BACLOSAL 25

118128010

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) – 1986

The medicine is dispensed with

a doctor’s prescription only

BACLOSAL 10, 25

Tablets

Composition:

Each tablet of Baclosal 10 contains:

Baclofen 10 mg

Each tablet of Baclosal 25 contains:

Baclofen 25 mg

For the list of inactive ingredients, please

see section 6.

Read this leaflet carefully in its entirety before

using the medicine. This leaflet contains

concise information regarding the medicine.

If you have further questions, refer to the

doctor or pharmacist.

This medicine has been prescribed for the

treatment of your ailment. Do not pass it

on to others. It may harm them, even if it

seems to you that their medical condition

is similar.

This medicine is not intended for use in

infants and children below the weight of

33 kg.

1. WHAT IS THE MEDICINE INTENDED

FOR?

Therapeutic group: Muscle relaxant with

spinal activity.

Therapeutic activity: Relaxation of muscles

and/or spasms caused by different factors.

Baclosal is used to reduce and relieve the

excessive rigidity and/or spasms in the

muscles in various conditions such as multiple

sclerosis, spinal cord diseases or injuries and

certain nervous system diseases.

As a result of muscle relaxation which leads

to a reduction in pain, Baclosal improves the

ability to move, makes it easier to perform

the daily activities and physical therapy.

If you have questions about the way Baclosal

works, or why this medicine was prescribed

for you, refer to the doctor.

2. BEFORE USING THE MEDICINE:

Do not use the medicine if:

∙ You are sensitive (allergic) to baclofen or

to any of the other ingredients contained

in the medicine (see section 6 “Further

Information”). If you think you are allergic

to baclofen, refer to the doctor for

consultation.

∙ If you have, or had in the past, a stomach

ulcer.

Before the treatment with Baclosal, tell

the doctor if:

∙ you are pregnant or breastfeeding.

∙ you had a stroke.

∙ you have epilepsy (convulsions).

∙ you have mental disorders.

∙ you have Parkinson’s disease.

∙ you take medicines for hypertension.

∙ you have a liver, kidney or lung disease.

∙ you have diabetes.

∙ you have difficulties in urinating.

Special warnings regarding use of the

medicine:

Follow the doctor’s instructions carefully.

Before

commencing

treatment

with

this medicine you need to undergo a

comprehensive medical examination. The

doctor may want to perform tests and

monitor you during treatment with the

medicine.

If you are about to undergo any surgery

(including dental) or emergency treatment,

inform the doctor in charge that you are

taking Baclosal.

In elderly patients (aged 65 and above) or

in patients with muscle spasms caused by

cerebral disease, there may be more side

effects. Therefore, the doctor will monitor

these patients accordingly and may adjust

the dose of Baclosal that they are taking.

If you have been treated for 6 to 8 weeks and

you do not feel an improvement, refer to the

doctor. The doctor will decide if you should

continue to receive Baclosal.

If you are taking, or have recently taken,

other medicines including non-prescription

medicines and nutritional supplements,

inform the doctor or pharmacist. Especially

inform the doctor or pharmacist if you are

taking:

∙ other medicines to relax muscles, e.g.,

tizanidine.

∙ medicines used to treat mood disorders,

e.g., tricyclic antidepressants (such as

amitriptyline) and lithium.

∙ medicines to treat hypertension, e.g.,

diltiazem.

∙ other medicines that may affect kidney

function, e.g., ibuprofen.

∙ medicines to treat Parkinson’s disease

(e.g., levodopa or carbidopa).

∙ medicines that depress the nervous

system, e.g., antihistamines (such as

promethazine),

sedatives

(such

temazepam), opiate pain relievers (such

as morphine) and anti-epileptic medicines

(such as carbamazepine).

Use of the medicine and food – Take the

medicine with a meal.

Use of the medicine and alcohol

consumption – Do not drink wines or

alcoholic beverages during the treatment

with the medicine.

Driving and using machinery – In some

patients, Baclosal may cause dizziness,

sleepiness or vision disturbances. If this

happens to you, do not drive, operate

machinery or do other things that require

your full attention until these effects have

worn off. Regarding children, they should be

cautioned against riding a bicycle, playing

near the road and the like.

Pregnancy and breastfeeding: If you

are pregnant, you should consult with the

doctor or pharmacist before taking any kind

of medicine. Do not use Baclosal during

pregnancy, unless the doctor advises you to

do so. Inform the doctor if you are pregnant,

or planning to become pregnant. The doctor

will discuss with you the risk involved with

taking Baclosal during pregnancy. If you need

to take Baclosal during pregnancy, your baby

may have convulsions right after birth. Only

a very small amount of Baclosal passes into

breast milk. The doctor will discuss with you

whether you should breastfeed while taking

Baclosal.

Use in children and adolescents – This

medicine is not intended for infants and

children below the weight of 33 kg.

3. HOW

SHOULD

yOU

USE

THE

MEDICINE?

Always use according to the doctor’s

instructions.

You should check with the doctor or

pharmacist if you are not sure.

The usual dosage is generally:

The doctor will tell you the optimal time to

take Baclosal. Some patients need to take the

medicine only at night or before doing tasks

such as washing, dressing, shaving, etc.

The final dose of Baclosal depends on the

individual response of the patient to the

medicine. You should start with a low dose and

increase the dose gradually over a few days,

under medical supervision, until you reach

the dose which is right for you. If the starting

dose is too high, or if the dose is increased

too quickly, you may suffer from side effects,

particularly if you are elderly, have kidney

problems or have had a stroke in the past.

Do not stop the treatment suddenly. If the

doctor decides to stop the treatment, the

dose will be reduced gradually to prevent

withdrawal symptoms such as muscle spasms

and increased muscle rigidity, fast heart rate,

fever, confusion, hallucinations, changes

in mood and emotions, mental disorders,

feeling persecuted or convulsions.

