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FLUOXETINE 20 MG HARD CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE

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FLUOXETINE 20mg CAPSULES
FLUOXETINE 60mg CAPSULES
(Fluoxetine)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE
Fluoxetine treats depression and anxiety disorders. Like all medicines it can have
unwanted effects. It is therefore important that you and your doctor weigh up the
benefits of treatment against the possible unwanted effects, before starting treatment.
Fluoxetine is not for use in children and adolescents under 18. See section 2,
Use in children and adolescents aged 8 to 18 years.
Fluoxetine won’t work straight away. Some people taking antidepressants feel
worse before feeling better. Your doctor should ask to see you again a couple of weeks
after you first start treatment. Tell your doctor if you haven’t started feeling better.
See section 3, How to take Fluoxetine capsules
Some people who are depressed or anxious think of harming or killing
themselves. If you start to feel worse, or think of harming or killing yourself, see
your doctor or go to a hospital straight away. See section 2.
Don’t stop taking Fluoxetine without talking to your doctor. If you stop taking
Fluoxetine suddenly or miss a dose, you may get withdrawal effects. See section 3 for
further information.
If you feel restless and feel like you can’t sit or stand still, tell your doctor.
Increasing the dose of Fluoxetine may make these feelings worse. See section 4,
Possible side-effects.
Taking some other medicines with Fluoxetine can cause problems. You may
need to talk to your doctor. See section 2, Other medicines and Fluoxetine capsules.
If you are pregnant or planning to get pregnant, talk to your doctor. See section
2 Pregnancy, breast-feeding and fertility.
Read this entire 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. 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.
What is in this leaflet:
1. What Fluoxetine Capsules are and what they are used for
2. What you need to know before you take Fluoxetine Capsules
3. How to take Fluoxetine Capsules
4. Possible side effects
5. How to store Fluoxetine Capsules
6. Contents of the pack and other information

1. What Fluoxetine Capsules are and what they are used for
The name of your medicine is Fluoxetine 20mg or 60mg capsules. The active
ingredient is Fluoxetine.
Fluoxetine capsules belong to a group of medicines called selective serotonin
re-uptake inhibitors (SSRI) and are antidepressants.
This medicine is used to treat the following conditions:
Adults:
• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Fluoxetine is used alongside psychotherapy for the reduction of
binge-eating and purging
Children and adolescents aged 8 years and above:
• Moderate to severe major depressive disorder, if the depression does not respond

to psychological therapy after 4-6 sessions. Fluoxetine should be offered to a child
or young person with moderate to severe major depressive disorder only in
combination with psychological therapy.

