Active ingredients: Morphine (Morphine sulfate)
MS Contin 10 mg, prolonged release tablets
MS Contin 30 mg, prolonged release tablets
MS Contin 60 mg, prolonged release tablets
MS Contin 100 mg, prolonged release tablets
MS Contin 200 mg, prolonged release tablets
Indications Why is Ms contin used? What is it for?
These prolonged-release tablets have been prescribed by your doctor for the remission of prolonged, severe and rebellious pains that require 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) which act by relieving pain For the other excipients contained in the prolonged-release tablet see section 6 of this leaflet.
MS Contin has a 12-hour efficacy of action if the prolonged-release tablets are swallowed whole. instead absorbed quickly: this can be harmful and cause serious problems and overdose is life-threatening.
Contraindications When Ms contin. Should not be used
Do not take MS Contin:
- if you are allergic (hypersensitive) to the active substance 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 breathe more slowly or weakly than expected (respiratory depression);
- if you have a head injury which causes severe headache or malaise. This is because prolonged-release tablets can worsen these symptoms or mask the actual severity of the head injury;
- if you have increased pressure in your head (intracranial or cerebrospinal hypertension);
- if you suffer from alcohol dependence (acute alcoholism, delirium tremens);
- if you suffer from depression of the central nervous system, in particular due to other medicines (hypnotics, sedatives, tranquilizers);
- if you have a condition where the small intestine is not functioning well (paralytic ileus), if your stomach empties more slowly than it should (slowed gastric emptying) or if you have severe abdominal pain;
- if you have heart problems (cardiac arrhythmias) and suffer from heart problems due to chronic lung disease,
- if you have recent liver disease (acute liver disease);
- if you are taking antidepressant medicines called monoamine oxidase inhibitors at the same time (for example tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolide) or if you have taken these medicines in the last two weeks.
Precautions for use What you need to know before taking Ms contin
Talk to your doctor or pharmacist before taking MS Contin
- if you are an elderly person, very old 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 dose of MS Contin;
- if you have severe headache or malaise, symptoms that could indicate increased pressure in the skull;
- 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 gallbladder problems;
- if you suffer from obstructive or inflammatory intestinal disorders;
- if you suffer from prostate (prostatic hypertrophy) and urinary tract (urethral stricture) disorders;
- if you have impaired adrenal function (hypoadrenalism);
- if you have or have been addicted to alcohol or drugs;
- if you have previously suffered from withdrawal symptoms such as agitation, anxiety, palpitations, tremors or sweating that occurred after stopping alcohol or drugs;
- if you suffer from seizures or convulsions;
- if you suffer from mental confusion or fainting;
- if you have breathing problems such as respiratory failure and chronic lung diseases (particularly if accompanied by increased secretion of mucus from the bronchi) and in all conditions in which the respiratory tract is closed (obstructive conditions);
- if you have long-lasting kidney or liver problems, you should only take MS Contin if recommended by your doctor
- if you are pregnant
Before surgery, tell your hospital doctor that you are taking these prolonged-release tablets, the medicine is not recommended in the preoperative period or in the 24 hours after an operation.
The administration of morphine, especially if prolonged, can determine the onset of tolerance and dependence.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Children and adolescents
MS Contin is not recommended for use in children and adolescents under 18 years of age.
Interactions Which drugs or foods can modify the effect of Continuous Ms
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those that do not require a prescription.
By taking MS Contin at the same time as some other drugs, the effect of MS Contin or that of the other drugs may be changed.
MS Contin must not be used at the same time as certain antidepressant medicines called monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolide) or if you have taken these medicines within the last two weeks.
Tell your doctor or pharmacist:
- if you are taking sleep medications (for example tranquilizers, hypnotics or sedatives);
- if you have recently taken an anesthetic;
- if you are taking medicines for depression (antidepressants);
- if you are taking medications for psychiatric or mental disorders;
- if you are taking other strong pain relievers or pain relievers;
- if you are taking muscle relaxants;
- if you are taking high blood pressure medications;
- if you are taking quinidine (medicine for heart beat problems);
- if you are taking cimetidine (anti-ulcer or heartburn medicine);
- if you are taking antibiotics (such as erythromycin);
- if you are taking antifungals (such as ketoconazole);
- if you are taking gabapentin.
