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RISPERIDONE 6MG FILM-COATED TABLETS

Active substance(s): RISPERIDONE

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The following medicines may increase the effect of
Risperidone
• Quinidine (used for certain types of heart disease)
• Antidepressants such as paroxetine, fluoxetines, tricyclic
PACKAGE LEAFLET: INFORMATION FOR THE USER
antidepressants
Read all of this leaflet carefully before you start taking this • Medicines known as beta blockers (used to treat high
blood pressure)
medicine because it contains important information for you.

Phenothiazines (e.g. used to treat psychosis or to calm
• Keep this leaflet. You may need to read it again.
down)
• If you have any further questions, ask your doctor or

Cimetidine, ranitidine (blockers of the acidity of
pharmacist.
stomach)
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
If you start or stop taking such medicines you may need a
signs of illness are the same as yours.
different dose of Risperidone.
• If you get any side effects, talk to your doctor or
If you are not sure if any of the above applies to you, talk
pharmacist. This includes any possible side effects not
to your doctor or pharmacist before using Risperidone.
listed in this leaflet. See section 4.
Risperidone with food, drink and alcohol
WHAT IS IN THIS LEAFLET:
You can take this medicine with or without food. You
1. What Risperidone is and what it is used for
should avoid drinking alcohol when taking Risperidone.
2. What you need to know before you take Risperidone
Pregnancy, breast-feeding and fertility
3. How to take Risperidone
• Talk to your doctor before using Risperidone. If you are
4. Possible side effects
pregnant or breastfeeding, think you may be pregnant
5. How to store Risperidone
or are planning to have a baby, ask your doctor for
6. Contents of the pack and other information
advice before taking any medicine

Risperidone 0.5, 1, 2, 3, 4 and 6 mg
Film-Coated Tablets

1

What Risperidone is and what it is used for

Risperidone belongs to a group of medicines called
‘anti-psychotics’.
Risperidone is used to treat the following:
• Schizophrenia, where you may see, hear or feel
things that are not there, believe things that are not
true or feel unusually suspicious, or confused
• Mania, where you may feel very excited, elated,
agitated, enthusiastic or hyperactive Mania occurs in
an illness called “bipolar disorder”
• Short-term treatment (up to 6 weeks) of long-term
aggression in people with Alzheimer’s dementia,who
harm themselves or others. Alternative (non-drug)
treatments should have been used previously
• Short-term treatment (up to 6 weeks) of long-term,
aggression in intellectually disabled children (at least
5 years of age) and adolescents with conduct
disorder.

2

• Risperidone can raise your levels of a hormone called
"prolactin" that may impact fertility (see Possible side
effects).
Driving and using machines
Dizziness, tiredness, and vision problems may occur
during treatment with Risperidone. Do not drive or use any
tools or machines without talking to your doctor first.
Important information about some of the ingredients of
Risperidone
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking this medicine.

What you need to know before you take
Risperidone

Do NOT take Risperidone:
• If you are allergic (hypersensitive) to Risperidone or any
of the other ingredients of this medicine (see section 6
‘Further information’).
If you are not sure if the above applies to you, talk to your
doctor or pharmacist before using Risperidone.
Take special care with Risperidone:
Warnings and precautions
Talk to your doctor before taking Risperidone if you:
• have a heart problem. Examples include an irregular
heart rhythm or if you are prone to low blood pressure
or if you are using medicines for your blood pressure.
Risperidone may cause low blood pressure. Your dose
may need to be adjusted
• know of any factors which would favour you having a
stroke, such as high blood pressure, cardiovascular
disorder or blood vessel problems in the brain
• have Parkinson’s disease or dementia
• are diabetic
• have epilepsy
• are a man and you have ever had a prolonged or
painful erection If you experience this while taking
Risperidone, contact your doctor straight away
• have problems controlling your body temperature or
overheating
• have kidney problems
• have liver problems
• have an abnormally high level of the hormone prolactin
in your blood or if you have a tumour, which is possibly
dependent on prolactin
• have or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots.
Tell your doctor immediately if you experience
• involuntary rhythmic movements of the tongue, mouth
and face. Withdrawal of Risperidone may be needed
• fever, severe muscle stiffness, sweating or a lowered
level of consciousness (a disorder called “neuroleptic
malignant syndrome). Immediate medical treatment
may be needed.
If you are not sure if any of the above applies to you, talk
to your doctor or pharmacist before using Risperidone.
As dangerously low numbers of a certain type of white
blood cell needed to fight infection in your blood has been
seen very rarely with patients taking Risperidone your
doctor may check your white blood cell counts.
Risperidone may cause you to gain weight. Significant
weight gain may adversely affect your health.
Your doctor should regularly measure your body weight.
As diabetes mellitus or worsening of pre-existing diabetes
mellitus have been seen with patients taking Risperidone,
your doctor should check for signs of high blood sugar. In
patients with pre-existing diabetes mellitus blood glucose
should be monitored regularly.
During an operation on the eye for cloudiness of the lens
(cataract), the pupil (the black circle in the middle of your
eye) may not increase in size as needed. Also, the iris (the
coloured part of the eye) may become
floppy during surgery and that may lead to eye damage. If
you are planning to have an operation on your eye, make
sure you tell your eye doctor that you are taking this
medicine.
Elderly people with dementia
In elderly patients with dementia, there is an increased
risk of stroke .You should not take risperidone if you have
dementia caused by stroke.
During treatment with Risperidone you should frequently
see your doctor.
Medical treatment should be sought straight away if you
or your care-giver notice a sudden change in your mental
state or sudden weakness or numbness of your face, arms
or legs, especially on one side, or slurred speech, even for
a short period of time. These may be signs of a stroke.
Children and adolescents
Before treatment is started in conduct disorder, other causes
of aggressive behaviour should have been ruled out.
Before treatment is started your, or your child’s body
weight may be measured and it may be regularly
monitored during treatment.
If during treatment with Risperidone tiredness occurs, a
change in the time of administration might improve
attention difficulties.
Other medicines and Risperidone
Tell your doctor or pharmacist if you are taking have
recently taken or might take any of the following:
• Medicines that work on your brain such as to help you
calm down (benzodiazepines) or some medicines for
pain (opiates), medicines for allergy (some
antihistamines), as Risperidone may increase the
sedative effect of all of these
• Medicines that may change the electrical activity of
your heart, such as medicines for malaria, heart rhythm
problems (such as quinidine), allergies
(anti-histamines), some antidepressants or other
medicines for mental problems
• Medicines that cause a slow heart beat
• Medicines that cause low blood potassium (e.g. certain
diuretics)
• Medicines to treat elevated blood pressure. Risperidone
can lower blood pressure
• Medicines for Parkinson's disease (such as levodopa)
• Water tablets (diuretics) used for heart problems or
swelling of parts of your body due to a build up of too
much fluid (such as furosemide or chlorothiazide).
Risperidone taken by itself or with furosemide, may
have an increased risk of stroke or death in elderly
people with dementia.
The following medicines may reduce the effect of
Risperidone
• Rifampicin (a medicine for treating some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital
If you start or stop taking such medicines you may need a
different dose of Risperidone.

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• The following symptoms may occur in newborn babies,
of mothers that have used Risperidone 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.

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3

HOW TO TAKE RISPERIDONE

How much to take
For the treatment of schizophrenia
Adults
• The usual starting dose is 2 mg per day, this may be
increased to 4 mg per day on the second day
• Your dose may then be adjusted by your doctor
depending on how you respond to the treatment
• Most people feel better with daily doses of 4 to 6 mg
• This total daily dose can be divided into either one or
two doses a day. Your doctor will tell you which is the
best for you.
Elderly people
• Your starting dose will normally be 0.5 mg twice a day
• Your dose may then be gradually increased by your
doctor to 1 mg to 2 mg twice a day
• Your doctor will tell you which is the best for you.
Children and adolescents
• Children and adolescents under 18 years old should not
be treated with Risperidone for schizophrenia.
For the treatment of mania
Adults
• Your starting dose will usually be 2 mg once a day
• Your dose may then be gradually adjusted by your
doctor depending on how you respond to the treatment
• Most people feel better with doses of 1 to 6 mg once a
day.
Elderly people
• Your starting dose will usually be 0.5 mg twice a day
• Your dose may then be gradually adjusted by your
doctor to 1 mg to 2 mg twice a day depending on how
much you respond to the treatment.
Children and adolescents
• Children and adolescents under 18 years old should not
be treated with Risperidone for bipolar mania.
For the treatment of long-standing aggression in people
with Alzheimer’s dementia
Adults (including elderly people)
• Your starting dose will normally be 0.25 mg twice a day
• Your dose may then be gradually adjusted by your
doctor depending on how you respond to the treatment
• Most people feel better with 0.5 mg twice a day. Some
patients may need 1 mg twice a day
• Treatment duration in patients with Alzheimer’s
dementia should be not more than 6 weeks.
For the treatment of conduct disorder in children and
adolescents
The dose will depend on your child’s weight:
For children who weigh less than 50 kg
3. The starting dose will normally be 0.25 mg once a day
4. The dose may be increased every other day in steps of
0.25 mg per day.
5. The usual maintenance dose is 0.25 mg to 0.75 mg once
a day.
For children who weigh 50 kg or more
• The starting dose will normally be 0.5 mg once a day
• The dose may be increased every other day in steps of
0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once a
day.
Treatment duration in patients with conduct disorder
should be not more than 6 weeks.
Children under 5 years old should not be treated with
Risperidone for conduct disorder.
People with kidney or liver problems
Regardless of the disease to be treated, all starting doses
and following doses of Risperidone should be halved.
Dose increases should be slower in these patients.
Risperidone should be used with caution in this patient
group.
How to take Risperidone
• Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
• Your doctor will tell you how much medicine to take and
for how long. This will depend on your condition and
varies from person to person. The amount of medicine
you should take is explained under the ‘How much to
take’ sub-heading below.
Risperidone film-coated tablets
• You should swallow your tablet with a drink of water
If you take more Risperidone than you should
• See a doctor right away. Take the medicine pack with you.
• In case of overdose you may feel sleepy or tired, or have
abnormal body movements, problems standing and
walking, feel dizzy due to low blood pressure, or have
abnormal heart beats or fits.
If you forget to take Risperidone
• If you forget to take a dose, take it as soon as you
remember it. However, if it is almost time for your next
dose, skip the missed dose and continue as usual. If you
miss two or more doses, contact your doctor
• Do not take a double dose (two doses at the same time)
to make up for a forgotten dose
If you stop taking Risperidone
You should not stop taking this medicine unless told to do
so by your doctor. Your symptoms may return. If your
doctor decides to stop this medicine, your dose may be
decreased gradually over a few days.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If the following happens, stop taking the tablet and tell
your doctor immediately or go to the casualty department
at your nearest hospital:
• An allergic reaction (Unresponsive to stimuli, loss of
consciousness, sudden swelling of lips and eyes along
with difficulty breathing, sudden weakness or numbness

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of the face, arms, or legs, especially on one side, or
instances of slurred speech that last for less than 24
hours (these are called mini-strokes or strokes),
involuntary movements of face, arms, or legs, ringing in
ears, face oedema.)
• Brain related disorder (Tardive dyskinesia (twitching or
jerking movements that you cannot control in your face,
tongue, or other parts of your body). If you experience
involuntary rhythmic movements of the tongue, mouth
and face. Withdrawal of Risperidone may be needed.

• Blood clot in the legs, blood clot in the lungs
• Swollen tongue, chapped lips, rash on skin related to
drug
• Priapism (a prolonged penile erection that may require
surgical treatment)
• A delay in menstrual periods, enlargement of the glands
in your breasts, breast enlargement, discharge from the
breasts
• Hardening of the skin

