M.O.S. SR Tablets 30mg: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take M.O.S.-SR as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to overdose and death.
• Life-threatening breathing problems can happen while taking M.O.S.-SR, especially if not taken as directed.
• Never give anyone your M.O.S.-SR. They could die from taking it. If a person has not been prescribed M.O.S.-SR, taking even one dose can cause a fatal overdose. This is especially true for children.

• Babies born to mothers who have taken M.O.S.-SR (for short or long periods, in small or large doses) during their pregnancy can suffer life-threatening withdrawal symptoms.

  This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has breathing changes (weak, difficult or fast), is unusually difficult to comfort, has tremors (shakiness), or has increased stools, sneezing, yawning, vomiting, or fever, seek immediate medical help for your baby.

What is M.O.S.-SR used for?

M.O.S.-SR is used for the long-term management of pain, when:

• the pain is severe enough to require daily, around-the-clock painkillers
• the doctor determines that other treatment options are not able to effectively treat your pain

M.O.S.-SR is NOT used (“as needed”) to treat pain that you only have once in a while.

How does M.O.S.-SR work?

M.O.S.-SR (Morphine Hydrochloride) is a painkiller belonging to the class of medicines known as opioids used to treat severe pain. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in M.O.S.-SR?

Medicinal ingredients: Morphine Hydrochloride

Non-medicinal ingredients: Microcrystalline cellulose, magnesium stearate, simetry and talc.

M.O.S.-SR comes in the following dosage forms:

Slow Release Tablets of 30 mg and 60 mg.

Do not use M.O.S.-SR if:

• you are allergic to Morphine Hydrochloride, other opioids, or any of the other ingredients of M.O.S.-SR
• your pain can be controlled by the occasional use of painkillers including those available without a prescription
• you have severe asthma, trouble breathing, or any heart problems
• you have bowel blockage or narrowing of the stomach or intestines
• you have a head injury or other risks for seizures
• you suffer from alcoholism
• you are going to have, or recently had, a planned surgery
• you are pregnant or plan to become pregnant, breastfeeding, or in labour. Morphine may cause addiction and withdrawal symptoms as well as other harmful effects in an unborn baby or nursing infant.
• you are under 18 years of age

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M.O.S.-SR. Talk about any health conditions or problems you may have, including if you:

• have a history of illicit or prescription drug or alcohol abuse
• have severe kidney, liver and gallbladder diseases
• have emphysema or other breathing problems
• have low blood pressure
• have past or current depression
• have history of mental illness, head injury or brain tumor
• suffer from chronic, severe constipation or intestinal blockage
• have stomach problems, Addison's disease, pancreatitis, hypothyroidism, urinary retention, an enlarged prostate, seizures or epilepsy

Other warnings you should know about:

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to M.O.S.-SR. Drowsiness, dizziness, or lightheadedness, can especially occur after the first dose and when the dose is increased.

If you are older than 60 years of age you may be more likely to experience side effects.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with M.O.S.-SR:

• alcohol, including prescription and non-prescription medications containing alcohol.

Do not drink alcohol while taking M.O.S.-SR. This can lead to drowsiness, depressed breathing, serious side effects or a fatal overdose

• other sedative drugs which may enhance the drowsiness caused by M.O.S.-SR
• other opioid analgesics (for pain) or opioid antagonists such as naltrexone or naloxone
• general anesthetics (used during surgery)
• drugs used to help you sleep or to reduce anxiety
• antidepressants (for depression and mood disorders). Do not take M.O.S.-SR with MAO inhibitors or if you have taken MAOI’s in the last 14 days before treatment with M.O.S.-SR.
• drugs used to treat serious mental or emotional disorders such as schizophrenia
• antihistamines (for allergies)
• anti-emetics (for prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• warfarin and other coumarin anticoagulants (for prevention/treatment of blood clots)
• anti-retroviral, anti-fungal and antibiotic drugs

Do not take medicinal products or natural/herbal remedies without consulting your doctor or pharmacist as they may aggravate your condition. Always carry a list of medicines you are taking, and make sure that any new or different health care provider be informed about this list in order to get a safe medicine not interacting with any other one included in that list.

How to take M.O.S.-SR:

Swallow whole. Do not break, chew, dissolve or crush, as it would cause too much drug to be released into your blood at one time and expose yourself to a potentially toxic dose of morphine. M.O.S-SR tablets are specially formulated to release morphine slowly into your system.

Take morphine exactly as directed by your doctor. Take each dose with a full glass of water or with food or milk if it upsets your stomach. Never take more of this medication than is prescribed for you as it could be very harmful.

Never take more morphine than is prescribed for you. This medicine may be habit-forming. If your pain is not being adequately treated, talk to your doctor.

Morphine is habit forming. Do not stop taking morphine suddenly if you have been taking it continuously for more than 5 to 7 days. Stopping suddenly could cause withdrawal symptoms and make you feel uncomfortable. Your doctor may want to gradually reduce your dose.

Usual Adult Starting Dose:

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly.

Overdose:

Signs of overdose may include abnormally slow or weak breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, extreme drowsiness, cold and clammy skin and small pupils.

If you think you have taken too much M.O.S.-SR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in succession, talk to your doctor before restarting your medication.

Refilling Prescriptions for M.O.S.-SR:

A new written prescription is required from your doctor each time you need more M.O.S.-SR. Therefore, it is important that you contact your doctor before your current supply runs out.

What are possible side effects from using M.O.S.-SR?

These are not all the possible side effects you may feel when taking M.O.S.-SR. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Drowsiness, insomnia
• Dizziness, fainting
• Nausea, vomiting, poor appetite, dry mouth
• Headache
• Problems with vision
• Weakness, uncoordinated muscle movement
• Itching
• Sweating
• Constipation

One of the most common documented side effects is constipation. Increase the amount of fiber and water (at least six to eight full glasses daily) in your diet to prevent constipation.

Talk with your doctor or pharmacist about ways to prevent constipation when you start using M.O.S.-SR.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional. Other, less serious side effects may be more likely to occur. Continue to take M.O.S.-SR and talk to your doctor if you experience: tiredness, decreased urination or decreased sex drive.

Reporting Side Effects

We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone. 3 ways to report:

• Online at MedEffect;
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

Storage:

M.O.S.-SR tablets should be stored at room temperature below 30ºC (86ºF), away from moisture, heat and direct light.

Keep unused or expired M.O.S.-SR in a secure place to prevent theft, misuse or accidental exposure.

Keep out of sight and reach of children and pets.

Disposal:

M.O.S.-SR should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about M.O.S.-SR:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website or by calling the manufacturer at: 1-800-361-4261

Last Revised AUG-01-2014