2.5 mg tablets
Bromocriptine

What Provider is and what it is used for

The provider is used for the following conditions:

  • Parkinson’s disease. The provider has the same effect as the body’s substance dopamine. Dopamine deficiency causes, among other things, Parkinson’s disease (which manifests itself in tremors, tremors, and muscle stiffness).
  • Acromegaly. In patients with giant growth ( acromegaly ), Pravidel reduces, among other things, the secretion of growth hormone.
  • Treatment of irregular or missed periods, nipple secretion from the nipple, infertility, or decreased sexual desire (decreased libido ) caused by excessive prolactin levels. Provider inhibits the secretion of the hormone et prolactin, which i.a. is necessary for normal milk production in breastfeeding mothers or a normal sexual function in both men and women.
  • To prevent initiation of or to discontinue breastfeeding, for medical reasons. Breast milk production should only be stopped for medical reasons, and once you and your doctor have decided this is necessary. Pravidel should not be used routinely to interrupt milk production. It should also not be used to relieve the symptoms of painful breast swelling after childbirth if these can be treated with non-medical means (eg with a sturdy bra) and/or with painkillers.

What you need to know before taking Pravidel

Do not take Pravidel

  • if you are allergic to bromocriptine or any of the other ingredients of this medicine (listed in section 6) or too powdery mildew preparations (ie certain anti-migraine medicines, bleeding disorders, and uterine contractions)
  • if you have high blood pressure
  • if you have had problems with blood pressure during pregnancy or after childbirth, e.g. pregnancy cramps ( eclampsia ), preeclampsia ( preeclampsia ), high blood pressure due to pregnancy, high blood pressure after childbirth
  • if you have or have had severe mental disorders
  • if you have or have had severe cardiovascular disease
  • in high blood pressure during pregnancy
  • in high blood pressure after childbirth
  • if you will be treated with Pravidel for a long time and have or have had fibrotic reactions (scar tissue) in your heart.

Warnings and cautions

Talk to your doctor or pharmacist before taking Pravidel.

  • Before starting treatment with Pravidel in women with high blood prolactin levels, the cause must be investigated.
  • If you have a stomach ulcer or have had a stomach ulcer before, you should consult a doctor before starting treatment with Pravidel.
  • In isolated cases, Pravidel has been shown to have a blood pressure-lowering effect and it is, therefore, advisable to monitor blood pressure at regular intervals during the first weeks of treatment.
  • In rare cases, some patients may suddenly fall asleep without any previous feeling of fatigue. Therefore, be especially careful during activities where increased attention is required, such as driving a car or driving machines. If you experience sudden drowsiness or pronounced drowsiness, consult a doctor.
  • If you have or have had fibrotic reactions (scar tissue) in the heart, lungs, or abdomen. If you are being treated with Pravidel for a long time, your doctor will check that your heart, lungs, and kidneys are in good condition before starting treatment. Your doctor will also take an echocardiogram (an ultrasound examination of the heart) before starting treatment. During treatment, your doctor will pay particular attention to any signs that may be associated with fibrotic reactions. If necessary, your doctor will take an echocardiogram. If fibrotic reactions occur, treatment will be stopped.
  • 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 impaired impulse control and may 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.
  • If you do not want to get pregnant, you must use reliable contraception during treatment with Pravidel.
  • If you have just given birth, you may be more prone to certain conditions. These are very rare but can include high blood pressure, heart attack, seizures, strokes, or mental problems. Therefore, your doctor will need to check your blood pressure regularly during the first few days of treatment. Talk to your doctor immediately if you experience high blood pressure, chest pain, or unusually severe or persistent headaches (with or without vision problems).

Children

Not relevant.

Other medicines and Pravidel

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of the treatment can be affected if this medicine is taken at the same time as certain other medicines. The treating physician, therefore, needs to know about other concomitant medications. Combination with erythromycin may require dose adjustment. Pravidel should not be combined with neuroleptics.

Pravidel with food and drink

To alleviate any side effects, Pravidel should always be taken with a meal.

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

No adverse effects on the fetus have been demonstrated.

Bromocriptine passes into breast milk but is unlikely to affect breastfed infants. Breastfeeding mothers should be aware that the amount of milk may decrease.

