Clopixol-acuphase

Leaflet accompanying the packaging: information for the user

Clopixol Acuphase, 50 mg/ml, solution for injection

Zuclopenthixol acetate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

• 1. What is Clopixol Acuphase and what is it used for
• 2. Important information before using Clopixol Acuphase
• 3. How to use Clopixol Acuphase
• 4. Possible side effects
• 5. How to store Clopixol Acuphase
• 6. Contents of the packaging and other information

1. What is Clopixol Acuphase and what is it used for

How Clopixol Acuphase works

Clopixol Acuphase contains the active substance zuclopenthixol. Clopixol Acuphase belongs to a group of medicines called antipsychotics (also called neuroleptics). These medicines work on the nerve pathways in certain areas of the brain and help to balance some of the natural chemicals in the brain that may be disturbed in patients with schizophrenia.

What Clopixol Acuphase is used for

Clopixol Acuphase is used in the initial treatment of acute schizophrenia, including mania and exacerbation of chronic schizophrenia.

2. Important information before using Clopixol Acuphase

When not to use Clopixol Acuphase:

• if you are allergic (hypersensitive) to zuclopenthixol acetate or any of the other ingredients of this medicine (listed in section 6).
• if you have circulatory collapse, impaired consciousness (e.g. due to alcohol, barbiturates or opioids) or coma.

Warnings and precautions

Before starting treatment with Clopixol Acuphase, discuss with your doctor or pharmacist:

• if you have liver function disorders;
• if you have had seizures in the past;
• if you have diabetes (your antidiabetic treatment may need to be adjusted);
• if you have an organic brain syndrome (a disease that may develop as a result of alcohol or organic solvent poisoning);
• if you have risk factors for stroke (e.g. smoking, hypertension);
• if you have hypokalemia (low potassium levels in the blood) or hypomagnesemia (low magnesium levels in the blood) or genetic predispositions to such disorders;
• if you have had cardiovascular disorders in the past;
• if you are taking other antipsychotic medicines;
• if you or a family member have had blood clots, as the use of medicines like this one is associated with the formation of blood clots.

Children and adolescents

Clopixol Acuphase is not recommended for use in this patient group.

Clopixol Acuphase with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.

• tricyclic antidepressants;
• guanethidine and similar medicines (that lower blood pressure);
• barbiturates and similar medicines (that cause drowsiness);
• medicines used to treat epilepsy;
• levodopa and similar medicines (used to treat Parkinson's disease);
• metoclopramide (a medicine used to treat gastrointestinal disorders);
• piperazine (an antiparasitic medicine that acts on pinworms and roundworms);
• medicines that disrupt water and electrolyte balance (too little potassium or magnesium in the blood);
• medicines known to increase blood levels of zuclopenthixol acetate, the active substance of Clopixol Acuphase.

The following medicines should not be taken at the same time as Clopixol Acuphase:

• medicines that change heart action (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
• other antipsychotic medicines (e.g. thioridazine).

Clopixol Acuphase with food, drink and alcohol

Clopixol Acuphase may enhance the sedative effect of alcohol, causing drowsiness. It is not recommended to drink alcoholic beverages while taking Clopixol Acuphase.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant or think you may be pregnant, tell your doctor. Clopixol Acuphase should not be used in pregnant women unless it is clearly necessary.

Breastfeeding

If you are breastfeeding, consult your doctor. Clopixol Acuphase should not be used by breastfeeding women, as small amounts of the medicine may be excreted in breast milk.

Fertility

Animal studies have shown that Clopixol affects fertility. You should consult your doctor for advice.

Driving and using machines

There is a risk of drowsiness and dizziness after using Clopixol Acuphase. If this happens, do not drive vehicles, operate machinery or use tools until these symptoms have resolved.

3. How to use Clopixol Acuphase

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

A small volume of Clopixol Acuphase is drawn into a syringe and then injected into the gluteal muscle.

Your doctor will decide on the dose and frequency of injections.

Recommended dose

Adults

The usual dose of the medicine is 50 mg to 100 mg (1 to 3 ml), given intramuscularly, and the dose can be repeated if necessary, preferably at intervals of 2 to 3 days. In some patients, an additional injection may be required after 24 or 48 hours after the first administration.

Zuclopenthixol acetate is not intended for long-term administration and treatment should not last longer than two weeks. The maximum cumulative dose during one course of treatment should not exceed 400 mg, and the number of injections should not exceed four.

