Document: Clozapine Actavis tablet ENG PL change

• Clozapine Actavis tablet PL
• Clozapine Actavis tablet ENG PL

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Package leaflet: Information for the patient

Clozapine Actavis 25 mg tablets 100 mg tablets

clozapine

Read this leaflet carefully before you start using this medicine because it contains important information for you

- 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 signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What is Clozapine Actavisand what is it used for

2. What you need to know before you take Clozapine Actavis

3. How to take Clozapine Actavis

4. Possible side effects

1. What Clozapine Actavis is and what it is used for

Clozapine Actavis belongs to a group of medicines called antipsychotics and exerts its effect on the central nervous system.

Clozapine Actavis is used to treat schizophrenia.

Clozapine Actavis can also be used for psychotic problems that has developed during treatment of Parkinson’s disease.

Before you start taking Clozapine Actavis a blood test will be taken to examine your blood and ensure whether you can be treated with Clozapine Actavis .

It is very important that you attend the blood tests that are needed once a week for the first 18 weeks of treatment. Thereafter a blood test is needed at least every fourth week as long as the treatment is ongoing and 4 weeks after the end of Clozapine Actavis treatment.

The blood tests are performed to check the amount of white blood cells (leukocytes and neutrophils) in your blood and minimise the risk of blood related side effects (decrease in the number of white blood cells).

Inform your doctor if you previously have taken Clozapine Actavis and had to stop treatment due to side effects of the blood.

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 are unable to undergo regular blood tests.

• if you suffer from untreated epilepsy.

• if you suffer from bone marrow disease or have ever suffered from bone marrow disease.

• if you have ever been told you have a low white blood cell count (e.g. leucopenia or agranulocytosis) especially if this was caused by medicines and it was not a result of cancer treatment.

• if you use any medicine that stops your bone marrow from working properly.

• if you use any medicine that reduces the number of white cells in your blood.

• if you had to stop using Clozapine Actavis previously because of severe side effects (e.g. agranulocytosis or heart problems).

• if you suffer from myocarditis (an inflammation of the heart muscle).

• if you suffer from any other severe heart disease.

- if you have suffer from mental illness caused by alcohol, drugs or other poisoning.

• if you suffer from severe kidney disease.

• if you have active liver disease with symptoms of nausea, loss of appetite or jaundice.

• if you suffer from any other severe liver disease.

• if you suffer from impaired bowel movements.

• if you are being or have been treated with long-acting depot injections of antipsychotics.

If any of the above applies to you, tell your doctor and do not take Clozapine Actavis.

Clozapine Actavis must not be given to anyone who is unconscious or in a coma.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clozapine Actavis

• if you suffer from high blood sugar levels which can cause weight loss, increased thirst and fatigue.

• if you suffer from prostate enlargement Clozapine Actavis may worsen these conditions.

• if you suffer from narrow-angle glaucoma (an eye disease). Clozapine Actavis may worsen these conditions.

- if you or anyone in your family have previously had blood clots, as medicines like these have been associated with formation of blood clots.

• if you simultaneously are taking medicines which cause constipation (antipsychotic medicines, antidepressants and medicines for Parkinson’s disease). This can lead to additional enhancement of the effect of Clozapine Actavis which can cause constipation (even ileus).

• if you previously have had disease of the large intestine or have had an operation in the lower part of the abdomen.

• if constipation occurs, contact your doctor, this should be treated actively.

• if you get any infection you need to inform your doctor straight away. Pay special attention if you get flu-like symptoms such as fever or a sore throat/ pharynx /mouth or other signs of infection. A blood test to exclude a reduction of white blood cells should immediately be performed.

• When initiating your medication you will be carefully monitored for drop in blood pressure when you suddenly stand up (orthostatic hypotension). If you have Parkinson´s disease your blood pressure will be monitored in both supine and standing positions during the first weeks of treatment.

• if you do not tolerate some sugars, e.g. galactose, contact your doctor before taking this medicine.

