25 mg, 100 mg tablets
clozapine

1. What Froidir is and what it is used for

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

Froidir is used to treat patients with schizophrenia for whom other medicines have not worked satisfactorily.

Schizophrenia is a mental illness, which affects how you think, feel, and behave. You should only take this medicine if you have already tried at least two other antipsychotic medicines to treat schizophrenia and none of these medicines have worked satisfactorily or caused serious side effects that cannot be treated. One of the drugs should have been a new so-called atypical antipsychotic drug.

Froidir is also used to treat severe mental, emotional and behavioral disorders in people with Parkinson’s disease for whom other medicines have not worked.

Clozapine contained in Froidir 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. What you need to know before using Froidir

Do not use Froidir

Do not take Froidir if you

  • is allergic to clozapine or any of the other ingredients of this medicine (listed in section 6)
  • do not have the opportunity to participate in regular blood tests
  • have previously been informed that you have low white blood cell counts (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 ).
  • have previously discontinued the use of clozapine due to serious side effects (eg agranulocytosis and heart problems)
  • treated with or have been treated with long-acting depot injections of antipsychotic drugs
  • have or have had any disease that results in impaired bone marrow function
  • have uncontrolled epilepsy (seizures and seizures)
  • have an acute mental illness caused by alcohol or drugs (eg drugs)
  • has impaired consciousness and pronounced drowsiness
  • has had a collapse of the blood circulation, which can occur as a result of severe shock
  • have severe kidney disease
  • have myocarditis ( inflammation of the heart muscle)
  • have any serious heart disease
  • have symptoms of active liver disease such as jaundice (yellowing of the skin and eyes, nausea, or poor appetite)
  • have any other serious liver disease
  • have paralytic ileus (your bowel does not function normally and you have severe constipation)
  • use drugs that prevent your bone marrow from functioning normally
  • Take 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 Froidir.

Froidir 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.

Tell your doctor before treatment with Froidir 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 or if someone in your family has had diabetes. Elevated blood sugar levels (sometimes very elevated), have occurred both in patients with preexisting diabetes 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)
  • intolerance to galactose, total lactase deficiency, or lack of glucose-galactose uptake
  • drug- controlled epilepsy
  • colon disease
  • underwent any abdominal surgery
  • if you have had a heart condition or if someone in your family has had disorders of the cardiac conduction system called “prolongation of the QT interval”
  • if you have an increased risk of stroke, for example, if you have high blood pressure, cardiovascular disease, or disease of the blood vessels of the brain.

Tell your doctor immediately before taking the next Froidir 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.
  • gets a sudden rapid increase 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.
  • have rapid 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.
  • is nauseous, vomits, and/or has a lack of appetite. Then your doctor needs to check your liver.
  • have severe constipation. Your doctor will treat this to avoid later complications.

Medical and blood tests

Before starting treatment with Froidir, your doctor will ask you about your medical history and take a blood sample 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 Froidir.

  • Your doctor will carefully inform you when and where to take a blood test. Froidir should only be taken if you have a normal number of blood cells.
  • Froidir 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 Froidir immediately. Your white blood cells will return to normal.
  • You will need to have a new blood test 4 weeks after stopping treatment with Froidir.

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 Froidir.

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

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

If Froidir 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 for a long time, discuss with your doctor the fact that you are taking Froidir. You are at risk of getting a blood clot in a vein ( thrombosis ).

Children and young people

Children and young people under 16 years of age

If you are under 16 years of age, do not take Froidir, 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 experience the following side effects during treatment with Froidir: fainting or dizziness after changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.

Tell your doctor or pharmacist if you suffer from dementia.

Other medicines and Froidir

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

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

  • carbamazepine (a medicine used to treat epilepsy )
  • certain antibiotics (chloramphenicol, sulfonamide such as co-triazole)
  • certain painkillers (pyrazolone analgesics such as phenylbutazone)
  • penicillamine (a medicine used to treat rheumatoid arthritis)
  • cytotoxic agents (drugs used in, among other things, cancer treatment)
  • long-acting injection of antipsychotic drugs.