In maintenance treatment, therapy should be continued by administering zuclopenthixol orally or zuclopenthixol decanoate intramuscularly, according to the following instructions.

• 1)Switching to oral zuclopenthixol hydrochlorideTwo to three days after the last injection, the patient treated with zuclopenthixol acetate at a dose of 100 mg takes zuclopenthixol hydrochloride orally at a dose of approximately 40 mg per day, if possible in divided doses. If necessary, the dose can be increased by 10-20 mg every 2 to 3 days to a dose of 75 mg per day or higher.
• 2) Switching to zuclopenthixol decanoate administrationAt the same time as (the last) injection of zuclopenthixol acetate (100 mg), the patient receives 200-400 mg (1 to 2 ml) of zuclopenthixol decanoate intramuscularly at a concentration of 200 mg/ml. The injection should be repeated every two weeks. Higher doses or shorter intervals between injections may be required.

Zuclopenthixol acetate and zuclopenthixol decanoate can be mixed in a syringe and administered in a single injection.

Elderly patients (over 65 years)

In elderly patients, it may be necessary to reduce the dose. The maximum dose given in a single injection should be 100 mg.

Use in children

Clopixol Acuphase is not recommended for use in children.

Patients with renal impairment

Patients with renal impairment can be given Clopixol Acuphase in the usual doses.

Patients with hepatic impairment

Patients with hepatic impairment should receive half the recommended dose and, if possible, it is recommended to monitor the blood levels of the medicine.

Method of administration

Clopixol Acuphase is administered by intramuscular injection into the upper outer quadrant of the buttock. If the volume of the injected medicine is greater than 2 ml, the divided dose should be injected into two different sites. Local tolerance is good.

If you feel that the effect of Clopixol Acuphase is too strong or too weak, ask your doctor.

Duration of treatment

This medicine is not intended for long-term therapy. Clopixol Acuphase should not be used for more than two weeks and during this time the patient should not receive more than four injections or a total of 8 ml (400 mg) of the medicine.

If further treatment is necessary after the end of Clopixol Acuphase treatment, your doctor will prescribe a suitable medicine.

It is important to complete the entire course of therapy as directed by your doctor.

Using a higher dose of Clopixol Acuphase than recommended

The medicine will be administered by a doctor or nurse and it is unlikely that you will receive a dose higher than recommended.

Symptoms of overdose may include:

• drowsiness;
• coma;
• abnormal movements;
• seizures;
• shock;
• increased or decreased body temperature;
• changes in heart rate, including irregularity or slowing of the heart rate, when Clopixol Acuphase is given in too high a dose in combination with medicines known to affect the heart.

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

4. Possible side effects

Like all medicines, Clopixol Acuphase can cause side effects, although not everybody gets them.

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

Uncommon side effects (occurring in 1 in 1000 to 1 in 100 patients):

• involuntary rhythmic movements of the lips and tongue; this may be a sign of a condition called tardive dyskinesia.

Rare but serious side effects (occurring in less than 1 in 10,000 patients):

• high fever, excessive muscle stiffness and impaired consciousness, with sweating and rapid heart rate; these may be symptoms of a rare condition called malignant neuroleptic syndrome, which can occur with the use of various antipsychotic medicines.
• yellowing of the skin and whites of the eyes (jaundice), which may indicate liver damage.
• blood clots in the veins, especially in the veins of the legs (symptoms include: swelling, pain and redness of the skin of the legs), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing.

The following side effects are most pronounced at the beginning of treatment and most of them disappear as treatment continues.

Very common side effects (occurring in more than 1 in 10 patients):

• drowsiness, inability to sit or stand for long periods without moving (akathisia), involuntary movements (hyperkinesia), slow or impaired movements (hypokinesia);
• dry mouth.

