MS KONTIN 10 mg Таблетки с контролируемым высвобождением

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1. MS Contin 10 mg, prolonged-release tablets, 30 mg, prolonged-release tablets, 60 mg, prolonged-release tablets, 100 mg, prolonged-release tablets, 200 mg, prolonged-release tablets
   1. What is MS Contin and what is it used for
   2. What you need to know before you take MS Contin
   3. How to take MS Contin
   4. Possible side effects
   5. How to store MS Contin
   6. Contents of the pack and other information

MS Contin 10 mg, prolonged-release tablets, 30 mg, prolonged-release tablets, 60 mg, prolonged-release tablets, 100 mg, prolonged-release tablets, 200 mg, prolonged-release tablets

Morphine sulfate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What MS Contin is and what it is used for
• 2. What you need to know before you take MS Contin
• 3. How to take MS Contin
• 4. Possible side effects
• 5. How to store MS Contin
• 6. Contents of the pack and other information

1. What is MS Contin and what is it used for

These prolonged-release tablets have been prescribed by your doctor for the remission of prolonged, severe and resistant pain that requires prolonged use of painkillers and their effect lasts 12 hours. The prolonged-release tablets contain the active ingredient morphine, a substance that belongs to the category of opioid analgesics (painkillers) that work by reducing pain. For the other excipients contained in the prolonged-release tablet, see the
MS Contin has a 12-hour duration of action if the prolonged-release tablets are swallowed whole. If a prolonged-release tablet is broken, crushed, dissolved in a liquid, or chewed, the entire dose that should act over 12 hours is instead absorbed rapidly: this can be harmful and cause serious problems and overdose is potentially fatal.

2. What you need to know before you take MS Contin

Do not take MS Contin:

