Package Insert: Information for the User

PARLODEL 2.5 mg Tablets

Bromocriptine mesylate

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Parlodel contains bromocriptine, which belongs to a group of medicines known as ergot alkaloids. Parlodel reduces the release of prolactin (a hormone produced by the pituitary gland in the brain). After childbirth or abortion, it is normal for prolactin levels to increase in women, causing milk production for breastfeeding.

Parlodel 2.5 mg tablets are used in the following cases:

• To interrupt milk production for breastfeeding, only for medical reasons, and when you and your doctor have decided that it is necessary.

Bromocriptine should not be used routinely to interrupt milk production. It should also not be used to relieve symptoms such as breast pain and tension after childbirth, if these can be adequately treated by non-medical means (such as firm breast compression, ice application...) and/or the use of analgesics.

• When menstruation is irregular or absent and is due to excessive prolactin levels.
• Infertility in women, polycystic ovary syndrome or ovulation cycles associated with increased prolactin levels.
• Alteration of sexual gland function in men (reduced sperm, loss of libido, impotence), caused by very high prolactin levels.
• In patients with non-malignant tumors that secrete prolactin (prolactinomas)
• In conditions where the body releases a large amount of growth hormone (acromegaly).
• For the complementary treatment of Parkinson's disease.

Do not take Parlodel 2.5 mg tablets:

• If you are allergic (hypersensitive) to bromocriptine or to any of the other components of Parlodel 2.5 mg tablets (listed in section 6).
• If you are allergic to other medications that contain ergot alkaloids.
• If you have high blood pressure.
• If you have ever had problems with high blood pressure during pregnancy or after delivery, such as eclampsia, pre-eclampsia, pregnancy-induced hypertension, or postpartum hypertension.
• If you have or have had any heart disease, or other serious vascular disease.
• If you have or have had any severe mental illness.
• If you are to be treated with Parlodel for a prolonged period and have or have had fibrotic reactions (scar tissue) that have affected the heart.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Parlodel 2.5 mg tablets.

If you have recently given birth, you may be at a higher risk of developing certain conditions. These are very rare, but may include high blood pressure, heart attack, convulsions, stroke, or mental problems. Therefore, your doctor will need to monitor your blood pressure regularly during the first few days of treatment. Inform your doctor immediately if you experience high blood pressure, chest pain, or unusually intense or persistent headaches (with or without vision problems).

Inform your doctor if you:

• Experience excessive daytime sleepiness and fall asleep unexpectedly.
• Have black stools or stomach ulcers.
• Have intolerance to certain sugars, for example, lactose (see Important Information about one of the components of Parlodel 2.5 mg tablets).
• Have or have had fibrotic reactions (scar tissue) that have affected the heart, lungs, or abdomen.

If you are to be treated with Parlodel for a prolonged period, your doctor will evaluate whether your heart, lungs, and kidneys are in good condition before starting treatment. Your doctor will also perform an echocardiogram (a test that uses ultrasound waves to observe the heart) before starting treatment. During treatment, your doctor will closely monitor any signs that may be related to a fibrotic reaction. If necessary, your doctor will perform an echocardiogram. If a fibrotic reaction occurs, treatment should be discontinued.

• Inform your doctor if you or your family/caregiver observe that you are developing unusual impulses or desires to behave in an unusual way, or if you cannot resist the impulse or temptation to engage in certain activities that may be harmful to you or others. These behaviors are known as impulse control disorders and may include excessive gambling, excessive eating or spending, abnormal sexual impulses, or increased thoughts and feelings of sex.Your doctor may need to adjust or discontinue your treatment.
• Your doctor will instruct you on what to do if you need to adjust or discontinue treatment, as this should be done gradually to avoid Neuroleptic Malignant Syndrome and/or withdrawal syndrome.

Inform your doctor immediately if you:

• Fall asleep suddenly.
• Have labored breathing or difficulty breathing.
• Have severe chest pain.
• Have severe lower back pain, swollen legs, and painful urination.
• After delivery or abortion: if you experience severe, progressive, or persistent headaches, or vision problems (e.g., blurred vision);
• If you are being treated for a prolactinoma and experience sudden nasal discharge.

Use of Parlodel with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

It is especially important that your doctor knows if you are taking any of the following medications:

• Macrolide antibiotics, such as erythromycin, josamycin (used to treat infections).
• Octreotide (a medication used to treat growth problems and severe diarrhea).
• Protease inhibitors such as ritonavir, nelfinavir, indinavir, delavirdine (used to treat HIV/AIDS).
• Medications such as itraconazole, voriconazole (used to treat fungal infections).
• So-called dopamine antagonists (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide, and domperidone) used, for example, to treat altered mental states and vomiting, as they reduce the effect of Parlodel.

The use of Parlodel is not recommended in women who, after delivery or abortion, use medications that constrict blood vessels, including those that contain ergot alkaloids.

Parlodel 2.5 mg with food and beverages

Always take Parlodel with food.

Avoid consuming alcohol during treatment with Parlodel. Alcohol may increase the risk of adverse effects.

Use in children

There is no information available on the use of Parlodel in children.

