SOGILEN 1 mg TABLETS

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 you 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 especially 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 redness - of the fingers, ears, and nose, as a result of the interruption of blood flow to them). Your condition may worsen.
• If you have severe hepatic insufficiency, you may need a lower dose.
• If you have a peptic ulcer or a history of gastrointestinal bleeding. Your condition may recur.
• 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 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 your 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 lung, kidney, or heart 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 of 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 reduce 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 discontinuation of 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 interrupt milk production.

Driving and using machines

Sogilen may cause sleepiness and sudden episodes of sleep. If this happens, you should not drive vehicles or perform activities that require attention, 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. In case of 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 (0.5 mg) or one Sogilen 1 mg tablet (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 forgotten doses.

If you stop taking Sogilen

Do not stop treatment before your doctor tells you to, as your symptoms may return more intensely. You should consult your doctor before stopping treatment.

If you have any further questions on the use of this product, 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 people):

• 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 people):

• Difficulty breathing (dyspnea)
• Hallucinations, sleep disturbances, excessive sexual desire, confusion,
• Headache, sleepiness, dizziness/vertigo, abnormal movements
• Chest pain and a feeling of tightness and suffocation in the chest, usually centered behind the sternum, and sometimes radiating (angina pectoris) when taking Sogilen with levodopa
• Feeling of 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 decrease in red blood cell count

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

• 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 redness, increased temperature, and pain and inflammation of the limbs caused by heat or exercise (erythromelalgia)
• Fluid retention (edema), tiredness (fatigue)
• Liver function changes
• Rash

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

• 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
• Vision changes
• Aggressive behavior, obsessive sexual desire (hypersexuality), gambling addiction
• 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, the need to make compulsive purchases or eat compulsively may appear.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed 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 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. Return the packages and any unused medicine to the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sogilen 1 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 score line on one side. They are also engraved with the number "7" to the left of the score line and the inscription "01" to the right of the score line.

Sogilen 1 mg tablets are presented in glass bottles with a screw cap made of aluminum sealed with a silica gel desiccant.

Sogilen 1 mg tablets are presented in polyethylene bottles with a child-resistant polypropylene cap with 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 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