Clozapine Rivopharm 25 mg tablets Clozapine Rivopharm 100 mg tablets Clozapine

Marketing Authorisation Holder

Marketing Authorisation Holder

Rivopharm Ltd.

17 Corrig Road

Sandyford, Dublin 18

Ireland

Manufacturer

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, HA1 4HF Middlesex, UK

Wessling Hungary Kft.

Foot out 56., 1047 Budapest, Hungary

Laboratori Fundació DAU

C / C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona, ​​Spain

Agent:

SanoSwiss UAB

Aukstaiciu str. 26A

LT-44169 Kaunas

Lithuania

+370 700 01320

info@sanoswiss.com

1. WHAT IS CLOZAPINE RIVOPHARM AND WHAT IS IT USED FOR?

The appearance of the drug:

25 mg pale yellow to yellow, round, approximately 6.0 mm in diameter, non -coated tablets, with “FC” and “1” on each side of the scoreline on one side of the tablet and smooth on the other side. The tablet can be divided into two equal doses.

100 mg pale yellow to yellow, round, about 10.0 mm in diameter, non -coated tablets with “FC” and “3” on each side of the scoreline on one side of the tablet and smooth on the other side. The tablet can be divided into two equal doses.

The tablets are available in Aluminum-PVC / PVDC blister packs.

Pack sizes:

25 mg: 7, 14, 20, 28, 30, 50, 60, 100 or 500 tablets in blisters.

100 mg: 14, 28, 30, 50, 60, 84, 100 or 500 tablets in blisters.

Not all pack sizes may be marketed.

6. Contents of the packaging and other information

Content declaration

  • The active substance is clozapine.
  • 25 mg: Each tablet contains 25 mg of clozapine.
  • 100 mg: Each tablet contains 100 mg of clozapine.
  • The other ingredients are lactose monohydrate, corn starch, povidone K30, colloidal anhydrous silica magnesium stearate, and talc.

What is Clozapine Rivopharm used for?

The active substance in Clozapine Rivopharm is clozapine which belongs to a group of medicines called antipsychotic medicines, which are used to treat specific mental conditions e.g. psychos.

Clozapine Rivopharm is used to treat patients with schizophrenia for whom other medicines have not worked satisfactorily. Schizophrenia is a mental illness that affects how you think, feel, and behave. You should only take this medicine if you have already tried at least two other antipsychotic drugs, including one of the newer so-called atypical antipsychotic drugs, to treat schizophrenia and none of these drugs have worked satisfactorily or have caused serious untreatable side effects.

Clozapine Rivopharm is also used to treat severe thoughts, feelings, and behaviors in people with Parkinson’s disease for whom other medicines have not worked.

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

2. BEFORE YOU USE CLOZAPINE RIVOPHARM

Take special care with Clozapine Rivopharm:

Do not take Clozapine Rivopharm:

  • 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 previously been informed that you have a low white blood cell count (eg leukopenia or agranulocytosis ), especially if this has been caused by other medicines. This does not apply if you have low blood cell counts due to previous cancer treatment ( chemotherapy ).
  • if you have previously stopped using Clozapine Rivopharm due to serious side effects (eg agranulocytosis or heart problems).
  • if you are being treated with or have been treated with long-acting depot injections of antipsychotic drugs.
  • if you have or have had impaired bone marrow function.
  • if you have uncontrolled epilepsy (seizures and seizures).
  • if you have an acute mental illness caused by alcohol or drugs (eg drugs).
  • if you have decreased consciousness and pronounced drowsiness.
  • if you have experienced a collapse of the blood circulation, which may occur as a result of severe shock.
  • if you have severe kidney disease.
  • if you have inflammation of the heart muscle ( myocarditis ).
  • if you have any other serious heart disease.
  • if you have symptoms of active liver disease such as jaundice (yellowing of the skin and eyes, nausea, or poor appetite).
  • if you have any other serious liver disease.
  • if your bowel is not functioning normally and you have severe constipation (paralytic ileus ).
  • if you are taking medicines that prevent your bone marrow from functioning normally.
  • if you are taking any medicine that reduces the number of white blood cells in your blood.

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

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

Warnings and cautions

The safety precautions in this section are very important. You must follow them to minimize the risk of serious life-threatening side effects.