• if you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6) or if you have experienced an allergic reaction to another opioid analgesic in the past;
• if you have breathing problems, such as airway obstruction, bronchial asthma or severe lung disease, or if you are breathing more slowly or weakly than expected (respiratory depression);
• if you have a head trauma that causes severe headache or discomfort. This is because prolonged-release tablets may worsen these symptoms or mask the true severity of the head trauma;
• if you have increased pressure in the head (intracranial or cerebrospinal hypertension); if you suffer from alcohol dependence (acute alcoholism, delirium tremens);
• if you suffer from states of depression of the central nervous system, particularly due to other medicines (hypnotics, sedatives, tranquilizers);
• if you suffer from a condition in which the small intestine does not function properly (paralytic ileus), if your stomach empties more slowly than it should (delayed gastric emptying) or if you have severe abdominal pain;
• if you have heart problems (cardiac arrhythmias) and suffer from heart disorders due to chronic lung diseases;
• if you have a newly developed liver disease (acute hepatopathy);
• if you are taking monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid) or if you have taken these medicines in the last two weeks. Tolerance, dependence This medicine contains morphine, an opioid medicine. Repeated use of opioids can make the medicine less effective (you get used to it, a phenomenon known as tolerance). Repeated use of MS Contin can also lead to dependence and abuse, which can cause a potentially fatal overdose. The risk of these undesirable effects may increase with a higher dose and a prolonged duration of use. Dependence may make you feel that you no longer have control over the amount of medicine needed or the frequency with which you have to use it. The risk of developing dependence varies from person to person. You may be at greater risk of becoming dependent on MS Contin if:
• you or a family member has suffered from abuse or dependence on alcohol, prescription drugs or illegal substances (“addiction”) in the past;
• you are a smoker;
• you have had mood problems in the past (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. The appearance of any of the following signs during the use of MS Contin may be an indication of dependence:
• you need to take the medicine for a longer period than indicated by the doctor;
• you need to take a higher dose than recommended;
• you use the medicine for reasons other than those prescribed, for example "to stay calm" or "to promote sleep";
• you have repeatedly tried to stop or control the use of this medicine, without success;
• when you stop treatment with the medicine you feel unwell, and when you resume using it you feel better (“withdrawal effects”). If you notice any of these signs, consult your doctor to discuss the best therapeutic path for you, including cases where it is appropriate to stop treatment and how to stop it safely (see section 3 If you stop taking MS Contin). Warnings and precautionsTalk to your doctor or pharmacist before taking MS Contin.
• if you are an elderly, very elderly person or if you are debilitated; in these cases it may be necessary to reduce the dose;
• if you have reduced thyroid function (hypothyroidism) which may require a reduction in the dosage of MS Contin;
• if you suffer from severe headache or discomfort, symptoms that may indicate increased intracranial pressure;
• if you have low blood pressure (hypotension) and markedly and persistently low (hypovolemic shock);
• if you suffer from mental disorders resulting from an infection (toxic psychosis);
• if you suffer from inflammation of the pancreas (pancreatitis) or disorders of the gallbladder;
• if you suffer from obstructive or inflammatory intestinal disorders;
• if you suffer from constipation;
• if you suffer from prostate disorders (prostatic hypertrophy) and urinary tract (urethral stenosis);
• if you have reduced adrenal function (adrenal insufficiency);
• if you have or have had alcohol or drug dependence in the past. Also tell your doctor if you feel you are becoming dependent on Ms Contin while taking it. You may have started to think a lot about when you can take the next dose, even if you don't need it for pain;
• if you have previously suffered from symptoms of withdrawal or dependence such as agitation, anxiety, palpitations, tremors or sweating after stopping taking alcohol or drugs; The most common withdrawal symptoms are mentioned in section 3. If this occurs, the doctor may change the type of medicine or the timing between doses;
• if you suffer from epileptic seizures or convulsions;
• if you suffer from confusion or fainting;
• if you have breathing problems such as respiratory failure and chronic lung conditions (particularly if accompanied by increased mucus secretion from the bronchi) and in all conditions where there is closure of the airways (obstructive conditions);
• if you suffer from sleep apnea;
• if you suffer from acute thoracic syndrome (ACS) associated with sickle cell disease (SCD);
• if you have long-lasting kidney or liver problems, you should only take MS Contin if recommended by your doctor;
• if you are pregnant;
• if you are taking medicines that depress the central nervous system or benzodiazepines at the same time (see also section “Other medicines and MS Contin”);
• if you have increased sensitivity to pain despite taking increasing doses (hyperalgesia). The doctor will decide whether a dose adjustment or a change of the strong analgesic (“painkiller”) is necessary (see section 2);
• if you feel weak, tired, have loss of appetite, nausea, vomiting or low blood pressure. This may be a symptom that the adrenal glands are producing insufficient amounts of cortisol hormone and you may need to take a hormonal supplement;
• if you experience loss of libido, impotence, cessation of menstruation. This may be due to a decrease in the production of sex hormones. Consult your doctor if you experience severe pain in the upper abdomen with possible radiation to the back, nausea, vomiting or fever, as these may be symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts. Acute generalized exanthematous pustulosis (AGEP) has been reported in association with MS Contin treatment. Symptoms usually appear within the first 10 days of treatment. Tell your doctor if you have developed severe skin rashes or peeling skin, blistering rash and/or mouth ulcers after taking MS Contin or other opioids. Stop using MS Contin and contact your doctor immediately if you observe any of the following symptoms: blistering rash, widespread scaly skin or pustules together with fever. Sleep-related breathing disorders MS Contin can cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood) or worsen existing sleep problems. Symptoms may include pauses in breathing during sleep, night-time awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or another person observe these symptoms, contact your doctor. The doctor may consider reducing the dose. Before surgery, inform the hospital doctor that you are taking these prolonged-release tablets, the medicine is not recommended in the pre-operative period or within 24 hours after surgery.

The administration of morphine, especially if prolonged, can lead to the appearance of tolerance and dependence.
Opioids can affect the hypothalamus-pituitary-adrenal or gonadal axis. Some changes that may be
noticed include increased serum prolactin and decreased cortisol and testosterone in plasma. Clinical symptoms of these hormonal changes may also occur.
For athletes: the use of the drug without therapeutic need constitutes doping and may still result in
positive doping tests.

Children and adolescents
The use of MS Contin is not recommended in children and adolescents under the age of 18.