MS Contin with food, drink 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 not to drink alcohol while taking MS Contin.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may feel sleepy when you first start treatment with MS Contin or when your dose is increased. If you feel sleepy 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.
Dosage and method of use How to use Ms contin: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist. This leaflet describes how many prolonged-release tablets to take and how often.
MS Contin pain treatment usually begins with 1 or 2 prolonged-release 10 mg tablets every 12 hours, except in elderly or debilitated people, where the starting dose is lower. The patented extended-release morphine system makes morphine easily absorbable in the intestine, maintaining its plasma levels for up to 12 hours.
To replace other oral morphine-based medicines with MS Contin, the same overall daily dose of morphine should be maintained, divided into two doses: morning and evening (one every 12 hours). If parenteral morphine administration is replaced with MS Contin, the dose of MS Contin should be increased to compensate for the reduction in analgesic effect due to oral administration. Generally it is necessary to increase the dose from approximately 50% to 100%. However, your doctor will prescribe the dose required to treat your pain. If you still have pain despite MS Contin treatment, discuss this with your doctor. Do not exceed the dose recommended by your doctor. If you are unsure, consult with your doctor. your doctor or pharmacist.
MS Contin prolonged-release tablets should be swallowed whole with water. The prolonged-release tablets should not be chewed, broken or dissolved. In fact, the patented prolonged-release drug system makes morphine easily absorbable in the intestinal tract, maintaining plasma levels for up to 12 hours.
You must take the prolonged-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 prolonged-release tablets in the first 24 hours after the surgery; then your doctor will prescribe MS Contin with the following dosage schedule:
- MS Contin 20 mg every 12 hours for patients weighing less than 70 kg;
- MS Contin 30 mg every 12 hours for patients weighing more than 70 kg.
If necessary, additional administration of morphine parenterally can be carried out, paying particular attention to the overall dose of morphine and taking into account the prolonged effect of morphine in the MS Contin formulation.
As with all morphine 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
MS Contin is not recommended for use in children and adolescents under 18 years of age.
You should only take MS Contin by mouth
The extended-release tablets should not be broken or injected as this could cause serious, potentially fatal side effects.
If you forget to take MS Contin
If it has not been 4 hours since you were due to take the prolonged-release tablet, take it straight away. Then take the next prolonged-release tablet at the scheduled time. If it has been more than 4 hours since you were supposed to take the prolonged-release tablet, call your doctor or pharmacist and ask for advice. Do not take a double dose to make up for it. forgetting the prolonged-release tablet.
If you stop taking MS Contin
You should not abruptly stop taking the prolonged-release tablets, unless directed by your doctor. If you want to stop treatment, please discuss this with your doctor first. Your doctor will be able to advise you on how to stop treatment, usually by reducing the dose of the drug. gradually, in order to avoid unpleasant unwanted effects.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Ms contin
Contact your doctor or the nearest hospital. In the event of an overdose, sleepiness and malaise may occur.Pneumonia ad ingestis, breathing difficulty that can lead to unconsciousness or even death, and emergency hospital treatment may also occur. When contacting a doctor, take this leaflet with you and show the doctor any prolonged-release tablets left in the used carton.
Side Effects What are the side effects of Ms contin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All drugs can cause allergic reactions, although severe allergic reactions are rare. Tell your doctor immediately if you notice difficulty in breathing, sudden wheezing, swelling of the eyelids, face or lips, rash or itching, especially if it has spread to your whole body.
Slow, shallow breathing (respiratory depression) is the main danger of an opiate overdose. It mainly occurs in elderly and debilitated patients. Opiates can also cause a severe drop in blood pressure in predisposed patients.
As with other opiates, there is a risk of developing physical or psychological dependence on MS Contin.
The following frequency data are used to evaluate side effects:
- Very common: affects more than 1 in 10 patients
- Common: affects 1 to 10 users in 100
- Uncommon: affects 1 to 10 patients in 1,000
- Rare: affects 1 to 10 patients in 10,000
- Very rare: affects less than 1 in 10,000
- Not known: frequency cannot be estimated from the available data
Very common side effects:
- Nausea: These problems usually tend to subside after a few days. However, your doctor may prescribe an anti-emetic medicine if the problem persists.