2. What you need to know before you take Fluoxetine Capsules
Do not take Fluoxetine if you are:
• allergic to fluoxetine or any of the other ingredients of this medicine (listed in
Section 6). If you develop a rash or other allergic reactions (like itching,
swollen lips or face or shortness of breath), stop taking the capsules straight
away and contact your doctor immediately.
• fluoxetine in combination with irreversible, non-selective monoamine oxidase
inhibitors, since serious or even fatal reactions can occur. Examples of such MAOIs
used to treat depression such as, iproniazide, and also linezolid (an antibiotic) and
methylthioninium chloride also called methylene blue (used to treat high levels of
methaemoglobin in the blood).
• metoprolol used in the treatment of heart failure.
Warnings and Precautions
Before taking Fluoxetine capsules, talk to your doctor or pharmacist before taking
this medicine, if any of the following applies to you:
• epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure
frequency, contact your doctor immediately; Fluoxetine might need to be
discontinued;
• mania now or in the past; if you have a manic episode, contact your doctor
immediately because Fluoxetine might need to be discontinued;
• diabetes (your doctor may need to adjust your dose of insulin or other antidiabetic
treatment);
• liver problems (your doctor may need to adjust your dosage);
• heart problems;
• low resting heart-rate and/or if you know that you may have salt depletion as a
result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics
(water tablets);
• glaucoma (increased pressure in the eye);
• ongoing treatment with diuretics (water tablets), especially if you are elderly;
• ongoing ECT (electro-convulsive therapy);
• history of bleeding disorders or appearance of bruises or unusual bleeding;
• ongoing treatment with medicines that thin the blood (see ‘Other medicines and
Fluoxetine capsules’);
• ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘Other medicines
and Fluoxetine capsules’);
• starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose
of Fluoxetine may make this worse;
• appearance of fever, muscle stiffness or tremor, changes in your mental state like
confusion, irritability and extreme agitation; you may suffer from the so-called
“serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome
occurs rarely it may result in potentially life threatening conditions; contact your
doctor immediately, since Fluoxetine might need to be discontinued.
• taking or have taken with in the last 14 days, another medicine known as irreversible,
non-selective monoamine oxidase inhibitors (MAOI) ( see “Other medicines and
Fluoxetine”)
Thoughts of suicide and worsening of your depression or anxiety disorder.
If you are depressed and/or have anxiety disorders you can sometimes have thoughts
of harming or killing yourself. These may be increased when first starting
antidepressants, since these medicines all take time to work, usually about two weeks
but sometimes longer.
You may be more likely to think like this:
- If you have previously had thoughts about killing or harming yourself.
- If you are a young adult. Information from clinical trials has shown an increased risk
of suicidal behaviour in adults aged less than 25 years with psychiatric conditions
who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor
or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or
have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell
you if they think your depression or anxiety is getting worse, or if they are worried
about changes in your behaviour.
Use in children and adolescents aged 8 to 18 years:
Patients under 18 have an increased risk of side-effects such as suicide attempt,
suicidal thoughts and hostility (predominantly aggression, oppositional behaviour
and anger) when they take this class of medicines. Fluoxetine should only be used in
children and adolescents aged 8 to 18 years for the treatment of moderate to severe
major depressive episodes (in combination with psychological therapy) and it should
not be used to treat other conditions.
Additionally, only limited information concerning the long-term safety of Fluoxetine
on growth, puberty, mental, emotional and behavioural development in this age group
is available. Despite this, and if you are a patient under 18, your doctor may prescribe
Fluoxetine for moderate to severe major depressive episodes, in combination with
psychological therapy, because he/she decides that this is in your best interests. If
your doctor has prescribed Fluoxetine for a patient under 18 and you want to discuss
this, please go back to your doctor. You should inform your doctor if any of the
symptoms listed above develop or worsen when patients under 18 are taking Fluoxetine.
Fluoxetine should not be used in the treatment of children under the age of 8 years.
Other medicines and Fluoxetine Capsules
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines (up to 5 weeks ago) including medicines obtained without prescription.
Fluoxetine may affect the way some other medicines work (interaction), especially
the following:
• Certain monoamine oxidase inhibitors (MAOIs, used to treat depression). Non
selective MAOIs and MAOIs type A (moclobemide) must not be used with
Fluoxetine as serious or even fatal reactions (serotonin syndrome) can occur (see
section “Do not take Fluoxetine”). However, treatment with fluoxetine can be
started the following day after discontinuation of certain reversible MAOIs (for
instance moclobemide, linezolid, methylthioninium chloride (methylene blue)).
Some MAOIs type B (selegeline) can be used with Fluoxetine provided that your
doctor monitors you closely. Treatment with Fluoxetine should only be started at
least 2 weeks after discontinuation of an irreversible MAOI (for instance
tranylcypromine). However, treatment with fluoxetine can be started the following
day after discontinuation of certain reversible MAOIs (for instance linezolid,
methylthioninium chloride (methylene blue)). Similarly, at least 5 weeks should
elapse after discontinuing fluoxetine treatment before starting an irreversible, nonselective MAOI.
• Metoprolol used in cardiac failure: there is an increased risk of metoprolol adverse
events like bradycardia.
• lithium, tryptophan; there is an increased risk of serotonin syndrome when these
drugs are taken with Fluoxetine. Your doctor will carry out more frequent checkups.
• phenytoin (for epilepsy); because Fluoxetine may influence the blood levels of this
drug, your doctor may need to introduce phenytoin more carefully and carry out
check-ups when given with Fluoxetine.
• tramadol (a painkiller) or triptans (for migraine); there is an increased risk of
hypertension (raised blood pressure).
• medicines that may affect the heart’s rhythm, e.g. Class IA and III antiarrhythmics,
antipsychotics (e.g. fentiazine derviatives, pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine,
certain antihistamines (astemizole, mizolastine).
• flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic
antidepressants (for example imipramine, desipramine and amitriptyline); because
Fluoxetine may possibly change the blood levels of these medicines, your doctor

