Bromocorn

Package leaflet: Information for the patient

Bromocorn
2.5 mg, tablets
Bromocriptine
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Bromocorn is and what it is used for

Bromocorn contains the active substance bromocriptine, which stimulates dopaminergic D receptors to release dopamine and increases dopamine concentration in the hypothalamus, thereby inhibiting prolactin secretion. By enhancing dopamine synthesis in the central nervous system, it improves neurotransmission. Additionally, it inhibits the secretion of somatotropin in the pituitary gland, which justifies its use in acromegaly. The effect of bromocriptine can be described as central (pituitary gland, hypothalamus) and peripheral (organs containing prolactin receptors and dopamine D receptors).

Therapeutic indications

• Parkinson's disease
• Acromegaly
• Prolactin-secreting adenomas (prolactinoma)
• Hyperprolactinaemia in men
• Suppression of lactation only for medical reasons and when deemed necessary by the doctor after consultation with the patient. Bromocriptine is not recommended for routine suppression of lactation. It should also not be used to reduce symptoms of painful breast engorgement after childbirth, which can be successfully treated by other methods (e.g. breast support, cold compresses) and (or) by administration of ordinary analgesics.
• Menstrual cycle disorders, female infertility

This medicine is intended for patients over 15 years of age.

2. Important information before using Bromocorn

When not to use Bromocorn

• if the patient is allergic to bromocriptine or any of the other ingredients of this medicine (listed in section 6) or to other ergot alkaloids,
• if the patient has uncontrolled hypertension, arterial hypertension during pregnancy (eclampsia, pre-eclampsia or hypertension due to pregnancy), arterial hypertension in women after childbirth and in the postpartum period,
• if the patient is to receive long-term treatment with Bromocorn and has current or past history of fibrotic reactions (scarring) of the heart muscle,
• if the patient has a history of coronary heart disease and other severe cardiovascular disorders or symptoms of psychiatric disorders or severe psychiatric disorders in their medical history.

In postpartum women, there is a risk of certain symptoms occurring. These are very rare and may include: arterial hypertension, myocardial infarction, seizures, stroke or psychiatric disorders. For this reason, the physician should monitor the patient's blood pressure, especially at the beginning of treatment. Immediate medical advice must be sought if the patient develops arterial hypertension, chest pain or severe, persistent headache (with or without visual disturbances).

Patients receiving this medicine for inhibition of lactation or in life-threatening conditions, or being treated with Bromocorn due to pituitary macroadenoma, should only use it when the expected benefits outweigh the potential risks.

Warnings and precautions

Before starting treatment with Bromocorn, discuss this with your doctor.

Seek immediate medical advice if:

• gastrointestinal bleeding or gastric ulcers occur,
• drowsiness or episodes of sudden sleep occur,
• if breathing becomes shallow or breathing difficulties occur,
• if the patient experiences sudden chest pain,
• if back pain, swelling of the lower limbs or kidney function disturbances occur,
• if severe headache and (or) transient visual disturbances (e.g. blurred vision) occur in postpartum women,
• unexpected nasal discharge in patients with prolactin-secreting pituitary adenoma.

Particular caution is required if the patient has current or past history of fibrotic reactions (scarring) of the heart muscle, lungs or abdominal organs. In patients receiving long-term treatment with Bromocorn, the physician will check heart, lung and kidney function before starting treatment. An echocardiographic examination (ultrasound of the heart) will also be performed before treatment initiation. During treatment, the physician will pay special attention to any signs potentially related to fibrotic reactions. If necessary, echocardiographic examination will be repeated. If fibrotic reactions occur, treatment will be discontinued.

Inform the doctor if the patient or their family members notice unusual behaviors resulting from an irresistible impulse, compulsion, or compulsive performance of certain actions harmful to the patient or others. These behaviors are called impulse control disorders and may include gambling addiction, compulsive or binge eating, increased sexual drive or intense sexual thoughts and feelings. The physician may decide to adjust or discontinue treatment.

Treatment with Bromocorn may restore fertility. Therefore, women of childbearing age who do not wish to become pregnant should use an effective method of contraception.

Special caution is required in patients recently or currently treated with drugs affecting blood pressure, e.g. vasoconstrictors such as sympathomimetics or ergot alkaloids together with ergometrine and methylergometrine. Concomitant administration of these drugs with Bromocorn in the postpartum period is not recommended.

Consult your doctor even if the above warnings relate to conditions that occurred in the past.

Children and adolescents

The medicine is not intended for use in children and adolescents under 15 years of age and therefore should not be used in this age group.

Bromocorn with other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

∙ Caution is advised when co-administering strong inhibitors and (or) substrates of the CYP3A4 enzyme (azole antifungal agents, HIV protease inhibitors).

∙ Concomitant use of macrolide antibiotics such as erythromycin or josamycin has been shown to increase plasma concentration of bromocriptine.

∙ Simultaneous administration of bromocriptine and octreotide in patients with acromegaly has resulted in increased plasma concentration of bromocriptine.

∙ Since the therapeutic effect of Bromocorn depends on stimulation of central dopamine receptors, its effect may be reduced by administration of dopamine antagonists such as antipsychotics (phenothiazines, butyrophenones and thioxanthenes), as well as metoclopramide and domperidone.

Bromocorn with food, drink and alcohol

For instructions on taking the medicine with food, see section 3.

Do not drink alcohol while taking Bromocorn, as it may worsen the medicine's side effects.

Pregnancy, breastfeeding and effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine. The doctor will decide whether to start, continue or discontinue treatment if there are appropriate indications.

No increased frequency of miscarriages has been observed after discontinuation of Bromocorn. Numerous observations indicate that Bromocorn used during pregnancy does not negatively affect its course or outcome. Patients with pituitary adenomas who become pregnant and in whom treatment with Bromocorn has been discontinued should be monitored throughout pregnancy. In patients with clear symptoms of prolactinoma enlargement, such as headaches or reduced visual fields, the physician may consider resuming Bromocorn treatment or consider surgical treatment.

This medicine should not be used during breastfeeding because it inhibits lactation.

Driving and using machines

Especially during the first days of treatment, hypotension may occur, leading to impaired concentration (episodes of sudden drowsiness or daytime sleep), therefore particular caution is required when driving and operating machinery.

Bromocorn contains lactose

One tablet contains 175.64 mg of lactose (equivalent to 184.88 mg of monohydrate lactose). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