- Constipation: Your doctor may prescribe a laxative to remedy this problem.
It is also possible that you may experience unusual sleepiness at the start of treatment or following dose increases. 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, sleepiness, feeling unusually weak or faint (especially when standing), insomnia (difficulty sleeping), general malaise.
- Involuntary muscle contractions.
- Vertigo or dizziness.
- Excessive sweating, redness of the skin.
Uncommon side effects:
- Bloating, bloating, gastrointestinal disturbances (e.g. abdominal pain or cramps), taste disturbances.
- Itching (hives) or skin rash from allergic reaction.
- A condition causing abnormal antidiuretic hormone production and characterized by intense thirst and urine retention (syndrome of inappropriate antidiuretic hormone secretion).
- Increase in enzymes produced by the liver (transaminases).
- Hallucinations, mood changes (eg depression or euphoria), unusual hyperactivity, agitation.
- Vertigo or dizziness, fainting, widespread muscle stiffness, seizures, decreased consciousness, decreased sensitivity to pain or touch, tingling.
- Blurred vision.
- Flushing of the face, low blood pressure.
- Difficulty breathing, shortness of breath, wheezing.
- Slow or shallow breathing, sudden wheezing.
- Thirst.
- Peripheral edema (swollen hands, ankles or feet).
Undesirable effects of unknown frequency:
- Acute generalized allergic reaction (anaphylactic reaction).
- Impotence, decreased desire, absence of the menstrual cycle.
- Abnormal thoughts or dreams, mood changes.
- Reduction in the size of the pupils.
- Biliary colic.
- Reduction of the cough stimulus.
- Withdrawal symptoms (eg agitation, anxiety, palpitations, tremors and sweating) which occur upon discontinuation of MS Contin.
- Stubborn pursuit of the drug even when it is not needed (addiction).
- Need to take more and more doses of the drug to achieve the same pain-relieving effect (tolerance).
- Hyperalgesia (excessive pain).
- Neonatal withdrawal syndrome
Uncommonly, MS Contin can alter the results of some blood tests done to check your liver function.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep MS Contin out of the sight and reach of children. An accidental overdose in a child is extremely dangerous and life-threatening.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25 ° C.
Do not take broken or crushed prolonged-release tablets, as it can be dangerous and cause serious problems such as an overdose.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What does MS Contin
- 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 what MS Contin looks like and contents of the pack
The strength of the drug contained is printed on one side of each MS Contin prolonged-release tablet. Depending on the dosage, the prolonged-release tablets are coated in the following colors: morphine 10 mg - ocher, 30 mg - purple red, 60 mg - orange, 100 mg - gray, 200 mg - turquoise. There are 16 prolonged-release tablets in each pack.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MS CONTIN LONG-RELEASE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
MS Contin 10 mg
1 prolonged-release tablet contains:
Active ingredient: Morphine sulfate 10 mg.
Excipient with known effect: lactose
MS Contin 30 mg
1 prolonged-release tablet contains:
Active ingredient: Morphine sulfate 30 mg.
Excipient with known effect: lactose
MS Contin 60 mg
1 prolonged-release tablet contains:
Active ingredient: Morphine sulphate 60 mg.
Excipient with known effect: lactose
MS Contin 100 mg
1 prolonged-release tablet contains:
Active ingredient: Morphine sulfate 100 mg.
MS Contin 200 mg
1 prolonged-release tablet contains:
Active ingredient: Morphine sulphate 200 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Prolonged-release tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Relief of prolonged, severe and rebellious pains requiring prolonged use of narcotics.
04.2 Posology and method of administration
Dosage
Two administrations per day 12 hours apart. MS Contin prolonged-release tablets should be swallowed whole, not divided into pieces and not chewed. Dosage should be tailored to each patient according to pain intensity and previous analgesic therapy. MS Contin pain treatment usually starts with 1 or 2 prolonged-release tablets of MS Contin 10 mg twice daily, done except for elderly, debilitated subjects, where the starting dose is lower.
Increased pain intensity or addiction to morphine requires an increase in dosage by administering MS Contin 10, 30, 60, 100 and 200 mg prolonged-release tablets used alone or in combination to achieve the desired effect.
