PARLODEL 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

PARLODEL 2.5 mg Tablets

Bromocriptine Mesylate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Parlodel 2.5 mg Tablets are and what they are used for.
2. What you need to know before you take Parlodel 2.5 mg Tablets.
3. How to take Parlodel 2.5 mg Tablets.
4. Possible side effects.
5. Storing Parlodel 2.5 mg Tablets.
6. Contents of the pack and other information.

1. What Parlodel 2.5 mg Tablets are and what they are used for

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, leading to milk production for breastfeeding.

Parlodel 2.5 mg Tablets are used in the following cases:

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

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

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

2. What you need to know before you take Parlodel 2.5 mg Tablets

Do not take Parlodel 2.5 mg Tablets:

• If you are allergic (hypersensitive) to bromocriptine or any of the other ingredients of Parlodel 2.5 mg Tablets (listed in section 6).
• If you are allergic to other medicines that contain ergot alkaloids.
• If you have high blood pressure.
• If you have ever 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 have or have ever had a heart disease or other serious blood vessel disease.
• If you have or have ever had a serious mental illness.
• If you are going to be treated with Parlodel for a prolonged period and have or have had fibrotic reactions (scar tissue) that have affected your 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 greater risk of developing certain conditions. These are very rare but can include high blood pressure, heart attack, seizures, 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 severe or persistent headache (with or without vision problems).

Inform your doctor if you:

• Experience excessive daytime sleepiness and fall asleep unexpectedly.
• Have black stools or stomach ulcers.
• Are intolerant to some sugars, for example, lactose (see section: Important information about some of the ingredients of Parlodel 2.5 mg Tablets).
• Have or have had fibrotic reactions (scar tissue) that have affected your heart, lungs, or abdomen.

If you are being treated with Parlodel for a prolonged period, before starting treatment, your doctor will assess whether your heart, lungs, and kidneys are in good condition. The 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, an echocardiogram will be performed. If a fibrotic reaction occurs, treatment should be discontinued.

• Inform your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way, or if you cannot resist the impulse or temptation to carry out certain activities that may be harmful to you or others. These behaviors are called impulse control disorders and may include addiction to gambling, excessive eating or spending, abnormally high sexual impulse, or increased thoughts and feelings of sex. Your doctor may need to adjust or discontinue your treatment.
• Your doctor will tell you how to act in case you need to adjust or discontinue treatment, as it must be done gradually to avoid Neuroleptic Malignant Syndrome and/or Withdrawal Syndrome.

Inform your doctor immediately if you:

• Fall asleep suddenly.
• Have shortness of breath or difficulty breathing.
• Have severe chest pain.
• Have lower back pain, swollen legs, and pain when urinating.
• After childbirth or abortion: if you experience severe, progressive, or persistent headaches and/or vision problems (e.g., blurred vision);
• If you are being treated for a prolactinoma and your nose starts to run suddenly.

Using Parlodel with other medicines

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

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

• Macrolide antibiotics, such as erythromycin, josamycin (used to treat infections).
• Octreotide (a medicine used to treat growth problems and severe diarrhea).
• Protease inhibitors, such as ritonavir, nelfinavir, indinavir, delavirdine (used to treat HIV/AIDS).
• Medicines such as itraconazole, voriconazole (used to treat fungal infections).
• So-called dopaminergic 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.

It is not recommended to use Parlodel in women who, after childbirth or abortion, use medicines that constrict blood vessels, including those that contain ergot alkaloids such as ergotamine.

Taking Parlodel 2.5 mg with food and drinks

Always take Parlodel with food.

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

Use in children

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

Use in elderly

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 using machines

Parlodel may cause you to feel sleepy and may cause sudden episodes of sleep. Therefore, you should not drive or operate machinery until these episodes have disappeared.

Additionally, Parlodel may lower your blood pressure, making you feel dizzy. Therefore, you should be especially careful when driving or operating machinery.

Important information about some of the ingredients of Parlodel 2.5 mg Tablets

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

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

3. How to take Parlodel 2.5 mg Tablets

Follow the instructions for taking Parlodel exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Oral use.

Parlodel 2.5 mg Tablets can be broken in half into equal doses. Remember to take Parlodel with food.

The 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 the dose later, depending 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 accidentally taken more Parlodel than you should, inform your doctor immediately. You may need medical attention. In cases of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Parlodel 2.5 mg Tablets

Take the missed dose as soon as possible, unless it is 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 make up for missed doses.

If you stop taking Parlodel 2.5 mg Tablets

Do not stop your treatment unless your doctor has told you to. Stopping Parlodel suddenly can cause side effects, including a rare reaction called Neuroleptic Malignant Syndrome, whose symptoms are muscle stiffness, agitation, very high fever, rapid heartbeat, and sudden changes in blood pressure.

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

4. Possible side effects

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

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

• Heartburn, stomach pain, or black stools.
• Falling asleep suddenly.
• Unexplained shortness of breath or difficulty breathing.
• Severe chest pain.
• Lower back pain, swollen legs, and pain when urinating.
• Severe, progressive, or persistent headaches, and vision problems (such as blurred vision).
• Symptoms such as muscle stiffness, agitation, very high fever, rapid heartbeat, and sudden changes in blood pressure.

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):headache, numbness, dizziness, nasal congestion, constipation, and vomiting.
• Uncommon (may affect up to 1 in 100 patients):allergic skin 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 standing up, which can sometimes cause fainting, 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/psychiatric disorders, sleep disturbances (insomnia), sleepiness, sensation of tingling or numbness in hands and feet, ringing in the ears.
• Very rare (may affect up to 1 in 10,000 patients):excessive daytime sleepiness, pale fingers and toes with cold. Heart valve disorders and related disorders, e.g., inflammation (pericarditis) or fluid accumulation in the pericardium (pericardial effusion).

One or more of the following symptoms may appear first: 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. The causal relationship of these side effects with Parlodel is, however, uncertain.

• You may also experience the following side effects:

• Unable to resist the impulse to perform an action that may be harmful, which may include:
• • Intense impulse to gamble excessively, despite serious personal or family consequences;
  • Altered or increased sexual interest and behavior that significantly affects you or others, for example, increased sexual impulse;
  • Uncontrollable compulsive shopping or spending;
  • Binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than usual and more than necessary to satisfy hunger).
• Withdrawal syndrome in cases of dose reduction or discontinuation, which may present 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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Parlodel 2.5 mg Tablets

Keep out of the sight and reach of children.

Do not use Parlodel 2.5 mg after the expiration date stated on the packaging after "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 shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Parlodel 2.5 mg Tablets

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

Appearance of the product and packaging contents

Each pack of Parlodel 2.5 mg contains 30 scored tablets.

Other presentations

Parlodel 5 mg capsules: packaging with 50 capsules.

Marketing Authorization Holder

Exeltis Healthcare, S.L.

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

Azuqueca de Henares,

Guadalajara, Spain

Manufacturer

Madaus GmbH

51101 Cologne

Germany

Date of last revision of this leaflet: May 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/