DENZAPINE 25MG TABLETS

Active substance: CLOZAPINE

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DENZAPINE® 25, 50,100 AND 200 mg TABLETS
CLOZAPINE
PACKAGE LEAFLET – INFORMATION FOR THE USER

The use of DENZAPINE is restricted to those patients registered with the Denzapine Monitoring Services.

*Trademark

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet
1. What DENZAPINE is and what it is used for
2. Before you take DENZAPINE
3. How to take DENZAPINE

4. Possible side effects
5. How to store DENZAPINE
6. Further information

DENZAPINE contains clozapine, which belongs to a group of medicines
called atypical antipsychotics. Antipsychotics are mainly used to treat
schizophrenia. Schizophrenia is a psychiatric disorder that affects the
way a person thinks and behaves.

DENZAPINE is used:
- to treat schizophrenia when other antipsychotic medicines have not
worked or have caused severe side effects
- to treat psychotic disorders occurring in patients with Parkinson’s
disease, when standard treatment has failed

DENZAPINE is available only with a doctor’s prescription. Ask
your doctor if you have any questions about why this medicine
has been prescribed for you

pressure)
- If you or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood clots.
If you are not mobile you are at increased risk of developing blood clots
while taking DENZAPINE.
Also tell your doctor if you are taking any other antipsychotic medicines
(see section “Taking other medicines” below)
Or if you are taking any other medicines that are known to affect the heart
DENZAPINE may lower the number of your white blood cells, making you
more prone to infections. Before and during your treatment with
DENZAPINE, your doctor will monitor your blood count closely to make
sure that the number of your white blood cells do not fall under a certain
level. Please tell your doctor if you develop any signs of infection, such as
fever, sore throat or flu-like symptoms.

cough preparations
- Medicines which may cause excessive salt loss, such as
diuretics (water tablets)
- Adrenaline (epinephrine), a medicine used in emergency situations
- Warfarin, a medicine to prevent blood clots
- Digoxin (for heart diseases)
- Cimetidine, used for stomach ulcers
- Erythromycin and rifampicin (antibiotics)
- Medicines to treat fungal infections, such as ketoconazole,
itraconazole and miconazole
- Medicines to treat epilepsy e.g. phenytoin, carbamazepine, valproic
acid
- Medicines for depression, such as fluvoxamine, fluoxetine,
paroxetine, sertraline, citalopram, amitriptyline, phenelzine,
moclobemide, chlorpromazine, mesoridazine or fluphenazine
- Lithium (for mental disorders)
- Medicines which affect how your body eliminates clozapine. Your
doctor will know which medicines these are.
- Omeprazole (a drug used to treat excess stomach acid).
- Ciprofloxacin (a drug used to treat infections)
Your doctor and pharmacist have more information on medicines to be
careful with or avoid while taking DENZAPINE.

2. BEFORE YOU TAKE DENZAPINE
DENZAPINE must not be given to anyone who is unconscious or in a coma.

Do NOT take DENZAPINE if:
- You are allergic (hypersensitive) to clozapine or to any of the other
ingredients of the DENZAPINE tablets (see section 6, “Further
information”). It is important to tell your doctor if you think you have
ever had an allergic reaction to any of these ingredients.
Symptoms of an allergic reaction can include:
- swelling of the face and mouth
- itchy skin rashes or hives
- difficulty breathing
- faintness
- If you are unable to digest lactose (milk sugar), due to one of the
following conditions:
- galactose intolerance
- Lapp-lactase deficiency
- glucose-galactose malabsorption
- You are unable to undergo regular blood tests
- You have a low number of white cells in the blood
(granulocytopenia/agranulocytosis)
- You have ever had a low white blood cell count that was unexplained
or was caused by medicinal treatment (except anticancer treatment)
- You are receiving treatment with other medicines that can cause a fall
in the number of white blood cells
- You have suffered from a very low white blood cell count
(agranulocytosis) caused by previous treatment with DENZAPINE
You have any of the following diseases:
- Disorders of the bone marrow (when the bone marrow does not make
enough blood cells)
- Uncontrolled epilepsy (fits or seizures)
- Acute mental illness caused by alcohol, medicines or other substances
- Poisoning caused by other medicines
- Circulatory collapse (a very pronounced fall in blood pressure that
may lead to unconsciousness)
- Disorders affecting the brain that can lead to drowsiness or
unconsciousness
- Severe kidney disease
- Heart disease (such as myocarditis, pericarditis or cardiomyopathy)
- Active liver disease with jaundice (yellow colouration of the skin and
eyes), feeling sick and loss of appetite
- Liver failure (very serious liver disease)
- Paralytic ileus (a disorder of the small intestine)

