Clopixol conc injection (500 mg/ml) – patient leaflet, side effects, dosage

1. What Clopixol Conc. Injection is and what it is used for

Tell your doctor, dentist, surgeon or anaesthetist before any operation as Clopixol Conc. Injection can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.

1. 2. What you need to know before you are given Clopixol Conc. Injection
2. 3. How Clopixol Conc. Injection is given
3. 4. Possible side effects
4. 5.

   Clopixol Conc. Injection with alcohol

   Clopixol Conc. Injection may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Clopixol Conc. Injection.

5. 6. Contents of the pack and other information
6. 1.

   What Clopixol Conc. Injection is and what it is used for

   Pregnancy, breast-feeding and fertility

The name of your medicine is Clopixol Conc. 500 mg/ml solution for injection (called Clopixol Conc. Injection in this leaflet). Clopixol Conc. Injection contains the active substance zuclopenthixol. It belongs to a group of medicines known as antipsychotics (also called neuroleptics).

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

Pregnancy

If you are pregnant or think you might be pregnant, tell your doctor. Clopixol Conc. Injection should not be used during pregnancy unless clearly necessary.

These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.

The following symptoms may occur in newborn babies, of mothers that have used Clopixol Conc. Injection in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/ or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Clopixol Conc. Injection is used for the treatment of schizophrenia and other psychoses.

Your doctor, however, may prescribe Clopixol Conc. Injection for another purpose. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Breast-feeding

If you are breastfeeding, ask your doctor for advice. Clopixol Conc. Injection should not be used when breast-feeding, as small amounts of the medicine can pass into the breast milk.

2. What you need to know before you are given Clopixol Conc. Injection

Fertility

Do not use Clopixol Conc. Injection

Zuclopenthixol may decrease your sexual activity and fertility. These are not lasting effects. Please talk to your doctor about any problems.

• If you are allergic to zuclopenthixol, other thioxanthene

  drugs or antipsychotic drugs or any of the other ingredients of this medicine (listed in section 6). Tell your doctor if you think you might be

  Driving and using machines

• If you are feeling less alert than usual, or are drowsy

  There is a risk of feeling drowsy and dizzy when being treated with Clopixol Conc. Injection, especially at the start of your treatment. If this happens do not drive or use any tools or machines until you know you are not affected in this way.

  or sleepy or have serious problems with your blood circulation

Warnings and precautions

Talk to your doctor, pharmacist or nurse before Clopixol Conc. Injection is given to you:

Do not drive if you have blurred vision.

• If you have a heart condition, including an irregular

  heart beat (such as a slower heart beat); have had a recent heart attack or have problems that cause ankle swelling or shortness of breath

3. How Clopixol Conc. Injection is given

• If you have severe breathing problems (such as asthma

  A small amount of Clopixol Conc. Injection is drawn up into a syringe and then injected into the muscle of your buttock or thigh.

  or bronchitis)

• If you have liver, kidney or thyroid problems

• If you suffer from epilepsy, or have been told that you

  are at risk of having fits (for example because of a brain injury or because of alcohol withdrawal)

  Your doctor will decide on the correct amount of medicine to give, and how often to give it. The medicine is slowly released from the injection site so that a fairly constant amount of medicine gets into your blood during the period between each dose.

• If you suffer from Parkinson’s disease, or myasthenia

  gravis (a condition causing severe muscular weakness)

• If you have an enlarged prostate or suffer from a

  condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney)

  Adults

• If you suffer from glaucoma (raised pressure within the

  The usual dose lies between 200-500 mg every 1 to 4 weeks but some patients require 600 mg every week. The maximum single dose at any one time is 600 mg. If you need more than 2 ml of medicine it will probably be divided between 2 injection sites.

  eye)

• If you have risk factors for stroke (e.g. smoking,

  hypertension)

• If you have too little potassium or magnesium in your

  blood or a family history of irregular heart beats

• If you use other antipsychotic medicines

  If you haven’t received an injection like Clopixol Conc. Injection before, a small dose of 100 mg is usually given one week before your normal dose to test how well you tolerate the medicine.

