0.5 mg tablets 

1. What Dostinex is and what it is used for

Dostinex stops the production of breast milk by reducing the levels of the breast milk stimulating hormone and prolactin. The drug is used when the formation of breast milk needs to be stopped for medical reasons. Dostinex can also be used to reduce abnormal levels of the hormone et prolactin in the blood.

Cabergoline contained in Dostinex may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Dostinex

Do not take Dostinex:

  • if you are allergic to cabergoline or other similar medicines (powdery mildew alkaloids) or any of the other ingredients of this medicine (listed in section 6)
  • if you have or have had some severe mental disorders
  • if you have had preeclampsia
  • if you have had high blood pressure after giving birth
  • if you have any liver damage
  • if you have been prescribed Dostinex for long-term treatment and have or have previously had fibrotic reactions (scar tissue) in your heart.

Warnings and cautions

Talk to your doctor or pharmacist before taking Dostinex:

  • if you have or have had fibrotic reactions (scar tissue) in the heart, lungs, or abdomen. If you are being treated with Dostinex for a long time, your doctor will check that your heart, lungs, and kidneys are in good condition before starting treatment. He/she will also take an echocardiogram (an ultrasound examination of the heart) before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment will be discontinued.
  • if you have or have had any of the following conditions: severe heart disease, stomach ulcer, kidney disease, or Raynaud’s disease.

Dostinex has in some cases been shown to have a blood pressure-lowering effect, especially in the next few days after treatment.

Tell your doctor if you or your family/caregiver notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called disturbed impulse control and can include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.

Other medicines and Dostinex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. The treatment effect can be affected if this medicine is taken at the same time as you are taking other medicines such as certain medicines for mental illness, certain antibiotics, and blood pressure-lowering medicines. The treating physician, therefore, needs to be aware of such concomitant medication.

Dostinex with food, drink, and alcohol

The tablets should be taken with a meal to reduce certain side effects such as nausea, vomiting, and abdominal pain.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is unknown how Dostinex affects the fetus or baby.

You should avoid becoming pregnant for at least one month after stopping treatment with Dostinex.

Infertility can be eliminated with Dostinex. It is therefore important to use contraception during treatment.

It is not known if Dostinex passes into breast milk. You should not breast-feed while you are being treated with Dostinex.

Driving and using machines

Dostinex may impair the reactivity of some people, which should be considered at times when increased attention is required, e.g. while driving and precision work. Dostinex can cause somnolence (pronounced drowsiness) and sudden drowsiness. The person affected by this should therefore not drive or participate in activities where reduced attention can lead to the risk of serious injury (eg when using machines).

You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dostinex contains lactose

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

3. How to use Dostinex

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by the doctor who adapts it individually for you.

If breastfeeding is to be stopped, 2 tablets are usually taken within 24 hours of delivery.

To stop the production of breast milk when you start breastfeeding, take half a tablet. This dose must not be exceeded.

At elevated levels of prolactin, initially take 1 tablet a week, but higher doses may then be needed.

If you take more Dostinex then you should

If you have ingested too much or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice. In case of overdose, symptoms such as nausea, vomiting, abdominal pain, drop in blood pressure, confusion/psychosis, or hallucinations may occur.

If you forget to take Dostinex

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

When breast milk production is stopped, about 14 out of 100 patients get some form of side effect. The most common are low blood pressure, dizziness and headaches. With elevated prolactin levels, side effects are more common because the tablets are taken for a longer period of time. About 70 out of 100 patients then get side effects, but these often disappear or subside after about 2 weeks.

Very common side effects (affects more than 1 user in 10):

Dizziness, headache, nausea, indigestion, abdominal pain, inflammation of the lining of the stomach, fatigue, weakness, heart valve impact, and related injuries, e.g. inflammation (pericarditis), accumulation of fluid in the pericardium (pericardial effusion).

Early symptoms of this may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain, and swollen legs. If you experience any of these symptoms, you must contact a doctor immediately.

Common side effects (affects more than 1 user in 100):

Somnolence (pronounced drowsiness), low blood pressure that can cause dizziness (especially when getting up), depression, vomiting, constipation, hot flashes, chest pain.

Uncommon side effects (affects 1 in 100 and 1 in 1000 users):

Vision changes, nosebleeds, difficulty breathing ( dyspnoea ), connective tissue formation in the lungs ( fibrosis ) which can cause symptoms such as shortness of breath, fluid accumulation around the lungs (pleural effusion), increased sexual desire, fainting, and crawling/tingling in the body, palpitations and cramps, convulsions. of chills on fingers and toes in combination with these becoming pale, swelling in the body including calves, feet, and fingers due to fluid retention, hair loss, rash, decreased levels of hemoglobin in women with no bleeding in the first months after menstruation.

Has been reported (occurs in unknown numbers of users): Allergic reactions, aggression, delusions, psychotic illness, changes in blood tests, hepatic dysfunction, respiratory failure, pleurisy, chest pain, angina, sudden sleep attack, tremors.

You can also experience the following side effects are

Inability to resist an impulse to perform an action that can be harmful such as:

  • A strong impulse to excessive gambling despite serious consequences for you personally or for your family.
  • Altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive.
  • Uncontrollable and excessive need to buy things and spend money.
  • Binge eating (eating large amounts of food in a short time) 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 to discuss ways to manage or reduce the symptoms.

5. How to store Dostinex

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton.

The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cabergoline.
  • The other ingredients are lactose 75.9 mg and leucine.

What the medicine looks like and the contents of the pack

Dostinex 0.5 mg tablets are available in the following pack sizes:

Glass jars containing 2 or 8 tablets.

Plastic jars contain 2 or 8 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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