Loanta Tablets contain the active substance baclofen,
which is a muscle-relaxant drug.
Loanta is used to reduce and relieve the excessive
tension in your muscles (spasms) occurring in various
illnesses such as cerebral palsy, multiple sclerosis,
cerebrovascular accidents, spinal cord diseases and
other nervous system disorders.

Do not take Loanta:
• If you are allergic to baclofen or any of the other
ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include rash, itching and
swelling of the face, lips, throat or tongue
• If you have ever had a stomach ulcer.
 

Warnings and precautions:
Talk to your doctor or pharmacist before taking
Loanta:
• If you suffer from a mental disorder
• If you suffer from liver or kidney disease
• If you have breathing difficulties or lung disease
• If you have diabetes as your doctor may want to
monitor your condition
• If you have suffered from a stroke
• If you suffer from epilepsy
• If you have difficulty urinating (urinary retention)
• If you suffer from Parkinson’s disease
• If you being treated for high blood pressure
• If you are pregnant or breast-feeding
• If you have a history of alcoholism, or your drink
alcohol to excess or you have a history of drug
abuse or dependence.
Some people being treated with Loanta have had
thoughts of harming or killing themselves or have
tried to kill themselves. Most of these people also
had depression, had been using alcohol excessively or
were prone to having thoughts of killing themselves.
If you have thoughts of harming or killing yourself at
any time, speak to your doctor straightaway or go to
a hospital. In addition, 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 going to have an operation when you will
have a general anesthetic, tell the doctor or dentist
that you are taking Loanta.
Your doctor may do regular blood tests to monitor
your liver function.
 

Children and adolescents:
Loanta tablets are not suitable for use in children
under 33 kg body weight.
 

Other medicines and Loanta:
Tell your doctor if you are taking, have recently taken
or might take any other medicines.
Some medicines may be affected by Loanta or they
may affect how well Loanta will work.
You must tell your doctor if you are already taking any
of the following medicines:
• other medicines to relax muscles e.g. tizanidine
• medicines to treat mood disorders such as lithium
or tricyclic depressants such as amitriptyline
• medicines for high blood pressure, e.g. diltiazem
• Medicines which affect the kidney, e.g. ibuprofen
• medicines for Parkinson’s disease, e.g. levodopa
and carbidopa
• medicines which slow down the nervous system,
such as anti-histamines (e.g. promethazine),
• sedatives (e.g. temazepam), opiates for pain
relief (e.g. morphine, fentanyl) and anti-epileptic
medicines (e.g. carbamazepine).
 

Loanta with drink and alcohol:
Do not drink alcohol whilst taking Loanta.
 

Pregnancy, breastfeeding and fertility:
If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Do not take Loanta during pregnancy unless your
doctor tells you otherwise.
If you have to take Loanta during pregnancy, your
unborn baby will also be exposed to Loanta. After
birth your baby may develop withdrawal symptoms
such as convulsions (symptoms of withdrawal are described in the section “If you stop taking Loanta”).
Although very small amounts of Loanta pass into
breast milk, your doctor will discuss with you whether
you should breast-feed whilst taking this medicine.
 

Driving and using machines:
Some people may feel drowsy and/or dizzy or have
problems with their eyes while they are taking these
tablets. If this happens, you should not drive or do
anything that requires you to be alert (such as
operating tools or machinery) until these effects have
worn off.

Always take this medicine exactly as your doctor or
your pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
You will be started on a low dose and this will be
increased gradually over a few days, under the
supervision of doctor, until you are having the dose
which is right for you.
If the starting dose is too high, or if the dose is
increased too quickly, you may experience side
effects, particularly if you are elderly, have kidney
problems or have had a stroke.
 

Adults
The recommended dose is 5 mg Loanta (half a tablet)
3 times a day for 3 days, then
- 10 mg Loanta (1 tablet) 3 times a day for the next
3 days, then
- 15 mg Loanta (one and half tablets) 3 times a day
for 3 days, then
- 20 mg Loanta (2 tablets) 3 times a day for the next
3 days.
The maximum daily dose is 100 mg except if you are in
hospital when a higher dose may be used.
Elderly patients
Elderly patients will usually start with a smaller daily
dose of Loanta.
 

