetal damage. 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 withdrawal symptoms in the newborn (abstinence syndrome), which should be treated by a doctor.

Do not use morphine during labor

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 given to 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 able 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

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

Vendal retard 200 mg containsponceau 4R and sunset yellow FCF

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 sudden release of large amounts of the medicine, which can lead to serious side effects.
Before starting and regularly 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 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). 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 not take more than 3 tablets of 10 mg Vendal retard per dose.

It is not recommended to use prolonged-release tablets of Vendal retard 60, 100, and 200 mg during 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, it is not recommended to use Vendal retard 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

The patient should immediately consult a doctor if they have taken too many tablets.
The greatest risk of Vendal retard overdose is respiratory depression. If the patient has taken more than the recommended dose of Vendal retard, they may experience respiratory depression, which can lead to respiratory arrest and death.
In addition to overdose symptoms, the patient may experience respiratory depression leading to loss of consciousness and even death, narrowing of the pupils, and a decrease in blood pressure. In severe cases, circulatory failure and deepening coma may occur. In children, generalized seizures have been observed. If it is suspected that a child has accidentally taken Vendal retard, the patient should immediately consult a doctor, without waiting for the 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 treatment

The patient should not stop taking Vendal retard unless their doctor recommends it. 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. This may be a condition called acute generalized exanthematous pustulosis (AGEP).

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

Other side effects:

• Frequent (occurs in 1 to 10 out of 100 patients):
  • Narrowing of the pupils
  • Nausea, vomiting, constipation If nausea, vomiting, and (or) constipation occur, the patient should consult a doctor, who will prescribe appropriate medicines
• Occasional (occurs in 1 to 10 out of 1,000 patients):
  • Rapid heartbeat
  • Excessive sweating, dizziness, headache, mood changes
  • Colic, dry mouth
  • Urination problems, ureteral spasm
  • Flush
  • Bile duct spasm
  • Hallucinations
• Rare (occurs in 1 to 10 out of 10,000 patients):
  • Accelerated or slowed heart rate
  • Blurred or double vision, involuntary eye movements
  • Hives, itching
  • Increased or decreased blood pressure
  • Fluid accumulation in tissues (edema), hypersensitivity to light, chills
  • Insomnia
• Frequency not known (cannot be estimated from the available data):
  • Cognitive disorders, brief muscle spasms or muscle group spasms
  • Increased sensitivity to pain
  • Sleep apnea (moments of breathing cessation during sleep)
  • Symptoms related to pancreatitis and bile duct disease, such as severe abdominal pain that may radiate to the back, nausea, vomiting, or fever

Reporting side effects

If the patient experiences any side effects, including those not mentioned in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
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 stored out of sight and reach of children.
Vendal retard should not be used after the expiration date (EXP) stated on the packaging. The expiration date refers to the last day of the given 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 packaging 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
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30%

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
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30%, indigo carmine (E 132), yellow quinoline (E 104)

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
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30%, quinoline yellow (E 104), sunset yellow FCF (E 110)

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
• macrogol 6000, talc, titanium dioxide (E 171), hypromellose, polyacrylate dispersion 30%, quinoline yellow (E 104), sunset yellow FCF (E 110)

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
• macrogol 6000, talc, hypromellose, polyacrylate dispersion 30%, ponceau 4R (E 124), sunset yellow FCF (E 110)

What does Vendal retard look like and what does the pack contain

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 marketing authorization holder's representative

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, biuro@gl-pharma.pl

Date of last revision of the leaflet