Cabergoline Renata

Package leaflet: Information for the patient

Cabergoline Renata 0.5 mg tablets

cabergoline
Read this entire leaflet carefully before taking this medicine because 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Cabergolina Renata is and what it is used for

Cabergolina Renata contains cabergoline, which belongs to a group of medicines known as prolactin inhibitors. Prolactin is a hormone produced in the pituitary gland of the brain. Cabergoline reduces the levels of the hormone prolactin.

Cabergolina Renata is used to:

• stop/inhibit lactation (milk production) for medical reasons.
• treat hormonal disorders resulting from high levels of prolactin, such as absent or irregular menstrual cycles, infertility, or milk discharge unrelated to childbirth, in female patients.
• treat high levels of prolactin caused by a pituitary tumour.

Cabergoline should only be used in adults. It is not suitable for children and adolescents under 16 years of age.

Consult your doctor or pharmacist if you do not feel better or if you feel worse.

2. What you need to know before taking Cabergolina Renata

Do not take Cabergolina Renata if

• you are allergic to cabergoline, to other ergot alkaloids (e.g. bromocriptine), or to any of the other ingredients of this medicine (listed in section 6)
• you have (or have previously had) psychosis or are at risk of postpartum psychosis
• you have swelling of the hands and feet with high blood pressure during pregnancy (pre-eclampsia, eclampsia)
• you have uncontrolled high blood pressure or high blood pressure after childbirth
• you have previously been diagnosed with conditions involving fibrosis (scar tissue) affecting the lungs, the back of the abdomen, kidneys, or heart
• you are being treated with cabergoline long-term and have or have had fibrotic reactions (scar tissue) affecting the heart.

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

• Heart or blood vessel disease (cardiovascular disease).
• Cold hands and feet (Raynaud's syndrome).
• Sharp abdominal pain when hungry (peptic ulcer) or bleeding from the stomach or intestines (gastrointestinal haemorrhage).
• History of severe mental illness, particularly psychotic disorders.
• Liver or kidney problems.
• Fibrotic reactions (scar tissue) affecting the heart, lungs, or abdomen. If you are being treated with cabergoline long-term, your doctor will check before starting treatment whether your heart, lungs, and kidneys are in good condition. You will also undergo an echocardiogram (an ultrasound examination of the heart) before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment must be stopped.
• Low blood pressure (postural hypotension) or taking medicines to lower blood pressure.
• Severe chest problems (e.g., chest pain during breathing, fluid in the lungs, lung inflammation or infection).

If you have recently given birth, you may be at higher risk for 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 problems).
Inform your doctor if you or your family/caregiver notice that you are developing urges or desires 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, compulsive eating or spending, abnormally increased sex drive, or increased sexual thoughts or feelings.
Your doctor may need to adjust or stop your dose.
During treatment, your doctor may need to monitor your blood pressure, especially during the first few days of treatment. A gynaecological evaluation may also be performed on cells of the cervix or lining of the uterus.
Infertility may be corrected in women taking cabergoline, and pregnancy can occur before menstrual cycles return to normal. Therefore, a pregnancy test is recommended at least every 4 weeks until menstruation resumes, and thereafter whenever your menstrual period is more than 3 days late. Thus, during treatment and for at least one month after stopping cabergoline, effective contraceptive methods must be used (see section “Pregnancy, breastfeeding and fertility”).

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

Other medicines and Cabergolina Renata
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Some medicines may reduce the effectiveness of cabergoline, including:

• Medicines to lower blood pressure.
• Medicines used to treat mental illnesses (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 headaches known as ergot alkaloids, such as ergotamine or dihydroergotamine, ergometrine, or methysergide.
• Antibiotics (e.g. erythromycin).

Cabergolina Renata with food and drink
This medicine should be taken with food to reduce certain side effects. See section 3 for details.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Experience with the use of cabergoline during pregnancy is limited.
If you are planning a pregnancy, cabergoline should be discontinued at least one month before the expected pregnancy. Therefore, you should consult your doctor if you are pregnant or planning a pregnancy before starting treatment.
Before starting cabergoline, you must undergo a test to ensure you are not pregnant. In addition, you must take care not to become pregnant during treatment and for at least one month after stopping treatment. An effective non-hormonal contraceptive method must be used; discuss the choice of contraceptive method with your doctor.
If you are being treated with cabergoline and become pregnant during this time, you must stop treatment and contact your doctor as soon as possible.

Breastfeeding
It is not known whether cabergoline passes into breast milk. Since cabergoline will prevent you from producing milk for your baby, you must not take this medicine if you intend to breastfeed. If you need to take cabergoline, you must use an alternative method to feed your baby.
Cabergoline is used to suppress milk production (lactation) when this is considered essential.

Fertility
Infertility may be corrected and pregnancy may occur before menstrual cycles have normalized in women taking cabergoline (see section “Warnings and precautions”).

