LEODIZCOL 1 mg /Ml Oral Solution

Зміст інструкції

1. Leodizcol 1 mg/mL oral solution
   1. What Leodizcol is and what it is used for
   2. What you need to know before taking Leodizcol
   3. How to take Leodizcol
   4. Possible side effects
   5. How to store Leodizcol
   6. Contents of the pack and other information

Leodizcol 1 mg/mL oral solution

baclofen

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Leodizcol is and what it is used for
• 2. What you need to know before you take Leodizcol
• 3. How to take Leodizcol
• 4. Possible side effects
• 5. How to store Leodizcol
• 6. Contents of the pack and other information

1. What Leodizcol is and what it is used for

Leodizcol contains the active substance baclofen. Baclofen belongs to a group of medicines
called muscle relaxants.
Baclofen is used in adults to reduce and relieve excessive muscle tension (spasms) that
occurs in various diseases, such as multiple sclerosis, spinal cord diseases, stroke and other
diseases of the nervous system.
Baclofen is used in children and adolescents aged between 0 and 18 years to reduce and
relieve excessive muscle tension (spasms) that occurs in various diseases, such as cerebral palsy
(brain damage that affects the ability to move), multiple sclerosis, spinal cord diseases, stroke and other
diseases of the nervous system.
This muscle relaxant effect improves the ability to move and relieves pain.

2. What you need to know before taking Leodizcol

Do not take Leodizcol

• if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Leodizcol

• if you have a serious mental illness, accompanied by confusion or depression
• if you have Parkinson's disease
• if you have epilepsy (seizures)
• if you have, or have had in the past, a stomach or intestinal ulcer
• if you have diseases of the blood vessels of the brain
• if you are already using medicines to lower blood pressure (see “Other medicines and Leodizcol”)
• if your lung function is impaired
• if your liver or kidney function is impaired
• in some bladder conditions (difficulty urinating)
• if you have diabetes mellitus
• if you have a history of alcoholism, if you drink excessive amounts of alcohol or if you have a history of abuse or dependence on narcotic substances

Some people treated with baclofen have developed self-harming or suicidal thoughts or have
attempted suicide. Most of these people were also suffering from depression, consumed
excessive amounts of alcohol or were prone to having suicidal thoughts. If at any time
you should develop self-harming or suicidal thoughts, consult your doctor immediately or go to
hospital. Also ask a relative or close friend to read this leaflet and to inform you of
any concerns due to any change in your behavior.
Do not stop treatment with this medicine without consulting your doctor. Treatment should
be discontinued gradually, over one or two weeks. Sudden discontinuation increases the
risk of adverse effects such as hallucinations, anxiety and confusion, palpitations, muscle pain,
fever and dark urine.
If one or more of these situations apply to you, tell your doctor. The doctor will take these aspects
into account during your treatment with Leodizcol.

Other medicines and Leodizcol
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including:

• medicines used to treat mental health disorders, such as antidepressants and lithium
• medicines that lower blood pressure
• medicines that can affect the kidneys (such as medicines for the treatment of joint inflammation or pain)
• medicines for the treatment of Parkinson's disease (levodopa/carbidopa)
• medicines with a calming effect on the central nervous system (e.g. opioids for pain relief such as morphine, other muscle relaxants such as tizanidine, sedatives, alcohol)
• medicines for the treatment of conditions such as depression and anxiety (such as selective serotonin reuptake inhibitors [SSRIs]).

Leodizcol with alcohol
Alcohol can increase the undesirable effects of this medicine, such as drowsiness and lethargy. Avoid
concomitant use of Leodizcol and alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, do not use Leodizcol unless your doctor considers it necessary. If
you use Leodizcol during pregnancy, there is a risk that the baby may experience seizures shortly after
birth.
Baclofen passes into breast milk, but in small amounts, and no effects on the baby are expected.

Driving and using machines
If you experience dizziness, drowsiness, lethargy, decreased attention and visual disturbances after taking
Leodizcol, do not drive vehicles and do not use machines.

