2 mg, 10 mg, 25 mg film-coated tablets 
zuclopenthixol

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your healthcare provider or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cisordinol is and what it is used for 
2. What you need to know before you use Cisordinol 
3. How to use Cisordinol 
4. Possible side effects 
5. How to store Cisordinol 
6. Contents of the packaging and other information 

What Cisordinol is and what it is used for

Cisordinol contains the active substance zuclopentixol. Cisordinol is a neuroleptic . It has an antipsychotic effect, which means that it alleviates or removes psychotic symptoms such as hallucinations, delusions and thought disorders and alleviates anxiety and worry. Cisordinol is used for schizophrenia and other psychotic conditions.

Zuclopentixol contained in Cisordinol may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Cisordinol

Do not use Cisordinol

Do not use Cisordinol

  • if you are allergic to zuclopentixol or any of the other ingredients of this medicine (listed in section 6).
  • in case of poisoning with alcohol, sleeping pills or strong painkillers (morphine or equivalent).
  • in certain forms of blood diseases.
  • in pheochromocytoma (a rare benign tumor of the adrenal glands).

Warnings and cautions

Talk to your doctor or pharmacist before taking Cisordinol if you:

  • has impaired liver function.
  • previously suffered from seizures and seizures.
  • has a brain injury caused by e.g. poisoning with alcohol or solvents.
  • have risk factors for stroke (eg smoking, high blood pressure ).
  • previously had low levels of white blood cells .
  • have previously suffered from cardiovascular disease or changes in heart rhythm.
  • use other antipsychotic drugs.
  • or someone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.

Dry mouth can lead to dental and oral mucosal damage during long-term treatment. Teeth should be thoroughly cleaned with fluoride toothpaste 2 times / day.

Children and young people

Cisordinol is not recommended for this patient group.

Other medicines and Cisordinol

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

Be especially careful to tell your doctor about the following medications:

  • Tricyclic antidepressant drugs.
  • Drugs that lower blood pressure et.
  • Barbiturates and similar medicines (medicines that make you sleepy).
  • Medicines for epilepsy .
  • Levodopa and similar medicines (used to treat Parkinson’s disease ).
  • Metoclopramide (used to treat gastrointestinal diseases).
  • Piperazine (used in infections caused by roundworms and roundworms).
  • Drugs that are diuretic, e.g. thiazide diuretics (affects the salt and fluid balance, which may cause too little potassium or magnesium in the blood).
  • Drugs known to increase the concentration of Cisordinol in the blood.

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

  • Drugs that affect the heart rhythm (eg quinidine , cisapride and lithium, certain antibiotics (moxifloxacin and erythromycin), malaria (mefloquine), methadone ).
  • Other antipsychotic drugs.
  • Painkillers ( codeine ).
  • Medicines used to stop the production of breast milk (bromocriptine, cabergoline).

Cisordinol with food, drink and alcohol

Cisordinol can be taken with or without food.

Fatigue associated with alcohol can be exacerbated. You should not drink alcohol during the treatment period.

Pregnancy, breastfeeding, and fertility

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 using this medicine.

Cisordinol should not be used during pregnancy unless clearly necessary.

The following symptoms may occur in newborns of mothers who have used Cisordinol during the last trimester (the last three months of pregnancy): tremors, muscle stiffness and / or weakness, drowsiness, anxiety, difficulty breathing and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.

Cisordinol passes into breast milk, but is unlikely to affect breast-fed infants. However, consult a physician if you are taking Cisordinol more than temporarily during breast-feeding.

Cisordinol may affect fertility . Please ask your doctor for advice.

Driving and using machines

Cisordinol may impair the ability of some people to react, which should be taken into account at times when increased attention is required, e.g. while driving and precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cisordinol contains lactose and hydrogenated castor oil

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Hydrogenated castor oil can cause stomach upset and diarrhea.

3. How to use Cisordinol

Always take Cisordinol exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults

The usual dose is 10-50 mg per day, but sometimes a significantly higher dose may be necessary. Dosage one varies greatly depending on the disease state.

Elderly patients

Elderly patients should be given the dose you at the low end of the dosing interval.

Use for children

Cisordinol is not recommended for use in children.

Cisordinol tablets are usually taken once a day, preferably late in the day as the medicine may make you tired. Swallow the tablets with a glass of water.

Note

The effect against the psychotic symptoms comes only after a few weeks of treatment.

The duration of treatment is determined in consultation with your doctor. Do not stop treatment without consulting your doctor.

4. Possible side effects

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

Contact your doctor or nearest hospital immediately if you experience any of the following side effects during treatment:

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

  • Unusual movements of mouth and tongue; This may be an early sign of a condition known as tardive dyskinesia .

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

  • Cisordinol can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with other symptoms of infection, you should see a doctor as soon as possible so that a lack of white blood cells ( agranulocytosis ) can be ruled out via blood tests . It is important that you then inform about your medication.

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

  • High fever, unusual muscle stiffness and effects on your level of consciousness, especially if accompanied by sweating and palpitations, these symptoms may be signs of a rare condition called malignant neuroleptic syndrome that has been reported with the use of various antipsychotics.
  • Yellowing of the skin and whites of the eyes, this can mean that your liver is affected and be a sign of a condition called jaundice.

