Leaflet: information for the user

Clopixol Acufase 50 mg/ml injectable solution

zuclopentixol acetate

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 Acufase contains the active ingredient zuclopentixol. Clopixol Acufase 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 Acufase is indicated for the treatment of chronic and subchronic schizophrenia, especially in agitated and/or aggressive patients.

Initiation of treatment in the acute phase.

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

Do not take Clopixol Acufase

• 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 Acufase if you:

• Have a liver problem.
• Have a severe respiratory disease.
• Have Parkinson's disease, thyroid disorder, myasthenia gravis, phaeochromocytoma, or benign prostatic hypertrophy.
• Have a history of seizures or convulsions.
• 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 (e.g. smoker, hypertension).
• Clopixol belongs to a group of medications that can cause alterations in the electrocardiogram, so it should be used with caution in patients with hypopotasemia or hypomagnesemia (low potassium or magnesium in the blood) or genetic predisposition to cardiac alterations.
• Have a history of cardiovascular disorders.
• Are taking other antipsychotic medications.

If you or a family member has a history of blood clots, as medications 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 in the blood.

With the use of different antipsychotics, a rare but serious condition called neuroleptic malignant syndrome has been reported, characterized by signs such as high fever, unusual muscle rigidity, 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 section on possible side effects).

Children and adolescents

Clopixol Acufase is not recommended for this group of patients.

Taking Clopixol Acufase with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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).
• Metoclopramide (used in the treatment of gastrointestinal disorders).
• Piperazina (used in the treatment of worm and oxyuris 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 Acufase in the blood.

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

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

Taking Clopixol Acufase with alcohol

Clopixol Acufase may increase the sedative effects of alcohol, making you feel drowsy. It is recommended not to drink alcohol during treatment with Clopixol Acufase.

Pregnancy, breastfeeding, and fertility

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

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

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

The following symptoms may appear in newborns of mothers who took 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 condition, 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. Your doctor will decide on the correct volume of medication and the frequency at which it should be administered.

A small volume of Clopixol Acufase is drawn up into the syringe and then injected intramuscularly into your buttock.

The recommended dose is:

Adults

The usual dose is an injection of 1 to 3 ml (50 to 150 mg/day). This may be repeated after an interval of 2 to 3 days. Some patients may need an additional injection 1 or 2 days after the first injection.

If your dose exceeds 2 ml, it should be divided between two injection sites.

Patients over 65 years old

The dose may need to be reduced. The maximum dose per injection should be 100 mg.

Patients with special risks

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

Use in children

Clopixol Acufase is not recommended for children.

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

Treatment duration

This medication should not be used for long-term treatment. The treatment duration should not be more than 2 weeks. During this time, no more than 4 injections or a total of 8 ml (400 mg) of medication should be administered.

If further treatment is required, your doctor will prescribe the appropriate medication.

It is essential that you complete the treatment course exactly as instructed by your doctor.

If you take more Clopixol Acufase than you should

This medication will be administered by your doctor/nurse, so it is unlikely that you will receive more Clopixol Acufase than you should.

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

The symptoms of overdose may include:

• Drowsiness.
• Coma.
• Unusual movements.
• Seizures.
• Shock.
• Abnormal body temperature, either high or low.
• Changes in heart rhythm, including irregular heartbeats or slow heart rate, have been observed when Clopixol Acufase was administered in overdose along with medications known to affect the heart.

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 the white 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 standing (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 balance 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 (photoreaction), pigment disorder, greasiness, shine, and yellowish color of the skin due to increased sebum secretion (seborrhea), eczema or skin inflammation (dermatitis), hematomas under the skin observed as purpura or red discolorations on the skin.
• 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).
• Redness or pain of the skin where Clopixol Acufase was administered.
• Abnormal liver function tests.
• Sexual disorder (delayed ejaculation, erection problems, women may experience difficulty reaching orgasm, vaginal 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, unaccompanied by sexual excitement or desire (priapism).

As with other medicines that act similarly to zuclopentixol acetate (the active ingredient in Clopixol Acufase), 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 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 Vigilance 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.

Your doctor or nurse will normally store this medication for you.

If you store it at home:

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.

Store the ampoules in the outer packaging to protect from light.

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

Clopicxol Acufase Composition

The active ingredient is zuclopentixol acetate.

Each milliliter (ml) of Clopicxol Acufase contains 50 mg of zuclopentixol acetate.

The other component is medium-chain triglycerides.

Product appearance and packaging contents

Clopicxol Acufase 50 mg/ml injectable is presented in glass vials containing 1ml (50 mg) in a cardboard package.

Clopicxol Acufase is a clear, yellowish liquid.

Not all presentations may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Lundbeck España, S.A.

Av. Diagonal, 605, 7º-2ª

08028 Barcelona

Spain

Tel.: 93 494 96 20

Manufacturer responsible

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Last review date of this leaflet: January 2014

Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/