PARLODEL 5 mg CAPSULES

Introduction

Package Leaflet: Information for the User

PARLODEL 5 mg capsules

Bromocriptine mesylate

Contents of the package leaflet:

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

1. What is Parlodel 5 mg capsules and what is it used for

Parlodel contains bromocriptine which belongs to a group of medicines known as ergot alkaloids.

Parlodel 5 mg capsules are used in Parkinson's disease, especially in patients with recent and mild Parkinson's disease, in those who show an inadequate response or intolerance to L-dopa, and in those whose usefulness is limited by the appearance of "on-off" phenomena (fluctuations of periods with and without symptoms).

2. What you need to know before you take Parlodel 5 mg capsules

Do not take Parlodel 5 mg capsules

• If you are allergic (hypersensitive) to bromocriptine or any of the other ingredients of Parlodel 5 mg capsules (listed in section 6).
• If you are allergic to other medicines that contain ergot alkaloids.
• If you have high blood pressure that is not controlled or if your blood pressure is too high during or after pregnancy.
• If you have any heart disease.
• If you have a history or symptoms of severe 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 5 mg capsules.

Tell 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 5 mg capsules).
• If you have or have had fibrotic reactions (scar tissue) that have affected your heart, lungs, or abdomen.
• If you are going to be 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.

• Tell 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 stop your treatment.
• Your doctor will tell you how to act in case you need to adjust or stop treatment, as it must be done gradually to avoid Neuroleptic Malignant Syndrome and/or Withdrawal Syndrome.

Tell 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 suffer from 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 bleeding suddenly.

Using Parlodel with other medicines

Tell your doctor or pharmacist if 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 5 mg capsules 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 have sudden episodes of sleep. Therefore, do 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 5 mg capsules

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.

3. How to take Parlodel 5 mg capsules

Follow exactly the administration instructions of Parlodel indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Oral use

Remember to take Parlodel with food.

The recommended dose is:

Start treatment with 1.25 mg of Parlodel, preferably at night during the first week. To do this, use Parlodel 2.5 mg tablets as these tablets can be broken in half. The daily dose will be gradually increased by 1.25 mg each week and administered in 2 or 3 doses. When doses of 5 mg or higher are used, it is preferable to use Parlodel 5 mg capsules.

The usual dose for both monotherapy and combination therapy in Parkinson's disease is 10-30 mg of bromocriptine per day.

Your doctor may adjust the dose later, depending on your response. Continue with your treatment for the time indicated by your doctor.

If you take more Parlodel 5 mg capsules 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 5 mg capsules

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 the missed doses.

If you stop taking Parlodel 5 mg capsules

Do not stop your treatment unless your doctor has told you to. Stopping Parlodel suddenly can cause you to experience 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.
• 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, dyskinesia (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 pain 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 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. The causal relationship of these side effects with Parlodel is, however, uncertain.

• You may also experience the following side effects:

• Inability 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 (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than necessary to satisfy hunger).
• Withdrawal syndrome in cases of dose reduction or discontinuation, 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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that does not appear 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. Storage of Parlodel 5 mg capsules

Keep out of the sight and reach of children.

Do not use Parlodel 5 mg after the expiration date stated on the packaging after "EXP" or "CAD". The expiration date is the last day of the month indicated.

Store below 25°C.

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. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Parlodel 5 mg capsules:

• The active ingredient is bromocriptine mesylate. Each capsule contains 5.74 mg of bromocriptine mesylate, equivalent to 5.0 mg of bromocriptine base.
• The other ingredients of the capsule are: maleic acid, colloidal anhydrous silica, magnesium stearate, cornstarch, lactose, gelatin, titanium dioxide (E 171), carmine indigo (E 132), red iron oxide (E 172), and shellac.

Appearance of the product and packaging contents

Each pack of Parlodel 5 mg contains 50 capsules.

Other presentations

Parlodel 2.5 mg scored tablets: packaging with 30 tablets.

Marketing Authorization Holder

Exeltis Healthcare, S.L.

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

Azuqueca de Henares,

Guadalajara, Spain

Manufacturer

Madaus GmbH

Lütticher Strasse 5, 53842 Troisdorf- Germany

or

Mylan Hungary Kft/Mylan Hungary Ltd.

Mylan utca 1

Komárom, 2900

Hungary

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

Date of last revision of this leaflet: 05/2020

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/