Bromocorn contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Bromocorn

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
The medicine should be taken during a meal.
The medicine is usually used as described below.
Adults
Parkinson's disease
To ensure optimal tolerance, treatment should be initiated at a dose of 1.25 mg (half a tablet) per
day, preferably administered in the evening, during the first week. The dose should be increased
slowly in order to determine, in each case, the minimum effective dose. The dose should be
increased gradually by 1.25 mg per day each week. The daily dose should be divided into 2 to 3
doses.
The expected therapeutic effect may be achieved within 6 to 8 weeks. If this does not occur, the dose
may be further increased by 2.5 mg per day each week.
The usual dose range used in monotherapy or combination therapy is 10 to 30 mg of bromocriptine
per day.
If adverse reactions occur during dose escalation, the daily dose should be reduced and maintained
at the reduced level for at least one week. After the adverse reactions subside, the dose may be
gradually increased again.
In patients treated with levodopa who experience motor disturbances, it is recommended to reduce
the levodopa dose before starting Bromocorn. After achieving a satisfactory response to Bromocorn,
the levodopa dose may be further gradually reduced. In some patients, levodopa administration may
be completely discontinued.
Acromegaly
Initially 1.25 mg (half a tablet) 2 to 3 times per day, with gradual dose increase up to 10–20 mg per day,
depending on clinical response and adverse effects.
Prolactinoma
1.25 mg (half a tablet) 2 to 3 times per day, with gradual dose increase up to several tablets per day,
to maintain adequate reduction of serum prolactin levels.
Hyperprolactinemia in men
1.25 mg (half a tablet) 2 to 3 times per day, with gradual dose increase up to 5–10 mg per day.
Menstrual cycle disorders, female infertility
1.25 mg (half a tablet) 2 to 3 times per day. If this dose proves ineffective, it should be gradually
increased to 2.5 mg 2 to 3 times per day. Treatment should be continued until normal menstrual cycle
and (or) ovulation is restored. If necessary, treatment may be continued for several cycles to prevent
disease recurrence.
Suppression of lactation exclusively for medical reasons and only if the physician, after consultation
with the patient, determines such necessity.
One tablet per day on the first day, 1 or 2 tablets per day on the second day, from the third day onward
1 tablet twice daily for 14 days. Gradual initiation of treatment is not required for this indication.
Patients with renal or hepatic impairment
In patients with impaired liver and (or) kidney function, the elimination rate of bromocriptine may be
reduced and plasma drug concentration may increase; in such cases, the physician may recommend
a reduced dose.
Elderly patients
Clinical experience, including adverse reaction reports collected after marketing authorization of
bromocriptine, does not indicate differences in product tolerance between elderly patients and
younger patients. However, dose selection for elderly patients should be cautious. Due to the higher
prevalence in this patient group of reduced liver, kidney, or heart function, presence of concomitant
diseases, or use of other medications, treatment should be initiated at a lower dose.
If you feel that the effect of Bromocorn is too strong or too weak, consult your doctor.
Use in children and adolescents
Bromocorn should not be used in children and adolescents under 15 years of age.
Use of a higher than recommended dose of Bromocorn
If a higher than recommended dose is taken, seek medical advice immediately.
Symptoms of overdose: vomiting, nausea, dizziness, hypotension, orthostatic hypotension, tachycardia,
hallucinations, lethargy, somnolence.
In children who accidentally ingested bromocriptine, the following adverse reactions have been
reported: vomiting, somnolence, and fever.
Missed dose of Bromocorn
Do not take a double dose to make up for a missed dose.
Discontinuation of Bromocorn
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Common adverse effects (occur in 1 to 10 out of 100 patients): headache, drowsiness, dizziness, nasal mucosa congestion, nausea, constipation, vomiting.
Uncommon adverse effects (occur in 1 to 10 out of 1,000 patients): disorientation, psychomotor agitation, hallucinations, involuntary movements, hypotension, orthostatic hypotension, orthostatic hypotonia (very rarely leading to fainting), dry mouth, allergic skin reactions, hair loss, leg cramps, feeling of fatigue.
Rare adverse effects (occur in 1 to 10 out of 10,000 treated patients): psychotic disorders, insomnia, somnolence, unusual sensory sensations, visual disturbances, blurred vision, tinnitus, tachycardia, bradycardia, cardiac arrhythmias, pleural effusion, pleural fibrosis, pleuritis, pulmonary fibrosis, dyspnea, diarrhea, abdominal pain, peritoneal fibrosis, gastrointestinal bleeding, peripheral edema.
Very rare adverse effects (occur less frequently than in 1 out of 10,000 treated patients): increased libido, heightened sexual activity, excessive daytime sleepiness, sudden sleep attacks, reversible pallor of fingers and toes triggered by cold (especially in patients with a history of Raynaud's disease), a syndrome resembling neuroleptic malignant syndrome following abrupt discontinuation of the product, cardiac valve disorders, and other related disorders such as pericarditis or fluid leakage into the pericardial sac (pericardial effusion).
One or more of the following early symptoms may occur: difficulty breathing, dyspnea, chest pain or back pain, swollen legs. If any of the above symptoms occur, a doctor should be notified immediately.
Additionally, other adverse effects may occur due to an inability to resist impulses, urges, or compulsions to perform actions that may be harmful to the patient or others, including:

• strong impulse to engage in uncontrolled gambling, despite serious personal or family consequences,
• altered or increased sexual interests and behaviors significant to the patient or others, e.g. activities related to heightened sexual drive,
• compulsive, uncontrolled spending or shopping,
• binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger). The doctor should be informed if the patient exhibits any of these behaviors, so that ways to manage or limit these symptoms can be discussed.

During the use of bromocriptine to suppress lactation in the postpartum period, rare cases of arterial hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders have been reported.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to collect more information on the safety of using the medicine.

5. How to store Bromocorn

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the specified month.
Store below 25°C.
Store in the original packaging in order to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Bromocorn contains

• The active substance is bromocriptine mesylate. One tablet contains 2.5 mg of bromocriptine (equivalent to 2.87 mg of bromocriptine mesilate).
• The excipients are: potato starch, sodium croscarmellose, monohydrate lactose, magnesium stearate, talc.

What Bromocorn looks like and contents of the pack
Bromocorn is an oral tablet.
Pack:
In a cardboard box there is 1 tablet container made of orange glass with a cap fitted with a cushion and a tamper-evident closure, containing 30 tablets.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz
For further information regarding this medicinal product, please contact the Marketing Authorisation Holder:
Farmaceutyczna Spółdzielnia Pracy Filofarm
ul. Pułaskiego 39, 85-619 Bydgoszcz
Tel.: (52) 342 67 88
Information for the blind and visually impaired: The package leaflet for Bromocorn is available in the Audio Leaflet system via the nationwide free telephone number 800 706 848.