25 mg and 100 mg tablets 
clozapineShow larger

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.• Save 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 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 doctor or pharmacist. This also applies to side effects that are not mentioned in this information. See section 4.

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

What Clozapine Actavis is and what it is used for

Clozapine Actavis belongs to the type of medicine called antipsychotic medicine that acts on the central nervous system.

Clozapine Actavis is used for schizophrenia.

Clozapine Actavis can also be used for psychotic disorders, which have arisen during the treatment of Parkinson’s disease.

What you need to know before using Clozapine Actavis

Do not use Clozapine Actavis

Before starting treatment with Clozapine Actavis, a blood sample is taken to examine your blood count and decide if you can be treated with Clozapine Actavis.

You must attend the blood tests that are to be performed every week for the first 18 weeks and thereafter at least every four weeks for the duration of the treatment and another 4 weeks after the end of the treatment.

Blood control is done to control the amount of white blood cell ( leukocyte you and neutrophilic granulocyte s) in the blood to minimize your risk of blood effects (low number of white blood cells ).

Tell your doctor if you have previously taken Clozapine Actavis and have had to discontinue treatment due to blood side effects.

Do not use Clozapine Actavis:

  • if you are allergic to clozapine or any of the other ingredients of this medicine (listed in section 6).
  • if you do not have the opportunity to participate in regular blood tests
  • if you have untreated epilepsy
  • if you have or have had impaired bone marrow function
  • if you have had low white blood cell counts (eg leukopenia)
  •  or agranulocytosis ), especially if the cause is drugs and it is not a result of cancer treatment
  • if you are taking any medicine that prevents your bone marrow from working properly.
  • if you are taking any medicine that reduces the number of white blood cells in your blood.
  • if you have previously been forced to stop taking Clozapine Actavis due to serious side effects (eg agranulocytosis ) or heart problems.
  • if you have myocarditis ( inflammation of the heart muscle)
  • if you have any other serious heart disease
  • if you have had mental changes triggered by alcohol, drugs, or another poisoning
  • if you have severe kidney disease
  • if you have an active liver disease with nausea, loss of appetite, or jaundice
  • if you have any other serious liver disease.
  • if you have impaired bowel activity.
  • if you are being treated or have been treated with long-acting depot injections with antipsychotics

If any of the above apply to you, talk to your doctor and do not take Clozapine Actavis. Clozapine Actavis should not be given to unconscious people or people in a coma.

Warnings and cautions

Talk to your doctor or pharmacist before taking Clozapine Actavis:

  • if you have too high blood sugar levels that may manifest as weight loss, increased thirst, and fatigue
  • if you have prostate enlargement, Clozapine Actavis can make this condition worse.
  • If you have narrow-angle glaucoma (a disease of the eye), Clozapine Actavis can make these conditions worse
  • if you or someone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.
  • if you are taking medicines that can cause constipation at the same time (antipsychotics, antidepressants, and parkinsonism medicines ), then this may lead to further aggravation of the effects of Clozapine Actavis, which may cause constipation (even intestinal upset).
  • if you have previously had a disease in the colon or undergone surgery in the lower abdomen.
  • If you get constipation, you should contact your doctor, as this should be treated actively.
  • When an infection breaks out, tell your doctor immediately. Pay special attention if you have flu-like symptoms such as fever or sore throat/throat/mouth or other signs of infection. Blood tests should be done immediately to rule out a lack of white blood cells.
  • When you start your medication, you will be carefully observed to find out if you have a drop in blood pressure when you get up quickly ( orthostatic hypotension). If you have Parkinson’s disease, your blood pressure will be checked in both supine and a standing position during the first weeks of treatment.
  • Contact your doctor if you do not tolerate certain sugars such as galactose before taking this medicine.
  • If you experience a persistent increase in heart rate at rest and/or heart rhythm disturbances, chest pain, and other signs of heart failure (eg unexplained fatigue, shortness of breath, shortness of breath) during the first 2 months of treatment, you should contact your doctor immediately.
  • If you have pronounced bradycardia (very slow heart rhythm), cardiovascular disease, or hereditary heart rhythm disorder (prolongation of the QT interval ), tell your doctor. Concomitant treatment with other drugs for mental illness should then be avoided.
  • Because Clozapine Actavis can cause dry mouth, which can increase the risk of caries, cleaning your teeth with fluoride toothpaste should be done twice a day.
  • Patients treated with Clozapine Actavis should contact a physician immediately in case of fever, sore throat/throat, or other signs of infection so that blood tests can be performed to rule out white blood cell deficiency.
  • Contact your doctor if you plan to quit smoking, as this may lead to increased side effects.
  • Contact your doctor if you are taking other antipsychotic medicines.