The therapeutic transition from other oral morphine preparations to substitution treatment with MS Contin is generally carried out by maintaining the same overall daily dosage of morphine divided into two administrations: one every 12 hours.
In patients who are given MS Contin as a substitute for parenteral morphine, the dosage should be increased to compensate for the reduction in analgesic effect due to oral administration. Generally it is necessary to increase the dosage from 50% to 100%. The dosage must be individually adjusted in all patients.
Post-operative pain: it is not recommended to take MS Contin prolonged-release tablets in the first 24 hours after surgery (see Par. 4.3); then, in the opinion of the doctor, the following dosage schedule is suggested:
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, additional administration of morphine parenterally can be carried out, paying particular attention to the overall dose of morphine and taking into account the prolonged effect of morphine in the MS Contin formulation.
As with all morphine-based preparations, MS Contin should be used with caution after surgery, especially in cases of acute abdomen and after abdominal surgery (see section 4.3).
Pediatric population
The safety and efficacy of MS Contin in children and adolescents have not yet been established (see section 4.4).
04.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Hypersensitivity to any morphine salt
• Respiratory depression, paralytic ileus, delayed gastric emptying, obstructive states of the airways (bronchial asthma), acute liver disease.
MS Contin is also contraindicated in cardiac arrhythmias, severe right heart failure, acute alcoholism, delirium tremens, increased intracranial or cerebrospinal pressure, severe CNS depression, head trauma, suspected surgical abdomen (see Section 4.2). - Simultaneous intake of monoamine oxidase inhibitors, and within two weeks of their treatment (see Par.4.5),
04.4 Special warnings and appropriate precautions for use
• Like all narcotic drugs, morphine should be administered with caution and in low doses in patients with:
• history of substance abuse
• increased intracranial pressure
• hypotension with hypovolaemia
• biliary tract diseases
• pancreatitis
• reduced kidney and liver function
• severe chronic obstructive pulmonary disease
• severe bronchial asthma
• respiratory depression.
The major risk of opioid excess is respiratory depression.
Furthermore, morphine should be administered with caution and in reduced doses in elderly or debilitated patients, in the presence of hypothyroidism, prostatic hypertrophy, urethral stricture, Addison's disease.
Morphine may decrease the seizure threshold in patients with a history of epilepsy.-MS Contin prolonged-release tablets should not be administered in case of potential ileus paralytic (see section 4.3). In cases of suspected or manifest paralytic ileus during treatment, the administration of MS Contin should be discontinued immediately. Like all morphine preparations, MS Contin should not be administered within 24 hours prior to surgery to patients undergoing cordotomy or other surgical pain treatments. If MS Contin therapy is subsequently re-initiated, the dosage should be adjusted to the new post-operative needs. MS Contin is not recommended in the preoperative period or in the 24 hours following an operation.
Addiction and dependence can occur.
The use of MS Contin in children and adolescents is not recommended (see Section 4.2).
The patient may develop tolerance to the drug through chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product can lead to physical dependence, and withdrawal syndrome may develop due to abrupt discontinuation of therapy. When a patient no longer requires morphine therapy, it is advisable to gradually decrease the dose to prevent withdrawal symptoms.
Morphine has a similar abuse profile to other strong opioids. Morphine can be abused by people with underlying or manifest problems of abuse. The development of psychological dependence on opioid analgesics in properly treated pain patients has been reported to be rare. However, no data are available to establish the true incidence of psychological dependence in patients with chronic pain.
The product should be used with particular caution in patients with a history of alcohol or drug abuse.
The concomitant use of alcohol and MS Contin may increase the undesirable effects of MS Contin; concomitant use should be avoided.
In case of nausea and vomiting, MS Contin can be easily associated with phenothiazine antiemetics. It must however be kept in mind that morphine enhances the action of alcohol, tranquilizers, anesthetics, hypnotics and sedatives whose simultaneous use therefore goes into generally avoided or implemented, under strict medical supervision, with great caution and at reduced doses. As with all morphine-based preparations, the onset of constipation is possible, which can be treated with appropriate laxatives.
