Consumer Information for: RIVA-BACLOFEN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
RIVA-BACLOFEN is one of a group of medicines called muscle
relaxants.
RIVA-BACLOFEN is used to reduce and relieve the excessive
stiffness and/or spasms in your muscles occurring in various
conditions such as multiple sclerosis and diseases or injuries of
the spinal cord.
What it does
Due to the relaxation of muscle and the consequent relief from
pain, RIVA-BACLOFEN improves your ability to move, makes
it easier for you to manage your daily activities and facilitates
physiotherapy.
If you have any questions about how RIVA-BACLOFEN works
or why this medicine has been prescribed for you, ask your
doctor.
When it should not be used
Do not take RIVA-BACLOFEN:
- If you are allergic (hypersensitive) to baclofen or any of the other ingredients listed in “What the non-medicinal ingredients are”.
If this applies to you, tell your doctor without taking RIVABACLOFEN.
If you think you may be allergic, ask your doctor for advice.
What the medicinal ingredient is
Baclofen
What the non-medicinal ingredients are
Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.
What dosage form it comes in
Tablets: 10 mg and 20mg.
Warnings and precautions
SERIOUS WARNINGS AND PRECAUTIONS
Taking RIVA-BACLOFEN with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
BEFORE you use RIVA-BACLOFEN talk to your doctor or pharmacist if you:
- Have kidney disease. Your doctor will decide whether or not RIVA-BACLOFEN is the appropriate treatment for you;
- Are suffering from epilepsy (seizures);
- Have acute pain in your stomach (ulcer) or intestines, breathing problems, liver disease, or a disturbance of blood circulation in your brain;
- Are taking medicines for arthritis or pain (see section: “Interactions with this medication”);
- Have difficulty urinating;
- Have Parkinson’s disease or certain mental illnesses accompanied by confusion or depression;
- Are diabetic;
- Have or had thoughts of harming or killing yourself, have or had depression, have a history of alcoholism or drink alcohol to excess, have a history of drug abuse and dependence, or are taking medicines associated with increased suicide risk;
- Have thoughts of harming or killing yourself at any time, speak to your doctor straightaway or go to a hospital. Also, ask a relative or close friend to tell you if they are worried about any changes in your behavior and ask them to read this leaflet.
Older people (aged 65 years or above) or people with a disturbance of circulation in the brain
If you are in one of these groups, you may experience more side effects. Therefore, your doctor will keep you under appropriate surveillance and may adapt the dose of RIVA-BACLOFEN you take.
Children and adolescents
Safe use of RIVA-BACLOFEN in children under age 12 has not been established and it is therefore not recommended for use in children.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
You should not use RIVA-BACLOFEN during pregnancy unless
your doctor advises you to do so. Tell your doctor if you are
pregnant, planning to become pregnant, or breast-feeding. He or
she will discuss with you the potential risk of taking RIVABACLOFEN during pregnancy or if you are
breast-feeding.Use
of RIVA-BACLOFEN during pregnancy may result in the
newborn experiencing withdrawal from the drug including, irritability, high-pitched crying,
trembling, increased muscle
tone, excessive sucking, disordered sleep, increase in body
temperature, uneven discolored patches on the skin, and
convulsions and other symptoms related to sudden stop of
treatment sometime after delivery. Your doctor may need to treat
your newborn for withdrawal reactions.
Driving and using machines
In some people, RIVA-BACLOFEN may be associated with dizziness, sleepiness or visual disturbance. If this happens to you, do not drive a car, use a machine, or do other things that need your full attention.
Further safety measures
Before having any kind of surgery (including by the dentist), or emergency treatment, tell the doctor in charge that you are taking RIVA-BACLOFEN.
Interactions with this medication
Drugs that may interact with RIVA-BACLOFEN include:
- Alcohol;
- Sedative drugs;
- Medicines used to treat mood disorders such as antidepressants and lithium;
- Medicines used to treat high blood pressure;
- Medicines used to treat Parkinson's disease;
- Medicines for arthritis or pain.
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
a prescription.
You should not drink alcohol during your treatment with RIVABACLOFEN.
Proper use of this medication
Usual Dose
Follow your doctor’s instructions carefully. Do not exceed the recommended dose.
How much RIVA-BACLOFEN to take
Treatment usually starts with 15mg daily, preferably taken in
divided doses. The dose is then gradually increased until the best
results are obtained; this may be between 40mg to 80 mg per
day, taken in divided doses.
The dose prescribed by your doctor may be different from that
written here. If this is the case, follow the doctor's instructions.
Your doctor will tell you exactly how many tablets of RIVABACLOFEN to take.
Depending on how you respond to the treatment, your doctor
may suggest a higher or lower dose.
When to take RIVA-BACLOFEN
Taking RIVA-BACLOFEN at the same time each day will help you remember when to take your medicine.
How to take RIVA-BACLOFEN
Be sure to take this medicine regularly, and exactly as your doctor tells you. This will help you to get the best results and reduce the risk of side effects.