Adults:

∙ The usual dose is 20 mg (2 tablets of

Baclosal 10) three times a day.

∙ The maximum daily dose is 100 mg a day,

except for hospitalized patients, where a

higher dose may be prescribed.

Children:

The dose in children is calculated according

to body weight.

Patients with kidney diseases:

Patients with kidney diseases will usually

receive a significantly lower dose of the

medicine, per the doctor's decision.

Do not chew! Swallow the medicine with a

little water.

If necessary, the tablets can be crushed or

halved for immediate use.

If you accidentally took a higher dose or if a

child accidentally swallowed the medicine,

refer immediately to the doctor or to the

hospital emergency room and bring the

package of the medicine with you. The main

symptoms of an overdose are sleepiness,

breathing difficulties, consciousness

disturbances and loss of consciousness.

Other symptoms can include: feeling

confused,

hallucinations,

agitation,

convulsions, blurry vision, abnormal muscle

limpness, sudden muscle contraction, weak

reflexes or lack of reflexes, high or low blood

pressure, slow, fast or irregular heartbeat,

low body temperature, nausea, vomiting,

diarrhea or excessive salivation.

If you forgot to take this medicine at the

required time, do not take a double dose.

Take the next dose at the regular time and

consult the doctor.

Adhere to the treatment as recommended

by the doctor.

Even if there is an improvement in your

health, do not stop treatment with the

medicine without consulting the doctor or

pharmacist.

Do not take medicines in the dark! Check

the label and the dose each time you take

medicine. Wear glasses if you need them.

If you have further questions regarding

use of the medicine, consult the doctor or

pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Baclosal may

cause side effects in some users. Do not be

alarmed when reading the list of side effects.

You may not suffer from any of them.

If you have one or more of these effects,

refer to the doctor immediately:

Breathing difficulties; feeling confused;

feeling

excessively

happy;

sadness

(depression); loss of coordination that

affects balance and walking, movement of

the limbs and eyes and/or speech (signs of

ataxia); tremor; hallucinations; nightmares;

blurry vision/vision disturbances; shortness

of breath at rest or with activity, swelling of

the legs and tiredness (signs of decreased

cardiac output); low blood pressure; skin rash

and urticaria; difficulty urinating, pain upon

urinating or sudden decrease in urine output;

convulsions; abdominal pain, yellowing of

the skin or eyes and tiredness (signs of a

liver disorder); low body temperature; slow

heartbeat; symptoms that appear after

suddenly stopping the use of the medicine

(withdrawal syndrome from the medicine) as

described in section 3 “How should you use

the medicine?”.

Very common side effects (appear in more

than 1 in 10 patients):

Tiredness, sleepiness, nausea.

Common side effects (appear in 1 to 10

patients in 100):

Weakness in arms and legs or a feeling of

significant general tiredness, muscle pain;

headache, dizziness; breathing difficulties;

insomnia; mood changes, confusion,

hallucinations or nightmares; dry mouth;

eye problems; unsteadiness, trembling or

additional effects associated with lack of

muscle control; low blood pressure (may

cause fainting), digestive system problems

such as retching (contraction of the stomach

muscles without vomiting up stomach

content), vomiting, constipation and diarrhea;

excessive sweating, rash; increased need to

pass urine or pain on passing urine; wetting

the bed.

Rare side effects (appear in 1 to 10 in

10,000 patients):

Tingling or numbness in the palms of the

hands and/or feet; muscle spasms; disturbed

sense of taste; speaking difficulty or slow

speech; abdominal pain; liver problems;

difficulty in passing urine; inability to reach

or maintain an erection (male impotence);

convulsions (particularly in epileptic

patients).

Very rare side effects (appear in less than

1 to 10 in 10,000 patients):

Low body temperature (hypothermia).

Additional

side

effects

(unknown

frequency):

Raised rash accompanied by itching

(urticaria); slow heartbeat; increase in blood

sugar; symptoms caused by suddenly

stopping the use of the medicine (withdrawal

syndrome from the medicine) as described

in section 3 “How should you use the

medicine?”.

If a side effect occurs, if any of the side effects

worsen or if you suffer from a side effect

not mentioned in the leaflet, consult with

the doctor.

Side effects can be reported to the

Ministry of Health by clicking on the link

“Report Side Effects of Drug Treatment”

found on the Ministry of Health homepage

(www.health.gov.il) that directs to the online

form for reporting side effects.

Alternatively,

they can be reported to “Unipharm Ltd.”.

5. HOW SHOULD THE MEDICINE BE

STORED?

Avoid poisoning! This medicine and any other

medicine must be kept in a safe place out of

the reach of children and/or infants to avoid

poisoning. Do not induce vomiting without

explicit instruction from the doctor.

Do not use the medicine after the expiry date

(exp. date) that appears on the package.

The expiry date refers to the last day of that

month.

Store at a temperature below 25°C and in a

place protected from light.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains:

Microcrystalline cellulose; Maize starch;

Povidone; Magnesium stearate.

What the medicine looks like and the

contents of the package:

Baclosal is packaged in trays (blister) which

are inserted into a carton package. Each

package contains 50 tablets.

Baclosal 10 are white, round, convex tablets

with a score line on one side.

Baclosal 25 are white, round, flat tablets with

a crossed score line on one side.

Name of registration holder: Unipharm Ltd.,

P.O.B. 21429, Tel Aviv 6121301.

Name of manufacturer and address:

Trima Ltd., Kibbutz Maabarot.

This leaflet was checked and approved by

the Ministry of Health in February 2017

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health:

Baclosal 10: 46 07 23779

Baclosal 25: 45 34 23780

0417D