Leodizcol contains sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl
parahydroxybenzoate (E 216), propylene glycol (E 1520) and sodium
This medicine contains 362.68 mg of sorbitol (E 420) per mL. Sorbitol is a source of
fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a
diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot
break down fructose, talk to your doctor before you (or your child) take this
medicine. Sorbitol can cause gastrointestinal problems and have a mild laxative effect.
This medicine contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216),
which can cause allergic reactions (including delayed reactions).
This medicine contains 1.05 mg of propylene glycol (E 1520) per mL. If the child is less than
4 weeks old, talk to your doctor or pharmacist before giving this medicine, in
particular if the child is taking other medicines containing propylene glycol or alcohol.
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. essentially “sodium-free”.
When the dose is greater than 30 mL, it cannot be considered “sodium-free”; this aspect
must be taken into consideration by patients who are following a low-sodium diet.
This medicine contains 92.6 mg of sodium (the main component of table salt) per daily dose
(120 mL). This is equivalent to 4.6% of the recommended maximum daily intake with the diet of an adult.

3. How to take Leodizcol

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Children under 8 years of age
The dose must be adjusted according to body weight and gradually increased. The recommended initial
dose is 0.3 mg/kg of body weight per day, divided into 2-4 doses, to be gradually increased
every 1-2 weeks until the optimal effect is achieved.
The maintenance dose is 0.75-2 mg/kg of body weight per day.
The maximum dose is 40 mg per day.

Children 8 years of age or older
The dose must be adjusted according to body weight and gradually increased. The recommended initial
dose is 0.3 mg/kg of body weight per day, divided into 2-4 doses, to be gradually increased
every 1-2 weeks until the optimal effect is achieved.
The maintenance dose is 0.75-2 mg/kg of body weight per day.
The maximum dose is 60 mg per day.

Adults
The dose must be gradually increased. The recommended initial dose is 15 mg per day,
divided into 2-4 doses, to be gradually increased at intervals of three days until the optimal effect is achieved.
The usual maintenance dose is 30-80 mg per day.
Patients hospitalised may be given 100-120 mg per day.

Patients with impaired renal function
The recommended initial dose is 5 mg per day. The dose adjustment will be decided by the doctor
based on their individual needs.

Patients with impaired hepatic function
The doctor may decide to administer a lower dose.

Elderly and patients with cerebral pathologies
Elderly patients should be carefully monitored by the doctor for undesirable effects that may
require a dose adjustment. The dose prescribed by the doctor may differ from those
described above. In this case, follow the doctor's instructions.

Method of administration
Take the solution orally during meals with some liquid.
The total daily dose can be divided into 2-4 doses.
The doctor will decide when to stop treatment with Leodizcol.
The box contains a 1 mL oral syringe, a 10 mL oral syringe and a
syringe adapter.
The 1 mL syringe has graduated markings from 0.05 mL and must be used for dosage volumes
up to 3 mL. The 10 mL syringe has graduated markings from 0.5 mL and must be used for dosage volumes
starting from 3 mL.
Instructions for using the syringes:

• 1. Open the bottle: press and rotate the cap counterclockwise. For the first use, remove the drop-saving ring (round plastic insert) and insert the syringe adapter into the bottle neck. Take the syringe and insert it into the adapter opening. Turn the bottle upside down.
• 2. Draw the medicine SLOWLY up to the mark of the required dose by pulling the plunger down. If air bubbles are present in the dispenser, empty the syringe and draw the medicine again slowly until the bubbles disappear. To measure the dose accurately, the top edge of the black ring must be aligned with the mark of the required dose. Place the bottle upright on the table and remove the dispenser. Confirm the accuracy of the dose.
• 3. Make sure the patient is in an upright position before administering the medicine. Insert the syringe into the patient's mouth. WARNING:press the plunger slowly to allow time to swallow; rapid delivery of the medicine can cause choking. Close the bottle over the adapter.

Clean the syringe IMMEDIATELY with water after each administration. It is ESSENTIAL
to press and retract the plunger several times to eliminate all traces of medicine from the inside
of the syringe tip. Allow the syringe to dry before reusing it.

