Parlodel 5 mg capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

PARLODEL 5 mg capsules

Bromocriptine mesilate

Package leaflet contents:

1. What Parlodel 5 mg capsules are and what they are used for.
2. What you need to know before taking Parlodel 5 mg capsules.
3. How to take Parlodel 5 mg capsules.
4. Possible side effects.
5. Storage of Parlodel 5 mg capsules.
6. Package contents and additional information.

1. What Parlodel 5 mg capsules is and what it is 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, particularly in patients with early and mild Parkinson's disease, in those who show an inadequate response or intolerance to L-dopa, and in those for whom the usefulness of L-dopa is limited by the onset of "on-off" phenomena (fluctuations between periods with and without symptoms).

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

Do not take Parlodel 5 mg capsules

• If you are allergic (hypersensitive) to bromocriptine or to any of the other ingredients of Parlodel 5 mg capsules (listed in section 6).
• If you are allergic to other medicines containing 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 suffer from heart disease.
• If you have a history or symptoms of severe mental illness.
• If you are to be treated with Parlodel for a prolonged period and have or have had fibrotic reactions (scar tissue) affecting the heart.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Parlodel 5 mg capsules.

Inform your doctor if you:

• Experience excessive daytime sleepiness and fall asleep suddenly.

• Have black stools or stomach ulcers.

• Have an intolerance to certain sugars, such as lactose (see section: Important information about some of the ingredients of Parlodel 5 mg capsules).

• Have or have had fibrotic reactions (scar tissue) affecting the heart, lungs, or abdomen.

• Are 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. Your doctor will also perform an echocardiogram (a test using ultrasound waves to view the heart) before starting treatment. During treatment, your doctor will closely monitor for any signs that could be related to a fibrotic reaction. If necessary, an echocardiogram will be performed. If any fibrotic reaction occurs, treatment must be discontinued.

• Inform your doctor if you or your family/caregiver notice that you are developing impulses or urges 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 known as impulse control disorders and may include gambling addiction, excessive eating or spending, abnormally increased sex drive, or increased sexual thoughts and feelings. Your doctor may need to adjust or discontinue your treatment.

• Your doctor will advise you on how to proceed if dose adjustment or discontinuation is needed, as this must be done gradually to avoid Neuroleptic Malignant Syndrome and/or withdrawal syndrome.

Inform your doctor immediately if you:

• Fall asleep suddenly.
• Have interrupted breathing 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).
• Are being treated for a prolactinoma and suddenly develop nasal leakage.

Taking Parlodel with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 disorders and severe diarrhea).
• Protease inhibitors such as ritonavir, nelfinavir, indinavir, delavirdine (used in the treatment of HIV/AIDS).
• Medicines such as itraconazole, voriconazole (used for fungal infections).
• Dopamine antagonists (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide, and domperidone), used, for example, to treat mental disturbances and vomiting, as they reduce the effect of Parlodel.

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

Taking Parlodel 5 mg capsules with food and drink

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 available information on the use of Parlodel in children.

Use in the elderly

No special precautions are necessary in this population group, 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will inform you about the potential risks of taking Parlodel during pregnancy.

Breastfeeding

Do not take Parlodel if you are breastfeeding.

Driving and using machines

Parlodel may cause drowsiness and sudden episodes of sleep. Therefore, you should not drive or operate machinery until these episodes have stopped.

In addition, Parlodel may lower your blood pressure, causing dizziness. Therefore, you should exercise particular caution 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 informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Parlodel 5 mg capsules

Follow exactly the instructions for administering Parlodel provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Oral use

Remember to take Parlodel with food.

Recommended dosage:

Begin 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 split in half. The daily dose should be gradually increased by 1.25 mg each week, administered in 2 or 3 doses. When doses of 5 mg or higher are required, 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 subsequently adjust your dose depending on your response. Continue your treatment for the duration 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 require medical attention. In cases of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Parlodel 5 mg capsules

Take the missed dose as soon as possible, except if there are less than 4 hours remaining 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 a missed dose.

If you stop taking Parlodel 5 mg capsules

Do not interrupt your treatment unless instructed by your doctor. Suddenly stopping Parlodel may cause adverse effects, including a rare reaction called Neuroleptic Malignant Syndrome, whose symptoms include muscle rigidity, agitation, very high fever, rapid heartbeat, and sudden changes in blood pressure.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• Stomach burning, repeated stomach pain, or black stools.
• Falling asleep suddenly.
• Unexplained shortness of breath and 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, very rapid heartbeat, and sudden changes in blood pressure.

Other adverse effects. If any of the following 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): skin allergic 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 may occasionally cause fainting—and leg cramps.
• Rare (may affect up to 1 in 1,000 patients): diarrhea, stomach or abdominal pain, swelling of arms and legs, fast or slow heartbeat, irregular heartbeat, shortness of breath or difficulty breathing, psychotic/mental 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 sleepiness, pale fingers of hands and feet upon cold exposure. 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 early signs: 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 adverse effects with Parlodel is uncertain.

• You may also experience the following side effects:

• Inability to resist the impulse to carry out an action that may be harmful, which may include:

  • Strong impulse to gamble excessively, despite serious personal or family consequences;
  • Altered or increased sexual interest and behavior, significantly affecting you or others, for example, increased sexual drive;
  • Compulsive, uncontrollable shopping or spending;
  • Binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating an amount of food larger than usual and more than needed to satisfy hunger).

• Withdrawal syndrome in cases of dose reduction or discontinuation, which may present with 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 expiry date stated on the packaging after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.

Store below 25 °C.

Do not use Parlodel if the packaging is damaged or if there are signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Parlodel 5 mg capsules:

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

Appearance of the product and contents of the pack

Each pack of Parlodel 5 mg contains 50 capsules.

Other presentations

Parlodel 2.5 mg scored tablets: pack containing 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 the most recent review of this leaflet: 05/2020

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