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

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

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 this medicine. They also know if the medicines you are currently taking belong to the medicines on the list. Talk to them.

Froderir with food and alcohol

Do not drink alcohol during treatment with Froidir.

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.

Pregnancy, breastfeeding, and fertility

Pregnancy

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 this medicine.

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 Froidir. This means that you must use an effective method of contraception.

Breast-feeding

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

Driving and using machines

Do not drive or use any tools or machines as Froidir may cause fatigue, drowsiness, and cramps, especially at the beginning 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.

Froidir contains excipients

Froidir contains lactose: (56 mg in 25 mg tablets and 225 mg in 100 mg tablets). 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 Froidir

To reduce the risk of low blood pressure, cramps, 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.

You mustn’t change your dose or stop taking Froidir 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 any side effects (See section 2 “What you need to know before taking Froidir”).

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

The tablets can be divided into two equal doses.

Treatment of schizophrenia

The recommended 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. Then, if necessary, the daily

dose one is 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 Froidir with good results for some period, your doctor may try a lower dose. You need to take Froidir 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.

Elderly (60 years and older)

If you are older (60 years and older), your doctor will start treatment with a lower dose of 12.5 mg. Your doctor may gradually increase the dose to a maximum daily dose of 25 mg.

If you use more Froidir than you should 

If you have ingested too much medicine or if e.g. If a child has ingested the medicine inadvertently, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

The symptoms of overdose are:

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

If you forget to use Froidir

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 Froidir in 48 hours.

If you stop using Froidir

Do not stop taking Froidir without consulting your doctor, as you may experience withdrawal reactions.

These reactions include sweating, headache, nausea, vomiting, and diarrheaIf 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 taking Froidir quickly, you will need to be checked by your doctor.

If your doctor decides that you should start treatment with Froidir again and it has been 48 hours since your last dose of Froidir, 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:

Talk to your doctor immediately before taking your next tablet of Froidir if you notice any of the following:

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

  • severe constipation. Your doctor will treat this to avoid further complications.
  • fast heartbeat.

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

  • signs of 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.
  • seizures
  • suddenly faints or loses consciousness ( syncope ).

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

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

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

  • signs of respiratory infection or pneumonia such as fever, cough, difficulty breathing or wheezing
  • severe, burning, pain in the upper abdomen extending to the back as well as nausea and vomiting (due to inflammation of the pancreas)
  • fainting and/or muscle weakness due to a sharp drop in blood pressure
  • difficulty swallowing (which may cause you to put food in the trachea)
  • nauseavomiting, and/or loss of appetite. In these cases, 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) :

  • rapid and irregular heartbeat, even at rest, palpitationsdifficulty breathingchest 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) :

  • persistent painful erection of the penis, if you are a man. 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.
  • spontaneous bleeding or bruising, which may be a sign of decreased platelet count
  • symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, stomach pain, increased thirst, urination abnormally, and often, confusion)
  • stomach pain, cramps, bloated stomach, vomiting, constipation, and problems with gas in the gastrointestinal tract which can be signs and symptoms of blockage in the intestine (intestinal obstruction)
  • poor appetite, swollen stomach, stomach pain, yellow skin, severe weakness, and malaise. These symptoms may be a sign that you have started to develop a liver disease that can lead to cell death in the liver.
  • nausea, vomiting, fatigue, weight loss that may be symptoms of inflammation of the kidneys
  • signs of severe imbalance in the acid-base and glucose balance in the body that can lead to coma.

