SOGILEN 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

SOGILEN 2 mg tablets

Cabergoline

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 experience 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 is Sogilen and what is it used for
2. What you need to know before you take Sogilen
3. How to take Sogilen
4. Possible side effects
5. Storage of Sogilen
6. Contents of the pack and further information

1. What is Sogilen and what is it used for

Sogilen belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain.

Sogilen is used, if other types of medication are not tolerated or are not effective, for the treatment of Parkinson's disease associated with levodopa administered in combination with a decarboxylase inhibitor.

2. What you need to know before you take Sogilen

Do not take Sogilen

• If you are allergic to the active substance cabergoline, to any ergot alkaloid, or to any of the other ingredients of Sogilen (listed in section 6).
  • If you have a moderate or severe liver disease (hepatic insufficiency).
  • If you are going to be treated with Sogilen for a prolonged period and have any heart valve problems.
  • If you have or have had fibrotic disorders (scarring tissue) that have affected your heart, lungs, or abdomen.

Warnings and precautions

Your doctor should carefully assess the treatment with Sogilen if you have any heart rhythm disorder or severe heart disease.

Be particularly careful with Sogilen in the following circumstances:

• If you have severe cardiovascular disease or Raynaud's syndrome (sudden changes in color - pallor and/or bluish discoloration followed by reddening - of the fingers, ears, and nose, as a result of the interruption of blood flow to them). It may worsen your disease.
• If you have severe hepatic insufficiency, you may need a lower dose.
• If you have peptic ulcer or a history of gastrointestinal bleeding. It may cause a relapse of the condition you have had.
• If you have a history of severe mental illness (psychosis). Symptoms of the disease may appear.
• If you are taking medications that lower your blood pressure. The administration of Sogilen may cause postural hypotension (drop in blood pressure when changing position), especially during the first few days of treatment.
• If you notice a feeling of sleepiness or the sudden onset of sleep, even during daily activities that you perform. Your doctor may decide to reduce the dose or discontinue treatment with Sogilen.
• If during treatment you develop an increased desire for sex or obsessive sexual desire.
• If during treatment you notice altered behavior related to gambling.
• If during treatment you make compulsive purchases or expenses.
• If during treatment you eat in a compulsive manner.

In case of prolonged treatment with Sogilen, 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 and at regular intervals during treatment. If any fibrotic reaction occurs, treatment should be discontinued. If you have or have had any of these disorders, you should not take Sogilen. Consult your doctor if you have symptoms that may suggest heart, lung, or kidney problems, such as difficulty breathing, fatigue, persistent cough, chest pain or abdominal pain, fluid accumulation (edema), or swelling of the legs, masses, or pain on palpation in the abdomen.

Taking Sogilen with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines, including those obtained without a prescription.

Certain medicines may interact with Sogilen; in these cases, it may be necessary to change the dose or discontinue treatment with one of the medicines.

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

• Medicines that are dopamine antagonists (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide), as they may decrease the effect of Sogilen.
• A type of antibiotic called macrolides (such as erythromycin), which may increase the adverse effects of Sogilen.

• Other medicines that contain ergot derivatives, as Sogilen should not be administered in combination with these medicines.

Taking Sogilen with food and drinks

It is recommended to take Sogilen with food. The tablets should be taken with water.

Pregnancy, breastfeeding, and fertility

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

It is recommended to use contraceptive methods during treatment with Sogilen. You should avoid becoming pregnant during treatment with Sogilen and for at least one month after discontinuing treatment. If you become pregnant during treatment with Sogilen, you should consult your doctor immediately, who will assess whether to continue or discontinue treatment with this medicine and take the necessary measures.

It is not known whether Sogilen passes into breast milk. However, it is not recommended to take Sogilen during breastfeeding, as it is likely to disrupt milk production.

Driving and using machines

Sogilen may cause sleepiness and sudden episodes of sleep. If this happens, you should not drive or operate machinery until these episodes and/or sleepiness have disappeared.

Sogilen contains lactose

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 Sogilen

Follow exactly the administration instructions of Sogilen indicated by your doctor. If in doubt, consult your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Sogilen. Do not discontinue treatment before.

Sogilen is administered orally. It is recommended to take Sogilen with food.

At the start of treatment, you will begin taking half a tablet of Sogilen 1 mg tablets (0.5 mg) or half a tablet of Sogilen 2 mg tablets (1 mg), once a day. The daily dose will be gradually increased until the maintenance dose suitable for your needs is reached.

The usual maintenance dose is 2 mg to 3 mg daily, taken in a single dose with levodopa/carbidopa treatment.

Use in elderly patients

No dose adjustment is necessary in this group of patients.

Use in patients with kidney problems

No dose adjustment is necessary in this group of patients.

Use in patients with mild liver problems

No dose adjustment is necessary in this group of patients.

If you take more Sogilen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

Always carry the package with you, whether there are Sogilen tablets left or not.

The following symptoms may appear: nausea, vomiting, stomach discomfort, decreased blood pressure, confusion, a type of mental disorder called psychosis, or hallucinations.

If you forget to take Sogilen

If you forget to take a dose, take it as soon as you remember and continue as previously indicated. Do not take a double dose to make up for the forgotten doses.

If you stop taking Sogilen

Do not stop treatment before your doctor indicates it, as the symptoms of your disease may return more intensely. You should consult your doctor before stopping treatment.

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

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 patients):

• Nausea
• Fluid retention
• Heart valve problems (valvular heart disease), inflammation of the membranes that cover the heart (pericarditis), and fluid accumulation in the membranes that cover the heart (pericardial effusion)

Common side effects (may affect up to 1 in 10 patients):

• Difficulty breathing (dyspnea)
• Hallucinations, sleep disturbances, excessive sexual desire, confusion,
• Headache, sleepiness, dizziness/vertigo, abnormal movements
• Chest pain and a feeling of acute and suffocating oppression, usually centered behind the sternum, and sometimes radiating (angina pectoris) when taking Sogilen with levodopa
• Dizziness when standing up from a lying or sitting position (postural hypotension), especially in prolonged treatment
• Constipation, stomach pain or discomfort (dyspepsia), stomach inflammation (gastritis), vomiting
• General feeling of tiredness (asthenia)
• Changes in liver function tests, decrease in normal hemoglobin values and red blood cell count

Uncommon side effects (may affect up to 1 in 100 patients):

• Fluid accumulation in the membranes that cover the lungs (pleural effusion), formation of fibrous tissue in the lungs that makes breathing difficult (pulmonary fibrosis)
• Severe allergic reaction
• Excessive movement (hyperkinesia)
• Delirium, sudden onset of emotional disorder or delusional ideas (psychotic disorder)
• Episodes of reddening, increased temperature, and pain and inflammation of the limbs caused by heat or exercise (erythromelalgia)
• Fluid retention (edema), tiredness (fatigue)
• Liver function disorder
• Rash

Rare side effects (may affect up to 1 in 10,000 patients):

• Formation of fibrous tissue in an organ (fibrosis), including in the lungs

Side effects of unknown frequency (cannot be estimated from the available data):

• Respiratory disorders, decreased breathing capacity (respiratory failure), inflammation of the membranes that cover the lungs, chest pain
• Sudden onset of sleep, tremors
• Visual disturbances
• Aggressive behavior, obsessive sexual desire (hypersexuality), addiction to gambling
• Narrowing of the blood vessels in the fingers (digital vasoconstriction)
• Hair loss
• Leg cramps
• Increased levels of a type of enzyme (creatine phosphokinase) in the blood

In patients treated with Sogilen, there may be a need to make compulsive purchases or expenses and to eat in a compulsive manner.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report side effects 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 Sogilen

Do not use Sogilen after the expiration date stated on the package. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Sogilen 2 mg tablets

• The active substance is cabergoline.
• The other ingredients are anhydrous lactose and leucine.

Appearance of the product and pack contents

The tablets are white, oval, biconcave, and have a notch on one side. They are also engraved with the number "7" to the left of the notch and the inscription "02" to the right of the notch.

Sogilen 2 mg tablets are available in glass bottles with a screw cap made of aluminum sealed with a silica gel desiccant.

Sogilen 2 mg tablets are available in polyethylene bottles with a child-resistant polypropylene cap and a silica gel desiccant.

Each bottle contains 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Pfizer Italia S.R.L.

Località Marino del Tronto – 63100

Ascoli Piceno (AP)

Italy

Date of the last revision of this leaflet:October 2022

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