• if for the first 2 months of treatment you get a prolonged increased heart rate when resting and/or irregular heartbeat, chest pain or other symptoms of heart failure (e.g. unexplained tiredness, breathing problems, shortness of breath), contact your doctor immediately.

• if you have pronounced bradycardia (very slow heart rate), cardiovascular disease or family history of abnormal conduction in the heart (prolongation of the QT interval) you should contact your doctor. Concomitant treatment with other medicines for mental ilness should then be avoided.

- Clozapine Actavis can cause dry mouth, which can lead to an increased risk for dental caries.Brushing of the teeth twice a day with fluoride toothpaste is therefore recommended.

- contact your doctor if you plan to quit smoking since this might lead to an increase in side effects.

- if you are taking other antipsychotic medication.

Children and adolescents

The safety and efficacy of Clozapine Actavis in children and adolescents under the age of 16 years have not been established. It should not be used in this group until further data become available.

Other medicines and Clozapine Actavis

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

This especially applies to:

• medicines used to treat cardiac arrhythmia.

• methadone.

• some diuretic (thiazide diuretic).

• cisapride.

• antihistamines (medicines used for allergy such as loratadine, chlorpheniramine) and benzodiazepines or other antipsychotics (used as sedative or hypnotic medicines).

• carbamazepine, phenytoin, valproic acid (medicines used to control epilepsy).

- medicines used to treat depression (such as flucoxamine, fluoxetine, paroxetine, amitriptyline, chlorpramine.

• medicines lowering the blood pressure (such as metoprolole, captopril).

• warfarin and digoxin.

• anticholinergic medicines such as biperidene, orphenadrine.

• cimetidine.

• certain antibiotics such as co-trimoxazole, erythromycin, rifampicin, moxifloxacin and antifungals such as fluconazole.

• some antivirals such as ritonavir, indinavir.

• medicines used to treat stomach problems such as omeprazole.

Clozapine Actaviswith food, drink and alcohol

Do not drink alcohol during treatment with Clozapine Actavis since it enhances the negative effect of alcohol. You might need to contact your doctor if your caffeine drinking habits substantialy changes, so that your Clozapine Actavis dose can get adjusted.

Pregnancy, breast-feeding 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 newborn babies of mothers that have used Clozapine Actavis during 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.

Women should not breast-feed during treatment with Clozapine Actavis since the medicine may pass into the milk and affect the baby.

Your periods might return if you change from other antipsychotic medicinesto Clozapine Actavis. Therefore you should use effective contraception.

Driving and using machines

Clozapine Actavis causes tiredness and a lower seizure threshold. You should therefore not drive or operate machines during the first weeks of treatment.

Clozapine Actavis contains lactose monohydrate

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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for treatment-resistant schizophrenic patients is:

Adults

Starting dose 12.5 mg (one half of a 25 mg tablet) once or twice on the first day followed by 25 mg once or twice on the second day. If tolerated well, your doctor will then gradually increase the daily dose in steps of 25‑50 mg over the next 2‑3 weeks until a dose up to 300 mg per day is reached.

Elderly

A very low dose (a single dose of 12.5 mg the first day - one half of a 25 mg tablet) is recommended when initiating the treatment.

Maintenance dose

When the highest therapeutic effect is reached, many patients can maintain it with a lower dose.

The recommended dose for psychotic disturbances in patients with Parkinson’s disease is:

Adults

The effective daily dose is usually between 25 mg and 37.5 mg.

The usual starting dose is 12.5 mg (one half of a 25 mg tablet) in the evening. Continuous increases in the dose are normally done in steps of 12.5 mg, not faster than two steps a week, up to a maximum dose of 50 mg.

Treatment with Clozapine Actavis should continue for a longer period of time. Earlier symptoms can return if it is discontinued. Therefore it is important to take the tablets every day.

Contact your doctor or pharmacist if you experience the effect of Clozapine Actavis to be too strong or weak.

Duration of treatment

Your doctor will tell you the duration of treatment with Clozapine Actavis. You should not change the dose or treatment without talking to your doctor.