• If you suffer from diabetes

• If you or someone else in your family has a history

  of blood clots, as medicines like these have been associated with formation of blood clots

• If you are being treated for cancer

  If you have been treated with Clopixol tablets and you are being transferred to Clopixol Conc. Injection you may be asked to continue taking the tablets for several days after the first injection.

Movement disorders such as tremors and muscle spasm may occur, especially during the first few days after initiating therapy. Inform your doctor as the dose may need to be reduced. Inform your doctor if symptoms of a constant urge to move are persistent, as these symptoms can be controlled by the appropriate medication. Inform your doctor if you experience uncontrolled movements of the face and jaw, as therapy discontinuation may be needed.

Your doctor may decide to adjust the amount given, or the interval between injections, from time to time.

Older patients (above 65 years)

Starting doses for older or frail patients are usually reduced to a quarter or a half of the dosage range.

Difficulty in swallowing may occur as a secondary effect of extrapyramidal symptoms (such as tremors, muscle spasm or movement disorder), sedation (sleepiness), increased salivation, and/or neuroleptic malignant syndrome (a rare dangerous reaction with fever, rigid muscles, changing blood pressure and coma).

Patients with special risks

If you have renal failure, your dosage should be reduced to half the usual dosage range. If you have liver problems, the level of zuclopenthixol in your blood may be checked. Patients with liver complaints normally receive doses at half the usual dosage range.

Children and adolescents

Use in children

Clopixol Conc. Injection is not recommended this patient group.

Clopixol Conc. Injection is not recommended for children.

Duration of treatment

It may take between four and six months before you feel better. Your doctor will decide the duration of treatment.

Other medicines and Clopixol Conc. Injection

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

It is important that you continue to receive your medicine at regular intervals even if you are feeling completely well, because the underlying illness may persist for a long time. If you stop your treatment too soon your symptoms may return.

The following medicines should not be taken at the same time as Clopixol Conc. Injection:

• Medicines that change the heartbeat (quinidine,

  amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)

• Other antipsychotic medicines

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

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

If you are given more Clopixol Conc. Injection than you should

• Tricyclic antidepressants

• Barbiturates or other medicines that make you feel

  drowsy

• Anticoagulant drugs used to prevent blood clots

  (e.g. warfarin)

The following information is intended for healthcare professionals only:

Clopixol Conc. 500 mg/ml solution for injection

Administration information for the healthcare professional

Consult the Summary of Product Characteristics for full information on this product

Clopixol Conc. 500 mg/ml solution for injection should be administered by deep intramuscular injection into the upper outer buttock or lateral thigh.

Note: As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

Injection volumes of greater than 2 ml should be distributed between two injection sites.

This product may be mixed in the same syringe with other products in the Clopixol Injection range, including Clopixol-Acuphase Injection (zuclopenthixol acetate 50 mg/ml).

It should not be mixed with any other injection fluids.

The maximum single dose at any one time is 600 mg. For example, 1200 mg every 2 weeks should not be given.

GB-056-60-500-13413

Symptoms of overdose may include:

• Drowsiness
• Unconsciousness
• Muscle movements or stiffness
• Fits

• Low blood pressure, weak pulse, fast heart rate, pale

  skin, restlessness

• High or low body temperature

• Changes in heart beat including irregular heart beat or

  slow heart rate

You will receive treatment for any of these symptoms from your doctor or nurse.

4. Possible side effects

Like all medicines, Clopixol Conc. Injection can cause side effects, although not everybody gets them. Older people tend to be more likely to suffer from some of these effects than younger people and this may mean your treatment is supervised more closely.

Serious side effects

Stop using Clopixol and seek medical advice immediately if you have any of the following allergic reactions:

• Difficulty in breathing

• Swelling of the face, lips, tongue or throat which causes

  difficulty in swallowing or breathing

• Severe itching of the skin (with raised lumps)

Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.

