CABERGOLINA 0.5 MG Tablet

Зміст інструкції

1. CABERGOLINA DOC 0,5 mg tablets
   1. What is CABERGOLINA DOC and what it is used for
   2. What you need to know before taking CABERGOLINA DOC
   3. How to take CABERGOLINA DOC
   4. Possible side effects
   5. How to store CABERGOLINA DOC
   6. Contents of the pack and other information

CABERGOLINA DOC 0,5 mg tablets

Equivalent medicine

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is CABERGOLINA DOC and what it is used for

CABERGOLINA DOC contains cabergoline which belongs to a group of medicines called prolactin inhibitors.
Prolactin is a hormone that is formed in the pituitary gland of the brain. CABERGOLINA DOC decreases the
levels of the hormone prolactin.
CABERGOLINA DOC is used:

• to stop/inhibit breastfeeding (milk production) for medical reasons.
• to treat hormonal disorders due to high levels of prolactin, such as absent or irregular menstrual cycles, infertility or milk flow not associated with childbirth.
• to treat high levels of prolactin due to a tumor in the pituitary gland.

2. What you need to know before taking CABERGOLINA DOC

Do not take CABERGOLINA DOC

• if you are allergic to cabergoline, to other medicines called ergot alkaloids (for example pergolide, bromocriptine, lisuride, ergotamine or ergometrine) or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a severe liver disease.
• If you have high blood pressure during pregnancy associated with swelling and protein in the urine (pregnancy toxaemia).
• If you are being treated with antipsychotics or have a history of mental illness associated with childbirth (postpartum psychosis).
• If you are pregnant or breastfeeding.
• If you are to be treated for a long period with CABERGOLINA DOC and have or have had fibrotic reactions (scar tissue) affecting the heart valves.
• If you have suffered in the past from fibrotic reactions (scar tissue) at the level of the heart, lungs or abdomen.

Warnings and precautions
Consult your doctor or pharmacist before taking CABERGOLINA DOC if you suffer or have suffered from one of the
following conditions:

• Disease involving the heart and blood vessels (cardiovascular disease).
• Cold hands and feet (Raynaud's syndrome).
• Stabbing pain in the abdomen when hungry (peptic ulcer) or bleeding from the stomach and intestines (gastrointestinal bleeding).
• History of severe mental disorders, especially psychotic disorders.
• Problems with the liver or kidneys.
• Fibrotic reactions (scar tissue) at the level of the heart, lungs or abdomen. If you need to be treated with CABERGOLINA DOC for a long period of time, your doctor will check that your heart, lungs and kidneys are in good condition before starting treatment. He/she will also perform an echocardiogram (an ultrasound test of the heart) before starting therapy and at regular intervals during treatment. If fibrotic reactions occur, treatment must be stopped.
• Low blood pressure (postural hypotension) or if you are taking medicines to lower blood pressure.

If you have recently given birth, you may be at increased risk of developing certain conditions. These may include
high blood pressure, heart attack, seizures, stroke or mental health problems. Therefore, your doctor will need to
regularly check your blood pressure during treatment. Contact your doctor immediately if you
develop high blood pressure, chest pain or unusually severe or persistent headache (with or without
visual disturbances).
Tell your doctor if you or someone in your family / or who cares for you notices that you are
developing impulses or desires to behave in ways that are unusual for you and you cannot resist the impulse,
urge or temptation to perform certain activities that could harm you or others. These
are called impulse control disorders and may include behaviors such as gambling addiction,
overeating or excessive spending, an abnormal, exaggerated sexual desire or an increase
in sexual thoughts or sensations. Your doctor may need to adjust or stop the dose.
Pregnancy may occur before your menstrual cycle has regularized.
Therefore, a pregnancy test is recommended at least every 4 weeks until menstruation resumes,
then whenever your menstrual cycle is delayed by more than 3 days.
Therefore, adequate methods of contraception should be used during treatment with CABERGOLINA
DOC and for at least one month after stopping treatment (see section “Pregnancy and
breastfeeding”).
It is recommended that women undergoing long-term treatment with CABERGOLINA DOC for hormonal disorders,
undergo regular gynecological examinations, including Pap tests. The doctor will continue to monitor your
conditions while taking CABERGOLINA DOC tablets.