How long to take RIVA-BACLOFEN
Continue taking RIVA-BACLOFEN as your doctor tells you.If you have questions about how long to take RIVA-BACLOFEN talk to your doctor or your pharmacist.
Do not suddenly stop taking RIVA-BACLOFEN without first
checking with your doctor. He or she will tell you when and
how you can stop taking this medicine; stopping suddenly can
make your condition worse.
If you stop your treatment suddenly, you may experience:
nervousness, feeling confused, hallucinations, abnormal thinking
or behaviour, convulsions, uncontrollable twitching, jerking or
writhing movements, fast heartbeat, high body temperature. The
excessive stiffness (spasms) in your muscles may also worsen.
Overdose
If you think you have taken too much RIVA-BACLOFEN, contact your healthcare professional, hospital emergency room department or regional Poison Control Centre immediately, even if there are no symptoms.
If you have accidentally taken many more tablets than your
doctor has prescribed, seek immediate emergency medical
treatment, even though you do not feel sick.
The main symptoms of overdose are drowsiness, breathing
difficulties, trouble of consciousness and being unconscious
(coma).
Other symptoms may include: feeling confused, hallucinations,
agitation, convulsions, blurred vision, unusual muscle weakness,
sudden contraction of the muscles, poor or absent reflexes, high
or low blood pressure, slow, fast or irregular heartbeat, low body
temperature, nausea, vomiting, diarrhea or excessive salivation,
trouble breathing during sleep (sleep apnoea), pain in muscles,
fever and dark urine (rhabdomyolysis).
If you have kidney disease and have accidentally taken more
tablets or more syrup than your doctor has prescribed, you may
experience neurological symptoms of overdose (e.g., drowsiness,
feeling confused, hallucinations).
Missed Dose
If you have forgotten to take one of your scheduled doses, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed one at the same time as the scheduled one, otherwise you will be doubling the dose. Just go back to your regular dosing timetable. If you have forgotten to take several doses you should contact your doctor.
Side effects and what to do about them
Like all medicines, RIVA-BACLOFEN can have some side effects, although not everybody gets them. These are often mild and are usually at the start of treatment; they normally wear off after a few days.
Very common side effects
These side effects may affect more than 1 in 10 patients:
- Drowsiness, sleepiness;
- Nausea.
If any of these affects you severely, tell your doctor.
Common side effects
These side effects may affect between 1 and 10 in every 100 patients:
- Feeling faint, tiredness, dizziness, headache, inability to sleep, weakness in arms and legs, pain in muscles, uncontrollable eye movements, dry mouth;
- Disturbance of the digestive tract, retching, vomiting, constipation, diarrhea;
- Sweating a lot;
- Passing more urine than normal, bedwetting.
If any of these affects you severely, tell your doctor.
Rare side effects
These side effects may affect between 1 and 10 in every 10,000 patients:
- Tingling or numbness of the hands and/or feet, difficulty in speaking, taste disturbance;
- Abdominal pain;
- Sudden decrease in urine;
- Inability to get or to maintain an erection (impotence).
Side effect also reported (frequency unknown)
- Increased blood sugar;
- Drug misuse, drug abuse, drug dependence.
If any of these affects you severely, tell your doctor.
If you notice any other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Breathing problems | ✔ | ||
| Feeling of confusion | ✔ | ||
| Feeling of extreme happiness | ✔ | ||
| Sad mood (depression) | ✔ | ||
| Loss of coordination affecting balance and walking, limb and eye movements and/or speech (signs of ataxia) | ✔ | ||
| Trembling | ✔ | ||
| Hallucinations | ✔ | ||
| Nightmares | ✔ | ||
| Blurred vision/visual disturbance | ✔ | ||
| Shortness of breath at rest or with activity, swelling in the legs and tiredness (signs of decreased cardiac output) | ✔ | ||
| Low blood pressure (hypotension) | ✔ | ||
| Skin rash and hives | ✔ | ||
| Difficulty passing urine, pain when passing urine or a sudden decrease in urine | ✔ | ||
| Rare | |||
| Abdominal pain, yellowing of the skin or eyes and tiredness (signs of liver disturbance) | ✔ | ||
| Convulsions | ✔ | ||
| Very rare | |||
| Low body temperature | ✔ | ||
| Not known | |||
| Symptoms following sudden discontinuation of the medicine (drug withdrawal syndrome) | ✔ | ||
| Slow heartbeat | ✔ | ||
| Suicidal Behavior: thoughts or actions about harming or killing yourself | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking RIVA-BACLOFEN, contact your doctor or pharmacist.
How to store
- Store between 15°C and 30°C.
- Do not use after the expiry date shown on the bottle.
- Keep out of the reach and sight of children.
Reporting side effects
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/medeffect-canada/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 RIVA-BACLOFEN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp), or by contacting the sponsor Laboratoire Riva Inc. at: 1-800-363-7988.
This leaflet was prepared by:
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
http://www.labriva.com/
Last revised:February 5, 2021
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