Other medicines and MS Contin
The concomitant use of MS Contin and sedative medicines such as benzodiazepines, or similar medicines, may increase the
risk of drowsiness, difficulty breathing (respiratory depression), coma and may lead to death. For these
reasons, the concomitant use of these medicines should only be considered if there are no alternative treatments.
In any case, if your doctor prescribes MS Contin together with sedative medicines, such as benzodiazepines or
similar medicines, the dose and duration of concomitant treatment must be limited by your doctor. Please inform your
doctor of the sedative medicines you are taking and strictly follow the doses recommended by your doctor.
It is advisable to inform friends and relatives to pay attention to the signs and symptoms indicated above. Contact your doctor
when you experience these symptoms.
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including
those that do not require a prescription.
Taking MS Contin at the same time as some other drugs, the effect of MS Contin or that of the other drugs
may be altered.
MS Contin should not be used at the same time as some antidepressant drugs called monoamine oxidase
inhibitors (e.g. tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid) or if you have
taken these medicines in the last two weeks (see also section Do not take MS Contin).
Tell your doctor or pharmacist:
Many drugs can interact with morphine sulfate injectable preparation, with a possible significant alteration of
their effects. These drugs include:

• if you are taking medicines for sleeping (e.g. tranquilizers, hypnotics or sedatives);
• if you have recently had an anesthetic;
• if you are taking medicines for depression (antidepressants);
• if you are taking medicines that depress the central nervous system and/or anxiolytics including benzodiazepines;
• if you are taking medicines for psychiatric or mental disorders;
• if you are taking other potent analgesics or painkillers;
• if you are taking muscle relaxants;
• if you are taking medicines for high blood pressure;
• if you are taking quinidine (drug for heart rhythm problems);
• if you are taking cimetidine (drug for ulcers or heartburn);
• if you are taking antibiotics (such as erythromycin);
• if you are taking rifampicin to treat, for example, tuberculosis;
• if you are taking some drugs used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have a delayed and reduced effect when taken in combination with morphine;
• if you are taking antifungal drugs (such as ketoconazole);
• if you are taking gabapentin or pregabalin for the treatment of epilepsy and pain due to nerve problems (neuropathic pain)

MS Contin with food, drinks and alcohol
Drinking alcohol while taking MS Contin may cause drowsiness or increase the risk of serious side effects such as
shortness of breath with the risk of respiratory depression and loss of consciousness. It is recommended to
not drink alcohol while taking MS Contin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
If Ms Contin is used for a long time during pregnancy, there is a risk that the newborn may experience withdrawal
symptoms (withdrawal) from substance abuse that must be treated by a doctor.
Studies in animals have shown that morphine can reduce fertility.

Driving and operating machinery
When you start treatment with MS Contin for the first time or when the dose is increased, you may experience
drowsiness. If you feel drowsy, you should avoid driving or operating machinery.

MS Contin contains lactose
MS Contin 10 mg, MS Contin 30 mg, MS Contin 60 mg contain lactose, a sugar. If you have an intolerance to
some sugars, contact your doctor before taking MS Contin.

3. How to take MS Contin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
regarding how long.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from using MS Contin, when and for how long it is necessary to use it, when to contact your doctor and when it is necessary to stop treatment (see also If you stop taking MS Contin in this section).
Usually, pain treatment with MS Contin starts with 1 or 2 extended-release tablets of 10 mg every 12 hours, except for elderly or debilitated subjects, in whom the initial dose is lower. The patented extended-release system of morphine makes morphine easily absorbed in the intestine, maintaining its plasma levels for up to 12 hours.
To replace MS Contin with other oral morphine-based medicines, the same total daily morphine dosage should be maintained, divided into two administrations: morning and evening (one every 12 hours). If parenteral morphine administration is replaced with MS Contin, the MS Contin dosage must be increased to compensate for the reduction in analgesic effect due to oral administration. Generally, it is necessary to increase the dosage by approximately 50% to 100%. However, your doctor will prescribe the dose required to treat your pain. If you still experience pain despite treatment with MS Contin, discuss it with your doctor. Do not exceed the dose recommended by your doctor. If you have any doubts, consult your doctor or pharmacist.
The extended-release tablets of MS Contin should be swallowed whole, with water. The extended-release tablets should not be chewed, broken, or dissolved. In fact, the patented extended-release system of the drug makes morphine easily absorbed in the intestinal tract, maintaining plasma levels for up to 12 hours.
You should take the extended-release tablets every 12 hours. For example, if you take an extended-release tablet at 8 am, you should take the next one at 8 pm.
Post-operative pain: your doctor will tell you not to take MS Contin extended-release tablets in the first 24 hours after surgery; afterwards, your doctor will prescribe MS Contin according to the following dosage scheme:
a) MS Contin 20 mg every 12 hours for patients weighing less than 70 kg;
b) MS Contin 30 mg every 12 hours for patients weighing more than 70 kg.
If necessary, supplemental administrations of morphine can be given parenterally, but with particular attention to the total morphine dose and taking into account the prolonged effect of morphine in the MS Contin formulation.
As with all morphine-based medicines, MS Contin should be used with caution after surgery, especially in cases of acute abdomen and after abdominal surgery.

