CLOPIXOL ACUFASE 50 mg/ml INJECTABLE SOLUTION

2. What you need to know before you take Clopixol Acufase

Do not take Clopixol Acufase

• If you are allergic (hypersensitive) to zuclopentixol or any of the other components of this medicine (listed in section 6).
• If you have a decreased level of consciousness.
• If you have circulatory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Clopixol Acufase if you:

• Suffer from a liver problem.
• Suffer from a severe respiratory disease.
• Suffer from Parkinson's disease, thyroid disorder, myasthenia gravis, pheochromocytoma, or prostatic hypertrophy.
• Have a history of seizures or fits.
• Suffer from diabetes (your antidiabetic therapy may need to be adjusted).
• Suffer from an organic brain syndrome (this 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 medicines that can cause changes in the electrocardiogram, to avoid this it should be used with caution in patients who have hypokalemia or hypomagnesemia (low potassium or magnesium in the blood) or genetic predisposition to cardiac disorders.
• Have a history of cardiovascular disorders.
• Use other antipsychotic medicines.

If you or a member of your family has a history of blood clots, as drugs in this group have been associated with the formation of blood clots.

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

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

Children and adolescents

Clopixol Acufase is not recommended in this group of patients.

Taking Clopixol Acufase with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Tricyclic antidepressants.
• Guanethidine and similar medicines (used to lower blood pressure).
• Barbiturates and similar medicines (their use with Clopixol may make you feel drowsy).
• Medicines used to treat epilepsy.
• Levodopa and similar medicines (used to treat Parkinson's disease).
• Metoclopramide (used in the treatment of gastrointestinal disorders).
• Piperazine (used in the treatment of worm and pinworm infections).
• Medicines that cause changes in the hydro-saline balance (too little potassium or magnesium in the blood).
• Medicines that are known to increase the concentration of Clopixol Acufase in the blood.

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

• Medicines that change heartbeats (e.g. quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium).
• Other antipsychotic medicines (e.g. thioridazine).

Taking Clopixol Acufase with alcohol

Clopixol Acufase may increase the sedative effects of alcohol, causing drowsiness. 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 medicine.

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

You should not use Clopixol Acufase during breastfeeding, as small amounts of the medicine 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): tremors, muscle stiffness and/or weakness, tendency to sleep, agitation, breathing problems, and difficulty feeding.

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

Animal studies have shown that Clopixol affects fertility. Please consult your doctor.

Driving and using machines

Clopixol may cause symptoms such as drowsiness, dizziness, or changes in vision, and may decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

3. How to take Clopixol Acufase

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

A small volume of Clopixol Acufase is drawn 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.

Elderly patients (over 65 years)

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 end of the dose range.

Use in children

Clopixol Acufase is not recommended in children.

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

Duration of treatment

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

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

It is important that you complete the course of treatment exactly as your doctor has indicated.

If you take more Clopixol Acufase than you should

This medicine 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 medicine and the amount administered.

The symptoms of overdose may include:

• Drowsiness.
• Coma.
• Abnormal movements.
• Seizures.
• Shock.
• High or low body temperature.
• Changes in heartbeats, including irregular heartbeats or slow heart rate, have been observed when Clopixol Acufase is administered in overdose along with drugs that are known to affect the heart.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Abnormal 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 it occurs with sweating and rapid heartbeat. These symptoms may be signs of a rare condition called neuroleptic malignant syndrome that has been reported with the use of different antipsychotics.

• Yellowing of the skin and whites of the eyes; this may mean 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):

• Rapid heartbeat (tachycardia), feeling of rapidity, force, or irregular heartbeats (palpitations).
• Tremors, 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), attention disorder, amnesia, abnormal gait.
• Difficulty focusing objects near the eye (accommodation disorder), vision abnormalities.
• Feeling of spinning or swaying when standing (vertigo).
• 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 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 unease (malaise), pain.
• Insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, decreased sexual desire (decreased libido).

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

• Overactive or overresponsive (hyperreflexia), jerky movements (dyskinesia), parkinsonism, fainting (syncope), inability to coordinate muscle activity (ataxia), speech disorder, decreased muscle tone (hypotonia), seizures, migraine.
• Circular movements of the eyes (oculogyration), dilated pupils (mydriasis).
• Increased sensitivity to certain sound frequencies or difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus).
• Abdominal pain, flatulence.
• Rash, skin reaction due to sensitivity to light (photosensitive reaction), skin pigmentation disorder, greasiness, shininess, and yellowish color of the skin due to increased sebum secretion (seborrhea), eczema or skin inflammation (dermatitis), bleeding under the skin observed as purple or red discolorations on the skin (purpura).
• Muscle stiffness, inability to open the mouth normally (trismus), twisting of the neck and an unnatural position of the head (torticollis, neck twist, neck stiffness).
• Decreased appetite, weight loss.
• Low blood pressure (hypotension), hot flashes.
• Dryness, low body temperature (hypothermia), fever (pyrexia).
• Redness or pain at the injection site of Clopixol Acufase.
• Abnormal liver function tests.
• Sexual disorder (delayed ejaculation, erection problems, women may have difficulty reaching orgasm, vaginal dryness (vulvovaginal dryness)).
• Marked indifference to one's surroundings (apathy), nightmares, increased sexual desire (increased libido), state of 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), reduction in the number of white blood cells in the blood (leukopenia), bone marrow poisoning (agranulocytosis).
• Increased prolactin level in the blood (hyperprolactinemia).
• High blood sugar (hyperglycemia), altered glucose tolerance, increased blood fat levels (hyperlipidemia).
• Excessive 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 acetate (the active substance of Clopixol Acufase), the following side effects have been reported in rare cases:

• Prolonged QT interval (slow heartbeat and change in ECG).
• Irregular heartbeats (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia).
• Torsades de Pointes (a special type of irregular heartbeat).

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

Blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs), can 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 who do not take them.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopixol Acufase

Normally, your doctor or nurse will keep this medicine for you.

If you store it at home:

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

Do not use this medicine after the expiration date that appears on the packaging after EXP.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Clopixol Acufase

The active substance is zuclopentixol acetate.

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

The other component is medium-chain triglycerides.

Appearance of the product and packaging contents

Clopixol Acufase 50 mg/ml injectable solution is presented in glass ampoules containing 1 ml (50 mg) in a cardboard box.

Clopixol Acufase is a clear, yellowish liquid.

Not all presentations may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Lundbeck España, S.A.

Av. Diagonal, 605, 7º-2ª

08028 Barcelona

Spain

Tel.: 93 494 96 20

Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Date of last revision of this leaflet: January 2014

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/