Parlodel

Package leaflet: Information for the patient

PARLODEL 5 mg hard capsules, 10 mg hard capsules

Bromocriptine mesylate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PARLODEL is and what it is used for

PARLODEL contains bromocriptine, a substance used in the treatment in adults of Parkinson's disease
(idiopathic, arteriosclerotic, post-encephalitic), a disorder of the central nervous system which may
manifest, for example, with tremor, muscle rigidity, slowness of movement, and difficulty maintaining
balance.
PARLODEL is useful:

• in patients who no longer respond adequately to levodopa therapy (another medicine used to treat Parkinson's disease) or who experience "on-off" phenomena (periods of good mobility alternating with periods of motor block);
• as initial treatment or for mild cases, either alone or in combination with other medicines;
• for the treatment of disorders of the endocrine system, which produces substances called hormones.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking PARLODEL

Do not take PARLODEL

• if you are allergic to bromocriptine mesylate, to any other ergot alkaloid, or to any of the other ingredients of this medicine (listed in section 6);
• if you have uncontrolled high blood pressure;
• if you have had blood pressure problems during pregnancy or after childbirth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure, or postpartum high blood pressure;
• if you currently have or have previously had heart disease or other serious blood vessel disorders;
• if you currently have or have previously had serious mental health disorders;
• if you have a heart valve disorder (cardiac valvulopathy) and require long-term treatment with bromocriptine.

Warnings and precautions
Talk to your doctor or pharmacist before taking PARLODEL.
Pay special attention and consult your doctor before taking PARLODEL if:

• you suffer or have suffered from stomach lesions (peptic ulcer) or severe gastrointestinal bleeding, as your doctor may advise you to take a different medicine;
• you have liver problems (as your doctor will need to evaluate the most appropriate dosage for your case);
• you are a patient with Parkinson’s disease and have previously experienced psychotic disorders, cardiac dysfunction, gastric ulcer, or gastrointestinal bleeding.

You must inform your doctor immediately if you experience:

• gastrointestinal disorders—in this case, stop treatment;
• difficulty breathing (dyspnea), chest pain, or dry cough, as these may be symptoms of serious lung or heart problems (pleural or pericardial effusions, pleural or pulmonary fibrosis, or constrictive pericarditis);
• back pain and/or fluid accumulation in the lower limbs (edema) and kidney function abnormalities, as these may be symptoms of a rare condition characterized by the formation of fibrous and inflammatory tissue in the posterior abdominal wall (retroperitoneal fibrosis);
• visual disturbances.

Additionally, inform your doctor if you develop behavioral disorders related to impulse control (including gambling addiction, obsessive increase in sexual desire and thoughts, compulsive shopping or excessive spending, and eating disorders such as bulimia or uncontrollable urges to eat).
Before starting treatment with PARLODEL, inform a family member or caregiver to notify your doctor if they notice you developing unusual urges, desires, behaviors, or engaging in activities that could harm yourself or others.
In such cases, your doctor will consider reducing the dose or gradually discontinuing the treatment.
If you are a woman, before starting and during treatment with this medicine, your doctor will perform semi-annual or annual gynecological examinations and blood tests to monitor your hormone levels.
If you are being treated with bromocriptine, your doctor must first exclude the presence of a pituitary adenoma (a benign tumor of the pituitary gland), as pregnancy must be avoided in this case. If this condition is ruled out, treatment with bromocriptine should be discontinued as soon as possible after conception; your doctor will advise you on how to perform an early pregnancy test.
If you are an infertile woman being treated with bromocriptine for certain hormonal disorders such as galactorrhea, prolactin-dependent amenorrhea, menstrual disorders, or acromegaly, be aware that bromocriptine may restore fertility. In this case, if you do not wish to become pregnant, you should use a barrier contraceptive method (e.g., condom or diaphragm) or other non-hormonal methods to prevent pregnancy (see also “Pregnancy, breastfeeding, and fertility”).
If you have recently given birth, you may be at increased risk of developing certain conditions, including high blood pressure, headache (with or without visual disturbances), or mental health problems.
Inform your doctor or pharmacist if you have recently taken or are currently taking medicines that may affect blood pressure. Your doctor should regularly monitor your blood pressure values during the first days of treatment.
Speak immediately with your doctor if episodes of increased blood pressure, chest pain, or unusual and persistent headache with or without visual disturbances occur (see section 4 “Possible side effects”).

