Package Insert: Information for the User

SOGILEN 2 mg Tablets

Cabergoline

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Sogilen belongs to a group of medications known as dopamine agonists, which stimulate dopamine receptors in the brain.

Sogilen is used, if another type of medication is not tolerated or is not effective, for the treatment of Parkinson's disease associated with levodopa administered in combination with a dopa-decarboxilase inhibitor.

Do not take Sogilen

-If you are allergic to the active ingredient cabergoline, to any ergot alkaloid, or to any of the other components of Sogilen (listed in section 6).

• If you have liver disease (hepatic insufficiency) of moderate or severe degree.
• If you are to be treated with Sogilen for a prolonged period and have any of your heart valves affected.
• 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 evaluate the treatment with Sogilen if you have any heart rhythm disorder or severe heart disease.

Be especially careful with Sogilen in the following circumstances:

• If you have severe cardiovascular disease or Raynaud's syndrome (sudden changes in color -paleness and/or blue discoloration followed by redness- of the fingers, ears, and nose, as a result of the interruption of blood flow to these areas). Your condition may worsen.
• If you have severe liver disease, you may need a lower dose.
• If you have a history of peptic ulcers or have had gastrointestinal bleeding. Your previous condition may recur.
• If you have a history of severe mental illness (psychosis). You may experience symptoms of the disease.
• If you take medications that lower your blood pressure. The administration of Sogilen may cause postural hypotension (a drop in blood pressure when changing position), especially during the first few days of treatment.
• If you experience drowsiness or sudden onset of sleep, even during daily activities you perform. Your doctor may decide to reduce your dose or discontinue treatment with Sogilen.
• If during treatment you develop an increased sex drive or obsessive sex drive.
• If during treatment you notice altered behavior related to gambling.
• If during treatment you make compulsive purchases.
• If during treatment you eat compulsively.

In the event of being treated with Sogilen for a prolonged period, your doctor will evaluate whether your heart, lungs, and kidneys are in good condition before starting treatment. 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 suspended. If you have or have had any of these disorders, do not take Sogilen. Consult your doctor if you experience symptoms that may suggest lung, kidney, or heart involvement, such as difficulty breathing, fatigue, persistent cough, chest or abdominal pain, fluid accumulation (edema) or swelling of the legs, masses, or pain upon palpation in the abdomen.

Taking Sogilen with other medications

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

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

It is especially important to inform your doctor if you take any of the following medications:

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

-Other medications containing ergot derivatives, as Sogilen should not be administered concurrently with these medications.

Taking Sogilen with food and beverages

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 intend to become pregnant, consult your doctor or pharmacist before taking this medication.

It is recommended to use contraceptive methods during treatment with Sogilen. You should avoid becoming pregnant for at least a month after discontinuing treatment with Sogilen. If you become pregnant during treatment with Sogilen, you should consult your doctor immediately, who will evaluate the advisability of discontinuing treatment with this medication and take the necessary measures.

The passage of Sogilen into breast milk is unknown. However, it is not recommended to take Sogilen during breastfeeding, as it is likely to interrupt milk production.

Driving and operating machinery

Sogilen may cause drowsiness and cause sudden onset of sleep. If this happens, do not drive vehicles or perform activities in which a lack of attention may put you or others at risk of death or serious injury (e.g., operating machinery), until these episodes and/or drowsiness have disappeared.

Sogilen contains lactose

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 Sogilen as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will inform you of 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 beginning of treatment, you will start taking half a tablet of Sogilen 1mg tablets (0.5mg) or half a tablet of Sogilen 2mg tablets (1mg), once a day. The daily dose will be gradually increased to reach the appropriate maintenance dose for your needs.

The usual maintenance dose is 2mg to 3mg per day, taken in a single dose along 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 medication and the amount ingested..

Always carry the packaging 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 alteration 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 compensate for the missed doses.

If you interrupt treatment with Sogilen

Do not discontinue treatment before your doctor tells you to, as your disease symptoms may return more intensely. You must consult with your doctor before discontinuing treatment.

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

Like all medicines, Sogilen may cause side effects, although not everyone will experience them.

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

• Nausea
• Fluid retention
• Alterations in heart valves (cardiac valvulopathy), inflammation of the heart membranes (pericarditis), and accumulation of fluid in the heart membranes (pericardial effusion)

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

• Difficulty breathing (dyspnea)
• Hallucinations, sleep disturbances, excessive sexual desire, confusion,
• Headache, drowsiness, dizziness/dizziness, abnormal movements
• Sharp chest pain and a feeling of suffocation, usually located behind the sternum, and sometimes radiating (angina pectoris)
• Dizziness when getting up from lying down or sitting (postural hypotension), especially with prolonged treatment
• Constipation, stomach pain or discomfort (dyspepsia), stomach inflammation (gastritis), vomiting
• Generalized feeling of fatigue (asthenia)
• Abnormal liver function test results, decreased normal hemoglobin values and red blood cell count

Rare side effects (may affect up to one in 100 patients):

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

Very rare side effects (may affect up to one in 10,000 patients):

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

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

• Respiratory disorders, decreased ability to breathe (respiratory insufficiency), inflammation of the lung membranes, chest pain
• Sudden onset of sleep, tremors
• Visual disturbances
• Aggressive behavior, obsessive sexual desire (hypersexuality), gambling addiction
• Narrowing of the blood vessels in the fingers (digital vasospasm)
• Hair loss
• Leg cramps
• Increased levels of a certain enzyme (creatine phosphokinase) in the blood

In patients treated with Sogilen, compulsive spending or buying and compulsive eating may occur.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Sogilen 2 mg tablets

• The active ingredient is cabergoline.
• The other components are anhydrous lactose and leucine.

Appearance of the product and contents of the packaging

The tablets are white, oval, bicavous, and have a groove on one of their faces. They also have the number “7”engraved to the left of the groove and the inscription “02” to the right of the same.

Sogilen 2 mg tablets are presented in glass containers with a screw-top aluminum closure sealed with silica gel desiccant.

Sogilen 2 mg tablets are presented in polyethylene containers with a polypropylene cap that is child-resistant and sealed with silica gel desiccant.

Each container contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Pfizer Italia S.R.L.

Località Marino del Tronto – 63100

Ascoli Piceno (AP)

Italy

Last review date of this leaflet:October 2022

The 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