Children and adolescents
The safety and efficacy of CABERGOLINA DOC in children and adolescents under the age of 16 years
have not been established.

Other medicines and CABERGOLINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines.
Some medicines may reduce the effectiveness of cabergoline, including:

• Medicines to lower blood pressure.
• Medicines used to treat mental illness (e.g. phenothiazines, butyrophenones or thioxanthenes).
• Medicines for nausea and vomiting (e.g. metoclopramide).

Some medicines may increase the side effects of cabergoline, including:

• Medicines used in the treatment of Parkinson's disease or severe headaches such as migraines, called ergot alkaloids, such as ergotamine or dihydroergotamine, ergometrine or methysergide
• Antibiotics (e.g. Erythromycin)

CABERGOLINA DOC with food and drink
See section 3 for details.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It is also advisable to avoid pregnancy for at least one month after stopping this
medicine. Use of CABERGOLINA DOC during pregnancy may cause congenital abnormalities.
Breastfeeding
Because CABERGOLINA DOC will stop milk production for your baby, you should not take
this medicine if you intend to breastfeed. If you need to take CABERGOLINA DOC you should use an
alternative method to feed your baby.

Driving and using machines
Because CABERGOLINA DOC can cause drowsiness and sudden onset of sleep, it is advisable not to
drive vehicles, use machines or perform activities that require mental attention or coordination
during treatment with this medicine.

CABERGOLINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take CABERGOLINA DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
It is recommended to take CABERGOLINA DOC during or after meals to help reduce the feeling
of nausea or vomiting.

• To prevent/stop milk production:You must take 2 tablets (1 mg of CABERGOLINA DOC) in a single dose within 24 hours of delivery.
• To stop lactation once breastfeeding has started:You must take a single dose of 0.25 mg (half a tablet of CABERGOLINA DOC 0.5 mg) every 12 hours for two days.
• To reduce prolactin levels in other conditions:Initially, it is recommended to take 0.5 mg of CABERGOLINA DOC per week, divided into one or two doses (half a 0.5 mg tablet) over a week (for example, half a tablet on Monday and the other half on Thursday). Your doctor may increase the dose up to a maximum of 4.5 mg per week or until complete response to treatment.

You must not take more than 3 mg of CABERGOLINA DOC in one day.
When you start taking the tablet for the first time, it is advisable to change position slowly
when trying to sit, stand up or lie down, because this medicine can cause a drop in
blood pressure which may cause dizziness when changing position. It is also recommended to
avoid alcohol and other medicines that cause drowsiness as this may increase the risk of dizziness.
During treatment, your doctor may need to check your blood pressure, especially in the first
days of treatment. A gynecological assessment of the cells of the cervix or the
lining of the uterus may also be performed.

If you take more CABERGOLINA DOC than you should
If you take too many tablets of CABERGOLINA DOC, contact your doctor immediately or go to the
emergency room of the nearest hospital. Symptoms of overdose may include nausea, vomiting, gastrointestinal
disorders, low blood pressure when standing, confusion/psychosis or hallucinations.

If you forget to take CABERGOLINA DOC
If you forget to take a dose, take the next one as usual and inform your doctor if you
have difficulty remembering to take the tablets. Do not take a double dose to make up for a forgotten dose.

If you stop taking CABERGOLINA DOC
Your doctor will advise you how long to take CABERGOLINA DOC. You should not stop
treatment until your doctor tells you to.
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.

