Details for: STATEX
Company: PALADIN LABS INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00594652 | STATEX TAB 5MG | MORPHINE SULFATE | 5 MG | TABLET | ORAL |
| 00594644 | STATEX TAB 10MG | MORPHINE SULFATE | 10 MG | TABLET | ORAL |
| 00594636 | STATEX TABLET 25MG | MORPHINE SULFATE | 25 MG | TABLET | ORAL |
| 00675962 | STATEX TABLETS 50MG | MORPHINE SULFATE | 50 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
STATEX is used to manage your pain.
What it does
STATEX is a painkiller belonging to the class of drugs known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
When it should not be used
Do not use STATEX if:
- your doctor did not prescribe it for you
- you are allergic to morphine sulfate or any of the other ingredients in STATEX.
- you can control your pain by the occasional use of other pain medications. This includes those available without a prescription.
- you have severe asthma, trouble breathing, or other breathing problems.
- you have any heart problems.
- you have bowel blockage or narrowing of the stomach or intestines.
- you have severe pain in your abdomen.
- you have a head injury.
- you are at risk for seizures.
- you suffer from alcoholism.
- you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline) .
- you are going to have, or recently had, a planned surgery.
What the medicinal ingredient is
Medicinal ingredient: morphine sulfate
What the non-medicinal ingredients are
Non-medicinal ingredients:
Drops and unflavoured syrup: citric acid anhydrous, dextrose monohydrate, glycerine, sodium
benzoate, sodium cyclamate, propylene glycol, water.
Orange flavoured syrup: citric acid anhydrous, glycerine, orange extract, propylene glycol,
sodium benzoate, sucrose, water.
Suppositories: hydrogenated vegetable oil
Tablets: FD&C Blue No.1 Lake (5mg, 10mg), FD&C red #3 Lake (25mg, 50mg), lactose
monohydrate, lake blend yellow (5mg, 50mg), magnesium stearate, microcrystalline cellulose
What dosage form it comes in
STATEX is available in oral drops (50 mg/mL), suppositories (5, 10, 20, 30 mg), syrup (1, 5 mg/mL) and tablets (5, 10, 25 and 50 mg).
Warnings and precautions
Serious Warnings and Precautions
- Even if you take STATEX as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
- When you take STATEX tablets it must be swallowed whole. Do not cut, break, crush, chew, dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
- You may get life-threatening breathing problems while taking STATEX. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of lifethreatening breathing problems if their mothers take opioids while pregnant or nursing.
- You should never give anyone your STATEX. They could die from taking it. If a person has not been prescribed STATEX, taking even one dose can cause a fatal overdose. This is especially true for children.
- If you took STATEX while you were pregnant, whether for short or long periods of
time or in small or large doses, your baby can suffer life-threatening withdrawal
symptoms after birth. This can occur in the days after birth and for up to 4 weeks
after delivery. If your baby has any of the following symptoms:
- has changes in their breathing (such as weak, difficult or fast breathing)
- is unusually difficult to comfort
- has tremors (shakiness)
- has increased stools, sneezing, yawning, vomiting, or fever
- You should not take STATEX with alcohol. This can be dangerous and can lead to death or seriously harm you.
- Taking STATEX with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take STATEX. 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 or lung disease
- have heart disease
- have low blood pressure.
- have past or current depression.
- suffer from chronic or severe constipation.
- have problems with your thyroid, adrenal or prostate gland.
- have, or had in the past hallucinations or other severe mental problems.
- have a biliary tract disorder.
- are pregnant or planning to become pregnant.
- suffer from migraines.
Other warnings you should know about:
Opioid dependence and addiction: There are important differences between physical
dependence and addiction. It is important that you talk to your doctor if you have questions or
concerns about abuse, addiction or physical dependence.
Pregnancy, nursing, labour and delivery: Opioids can be transferred to your baby through
breast milk, or while still in the womb. STATEX can then cause life-threatening breathing
problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of
using STATEX outweigh the risks to your unborn baby or nursing infant.
If you are pregnant and are taking STATEX, it is important that you don’t stop taking your
medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your doctor will
monitor and guide you on how to slowly stop taking STATEX. This may help avoid serious
harm to your unborn baby.
Driving and using machines: Before you do tasks which may require special attention, you
should wait until you know how you react to STATEX. STATEX can cause:
- drowsiness;
- dizziness or;
- lightheadedness.
This can usually occur after you take your first dose and when your dose is increased.
Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal
insufficiency. This means that your adrenal gland is not making enough of certain hormones.
You may experience symptoms such as:
- nausea, vomiting
- feeling tired, weak or dizzy
- decreased appetite
You may be more likely to have problems with your adrenal gland if you have been taking
opioids for longer than one month. Your doctor may do tests, give you another medication, and
slowly take you off STATEX.