If you take more Leodizcol than you should
If you take more Leodizcol than you should, contact your doctor or hospital immediately.
In case of overdose, the most characteristic symptoms are difficulty breathing, decreased
consciousness and unconsciousness (coma). Other symptoms may include: drowsiness, feeling of confusion,
hallucinations, memory loss, intense anxiety, cramps, blurred vision, abnormal muscle weakness,
sudden muscle contractions, weak or absent reflexes, high or
low blood pressure, slow, accelerated or irregular heartbeat, low body temperature, nausea, vomiting,
diarrhoea, excessive salivation, ringing in the ears, difficulty breathing during sleep (sleep apnea syndrome), muscle pain,
fever and dark urine (rhabdomyolysis).

If you forget to take Leodizcol
Do not take a double dose to make up for a missed dose.

If you stop taking Leodizcol
Do not stop treatment with this medicine without consulting your doctor (see paragraph 2).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common(may affect more than 1 in 10 people):

• drowsiness
• torpor
• nausea

Common(may affect up to 1 in 10 people):

• confusion
• insomnia
• slowed breathing
• dizziness
• hallucination
• fatigue
• muscle weakness
• problems with coordination
• tremor
• muscle pain
• headache
• involuntary eye movements
• dry mouth
• impaired vision
• difficulty seeing
• impaired heart function
• decreased blood pressure
• indigestion
• retching
• vomiting
• constipation
• diarrhea
• excessive sweating
• skin rash
• frequent urination
• inability to control urination
• difficulty urinating or pain during urination

Uncommon(may affect up to 1 in 100 people):

• nightmares

Rare(may affect up to 1 in 1,000 people):

• euphoria
• asthenia
• depression
• tingling, prickling, or pins and needles sensation, without a cause
• problems with speech
• impaired sense of taste
• shortness of breath
• fainting
• abdominal pain
• impaired liver function
• retention of urine or residual urine in the bladder
• erectile dysfunction

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

• severe decrease in body temperature

Not known(frequency cannot be estimated from the available data):

• difficulty breathing during sleep
• slow heartbeat
• itchy skin rash and hives
• symptoms caused by sudden discontinuation of treatment
• increased blood sugar levels

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. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Leodizcol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Do not use this medicine after 8 weeks from the date of first opening.
Do not store at a temperature above 30 °C. Keep the bottle in the outer pack protected from
light. Do not store in a refrigerator and do not freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Leodizcol contains

• The active ingredient is baclofen. Each mL of oral solution contains 1 mg of baclofen.
• The other ingredients are sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium carboxymethylcellulose (E 466), raspberry aroma (containing propylene glycol [E 1520]) and water. See section 2 “Leodizcol contains sorbitol (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol (E 1520) and sodium”.

Description of the appearance of Leodizcol and contents of the pack
Leodizcol is a clear, slightly yellow solution with a raspberry odour and taste.
It is available in amber glass bottles of 300 mL. The pack contains a 1 mL oral syringe, a 10 mL oral syringe and a syringe adapter.

Marketing authorisation holder
Essential Pharma Ltd,
Vision Exchange Building,
Triq it-Territorjals, Zone 1, Central Business District,
Birkirkara, CBD 1070, Malta

Manufacturer
Delpharm Bladel B.V., Industrieweg 1, 5531 AD
Bladel, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: Baclofen EssPharm 1 mg/ml oral solution
Baclofen EssPharm 1 mg/ml drink
Baclofen EssPharm 1 mg/ml solution for oral use
France: BACLOFENE ESSENTIAL PHARMA 1 mg/mL, oral solution
Germany: Leodizcol 1 mg/ml solution for oral use
Italy: Leodizcol
Netherlands: Leodizcol 1 mg/ml drink
Spain: Leodizcol 1 mg/ml oral solution
Denmark: Leodizcol 1 mg/ml oral solution
Sweden: Leodizcol 1 mg/ml oral solution
Norway: Leodizcol