may need to lower their dose when administered with Fluoxetine.
• tamoxifen (used to treat breast cancer), because Fluoxetine may change the blood
levels of this drug and a reduction of the effect of tamoxifen cannot be excluded,
your doctor may need to consider different antidepressant treatments.
• warfarin, NSAID or other medicines which can thin the blood (including clozapine,
used to treat certain mental disorders); Fluoxetine may alter the effect of these
medicines on the blood. If Fluoxetine treatment is started or stopped when you are
taking warfarin, your doctor will need to perform certain tests.
• You should not start to take the herbal remedy St John’s wort while you are being
treated with Fluoxetine since this may result in an increase in side effects. If you are
already taking St John’s wort when you start on Fluoxetine, stop taking St John’s
wort and tell your doctor at your next visit.
• Mequitazine (used to treat allergy)
• Cyproheptadine (used to treat allergy)
• Drugs associated with hyponatremia (e.g. diuretics, desmopressin, carbamazepine
and oxcarbazepine)
• Drugs which may lower the seizure threshold (for example, tricyclic antidepressants,
other SSRIs, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion,
tramadol)
• Drugs metabolised by CYP2D6 (such as flecainide, propafenone, nebivolol,
atomoxetine, carbamazepine, tricyclic antidepressants and risperidone)
Fluoxetine capsules with food, drink and alcohol
• You can take Fluoxetine with or without food, whatever you prefer.
• You should avoid alcohol while you are taking this medicine.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Talk to your doctor as soon as possible if you’re pregnant, if you might be pregnant,
or if you’re planning to become pregnant.
In babies whose mothers took fluoxetine during the first few months of pregnancy,
there have been some reports suggesting an increased risk of birth defects affecting the
heart. In the general population, about 1 in 100 babies are born with a heart defect.
This increased to about 2 in 100 babies in mothers who took fluoxetine. You and your
doctor may decide that it is better for you to gradually stop taking Fluoxetine while
you are pregnant. However, depending on your circumstances, your doctor may
suggest that it is better for you to keep taking Fluoxetine.
When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines
like fluoxetine may increase the risk of a serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN), making the baby breathe faster
and appear bluish. These symptoms usually begin during the first 24 hours after the
baby is born. If this happens to your baby you should contact your midwife and/or
doctor immediately.
Caution should be exercised when used during pregnancy, especially during late
pregnancy or just before giving birth since the following effects have been reported in
new born children: irritability, tremor, muscle weakness, persistent crying, and
difficulty in sucking or in sleeping.
Breast-feeding
Fluoxetine is excreted in breast milk and can cause side effects in babies. You should
only breast-feed if it is clearly necessary. If breast-feeding is continued, your doctor
may prescribe a lower dose of fluoxetine.
Fertility
Fluoxetine has been shown to reduce the quality of sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not been
observed as yet.
Driving and using machines
Fluoxetine may affect your judgment or co-ordination. Do not drive or use machinery
without advice from your doctor or pharmacist.
Fluoxetine capsules contain Sunset yellow
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3. How to take Fluoxetine Capsules
Always take Fluoxetine exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure. The instructions will also be on the
label on the pack. Do not take more capsules than your doctor tells you.
Swallow the capsules with a drink of water. Do not chew the capsules.
Adults:
The usual dose is:
• Depression: The recommended dose is 1 capsule (20 mg) daily. Your doctor will
review and adjust your dosage if necessary within 3 to 4 weeks of the start of
treatment. If required, the dosage can be gradually increased up to a maximum of
60 mg daily. The dose should be increased carefully to ensure that you receive the
lowest effective dose. You may not feel better immediately when you first start
taking your medicine for depression. This is usual because an improvement in
depressive symptoms may not occur until after the first few weeks. Patients with
depression should be treated for at least 6 months.
• Bulimia nervosa: The recommended dose is 60mg once daily.
• Obsessive-compulsive disorder: The recommended dose is 1 capsule (20 mg)
daily. Your doctor will review and adjust your dosage if necessary after 2 weeks of
treatment. If required, the dosage can be gradually increased up to a maximum of
60 mg daily. If no improvement is noted within 10 weeks, your doctor will
reconsider your treatment.
Children and adolescents aged 8 to 18 years with depression:
• Treatment should be started and be supervised by a specialist. The starting dose is
10mg/day. A liquid formulation will be more suitable for this starting dose.
After 1 to 2 weeks, your doctor may increase the dose to 20mg/day. The dose
should be increased carefully to ensure that you receive the lowest effective dose.
Lower weight children may need lower doses. If there is a satisfactory response to
treatment, your doctor will review the need for continuing treatment beyond 6
months. If you have not improved within 9 weeks, your doctor will reassess your
treatment.
Elderly:
• Your doctor will increase the dose with more caution and the daily dose should
generally not exceed 40 mg. The maximum dose is 60 mg daily.
Liver impairment:
• If you have a liver problem or are using other medication that might affect Fluoxetine,
your doctor may decide to prescribe a lower dose or tell you to use Fluoxetine every
other day.
If you take more Fluoxetine than you should
• If you take too many capsules, go to your nearest hospital emergency department
(or casualty) or tell your doctor straight away.
• Take the pack of Fluoxetine with you if you can.
• Symptoms of overdose include: nausea, vomiting, seizures, heart problems (like
irregular heart beat and cardiac arrest), lung problems and change in mental condition
ranging from agitation to coma.
If you forget to take Fluoxetine
• If you miss a dose, do not worry. Take your next dose the next day at the usual time.
Do not take a double dose to make up for a forgotten dose.
• Taking your medicine at the same time each day may help you to remember to take
it regularly.
If you stop taking Fluoxetine
• Do not stop taking Fluoxetine without asking your doctor first, even when you
start to feel better. It is important that you keep taking your medicine.
• Make sure you do not run out of capsules.
• You may notice the following effects (withdrawal effects) when you stop taking
Fluoxetine: dizziness; tingling feelings like pins and needles; sleep disturbances
(vivid dreams, nightmares, inability to sleep); feeling restless or agitated; unusual