The prolonged-release tablets must be swallowed whole and must not be broken, chewed or crushed. Administration of broken, chewed or crushed prolonged-release morphine tablets leads to rapid release and absorption of a potentially fatal dose of morphine (see section 4.9).
Abuse of oral forms by parenteral administration can lead to serious adverse events that can be fatal.
MS Contin 10 mg, MS Contin 30 mg, MS Contin 60 mg contain lactose: patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Hyperalgesia unresponsive to further increases in morphine sulfate dosage may occur especially at high doses. In these cases a dose reduction or change of opioid may be necessary.
04.5 Interactions with other medicinal products and other forms of interaction
The depressant effects of morphine are enhanced by CNS depressant drugs, e.g. other opiates, anesthetics, sedatives, hypnotics, barbiturates, phenothiazines, gabapentin, chloral hydrates, and alcohol.
In general, the effects of morphine can be antagonized by acidifying agents and enhanced by alkalizing agents. The analgesic effect of morphine is enhanced by amphetamines, chlorpromazine and methocarbamol.
Morphine can increase the activity of coumarin and other anticoagulants.
Interactive effects such as respiratory depression, hypotension, profound sedation or coma may result if these drugs are taken in combination with the usual doses of morphine.
Morphine should not be administered concomitantly with monoamine oxidase inhibitors or in the two weeks following such therapy. MAO inhibitors (including procarbazine hydrochloride), pyrazolidone, antihistamines, beta blockers and alcohols potentiate the depressant effects of morphine (see Section 4.3).
Alcohol may enhance the pharmacodynamic effects of MS Contin; concomitant use should be avoided.
04.6 Pregnancy and breastfeeding
Pregnancy
MS Contin is not recommended in pregnancy. The medicine should only be given if the potential benefit justifies the potential risk to the fetus.
Feeding time
MS Contin is not recommended during breastfeeding because morphine is excreted in breast milk. Withdrawal symptoms may be observed in the newborn from mothers undergoing chronic treatment.
The use of this product should be avoided to the maximum extent possible in pregnant or breastfeeding patients.
04.7 Effects on ability to drive and use machines
Morphine can alter mental and / or physical abilities making dangerous activities such as driving cars or using dangerous machines.
04.8 Undesirable effects
The following frequencies are the basis for assessing undesirable effects:
Very common (≥ 1/10)
Common (≥ 1/100 e
Uncommon (≥ 1/1000 e
Rare (> 1 / 10,000 e
Very rare (
Not known (cannot be estimated from the available data)
The undesirable effects listed below are classified by body area according to their incidence (common or uncommon). Common side effects have an "incidence ≥1% while uncommon side effects have a" incidence
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili".
04.9 Overdose
Overdose with morphine can manifest itself with: pinpoint pupils, flaccidity of skeletal muscles, bradycardia, respiratory depression, aspiration pneumonia, somnolence leading to stupor or coma, rhabdomyolysis leading to renal failure, hypotension, circulatory decompensation and death .
The use of crushed prolonged-release tablets results in immediate release of morphine, which can lead to a fatal overdose.
Morphine overdose treatment
The patency of the airways must be preserved. Pure opioid antagonists are specific antidotes to the effect of an opioid overdose. Other supportive measures should be instituted as needed.
In case of overdose, administer 0.8 mg of naloxone intravenously, repeat the administration at intervals of 2 - 3 minutes as needed or by infusion of 2 mg in 500 ml of saline, or in 500 ml of 5-glucose solution. % (0.004 mg / ml). The infusion should be performed at a rate adjusted according to the amount of drug taken and the patient's response.
Carry out a gastric lavage. For washing, a 0.02% aqueous solution of potassium permanganate can be used. If necessary, provide respiratory assistance. Maintain the hydro-electrolyte balance. When using MS Contin, the physician should bear in mind that the prolonged-release tablets left in the intestine continue to release morphine sulphate for a period of several hours.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: natural opium alkaloids, ATC code: N02AA01.
Morphine is an analgesic opioid that acts as an agonist on specific receptors located in the central nervous system and in the mesenteric plexus of the abdominal wall.