Common side effects (occurring in more than 1 in 100 and less than 1 in 10 patients):

• rapid heartbeat (tachycardia), feeling of rapid, strong or irregular heartbeat (palpitations);
• tremors, twisting or repetitive movements or abnormal postures due to continuous muscle contraction (dystonia), increased muscle stiffness (hypertonia), dizziness, headache, feeling of tingling of the skin (paresthesia), attention disorders, memory loss, abnormal gait;
• visual disturbances, blurred vision, abnormalities of vision;
• feeling of spinning or swaying when the body is at rest (dizziness);
• “stuffy nose”, difficulty breathing or painful breathing (dyspnea);
• increased salivation, constipation, vomiting, gastrointestinal problems or feeling of discomfort located in the upper abdomen (indigestion), diarrhea;
• urination disorders, urinary retention, increased urine output (polyuria);
• excessive sweating, itching (pruritus);
• muscle pain;
• increased appetite, weight gain;
• fatigue, feeling of weakness (asthenia), general feeling of discomfort or anxiety, pain;
• insomnia, depression, anxiety, nervousness, abnormal dreams, agitation, decreased libido;

Uncommon side effects (occurring in more than 1 in 1,000 and less than 1 in 100 patients):

• excessive reflexes (hyperreflexia), non-smooth movements (dyskinesia), parkinsonism, falls (syncope), inability to coordinate muscle movements (ataxia), speech disorders, decreased muscle tone (hypotonia), seizures, migraine;
• episode of forced gaze with rotation of the eyeballs, dilation of the pupils;
• hypersensitivity to certain sound frequencies or difficulty tolerating normal (everyday) sounds, ringing in the ears;
• abdominal pain, nausea, bloating with gas;
• rash, skin reactions related to hypersensitivity to light (phototoxicity), pigmentation disorders, oily, shiny and yellowish skin due to increased secretion of sebum by the skin (seborrhoea), eczema or skin inflammation, subcutaneous bleeding observed as red discoloration of the skin (purpura);
• muscle stiffness, inability to normally open the mouth, twisting of the neck and unnatural position of the head (stiffness of the neck);
• decreased appetite, weight loss;
• low blood pressure (hypotension), hot flashes;
• thirst, abnormally low body temperature (hypothermia), fever;
• redness or pain of the skin at the injection site of Clopixol Acuphase;
• abnormal liver function test results;
• sexual disorders (delayed ejaculation, erection problems, in women may experience orgasm disorder, vaginal dryness);
• marked apathy, nightmares, increased libido, confusion;

Rare side effects (occurring in more than 1 in 10,000 and less than 1 in 1,000 patients):

• low platelet count (thrombocytopenia), low white blood cell count (neutropenia), decreased white blood cell count (leukopenia), toxic bone marrow damage (agranulocytosis);
• increased prolactin levels in the blood (hyperprolactinemia);
• increased blood sugar levels (hyperglycemia), impaired glucose tolerance, increased lipid levels in the blood (hyperlipidemia);
• hypersensitivity (allergy), acute systemic and severe allergic reaction (anaphylaxis);
• breast enlargement in men (gynecomastia), excessive milk production (galactorrhea), absence of menstruation, persistent and painful erection not associated with sexual arousal (priapism);
• as with other medicines that work similarly to zuclopenthixol acetate (the active substance of Clopixol Acuphase), rare cases of the following side effects have been reported: slow heart rate and changes in the ECG (prolongation of the QT interval);
• irregular heart rhythm (ventricular arrhythmia, torsade de pointes);
• in rare cases, irregular heart rhythm (arrhythmia) can lead to sudden death.

In a group of elderly patients with dementia, taking antipsychotic medicines, a slightly higher number of deaths was found compared to patients not taking antipsychotic medicines.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to:

Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Al. Jerozolimskie 181C;

PL-02 222 Warsaw

Tel.: + 48 22 49 21 301

Fax: + 48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clopixol Acuphase

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

Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.

Do not store above 30°C.

Protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Clopixol Acuphase contains

• The active substance is zuclopenthixol acetate. Each milliliter (ml) of Clopixol Acuphase contains 50 mg of zuclopenthixol acetate.
• The other ingredient is: vegetable oil (medium-chain triglycerides).

What Clopixol Acuphase looks like and contents of the pack

Clopixol Acuphase is available as a solution for injection with a concentration of 50 mg/ml.

Clopixol Acuphase is a clear, yellowish liquid.

Clopixol Acuphase is available in ampoules made of colorless glass containing 1 ml (50 mg) of the medicine.

The ampoules are packed in cardboard boxes containing 5 ampoules of 1 ml each.

Marketing Authorisation Holder and Manufacturer

• H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby Denmark

For more detailed information, please contact the representative of the Marketing Authorisation Holder.

Lundbeck Poland Sp. z o.o.

ul. Marszałkowska 142

00-061 Warsaw

Tel.: + 48 22 626 93 00

Date of last revision of the leaflet: