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ZAPONEX 100 MG TABLETS

Active substance(s): CLOZAPINE / CLOZAPINE / CLOZAPINE

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Zaponex 25 mg Tablets
Zaponex 100 mg Tablets
Clozapine

Package leaflet: information for the user

Read all of this leaflet carefully before you start taking 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.

and do a blood test to ensure that your white blood cell count is normal. It is
important to find this out, as your body needs white blood cells to fight
infections.

Make sure that you have regular blood tests before you start treatment,
during treatment and after you stop treatment with Zaponex.
• Your doctor will tell you exactly when and where to have the tests. Zaponex
may only be taken if you have a normal blood cell count.
• Zaponex can cause a serious decrease in the number of white cells in your
blood (agranulocytosis). Only regular blood tests can tell the doctor if you are
at risk of developing agranulocytosis.
• During the first 18 weeks of treatment, tests are needed once a week. Between
weeks 18 and 52, tests are needed at least every 2 weeks. Afterwards, tests
are needed at least once a month.
• If there is a decrease in the number of white blood cells, you will have to stop
Zaponex treatment immediately. Your white blood cells should then return to
normal.
• You will need to have blood tests for another 4 weeks after the end of Zaponex
treatment.
Your doctor will also do a physical examination before starting treatment. Your
doctor may do an electrocardiogram (ECG) to check your heart, but only if this
is necessary for you, or if you have any special concerns.
If you have a liver disorder you will have regular liver function tests as long as
you continue to take Zaponex. If you suffer from high levels of sugar in the blood
(diabetes) your doctor may regularly check your level of sugar in the blood.
Zaponex may cause alteration in blood lipids. Zaponex may cause weight gain.
Your doctor may monitor your weight and blood lipid level.
If Zaponex makes you feel light-headed, dizzy or faint, be careful when getting
up from a sitting or lying position.

What is in this leaflet:
1. What Zaponex is and what it is used for
2. What you need to know before you take Zaponex
3. How to take Zaponex
4. Possible side effects
5. How to store Zaponex
6. Contents of the pack and further information

If you have to undergo surgery or if for some reason you are unable to walk
around for a long time, discuss with your doctor the fact that you are taking
Zaponex. You may be at risk of thrombosis (blood clotting within a vein).

Children and adolescents under 16 years
If you are under 16 years of age you should not use Zaponex as there is not
enough information on its use in that age group.

Older people (aged 60 years and over)

1

What Zaponex is and what it is used for

Older people (aged 60 years and over) may be more likely to have the following side
effects during treatment with Zaponex: faintness or light-headedness after changing
position, dizziness, fast heart beat, difficulty in passing urine, and constipation.
Tell your doctor or pharmacist if you suffer from a condition called dementia.

The active ingredient of Zaponex is clozapine which belongs to a group of
medicines called antipsychotics (medicines that are used to treat specific mental
disorders such as psychosis).
Zaponex is used to treat people with schizophrenia in whom other medicines
have not worked. Schizophrenia is a mental illness which affects how you think,
feel and behave. You should only use this medicine if you have already tried at
least two other antipsychotic medicines, including one of the newer atypical
antipsychotics, to treat schizophrenia, and these medicines did not work, or
caused severe side effects that cannot be treated.
Zaponex is also used to treat severe disturbances in the thoughts, emotions and
behaviour of people with Parkinson’s disease in whom other medicines have
not worked.

2

What you need to know before you take
Zaponex

Do not take Zaponex if you:
• are allergic (hypersensitive) to clozapine or any of the other ingredients of
Zaponex (see section 6)
• are not able to have regular blood tests
• have ever been told you have a low white blood cell count (e.g. leukopenia or
agranulocytosis), especially if this was caused by medicines. This does not apply
if you have had low white blood cell count caused by previous chemotherapy.
• suffer from bone marrow disease or have ever suffered from bone marrow
disease
• use any medicine that stops your bone marrow from working properly
• use any medicine that reduces the number of white cells in your blood
• had to stop using Zaponex previously because of severe side effects (e.g.
agranulocytosis or heart problems)
• suffer from uncontrolled epilepsy (seizures or fits)
• have an acute mental illness caused by alcohol or drugs (e.g. narcotics)
• suffer from myocarditis (an inflammation of the heart muscle)
• suffer from any other severe heart disease
• suffer from any severe kidney disease
• have symptoms of active liver disease such as jaundice (yellow colouring of
the skin and eyes, feeling sick and loss of appetite)
• suffer from any other severe liver disease
• suffer from reduced consciousness and severe drowsiness
• suffer from circulatory collapse which may occur as a result of severe shock
• suffer from paralytic ileus (your bowel does not work properly and you have
severe constipation)
• 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 Zaponex.
Zaponex must not be given to anyone who is unconscious or in a coma.

Warnings and Precautions
The safety measures mentioned in this section are very important. You must
comply with them to minimise the risk of serious life-threatening side effects.

Other medicines and Zaponex
Tell your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines. This includes medicines obtained without a
prescription or herbal therapies. You might need to take different amounts of
your medicines or take different medicines.
Do not take Zaponex together with medicines that stop the bone marrow from
working properly and/or decrease the number of blood cells produced by the
body, such as:
• carbamazepine, a medicine used in epilepsy
• certain antibiotics: chloramphenicol, sulphonamides such as co-trimoxazole
• certain painkillers: pyrazolone analgesics such as phenylbutazone
• penicillamine, a medicine used to treat rheumatic joint inflammation
• cytotoxic agents, medicines used in chemotherapy
• long-acting depot injections of antipsychotic medicines.
These medicines increase your risk of developing agranulocytosis (lack of white
blood cells).
Taking Zaponex at the same time as another medicine may affect how well
Zaponex and/or the other medicine works. Tell your doctor if you plan to take,
if you are taking (even if the course of treatment is about to end) or if you have
recently had to stop taking any of the following medicines:
• medicines used to treat depression such as lithium, fluvoxamine, tricyclic
antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and
sertraline
• other antipsychotic medicines used to treat mental illnesses
• benzodiazepines and other medicines used to treat anxiety or sleep
disturbances
• narcotics and other medicines which can affect your breathing
• medicines used to control epilepsy such as phenytoin and valproic acid
• medicines used to treat high or low blood pressure such as adrenaline and
noradrenaline
• warfarin, a medicine used to prevent blood clots
• antihistamines, medicines used for colds or allergies such as hay fever
• anticholinergic medicines, which are used to relieve stomach cramps, spasms
and travel sickness
• medicines used to treat Parkinson’s disease
• digoxin, a medicine used to treat heart problems
• medicines used to treat a fast or irregular heart beat
• some medicines used to treat stomach ulcers, such as omeprazole or
cimetidine
• some antibiotic medicines, such as erythromycin and rifampicin
• some medicines used to treat fungal infections (such as ketoconazole) or viral
infections (such as protease inhibitors, used to treat HIV infections)
• atropine, a medicine which may be used in some eye drops or cough and cold
preparations
• adrenaline, a medicine used in emergency situations.
• hormonal contraceptives (birth control medicines).
This list is not complete. Your doctor and pharmacist have more information on
medicines to be careful with or to avoid while taking Zaponex. They will also
know if the medicines you are taking belong to the listed groups. Speak to them.

Taking Zaponex with food and drink
Talk to your doctor or pharmacist before taking Zaponex and tell your doctor if
you suffer from or have ever suffered from:
• blood clots or family history of blood clots, as medicines like these have been
associated with formation of blood clots
• glaucoma (increased pressure in the eye)
• diabetes. Elevated (sometimes considerably) blood sugar levels have occurred in
patients with or without diabetes mellitus in their medical history (see section 4)
• prostate problems or difficulty in urinating
• any heart, kidney or liver disease
• chronic constipation or if you are taking medicines which cause constipation
(such as anticholinergics)
• galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• controlled epilepsy
• large intestine diseases
• if you have ever had abdominal surgery
• if you have had a heart disease or family history of abnormal conduction in
the heart called “prolongation of the QT interval”
• if you are at risk for having a stroke, for example if you have high blood
pressure, cardiovascular problems or blood vessel problems in the brain.

Do not drink alcohol during treatment with Zaponex.

Tell your doctor immediately before taking the next Zaponex tablet:

Breast-feeding
Do not breast-feed during treatment with Zaponex. Clozapine, the active
substance of Zaponex, may pass into your milk and affect your baby.

• if you get signs of a cold, fever, flu-like symptoms, sore throat or any other
infection. You will have to have an urgent blood test to check if your symptoms
are related to your medicine
• if you have a sudden rapid increase in body temperature, rigid muscles which
may lead to unconsciousness (neuroleptic malignant syndrome) as you may
be experiencing a serious side effect which requires immediate treatment
• if you have fast and irregular heartbeat, even when you are at rest,
palpitations, breathing problems, chest pain or unexplained tiredness. Your
doctor will need to check your heart and if necessary refer you to a cardiologist
immediately
• if you experience nausea (feeling sick), vomiting (being sick) and/or loss of
appetite. Your doctor will need to check your liver
• if you have severe constipation. Your doctor will have to treat this in order to
avoid further complications.

Tell your doctor if you smoke and how often you have drinks containing caffeine
(coffee, tea, cola). Sudden changes in your smoking habits or caffeine drinking
habits can also change the effects of Zaponex.

Pregnancy and breast-feeding
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. Your doctor will discuss with you the benefits and possible risks of
using this medicine during pregnancy. Tell your doctor immediately if you
become pregnant during treatment with Zaponex.
Pregnancy
The following symptoms may occur in newborn babies, of mothers that have
used Zaponex in 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 of childbearing potential
Some women taking some medicines to treat mental illnesses have irregular or
no periods. If you have been affected in this way, your periods might return
when your medicine is changed to Zaponex. This means you should use
effective contraception.

Driving and using machines
Zaponex might cause tiredness, drowsiness and seizures, especially at the
beginning of treatment. You should not drive or operate machines while you
have these symptoms.

Zaponex contains lactose
Medical check-ups and blood tests
Before you start taking Zaponex, your doctor will ask about your medical history

If you have been told by your doctor that you have an intolerance to some
sugars, discuss this with your doctor before taking Zaponex.

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If the dose you are prescribed cannot be achieved with this strength tablet, other
strengths of this medicinal product are available to achieve the dose.

• if you experience crushing chest pain, sensation of chest tightness, pressure
or squeezing (chest pain may radiate to the left arm, jaw, neck and upper
abdomen), shortness of breath, sweating, weakness, light headedness,
nausea, vomiting and palpitations (symptoms of heart attack). You should seek
emergency medical treatment immediately.
• if you experience chest pressure, heaviness, tightness, squeezing, burning or
choking 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
include swelling, pain and redness in the leg), which may travel through blood
vessels to the lungs causing chest pain and difficulty in breathing.
• if you experience profuse sweating, headache, nausea, vomiting and
diarrhoea (symptoms of cholinergic syndrome).
• if you experience severely decreased urine output (sign of kidney failure).
• if you experience an allergic reaction (swelling mainly of the face, mouth and
throat, as well as, the tongue, which may be itchy or painful).

Zaponex tablets can be divided into equal doses.

Other side effects:

Treatment of schizophrenia

Very common (may affect more than 1 in 10 people):
Drowsiness, dizziness, increased production of saliva.

3

How to take Zaponex

In order to minimise the risk of low blood pressure, seizures and drowsiness it
is necessary that your doctor increases your dose gradually. Always take this
medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
It is important that you do not change your dose or stop taking Zaponex without
asking your doctor first. Continue taking the tablets for as long as your doctor
tells you. If you are aged 60 years or older, your doctor may start you on a lower
dose and increase it more gradually because you might be more likely to
develop some unwanted side effects (see section 2 “Before you take Zaponex”).

The recommended starting dose is 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.
Swallow the tablet with water. If tolerated well, your doctor will then gradually
increase the dose in steps of 25-50 mg over the next 2-3 weeks until a dose up
to 300 mg per day is reached. Thereafter, if necessary, the daily dose may be
increased in steps of 50 to 100 mg half-weekly or, preferably, at weekly intervals.
The recommended daily dose is between 200 mg and 450 mg, divided into
several single doses per day. Some people might need more. A daily dose of
up to 900 mg is allowed. Increased side effects (in particular seizures) are
possible at daily doses over 450 mg. Always take the lowest effective dose for
you. Most people take part of their dose in the morning and part in the evening.
Your doctor will tell you exactly how to divide your daily dose. If your daily dose
is only 200 mg, then you can take this as a single dose in the evening. Once you
have been taking Zaponex with successful results for some time, your doctor
may try you on a lower dose. You will need to take Zaponex for at least 6
months.

Treatment of severe thought disturbances in patients with Parkinson’s
disease
The recommended starting dose is 12.5 mg (one half of a 25 mg tablet) in the
evening. Swallow the tablet with water. Your doctor will then gradually increase
the dose in steps of 12.5 mg, not faster than two steps a week, up to a maximum
dose of 50 mg by the end of the second week. Increases in the dosage should
be stopped or postponed if you feel faint, light-headed or confused. In order to
avoid such symptoms your blood pressure will be measured during the first
weeks of treatment.
The recommended daily dose is between 25 mg and 37.5 mg, taken as one 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 effective
dose for you.

If you take more Zaponex than you should
If you think that you may have taken too many tablets, or if anyone else takes any
of your tablets, contact a doctor immediately or call for emergency medical help.
The symptoms of overdose are:
Drowsiness, tiredness, lack of energy, unconsciousness, coma, confusion,
hallucinations, agitation, incoherent speech, stiff limbs, trembling hands,
seizures (fits), increased production of saliva, widening of the black part of the
eye, blurred vision, low blood pressure, collapse, fast or irregular heart beat,
shallow or difficult breathing.

If you forget to take Zaponex
If you forget to take a dose, take it as soon as you remember. If it is almost time
for your next dose, leave out the forgotten tablets and 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 any Zaponex for more
than 48 hours.

If you stop taking Zaponex
Do not stop taking Zaponex without asking your doctor, because you might get
withdrawal reactions. These reactions include sweating, headache, nausea
(feeling sick), vomiting (being sick) and diarrhoea. If you have any of the above
signs, tell your doctor straight away. These signs may be followed by more
serious side effects unless you are treated immediately. Your original symptoms
might come back. A gradual reduction in dose in steps of 12.5 mg over one to
two weeks is recommended, if you have to stop treatment. Your doctor will
advise you on how to reduce your daily dose. If you have to stop Zaponex
treatment suddenly, you will have to be checked by your doctor.
If your doctor decides to re-start the treatment with Zaponex and your last dose
of Zaponex was over two days ago, this will be with the starting dose of 12.5 mg.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4

Possible side-effects

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

Common (may affect up to 1 in 10 people):
Low level of white blood cells (leukopenia), high level of white blood cells
(leukocytosis), high level of a specific type of white blood cell (eosinophilia),
weight gain, blurred vision, headache, trembling, stiffness, restlessness, jerks,
abnormal movements, inability to initiate movement, inability to remain
motionless, changes in ECG heart readings, 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, minor
abnormalities in liver function tests, loss of bladder control, difficulty in passing
urine, tiredness, fever, increased sweating, raised body temperature, speech
disorders (e.g. slurred speech).
Uncommon (may affect up to 1 in 100 people):
Lack of white blood cells (agranulocytosis), speech disorders (e.g. stuttering).
Rare (may affect up to 1 in 1,000 people):
Low level of red blood cells (anaemia), restlessness, agitation, confusion,
delirium, circulatory collapse, irregular heartbeat, inflammation of the heart
muscle (myocarditis) or the membrane surrounding the heart muscle
(pericarditis), fluid collection around the heart (pericardial effusion), difficulty
in swallowing (e.g. food going down the wrong way), high level of sugar in the
blood, diabetes mellitus, blood clot in the lungs (thromboembolism), raised
levels of an enzyme called creatinine phosphokinase in the blood.
Very rare (may affect up to 1 in 10,000 people):
Increase in numbers of blood platelets with possible clotting in the blood
vessels, uncontrollable movements of mouth/tongue and limbs, obsessive
thoughts and compulsive repetitive behaviours (obsessive compulsive
symptoms), skin reactions, swelling in front of the ear (enlargement of saliva
glands), difficulty in breathing, complications due to uncontrolled blood sugar
(e.g. coma or ketoacidosis), very high levels of triglycerides or cholesterol in the
blood, disorder of the heart muscle (cardiomyopathy), stopped heartbeat
(cardiac arrest), swollen abdomen, abdominal pain, severe liver damage
(fulminant hepatic necrosis), inflammation of the kidneys, sudden unexplained
death.
Not known (frequency cannot be estimated from the available data)
Liver disorders including fatty liver disease, death of liver cells, liver
toxicity/injury, liver disorders that involve replacement of normal liver tissue
with scar tissue leading to loss of liver function, including those liver events
leading to life-threatening consequences such as liver failure (which may lead
to death), liver injury (injury of liver cells, bile duct in the liver, or both) and liver
transplant, changes in brain waves readings (electroencephalogram/EEG),
diarrhoea, stomach discomfort, heartburn, stomach discomfort after a meal,
muscle weakness, muscle spasms, muscle pain, stuffy nose, nocturnal
bedwetting, sudden, uncontrollable increase in blood pressure (pseudophaeochromocytoma), uncontrolled bending of the body to one side (pleurothotonus),
ejaculatory disorder if you are a male, in which semen enters the bladder
instead of ejaculating through the penis (dry orgasm or retrograde ejaculation),
rash, purplish-red spots, fever or itching due to inflammation of blood vessel,
inflammation of the colon resulting in diarrhoea, abdominal pain, fever, change
in skin colour, “butterfly” facial rash, joint pain, muscle pain, fever and fatigue
(lupus erythematous).
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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety
of this medicine.

