Dostinex 0.5 Mg 8 Tablets ingredient Cabergoline

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INSTRUCTIONS FOR USE

DOSTINEX 0.5 mg tablet is taken orally.

Active ingredient

Each tablet contains 0.5 mg of cabergoline.

Read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is DOSTINEX and what is it used for?

2. Considerations before using DOSTINEX

3. How to use DOSTINEX?

4. What are the possible side effects?

5. DOSTINEX storage

headers are included.

2. What isDOSTINEX and what is it used for?

DOSTINEX is an oral tablet containing cabergoline. Amber colored glass bottles are packed. There is silica gel in the lid. Packing size is 2 and 8 notched tablets.

DOSTINEX can also be used in the treatment of other disorders caused by hormonal disorder, which may result in high levels of prolactin production. This includes high levels of prolactin in men and women caused by tumors in the pituitary gland.

DOSTINEX belongs to a class of drugs called dopamine agonists. Dopamine is naturally produced in the body and helps to deliver messages to the brain.

Cabergoline mimics the effect of dopamine to reduce prolactin production in the blood. Prolactin is the hormone that stimulates milk production in the breast.

DOSTINEX should only be used in adults. Not suitable for children under 16 years of age.

3. How to useDOSTINEX?

Instructions for proper use and instructions for dose / frequency of administration

:

• To reduce prolactin levels: You should take a 0.5 mg tablet (spread in two doses at the beginning) to spread over a week (for example, half of a tablet on Monday and the other half on Thursday) ). Your dose will be increased to a maximum dose of 3 mg or until fully responding to treatment.

The maximum dose should not exceed 3 mg / day.

When you first start taking the tablet, it is recommended that you change your position slowly while sitting, standing or reaching out; this is because DOSTINEX can lower your blood pressure, causing your head to turn when you change positions. It is also recommended that you avoid alcohol and other medications that cause drowsiness, as this may increase the risk of dizziness.

During treatment, especially in the first few days of treatment, your doctor may need to check your blood pressure. Gynecological evaluation of the cells in your cervix or uterine wall may also be necessary.

The route and method of

administration are taken orally.

It is recommended that you take DOSTINEX with or without food to help reduce nausea or vomiting.

Different age groups:

Use in children The

safety and efficacy of DOSTINEX in patients younger than 16 years have not been established.

Age

Elderly use

DOSTINEX has not been investigated in elderly patients; however, no significant risk was detected in experiments with cabergoline in a different population of elderly patients. DOSTINEX has not been formally reviewed in elderly patients with hyperprolactinemic disorders.

Specific conditions of use

Liver failure:

If you have severe liver failure, your doctor will be using DOSTINEX at lower doses.

If you have an impression that the effect of DOSTINEX is too strong or weak, talk to your doctor or pharmacist.

If you use more DOSTINEX than you should use

If you have received too many DOSTINEX tablets, contact your doctor immediately or contact the nearest hospital's emergency department.

If you have used more than you should use DOSTINEX, talk to a doctor or pharmacist.

If you have forgotten to use DOSTINEX, it

is important to remember to take your dose. If you forget to take a dose, take the next dose normally and tell your doctor if you have trouble remembering to take your tablets.

Do not take double doses to compensate for forgotten doses. Effects that may occur when treatment with DOSTINEX is terminated:

Your doctor will tell you how long you should use DOSTINEX. You should not leave the drug without telling your doctor.

If you have further questions about how to take this medicine, ask your doctor or pharmacist.

4. What are the possible side effects?

As with all medicines, there may be side effects in subjects who are sensitive to substances found in the content of DOSTINEX.

Side effects may occur in people who are sensitive to substances found.

If you experience any of the following symptoms after taking this medicine, tell your doctor immediately. These symptoms may be severe:

• Abnormal or unusual considerations.

• Heart valve and related disorders, e.g. fluid leakage in the pericardium (pericardial effusion) or inflammation (pericarditis). This is a very common side effect (more than 1 out of 10 patients). Early symptoms may be one or more of the following: difficulty breathing, shortness of breath, heart palpitations, feeling of fainting, chest pain, back pain, pelvic pain or swelling of the legs. These; They may be the first signs of fibrosis, which may affect the lungs, heart / heart valves or the lower back of the back.

• Common pruritus, difficulty in wheezing or wheezing, fainting sensation, unexplained swelling in the body or tongue, or the development of other symptoms that appear immediately after taking this medicine and make you feel unwell. They may be indicative of an allergic reaction.

• Strong desire to gamble despite serious personal or family consequences.

• Increased sexual desire for the individual or for others to be a major problem.

