Sogilen 2 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SOGILEN 2 mg tablets

Cabergoline

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Sogilen is and what it is used for

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

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

2. What you need to know before taking 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 moderate or severe liver disease (hepatic insufficiency).
• If you are to be treated with Sogilen for a prolonged period and have heart valve abnormalities.
• If you have or have had fibrotic disorders (scar tissue formation) affecting the heart, lungs, or abdomen.

Warnings and precautions

Your doctor must carefully evaluate treatment with Sogilen if you have any heart rhythm disorders or severe heart disease.

Take special care with Sogilen under 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 fingers, ears, and nose due to interrupted blood flow). Your condition may worsen.
• If you have severe hepatic insufficiency, you may require a lower dose.
• If you have peptic ulcer disease or a history of gastrointestinal bleeding. The condition may recur.
• If you have a history of severe mental illness (psychosis). Symptoms of the disease may reappear.
• If you are taking medications that lower your blood pressure. Administration of Sogilen may cause postural hypotension (drop in blood pressure upon changing position), especially during the first days of treatment.
• If you experience drowsiness or sudden, unexpected episodes of falling asleep, even during routine daily activities. Your doctor may decide to reduce your dose or discontinue treatment with Sogilen.
• If during treatment you develop an increased or obsessive sexual desire.
• If during treatment you develop impulsive or compulsive gambling behavior.
• If during treatment you engage in compulsive spending or shopping.
• If during treatment you experience compulsive eating.

If you are to be treated with Sogilen for a prolonged period, your doctor will assess the condition of your heart, lungs, and kidneys before starting treatment. Your doctor will also perform an echocardiogram (a test using ultrasound waves to view the heart) before starting treatment and at regular intervals during treatment. If fibrotic reactions occur, treatment must be discontinued. You should not take Sogilen if you have or have had any of these disorders. Consult your doctor if you develop symptoms suggesting involvement of the lungs, kidneys, or heart, such as difficulty breathing, fatigue, persistent cough, chest or abdominal pain, fluid accumulation (edema), leg swelling, abdominal masses, or tenderness upon palpation.

Taking Sogilen with other medicines

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

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

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

• Dopamine antagonists (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide), as they may reduce the effect of Sogilen.
• A type of antibiotics called macrolides (such as erythromycin), which may increase the adverse effects of Sogilen.
• Other medicines containing ergot derivatives, as Sogilen must not be administered concomitantly with these medicines.

Taking Sogilen with food and drink

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 for at least one month after stopping treatment with Sogilen. If you become pregnant while taking Sogilen, consult your doctor immediately. Your doctor will assess whether treatment with this medicine should be discontinued and will take appropriate measures.

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

Driving and using machines

Sogilen may cause drowsiness and sudden episodes of falling asleep. If this occurs, you must not drive or perform activities where lack of attention could place you or others at risk of death or serious injury (e.g., operating machinery), until these episodes and/or drowsiness have resolved.

Sogilen contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Sogilen

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

Your doctor will determine the duration of your treatment with Sogilen. Do not stop treatment prematurely.

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

At the beginning of treatment, you will start by taking half a tablet of Sogilen 1 mg tablets (0.5 mg) or half a tablet of Sogilen 2 mg tablets (1 mg), once daily. The daily dose will be gradually increased until reaching the maintenance dose appropriate for your needs.

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

Use in elderly patients

Dose adjustment is not necessary in this patient group.

Use in patients with kidney problems

Dose adjustment is not necessary in this patient group.

Use in patients with mild liver problems

Dose adjustment is not necessary in this patient group.

If you take more Sogilen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

Always carry the packaging with you, whether or not any Sogilen tablets remain.

The following symptoms may occur: nausea, vomiting, stomach discomfort, decreased blood pressure, confusion, a type of mental disturbance 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 then continue as previously directed. Do not take a double dose to make up for missed doses.

If you stop taking Sogilen

Do not stop treatment before your doctor instructs you to do so, as your disease symptoms may return more intensely. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, Sogilen may produce adverse effects, although not everyone experiences them.

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

• Nausea
• Fluid retention
• Heart valve disorders (cardiac valvulopathy), inflammation of the membranes covering the heart (pericarditis), and accumulation of fluid in the membranes covering the heart (pericardial effusion)

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

• Sensation of difficulty breathing (dyspnea)
• Hallucinations, sleep disturbances, exaggerated sexual desire, confusion
• Headache, drowsiness, dizziness/vertigo, abnormal movements
• Pain and sensation of acute, suffocating tightness in the chest, usually located behind the sternum and sometimes radiating (angina pectoris) when Sogilen is taken together with levodopa
• Dizziness upon standing up when lying down or sitting (postural hypotension), especially during prolonged treatment
• Constipation, stomach pain or discomfort (dyspepsia), inflammation of the stomach (gastritis), vomiting
• Generalized feeling of tiredness (asthenia)
• Abnormal liver function tests, decreased haemoglobin levels and reduced number of red blood cells

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

• Accumulation of fluid in the membranes covering the lung (pleural effusion), formation of fibrous tissue in the lung impairing breathing (pulmonary fibrosis)
• Exaggerated allergic reaction
• Excessive movements (hyperkinesia)
• Delusions, sudden onset of emotional disturbance or delusional ideas (psychotic disorder)
• Episodes of redness, increased temperature, pain and inflammation in the extremities triggered by heat or exercise (erythromelalgia)
• Fluid retention (edema), tiredness (fatigue)
• Impaired liver function
• Rash

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Fibrous tissue formation in an organ (fibrosis), including in the lung

Adverse effects with unknown frequency (cannot be estimated from available data):

• Respiratory disorders, reduced ability to breathe (respiratory failure), inflammation of the membranes covering the lung, chest pain
• Sudden onset of sleep, tremor
• Visual disturbances
• Aggressive behaviour, obsessive sexual desire (hypersexuality), gambling addiction
• Constriction of blood vessels in the fingers (digital vasospasm)
• Hair loss
• Leg cramps
• Increase in a type of enzyme (creatine phosphokinase) in the blood

In patients treated with Sogilen, there may be an urge to make compulsive purchases or compulsive eating.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sogilen

Do not use Sogilen after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Instead, return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Sogilen 2 mg tablets

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

Appearance of the product and contents of the pack

The tablets are white, oval-shaped, biconcave, and have a score line on one side. The number “7” is engraved to the left of the score line and the inscription “02” to the right.

Sogilen 2 mg tablets are available in glass containers with an aluminum screw cap sealed with a silica gel desiccant.

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

Each container 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 most recent revision of this leaflet: October 2022

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