Very rare (affects less than 1 user in 10,000):
• Blood clots in the veins especially in the legs (symptoms • Life threatening complications of uncontrolled diabetes.
• Swelling beneath the surface of the skin with or without
include swelling, pain and redness in the leg), which
redness.
may travel through blood vessels to the lungs causing
• Lack of bowel muscle movement that causes blockage.
chest pain and difficulty in breathing.
Unknown frequency of occurrence (frequency cannot be
• Heart related disorder (Abnormal electrical conduction
estimated from the available data):
of the heart, prolongation of the QT interval from your
• Severe allergic reaction resulting in difficulty in
heart, drop in blood pressure after standing, low blood
breathing and shock
pressure, feeling dizzy after changing body position,
• No granulocytes (a type of white blood cell to help you
abnormal electric activity tracing of the heart (ECG),
against infection)
abnormal heart rhythm, awareness of heart beating,
• Prolonged and painful erection
heart rate increased or decreased)
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the
available data.
The following side effects may happen:
Very Common (affects more than 1 user in 10):
• Parkinsonism. This is a medical term that includes many
symptoms. Each individual symptom may occur less
frequently than in 1 in 10 people. Parkinsonism includes:
increase in saliva secretion or watery mouth,
musculoskeletal stiffness, drooling, jerks when bending
the limbs, slow, reduced or impaired body movements,
no expression on the face, muscle tightness, stiff neck,
muscle stiffness, small, shuffling, hurried steps and lack
of normal arm movements when walking, persistent
blinking in response to tapping of the forehead (an
abnormal reflex)
• Headache, difficulty falling or staying asleep.
• Feeling sleepy, or less alert
Common (affects 1 to 10 users in 100):
• Drowsiness, fatigue, restlessness, inability to sit still,
irritability, anxiety or nervous excitement, sleepiness,
dizziness, poor attention, feeling exhausted, sleep
disorder, depression, weakness
• Vomiting, diarrhoea, constipation, nausea, increased
appetite, abdominal pain or discomfort, sore throat, dry
mouth, toothache
• Weight increased, increase in body temperature,
decreased appetite
• Difficulty breathing, lung infection (pneumonia), flu,
infection of the breathing passages, blurred vision, eye
infection, nose congestion, nose bleeding, cough
• Urinary tract infection, sinus infection, ear infection, bed
wetting
• Muscle spasm, involuntary movements of face or arms
and legs, joint pain, back pain, swelling of arms and
legs, pain in arms and legs, bone or muscle ache
• Rash, skin redness
• Fast beating heart, chest pain
• Incontinence (lack of control) of urine
• Risperidone can raise your levels of a hormone called
“prolactin” found in a blood test (which may or may not
cause symptoms). When symptoms of high prolactin
occur, they may include in men breast swelling,
difficulty in getting or maintaining erections, or other
sexual dysfunction. In women they may include breast
discomfort, leakage of milk from the breasts, missed
menstrual periods, or other problems with your cycle..
• Fall.
Uncommon (affects 1 to 10 users in 1000):
• Excessive drinking of water, stool incontinence,
excessive passing of gas, thirsty, very hard faeces,
hoarseness or voice disorder
• Lung infection caused by inhaling of food into the
breathing passages, bladder infection, ‘pink eye’, sinus
infection, viral infection, ear infection, tonsil infection,
infection under the skin, eye infection, stomach or
intestinal infection, eye discharge, yeast infection of
nails, skin rash
• Pain when passing urine, frequent passing of urine,
inability to pass urine
• Confused, disturbance in attention, low level of
consciousness, excessive sleep, nervousness, elated
mood (mania) , lack of energy and interest, nightmares
• Diabetes or worsening of diabetes ,blood sugar
increased, liver enzymes increased, white blood cell
count decreased, low haemoglobin or red blood cell
count (anaemia), increase in eosinophils (special white
blood cells), blood creatinine phosphokinase increased,
decrease in platelets (blood cells that help you stop
bleeding)
• Increased cholesterol in your blood
• Muscle weakness, muscle pain, ear pain, neck pain, joint
swelling, abnormal posture, joint stiffness,
musculoskeletal chest pain, chest discomfort, sensation
of spinning (vertigo)
• Skin lesion, skin disorder, dry skin, intense itching of
skin, acne, hair loss, skin inflammation caused by mites,
skin discoloration, thickening of skin, flushing, reduced
skin sensitivity to pain or touch, inflammation of oily skin
• No menstruation, sexual dysfunction, erectile
dysfunction, ejaculation disorder, breast discharge,
breast pain, enlargement of breast in men, decreased
sexual drive, irregular menstruation, vaginal discharge
• Fainting, gait disturbance, sluggishness, decreased
appetite resulting in malnutrition and low body weight,
feeling ‘out of sorts’, balance disorder, allergy, oedema,
speech disorder, chills, abnormal coordination
• Painful oversensitivity to light, increased blood flow to
the eye, eye swelling, dry eye, increase in tears
• Breathing passage disorder, lung congestion, crackly
lung noise, congestion of breathing passages, trouble
speaking, difficulty swallowing, cough with sputum,
coarse/whistling sound during breathing, flu-like illness,
sinus congestion,
• Convulsion (fits), fainting
• Complete lack of taste
• A restless urge to move parts of your body, balance
disorder, abnormal coordination, dizziness upon
standing, disturbance in attention, problems with
speech, loss or abnormal sense of taste, reduced
sensation of skin to pain and touch, a sensation of
tingling, pricking, or numbness skin
• Chills, an increase in body temperature
• Feeling unwell, chest discomfort, feeling “out of sorts”,
discomfort
• Increased liver transaminases in your blood, increased
GGT (a liver enzyme called gammaglutamyltransferase) in your blood, Increased liver enzymes
in your blood
• Procedural pain.