Before treatment with Clozapine Rivopharm, tell your doctor if you have or have had:

  • blood clots or if someone in your family has had a blood clot in the past, as medicines like these have been linked to blood clots.
  • glaucoma (increased pressure in the eye)
  • diabetes. Elevated blood sugar levels (sometimes very elevated), have occurred in both patients with or without previous diabetes (see section 4)
  • prostate problems or difficulty urinating
  • heart, kidney, or liver disease
  • chronic constipation or if you are taking medicines that can cause constipation (such as anticholinergics)
  • galactose intolerance, total lactase deficiency, or lack of glucose-galactose uptake
  • controlled epilepsy
  • colon disease
  • underwent any abdominal surgery
  • heart disease or if someone in your family has had disorders of the cardiac conduction system called ” QT prolongation”,
  • increased risk of stroke, for example, if you have high blood pressure, cardiovascular problems, or disease of the blood vessels of the brain.

Tell your doctor immediately before taking the next Clozapine Rivopharm tablet:

  • if you get signs of a cold, fever, flu-like symptoms, sore throat, or any other infection. You will then immediately need to take a blood sample to check if your symptoms are related to your medicine.
  • if you have a sudden rapid rise in body temperature and stiff muscles that can lead to unconsciousness. It can be a serious side effect (malignant neuroleptic syndrome) that requires immediate treatment.
  • if you have a fast and irregular heartbeat, even at rest, difficulty breathing, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you immediately to a cardiologist.
  • if you experience nausea, vomiting, and/or have a lack of appetite. Then your doctor needs to check your liver.
  • if you have severe constipation. Your doctor will treat this to avoid later complications.

Medical and blood tests

Before starting treatment with this medicine, your doctor will ask you about your medical history and take a blood test to make sure that your white blood cell count is normal. It is important to find out this because your body needs white blood cells to fight your infection.

Make sure you have regular blood tests before starting treatment, during treatment, and after stopping treatment with Clozapine Rivopharm.

  • Your doctor will carefully inform you when and where to take a blood test. Clozapine Rivopharm should only be taken if you have a normal number of blood cells.
  • This medicine can cause a large decrease in the number of white blood cells in your blood ( agranulocytosis ). Only regular blood tests can tell your doctor if you are at risk of developing agranulocytosis.
  • During the first 18 weeks of treatment, blood tests are performed once a week. Later, blood tests are taken at least once a month.
  • If there is a decrease in the number of white blood cells, you must stop treatment with Clozapine Rivopharm immediately. Your white blood cells will return to normal.
  • You will need to have a new blood test 4 weeks after stopping Clozapine Rivopharm treatment.

Your doctor will also examine you before you start treatment. Your doctor may take an ECG to examine your heart, but only if it is considered necessary or if you have special concerns.

If you have impaired liver function, you will need regular liver function tests while you are taking this medicine.

If you suffer from high blood sugar levels ( diabetes ), your doctor may need to check your blood sugar levels regularly.

This medicine can cause changes in blood fats. This medicine may lead to weight gain. Your doctor may need to check your weight and blood fats.

If this medicine makes you dizzy, dizzy, or faint, be careful when standing up from a sitting or lying position.

If you need surgery or if for some reason you can not walk around for a long period of time, discuss the fact that you are taking this medicine with your doctor. You are at risk of getting a blood clot in a vein ( thrombosis ).

Taking Clozapine Rivopharm with food and drink:

Clozapine Rivopharm with food, drink, and alcohol

Do not drink alcohol during treatment with this medicine.

Tell your doctor if you smoke and how often you drink caffeinated beverages (coffee, tea, and Coca-cola). Sudden changes in your smoking or caffeine habits can also change the effect of this medicine.

Children and young people under 16 years of age

If you are under 16 years of age, do not take Clozapine Rivopharm, as there is not enough information on its use in this age group.

Elderly people (60 years and older)

Elderly people (60 years and older) are more likely to get the following side effects while being treated with this medicine:

Fainting or dizziness in the head after changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.

Tell your doctor or pharmacist if you suffer from dementia.

Other medicines and Clozapine Rivopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines and natural remedies. You may need to take a different amount of your medicine or take other medicines.

