CABOTRIM 0.5

101018010

0115E

PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with a doctor’s prescription only.

Cabotrim 0.5

Tablets

Active ingredient:

Each tablet contains cabergoline 0.5 mg

Inactive ingredients in the preparation - see section 6 “Further Information”.

Read this leaflet carefully in its entirety before using the medicine. This

leaflet contains concise information about the medicine. If you have further

questions, refer to the doctor or pharmacist.

This medicine has been prescribed for treatment of your ailment. Do not

pass it on to others. It may harm them even if it seems to you that their

ailment is similar.

The medicine is not intended for youngsters under the age of 16.

∙ Prevent pregnancy for at least one month after completing use of the

medicine. Before using the medicine, and if your period is more than three

days late, tests to rule out pregnancy should be performed. While using

the medicine, nonhormonal contraceptive methods should be used. In

case of pregnancy, stop taking the medicine immediately.

∙ It is recommended to monitor blood pressure, especially in the first days

of treatment, since especially in the first days of treatment, low blood

pressure may develop.

∙ The preparation belongs to a group of medicines which might cause the

following effects: addictive gambling, overspending, compulsive eating,

increased sexual desire (libido) and hypersexuality. These effects generally

subside upon reduction of the dosage or treatment modification by the

doctor.

1. WHAT IS THIS MEDICINE INTENDED FOR?

The medicine is intended to treat cases of hyperprolactinemia (excess blood

prolactin). The medicine is intended for inhibition and suppression of lactation

(cessation of breastfeeding).

Therapeutic group: dopamine receptor agonist.

2. BEFORE USING THE MEDICINE

Do not use this medicine if:

∙ you are sensitive/allergic to the active ingredient or to any of the other

ingredients contained in the medicine and/or to ergot alkaloids.

∙ you are suffering from uncontrolled hypertension.

∙ you are suffering, or have suffered in the past, from pericardial or pulmonary

and/or retroperitoneal fibrotic reactions (thickening and scarring).

∙ you are suffering from structural damage of the cardiac valves.

∙ you are being treated with antipsychotics in parallel to this treatment or

you have suffered in the past from postpartum depression.

∙ you are suffering from a severe liver disease.

∙ you are suffering from preeclampsia (high blood pressure accompanied

by edemas and protein in the urine).

∙ you are pregnant or breastfeeding (unless the medicine is intended for

cessation of breastfeeding).

Before treatment with Cabotrim, tell the doctor if:

∙ you are suffering, or have suffered in the past, from impaired function of:

the respiratory system, the heart and/or blood vessels, the liver, the kidney/

urinary system, the digestive system (e.g., ulcer), Raynaud’s syndrome

(which causes a cold sensation in the hands and legs).

∙ you have suffered in the past, from psychotic or mental disorders.

∙ you are suffering from low blood pressure and/or are being treated with

antihypertensives.

∙ after giving birth your blood pressure went up.

Special warnings regarding use of the medicine:

∙ If you are sensitive to any food or medicine, inform the doctor before taking

the medicine.

∙ Before using the medicine, and if your period is more than three days late,

tests to rule out pregnancy should be performed. While using the medicine,

nonhormonal contraceptive methods should be used. In case of pregnancy,

stop taking the medicine immediately. Prevent pregnancy for at least one

month after completing use of the medicine.

∙ The preparation belongs to a group of medicines which might cause the

following effects: addictive gambling, overspending, compulsive eating,

increased libido and hypersexuality. These effects generally subside upon

reduction of the dosage or treatment modification by the doctor.

∙ In certain cases, long-term treatment with cabergoline may cause fibrosis and

inflammatory conditions of the lungs, pericardium and the retroperitoneum

as well as cardiac valve damage. In some cases, cardiac valve damage

improves upon cessation of treatment with cabergoline. Patients who are

taking cabergoline and experience breathing disturbances or difficulties

should immediately refer to the doctor who will consider performing a chest

x-ray, blood sedimentation and/or serum creatinine measurement.