Take special care with DENZAPINE
Please tell your doctor if you have or have had any medical conditions or
illnesses, especially the following:
- Low number of white blood cells (leukopenia, neutropenia,
granulocytopenia, agranulocytosis)
- High number of a certain type of white blood cells called eosinophil
granulocytes (eosinophilia)
- Low number of platelets in the blood (thrombocytopenia)
- Pericarditis or pericardial effusion (inflammation of the membranes
around the heart)
- If you or any member of your family have changes on the heart trace (ECG)
- Orthostatic hypotension (a fall in blood pressure on standing up)
- Epilepsy or fits, even if they are well controlled
- Liver disease
- Enlargement of the prostate
- Glaucoma (raised pressure in the eye)
- Constipation, paralytic ileus, disease of the large bowel or operations
on the abdomen
- Fever
- Neuroleptic Malignant Syndrome, a serious reaction to some
anti-psychotic medicines. Symptoms include a sudden increase in
body temperature, sweating, a fast heart beat, muscle stiffness and a
fluctuating blood pressure. It can lead to coma.
- Diabetes
- Stroke (Risk factors of stroke e.g smoking, diabetes and high blood

If this medicine makes you feel dizzy, light-headed or faint, be careful
when getting up from a sitting or lying position. DENZAPINE may lower
your blood pressure, especially at the start of treatment. These symptoms
can usually be prevented by getting up slowly and flexing leg muscles
and toes to get the blood circulating. When getting out of bed, dangle
your legs over the side for a minute or two before standing up.
Be careful when drinking alcohol or when taking antihistamines
(medicines used for hay fever, allergies or colds), sleeping tablets or
tablets to relieve pain while taking this medicine. DENZAPINE can
increase drowsiness caused by alcohol and by medicines affecting your
nervous system.
DENZAPINE may affect the way your body controls temperature, and it
may prevent sweating even in very hot weather. Exercise, hot baths or
saunas may make you feel dizzy or faint while you are taking this medicine.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Some medicines must NOT be used when you are taking DENZAPINE.
These include:
- Medicines that affect the bone marrow. These can decrease the
number of blood cells produced by the bone marrow. They include:
- some antibiotics (e.g. co-trimoxazole, chloramphenicol,
sulphonamides)
- certain pain-killers (e.g. phenylbutazone, oxybutazone, antipyrine,
dipyrone)
- penicillamine (for rheumatoid arthritis)
- carbamazepine (for epilepsy and for neuralgic pain)
- cytotoxic (anticancer) medicines
- Other antipsychotic medicines (neuroleptics), especially when given
as a depot (for long-term treatment)
Other medicines can be affected by DENZAPINE or may affect how well
DENZAPINE works. Your doctor will tell you what medicines you can take
and their doses. Please also consult your doctor if you are taking any of
the medicines listed below:
- Medicines that can make you drowsy e.g. morphine (for pain),
benzodiazepines (sleeping pills) and antihistamines (for allergies) such
as loratadine, chlorpheniramine
- Anticholinergic medicines, which are used to relieve stomach cramps,
spasms and travel sickness
- Medicines used to treat high blood pressure, e.g. metoprolol,
captopril, enalapril.
- Medicines used to treat a fast or irregular heart beat (antiarrhythmics,
e.g. flecainide, pilsicainide)
- Medicines that can cause changes on the heart trace (ECG). Your
doctor will know which medicines these are
- Medicines that can cause constipation, particularly certain
medicines to treat psychosis, depression or Parkinson’s disease.
Your doctor will know which medicines these are
- Atropine, a medicine which may be used in some eye drops or