Use in children and adolescents
The use of MS Contin is not recommended in children and adolescents under 18 years of age.

You must take MS Contin only by mouth
The extended-release tablets must not be broken or injected, as this could cause serious adverse effects, potentially fatal.

If you take more MS Contin than you should
Contact your doctor or the nearest hospital. In case of overdose, drowsiness and malaise may occur. People who have taken an excessive dose may suffer from a brain disorder (known as toxic leukoencephalopathy), develop pneumonia from inhalation of vomit or foreign bodies, whose symptoms may include shortness of breath, cough, and fever. Respiratory distress may also occur, which can lead to unconsciousness or even death, and emergency hospital treatment may be necessary. When contacting a doctor, bring with you

If you forget to take MS Contin
If less than 4 hours have passed since you were supposed to take the extended-release tablet, take it immediately. Then take the next extended-release tablet at the scheduled time. If, however, more than 4 hours have passed since you were supposed to take the extended-release tablet, call your doctor or pharmacist for advice. Do not take a double dose to make up for the missed extended-release tablet.

If you stop taking MS Contin
You should not abruptly stop taking the extended-release tablets unless directed by your doctor. If you want to stop treatment, discuss it with your doctor first. Your doctor will be able to tell you how to discontinue treatment, generally by gradually reducing the dose of the medicine, in order to avoid unpleasant side effects and withdrawal symptoms. Withdrawal symptoms may include muscle pain, tremors, diarrhea, stomach pain, nausea, flu-like symptoms, rapid heartbeat, and dilated pupils. Psychological symptoms include an intense feeling of dissatisfaction, anxiety, and irritability.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using MS Contin and contact your doctor immediately if you experience any of the following symptoms:

• All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you notice difficulty breathing, sudden wheezing, swelling of the eyelids, face or lips, skin rash or itching, especially if it is widespread over your body.
• Severe skin reaction with blisters, widespread scaly skin, spots containing pus together with fever. This could be a condition called acute generalized exanthematous pustulosis (AGEP).
• Slow and shallow breathing (respiratory depression) is the main danger of an opioid overdose. It occurs especially in elderly and debilitated patients. Opioids can also cause a severe drop in blood pressure in predisposed patients. As with other opioids, there is a risk of developing physical or psychological dependence on MS Contin. The following frequency data are used to assess side effects: Very common: affects more than 1 in 10 people - Common: affects 1 to 10 people in 100 - Uncommon: affects1 to 10 people in 1,000 - Rare: affects 1 to 10 people in 10,000 - Very rare: affects less than 1 in 10,000 -Not known: the frequency cannot be estimated based on available dataVery common side effects:
• Nausea: these problems usually tend to subside after a few days. However, your doctor may prescribe you an antiemetic medicine if the problem persists.
• Constipation: Your doctor may prescribe a laxative to alleviate this problem. You may also experience unusual drowsiness at the beginning of treatment or after increases in dosage. This disorder tends to resolve spontaneously after a few days. Common side effects:
• Dry mouth, loss of appetite, slowed digestion, abdominal pain, vomiting
• Itching
• Headache, confusion, drowsiness, feeling of unusual weakness or fainting (especially when standing up), insomnia (difficulty sleeping), general malaise, fatigue
• Involuntary muscle contractions
• Dizziness or lightheadedness
• Excessive sweating, flushing of the skin
• Dry mouth.

