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1. Name of the medicinal product
Rhotard Morphine SR 30 mg Tablets
Morphgesic SR 30 mg Tablets

2. Qualitative and quantitative composition
Rhotard Morphine SR 30 mg Tablets/ Morphgesic SR 30 mg Tablets.
Each tablet contains 30 mg of morphine sulphate.
Excipients with known effect:
Lactose (63.000 mg per tablet).

3. Pharmaceutical form
Controlled release tablets
Each 30 mg tablet is a violet coloured biconvex round film coated tablet.

4. Clinical particulars
4.1 The*****utic indications
Rhotard Morphine SR / Morphgesic SR tablets are indicated in adults for the prolonged relief of severe pain.

4.2 Posology and method of administration
Posology
Paediatric population
Rhotard Morphine SR / Morphgesic SR tablets are not recommended for paediatric use.

Adults:
The dosage is dependent upon the severity of the pain and the patient’s previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets (10 mg) twice daily is the recommended starting dosage for a patient presenting with severe pain. With increasing severity of pain it is recommended that the dosage of morphine be increased to achieve the desired relief. The dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100 mg) or by using higher strength tablets alone.
It is recommended that a patient transferred from another oral morphine preparation, having similar bioavailability to oral morphine liquid, should receive the same total morphine dose in one 24-hour period. This total dose should be divided between the morning and evening administration. Dosage titration and clinical assessment may be appropriate.
Where a patient had previously received parenteral morphine prior to being transferred to Rhotard Morphine SR/ Morphgesic SR tablets, a higher dosage of morphine may be required. Individual dosage adjustment will be necessary to compensate for any reduction in analgesic effect associated with oral administration.
When Rhotard Morphine SR/ Morphgesic SR tablets is to be given for the relief of postoperative pain, it is not advisable to administer it during the first 24 hours. Following this initial period, the dosage should be at the physician’s discretion.
Some patients may require supplemental parenteral morphine which is perfectly acceptable. Careful attention should be paid to the total morphine dosage however, and the prolonged effects of morphine in the Rhotard Morphine SR/ Morphgesic SR formulation should also be borne in mind.
Rhotard Morphine SR/ Morphgesic SR tablets should be used with caution post-operatively (as with all morphine preparations) but especially following abdominal surgery.
Gastric motility should have returned and be maintained.

Method of administration
Oral
Rhotard Morphine SR / Morphgesic SR tablets should be swallowed whole and not chewed.

5.1 Pharmacodynamic properties
Pharmacothe*****utic group: Opioids
ATC code: N02A

Mechanism of action
MAGNUS MR SULFATE ER 30 MG acts as an agonist at opiate receptors in the CNS particularly Mu and to a lesser extent Kappa receptors. Mu receptors are thought to mediate supraspinal analgesia, respiratory depression and euphoria, and Kappa receptors, spinal analgesia, miosis and sedation.

Central Nervous System:
The principal actions of the*****utic value of morphine are analgesia and sedation (i.e., sleepiness and anxiolysis). MAGNUS MR SULFATE ER 30 MG produces respiratory depression by direct action on brain stem respiratory centres. Morphine depresses the cough reflex by direct effect on the cough centre in the medulla. Antitussive effects may occur with doses lower than those usually required 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 haemorrhagic or ischaemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of morphine overdose.

MAGNUS MR SULFATE ER 30 MG and related analgesics may produce both physical and psychological dependence and should therefore be used with discrimination. Tolerance may also develop.

Gastrointestinal Tract and Other Smooth Muscle
MAGNUS MR SULFATE ER 30 MG causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation. Morphine generally increases smooth muscle tone, especially the sphincters of the gastrointestinal and biliary tracts. Morphine may produce spasm of the sphincter of Oddi, thus raising intrabiliary pressure.

Cardiovascular System
MAGNUS MR SULFATE ER 30 MG may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Endocrine System
Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone in association with inappropriately low or normal ACTH, LH or FSH levels. Some premenopausal women may have low oestrogen levels. Clinical symptoms may be manifest from these hormonal changes.

Other Pharmacological Effects
In vitro and animal studies indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown.

Routes of administration include the oral, subcutaneous, intramuscular, intravenous, intraspinal and rectal routes. Parenteral doses may be intermittent injections or continuous or intermittent infusions adjusted according to individual analgesic requirements.

USES
This medication is used to help relieve severe ongoing pain (such as due to cancer). Morphine belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.

The higher strengths of this drug (100 milligrams or more per tablet) should be used only if you have been regularly taking moderate to large amounts of opioid pain medications. These strengths may cause overdose (even death) if taken by a person who has not been regularly taking opioids.

Do not use the extended-release form of morphine to relieve pain that is mild or that will go away in a few days. This medication is not for occasional (“as needed”) use.

HOW TO USE MAGNUS MR SULFATE ER 30 MG TABLET

Read the Medication Guide provided by your pharmacist before you start using morphine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain. Take this drug with or without food as directed by your doctor, usually every 8 hours or 12 hours. Some brands should only be taken every 12 hours. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible). If nausea persists, see your doctor.

Swallow the tablets whole. Do not break, crush, chew, or dissolve the tablet. Doing so can release all of the drug at once, increasing the risk of morphine overdose.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed, because your risk of side effects may increase. Properly stop the medication when so directed.

Before you start taking this medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication(s). Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using morphine safely with other drugs.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used morphine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your pain lasts or gets worse.