Dom-Baclofen-Tab 20mg: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Dom-BACLOFEN is one of a group of medicines called muscle relaxants.

Dom-BACLOFEN is used to reduce and relieve the excessive tension (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, Dom-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 Dom-BACLOFEN works or why this medicine has been prescribed for you, ask your doctor.

When it should not be used:

Do not take Dom-BACLOFEN:

• If you are allergic (hypersensitive) to baclofen or

  any of the other ingredients listed in “What the nonmedicinal ingredients are”.

If this applies to you, tell your doctor without taking Dom-BACLOFEN.

If you think you may be allergic, ask your doctor for advice.

What the medicinal ingredient is:

The active substance of Dom-BACLOFEN is baclofen.

What the non-medicinal ingredients are:

The non-medicinal ingredients are: colloidal silicon dioxide, dibasic calcium phosphate, lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

What dosage forms it comes in:

Tablets: 10 mg and 20 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use Dom-BACLOFEN talk to your doctor or pharmacist if you:

• Have kidney disease. Your doctor will decide whether or not Dom-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 circulation in your brain;
• Are taking medicines for arthritis or pain (see section:“Interactions with this medication”);
• Have difficulty urinating;
• Have certain mental illnesses accompanied by confusion or depression;
• Are diabetic.

Older people 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 Dom-BACLOFEN you take.

Children and adolescents

Safe use of Dom-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 Dom-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 Dom-BACLOFEN during pregnancy or if you are breast-feeding. Use of Dom-BACLOFEN during pregnancy may result in the newborn experiencing withdrawal from the drug

sometime after delivery; in one case, the main symptom in the newborn was generalized convulsions.

Driving and using machines

In some people, Dom-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 of you that you are taking Dom-BACLOFEN.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Dom-BACLOFEN include:

• Alcohol;

• Sedative drugs;
• Medicines used to treat depression;
• 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 Dom-BACLOFEN.

PROPER USE OF THIS MEDICATION

Usual dose:

Follow your doctor’s instructions carefully. Do not exceed the recommended dose.

How much Dom-BACLOFEN to take

Treatment usually start with 15 mg daily, preferably taken in divided doses. The dose is then gradually increased until the best results are obtained; this may be between 40 mg 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 Dom-BACLOFEN to take.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

When to take Dom-BACLOFEN

Taking Dom-BACLOFEN at the same time each day will help you remember when to take your medicine.

How to take Dom-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 Dom-BACLOFEN

Continue taking Dom-BACLOFEN as your doctor tells you. If you have questions about how long to take Dom-BACLOFEN talk to your doctor or your pharmacist.

Do not suddenly stop taking Dom-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 heart beat, high body temperature. The excessive tension (spasms) in your muscles may also become worse.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are not 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 heart beat, low body temperature, nausea, vomiting, diarrhea or salivating a lot.

Missed Dose:

If you have forgotten to take one dose as scheduled, 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, Dom-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, exhaustion, dizziness, headache, inability to sleep, weakness in arms and legs, pain in muscles, uncontrollable eye movement, 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).

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.

This is not a complete list of side effects. For any unexpected effects while taking Dom-BACLOFEN, contact your doctor or pharmacist.

HOW TO STORE IT

• Store between 15EC and30EC
• Protect from heat and humidity.

• Do not use after the expiry date shown on the

  bottle.

• Keep out of the reach and sight of children

MORE INFORMATION

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Dominion Pharmacal at, 1-888-550-6060.

Dominion Pharmacal

Montreal Quebec

H4P 2T4

Last revised February 6, 2013

REPORTING SUSPECTED SIDE EFFECTS