Patients with kidney problems
You will probably be given a much lower dose. The
doctor will decide what the dose should be.
 

Use in children and adolescents
Children's treatment is adjusted to their body weight.
Children's treatment usually starts with a very low
dose (approximately 0.3 mg/kg/day), in 2-4 divided
doses (preferably in 4 doses). The dosage is then
gradually increased until it becomes sufficient for
the child's individual requirements, this may be
between 0.75 and 2 mg/kg body weight. The total
daily dose should not exceed a maximum of 40 mg/
day in children below 8 years of age. In children over
8 years of age a maximum daily dose of 60 mg/day
may be given. Loanta tablets are not suitable for use
in children below 33 kg body weight. Other forms of
this medicine may be more suitable for children, ask
your doctor or pharmacist.
 

How to take the tablets
You should take the tablets with food or a milk drink,
especially if you feel sick when you take them.
Loanta may be taken just at night-time to help painful
night cramps or approximately 1 hour before doing
specific tasks such as washing or physiotherapy, which
are helped by taking Loanta. Your doctor will tell you
what is best for you.
 

If you take more Loanta than you should
If you take more Loanta than you have been
prescribed, contact your doctor or local hospital
immediately. Take the medicine with you.
 

If you forget to take Loanta
If you forget to take a dose, take the next dose at the
usual time. Do not take a double dose to make up for
a forgotten dose.
 

If you stop taking Loanta
Do not stop taking Loanta suddenly unless your
doctor tells you. If you stop taking your Loanta
Tablets without gradually reducing the dose you may
suffer from unpleasant side effects such as muscle
spasms and increased muscle rigidity, fast heart rate,
fever, hallucinations, changes in mood and emotion,
confusion, mental disorders, feeling persecuted or
convulsions (fits).
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you have breathing difficulties, stop using Loanta
and tell your doctor or go to your nearest hospital
emergency room immediately as you may need
urgent medical treatment
Other side effects include:
Very Common (may affect ≥ 1 in 10 people)
• drowsiness
• sleepiness
• feeling sick.
Common (may affect ≥ 1 in 100 to > 1 in 10 people)
• dry mouth
• headache, dizziness or light-headedness
• fatigue
• excessively weak limbs or feeling tired and
exhausted, aching muscles
• unsteadiness, trembling or other problems with
muscle control
• confusion, depression
• mood changes with extreme excitement,

hallucinations (seeing or feeling or hearing things
that are not really there) or nightmares,
• low blood pressure (fainting)
• stomach upset including retching, vomiting,
diarrhoea or constipation
• sleeplessness
• skin rash, excessive sweating
• rapid, uncontrollable movements of the eyes or
other eyesight problems
• pain when passing urine or passing more urine
than normal
Rare (may affect ≤ 1 in 10,000 to > 1 in 1,000 people)
• numbness or pins and needles in hands or feet
• increased muscle spasm
• slurred or slow speech
• disturbed sense of taste
• stomach pain
• difficulty passing urine
• problems getting or keeping an erection
• liver problems. Your doctor may do regular blood
tests to monitor your liver function
Very rare (may affect > 1 in 10,000 people)
• low body temperature (hypothermia)
Unknown (frequency cannot be estimated of data available)
• raised, itchy rash (‘nettle rash’)
• slow heart beat
• increase in blood sugar
• trouble breathing during sleep (sleep apnoea
syndrome)
• symptoms caused by stopping treatment suddenly
(see "How to take the tablets")
If have epilepsy you may experience more convulsions
than usual.
If you are elderly or if you have mental problems or
you have suffered from a stroke, the side effects may
be more serious.
 

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

• Keep this medicine out of the sight and reach of
children and in original packages
• Do not use this medicine after the expiry date which
is stated on the carton and blister. The expiry date
refers to the last day of that month.
• Do not store above 30°C
• 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 environment.