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1. Name of the medicinal product
Rhotard Morphine SR 30mg Tablets
Morphgesic SR 30 mg Tablets
2. Qualitative and quantitative composition
Rhotard Morphine SR 30mg Tablets/ Morphgesic SR 30mg Tablets.
Each tablet contains 30mg 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 Therapeutic 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
Rhotard Morphine SR / Morphgesic SR tablets are not recommended for paediatric use.
Method of administration
Rhotard Morphine SR / Morphgesic SR tablets should be swallowed whole and not chewed.
5.1 Pharmacodynamic properties
Pharmacotherapeutic 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 therapeutic 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.
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.
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