∙ During treatment with the preparation, refer to a doctor immediately if you

experience the following signs: difficulty breathing, shortness of breath,

prolonged cough and/or chest pains, pains and swelling in the waist area

and/or heart failure.

Tests that should be performed before starting use of the medicine:

∙ Perform tests to rule out pregnancy.

∙ The patient must undergo cardiovascular evaluation including an

echocardiogram. It is also recommended to perform, before starting the

treatment, blood sedimentation test, lung function/chest x-ray and kidney

function tests. Do not use the preparation if damage to the cardiac valves

is diagnosed.

∙ In case of hyperprolactinemia, perform a pituitary gland test.

∙ It is recommended to monitor blood pressure, especially in the first days of

treatment, since especially in the first days of treatment, low blood pressure

may develop.

If you are taking, or have recently taken, other medicines including

nonprescription medicines and nutritional supplements, tell the doctor

or pharmacist. It is especially important to inform the doctor or pharmacist

if you are taking:

medicines that might impair the effectiveness of Cabotrim:

∙ antiemetics (e.g., metoclopramide)

∙ antipsychotics and medicines to treat mental disorders (e.g., phenothiazines,

thioxanthenes, butyrophenones),

∙ antihypertensives

medicines that may cause side effects:

∙ macrolide antibiotics (e.g., erythromycin),

∙ medicines to treat Parkinson’s disease,

∙ medicines to treat migraine (e.g., ergot-alkaloids)

Use of the medicine and food

Swallow the medicine after a meal.

Use of the medicine and alcohol consumption

It is recommended not to consume alcohol during treatment, in order not to

increase the risk of dizziness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, do not use the preparation (unless the

medicine is intended for cessation of breastfeeding).

Before using the medicine, and if your period is more than 3 days late,

tests to rule out pregnancy should be performed. While using the medicine,

nonhormonal contraceptive methods should be used. In case of pregnancy,

stop taking the medicine immediately. In addition, prevent pregnancy for at

least one month after completing use of the medicine, since cabergoline may

cause congenital defects if taken during pregnancy.

Driving and use of machinery

Use of this medicine may impair alertness and may cause sudden onset

of sleep. If you experience these effects, do not drive, do not operate

dangerous machinery and do not perform any activity that requires alertness

or coordination. Your doctor will decide if you can continue treatment with

the medicine if these effects occur.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor’s instructions. Check with the doctor or

pharmacist if you are uncertain about the manner of use.

The dosage and treatment regimen will be determined by the doctor only. The

usual dosage is generally:

To prevent milk production – take 1 mg (2 tablets of 0.5 mg) on the first day

after delivery.

For cessation of breastfeeding (after a period during which you breastfed) –

take 0.25 mg (half a tablet) every 12 hours for two days.

To lower prolactin levels in other conditions – start with 0.5 mg in two doses

during the first week of treatment (for example, half a tablet [0.25 mg] on

Monday and half a tablet [0.25] on Thursday). The doctor will gradually increase

the dosage until reaching the full response to treatment. The weekly dosage

can range from 0.25 mg to 4.5 mg, depending on the response.

When first taking Cabotrim, it is recommended to carefully switch from a lying/

standing/sitting position, since the preparation may cause a drop in blood

pressure that is manifested by dizziness when changing position.

Do not exceed the recommended dose.

Do not chew! Swallow the medicine with water after a meal, to reduce the

side effects such as nausea and vomiting.

The tablet can be halved or crushed.

Tests and follow up:

∙ The first echocardiogram is required after 3-6 months of treatment and should

be repeated every 6-12 months. If damage or worsening of the condition of

the cardiac valves is observed, stop treatment with the preparation.

∙ It is recommended to perform periodic monitoring that includes blood, heart,

lung, and kidney tests (to diagnose development of adhesion, fibrosis and/

or damage of cardiac valves).

∙ It is recommended that you regularly undergo a gynecological test (including

a smear of the uterus and/or cervix) if you are taking the preparation for a

prolonged time to regulate hormonal disorders.

