Dostix 0.5

Dostix 0.5

Dostix® contains the active ingredient cabergoline, which belongs to a class of
  medicines called 'dopamine agonists'.

It has a lowering effect on the level of   prolactin in the blood.
  Prolactin is a hormone secreted by the pituitary gland located in the brain. During
  pregnancy, it stimulates milk formation. In non-pregnant women, it is secreted in
  small quantities. 
  Excess prolactin production, referred to as hyperprolactinemia, in women who are
  not pregnant can result in breast discharge, irregular or absent periods, infrequent or 
  lack of ovulation, and sometimes headaches and visual symptoms. Women with 
  hyperprolactinemia also can have problems conceiving. Causes for excess prolactin
  levels include pituitary tumors (adenomas), hypothyroidism (underactive thyroid).

* Each film-coated tablet of Dostix® contains: 
   Cabergoline                   0.5 mg
   Cabergoline    1 mg
   Cabergoline    2 mg

Do not use Dostix® 
• 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. 
• If you have severe liver disease. 
• If you have high blood pressure in pregnancy associated with swelling and protein
  in the urine (toxaemia of pregnancy). 
• If you are being treated with anti-psychotics or have a history of mental illness
  associated with child-birth (puerperal psychosis). 
• If you are pregnant or breast-feeding. 
• If you will be treated with Dostix® for a long period and have stiff and inflamed
  heart valves (cardiac valvopathy). 
• If you have had fibrotic reactions (scar tissue) affecting your abdomen, heart or

  Tell your doctor or pharmacist if you are taking, have recently taken or might take
  any other medicines, including medicines obtained without a prescription. Some
  medicines can reduce the effectiveness of  Dostix® , these include: 
• Medicines used to treat mental illness (e.g. antipsychotic medicines like
  chlorpromazine, haloperidol). 
• Medicines for nausea and vomiting (e.g. domperidone, metoclopramide). 
  Some medicines can increase the amount of Cabergoline in your blood and so could
  increase the side effects, these include: 
• Medicines for Parkinson’s disease. 
• Medicines for severe migraine headaches (e.g. pergolide, bromocriptine, lisuride,
  ergotamine, dihydroergotamine, ergometrine or methysergide). 
• Antibiotics (e.g. erythromycin).

Use in specific populations:
Pregnancy and breastfeeding 
  If you are pregnant, think you may be pregnant or are planning to have a baby, ask
  your doctor or pharmacist for advice before taking this medicine. You should also
  take care not to become pregnant for at least one month once you have stopped
  taking this medicine. If you become pregnant during treatment with Dostix® , stop
  taking Dostix® and inform your doctor who will then monitor your pregnancy as
  Dostix® can result in congenital abnormalities if you use it during pregnancy.  
  As Dostix® will stop you producing milk for your baby, you should not take this
  medicine if you plan to breast-feed. If you need to take Dostix® you should use
  another method of feeding your baby.

Like all medicines, Dostix® 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 can be severe: 
• Abnormal or unusual thoughts. 
• Heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in
  the pericardium (pericardial effusion). This is a very common side effect (may affect 
  more than 1 in 10 people). The early symptoms may be one or more of the following:
  difficulty breathing, shortness of breath, pounding heart, feeling faint, chest pain, back
  pain, pelvic pain or swollen legs. These may be the first signs of a condition called 
  pulmonary fibrosis, which can affect the lungs, heart/heart valves or lower 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
  symptoms which appear to come on rapidly after taking this medication and make you
  feel unwell. These may be indicative of an allergic reaction.
  You may experience the following side effects: 
• Inability to resist the impulse, drive or temptation to perform an action that could be
   harmful to you or others, which may include: 
• Strong impulse to gamble excessively despite serious personal or family
• Aggression and altered or increased sexual interest and behavior of significant concern
  to you or to others, for example, an increased sexual drive. 
• Uncontrollable excessive shopping or spending. 
• Binge eating (eating large amounts of food in a short time period) or compulsive eating 
  (eating more food than normal and more than is needed to satisfy your hunger). 
  Tell your doctor if you experience any of these behaviors; they will discuss ways of
  managing or reducing the symptoms. 
  During treatment you may also notice the following effects: 
• Very common: may affect more than 1 in 10 people: drowsiness, nausea, headache, 
  dizziness, vertigo, stomach pain, indigestion, inflamed stomach lining, fatigue, lack of 
  bodily strength, weakness. 
• Common: may affect up to 1 in 10 people: constipation, blurred vision, low blood
  pressure after childbirth which may not have any symptoms, breast pain, depression, 
  sleep disturbances, excessive daytime drowsiness/sleepiness, vomiting, low blood
  pressure, hot flushes. 
• Uncommon: may affect up to 1 in 100 people: loss of hair, severe itching, 
  hypersensitivity reaction, shortness of breath, fainting, nosebleed, leg cramps, 
  swelling due to accumulation of fluid in the tissues (oedema), rash, irregular or strong
  heartbeat (palpitations), pins and needles sensation, decrease in hemoglobin in women
  whose periods had stopped and then re-started, temporary partial vision loss, cold 
  hands and feet. 
• Rare: may affect up to 1 in 1000 people: pain in the stomach.
   this include any possible side effects not listed in this leaflet. you can report side effect
  directly via the: http\\\adrs.pdf,
  and send to us on:

  Talk to your doctor or pharmacist before taking Dostix® if you have or had any of the
  following conditions: 
• Disease that involves the heart and blood vessels (cardiovascular disease). 
• Cold hands and feet (Raynaud’s syndrome). 
• Gnawing pain in the abdomen when hungry (peptic ulcer) or bleeding from the
   stomach and intestines (gastrointestinal bleeding). 
• History of serious mental disease, particularly psychotic disorders. 
• Reduced liver function. 
• Kidney function abnormality or kidney disease. 
• Increased blood pressure after giving birth. 
• Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you
  are treated with Dostix® for a long period, your physician will check before starting
  treatment whether your heart, lungs and kidneys are in good condition. They will also
  have an echocardiogram (an ultrasound test of the heart) taken before treatment is
  started and at regular intervals during treatment. If fibrotic reactions occur treatment
  will have to be discontinued. 
• Low blood pressure (postural hypotension) or you are taking any medicines to lower
  your blood pressure.

Driving and using machines 
  Dostix® can cause drowsiness (somnolence) and sudden sleepy episodes, in some
  cases without any warning signs or awareness. You are advised not to drive or
  operate machines or engage in activities requiring mental alertness or coordination
  during treatment with this medicine. Your doctor will decide if you can continue
  treatment on Dostix®  if this occurs

Dostix® 0.5 Tablets (Blister of 2 Tablets, Pack of one blister).
- Dostix® 1 Tablets (Blister of 2 Tablets, Pack of one blister).
- Dostix® 2 Tablets (Blister of 2 Tablets, Pack of one blister).

- Store in a dry place at a temperature not exceeding 25 ºC.
- Keep the container tightly closed. Do not use Dostix® if you notice any deterioration
  or damage to the outer packaging.