You may also notice the following effects during treatment: Very common (seen in more than 1 out of 10 patients):

• Drowsiness

• Nausea

Common (seen in less than 1 in 10 patients):

• Constipation

• Blurred vision

• Lower blood pressure after birth

• Headache

• Dizziness of vertigo due to vertigo (vertigo)

• Fainting

• Chest pain

• Depression

• Stomach pain

• Indigestion

• Gastrointestinal inflammation (gastritis)

Uncommon (seen in less than one in 100 patients):

• Cases of sudden onset of sleep

• During the day excessive sleepiness / drowsiness

• Hair loss

• Severe itching and rash

• Shortness of breath

• Swelling due to fluid accumulation in tissues

• Abnormal liver and liver function abnormal blood test results

• Incomplete oxygen intake related breathing problems

• Increase in some enzyme levels in the blood

Sparse (1000 less than 1 patient also seen):

• Vomiting

• Low blood pressure

• allergic skin reactions (rash, itching, etc.)

• Fatigue / muscle weakness are

• be aware of the Heartbeat

• nosebleeds

• Hot flashes

• Tingling

• in the hands and feet cold and leg cramps

2. Things to consider before using

DOSTINEX DO NOT use DOSTINEX in the following cases

:

• Cabergoline, other medicines called ergot alkaloids (eg. If you are hypersensitive (allergic) to pergolide, bromocriptine, lisuride, ergotamine or ergometrin) or any of the other components in the tablet.

• If you have severe liver disease.

• If you have high blood pressure associated with swelling in pregnancy and protein in your urine (pregnancy toxemia).

• If you are being treated with antipsychotics or if you have a history of mental illness (puerperal psychosis).

• If you are pregnant or breast-feeding.

• If you are going to be treated with DOSTINEX for a long time and if you have or have had fibrotic reactions (scar tissue) affecting your heart.

USE DOSTINEX CAREFULLY

,If you have a

•heart and blood vessel disease (cardiovascular disease).

• EI and foot cold (Raynaud syndrome).

• If you suffer from abdominal pain (peptic ulcer) or bleeding from the stomach and intestines (gastrointestinal bleeding).

• If you have a history of serious mental illness, especially mental disorder.

• If you have liver or kidney disease.

• If your kidney function is abnormal.

• If your blood pressure increases after birth.

• If you have fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen.

If you are treated with DOSTINEX for a long time, your physician will check that your heart, lungs and kidneys are in good condition before starting treatment. It will also require an echocardiogram (ultrasound test of the heart) to be taken at regular intervals before and during treatment. Treatment should be discontinued if fibrotic reactions occur.

For hormonal disorders, women receiving long-term treatment with DOSTINEX are recommended to undergo a regular gynecological examination including smear tests. Your doctor will continue to monitor your medical condition while you are taking DOSTINEX tablets.

If the daily treatment dose exceeds 3 mg, the risk of increased fibrous connective tissue (fibrosis) may increase between the cells.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using DOSTINEX with food and drink

To help reduce side effects, DOSTINEX should be taken with or without food. The effect of alcohol is unknown, so alcohol should be avoided.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

If you are pregnant or are planning to become pregnant, discuss this with your doctor before treatment.

Make sure you are not pregnant before using DOSTINEX. In addition, you should be careful not to get pregnant for at least one month after you stop taking DOSTINEX.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

DOSTINEX will not prevent you from producing milk for your baby. If you need to use DOSTINEX, you should use another method to feed your baby.

Use ofand machinery

toolsDOSTINEX may cause drowsiness or sudden sleep incidents without warning signs or awareness in some cases. It is recommended that you do not use vehicles or machinery during DOSTINEX treatment or do not participate in activities requiring mental alertness or coordination. In such a case, your doctor will decide whether your DOSTINEX treatment can continue.

Important information oncontained in

certain excipientsDOSTINEX contains DOSTINEX lactose. If you have been told by your doctor that you are intolerant of some sugars, contact your doctor before taking this medicinal product.

Other drugs i1e co-

medication Drugs that reduce the effectiveness of DOSTINEX include:

• Drugs that lower your blood pressure.

• Drugs used in the treatment of mental illness (eg antipsychotic drugs such as chlorpromazine, haloperidol).

• Drugs used for nausea and vomiting (eg domperidone, metoclopramide).

Drugs that increase the amount of DOSTINEX in your blood that can increase side effects include:

• Drugs for Parkinson's disease.

Drugs for severe migraine pain (eg pergolide, bromocriptine, lisuride, ergotamine, dihydroergotamine, ergometrin or methysergide).

• Antibiotics (eg erythromycin).

Storage of

DOSTINEX Keep DOSTINEX out of reach of children and in its packaging. Store at room temperature below 25 ° C. Use in accordance with the expiration date.