Lioresal ® 25 mg Tablets

What LIORESAL is

The active substance of LIORESAL tablets is baclofen.

What LIORESAL is used for

LIORESAL is one of a group of medicines called muscle relaxants. LIORESAL is used to reduce and relieve the excessive tension (spasms) in your muscles occurring in various conditions such as multiple sclerosis, diseases or injuries of the spinal cord, and certain brain diseases. Due to the relaxation of muscle and the consequent relief from pain, LIORESAL improves your ability to move, makes it easier for you to manage your daily activities and facilitates physiotherapy.

BEFORE TAKING THE MEDICINE:

It is important to tell your doctor if you have other medical problems or if you are taking other medicines.

Do not take LIORESAL

• If you are allergic to baclofen or any of the other ingredients of LIORESAL listed in section 6.
• Porphyria. If you think you may be allergic, ask your doctor for advice.

Warnings and precautions

• If you have certain mental illnesses accompanied by confusion or depression.
• If you are suffering from epilepsy (seizures).
• If you have acute pain in your stomach (ulcer) or intestines, breathing problems, a kidney or liver disease, or a disturbance of circulation in your brain.
• If you have kidney disease. Your doctor will decide whether or not LIORESAL is the appropriate treatment for you.
• If you have difficulty urinating.
• If you are diabetic.
• If you have or had depression, if you have been using alcohol excessively or if you had thoughts of killing yourself tell your doctor before you take LIORESAL.
• If you 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.
• If you are elderly or have muscle spasms caused by a brain disease. You may experience more side effects therefore your doctor will keep you under appropriate surveillance and may adapt the dose of LIORESAL you take.

If any of these apply to you, tell your doctor before you take LIORESAL.

Children and adolescents

Children's dosing is based on their body weight; the doctor will calculate the dose for the child.

How to use LIORESAL

Do not share medicines prescribed for you with any other person. Always take LIORESAL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not exceed the recommended dose.

How much to take

Your doctor will tell you how long your treatment with LIORESAL will last. Do not stop treatment early because it might make you ill. If you have the impression that the effect of LIORESAL is too strong or too weak, tell your doctor or pharmacist.

Adults usually start treatment with 5 mg taken 3 times daily. The dose is then gradually increased until the best results are obtained; this may be between 30 mg to 80 mg per day, taken in 3 doses. Your doctor may even decide to give you a higher dosage.

Children's treatment is adjusted to their weight.

LIORESAL is always given in divided daily doses, i.e., usually 3 or 4 times a day. 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 LIORESAL to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

When and how to take LIORESAL

Take LIORESAL during meals and swallow the tablets with some liquid. If necessary, the tablets may be broken. 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.

The score line on one side of 10 mg tablet is to divide the tablets into equal doses. The score line on the 25 mg tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

How long to take LIORESAL

If you have been treated for 6 to 8 weeks and you feel no improvement, tell your doctor. Your doctor will decide if you should continue LIORESAL.

If you forget to take LIORESAL

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 a double dose to make up for forgotten individual doses. Just go back to your regular dosing timetable. If you have forgotten to take several doses you should contact your doctor.

If you take more LIORESAL than you should

In the event of over-dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. The main symptoms of overdose are drowsiness, breathing difficulties, trouble of consciousness, being unconscious (coma) and ringing in the ears. Other symptoms may include: feeling confused, hallucinations, agitation, convulsions, blurred vision, unusual muscle slackness, sudden contraction of the muscles, poor or absent reflexes, high or low blood pressure, slow or fast heartbeat, low body temperature, nausea, vomiting, diarrhoea or salivating a lot.

Effects when treatment with LIORESAL is stopped

Do not suddenly stop taking LIORESAL 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 and too much muscle tone. The excessive tension (spasms) in your muscles may also become worse.

LIORESAL can have some side effects. Not all side effects reported for LIORESAL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LIORESAL, please consult your health care provider for advice.

Some effects could be serious: If you experience any of these, tell your doctor straight away.

Common: may affect up to 1 in every 10 people

• 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.
• Difficulty passing urine, pain when passing urine or a sudden decrease in urine.
• Convulsions (particularly in patients with epilepsy).

Rare: may affect up to 1 in every 1,000 people

• Abdominal pain, yellowing of the skin or eyes and tiredness (signs of liver disturbance).

Very rare: may affect up to 1 in every 10,000 people

• Low body temperature.

Not known: frequency cannot be estimated from the available data

• Hives.
• Slow heartbeat.
• Symptoms after suddenly stopping taking the medicine (drug withdrawal syndrome) as explained above in Section 3 (if you stop taking LIORESAL).

Tell your doctor if you notice any of the following:

Other very frequent side effects:

Very common: may affect more than 1 in 10 people

• Sedation, sleepiness, nausea.

Other frequent side effects:

Common: may affect up to 1 in every 10 people

• Feeling faint, weariness, 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, diarrhoea, sweating a lot, passing more urine than normal, bedwetting.

Other less frequent side effects:

Rare: may affect up to 1 in every 1,000 people

• 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).

Also reported (frequency unknown)

• Increased blood sugar.
• Swelling of the ankles, feet or lower legs.
• Swelling face.
• Allergic reaction (hypersensitivity).
• Hair loss.
• Sexual difficulties.

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.

Store below 25 °C and protect from moisture.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).