Other medicines and PARLODEL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• ergot alkaloids or antihypertensives (medicines that lower blood pressure);
• medicines that affect how the liver or intestine works, such as azole antifungals (medicines used to treat fungal skin infections) and medicines for the treatment of AIDS (HIV protease inhibitors);
• certain antibiotics used to treat bacterial infections (erythromycin and josamycin, or macrolide antibiotics);
• medicines that affect the nervous system, such as antipsychotics (phenothiazines, butyrophenones, and thioxanthenes) used to treat mental disorders;
• metoclopramide and domperidone (medicines for nausea and vomiting).

PARLODEL and alcohol
Avoid consuming alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Do not take this medicine during pregnancy or if you suspect you are pregnant, unless your doctor considers it necessary for you to continue taking it.
Your doctor will prescribe PARLODEL only if clearly needed.

Breastfeeding
Do not take this medicine if you are breastfeeding.

Fertility
If you start taking this medicine, you may regain fertility; therefore, if you do not intend to become pregnant, you should use an appropriate mechanical contraceptive method (such as condom or diaphragm).

Driving and using machines
PARLODEL may impair your ability to drive or operate machinery.
In particular, especially at the beginning of treatment, a drop in blood pressure with reduced alertness may occur.
Furthermore, if you experience episodes of drowsiness or sudden sleep attacks during treatment with this medicine, do not drive or operate machinery until these symptoms have resolved.

PARLODEL contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PARLODEL

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much to take
Starting dose: 2.5 mg twice daily.
Recommended dose: 10–20 mg per day.
Maximum recommended dose: 30 mg per day.
If you are also taking levodopa (another medicine for the treatment of Parkinson's disease), your doctor will
advise you on how to reduce the levodopa dose.
The duration of treatment will be determined by your doctor according to your health condition.
How to take PARLODEL
Capsules must always be taken with meals.
Use in children and adolescents
There is no indication for a specific use of PARLODEL in children and adolescents.
If you take more PARLODEL than you should
In case of accidental ingestion/overdose of PARLODEL, contact your doctor immediately or go to the nearest
hospital.
The symptoms you may experience are:

• nausea and vomiting
• dizziness
• decrease in blood pressure
• drop in blood pressure upon changing from sitting or lying position to standing
• increased heart rate
• stupor
• drowsiness
• deep sleep state with reduced response to normal stimuli
• perception of things that do not exist in reality

Treatment
Your doctor will provide appropriate supportive therapy (such as administration of activated charcoal,
metoclopramide, or gastric lavage), after evaluating your symptoms and their severity.
If you forget to take PARLODEL
Do not take a double dose to make up for the missed capsule.
If you stop taking PARLODEL
Do not stop taking this medicine abruptly, especially if you are taking high doses. If you intend to stop taking
the medicine, discuss this first with your doctor, who will advise you when and how to discontinue.
If you stop treatment with PARLODEL, you may develop a serious nervous system disorder (Neuroleptic
Malignant Syndrome) or drug withdrawal syndrome (see section “Possible side effects”).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediately contact your doctor if you experience any of the following side effects while being treated with PARLODEL, as the doctor will assess whether treatment should be discontinued:

• drowsiness
• sudden sleep
• gastrointestinal disorders: stomach damage (gastrointestinal ulcer)
• severe bleeding of the stomach and intestine (gastrointestinal haemorrhage)
• difficulty breathing (dyspnoea), chest pain, dry cough, as these may be symptoms of serious impairment of lung or heart function (pleural and pericardial effusions, pleural and pulmonary fibrosis, or constrictive pericarditis)
• back pain and swelling of the legs (peripheral oedema), as these may be symptoms of a rare condition characterised by the formation of inflammatory and fibrous tissue in the posterior abdominal wall (retroperitoneal fibrosis).

In particular, if you have given birth, contact your doctor immediately if you experience any of the following side effects, as treatment with this medicine will be discontinued:

• increased blood pressure
• severe headache with or without visual disturbances
• chest pain
• epileptic seizures.

The following side effects have been observed and reported during treatment with PARLODEL, with the frequencies indicated below:
Common (may affect up to 1 in 10 people)

• headache
• lethargy
• dizziness
• nasal congestion (nasal congestion)
• nausea, vomiting, constipation

Uncommon (may affect up to 1 in 100 people)

• confusion
• excessive repetitive motor activity (psychomotor agitation)
• perception of things not present in reality (hallucinations)
• movement difficulties (dyskinesia)
• low blood pressure
• drop in blood pressure upon changing from sitting or lying down to standing, accompanied by symptoms such as dizziness/light-headedness, which may lead to fainting
• dry mouth
• allergic skin reactions
• hair loss
• leg cramps
• feeling of fatigue

Rare (may affect up to 1 in 1,000 people)

• mental disorders
• insomnia
• drowsiness
• sensation of numbness and tingling in legs, arms, or other parts of the body (paraesthesia)
• visual disturbances
• blurred vision
• ringing in the ears (tinnitus)
• problems affecting the heart lining called pericardium (pericardial effusion or constrictive pericarditis)
• increased heart rate (tachycardia)
• decreased heart rate (bradycardia)
• irregular heart rhythm (arrhythmia)
• lung problems (pleural effusions, pleural fibrosis, pleuritis, pulmonary fibrosis)
• difficulty breathing (dyspnoea)
• diarrhoea
• abdominal pain
• a rare disease characterised by the formation of inflammatory and fibrous tissue in the posterior abdominal wall (retroperitoneal fibrosis)
• bleeding of the stomach or intestine (gastrointestinal haemorrhage)
• damage to the stomach or intestine (gastrointestinal ulcer)
• fluid accumulation in arms or legs (peripheral oedema)

Very rare (may affect up to 1 in 10,000 people)

• increased sexual desire (increased libido)
• altered sexual interest (hypersexuality)
• gambling disorder
• excessive daytime sleepiness, sudden sleep
• cardiac valvulopathy, including regurgitation, pleural and pericardial effusions
• reversible paleness of fingers and toes triggered by cold (especially in patients suffering from a blood circulation disorder called Raynaud's phenomenon)
• a neurological condition called Neuroleptic Malignant Syndrome

Not known (frequency cannot be estimated from available data)

• Withdrawal syndrome: apathy, anxiety, depression, fatigue, sweating, pain.

The following side effects may occur:
Inability to resist the impulse to carry out actions that could be harmful, which may include:

• strong urge to gamble excessively, despite serious personal or family consequences
• altered or increased sexual interest and behaviour causing significant concern to you or others, such as increased sexual desire
• uncontrollable shopping or excessive spending
• compulsive eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than needed to satisfy hunger)
  Inform your doctor if any of these behaviours occur, so that he or she can decide how to intervene to manage or reduce the symptoms.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PARLODEL

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 container after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PARLODEL contains
PARLODEL 5 mg hard capsules

• The active substance is bromocriptine mesylate. Each capsule contains 5.735 mg of bromocriptine mesylate equivalent to 5 mg of bromocriptine base.
• The other components are: anhydrous colloidal silica, magnesium stearate, maleic acid, dried corn starch, lactose (see section “PARLODEL contains lactose”), titanium dioxide (E171), indigo carmine, gelatin.

PARLODEL 10 mg hard capsules

• The active substance is bromocriptine mesylate. Each capsule contains 11.470 mg of bromocriptine mesylate equivalent to 10 mg of bromocriptine base.
• The other components are: anhydrous colloidal silica, magnesium stearate, maleic acid, corn starch, lactose (see section “PARLODEL contains lactose”), titanium dioxide (E171), gelatin.

Description of the appearance of PARLODEL and package contents
PARLODEL 5 mg hard capsules are white-blue capsules supplied in a blister pack. Each pack contains 30 capsules.
PARLODEL 10 mg hard capsules are white capsules supplied in a blister pack. Each pack contains 20 capsules.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Mylan Hungary Kft/Mylan Hungary Ltd., Mylan utca 1, H-2900 Komárom (Hungary)
Madaus GmbH, Luetticher Strasse 5, 53842 Troisdorf (Germany)

Package leaflet: information for the patient

PARLODEL 2.5 mg tablets

Bromocriptine mesylate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PARLODEL is and what it is used for

PARLODEL contains bromocriptine, a substance used in the treatment in adults of certain disorders
of the endocrine system (responsible for hormone production) and for alleviating symptoms associated with
Parkinson's disease.
Specifically, for the treatment of endocrine system disorders, this medicinal product is used:

• to treat galactorrhea (abnormal milky discharge from the nipple), with or without amenorrhea (absence of menstruation), when of unknown cause (idiopathic, Argonz-del Castillo syndrome), caused by a tumor (Forbes-Albright syndrome), or caused by medications (e.g. psychotropic drugs or contraceptives);
• to treat hyperprolactinemic infertility (infertility associated with elevated prolactin levels in men or women);
• to prevent or suppress lactation exclusively for clinical reasons, when the physician has determined it is necessary. Bromocriptine must not be routinely used to suppress lactation. Furthermore, it must not be used to relieve symptoms of painful breast engorgement following childbirth when these can be adequately managed with non-pharmacological measures (such as adequate breast support, ice applications...) and/or analgesics;
• in women to treat prolactin-dependent amenorrhea (absence of menstruation during reproductive age caused by abnormal prolactin production) without galactorrhea;
• in women to treat menstrual cycle disorders (short luteal phase);
• in men to treat prolactin-dependent male hypogonadism (reduced testicular function caused by abnormal prolactin production);
• to treat acromegaly (a disease caused by increased production of a substance in the body called growth hormone during adulthood), as an adjunct to surgical and/or radiotherapeutic treatment or as independent therapy;

for the treatment of Parkinson's disease (idiopathic or arteriosclerotic), a disorder of the central nervous
system characterized, for example, by tremor, muscle rigidity, slowness of movement,
and difficulty maintaining balance, this medicinal product is used:

• in patients who no longer respond adequately to levodopa therapy or who experience "on-off" phenomena (periods of good mobility alternating with periods of motor block);
• as initial treatment or for mild cases, alone or in combination with other medicinal products.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking PARLODEL

Do not take PARLODEL

• if you are allergic to bromocriptine mesylate, to any other ergot alkaloid, or to any of the other ingredients of this medicine (listed in section 6);
• if you have uncontrolled high blood pressure;
• if you have had blood pressure problems during pregnancy or after childbirth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure, or postpartum high blood pressure;
• if you currently have or have previously had heart disease or other serious blood vessel disorders;
• if you currently have or have previously had serious mental health problems;
• if you have a heart valve disorder (cardiac valvulopathy) and require long-term treatment with bromocriptine.

Warnings and precautions
Talk to your doctor or pharmacist before taking PARLODEL.
Pay special attention and consult your doctor before taking PARLODEL if:

• you suffer or have suffered from stomach lesions (peptic ulcer) or severe gastrointestinal bleeding, as your doctor may advise you to take another medicine;
• you have liver problems (as your doctor will need to assess the most appropriate dosage for your condition);
• you are a patient with Parkinson’s disease who has previously experienced psychotic disorders, cardiac dysfunction, gastric ulcer, or gastrointestinal bleeding.

You must contact your doctor immediately if you experience any of the following:

• gastrointestinal disturbances—in this case, stop treatment;
• difficulty breathing (dyspnea), chest pain, dry cough, as these may be symptoms of serious lung or heart problems (pleural and pericardial effusions, pleural and pulmonary fibrosis, or constrictive pericarditis);
• back pain and/or fluid accumulation in the lower limbs (edema) and kidney function abnormalities, as these may indicate a rare condition characterized by the formation of inflammatory and fibrous tissue in the posterior abdominal wall (retroperitoneal fibrosis);
• visual disturbances.

Additionally, inform your doctor if you develop behavioral control disorders (impulse control disorders), including gambling addiction, obsessive increase in sexual desire and thoughts, compulsive shopping or excessive spending, and eating disorders such as bulimia or uncontrollable urges to eat.
Before starting treatment with PARLODEL, inform a family member or caregiver to notify your doctor if they notice you developing unusual urges, desires, behaviors, or engaging in activities that could harm yourself or others.
In such cases, your doctor will consider reducing the dose or gradually discontinuing treatment.
If you are a woman, before starting and during treatment with this medicine, your doctor will perform gynecological examinations every six months or annually and blood tests to monitor hormone levels.
If you are being treated with bromocriptine, your doctor must first exclude the presence of a pituitary adenoma (a benign tumor of the pituitary gland), as pregnancy should be avoided in this case. If this condition is ruled out, treatment with bromocriptine should be discontinued as soon as possible after conception; your doctor will advise you on how to perform an early pregnancy test.
If you are an infertile woman being treated with bromocriptine for galactorrhea, prolactin-dependent amenorrhea, menstrual disorders, or acromegaly, be aware that bromocriptine may reverse infertility and restore fertility. In this case, if you do not wish to become pregnant, you must use a barrier contraceptive method (e.g., condom or diaphragm) or other non-hormonal methods to prevent pregnancy (see also “Pregnancy, breastfeeding, and fertility”).
If you have recently given birth, you may be at increased risk of developing certain conditions. These are very rare but may include high blood pressure, heart attack, seizures, stroke, or mental health problems.
Inform your doctor or pharmacist if you have recently taken or are currently taking medicines that can affect blood pressure.
Your doctor should regularly monitor your blood pressure values during the first days of treatment.
Contact your doctor immediately if you experience episodes of increased blood pressure, chest pain, or unusual and persistent headache with or without visual disturbances (see section 4 “Possible side effects”).
The use of PARLODEL is not recommended in patients with benign breast disorders or for the treatment of premenstrual symptoms.

Other medicines and PARLODEL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• ergot alkaloids or antihypertensives (medicines that lower blood pressure);
• medicines that affect how the liver or intestine works, such as azole antifungals (medicines used to treat fungal skin infections) and medicines for the treatment of AIDS (HIV protease inhibitors);
• certain antibiotics used to treat bacterial infections (erythromycin, josamycin, or macrolide antibiotics);
• octreotide (a medicine used to treat acromegaly);
• medicines that affect the nervous system, such as antipsychotics (phenothiazines, butyrophenones, and thioxanthenes) used to treat mental disorders;
• metoclopramide and domperidone (medicines for nausea and vomiting).

PARLODEL and alcohol
Avoid consuming alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Do not take this medicine during pregnancy or if you suspect you are pregnant, unless your doctor considers it necessary for you to continue taking it.
Your doctor will prescribe PARLODEL only if clearly needed.

Breastfeeding
Do not take this medicine if you are breastfeeding.

Fertility
If you start taking this medicine, you may regain fertility. Therefore, if you do not intend to become pregnant, you must use an appropriate mechanical contraceptive method (such as a condom or diaphragm).

Driving and using machines
PARLODEL may impair your ability to drive vehicles or operate machinery.
In particular, at the beginning of treatment, a drop in blood pressure with reduced alertness may occur.
Furthermore, if you experience episodes of drowsiness or sudden sleep attacks during treatment with this medicine, do not drive or operate machinery until these symptoms have resolved.

PARLODEL contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

PARLODEL contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free.”

3. How to take PARLODEL

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much to take

• Galactorrhea, prolactin-dependent amenorrhea, hyperprolactinemic infertility, male hypogonadism
  The recommended dose is half a tablet three times a day. Your doctor may decide to increase the dose up to one tablet two or three times a day.
• Menstrual cycle disorders
  The recommended dose is half a tablet three times a day. Your doctor may decide to increase the dose up to one tablet twice a day.
• Acromegaly
  The recommended dose is one tablet per day. Your doctor may decide to increase the dose, within 1–2 weeks, up to 4–8 tablets daily, divided into four daily administrations.
• Parkinson's disease
  Anti-Parkinson effects can be achieved with low doses, from 10 to 15 mg per day. The maximum daily dose is approximately 30 mg per day.

If bromocriptine is used in combination with levodopa or other dopa-decarboxylase inhibitors, the recommended starting dose is one tablet twice daily for one week.
Subsequently, your doctor will advise you on how to increase the dose.
If you are also taking levodopa (another medicine used to treat Parkinson's disease), your doctor will instruct you on how to reduce the levodopa dose.
The duration of treatment will be determined by your doctor based on your health status.
How to take PARLODEL
The tablets must always be taken with meals.
Use in children and adolescents
There is no indication for a specific use of PARLODEL in children and adolescents.
If you take more PARLODEL than you should
In case of accidental ingestion or overdose of PARLODEL, contact your doctor immediately or go to the nearest hospital.
The symptoms you may experience are:

• nausea and vomiting
• dizziness
• decreased blood pressure
• decreased blood pressure upon changing from a sitting or lying position to standing (orthostatic hypotension)
• increased heart rate
• stupor
• drowsiness
• deep sleep with reduced response to normal stimuli (lethargy)
• perception of things not present in reality (hallucinations)

Treatment
Your doctor will provide appropriate supportive therapy (such as administration of activated charcoal, metoclopramide, or gastric lavage), after evaluating the symptoms and their severity.
If you forget to take PARLODEL
Do not take a double dose to make up for the forgotten tablet.
If you stop taking PARLODEL
Do not stop taking this medicine suddenly, especially if you are taking high doses. If you intend to stop taking the medicine, discuss this with your doctor first, who will advise you when and how to discontinue it.
If you stop treatment with PARLODEL, you may develop a serious nervous system disorder (Neuroleptic Malignant Syndrome) or drug withdrawal syndrome (see section “Possible side effects”).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately contact your doctor if you experience any of the following side effects while taking PARLODEL, as your doctor will assess whether treatment should be discontinued:

• drowsiness
• sudden sleep
• gastrointestinal disorders: stomach damage (gastrointestinal ulcer), severe bleeding of the stomach and intestine (gastrointestinal haemorrhage)
• difficulty breathing (dyspnoea), chest pain, dry cough, as these may be symptoms of serious lung or heart function disorders (pleural and pericardial effusions, pleural and pulmonary fibrosis, or constrictive pericarditis)
• back pain and leg swelling (peripheral oedema), as these may be symptoms of a rare condition characterised by the formation of inflammatory and fibrous tissue in the posterior abdominal wall (retroperitoneal fibrosis).

In particular, if you have given birth, immediately contact your doctor if you experience any of the following side effects, as treatment with this medicine will be discontinued:

• increased blood pressure
• severe headache, with or without visual disturbances
• chest pain
• epileptic seizures.

The following side effects have been observed and reported during treatment with PARLODEL, with the frequencies indicated below:
Common (may affect up to 1 in 10 people)

• headache
• lethargy
• dizziness
• nasal congestion (nasal congestion)
• nausea, vomiting, constipation

Uncommon (may affect up to 1 in 100 people)

• confusion
• excessive repetitive motor activity (psychomotor agitation)
• perception of non-existent things (hallucinations)
• movement difficulties (dyskinesia)
• low blood pressure
• drop in blood pressure upon changing from a sitting or lying position to standing, accompanied by symptoms such as dizziness/light-headedness, which may lead to fainting
• dry mouth
• allergic skin reactions
• hair loss
• leg cramps
• feeling of fatigue

Rare (may affect up to 1 in 1,000 people)

• mental disorders
• insomnia
• drowsiness
• sensation of numbness and tingling in legs, arms, or other body parts (paraesthesia)
• visual disturbances, blurred vision
• ringing in the ears (tinnitus)
• heart lining problems called pericardium (pericardial effusion or constrictive pericarditis)
• increased heart rate (tachycardia)
• decreased heart rate (bradycardia)
• irregular heart rhythm (arrhythmia)
• lung problems (pleural effusions, pleural fibrosis, pleuritis, pulmonary fibrosis)
• difficulty breathing (dyspnoea)
• diarrhoea
• abdominal pain
• a rare disease characterised by the formation of inflammatory and fibrous tissue in the posterior abdominal wall (retroperitoneal fibrosis)
• bleeding of the stomach or intestine (gastrointestinal haemorrhage)
• damage to the stomach or intestine (gastrointestinal ulcer)
• fluid accumulation in the arms or legs (peripheral oedema)

Very rare (may affect up to 1 in 10,000 people)

• increased sexual desire (increased libido)
• altered sexual interest (hypersexuality)
• gambling addiction
• excessive daytime sleepiness, sudden sleep
• heart function disorders (cardiac valvulopathy, including regurgitation, pleural and pericardial effusions)
• reversible paleness of fingers and toes triggered by cold (especially in patients suffering from a blood circulation disorder called Raynaud's phenomenon)
• a neurological disorder called Neuroleptic Malignant Syndrome

Not known (frequency cannot be estimated from the available data)

• Withdrawal syndrome: apathy, anxiety, depression, fatigue, sweating, pain

The following side effects may occur:
Inability to resist the impulse to carry out actions that could be harmful, which may include:

• strong urge to gamble excessively, despite serious personal or family consequences
• altered or increased sexual interest and behaviour causing significant concern to you or others, such as increased sexual desire
• uncontrollable shopping or excessive spending
• compulsive eating (eating large amounts of food in a short period of time) or bulimia (eating more food than normal and more than needed to satisfy hunger)

Inform your doctor if any of these behaviours occur, so that he or she can decide how to intervene to manage or reduce the symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PARLODEL

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PARLODEL contains

• The active substance is bromocriptine mesilate. Each tablet contains 2.87 mg of bromocriptine mesilate, equivalent to 2.5 mg of bromocriptine base.
• The other ingredients are anhydrous colloidal silica, magnesium stearate, malic acid, lactose (see section “PARLODEL contains lactose”), sodium edetate (dihydrate), maize starch.

Description of the appearance of PARLODEL and contents of the pack
PARLODEL is presented as whitish tablets with a score line, contained in a blister. Each
pack contains 30 tablets.
Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy
Manufacturer
Madaus GmbH, Luetticher Strasse 5, 53842 Troisdorf (Germany)