Cabergoline Doc Generici

Patient Information Leaflet: Information for the User

CABERGOLINE DOC 0.5 mg tablets

Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

CABERGOLINA DOC contains cabergoline, which belongs to a group of medicines called prolactin inhibitors. Prolactin is a hormone produced in the pituitary gland of the brain. CABERGOLINA DOC lowers the levels of the hormone prolactin.

CABERGOLINA DOC is used:

• to stop/inhibit breastfeeding (milk production) for medical reasons.
• to treat hormonal disorders caused by high levels of prolactin, such as absent or irregular menstrual cycles, infertility, or milk discharge not related to childbirth.
• to treat high levels of prolactin caused by a tumour 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 (e.g. pergolide, bromocriptine, lisuride, ergotamine or ergometrine) or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you have high blood pressure during pregnancy associated with swelling and protein in the urine (pregnancy toxemia).
• if you are being treated with antipsychotics or have a history of mental illness related to childbirth (postpartum psychosis).
• if you are pregnant or breastfeeding.
• if long-term treatment with CABERGOLINA DOC is required and you have or have had fibrotic reactions (scar tissue) affecting heart valves.
• if you have previously experienced fibrotic reactions (scar tissue) in the heart, lungs or abdomen.

Warnings and precautions
Talk to your doctor or pharmacist before taking CABERGOLINA DOC if you have or have had any of the following conditions:

• Disease affecting the heart and blood vessels (cardiovascular disease).
• Cold hands and feet (Raynaud's syndrome).
• Sharp abdominal pain when hungry (peptic ulcer) or bleeding from the stomach and intestines (gastrointestinal haemorrhage).
• History of serious mental disorders, particularly psychotic disorders.
• Liver or kidney problems.
• Fibrotic reactions (scar tissue) in the heart, lungs or abdomen. If long-term treatment with CABERGOLINA DOC is required, your doctor will check that your heart, lungs and kidneys are in good condition before starting treatment. An echocardiogram (an ultrasound test of the heart) will be performed before starting therapy and at regular intervals during treatment. If fibrotic reactions occur, treatment must be discontinued.
• 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 should regularly monitor 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 vision disturbances).
Inform your doctor if you or someone in your family or someone caring for you notices that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, drive or temptation to carry out certain activities that could harm you or others. These are called impulse control disorders and may include behaviours such as gambling addiction, excessive eating or spending, abnormally increased sexual desire or an increase in sexual thoughts or feelings. Your doctor may consider it necessary to adjust or discontinue your dose.
Pregnancy may occur before your menstrual cycle has returned to normal.
Therefore, a pregnancy test is recommended at least every 4 weeks until menstruation resumes, and then every time your menstrual period is delayed by more than 3 days.
Adequate contraceptive measures should therefore be used during treatment with CABERGOLINA DOC and for at least one month after stopping treatment (see section “Pregnancy and breastfeeding”).
Women undergoing long-term treatment with CABERGOLINA DOC for hormonal disorders are advised to have regular gynaecological examinations, including Pap smears. Your doctor will continue to monitor your condition while you are taking CABERGOLINA DOC tablets.

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

Other medicines and CABERGOLINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.
Some medicines may reduce the effectiveness of cabergoline, including:

• Medicines to lower blood pressure.
• Medicines used to treat psychiatric disorders (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 to treat Parkinson's disease or severe migraine-type headaches, known as 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 may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
It is also recommended that you avoid pregnancy for at least one month after stopping this medicine. The use of CABERGOLINA DOC during pregnancy may cause congenital abnormalities.

Breastfeeding
Since CABERGOLINA DOC will stop milk production for your baby, you must 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
Since CABERGOLINA DOC may cause drowsiness and sudden onset of sleep, you are advised not to drive, operate machinery or perform activities requiring mental alertness 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 exactly as directed by 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 breast milk production: You should take 2 tablets (1 mg of CABERGOLINA DOC) as a single dose within 24 hours after delivery.
• To stop lactation after breastfeeding has started: You should 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 tablet of 0.5 mg) over the course of 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 full therapeutic response is achieved.

Do not take more than 3 mg of CABERGOLINA DOC in one day.
When starting the tablet for the first time, it is advised to change positions slowly when sitting, standing up, or lying down, as this medicine may cause a drop in blood pressure that could lead to dizziness upon changing position. It is also recommended to avoid alcohol and other medicines that cause drowsiness, as they may increase the risk of dizziness.
During treatment, your doctor may need to monitor your blood pressure, especially during the first
days of treatment. A gynecological evaluation of cervical or endometrial cells may also be performed.
If you take more CABERGOLINA DOC than you should
If you take too many CABERGOLINA DOC tablets, contact your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose may include nausea, vomiting, gastric disturbances, low blood pressure in the upright position, confusion/psychosis, or hallucinations.
If you forget to take CABERGOLINA DOC
If you forget to take a dose, take the next dose as scheduled and inform your doctor if you have difficulty remembering to take the tablets. Do not take a double dose to make up for a missed dose.
If you stop taking CABERGOLINA DOC
Your doctor will advise you on how long to take CABERGOLINA DOC. Do not stop treatment unless instructed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Immediately inform your doctor 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, for example, inflammation (pericarditis) or leakage of fluid into the pericardium (pericardial effusion). One or more of the following preliminary symptoms may occur: shortness of breath, breathlessness, sensation of rapid or strong heartbeat, feeling faint, chest pain, back pain, pelvic pain, or swollen legs. These could be early signs of a condition called pulmonary fibrosis, which may affect the heart/heart valves or the back.
• Development of widespread itchy rash, difficulty breathing with or without wheezing, feeling faint, unexplained swelling of the body or tongue, or any other symptom that appears rapidly after taking this medicine and makes you feel unwell. These could indicate an allergic reaction.
• Inability to resist the impulse, urge, or temptation to carry out an action that could be harmful to yourself or others, which may include:
  • Strong urge to gamble excessively despite severe personal or family consequences.
  • Aggressiveness and altered or increased sexual interest and behaviour causing significant concern to you or others, for example, increased libido.
  • Excessive and uncontrollable shopping or spending.
  • Uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).

Inform your doctor if you notice any of these behaviours; he or she will advise you on how to manage or reduce the symptoms.

Other possible side effects include:

Very common (may affect more than 1 in 10): nausea, stomach ache, headache, dizziness or vertigo, inflammation of the stomach wall, muscle weakness, feeling weak or tired.

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

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

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

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

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

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 CABERGOLINE DOC

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and on the label of the bottle after the word "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 special storage temperature.
• Store in the original packaging to protect the medicine from light.
• The bottle contains a desiccant (silica gel). Do not remove the desiccant packet from the bottle, and do not transfer the tablets to another container.

Do not dispose of medicines via 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 substance is cabergoline. Each tablet contains 0.5 mg of cabergoline.
• The other components are: Microcrystalline cellulose (type 102), Croscarmellose sodium, Magnesium stearate and Citric acid.

Description of the appearance of CABERGOLINA DOC and pack contents
White to almost white tablet, oval, flat, with bevelled edges and a score line; marked with the letter "c" and the number "05" separated by the score line on one side, 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 a desiccant (silica gel).
Each bottle contains either 2 or 8 tablets and is placed in an outer cardboard box.
Not all pack sizes may be marketed.

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