Additional side effects in children and adolescents
In general, side effects in children are expected to be
similar to those in adults.
The following side effects were reported more often in
children and adolescents (5 to 17 years) than in adults:
feeling sleepy, or less alert, fatigue (tiredness), headache,
increased appetite, vomiting, common cold symptoms,
nasal congestion, abdominal pain, dizziness, cough, fever,
tremor (shaking), diarrhoea, and incontinence (lack of
control) of urine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: 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 RISPERIDONE

Keep this medicine out of the sight and reach of children.
Do not use Risperidone after the expiry date which is
stated on the outer packaging or bottle. The expiry date
refers to the last day of the month.
Do not store above 25oC.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6

Contents of the pack and other Information

What Risperidone contains:
• The active ingredient is risperidone.
• Other ingredients are lactose monohydrate, sodium
lauril sulfate, hypromellose (E464), macrogol 6000,
macrogol 400, colloidal anhydrous silica,
microcrystalline cellulose, pregelatinised starch, sodium
starch glycolate (Type A) and magnesium stearate. The
tablets contain the following colours:
• 0.5 mg tablets: iron oxide red (E172), iron oxide
yellow (E172) and titanium dioxide (E171)
• 1 mg tablets: titanium dioxide (E171)
• 2 mg tablets: iron oxide red (E172), Iron oxide yellow
(E172) and titanium dioxide (E171)
• 3 mg tablets: titanium dioxide (E171) and quinoline
yellow aluminium lake (E104)
• 4 mg tablets: titanium dioxide (E171), quinoline
yellow aluminium lake (E104), indigo carmine
aluminium lake (E132) and iron oxide yellow (E172)
• 6 mg tablets: titanium dioxide (E171), iron oxide red
(E172) and iron oxide yellow (E172).
What Risperidone looks like and the contents of the pack:
• Risperidone 0.5 mg Film-Coated Tablets are
brownish-red, round slightly arched tablets, with
approx. 6.5 mm diameter and 3 mm thickness, debossed
RIS 0.5 and scoreline on one side and scoreline on the
other side
• Risperidone 1 mg Film-Coated Tablets are white, round,
slightly arched tablets, with approx. 8 mm diameter and
3.5 mm thickness, debossed RIS 1 and scoreline on one
side and scoreline on the other side.
• Risperidone 2 mg Film-Coated Tablets are tan, round,
slightly arched tablets, with approx. 8 mm diameter and
3.5 mm thickness,debossed RIS 2 and scoreline on one
side and scoreline on the other side
• Risperidone 3 mg Film-Coated Tablets are yellow, round,
slightly arched tablets, with approx. 9.5 mm diameter
and 4 mm thickness, debossed RIS 3 and scoreline on
one side and scoreline on the other side
• Risperidone 4 mg Film-Coated Tablets are green, round,
slightly arched tablets, with approx. 10.5 mm diameter
and 4.5 mm thickness, debossed RIS 4 and scoreline on
one side and scoreline on the other side
• Risperidone 6 mg Film-Coated Tablets are tan, round,
slightly arched tablets, with approx. 10.5 mm diameter
and 4.5 mm thickness, debossed RIS 6 and scoreline on
one side and scoreline on the other side
• The 0.5 mg tablets are available in pack sizes of 10, 20
and 60 film-coated tablets
• The 1 mg tablets are available in pack sizes of 6, 10, 20,
50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated
tablets
• The 2 mg tablets are available in pack sizes of 10, 20, 50,
60, 100, 100 (5x20 hospital pack) and 500 film-coated
tablets
• The 3 mg tablets are available in pack sizes of 10, 20, 50,
60, 100, 100 (5x20 hospital pack) and 500 film-coated
tablets
• The 4 mg tablets are available in pack sizes of 10, 20, 30,
50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated
tablets
• The 6 mg tablets are available in pack sizes of 7, 20, 28,
30, 50, 60, 100 and 100 (5x20 hospital pack) film-coated
tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company
responsible for manufacture is TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: May 2016

Rare (affects 1 to 10 users in 10,000):






















REG0068357

Infection
Inability to reach orgasm, menstrual disorder
Dandruff
Drug allergy, coldness in arms and legs, lip swelling, lip
inflammation
Glaucoma, reduced visual clarity, eyelid margin
crusting, eye rolling
Lack of emotion
Change in consciousness with increased body
temperature and twitching of muscles, oedema all over
the body, drug withdrawal syndrome, body temperature
decreased
Fast shallow breathing, trouble breathing during sleep,
chronic otitis media
Obstruction of intestine,
Reduced blood flow to the brain
Decrease in white blood cells, inappropriate secretion of
a hormone that controls urine volume
Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis), movement disorder, increase in heart
rate
Coma due to uncontrolled diabetes
Yellowing of the skin and the eyes (jaundice)
Inflammation of the pancreas.
Dangerously excessive intake of water
Eye problems during cataract surgery, a condition called
intraoperative floppy iris syndrome (IFIS) can happen if
you take or have taken Risperidone. If you need to have
cataract surgery, be sure to tell your doctor
Increased insulin (a hormone that controls blood sugar
levels) in your blood

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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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