Children and young people

The safety and efficacy of Clozapine Actavis in children and adolescents below 16 years of age have not been established. The drug should not be used for this group until more data are available.

Other medicines and Clozapine Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or will take any other medicines. This applies in particular to:

  • drugs that inhibit bone marrow (eg carbamazepine, chloramphenicol, phenylbutazone)
  • medicines for heart rhythm disorders
  • methadone
  • mefloquine (malaria medicine)
  • certain diuretics (thiazide diuretics)
  • cisapride
  • antihistamines (allergy medicines such as loratadine, chlorpheniramine) and benzodiazepines or other psychotropic drugs (medicines used as sedatives or sleeping pills)
  • carbamazepine, phenytoin, valproic acid (antiepileptic drugs)
  • lithium
  • antidepressants (eg fluvoxamine, fluoxetine, paroxetine, amitriptyline, clomipramine)
  • antihypertensive drugs (eg metoprolol, captopril )
  • warfarin and digoxin
  • anticholinergic drugs such as biperiden, orphenadrine
  • cimetidine
  • certain antibiotics such as cotrimoxazole, erythromycin, rifampicin, moxifloxacin, and antifungals such as fluconazole
  • certain antiviral agents such as ritonavir, indinavir.
  • gastric medicines such as omeprazole

Using Clozapine Actavis with food and drink

Alcohol should not be taken concomitantly with Clozapine Actavis because it enhances the negative effects of alcohol. If your coffee habits change significantly, you may need to contact your doctor so that your Clozapine Actavis dose can be adjusted.

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 or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborns of mothers who have used Clozapine Actavis during the last trimester (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.

Breast-feeding

Breast-feeding women should not take Clozapine Actavis as the medicine may be transferred from the mother’s milk to the baby.

Women of childbearing age

If you switch from other antipsychotic drugs to Clozapine Actavis, this may result in you returning to your normal periods. Therefore, you should use the appropriate method of contraception.

Driving and using machines

Clozapine Actavis has a sleep-inducing effect and provides a lower seizure threshold. Therefore, do not drive or use any tools or machines during the first weeks of treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Clozapine Actavis contains lactose monohydrate

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

How to use Clozapine Actavis

Always take Clozapine Actavis exactly as your doctor and pharmacist have told you. If you are not sure, talk to your doctor or pharmacist.

The recommended dose for treatment-resistant schizophrenic patients is:

Adults

Starting dose

12.5 mg (half a 25 mg tablet) once or twice on the first day, followed by one or two 25 mg tablets on the second day. If you tolerate this well, your doctor may increase the daily dose slowly by 25 mg to 50 mg at a time, until a dose level of 300 mg/day is reached within 2-3 weeks.

Older

A very low dose (a single dose of 12.5 mg on the first day – half a 25 mg tablet) is recommended at the start of treatment.

Maintenance dose

When the highest therapeutic effect has been achieved, this can be maintained in many patients with a lower dose.

The recommended dose for patients with psychotic disorders due to Parkinson’s disease is:

Adults

The effective dose is normally between 25 and 37.5 mg per day.

Treatment is usually started with 12.5 mg/day (half a 25 mg tablet) and should be taken in the evening. Continued dose increases are usually made with 12.5 mg at a time with a maximum of two dose increases per week up to a maximum of 50 mg.

Clozapine Actavis is a treatment that should last for a long time, if it is stopped, previous symptoms may return. Therefore, the tablets must be taken every day.

If you have the impression that the effect of Clozapine Actavis is too strong or too weak, talk to your doctor or pharmacist .