If you take more Clozapine Actavis than you should

If you have taken more Clozapine Actavis than recommended by your doctor, always contact your doctor or hospital.

The symptoms of overdose are drowsiness, confusion, hallucinations, seizures, twitching of arms and legs, blurred vision, low blood pressure, difficult breathing, fast heart rate and heartbeat (see section Possible Side Effect).

If you forget to take Clozapine Actavis

Contact your doctor if you forget to take Clozapine Actavis or if you have questions regarding the dosing. Do not take a double dose to make up for a forgotten dose.

If you stop taking Clozapine Actavis

The psychotic symptoms can re-occur if the treatment has to suddenly stop. The following reactions might also appear: such as excessive sweating, headache, nausea (feeling sick), vomiting (being sick) and diarrhea.

4. Possible side effects

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

Stop taking Clozapine Actavis and seek medical help immediately if you experience any of the following:

- Blood clotting - especially in the legs (symptoms are swelling, pain and reddening of the legs) and can be transported to the lungs and cause chest pain and difficulties in breathing. This is rare (may affect up to 1 in 1,000 people).

- Jaundice(yellowing of the skin or whites of the eyes) due to blocked bile duct. This is rare (may affect up to 1 in 1,000 people).

- Neuroleptic malignant syndrome(muscle stiffness, fever, impaired consciousness). This is uncommon (may affect up to 1 in 100 people).

Below is a list of other reported side effects.

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

- Drowsiness, dizziness.

- Fast heartbeat.

- Constipation, increased production of saliva.

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

- Reduced level of white blood cells (granulocytes), elevated level of white blood cells.

- Weight gain.

- Blurred vision.

- Trembling, stiffness, restlessness, jerks, seizures, convulsions, muscle twitching.

- Changes in ECG, high blood pressure.

- Faintness or light-headedness after changing position, sudden loss of consciousness.

- Nausea (feeling sick), vomiting (being sick), loss of appetite, dry mouth.

- Loss of bladder control, difficulty in passing urine.

- Tiredness, fever, heat sensation, disturbances in sweating/temperature regulation.

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

- Pronounced lack of white blood cells (granulocytes).

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

- Diabetes which can cause weight loss, increased thirst, tiredness, restlessness, confusion, delirium.

- Difficulty in swallowing (e.g. food going down the wrong way), inflammation of the liver, inflammation of the pancreas.

- Cardiac arrhythmia, ECG changes associated with irregular heartbeats, cardiac arrest, inflammation of the heart muscle.

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

- Decrease in numbers of blood platelets, increase in numbers of blood platelets, very high blood sugar levels and increased acidity of the blood (ketoacidosis), increased levels of lipids in the blood, increased levels of cholesterol.

- Uncontrollable twitching of legs and arms.

- Disorder of the heart muscle.

- Enlargement of parotid glands.

- Severe liver and kidney damage.

- Skin reactions.

- Constipation, ileus.

- Persistent painful erection of the penis.

Not known(frequency cannot be estimated from the available data):

- In elderly people with dementia, a small increase in the number of people dying has been reported for patients taking antipsychotics compared with those not taking antipsychotics.

- Obsessive compulsive symptoms.

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clozapine Actavis

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

This medicinal product does not require any special storage conditions.

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

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 protect the environment.

6. Contents of the pack and other information

What Clozapine Actavis contains

- The other ingredients are:lactose monohydrate, magnesium stearate, povidone, talc, maize starch, silica, colloidal anhydrous and pregelatinised starch.

What Clozapine Actavis looks like and contents of the pack

• The 25 mg tablet is round, yellow, 6 mm in diameter, dividing score on both sides, marked 'CPN 25'.

• The 100 mg tablet is round, yellow, 10 mm in diameter, dividing score on both sides, marked 'CPN 100'.

Marketing Authorisation Holder and Manufacturer

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<[See Annex I - To be completed nationally]> [For referral procedures]

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<This medicinal product is authorised in the Member States of the EEA under the following names:>

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

<[See Annex I - To be completed nationally]> [For referral procedures, as appropriate]

This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.

2016-07-28