The following side effects are most characteristic at the beginning of treatment and most of them disappear during further treatment:

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

  • Drowsiness ( somnolence ), inability to sit or stand still ( akathisia ), involuntary movements (hyperkinesia), slow or reduced movements ( hypokinesia ).
  • Dry mouth .

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

  • Palpitations ( tachycardia ), feeling of fast, powerful or irregular heartbeat ( palpitation ).
  • Tremor , twisting or repeated movements or abnormal posture due to persistent muscle tension ( dystonia ), increased muscle stiffness ( hypertension ), dizziness, headache, stinging sensation of numbness in the skin ( paresthesias ), impaired attention, amnesia , gait disturbance.
  • Difficulty focusing on objects close to the eye (accommodation disorders), visual disturbances.
  • Nasal congestion, difficulty breathing or painful breathing ( dyspnoea ).
  • Increased saliva production (saliva hypersecretion), constipation, vomiting, indigestion or problems centered on the upper abdomen ( dyspepsia ), diarrhea.
  • Difficulty urinating (micturition), inability to urinate ( urinary retention ), increased amount of urine ( polyuria ).
  • Increased sweating ( hyperhidrosis ), itching ( pruritus ).
  • Muscle pain ( myalgia ).
  • Increased appetite, increased weight.
  • Fatigue, weakness ( asthenia ), general malaise, pain.
  • Sleeplessness ( insomnia ), depression, anxiety, nervousness, abnormal dreams, agitation , decreased libido (decreased libido ).

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

  • Overactive or sensitive reflexes ( hyperreflexia ), jerky movements ( dyskinesia ), parkinsonism , fainting ( syncope ), inability to coordinate muscle movements ( ataxia ), speech difficulties, decreased muscle tone ( hypotension ), seizures, migraines .
  • Circulating eye movements (oculogyration), enlarged pupils ( mydriasis ).
  • Hypersensitivity to certain sound frequencies or difficulty tolerating everyday sounds (hyperacusis), earrings ( tinnitus ).
  • Stomach pain, nausea, flatulence .
  • Rash, skin reactions due to photosensitivity (photosensitization), pigmentation disorders, oily, shiny and yellowish skin due to increased sebum secretion ( seborrhea ), eczema or inflammation of the skin ( dermatitis ), bleeding under the skin seen as red or purple color changes of the skin (purple ).
  • Muscle stiffness, inability to open the mouth normally (trismus), twisting of the neck and an unnatural positioning of the head ( torticollis )
  • Decreased appetite, decreased weight.
  • Low blood pressure ( hypotension ), hot flashes.
  • Thirst, abnormally low body temperature ( hypothermia ), fever ( pyrexia ).
  • Abnormal liver function test.
  • Sexual disorders (failure to ejaculate, erection problems, women may experience difficulty getting an orgasm, vaginal dryness ( vulvovaginal dryness)).
  • Characteristic indifference to the outside world ( apathy ), nightmares, increased sexual drive (increased libido ), states of confusion.

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

  • Low platelet count ( thrombocytopenia ), low / decreased white blood cell count ( neutropenia , leukopenia ).
  • Increased prolactin levels in the blood ( hyperprolactinemia ).
  • High blood sugar ( hyperglycaemia ), impaired glucose tolerance, increased blood fat levels ( hyperlipidemia ).
  • Hypersensitivity (hypersensitivity), acute systemic and severe allergic reaction ( anaphylactic reaction ).
  • Development of breasts in men ( gynecomastia ), excessive milk production ( galactorrhea ), missed periods ( amenorrhea ), persistent, painful erection of the penis in the absence of sexual arousal or desire (priapism).

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

  • Blood clot (see information in the text below).

As with other medicines that work in a similar way to zuclopentixol

(Cisordinol active substance) rare cases of the following side effects have been reported:

  • QT prolongation (slow heart rate and ECG changes).
  • Irregular heart rhythm (ventricular arrhythmias, ventricular fibrillation , ventricular tachycardia).
  • Torsades de Pointes (a special kind of irregular heartbeat).
  • Cardiac arrest.

In rare cases, irregular heart rhythms ( arrhythmias ) have resulted in sudden death.

Blood clots, especially in the legs (symptoms are swelling, pain and redness on the legs), can be transported to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

In elderly people with dementia who are treated with antipsychotic drugs, a small increase in the number of deaths has been reported compared with those who do not receive such treatment.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Cisordinol

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 after EXP. The expiration date is the last day of the specified month.

2 mg: Store in the original package. Sensitive to light.

10 mg, 25 mg: No special storage instructions.

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

6. Contents of the packaging and other information

Content declaration

The active substance is zuclopentixol dihydrochloride equivalent to 2 mg, 10 mg and 25 mg zuclopentixol per tablet respectively.

The other ingredients are potato starch, lactose monohydrate , microcrystalline cellulose, copovidone, glycerol (85%), talc, hydrogenated castor oil, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171) and iron oxide (E172).

Marketing Authorization Holder and Manufacturer

H. Lundbeck A / S

Ottiliavej 9

2500 Valby

Denmark

Contact the representative of the marketing authorization holder to find out more about this medicine.

Agent

H. Lundbeck AB

Slagthuset

211 20 Malmö

Tel: 040-699 82 00

Muhammad Nadeem

Leave a Reply