If you accidentally took an overdose or if a child has accidentally swallowed

the medicine, immediately refer to a doctor or proceed to a hospital emergency

room and bring the package of the medicine with you. Possible signs of

overdose: nausea, vomiting, discomfort in the digestive system, orthostatic

hypotension, confusion/psychosis, hallucinations.

If you forgot to take the medicine, take the next dose at the regular time

and consult the doctor. Do not take a double dose.

Adhere to the treatment as recommended by the doctor.

Even if there is an improvement in your health condition, do not stop treatment

with the medicine without consulting the doctor.

Do not take medicines in the dark! Check the label and dose each time you

take medicine. Wear glasses if you need them.

If you have further questions regarding use of the medicine, consult a doctor

or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of the medicine may cause side effects in some

users. Do not be alarmed when reading the list of side effects. You may not

experience any of them.

Stop treatment and refer to the doctor immediately if the following effects

develop:

∙ Very common side effects (occur in more than one in ten users) that may

indicate fibrosis (thickening and scarring) of the cardiac, pulmonary and/or

retroperitoneal tissue such as: faint feeling, chest/rib/waist/back/pelvic pain,

movement disorders, swelling of the legs, shortness of breath, breathing

difficulties, heart rhythm changes, palpitations.

∙ An allergic reaction manifested by skin rash, itching, skin blisters, swelling

of the face, tongue, neck and/or limbs, shortness of breath, worsening of

asthma, shock.

Refer to the doctor as soon as possible if the following effects develop:

∙ aggressiveness, psychotic disorder (e.g., urge to gamble, increased libido,

hypersexuality, overspending, compulsive eating), hallucinations – seeing

and hearing things that do not exist, low blood pressure, mainly when getting

up from a lying position, palpitations.

∙ changes in blood test results and/or liver functions (increased enzymatic

activity).

Additional side effects:

∙ Very common (may occur in more than one in ten users): drowsiness/

sleepiness, nausea, headache, dizziness, vertigo, abdominal pain, digestive

disorders, fatigue, weakness, gastritis.

∙ Common (may occur at a frequency of one in ten users): constipation,

blurred vision, vomiting, sleep disturbances, daytime sleepiness, breast

pain/tenderness, hot flushes, depression, changes in sensation, tingling

of the hands and legs, low blood pressure after childbirth, even without

symptoms.

∙ Uncommon (may occur at a frequency of one in one hundred users): hair

loss, nosebleed, partial/temporary loss of vision, changes in vision, cramps

of the leg muscles, edemas, severe itching, stinging sensation, decreased

hemoglobin levels in women whose monthly periods had stopped and then

restarted.

∙ Rare (may occur at a frequency of one in one thousand users): cold sensation

in the hands and legs, muscle weakness.

∙ Frequency unknown: sudden onset of sleep, delusions.

If a side effect occurs, if any of the side effects worsen or if you suffer from a

side effect not mentioned in this leaflet, consult with the doctor.

5. HOW SHOULD THE MEDICINE BE STORED?

∙ Avoid poisoning! This medicine and any other medicine should be kept in

a safe place out of the reach of children and/or infants in order to avoid

poisoning. Do not induce vomiting without explicit instruction from the

doctor.

∙ Do not use the medicine after the expiry date (exp. date) appearing on the

package/label. The expiry date refers to the last day of that month.

∙ Store in a cool, dark and dry place (below 25°C).

∙ After first opening, use the preparation within 90 days.

6. FURTHER INFORMATION

∙ In addition to the active ingredient, the preparation also contains the

following inactive ingredients:

Microcrystalline cellulose, croscarmellose sodium, citric acid (anhydrous),

magnesium stearate.

∙ What does the medicine look like and what are the contents of the

package?

∙ Each package contains 2 or 8 white to off-white tablets with a breakline on

one side.

∙ Manufacturer and license holder: Trima, Israel Pharmaceutical Products

Maabarot Ltd., Maabarot 4023000, Israel.

∙ This leaflet was checked and approved by the Ministry of Health in January

2015.

∙ Registration number of the medicine in the National Drug Registry of the

Ministry of Health: 135.73.31180.00