Uncommon side effects:

• Flatulence, abdominal bloating, gastrointestinal disorders (e.g. abdominal pain or cramps), altered taste
• Itching (urticaria) or skin rash due to allergic reaction
• A condition that causes abnormal production of antidiuretic hormone and is characterized by intense thirst and urine retention (syndrome of inappropriate antidiuretic hormone secretion)
• Increased liver enzymes (transaminases)
• Hallucinations, changes in mood (e.g. depression or euphoria), unusual hyperactivity, agitation
• Dizziness or lightheadedness, fainting, widespread muscle stiffness, convulsions, reduced level of consciousness, reduced sensitivity to pain or touch, tingling
• Blurred vision
• Facial flushing, low blood pressure
• Pulmonary edema, difficulty breathing, shortness of breath, wheezing
• Slowed or shallow breathing, sudden shortness of breath
• Thirst
• Peripheral edema (swelling of hands, ankles or feet)
• Allergic reaction
• Neonatal abstinence syndrome.

Side effects with unknown frequency:

• Acute generalized allergic reaction (anaphylactic reaction)
• Impotence, decreased libido, absence of menstrual cycle
• Increased sensitivity to pain
• Excessive sweating
• Abnormal thoughts or dreams, changes in mood, increased intracranial pressure
• Reduced pupil size
• Biliary colic
• Reduced cough reflex
• Withdrawal or dependence symptoms (e.g. agitation, anxiety, palpitations, tremors and sweating) that occur when treatment with MS Contin is stopped. (see section 3: If you stop taking MS Contin for symptoms)
• Persistent craving for the medicine even when it is not needed (dependence)
• Need to take ever-increasing doses of the drug to obtain the same pain-relieving effect (tolerance)
• Hyperalgesia (excessive pain sensitivity)
• Sleep apnea (pauses in breathing during sleep)
• Symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts, such as severe pain in the upper abdomen with possible radiation to the back, nausea, vomiting or fever. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 MS Contin

Keep MS Contin out of the sight and reach of children. An accidental overdose in a child is
extremely dangerous and potentially fatal.
Do not use this medicine after the expiry date that is reported on the blister and on the box after Exp. The expiry
date refers to the last day of that month. Store at a temperature not exceeding 25°C.
Do not take the prolonged-release tablets if broken or crushed, as this may be dangerous and cause serious
problems such as an overdose.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the medicines
that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MS Contin contains
The active ingredient is morphine sulfate. Each prolonged-release tablet contains 10 mg, 30 mg, 60 mg, 100 mg or 200
mg of morphine sulfate.
The other ingredients are:
 MS Contin 10 mg: Anhydrous lactose, Hydroxyethylcellulose, Cetostearyl alcohol, Magnesium stearate, Talc, Opadry.
 MS Contin 30 mg: Anhydrous lactose, Hydroxyethylcellulose, Cetostearyl alcohol, Magnesium stearate, Talc, Opadry
OY-6708.
 MS Contin 60 mg: Anhydrous lactose, Hydroxyethylcellulose, Cetostearyl alcohol, Magnesium stearate, Talc, Opadry
OY-3508.
 MS Contin 100 mg: Hydroxyethylcellulose, Cetostearyl alcohol, Magnesium stearate, Talc, Opadry OY-8215.
 MS Contin 200 mg: Hydroxyethylcellulose, Cetostearyl alcohol, Magnesium stearate, Talc, Opadry OY-5970,
Polyethylene glycol 400.

Description of the appearance of MS Contin and contents of the pack
On one side of each prolonged-release tablet of MS Contin, the dosage of drug contained is printed (10, 30,
60, 100, 200). Depending on the dosage, the prolonged-release tablets are coated in the following colours: morphine 10
mg – ochre, 30 mg – deep purple, 60 mg – orange, 100 mg – grey, 200 mg – turquoise. Each pack contains
16 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Mundipharma Pharmaceuticals S.r.t.
Via F. Turati, 40 20121 Milano
Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden
Netherlands