However, consult a physician if you use Pravidel more than temporarily during breastfeeding.

If you are being treated with Pravidel for infertility then consult a doctor as soon as pregnancy is confirmed.

Driving and using machines

Pravidel may impair the ability to react. In rare cases, some patients may suddenly fall asleep without any previous feeling of fatigue. You should therefore avoid activities where heightened attention is required, so as not to expose yourself or others to the risk of serious injury or death, for example when using machines, until such recurring periods of sleep attacks have disappeared.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Pravidel contains lactose and sodium

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

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Pravidel

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 adjusts it individually for you.

If you take more Pravidel than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

If you forget to use Pravidel

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

If you stop taking Pravidel

Do not stop taking this medicine without a doctor’s advice.

Rare cases of the neuroleptic malignant syndrome (symptoms of fever, muscle stiffness, unconsciousness) have occurred with abrupt discontinuation of Pravidel treatment in Parkinson’s patients. If you stop taking Pravidel quickly, there is also a risk of withdrawal syndrome ( apathy, anxiety, depression, fatigue, sweating, pain, etc.).

If you need to stop taking Pravidel, your doctor will usually reduce your dose gradually.

Possible side effects

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

If troublesome side effects occur, such as severe headaches, a doctor should be consulted.

Common (may affect up to 1 in 10 people): Nausea.

Uncommon (may affect up to 1 in 100 people): Headache, hallucinations, drop in blood pressure with dizziness, especially during the first day of treatment, vomiting, involuntary or painful movements.

Rare (may affect up to 1 in 1,000 people): Irregular heartbeat, temporary paleness of the fingers and toes caused by cold. Restlessness, fatigue, and Parkinson’s patient’s muscle cramps, drowsiness, confusion, and involuntary movements are caused by mental tension and anxiety. Self-starvation (anorexia), dry mouth (careful oral hygiene is therefore important), constipation, diarrhea, and a metallic taste in the mouth. Connective tissue change in the lungs ( pulmonary fibrosis ). Calf cramps especially in Parkinson’s patients. Sore and swollen breasts, burning sensation in the eyes, double vision, allergic skin reactions, peripheral edema, skin redness, skin rash, eczema around the mouth, nasal congestion, hair loss, connective tissue change behind the peritoneum (retroperitoneal fibrosis ), pneumonia.

A few cases of gastrointestinal bleeding and worsening gastric ulcers have been reported. Reports of connective tissue changes (in the abdomen and lungs) have affected patients receiving doses higher than 30 mg Pravidel for a long time.

Isolated cases of serious side effects (high blood pressure, heart attack, epileptic seizures, strokes, mental disorders) have been reported in women treated to prevent initiation of or discontinue postpartum breastfeeding.

Rare cases of neuroleptic malignant syndrome have occurred with abrupt discontinuation of Pravidel treatment in Parkinson’s patients, see also section 3 “If you stop taking Pravidel”.

Sudden falling asleep with or without previous drowsiness ( somnolence ).

Very rare side effects (may affect up to 1 in 10,000 people): Heart valve changes and related injuries, such as pericarditis (pericarditis) or pericardial effusion (pericardial effusion).

The first symptoms 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 your doctor immediately.

No known frequency (can not be calculated from the available data): Temporary visual changes.
For withdrawal syndrome, see section 3 “If you stop taking Pravidel”.

You may experience the following side effects

  • 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 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.

How to store Pravidel

Store below 25 ° C. Store in the original package. Sensitive to light.

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

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

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.

Contents of the pack and other information

Content declaration

  • The active substance is: bromocriptine mesylate corresponding to bromocriptine 2.5 mg
  • The other ingredients are:
    lactose monohydrate 116 mg, anhydrous colloidal silica, maleic acid, disodium edetate, magnesium stearate, corn starch.

What the medicine looks like and the contents of the pack

7 mm Ø, white with break notch, marked with 2.5 mg on one side.

Blister (Aluminum / PVC / PVdC) containing 30 tablets.

Glass jar with hard plastic lid containing 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Manufacturer

Madaus GmbH

51101 Cologne, Germany

Muhammad Nadeem

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