Tell your doctor immediately if you experience any of the following symptoms after taking this
medicine. These symptoms may be serious:

• Very common (may affect more than 1 in 10 people): heart valve disease and related disorders, e.g. inflammation (pericarditis) or fluid leakage into the sac around the heart (pericardial effusion). One or more of the following preliminary symptoms may occur: shortness of breath, wheezing, feeling of a racing heartbeat, feeling faint, chest pain, back pain, pelvic pain or swollen legs. These could be early signs of a condition called pulmonary fibrosis, which can affect the heart/heart valves or the back.
• Development of a widespread itchy rash, difficulty breathing with or without wheezing, feeling faint, unexplained swelling of the body or tongue or any other symptom that seems to come on quickly after taking this medicine and makes you feel unwell. These could be indicative of an allergic reaction.
• Inability to resist the impulse, urge or temptation to perform an action that could be harmful to you or others, which may include:
• A strong urge to gamble excessively despite serious personal or family consequences.
• Aggression and altered or increased sexual interest and behaviour that causes significant distress to you or others, for example increased libido.
• Excessive and uncontrollable shopping or spending.
• Uncontrolled eating (eating large amounts of food in a short space of time) or compulsive eating (eating more food than normal and more than is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviours; they will advise you on how to
manage or reduce the symptoms.
Other side effects that may occur are:
Very common (may affect more than 1 in 10 people):nausea, stomach pain, headache, dizziness or
vertigo, feeling weak or tired, inflammation of the stomach lining, muscle weakness.

Common (may affect up to 1 in 10 people):constipation, drop in blood pressure in the first 3-
4 days after childbirth, breast pain, depression, sleep disorders, low blood pressure (long-term
treatment), low blood pressure when standing up, hot flushes, vomiting, drowsiness, tingling in the
fingers or toes.

Uncommon (may affect up to 1 in 100 people):partial loss of vision in one or both
eyes, fainting, sensation of tingling or pins and needles (digital vasospasm or paraesthesia), awareness
of abnormal heartbeat (palpitations), reduction in the number of blood cells that carry oxygen
(reduced haemoglobin levels) in women whose menstrual cycle has stopped and then resumed, hair loss, intense itching, shortness of breath, leg cramps, nosebleeds, swelling due to fluid
accumulation in the tissues (oedema), rash, skin reactions, loss of consciousness, lung scarring
tissue, fluid in the lungs.

Rare (may affect up to 1 in 1,000 people):allergic skin reactions, fingers or toes that
become white or blue with a feeling of numbness after exposure to the cold.

Very rare (may affect up to 1 in 10,000 people):scarring tissue (fibrosis).

Not known (frequency cannot be estimated from available data):abnormalities in liver
function tests and blood tests, breathing problems with insufficient oxygen supply, increased levels of
certain enzymes in the blood, vision changes, breathing disorders, sudden sleep attacks, seeing or
hearing things that are not real (hallucinations), delusional ideas, psychotic disorders, allergic reaction, abnormalities in blood tests.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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 CABERGOLINA DOC

• Keep this medicine out of the sight and reach of children.
• Do not use the medicine after the expiry date stated on the packaging and on the bottle label after the wording Exp. The expiry date refers to the last day of the month.
• Use within 4 months of first opening.
• This medicine does not require any particular storage temperature.
• Store in the original package to protect the medicine from light.
• The bottle contains a desiccant (silica gel). Do not remove the desiccant sachet from the bottle or transfer the tablets to another container.

Do not dispose of any medicine in wastewater 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 CABERGOLINA DOC contains

• The active ingredient is cabergoline. Each tablet contains 0.5 mg of cabergoline.
• The other ingredients are: Microcrystalline cellulose (type 102), Sodium croscarmellose, Magnesium stearate and Citric acid.

Description of the appearance of CABERGOLINA DOC and contents of the pack
Tablet of colour from white to off-white, with a fracture line, oval, flat, with bevelled edges, imprinted with
the letter "c" and the number "05 separated by the fracture line and smooth on the other side.
The tablet can be divided into equal doses.
The tablets are contained in an amber-coloured HDPE bottle with a child-resistant polypropylene cap
and desiccant (silica gel).
Each bottle contains 2 or 8 tablets and is contained in an outer cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
DOC Generici Srl -Via Turati 40, 20121 Milano -Italy

Manufacturer:
Pharmadox Healthcare Ltd. -KW20A Kordin Industrial Park -Paola PLA 3000 – Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Malta: Cabergoline DOC
Italy: CABERGOLINA DOC