Serotonin Syndrome: STATEX can cause Serotonin Syndrome, a rare but potentially lifethreatening condition. It can cause serious changes in how your brain, muscles and digestive
system work. You may develop Serotonin Syndrome if you take STATEX with certain antidepressants or migraine medications.
Serotonin Syndrome symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting;
- muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
- fast heartbeat, changes in blood pressure;
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.
Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex
hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being
infertile.
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with STATEX:
- Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking STATEX. It can lead to:
- drowsiness
- unusually slow or weak breathing
- serious side effects or
- a fatal overdose
- other sedative drugs which may enhance the drowsiness caused by STATEX;
- other opioid analgesics (drugs used to treat pain);
- general anesthetics (drugs used during surgery);
- benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
- antidepressants (for depression and mood disorders). Do not take STATEX with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days;
- drugs used to treat serious mental or emotional disorders (such as schizophrenia);
- antihistamines (drugs used to treat allergies);
- anti-emetics (drugs used for the prevention of vomiting);
- drugs used to treat muscle spasms and back pain;
- warfarin (such as coumadin) and other anticoagulants (used for prevention or treatment of blood clots);
- some heart medication (such as beta blockers);
- antimuscarinic medicine;
- drugs used to treat migraines (e.g. triptans);
- St. John’s Wort.
Proper use of this medication
How to take STATEX:
STATEX drops, syrup and tablets are not indicated for rectal administration
Swallow STATEX tablets whole. Do not cut, break, crush, chew or dissolve the tablet. This
can be dangerous and can lead to death or seriously harm you.
You can take your dose of STATEX with or without food. You can take you STATEX tablet
with a glass of water.
To improve the taste, you can dilute STATEX oral unflavoured drops and syrup in a glass of
fruit juice just before taking your dose.
You should place your STATEX suppository against the rectal mucosa. The medicine will not be
absorbed if you push the suppository into a mass of stool or if you place it in the anal canal.
Usual Adult Starting Dose:
Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing
instructions exactly. Do not increase or decrease your dose without consulting your doctor.
Your doctor will prescribe the lowest dose that works to control your pain and will determine the
best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more
side effects and a greater chance of overdose.
Review your pain regularly with your doctor to determine if you still need STATEX. Be sure to
use STATEX only for the condition for which it was prescribed.
If your pain increases or you develop any side effect as a result of taking STATEX, tell your
doctor immediately.
Stopping your Medication
If you have been taking STATEX for more than a few days you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking STATEX. You should do it slowly to avoid uncomfortable symptoms such as having:
- body aches;
- diarrhea;
- goosebumps;
- loss of appetite;
- nausea;
- feeling nervous or restless;
- runny nose;
- sneezing;
- tremors or shivering;
- stomach cramps;
- rapid heart rate (tachycardia);
- having trouble sleeping;
- an unusual increase in sweating;
- an unexplained fever;
- heart palpitations;
- weakness;
- yawning.
By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking STATEX.
Refilling your Prescription for STATEX:
A new written prescription is required from your doctor each time you need more STATEX.
Therefore, it is important that you contact your doctor before your current supply runs out.
Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not
seek prescriptions from other doctors unless you switch to another doctor for your pain
management.
Overdose
Signs of overdose may include:
- unusually slow or weak breathing;
- dizziness;
- confusion;
- extreme drowsiness;
- cold or clammy skin;
- low muscle tone.
Missed Dose
If you miss one dose, take your next dose at the scheduled time as usual. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking STATEX. If you experience
any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Drowsiness;
- Insomnia;
- Dizziness;
- Fainting;
- Nausea, vomiting, or a poor appetite;
- Dry mouth;
- Headache;
- Problems with vision;
- Weakness, uncoordinated muscle movement;
- Itching ;
- Sweating;
- Constipation;
- Low sex drive, impotence (erectile dysfunction), infertility.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone cold and clammy skin | ✔ | ||
| Respiratory Depression: Slow, shallow or weak breathing | ✔ | ||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | ✔ | ||
| Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating | ✔ | ||
| Fast, Slow or Irregular Heartbeat: heart palpitations | ✔ | ||
| Low Blood Pressure: dizziness, fainting, light-headedness | ✔ | ||
| Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea | ✔ | ||
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.
How to store
- Store all preparations between 15-30oC in a well closed light resistant container.
- Keep unused or expired STATEX in a secure place to prevent theft, misuse or accidental exposure.
- Keep STATEX under lock, out of sight and reach of children and pets.
- Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes STATEX, get emergency help right away.
Disposal:
STATEX should never be thrown into household trash, where children and pets may find
it. It should be returned to a pharmacy for proper disposal.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about STATEX:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website www.paladinlabs.com, or by calling 1-888-867-7426.
This leaflet was prepared by Paladin Labs Inc.
Last Revised: August 2, 2019.