Central nervous system
The main effects of the therapeutic action of morphine are analgesia and sedation (eg sleepiness, anxiolysis). Morphine induces respiratory depression by acting directly on the respiratory centers of the brain stem. Morphine reduces the cough reflex through a direct effect on the cough center in the medulla. The anti-cough effect can occur with lower doses than those used for analgesia. Morphine causes miosis even in total darkness. Pinpoint pupils are a sign of narcotic overdose but are not pathognomonic (e.g. pontine lesions of hemorrhagic or ischemic origin may produce similar evidence). Rather than miosis, mydriasis marked with hypoxia may occur during a morphine overdose.
Gastrointestinal system and smooth muscle
Morphine causes a reduction in motility associated with an increase in smooth muscle tone in the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are reduced. Peristaltic waves in the colon are decreased, while muscle tone is increased to cause spasms that cause constipation. Morphine generally increases muscle tone. smooth, especially at the level of the sphincters of the gastrointestinal and biliary tract, increase in intestinal tone with reduction of propulsive force, increase in bile pressure and tone of the ureter and bladder sphincter and increase in intestinal tone.
Cardiovascular system
Morphine can cause histamine release, with or without associated peripheral vasodilation. Clinical manifestations of histamine release and / or peripheral vasodilation may include itching, flushing, red eyes, sweating and / or orthostatic hypotension.
Endocrine system
Opioids can affect the hypothalamic-pituitary-adrenal axis or gonads. Some changes that may be noted include an increase in serum prolactin and a decrease in plasma cortisol and testosterone. Clinical symptoms of these hormonal changes may also occur.
Other pharmacological effects
Education in vitro and on animals indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown.
Morphine increases the pain threshold and is particularly effective against persistent pain.
05.2 Pharmacokinetic properties
Morphine is absorbed from the gastrointestinal tract.
After the first oral administration its efficacy is lower than the parenteral administration - variable ratio from 1: 6 to 1: 2. In case of chronic administration the ratio is reduced to 1/2 - 1/3.
After absorption, approximately 30 - 35% of morphine is reversibly bound to plasma proteins. The free morphine leaves the bloodstream and concentrates in the liver, kidneys, lungs, spleen and, to a lesser extent, in the skeletal muscles.
The main metabolic pathway passes through conjugation with glucuronic acid. The mean elimination half-life is between 2 and 4 hours with great variability according to the patients. The main route of elimination is via the kidney: about 7 - 10% is eliminated by the faecal route. Conjugated morphine, excreted with bile, can be hydrolyzed and reabsorbed in the intestine.
MS Contin, a prolonged release morphine sulphate according to a patented system, is able to guarantee adequate analgesia for 12 hours in most patients.
05.3 Preclinical safety data
LD50 in mice per os 650 mg / kg; in the rat per os 460 mg / kg; in the guinea pig per os 1000 mg / kg.
In humans the toxicity of morphine has been studied in case of overdose, but due to the great variability in individual sensitivity to opioids it is difficult to determine the exact toxic or lethal dose. The presence of pain or tolerance decreases the toxic effects of morphine.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
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, Hydroxyethyl Cellulose, 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.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store in a dry place, below 25 ° C, away from light.
06.5 Nature of the immediate packaging and contents of the package
MS Contin 10 mg, box of 16 prolonged-release tablets in opaque blister;
MS Contin 30 mg, box of 16 prolonged-release tablets in opaque blister;
MS Contin 60 mg, box of 16 prolonged-release tablets in opaque blister;
MS Contin 100 mg, box of 16 prolonged-release tablets in opaque blister;
MS Contin 200 mg, box of 16 prolonged-release tablets in opaque blister.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
MUNDIPHARMA PHARMACEUTICALS SRL - Via G. Serbelloni n ° 4, 20122 Milan, Italy
08.0 MARKETING AUTHORIZATION NUMBER
MS Contin 10 mg - A.I.C. No. 025624014
MS Contin 30 mg - A.I.C. No. 025624026
MS Contin 60 mg - A.I.C. No. 025624038
MS Contin 100 mg - A.I.C. No. 025624040
MS Contin 200 mg - A.I.C. No. 025624053
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first A.I.C .: 30/7/1987.
A.I.C renewal: June 2010.
10.0 DATE OF REVISION OF THE TEXT
January 2017