5

How to store Zaponex

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

Some side effects can be serious and need immediate medical attention:
Tell your doctor immediately before taking the next Zaponex tablet:

Do not use Zaponex after the expiry date [EXP] which is stated on the outer
carton box and on each blister or on the label of the container. The first two
digits indicate the month and the last four digits indicate the year. The expiry
date refers to the last day of that month.

Very common (may affect more than 1 in 10 people):
• if you have severe constipation. Your doctor will have to treat this in order to
avoid further complications.

Zaponex should be stored in its original package below 25°C.

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. You will have to have an urgent blood test to check if your symptoms
are related to your medicine.
• if you experience seizures.
• if you feel you have a fast heartbeat.

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 pack and further information

What Zaponex contains
Uncommon (may affect up to 1 in 100 people):
• if you have a sudden rapid increase in body temperature, rigid muscles which
may lead to unconsciousness (neuroleptic malignant syndrome) as you may
be experiencing a serious side effect which requires immediate treatment.

The active substance is clozapine. Each tablet contains either 25 or 100 mg
clozapine. The other ingredients are: lactose monohydrate, povidone,
pregelatinised starch, maize starch, talc, colloidal anhydrous silica, magnesium
stearate.

Rare (may affect up to 1 in 1,000 people):
• if you get signs of a respiratory tract infection or pneumonia such as fever,
coughing, difficulty breathing, wheezing.
• if you experience nausea (feeling sick), vomiting (being sick) and/or loss of
appetite. Your doctor will need to check your liver.
• if you develop jaundice (yellowing of the skin or whites of the eyes) and
darkening of urine (symptoms of liver inflammation or liver failure).
• if you develop pain around the top of your stomach and/or jaundice and/or
darkening of urine (symptoms of pancreas inflammation).

What Zaponex looks like and contents of the pack

Rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in
10,000 people):
• if you have fast and irregular heartbeat, even when you are at rest,
palpitations, breathing problems, chest pain or unexplained tiredness. Your
doctor will need to check your heart and if necessary refer you to a cardiologist
immediately.

Marketing Authorisation Holder:
Leyden Delta B.V.
Neerbosscheweg 620
6544 LL Nijmegen
The Netherlands.

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 which lasts more than 4 hours,
immediate medical treatment may be needed in order to avoid further
complications.
• If you experience severe constipation with abdominal pain and stomach
cramps caused by obstruction of the bowel (paralytic ileus).
• If you experience spontaneous bleeding or bruising, as this might be a sign
of decreased numbers of blood platelets.
Not known (frequency cannot be estimated from the available data):

The tablets are yellow and round, scored with a division mark on both sides and
debossed with “CPN 25” or “CPN 100” on one side.
They are supplied in blister packs of 28, 30, 60, 84, 90 and 300 tablets or in plastic
containers containing 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Manufacturer(s):
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain.
National registration number:
Zaponex 25 mg Tablets PL 32553/0001
Zaponex 100 mg Tablets PL 32553/0002

This leaflet was last revised in November 2016
201601-Z

WT REG LD ZAPONEX TABL - LFT73.qxp_260 x 480 mm 29-11-16 15:29 Pagina 3

Leyden Delta BV (NL)
Market

UK

Patient Leaflet

Zaponex 25 mg Tablets
Zaponex 100 mg Tablets
Clozapine

Dimensions

260 x 480 mm.

Laetus Code
Item Code

201601-Z

Software Application

QuarkXPress 2015

Artwork version

7.3

Date

NOV 2016

Printing Color

Black
Pantone 2716 U
Key-Lines

Typefont settings

Univers Condensed: 9 pnts.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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