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1. WHAT DENZAPINE IS AND WHAT IT IS USED FOR

Taking DENZAPINE with food and drink
You can take your DENZAPINE tablets with or without food.
DENZAPINE may increase the effect of alcohol. Therefore, you should
not drink alcohol during treatment.
Coffee can affect the levels of clozapine (the active substance of
DENZAPINE) in your blood. You may drink coffee. However, if you stop
drinking coffee suddenly, the levels of clozapine in your blood may fall.
This will make the medicine less effective. Equally, if you start drinking
coffee, the levels may rise, increasing the risk of side effects.

Smoking
Smoking can affect the levels of clozapine in your blood. If you stop
smoking suddenly, the levels of clozapine in your blood may rise. This
may increase the risk of side effects.

Children
DENZAPINE is not recommended for use in children.

Elderly
Please tell your doctor if you have dementia or a family history of
dementia

Pregnancy
Tell your doctor if you are or think you may be pregnant or if you are
planning to become pregnant.
There is limited information on the safety of DENZAPINE tablets in
pregnancy. Your doctor will discuss with you the risks and benefits of
taking this medicine during pregnancy.
Some women taking antipsychotic medicines have irregular or no
periods. If you have been affected in this way, your periods may return
when your medication is changed to DENZAPINE. In these
circumstances you should be sure to take adequate contraceptive
precautions.
The following symptoms may occur in newborn babies, of mothers that
have used Denzapine 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.

Breast-feeding
If you are breast-feeding, DENZAPINE can reach your baby through
your breast milk. DENZAPINE should not be used when breast-feeding.

Driving and using machines
You may feel tired, drowsy, dizzy or you may feel faint while taking
DENZAPINE, especially during the early stages of treatment. If you
have any of these symptoms, do not drive, operate machinery or do
any tasks where you need to be alert.

3. HOW TO TAKE DENZAPINE
Your dose of DENZAPINE has been determined by your doctor. The dose
will depend on how well you respond to the medicine. It will also depend
on the other medicines you are taking and other medical conditions you
may have. The dose may be altered from time to time.

If you have heart, kidney or liver disease, epilepsy or are elderly, or if you
are taking any other medicines that may affect the way DENZAPINE
works, your doctor may start you on a lower dose to prevent unwanted
effects. The dose will be increased slowly.

When changing from a previous antipsychotic treatment to
DENZAPINE, the first treatment should be gradually withdrawn before
starting DENZAPINE.
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Dosage
The total amount of DENZAPINE you take each day is usually divided into
two doses. If you have to divide your dose, you should take the larger
dose at bed time. However, if your total daily dose is not over 200 mg, it
is not necessary to divide the dose. In this case, it is usually taken in the
evening.
Swallow DENZAPINE tablets with a full glass of water or other
liquid. Taking the tablets at the same time each day will have the
best effect and will help you remember to take them.
Schizophrenic patients resistant to other treatments
When you first start taking DENZAPINE, the usual dose is half a 25 mg
tablet (12.5 mg) taken once or twice on the first day, followed by one or
two 25 mg tablets taken on the second day. If this dose is well tolerated,
it may be increased gradually, usually to between 200 mg and 450 mg
per day.
However, some people may need a higher dose. The maximum
permissible dose is 900 mg per day. Once the maximum benefit is
achieved, your doctor may reduce the dose gradually to a lower level.
Your doctor will determine the most appropriate dose for you.
Parkinsonian patients with psychotic disorders that do not respond
to standard treatment.
The initial dose is of 12.5 mg (half a 25 mg tablet) taken in the evening.
The dose is gradually increased to a maximum of 50 mg per day, taken
in the evening. The effective dose is usually between 25 mg and 37.5
mg (one to one-and-a-half 25 mg tablets). If the 50 mg dose is not
effective, it can be increased to 100 mg in some patients. This dose (100
mg) must not be exceeded.
Elderly patients:
DENZAPINE tablets can be used in the elderly (over 65 years of age).
Treatment usually begins with a lower dose (e.g. 12.5 mg daily), which is
then gradually increased.

