Cabaser (Cabergoline) 20 Tablets

CABASER 1 mg notched tablet is taken orally.

Active Ingredient

Cabergoline 1 mg

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is CABASER and what is it used for?

2. Things to consider before using

3. CABASERHow to use CABASER?

4. What are the possible side effects?

5. CABASER storage

headers are included.

2. What is CABASER and what is it used for?

• CABASER is available in glass vials with a special cover containing 20 mg of orally-drawn tablets, each containing 1 mg of cabergoline.

• CABASER is a medication used to treat symptoms of Parkinson's disease. Your doctor is used to help control symptoms by adding to the medications you have already used for or after you have tried other treatments and have no benefit.

• CABASER is a group of drugs called dopamine agonists. The active substance, cabergoline, has a similar effect to the chemical dopamine in the body. Patients with Parkinson's disease do not have enough of this chemical. CABASER acts by increasing the effect of dopamine.

3. How to use CABASER?

Instructions for proper use and dose / frequency of

administration The usual daily starting dose of CABASER is 1mg. Your doctor may increase the dose of the drug in order to reach the appropriate dose to control your symptoms. This dose should generally not exceed 3 mg daily.

The method and method of

administration of CABASER are taken by mouth with a glass of water. To reduce side effects, it is recommended that CABASER is preferably taken after meals.

Different age groups

Use in

children Since no Parkinson's disease is seen in children, no safety and efficacy studies have been conducted on this group.

Use in the elderly

There is no special use.

Special Use Conditions

Kidney failure: No special recommendations for use.

Hepatic impairment: If you have severe hepatic impairment, you should consider using lower doses of CABASER.

If you have an impression that CABASER's effect is too strong or too weak, talk to your doctor or pharmacist.

If you use more CABASER

than you should, talk to a doctor or pharmacist who has used more than you should use from CABASER.

If you forgot to use

CABASER 4. What are the side effects?

As with all drugs, there may be side effects in people who are sensitive to substances found in CABASER's content.

If you have any of the following, stop using the CABASER and IMMEDIATELY tell your doctor or contact the emergency department of your nearest hospital:

• Difficulty in breathing, shortness of breath, heart palpitations, feeling unconscious, chest pain, back pain, pelvic (caused by the area between the pelvis) ) pain or swelling of the legs. These may be the first signs of the condition known as fibrosis, affecting your lungs, the back of your heart or the inside / heart valves.

• The impulse to gamble despite serious personal or familial consequences

• Significantly increased sexual desire that concerns the person or his / her environment

.

CABASER may cause dizziness. In some cases, it was found to be associated with excessive daytime sleepiness and sudden

falling asleep.

In clinical studies, the following side effects were observed in the use of CABASER with levadopa.

Very common (more than 1 out of 10) side effects

• Heart valve and related disorders such as the cardiovascular status (pericarditis), fluid accumulation in the heart membrane (pericardial effusion). Early symptoms of these conditions may be one or more of the following: respiratory distress, shortness of breath, chest or back pain, swelling of the legs. Tell your doctor immediately if you encounter any of these symptoms.

• Disruption of voluntary movements (dyskinesia)

• Excessive mobility (hyperkinesia)

• False sensation without a stimulus (hallucination)

• Mind blurring

• Dizziness

• Low blood pressure during sitting up or down (postural hypotension)

• Swelling of the arms and legs ( peripheral edema

• Nausea

• Vomiting

• Indigestion

• Gastrointestinal inflammation (gastritis) Common side effects (1 to 10 patients in 100 patients) Side effects

• Breast contraction, pressure or feeling of heaviness (Anjina)

Uncommon ( Side effects seen in 1 to 100 patients in 1 to 1000 patients

• Burned pain in the skin, temperature increase and redness, visible in the hands and feet in seizures, a distinctive disease with burning sensation (erythromelalgia)

Respiratory system effect in 13% of cases pleural effusion / pulmonary fibrosis less than 2% It is large.

Clinical studies have shown the following side effects of CABASER in newly diagnosed Parkinson patients.

