Package Insert: Information for the User

PARLODEL 5 mg Capsules

Bromocriptine mesylate

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 recent and mild cases of Parkinson's disease, in those who show an inadequate response or intolerance to L-dopa and in those where the usefulness of the latter is limited by the appearance of "on-off" phenomena (fluctuations of periods with and without symptoms).

Do not take Parlodel 5 mg capsules

• If you are allergic (hypersensitive) to bromocriptine or to any of the other components of Parlodel 5 mg capsules (including those listed in section 6).
• If you are allergic to other medications that contain ergot alkaloids.
• If you have high blood pressure and it 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 a 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 5 mg capsules.

Inform your doctor if you:

• Experience excessive daytime sleepiness and fall asleep unexpectedly.
• Have black stools or stomach ulcers.
• Have intolerance to some sugars, for example lactose, (see section: Important information about some of the components of Parlodel 5 mg capsules).
• Have or have had fibrotic reactions (scar tissue) that have affected the heart, lungs, or abdomen.
• After 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. 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 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 excessive gambling, excessive eating, excessive spending, abnormal sexual urges, 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 it must be done gradually to avoid Neuroleptic Malignant Syndrome and/or withdrawal syndrome.

Informimmediatelyyour doctor if you:

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

Use of Parlodel with other medications

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

It is especially important for your doctor to know 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).
• The 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.

It is not recommended to use Parlodel in women who, after delivery or abortion, use medications 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 adverse effects.

Use in children

No information is 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, making you feel dizzy. Therefore, you should exercise special caution when driving or operating machinery.

Important information about some of the components of Parlodel 5 mg capsules

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.

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

Oral route

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 since these tablets can be split in half. The daily dose will be gradually increased by 1.25 mg each week and administered in 2 or 3 doses. When using doses of 5 mg or higher, 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 your dose based on your response. Continue with your treatment for the time indicated by your doctor

If you take more Parlodel 5 mg capsulesthan 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 Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Parlodel 5 mg capsules

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 time it is due. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Parlodel 5 mg capsules

Do not stop your treatment unless your doctor has told you to. 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 medicines, this medicine can 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:

• Stomach burning, repeated stomach pain, or black stools.
• Falling asleep suddenly.
• Unexplained shortness of breath and difficulty breathing.
• Severe chest pain.
• Pain in the lower back, swollen legs, and pain while urinating.
• Severe headaches, progressive or persistent, and vision problems (such as blurred vision).
• Symptoms such as muscle stiffness, agitation, 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 (can affect up to 1 in 10 patients):headaches, numbness, dizziness, nasal congestion, constipation, and vomiting.
• Rare (can 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 making voluntary movements), fatigue, low blood pressure, especially when getting up, which may cause dizziness, leg cramps.
• Rare (can affect up to 1 in 10,000 patients):diarrhea, stomach or abdominal pain, swelling of arms and legs, rapid or slow heartbeat, irregular heartbeat, shortness of breath or difficulty breathing, psychotic/psychological disorders, sleep disturbances (insomnia), drowsiness, tingling or numbness in hands and feet, ringing in the ears.
• Very rare (can 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, convulsions, stroke, or psychological disorders have been reported. However, the causal relationship of these side effects with Parlodel is uncertain.

• You may also experience the following side effects:

• Difficulty resisting 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;
  • Uncontrollable compulsive buying or 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 not listed 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 medicine.

Keep out of the sight and reach of children.

Do not use Parlodel 5 mg after the expiration date that appears on the packaging after “CAD” or “EXP”. 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 there are signs that it has been tampered with.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Parlodel 5 mg capsules:

• The active ingredient is bromocriptine mesylate. Each capsule contains 5.74 mg of bromocriptine mesylate corresponding to 5.0 mg of bromocriptine base.
• The other components of the capsule are: maleic acid, anhydrous colloidal silica, magnesium stearate, cornstarch, 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 packaging

Each package of Parlodel 5 mg contains 50 capsules.

Other presentations

Parlodel 2.5 mg scored tablets: package with 30 tablets.

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

Lütticher Strasse 5, 53842 Troisdorf- Germany

or

Mylan Hungary Kft/Mylan Hungary Ltd.

Mylan utca 1

Komárom, 2900

Hungary

Last review date of this leaflet:05/2020

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/