Duration of treatment:
You should take DENZAPINE for at least 6 months. Do not stop taking this
medicine without first talking to your doctor.

WHILE TAKING DENZAPINE
Tell all of the doctors and pharmacists who are treating you that you are
taking DENZAPINE.
You must have regular blood tests while taking DENZAPINE.

Blood tests
Before starting DENZAPINE you will have a blood test to make sure that
you can take this medicine.
DENZAPINE can cause agranulocytosis. In this condition, the number of
white blood cells (which are necessary to fight infection) is too low. If this
occurs, you are at risk of suffering infections which may be lifethreatening. Warning signs include flu-like symptoms, a sore throat or
fever. If you develop these or any other signs suggestive of infection, you
should contact your doctor immediately.
There is no way of knowing who is at risk of developing agranulocytosis.
Deaths have occurred in severe cases of agranulocytosis, although with
regular blood tests, agranulocytosis can be detected early. If DENZAPINE
is stopped as soon as a problem is detected, the white blood cell
numbers should return to normal. You must understand the importance of
regular blood tests by your doctor while taking DENZAPINE.
After starting treatment with DENZAPINE, you will have a blood test once
a week for the first 18 weeks. The risk of agranulocytosis is highest in
this period. For the rest of the first year of treatment, blood tests will be
performed every 2 weeks. After the first year, tests will be performed
every 4 weeks for as long as you continue to take DENZAPINE. Tests will
also be performed for one month after stopping the medicine. These tests
will tell the doctor if there is any problem with the number of white cells
in your blood. There are some situations where you may need to have
blood tests more often (e.g. twice a week). Your doctor will talk to you
about this.
If the number of your white blood cells falls below a critical level,
DENZAPINE must be stopped immediately and you must never take
any medicines containing clozapine again.

Things which I must not do
- Do not stop taking DENZAPINE or lower the dosage even if you are
feeling better, unless your doctor tells you to do so. Your condition
may worsen if you suddenly stop taking it. Your doctor will gradually
reduce the amount you take each day before stopping the medicine
completely.
- Do not give DENZAPINE to anyone else even if they have the same
symptoms as you. It may harm them even if their condition seems
similar to yours.

- Do not use DENZAPINE to treat other complaints unless your doctor
tells you to.

If you take more DENZAPINE than you should
If you suspect that you or someone else has taken too many
DENZAPINE tablets, contact a doctor immediately or go to the Accident
and Emergency Department at your nearest hospital. Do this even if
there are no signs of discomfort or poisoning. You may need urgent
medical attention. Keep the telephone numbers for these places
handy.
The most common signs and symptoms of overdose include:
- drowsiness
- confusion and coma
- delirium
- agitation
- light-headedness
- a fall in blood pressure
- collapse
- shallow or slow breathing or sometimes shortness of breath
- fast or irregular heartbeat
- dribbling
- fits.

If you forget to take DENZAPINE

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Carefully follow all the instructions given to you by your doctor and
pharmacist. Their instructions may differ from the information contained
in this leaflet. If you do not understand the instructions on the label, ask
your doctor or pharmacist for help. Take DENZAPINE exactly as
prescribed by your doctor to prevent unwanted side effects.
Do not take more or less DENZAPINE than your doctor has prescribed. If
you think the dose is too weak or too strong, talk to your doctor.