Very common (more than 1 out of 10) side effects

• Sleep disorder

• Nausea

• Vomiting

• Indigestion

• Inflammation of the layer (mucosa) that covers the inside of the stomach

• Constipation

• Dizziness

• Low blood pressure when sitting or lying down postural hypotension)

• Swelling of the arms and legs (peripheral edema)

Common (1 in 10 patients in 1 patient) side effects

• Disruption of voluntary movements (dyskinesia)

• Misdiagnosis (hallucination) without a stimulus

During the post-marketing experience with CABASER The following side effects were observed:

• Aggression

• Hair loss

• Fatigue (asthenia)

• Blood creatinine phosphokinase (a blood test) increase

• Imagination and delusion

• Shortness of breath

• Edema

• Fatigue

• Fibrosis affecting your lungs, the back of your heart or inside

• Headache

• Allergicreaction)

•• Increased sexuality and sexual desire

• Abnormal liver function tests

• Gambling despite serious personal or familial consequences

• Disorder of thought and sensation (psychotic disorder)

• Rash

• Respiratory disorder

• Respiratory failure

•

SleepinessSudden sleepings

•• Unconsciousness ( syncope

• Heart valve problems (valvulopathy)

2.CABASER should bebefore using

considered DO NOT USE

CABASER • cabergoline, the active ingredient of CABASER, or other substances contained in it, or your allergies to other drugs known as ergot alkaloids (hypersensitivity) If

• your lung, fibrotic effects affecting your heart or your abdominal cavity (defective tissue, such as scar) if or if it

• have been told that you have a problem that affects your heart valves

• are pregnant

cabaser your care with the following conditions

following situations if you are in the past or at the moment:

• Heart disease

• Raynaud's syndrome (circulatory problem that causes hand fingers to appear pale or bruised)

• Severe chest problems such as inflammation of the chest membrane ()

liver• Liver disease

• Gastric ulcer , stomach or intestinal haemorrhage

• Mental disorder, especially psychotic disorder

• Liver failure

• Low blood pressure (sitting) when you sit or stand up (postural

hypotension)

Inform your doctor before using CABASER. If the daily treatment dose exceeds 3 mg, the risk of developing the condition known as fibrosis increases with your lungs, heart or abdominal cavity.

If you used a drug containing pergolide in your treatment, it is reported that this risk is higher. Consult your doctor about this.

If you have or have had fibrotic effects that affect your heart, lungs or abdominal cavity, your doctor will check that your heart, lungs and kidneys are in good condition before treatment. It will also take echocardiography (heart ultrasound) at regular intervals before and during the treatment. If fibrotic effects occur, your treatment will have to be discontinued.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using CABASER with food and drink

To reduce side effects, CABASER should be taken after a meal.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

Do not use CABASER if you are pregnant. If you are a child with fertility age andan effective contraceptiveif you are

do not usemethod orplanning to become pregnant, CABASER consult your doctor before use.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

It is not recommended to use CABASER if you are breastfeeding. Tell your doctor if you are breastfeeding, because CABASER can affect milk production (lactation).

Use ofand machinery

toolsCABASER may cause somnolence and sudden sleepiness. For this reason, you should avoid carrying out any activity (eg machine use), which may expose you or others to risk of serious injury or death until you have recuperated sleep and somnolence.

Important information about some of the ingredients of CABASER

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Use with other drugs

CABASER 's effect may be reduced when used with some drugs. These are:

• Drugs used in the treatment of mental disorders (eg phenothiazines, butyrophenones, thioxanthenes)

• Drugs used to treat nausea (eg metoclopramide)

. These include:

• Macrolide antibiotics (eg erythromycin)

• Drugs used in the treatment of migraine (eg ergotamine).

Storage of CABASER in a place

CAABER Keepwhere children cannot see, reach, and pack. Use in accordance with the

expiry date Do not use CABASER after the expiration date in the packaging.

Do not remove the material contained in the bottle cap and which has a moisture absorbing feature.