This medicine is used on prescription from a doctor. Baclocan belongs to a group of medicines called muscle relaxants.

Baclocan is used on prescription from your doctor to reduce and relieve muscle spasms occurring in various conditions such as multiple sclerosis, diseases or injuries of the spinal cord and certain brain diseases.

By relaxing your muscles and thereby relieving pain, Baclocan improves your ability to move to make it easier for you to carry out your daily activities and physiotherapy.

Treatment with Baclocan should only be started after a thorough medical examination. Baclocan is suitable for many patients with muscle spasms, but not all.

I.            Do not take Baclocan

If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Baclocan.

II.            Take special care with Baclocan

Talk to your doctor before using Baclocan if you have or have had any of the following illnesses or conditions:

§  Certain mental illnesses accompanied by confusion or depression.

§  Epilepsy (seizures).

§  Acute pain in your stomach or intestines (ulcers), breathing problems, liver or kidney diseases, blood circulation problems in your brain.

§  Difficulty urinating.

§  Diabetes.

§  If you take Baclocan during pregnancy, your newborn baby may experience convulsions and other symptoms that are directly associated with suddenly no longer being exposed to Baclocan immediately after birth. Your doctor may need to give your newborn baby small doses of Baclocan and gradually reduce the dose to control/prevent the symptoms.

Tell your doctor if you have a history of alcoholism, consume excessive amounts of alcohol or have a history of misusing medicines or addiction to medicines.

Some people treated with baclofen develop thoughts of hurting themselves or taking their own life, or have attempted to take their own life. Most of these people also suffered from depression, had consumed excessive amounts of alcohol or already had a tendency to have suicidal thoughts.

If you ever think about hurting yourself or taking your own life, talk to your doctor or go to a hospital immediately. Also ask a person you trust to tell you if they are worried about any change in your behaviour and ask them to read this leaflet.

III.            Taking other medicines, herbal or dietary supplements

Also tell your doctor if you are taking any other medicines such as other medicines used to treat muscle spasms, sleeping medication, sedatives and medicines used to treat depression, high blood pressure or Parkinson’s disease. These medicines may interfere with the effect of Baclocan. Alcohol may also interfere with its effect.

You should not drink alcohol during treatment as it may interact with Baclocan.

IV.            Pregnancy and breast-feeding

Do not use Baclocan during pregnancy unless your doctor advises you to do so.

Small amounts of the active substance of Baclocan pass into the breast milk. Baclocan should therefore not be used during breast-feeding.

V.            Driving and using machinery

This medicine may affect your reactions, your ability to drive and your ability to use tools or machines.

Tiredness, dizziness, drowsiness or blurred vision may occur during treatment with Baclocan in some cases. If you experience any of these effects, do not drive, use machines or carry out any other activity that requires your full attention.

Other special warnings

Before any surgical procedure (including at the dentist’s) or emergency treatment tell the doctor treating you that you are taking Baclocan.

Take this medicine regularly and exactly as instructed by your doctor. This is the only way to achieve the best results and reduce the risk of side effects.

Usual dosage

§  Adults usually start with 5 mg (half a tablet) three times daily. The dose is then gradually increased every three days until the best results are obtained; this may be at 30 mg to 75 mg per day, taken in 3 separate doses. Your doctor may also prescribe you a higher dosage.

§  For children the dosage is based on their weight and is determined by the doctor. Baclocan must always be taken in separate doses, usually 3‑4 times daily.

§  If your doctor prescribes a different dose from any of those given above, follow your doctor’s instructions.

§  Take Baclocan during meals with a small amount of liquid. If necessary, the tablets may be divided.

        I.If you take Baclocan tablets more than you should

If you ever take considerably more tablets than your doctor has prescribed, consult your doctor or go to the nearest hospital immediately.

The main symptoms of an overdose are drowsiness, breathing problems, disorders of consciousness and unconsciousness.

Other symptoms are: confusion, hallucinations, agitation, convulsions, blurred vision, unusual muscle slackness, sudden muscle contractions, poor or absent reflexes, high or low blood pressure, slow or fast heartbeat, decreased body temperature, nausea, vomiting, diarrhoea, excessive amount of saliva, trouble breathing during sleep (sleep apnoea), muscle pain, fever and dark urine (rhabdomyolysis), tinnitus.

If you have a kidney disease and have accidentally taken more tablets than your doctor has prescribed, you may experience neurological symptoms of an overdose (e.g. drowsiness, confusion, hallucinations).

II.What if you forget to take Baclocan Tablets

Do not worry if you forget to take a dose at the correct time. Take it as soon as you remember. However, if it is almost time for the next dose, do not take the next dose together with the missed dose. This avoids ever taking a double dose. Simply continue taking Baclocan at the usual times. However, consult your doctor if you have forgotten more than one dose.

Do not change the prescribed dosage yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor or pharmacist.

III. If you stop taking Baclocan

Do not stop Baclocan treatment suddenly without consulting your doctor. Your doctor will tell you how and when to stop treatment. Suddenly stopping Baclocan may worsen your condition.

If you stop treatment suddenly, you may experience the following symptoms: nervousness, confusion, hallucinations, abnormal behaviour, convulsions, uncontrollable twitching, jerking or writhing movements, fast heartbeat, increased body temperature, muscle pain, fever and dark urine. The excessive stiffness (spasms) in your muscles may also get worse.

The following side effects may occur when taking Baclocan:

Some side effects may be serious. Consult your doctor as soon as possible if you experience any of the following side effects as you may need medical treatment:

Confusion, mood swings, depressed mood, loss of coordination affecting balance when walking, limb and eye movements and/or speech (signs of ataxia), trembling, hallucinations, nightmares, blurred vision/visual disturbances, shortness of breath when resting or when active, swelling in the legs and tiredness (signs of decreased heart function), difficulty/pain urinating, rash and hives, breathing problems, convulsions, sudden decrease in amount of urine, allergic (hypersensitivity) reactions, yellowing of the skin and eyes and tiredness (signs of liver function disorders).

Other side effects

Very common: Drowsiness, sedation, nausea.

Common: Feeling faint, tiredness, dizziness, light-headedness, exhaustion, headache, sleeplessness, weakness in arms and legs, muscle pain, continuous, uncontrollable eye movements, vision problems, dry mouth, digestion disorders, retching, vomiting, constipation, diarrhoea, severe sweating, rash, low blood pressure, frequent urination, bed wetting.

Rare: Tingling or numbness in the arms and legs, speech disorder, taste disturbances, abdominal pain, sudden decrease in amount of urine, erectile dysfunction.

Very rare: Decreased body temperature, increased blood sugar level, heart rhythm disorder.

If you notice any side effects which are not described here, tell your doctor or pharmacist. This also applies particularly to side effects not listed in this leaflet.

§  Keep this medicine out of the sight and reach of children.

§  Do not store above °30C.

§  Do not use Baclocan tablets after the expiry date stated on the carton. The expiry date refers to the last day of that month.

§  Shelf life: 24 Months

§  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environmen