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

  • 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.
  • 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.
  • periodic “throbbing”, “throbbing” or “fluttering” sensation in the chest (palpitations)
  • rapid and irregular heartbeat ( atrial fibrillation ). It can cause symptoms such as temporary palpitations, fainting, shortness of breath, or chest pain. Your doctor will need to check your heart.
  • symptoms of low blood pressure such as dizziness, dizziness, fainting, blurred vision, unusual tiredness, cold and damp/sticky skin, and nausea
  • signs of blood clots in the veins, especially in the legs, (symptoms are swelling, pain, and redness of the legs). The blood clots can be transported via the blood vessels to the lungs and cause chest pain and difficulty breathing.
  • diagnosed or suspected infection with fever or low body temperature, abnormally fast breathing, fast heart rate, altered alertness, and consciousness, drop in blood pressure (symptoms of blood poisoning)
  • heavy sweating, headache, nausea, vomiting, and diarrhea (symptoms of the cholinergic syndrome)
  • severely decreased urine production (signs of kidney failure )
  • allergic reaction (swelling mainly of the face, mouth, and throat, as well as the tongue) which can be itchy or painful.
  • poor appetite, swollen stomach, stomach pain, yellow skin, severe weakness, and malaise. It can be a sign of a kind of liver disease which means that normal liver tissue is replaced with scar tissue. This leads to reduced liver function, including liver effects that have life-threatening consequences such as liver failure (which can lead to death), liver damage (damage to liver cells, bile duct in the liver, or both), and liver transplantation.

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

Other side effects are

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

  • drowsiness, dizziness
  • 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
  • dimsyn
  • headache
  • tremors, stiffness, internal anxiety, cramps, muscle twitching, abnormal movements, inability to initiate movement, inability to remain immobile
  • changes in ECG, high blood pressure
  • fainting when getting up quickly
  • nausea, vomiting, loss of appetite, dry mouth
  • slightly elevated values ​​in liver samples
  • urinary incontinence, difficulty urinating
  • fatigue, fever, sweating, increased body temperature
  • speech difficulties (eg slurred speech).

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

  • decreased white blood cell count ( agranulocytosis )
  • speech difficulties (eg stuttering).

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

  • decreased number of red blood cells ( anemia )
  • restlessness, agitation, confusion, delirium
  • irregular heartbeat, inflammation of the heart muscle ( myocarditis ) or membranes surrounding the heart muscle (pericarditis), fluid accumulation around the pericardium (pericardial effusion)
  • high blood sugar, diabetes mellitus
  • blood clots in the lungs ( thromboembolism )
  • inflammation of the liver (hepatitis), liver disease causing yellowing of the skin / dark urine/itching
  • elevated levels of an enzyme called creatinine phosphokinase in the blood.

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

  • increased number of platelets with risk of blood clots
  • involuntary twitching of the 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
  • very high levels of triglycerides or cholesterol in the blood
  • heart muscle disease ( cardiomyopathy ), cardiac arrest
  • sudden unexplained death.

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

  • changes in brain activity (seen on electroencephalogram / EEC)
  • 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 (pseudopheochromocytoma)
  • uncontrolled bending of the body to one side (pleurothotonus)
  • disturbed ejaculation in men which means that semen enters the bladder instead of ejaculation through the penis (dry orgasm or retrograde ejaculation)
  • rash, purple-red spots, fever, or itching due to inflammation of blood vessels
  • inflammation of the colon that causes 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.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Froidir

  • 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 label after EXP. The expiration date is the last day of the specified month.
  • 25 mg: No special storage instructions.
    100 mg: Do not store above 30 ° C.
  • 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 mg or 100 mg of clozapine.
  • The other ingredients are lactose monohydrate, corn starch, povidone, colloidal anhydrous silica, talc, magnesium stearate.

What the medicine looks like and the contents of the pack

  • 25 mg: Light yellow, round, flat, uncoated tablet with a beveled edge. Marked with “C” and “Z” on each side of a breaker notch on one side and “25” on the opposite side. Diameter: 6.35 mm.
  • 100 mg: Light yellow, round, flat, uncoated tablet with a beveled edge. Marked with “C” and “Z” on each side of a breaker notch on one side and “100” on the opposite side. Diameter: 100 mm.

Pack sizes:

Blisters: 7, 12, 14, 20, 24, 28, 30, 40, 48, 50, 56, 60, 72, 84, 86, 98, 100 and 250 tablets.

HDPE can: 30, 50, 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd,

medinfo@orionpharma.com

Muhammad Nadeem

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