Do not take Clozapine Rivopharm with medicines that prevent bone marrow from functioning normally and/or reducing the number of blood cells produced by the body, such as:

  • carbamazepine, a medicine used to treat epilepsy
  • certain antibiotics: chloramphenicol, sulfonamide (eg trimethoprim/sulfamethoxazole)
  • certain painkillers: pyrazolone analgesics such as phenylbutazone
  • penicillamine, a drug used to treat rheumatoid arthritis
  • cytotoxic agents, drugs used in chemotherapy
  • long-acting depot injections of antipsychotic drugs

These medicines increase your risk of developing agranulocytosis (lack of white blood cells ).

Treatment with Clozapine Rivopharm with other medicines may affect how well Clozapine Rivopharm and/or the other medicines work. Tell your doctor if you are planning to take, if you are taking (even if your treatment is about to end) or if you have recently taken any of the following medicines:

  • drugs used to treat depression e.g. lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline
  • other antipsychotic drugs to treat mental illness, such as perazine
  • benzodiazepines and other medicines used to treat anxiety and difficulty sleeping
  • drugs and other drugs that may affect breathing
  • drugs that control epilepsy such as phenytoin and valproic acid
  • drugs used to treat high or low blood pressure such as adrenaline and norepinephrine
  • warfarin, a drug used to prevent blood clots
  • antihistamines, medicines used for allergies such as hay fever
  • anticholinergic drugs, which are used to relieve stomach cramps, spasms, and motion sickness
  • drugs used in Parkinson’s disease
  • digoxin, a drug used in heart problems
  • drugs used to treat fast or irregular heartbeat
  • some medicines used to treat stomach ulcers, such as omeprazole or cimetidine
  • some antibiotics, such as erythromycin and rifampicin
  • some medicines used to treat fungal infections (such as ketoconazole ) or viral infections (eg protease inhibitors, used to treat HIV infections)
  • atropine, a drug that can be used in certain eye drops or in cough and cold products
  • adrenaline, a drug used in emergencies
  • hormonal contraceptives.

This list is not complete. Your doctor and pharmacist have more information about the medicines that you should be careful with or avoid when taking Clozapine Rivopharm. They also know if the medicines you are currently taking belong to the medicines on the list. Talk to them.

Breast-feeding

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. Your doctor will discuss the benefits and possible risks for you of using this medicine during pregnancy. Tell your doctor immediately if you become pregnant during treatment with Clozapine Rivopharm.

The following symptoms may occur in newborns of mothers who have used clozapine 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.

Some women who take medication to treat mental illness have irregular periods or none at all. If you have been affected in this way, your periods may return when you are treated with Clozapine Rivopharm. This means that you must use an effective method of contraception.

Do not breast-feed during treatment with this medicine. Clozapine, the active substance in Clozapine Rivopharm, may pass into your breast milk and affect your baby.

Driving and using machines

This medicine can cause fatigue, drowsiness, and cramps, especially at the beginning of treatment. You should not drive or use machines while you have these symptoms.

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 Rivopharm contains lactose

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

3. HOW TO USE CLOZAPINE RIVOPHARM

Administration

To reduce the risk of low blood pressure, seizures, and drowsiness, it is necessary for your doctor to increase the dose gradually. Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

It is important that you do not change your dose or stop taking your medicine without first consulting your doctor. Keep taking the tablets for as long as your doctor tells you to. If you are 60 years of age or older, your doctor may start with a lower dose and gradually increase it as you are at greater risk of developing certain side effects (See section 2 “What you need to know before you take Clozapine Rivopharm”).

If the dose one you have been prescribed cannot be achieved with this strength on the tablet, there are other strengths of this medicine that may make it possible to achieve dose one.

The tablet can be divided into two equal doses.

Treatment of schizophrenia

The usual starting dose is 12.5 mg (half a 25 mg tablet) once or twice on the first day followed by 25 mg once or twice daily on the second day. Swallow the tablet with water. If you tolerate this well, your doctor will gradually increase the dose one in steps of 25 mg-50 mg over the next 2-3 weeks until a dose of 300 mg per day is reached. Thereafter, if necessary, the daily dose may be increased in increments of 50 to 100 mg twice a week or preferably at weekly intervals.

The effective daily dose is usually between 200 mg and 450 mg, divided into several single doses per day. Some patients may need a higher dose. A daily dose of up to 900 mg is allowed. Increased side effects (especially seizures) may occur with daily doses above 450 mg. Always take the lowest dose that is effective for you. Most people take part of their dose in the morning and the other part in the evening. Your doctor will tell you exactly how to distribute the daily dose. About your daily dose only 200 mg, you can take it as a single dose in the evening. Once you have taken Clozapine Rivopharm with good results for some period, your doctor may try a lower dose. You need to take this medicine for at least 6 months.

Treatment of severe thought disorders in patients with Parkinson’s disease

The usual starting dose is 12.5 mg (half a 25 mg tablet) in the evening. Swallow the tablet with water.

Your doctor will then gradually increase the dose one step by 12.5 mg, not faster than 2 steps in a week, up to a maximum dose of 50 mg at the end of the second week. Increases in dosage one should be discontinued or postponed if you feel dizzy, dizzy, or confused. To avoid such symptoms, your blood pressure will be measured during the first few weeks of treatment.

The effective dose is usually between 25 mg and 37.5 mg, it is taken as a dose in the evening. Doses of 50 mg per day should only be exceeded in exceptional cases. The maximum daily dose is 100 mg.

Always take the lowest dose that is effective for you.

If you use more Clozapine Rivopharm than you should:

The symptoms of overdose are:

Drowsiness, fatigue, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, stiff joints, trembling hands, convulsions (seizures), increased production of saliva, dilation of pupil one, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing or heavy breathing.

If you forget to take Clozapine Rivopharm:

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the forgotten tablets but take the next dose at the right time.

Do not take a double dose to make up for a forgotten dose. Contact your doctor as soon as possible if you have not taken Clozapine Rivopharm for more than 48 hours.

Effects that may occur when treatment with Clozapine Rivopharm is stopped:

Do not stop taking Clozapine Rivopharm without consulting your doctor, as you may experience withdrawal reactions. These reactions include sweating, headache, nausea, vomiting, and diarrhea. If you get any of these reactions, contact your doctor immediately. These reactions can be followed by more serious side effects if you are not treated immediately. Your underlying symptoms may return. A gradual dose reduction of 12.5 mg over one to two weeks is recommended if you need to stop treatment. Your doctor will advise you on how to reduce your daily dose. If you need to stop treatment with Clozapine Rivopharm quickly, you must be checked by your doctor. If your doctor decides to start treatment with Clozapine Rivopharm again and it has been more than 48 hours since your last dose of Clozapine Rivopharm, the starting dose should be 12.5 mg.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Some side effects may be serious and require immediate medical attention:

Tell your doctor immediately before taking the next Clozapine Rivopharm tablet:

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

  • if you have severe constipation. Your doctor will treat this to avoid further complications.

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

  • if you get signs of a cold, fever, flu-like symptoms, sore throat, or any other infection. Then you will need to take a blood test quickly to check if your symptoms are related to your medicine.
  • if you have seizures.

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

  • If you have a sudden rapid increase in body temperature, stiff muscles, which can lead to unconsciousness (malignant neuroleptic syndrome) then this can be a serious side effect that requires immediate treatment.

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

  • if you get signs of respiratory infection or pneumonia such as fever, cough, difficulty breathing, or wheezing.
  • if you are nauseous, vomit, and/or have a lack of appetite. Then your doctor needs to check your liver.

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

  • if you have fast and irregular heartbeats even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you immediately to a cardiologist.

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

  • if you are a man and experience persistent painful erection of the penis. This is called priapism. If you have an erection that lasts for more than 4 hours, immediate medical treatment may be necessary to avoid further complications.

Has been reported (occurs in an unknown number of users):

  • if you experience oppressive chest pain, feeling of tightness in the chest (chest pain may radiate to the left arm, jaw, neck, and upper abdomen), difficulty breathing, sweating, weakness, dizziness, nausea, vomiting, and palpitations (signs of heart attack). Seek emergency medical treatment immediately.
  • if you get pressure over the chest, heaviness, tightness, burning, or suffocating sensation (signs of insufficient blood flow and oxygen to the heart muscle). Your doctor will need to check your heart.
  • if you get signs of blood clots in the veins, especially in the legs, (symptoms are swelling, pain, and redness of the legs), which can be transported via the blood vessels to the lungs and cause chest pain and difficulty breathing.
  • if you experience heavy sweating, headache, nausea, vomiting, and diarrhea (symptoms of the cholinergic syndrome).
  • if you have a severe decrease in urine production (signs of kidney failure ).
  • if you get an allergic reaction (swelling mainly of the face, mouth, and throat, as well as the tongue, which can be itchy or painful).