Driving and using machines
You must exercise caution when performing activities requiring rapid and accurate responses at the beginning of treatment.
Cabergoline may cause drowsiness (extreme sleepiness) and sudden onset of sleep. People affected by this should not drive or engage in activities where reduced alertness could pose a risk of serious harm (e.g. operating machinery) until these recurrent episodes and drowsiness have resolved. If affected, consult your doctor.

Cabergolina Renata contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Cabergoline Renata

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose will be determined by your doctor, who will adjust it for you on an individual basis.
The tablets should be taken orally with food to reduce certain side effects
such as nausea, vomiting and stomach pain.

• To prevent/inhibit the production of breast milk: You should take 2 tablets (1 mg of cabergoline) as a single dose within 24 hours after childbirth.
• To stop lactation once breastfeeding has already started: You should take 0.25 mg (half of a 0.5 mg tablet) every 12 hours for two days.
• To reduce prolactin levels in the body: Initially, you should take 0.5 mg of cabergoline per week, in one or two divided doses (half of a 0.5 mg tablet) taken at intervals over the week (e.g. half a tablet on Monday and the other half on Thursday). Your dose may be increased up to a maximum of 4.5 mg per week, or until you have fully responded to treatment.

The tablet may be divided into equal parts.
Do not take more than 3 mg of cabergoline in one day.
If you take more Cabergoline Renata than you should
If you take too many tablets, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include nausea, vomiting, gastrointestinal disorders, low blood pressure upon standing, confusion/psychosis or hallucinations.
If you forget to take Cabergoline Renata
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 the missed dose.
If you stop taking Cabergoline Renata
Your doctor will advise you how long to take cabergoline. Do not stop unless your doctor tells you to do so.
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 everybody gets them.
Immediately inform your doctor if you experience any of the following symptoms after taking this
medicine. These symptoms can be serious:

• Very common side effects (may affect more than 1 in 10 people): heart valve disorders and related problems, such as inflammation (pericarditis) or fluid leakage in the pericardium (pericardial effusion). Early symptoms may include one or more of the following: difficulty breathing, shortness of breath, sensation of rapid heartbeat, feeling faint, chest pain, back pain, pelvic pain, or leg swelling. These may be the first 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 may indicate an allergic reaction.

• Inability to resist the impulse, desire, or temptation to carry out an action that could be harmful to you or others, which may include:

  o Strong urge to gamble excessively despite serious personal or family consequences.
  o Aggressiveness and altered or increased sexual interest and behaviour causing significant concern to you or others, for example increased libido.
  o Uncontrollable excessive shopping or spending.
  o Eating uncontrollably (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 experience any of these behaviours; your doctor will discuss ways to manage or reduce the symptoms.
  Other possible side effects include:

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

• Common (may affect up to 1 in 10 people): constipation, a reduction 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, feeling unwell (vomiting), drowsiness, tingling in the fingers or toes.

• Uncommon (may affect up to 1 in 100 people): loss of half the vision in one or both eyes, fainting, a sensation of tingling or “pins and needles” (digital vasospasm or paresthesia), altered awareness of heartbeat (palpitations), reduced levels of the part of the blood that carries oxygen (haemoglobin) in women whose menstruation stopped and then restarted; 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 scar tissue, fluid in the lungs.

• Rare (may affect up to 1 in 1,000 people): allergic skin reactions, fingers of the hands or feet turning white or blue with a numb sensation after exposure to cold.

• Very rare (may affect up to 1 in 10,000 people): scar tissue formation (fibrosis).
  Not known (frequency cannot be estimated from the available data): liver-related changes and abnormal liver function blood tests, breathing problems with inadequate oxygen supply, increased levels of certain enzymes in the blood, vision changes, breathing disorders, sudden onset of sleep, seeing or hearing things that are not really there (hallucinations), delirium, psychotic disorder, allergic reaction, changes in blood tests.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website 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 Renata

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and on the label of the bottle after "Exp.". The expiry date refers to the last day of that month.
• Do not store above 25°C. Keep the bottle tightly closed to protect the medicine from moisture.
• Each bottle contains 2 silica gel desiccant pads weighing 1 g each. The silica gel desiccant pads must not be removed from the bottles after opening.

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. Package contents and other information

What Cabergoline Renata contains
The active substance is cabergoline 0.5 mg.
The other ingredients are anhydrous lactose, L-leucine and magnesium stearate.
Description of the appearance of Cabergoline Renata and contents of the pack
Cabergoline Renata tablets are white, oval-shaped, 7.5 × 4 mm in size. On one side they are embossed with a “c” on the left and a “1” on the right; the other side is smooth.
The tablets are contained in high-density polyethylene bottles with a child-resistant polypropylene cap and silica gel desiccant cushions inside.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Renata Pharmaceuticals (Ireland) Limited
12 Crowe Street, Dundalk, Co. Louth
Ireland
Manufacturer
Alterno Labs d.o.o.
Brnčičeva ulica 29, Ljubljana-Črnuče, 1231
Slovenia
This medicinal product is authorized in the European Economic Area Member States under the following names: