Leaflet: information for the user

Clopixol 10 mg film-coated tablets

Zuclopentixol

Read this leaflet carefully before you start taking this medicine, because 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 must 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 leaflet. See section 4.

Clopixol contains the active ingredient zuclopentixol. Clopixol belongs to a group of medicines called antipsychotics (also known as neuroleptics).

These medicines act on the nervous pathways in specific areas of the brain and help correct certain chemical imbalances in the brain that produce the symptoms of your disease.

Clopixol is used for the treatment of chronic and subchronic schizophrenia, with acute crises, especially in agitated and/or aggressive patients.

Your doctor, however, may prescribe Clopixol for another purpose. Talk to your doctor for any questions about why you have been prescribed Clopixol.

Do not take Clopixol

• If you are allergic (hypersensitive) to zuclopentixol or any of the other components of this medication (listed in section 6).
• If you have a decrease in consciousness.
• If you have circulatory insufficiency.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Clopixol if you: Have a liver problem (liver disease).
• Have a severe respiratory disease.
• Have Parkinson's disease, thyroid dysfunction, myasthenia gravis, phaeochromocytoma, or benign prostatic hypertrophy.
• Have a history of seizures or fits.
• Have diabetes (may need to adjust your antidiabetic therapy).
• Have an organic cerebral syndrome (may be a condition resulting from poisoning with alcohol or organic solvents).
• Have risk factors for stroke (cerebral infarction), e.g. smoker, hypertension.
• Clopixol belongs to a group of medications that can cause alterations in the electrocardiogram, to avoid this, it should be used with caution in patients who have hypopotasemia or hypomagnesemia (low potassium or magnesium in the blood) or genetic predisposition to cardiac alterations.
• Have a history of cardiovascular disorders.
• Are using other antipsychotic medications.
• You or a family member has a history of blood clots, as drugs in this group have been associated with the formation of blood clots.

If you have persistent infection symptoms, consult your doctor, as this may be indicative of a decrease in white blood cells (leukocytes) in the blood.

A very rare but serious condition called neuroleptic malignant syndrome has been reported with the use of different antipsychotics, characterized by signs such as high fever, unusual muscle stiffness, and altered consciousness, especially if it occurs with sweating and rapid heart rate. If you experience these symptoms, they may be indicative of this condition and you should consult your doctor (see possible side effects section).

Children and adolescents

Clopixol is not recommended for this group of patients.

Taking Clopixol with other medications

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

Inform your doctor or pharmacist if you are taking any of the following medications:

• Tricyclic antidepressants.
• Guanetidina and similar medications (used to lower blood pressure).
• Barbiturates and similar medications (use with Clopixol may make you feel drowsy).
• Medications used to treat epilepsy.
• Levodopa and similar medications (used to treat Parkinson's disease).
• Metoclopramida (used in the treatment of gastrointestinal disorders).
• Piperazina (used in the treatment of worm and pinworm infections).
• Medications that cause alterations in hydro-saline balance (too little potassium or magnesium in the blood).
• Medications that are known to increase the concentration of Clopixol in the blood.

The following medications cannot be taken at the same time as Clopixol:

• Medications that change heartbeats (e.g. quinidina, amiodarona, sotalol, dofetilida, eritromicina, terfenadina, astemizol, gatifloxacino, moxifloxacino, cisaprida, litio).
• Other antipsychotic medications.

Taking Clopixol with food and alcohol

Clopixol can be taken with or without food.

Clopixol may increase the sedative effects of alcohol, causing drowsiness. It is recommended not to drink alcohol during treatment with Clopixol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Do not take Clopixol if you are pregnant unless it is clearly necessary.

Do not use Clopixol during breastfeeding as small amounts of the medication may pass into breast milk.

The following symptoms may appear in newborns of mothers who have taken Clopixol during the third trimester (last three months of pregnancy): tremor, rigidity, and/or muscle weakness, tendency to sleep, agitation, respiratory problems, and difficulty feeding.

If your baby experiences any of these symptoms, you should contact your doctor.

Studies in animals have shown that Clopixol affects fertility. Please consult your doctor.

Driving and operating machinery

Clopixol may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Clopixol contains lactose and hydrogenated ricin oil

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Hydrogenated ricin oil may cause stomach discomfort and diarrhea.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose varies significantly and depends on the severity of the disease.

The recommended dose is:

Adults

The usual starting dose is between 20 mg and 30 mg per day, which can be gradually increased to a maximum of 150 mg per day, divided into several doses.

In some cases, a significant increase in dose may be required. The maximum dose is 150 mg per day.

The maintenance dose is usually 20-40 mg per day.

Older patients

The dose is normally between 2 mg and 6 mg per day taken in the evening. The dose can be increased to 10-20 mg per day.

Patients with special risks

Patients with liver problems usually receive the lowest range of the dose.

Use in children

Clopixol is not recommended for children.

If you feel that the effect of Clopixol is too strong or too weak, talk to your doctor or pharmacist.

How and when to take Clopixol

Swallow the tablets with a glass of water. Do not chew them.

At the beginning of treatment, Clopixol should be taken normally in 2 or 3 separate doses during the day.

In maintenance treatment, Clopixol can be taken as a single daily dose.

Duration of treatment

As with other psychosis medications, it may take a couple of weeks before you start to feel better.

Your doctor will decide the duration of treatment. Follow the recommended dosage by your doctor. The underlying disease may persist for a long time, and if you interrupt your treatment too soon, your symptoms may reappear.

Never change the dose of your medication without talking to your doctor first.

If you take more Clopixol than you should

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

The symptoms of overdose may include:

• Drowsiness.
• Unconsciousness.
• Unusual muscle movements or stiffness.
• Seizures.
• Low blood pressure, weak pulse, rapid heart rate, pallor, restlessness.
• High or low body temperature.
• Abnormal heartbeats, including irregular heartbeats or slow heart rate, have been observed when Clopixol was administered in overdose with medications known to affect the heart.

If you forgot to take Clopixol

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Clopixol

Your doctor will decide when and how to interrupt your treatment to avoid unpleasant symptoms that may occur if you stop treatment abruptly (e.g., difficulty sleeping, muscle stiffness, feeling unwell).

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you have any of the following symptoms, contact your doctor or go to the hospital immediately.

Rare (May affect up to 1 in 100 people):

• Unusual movements of the mouth and tongue.

This may be an initial sign of a condition called tardive dyskinesia.

Very rare (May affect up to 1 in 10,000 people):

• High fever, unusual muscle stiffness, and altered consciousness, especially if accompanied by sweating and rapid heart rate. These symptoms may be signs of a rare condition called neuroleptic malignant syndrome, which has been reported with the use of different antipsychotics.

• Yellowing of the skin and whitening of the eyes; this may indicate that your liver is affected and is a sign of a condition known as jaundice.

The following side effects are more pronounced at the beginning of treatment and most of them usually disappear during continued treatment.

Very common (May affect more than 1 in 10 people):

• Drowsiness (somnolence), difficulty sitting or staying upright (akathisia),

involuntary movements (hyperkinesia), slow or decreased movements (hypokinesia).

• Dry mouth.

Common (May affect up to 1 in 10 people):

• Fast heart rate (tachycardia), sensation of rapidness, force, or irregular heartbeats (palpitations).
• Tremor, circles, or repetitive movements or abnormal postures due to continuous muscle contractions (dystonia), increased muscle stiffness (hypertonia), dizziness, headache, sensation of tingling, itching, or numbness of the skin (paresthesia), alteration in attention, amnesia, abnormal gait.
• Difficulty focusing on objects close to the eye (accommodation disorder), visual abnormalities.
• Sensation of dizziness or spinning when the body is standing (vertigo).
• Blockage of nasal passages (nasal congestion), difficulty breathing or painful breathing (dyspnea).
• Increased salivation (hypersalivation), constipation, vomiting, digestive problems or discomfort centered in the upper abdomen (dyspepsia), diarrhea.
• Urinary tract disorder (urinary retention), increased urine volume (polyuria).
• Increased sweating (hyperhidrosis), itching (pruritus).
• Muscle pain (myalgia).
• Increased appetite, weight gain.
• Fatigue, weakness (asthenia), general feeling of discomfort or restlessness (malaise), pain.
• Insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, decreased sexual behavior (decreased libido).

Rare (May affect up to 1 in 100 people):

• Hyperactive or hyperresponsive (hyperreflexia), interrupted movements (dyskinesia), parkinsonism, fainting (syncope), inability to coordinate muscle activity (ataxia), speech disorder, decreased muscle tone (hypotonia), seizures, migraine.
• Circular eye movements (oculogyric crisis), dilated pupils (mydriasis).
• Increased sensitivity to certain sound frequencies or difficulty tolerating daily sounds (hyperacusis), ringing in the ears (tinnitus).
• Abdominal pain, flatulence.
• Rash, skin reaction due to light sensitivity (photosensitivity reaction), pigment disorder, greasiness, shine, and yellowish color of the skin due to increased sebum secretion (seborrhea), eczema or skin inflammation (dermatitis), hemorrhage under the skin observed as purpura or red discolorations on the skin (purpura).
• Muscle stiffness, inability to open the mouth normally (trismus), neck twists and unnatural head position (torticollis, neck strain, neck stiffness).
• Decreased appetite, weight loss.
• Low blood pressure (hypotension), hot flashes.
• Thirst, abnormally low body temperature (hypothermia), fever (pyrexia).
• Abnormal liver function tests.
• Sexual disorder (delayed ejaculation, erection problems, women may experience difficulty reaching orgasm, vaginal dryness (vulvovaginal dryness)).
• Marked indifference to the environment (apathy), nightmares, increased sexual behavior (increased libido), confusion.

Rare (May affect up to 1 in 1,000 people):

• Low platelet count in the blood (thrombocytopenia), low white blood cell count in the blood (neutropenia), reduced number of white blood cells in the blood (leucopenia), bone marrow poisoning (agranulocytosis).
• Increased prolactin levels in the blood (hyperprolactinemia).
• Elevated blood sugar (hyperglycemia), altered glucose tolerance, increased levels of blood fat (hyperlipidemia).
• Increased sensitivity (hypersensitivity), acute and severe systemic allergic reaction (anaphylactic reaction).
• Development of breasts in men (gynecomastia), excessive milk production (galactorrhea), absence of menstrual periods (amenorrhea), painful and persistent erection of the penis, not accompanied by sexual excitement or desire (priapism).

As with other medicines that act similarly to zuclopentixol (the active ingredient of Clopixol), the following side effects have been reported in rare cases:

• Lengthening of the QT interval (slow heart rate and ECG change).
• Irregular heartbeats (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia).
• Torsades de Pointes (a special type of irregular heartbeats).

In rare cases, irregular heartbeats (arrhythmias) may result in sudden death.

Clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs), may move through the blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

In elderly patients with dementia, a small increase in the number of deaths has been reported in those patients taking antipsychotics compared to those not taking them.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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.

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

Do not use this medication after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Clopixol Composition

The active ingredient is zuclopentixol (as dihydrochloride).

Each film-coated tablet contains 10 mg of zuclopentixol as dihydrochloride.

The other components are: potato starch, lactose monohydrate, microcrystalline cellulose, copovidone, 85% glycerol, talc, hydrogenated ricin oil, and magnesium stearate.

Coating: hypromellose 5 and macrogol 6000.

Colorants: titanium dioxide (E-171) and iron oxide red (E-172).

Product appearance and packaging contents

Clopicxol is presented in film-coated tablet (tablet) packaging of 10 mg.

Description of the film-coated tablets:

The 10 mg film-coated tablets are, round, biconvex, light reddish-brown.

Clopicxol film-coated tablets are available in packaging containing 30 or 50 tablets.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Lundbeck España, S.A.

Av. Diagonal, 605, 7º2ª

E-08028 Barcelona

Tel.: 93 494 96 20

Manufacturer responsible

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Last review date of this leaflet: February 2017

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/