If it is almost time for your next dose (within four hours),
forget the dose you missed and take your next dose at its
normal time. Otherwise take it as soon as you remember,
and then go back to taking your tablets as you would
normally.
If you miss a dose of DENZAPINE do not take a double dose
to make up for the missed dose.
If you have stopped taking DENZAPINE for more than two
days, you must contact your doctor before starting to take it
again. In this case, the medicine must be started again at a
low dose and then increased.
If you have trouble remembering to take your medicine, ask
your pharmacist for some hints.

If your doctor tells you to stop taking DENZAPINE
If the medicine needs to be stopped abruptly due to side effects, you
will be monitored closely for psychotic symptoms. Other symptoms
can also arise, including increased sweating, headache, nausea
(feeling sick), vomiting and diarrhoea.

4. POSSIBLE SIDE EFFECTS
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 notice any of these symptoms seek medical advice immediately.
Like all medicines, DENZAPINE can cause side effects although not
everybody gets them. The frequency of side effects is based on the
following:
Very common:
Common:

In more than 1 in 10 patients treated
In less than 1 in 10, but more than 1 in 100
patients treated
In less than 1 in 100, but more than 1 in
1,000 patients treated
In less than 1 in 1,000, but more than 1 in
10,000 patients treated
In less than 1 in 10,000 patients treated,
including single reports

Problems of coordination
Epileptic fits (localised or generalised)
Changes on the heart trace (ECG)
High blood pressure (hypertension)
A fall in blood pressure on standing up (orthostatic hypotension)
Fainting
Nausea (feeling sick)
Vomiting
Loss of appetite (anorexia)
Dry mouth
Changes in the blood tests that assess how the liver is working
Urinary incontinence
Urinary retention (the inability to pass urine)
Fatigue
Fever
Benign hyperthermia (drug fever; changes in body temperature caused
by certain medicines)
Alterations in the body’s control of temperature
Alterations of sweating
Slurring of words

the heart)
Blood clots in the veins that may cause lung problems
Inhaling of food into the lungs (aspiration)
Difficulty swallowing (dysphagia)
Inflammation of the liver (hepatitis)
Jaundice (yellow colouration of the skin and eyes)
Inflammation of the pancreas (pancreatitis)
A rise in the CPK values (a blood test)
A low number of red blood cells (anaemia)
Chest infection and pneumonia

Very rare:

Very common:

Uncommon:

Drowsiness
Dizziness
A fast heart beat (tachycardia)
Constipation
Hypersalivation (forming a large volume of saliva)

Agranulocytosis (a very low number of white cells in the blood)
Neuroleptic malignant syndrome (fever, sweating, a fast heart beat,
muscle stiffness and changes in blood pressure)
Stammering

Rare:

Common:

Impaired glucose tolerance (excess sugar levels in the blood)
Diabetes mellitus
Restlessness (agitation)
Confusion
Delirium
Circulatory collapse (a very low blood pressure that can lead to
unconsciousness)
Irregular heart beat (arrhythmia)
Ventricular arrhythmias (life-threatening disorders of the heart. These are
medical emergencies.)
Inflammation of the heart muscle (myocarditis)
Pericarditis (inflammation of the membranes around the heart)
Pericardial effusion (a collection of liquid in the membranes around

A fall in the number of platelets in the blood (thrombocytopenia)
Complications of excessive sugar in the blood (severe hyperglycaemia,
ketoacidosis, hyperosmolar coma)
Excessive fat in the blood (hypertriglyceridaemia)
Tardive dyskinesia (slow, abnormal movements of the face, tongue
and limbs)
Disease of the heart muscle (cardiomyopathy)
Cardiac arrest
Torsades de pointes (a life-threatening disorder of the heart. This is a
medical emergency.)
Very slow or shallow breathing (respiratory depression)
Absence of breathing (respiratory arrest)
Enlargement of the parotid glands (salivary glands)
Altered bowel movement (intestinal obstruction, paralytic ileus, faecal
impaction)
Death of the liver (fulminant hepatic necrosis)
Skin reactions
Inflammation of the kidney (interstitial nephritis)
A persistent and possibly painful erection (priapism)
Sudden unexplained death
Obsessive thoughts and compulsive behaviours (obsessive compulsive
symptoms)
In elderly patients with dementia, a small increase in the number of
people dying has been reported for patients taking antipsychotics
compared with those who are not taking antipsychotics.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

tampering.
Do not store above 30°C. Store in the original packaging. Keep in the
outer carton to protect from light
Keep your tablets in the original container until it is time to take them.
Do not store DENZAPINE or any medicine in the bathroom or near a sink.
Do not leave it in a car or on a window sill. Heat and dampness can

destroy medicines. If your tablets appear to change in their
appearance or show any other apparent signs of deterioration, do not
take the tablets but refer immediately to the pharmacist.
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.

DENZAPINE 50 mg tablets are small, round, yellow tablets with “50”
embossed over a breakline on one face, the other side is plain.
DENZAPINE 100 mg tablets are small, round, yellow tablets with “100”
embossed over a breakline on one face, the other side is plain.
DENZAPINE 200 mg tablets are large, oval shaped, yellow tablets with
“200” on one side and a breakline on the other side..
The breakline allows the tablet to be broken for easier swallowing.
DENZAPINE 25 and 100 mg tablets are supplied in bottles of 100 tablets
and in blister packs containing 28 or 84 tablets.
DENZAPINE 50 mg tablets are supplied in bottles of 100 tablets and in
blister packs containing 20 or 50 tablets.
DENZAPINE 200 mg tablets are supplied in blister packs containing 50
tablets.
The quantity provided to you by the pharmacy will be determined
by your doctor.

The Marketing Authorisation holder and manufacturer:

Uncommon:
Rare:
Very rare:

The following side effects have been associated with DENZAPINE:

A fall in the number of white cells in the blood (leukopenia, neutropenia,
granulocytopenia, agranulocytosis) (see Section 3, “How to take
DENZAPINE”)
Eosinophilia (an increase in the number of a certain type of white blood
cells called eosinophil granulocytes)
Leukocytosis (an increase in the number of white blood cells)
Weight gain
Blurred vision
Headache
Tremor
Stiffness of the limbs (rigidity)
Restlessness (akathisia)

5. HOW TO STORE DENZAPINE
Keep DENZAPINE out of the reach and sight of children.
A locked cupboard at least one and a half metres from the ground is a
good place to store medicines.
Do not take DENZAPINE after the expiry date shown on the outer carton
or on the blister strip. The expiry date refers to the last day of that month.
Do not take DENZAPINE if the packaging is damaged or shows signs of

6. FURTHER INFORMATION
What DENZAPINE contains
- The active substance is clozapine.
One DENZAPINE 25 mg tablet contains 25 mg clozapine.
One DENZAPINE 50 mg tablet contains 50 mg clozapine.
One DENZAPINE 100 mg tablet contains 100 mg clozapine.
One DENZAPINE 200 mg tablet contains 200 mg clozapine.
- The other ingredients are
– Microcrystalline cellulose
– Lactose monohydrate
– Povidone
– Sodium starch glycolate
– Magnesium stearate

What DENZAPINE looks like and contents of the pack
DENZAPINE 25 mg tablets are small, round, yellow tablets with “25”
embossed over a breakline on one face, the other side is plain.

Genus Pharmaceuticals, Park View House, 65 London Road, Newbury,
Berkshire RG14 1JN, UK.
Manufacturer: Britannia Pharmaceuticals Ltd., Park View House,
65 London Road, Newbury, Berkshire RG14 1JN, UK.
If you have any further questions about your medicine or are unsure
about any of the advice in this leaflet, ask your doctor or pharmacist.

Marketing Authorisation number:
DENZAPINE 25 mg tablets PL 06831/0266
DENZAPINE 50 mg tablets PL 06831/0268
DENZAPINE 100 mg tablets PL 06831/0267
DENZAPINE 200 mg tablets PL 06831/0269
This leaflet was last approved in December 2013. 9249637 XXXX
xxxxx

GEN-DNZTAB-PIL-256_01
13/12/2013

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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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