The tablet can be divided into two equal doses.

How long to take Clozapine Actavis

Your doctor will decide how long you should be treated with Clozapine Actavis. You should not change the dose or treatment without talking to your doctor.

If you use more Clozapine Actavis than you should 

In case of overdose, signs such as drowsiness, confusion, hallucinations, cramps, twitching in the arms and legs, blurred vision, low blood pressure, shortness of breath, fast pulse, and heart rhythm are seen. (See section Any side effects ar.)

If you forget to use Clozapine Actavis

If you forget to take Clozapine Actavis or have any other thoughts about dosing one, contact your doctor. Do not take double dose to make up for forgotten dose .

Effects that may occur when treatment with Clozapine Actavis is stopped

If treatment must be stopped abruptly, the psychotic symptoms may recur and the following symptoms may occur: eg profuse sweating, headache, nausea, vomiting and diarrhea.

4. Possible side effects

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

Stop taking Clozapine Actavis and seek immediate medical attention if you experience any of the following:

  • 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. This is rare (may affect up to 1 in 1,000 people).
  • Jaundice (yellowing of the skin or eyes) due to blocked bile duct. This is rare (may affect up to 1 in 1,000 people).
  • Malignant neuroleptic syndrome (muscle stiffness, fever, unconsciousness). This is less common (may affect up to 1 in 100 people).

Below is a list of other side effects that have been reported.

Very common (may affect up to 1 in 10 people):

  • Drowsiness, dizziness.
  • Elevated heart rate.
  • Constipation increased saliva flow.

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

  • Decreased number of white blood cells ( granulocytes ), increased number of white blood cells .
  • Weight gain.
  • Dimsyn.
  • Tremors, stiffness, internal anxiety, twitching of arms and legs, cramps, muscle twitching.
  • ECG changes, high blood pressure .
  • Drop-in blood pressure when getting up quickly, fainting.
  • Nausea, vomiting, loss of appetite, dry mouth.
  • Urinary incontinence, difficulty urinating.
  • Fatigue, fever, feeling hot, disturbances in sweating / temperature regulation.

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

  • A pronounced decrease in white blood cell count ( granulocytes ).

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

  • Diabetes can cause weight loss, increased thirst, fatigue, restlessness, confusion, delirium.
  • Difficulty swallowing, “puts in the esophagus”, hepatitis, inflammation of the pancreas.
  • Cardiac arrhythmias, irregular heartbeat and ECG changes associated with it, cardiac arrest, inflammation of the heart muscle.

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

  • Decreased platelet count,
  • Involuntary twitching of legs and arms.
  • The disease of the heart muscle.
  • Enlargement of the parotid gland.
  • Serious kidney and liver damage.
  • Skin reactions.
  • Constipation, intestinal upset.
  • Painful, spasmodic erection of the penis.

No known frequency (cannot be calculated from the available data): 

  • 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.
  • Obsessive-compulsive disorder.

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. Postal address

5. How to store Clozapine Actavis

Keep out of sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton.

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 clozapine. Each tablet contains 25 and 100 mg respectively.
  • The other ingredients are: lactose monohydrate , magnesium stearate, povidone, talc, corn starch, colloidal anhydrous silica and pregelatinized starch .

What the medicine looks like and the contents of the pack

Clozapine Actavis 25 mg tablets:

Yellow, round tablet, 6 mm in diameter, with partial notches on both sides and embossed with “CPN 25” on one side.

Clozapine Actavis 100 mg tablets:

Yellow, round tablet, 10 mm in diameter, with partial notches on both sides and embossed with “CPN 100” on one side.

Marketing Authorization Holder and Manufacturer

Holder of a marketing authorization

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Local representative

Box 1070

251 10 Helsingborg

Manufacturer

Synthon Hispania SL

C / Castelló, no 1, Pol. Las Salinas

Sant Boi de Llobregat

08830 Barcelona

Spain

Balkanpharma Dupnitsa AD,

3 Samakovsko Shosse Str.

Dupnitsa, 2600

Bulgaria

Muhammad Nadeem

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