If you get any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped:

Common (may affect more than 1 in 10 people):

• Unusual muscle movements such as stiffness, tremor

  and restlessness (for example difficulty in sitting or standing still) as these may be signs of a so-called “extra pyramidal” reaction

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

• Unusual movements of the mouth and tongue as these

  may be early signs of a condition known as tardive dyskinesia

• Circular movements of the eyes

Rare (may occur in up to 1 out of 1000 people):

• Difficulty in swallowing (see section 2)

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

• High fever, unusual stiffness of the muscles and

  changes in consciousness, especially if occurring with sweating and fast heart rate. These symptoms may be signs of a rare but serious condition called neuroleptic malignant syndrome that has been reported with the use of Clopixol and similar medicines

• Any yellowing of the skin and the white in the eyes

  (jaundice); your liver may be affected

Other side effects

Side effects are most pronounced in the beginning of the treatment and most of them usually wear off during continued treatment.

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

• Drowsiness
• Dry mouth

• Movement disorder (Extrapyramidal symptoms) –

  due to effects on a part of the brain that regulates movements which may result in tremors, muscle spasms or movement disorders (see section 2)

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

• Throbbing or fast heartbeats
• Tremor
• Dizziness or vertigo
• Headache
• Numbness or tingling in the arms and legs
• Poor concentration, loss of memory or confusion
• A changed walking pattern
• Stuffy nose
• Shortness of breath
• Increase in saliva
• Abnormal vision
• Feeling sick or vomiting
• Constipation or diarrhoea

• Abnormal urination (increases or decreases in the

  frequency or amount)

• Increased sweating
• Itching
• Muscle pain
• Increased appetite, weight increased
• General weakness or pain, tiredness or feeling unwell
• Insomnia, abnormal dreams or nightmares
• Depression or anxiety
• Nervousness or agitation
• Decreased sexual drive (libido decreased)

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

• Loss of co-ordination or altered muscle movements

  (including unusual movements of the mouth, tongue and eyeballs)

• Stiff or floppy muscles (including stiff jaw and neck

  muscles)

• Abnormal reflexes
• Rigidity of the whole body
• Fainting
• Migraine
• Speech problems
• Sensitive hearing or ringing in the ears (tinnitus)
• Enlarged pupils or blurred vision
• Indigestion or stomach pain
• Flatulence (wind)
• Greasy skin

• Rashes or skin reactions (including sensitivity to

  sunlight)

• Skin reactions at injection site
• Changes in skin colour
• Decreased appetite, weight decreased
• Low blood pressure
• Hot flushes

• Reduced or increased body temperature (including

  fever)

• Abnormal liver function tests

• Lack of emotion or indifference to your surroundings

  (apathy)

• Increased sexual drive (libido increased)

  • Men may experience breast enlargement or problems with ejaculation or erections (including prolonged erections)
  • Women may experience an absence of menstrual periods, vaginal dryness or problems with orgasms
  • Fits
  • Bruising under the skin
  • Increased thirsts

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

• Reduction in blood platelets (which increases the risk of bleeding or bruising) and other blood cell changes
• Raised blood levels of glucose, lipids or the hormone prolactin
• Loss of control of blood sugar levels
• Unexpected excretion of breast milk

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

• Liver enlargement

As with other medicines that work in a way similar to zuclopenthixol (the active ingredient of Clopixol), rare cases of the following side effects have been reported:

• Slow heartbeat and abnormal ECG heart tracing
• Life threatening irregular heart beats

In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death.

In older people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below)

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

United Kingdom

Via Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Clopixol Conc. Injection

Usually your doctor or nurse will store the medicine for you. If you keep it at home:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• Keep the ampoules in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Clopixol Conc. Injection contains

The active substance is zuclopenthixol decanoate.

Each millilitre (ml) of Clopixol Conc. Injection contains 500 mg zuclopenthixol decanoate.

The other ingredient is thin vegetable oil.

What Clopixol Conc. Injection looks like and contents of the pack

Clopixol Conc. Injection is an oily liquid.

Clopixol Conc. Injection is available in glass ampoules containing 1 ml (500 mg) in cartons of 5 ampoules.

Marketing Authorisation Holder

Lundbeck Limited

Iveco House,

Station Road,

Watford,

Hertfordshire,

WD17 1ET,

UK

Manufacturer

H. Lundbeck A/S

Ottiliavej 9

DK-2500 Valby

Denmark

This leaflet was last revised in 04/2026.

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Product name Product code number

Clopixol Conc. Injection PL 00458/0060

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