Use in the elderly

No special precautions are necessary in this age group, although it is recommended to start with the lowest dose.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Your doctor will inform you of the potential risks of taking Parlodel during pregnancy.

Breastfeeding

Do not take Parlodel if you are breastfeeding.

Driving and operating machinery

Parlodel may cause drowsiness and cause sudden episodes of sleep. Therefore, do not drive or operate machinery until the episodes have disappeared.

Additionally, Parlodel may lower blood pressure, causing you to feel dizzy. Therefore, you should exercise special caution when driving or operating machinery.

Important information about one of the components of Parlodel 2.5 mg tablets

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for Parlodel as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Oral administration.

Parlodel 2.5 mg tablets can be split in half to equal doses. Remember to take Parlodel with food.

Recommended dose is:

Start treatment with half a tablet (1.25 mg) on the first day with breakfast and dinner, followed by one tablet twice a day for 14 days. Your doctor may adjust your dose based on your response, or switch you to Parlodel 5 mg capsules. Continue treatment for the time indicated by your doctor.

If you take more Parlodel 2.5 mg tablets than you should

If you have taken more Parlodel than you should by accident, inform your doctor immediately. You may need medical attention. In cases of overdose or accidental ingestion, contact the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Parlodel 2.5 mg tablets

Take the missed dose as soon as possible, except if there are less than 4 hours before the next dose. In this case, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Parlodel 2.5 mg tablets

Do not stop treatment unless your doctor has instructed you to do so. Sudden interruption of Parlodel may cause adverse effects, including a rare condition called Malignant Neuroleptic Syndrome, whose symptoms are muscle rigidity, agitation, very high fever, rapid heart rate, and sudden changes in blood pressure.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Some side effects can beserious. If you experience any of the following side effects, inform your doctor immediately:

Other side effects. If any of the following side effects affect you severely, inform your doctor:

• Frequent (may affect up to 1 in 10 patients):headaches, numbness, dizziness, nasal congestion, constipation, and vomiting.
• Rare (may affect up to 1 in 100 patients):skin allergic reactions, hair loss, confusion, psychomotor agitation, hallucinations (seeing, hearing, smelling, or feeling things that do not exist), dry mouth, dyskinesias (difficulty performing voluntary movements), fatigue, low blood pressure, especially when getting up, which may cause dizziness, leg cramps.
• Rare (may affect up to 1 in 1,000 patients):diarrhea, stomach or abdominal pain, swelling of arms and legs, rapid or slow heartbeat, irregular heartbeat, shortness of breath or difficulty breathing, psychotic/psychic disorders, sleep disturbances (insomnia), drowsiness, tingling or numbness in hands and feet, ringing in the ears.
• Very rare (may affect up to 1 in 10,000 patients):excessive daytime drowsiness, pale fingers and toes with cold. Heart valve disorders and related disorders, such as inflammation (pericarditis) or fluid leakage into the pericardium (pericardial effusion).

One or more of the following symptoms may be the first to appear: difficulty breathing, shortness of breath, chest or back pain, and swollen legs. If you experience any of these symptoms, inform your doctor immediately.

In women after childbirth or abortion, rare cases of hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders have been reported. However, the causal relationship of these side effects with Parlodel is uncertain.

• You may also experience the following side effects:

• Inability to resist the urge to perform an action that may be harmful, which may include:
• • Intense urge to gamble excessively, despite severe personal or family consequences;
  • Altered or increased sexual behavior that significantly affects you or others, such as increased libido;
  • Compulsive buying or uncontrolled spending;
  • Binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than usual and more than needed to satisfy hunger).
• Syndrome of abstinence in cases of dose reduction or suspension, in which you may experience the following symptoms: apathy, anxiety, depression, fatigue, sweating, pain, etc. If you experience any of these symptoms, inform your doctor immediately.

Inform your doctor if you experience any of these behaviors; they will help you develop ways to manage or reduce the symptoms.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not use Parlodel 2.5 mg after the expiration date that appears on the packagingafter “CAD” or “EXP”. The expiration date is the last day of the month indicated.

Store below 25 °C, in the original packaging.

Do not use Parlodel if the packaging is damaged or there are signs that it has been manipulated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubt, please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Parlodel 2.5 mg tablets

• The active ingredient is bromocriptine mesylate. Each tablet contains 2.87 mg of bromocriptine mesylate corresponding to 2.5 mg of bromocriptine base.
• The other components of the tablet are: maleic acid, anhydrous colloidal silica, disodium edetate, magnesium stearate, cornstarch, lactose.

Appearance of the product and contents of the packaging

Each package of Parlodel 2.5 mg contains 30 scored tablets.

Other presentations

Parlodel 5 mg capsules: package with 50 capsules.

Holder of the Marketing Authorization

Exeltis Healthcare, S.L.

Pol. Ind.Miralcampo, Avda. de Miralcampo, 7, 19200

Azuqueca de Henares,

Guadalajara, Spain

Responsible for manufacturing:

Madaus GmbH

51101 Cologne

Germany

Date of the last review of this leaflet: May 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/