If you get any of these side effects , talk to your doctor immediately before taking your next Clozapine Rivopharm tablet.

Other side effects are

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

Drowsiness, dizziness, rapid heartbeat, increased saliva flow.

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

Increased white blood cell count ( leukocytosis ), increased white blood cell count ( eosinophilia ), weight gain, blurred vision, headache, tremors, stiffness, restlessness, cramps, muscle twitching, abnormal movements, inability to initiate movement, inability to remain immobile changes in ECG, high blood pressure, fainting or fainting when getting up quickly, sudden loss of consciousness, nausea, vomiting, loss of appetite, dry mouth, slightly elevated liver test results, urinary incontinence, difficulty urinating, fatigue, fever, increased sweating, increased body temperature, increased body temperature (eg slurred speech).

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

A pronounced decrease in white blood cell count ( agranulocytosis ), speech difficulties (eg stuttering).

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

Decreased red blood cell count ( anemia ), restlessness, agitation, confusion, delirium, the collapse of the blood circulation, irregular heartbeat, inflammation of the heart muscle ( myocarditis ) or membranes surrounding the heart muscle (pericarditis), fluid accumulation around the pericardium (pericardial ulcers) “Put in the esophagus”), high blood sugar, diabetes mellitus, blood clots in the lungs ( thromboembolism ), inflammation of the liver ( hepatitis ), a liver disease that causes yellowing of the skin / dark urine/itching, inflammation in the pancreas leading to severe pain in the upper abdomen, elevated levels of an enzyme called creatinine phosphokinase in the blood.

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

Increased platelet count with the risk of blood clots, decreased platelet count, involuntary twitching of mouth/tongue and legs and arms, obsessions and obsessive-compulsive behaviors (signs of obsessive-compulsive disorder), skin reactions, swelling in front of the ear (enlargement of the parotid glands), difficulty breathing caused by uncontrolled blood sugar (eg coma or ketoacidosis ), very high levels of triglycerides or cholesterol in the blood, heart muscle disease ( cardiomyopathy ), cardiac arrest, severe constipation with abdominal pain and stomach cramps caused by an intestinal obstruction (paralytic ileus ), swollen abdomen, abdominal pain, severe liver damage, (fulminant hepatic necrosis ), renal inflammation, sudden unexplained death.

Has been reported (occurs in an unknown number of users):

Liver disease including fatty liver , liver cell death, liver toxicity / damage, liver disease involving replacement of normal liver tissue with scar tissue leading to impaired liver function, including liver damage that has life-threatening consequences such as liver failure (which can lead to death), liver damage (liver damage, bile duct in the liver or both) and liver transplantation, changes in brain activity (seen on electroencephalogram / EEG), diarrhea, stomach pain, heartburn, stomach pain after a meal, muscle weakness, muscle cramps, muscle aches, nasal congestion, nocturnal bedwetting, sudden, uncontrollable increase in blood pressure ( pseudosclerosis) ), uncontrolled bending of the body to one side (pleurototonus), disturbed ejaculation in men which means that semen enters the bladder instead of ejaculation through the penis (dry orgasm or retrograde ejaculation), rash, purpleish red spots, fever or itching due to inflammation of blood vessels, inflammation of the colon causing diarrhea , abdominal pain, fever, changes in skin color, flushing, joint pain, muscle aches, fever and fatigue ( lupus erythematosus) .

In the elderly with dementia, a small increase in the number of deaths has been reported for patients who have been treated with antipsychotics compared with those who have not been treated.

Reporting of side effects ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

Läkemedelsverket 
Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. STORING CLOZAPINE RIVOPHARM

No special storage instructions.

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

Do not use this medicine if the package is damaged or shows signs of tampering.

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

Muhammad Nadeem

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