tiredness or weakness; feeling anxious; nausea/vomiting (feeling sick or being sick);
tremor (shakiness); headaches.
• Most people find that any symptoms on stopping Fluoxetine are mild and disappear
within a few weeks. If you experience symptoms when you stop treatment, contact
your doctor.
• When stopping Fluoxetine, your doctor will help you to reduce your dose slowly
over one or two weeks - this should help reduce the chance of withdrawal effects.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Fluoxetine Capsules can cause side effects, although not everybody
gets them.
• If you have thoughts of harming or killing yourself at any time, contact your doctor
or go to a hospital straight away (see Section 2).
• If you get a rash or allergic reaction such as itching, swollen lips/tongue or
wheezing/shortness of breath, stop taking the capsules straight away and tell
your doctor immediately.
• If you feel restless and cannot sit or stand still, you may have akathisia; increasing
your dose of Fluoxetine may make you feel worse. If you feel like this, contact
your doctor.
• Tell your doctor immediately, if your skin starts to turn red or you develop a
varied skin reaction or your skin starts to blister or peel. This is rare.
• Tell your doctor immediately, if you experience serious illness with blistering of
the skin, mouth, eyes and genitals (Toxic Epidermal Necrolysis or Stevens-Johnson
Syndrome)
• Tell your doctor immediately, if you notice yellowing of your skin or eyes and
your urine becomes darker in colour. This could be a liver problem, such as hepatitis.
• Tell your doctor immediately, if you have gastro-intestinal bleeding symptoms
which include bleeding gums, blood vomits, blood in stools, bleeding from the
bottom, black tarry faeces.
Some patients have had:
• a combination of symptoms (known as “serotonin syndrome”) including unexplained
fever with faster breathing or heart rate, sweating, muscle stiffness or tremor,
confusion, extreme agitation or sleepiness (only rarely);
• feelings of weakness, drowsiness or confusion mostly in elderly people and in
(elderly) people taking diuretics (water tablets);
• prolonged and painful erection;
• irritability and extreme agitation.
• heart problems, such as fast or irregular heart rate, fainting, collapsing or dizziness
upon standing which may indicate abnormal functioning of the heart rate.
If you have any of the above side effects, you should tell your doctor immediately.
The following side effects have also been reported in patients taking Fluoxetine:
Very common (may affect more than 1 in 10 people)
• insomnia
• headache
• diarrhoea, feeling sick (nausea)
• fatigue
Common (may affect up to 1 in 10 people)
• not feeling hungry, weight loss
• nervousness, anxiety
• restlessness, poor concentration
• feeling tense
• decreased sex drive or sexual problems (including difficulty maintaining an erection
for sexual activity)
• sleep problems, unusual dreams, tiredness or sleepiness
• dizziness
• change in taste

• uncontrollable shaking movements
• blurred vision
• rapid and irregular heartbeat sensations
• flushing
• yawning
• indigestion, vomiting
• dry mouth
• rash, urticaria, itching
• excessive sweating
• joint pain
• passing urine more frequently
• unexplained vaginal bleeding
• feeling shaky or chills
Uncommon (may affect up to 1 in 100 people)
• feeling detached from yourself
• strange thinking
• abnormally high mood
• orgasm problems
• teeth grinding
• muscle twitching, involuntary movements or problems with balance or co-ordination
• enlarged (dilated) pupils
• low blood pressure
• shortness of breath
• difficulty swallowing
• hair loss
• increased tendency to bruising
• cold sweat
• difficulty passing urine
• feeling hot or cold
• ringing in the ears
• memory impairment
• nose bleeds
• unexplained bruising or bleeding
• reduced number of white blood cells (causes infection)
Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• untypical wild behaviour
• inappropriate antidiuretic hormone secretion (a condition associated with abnormally
low levels of sodium in the blood)
• hallucinations
• agitation
• aggression
• reduction in blood platelets, which increases risk of bleeding or bruising
• problems urinating
• confusion
• stuttering
• lung problems
• hepatitis, abnormal liver function text results
• muscle pain
• abnormally high levels of prolactin in the blood
• panic attacks
• fits
• vasculitis (inflammation of a blood vessel)
• rapid swelling of the tissues around the neck, face, mouth and/or throat
• pain in the tube that takes food or water to your stomach
• sensitivity to sunlight
• producing breast milk
Bone fractures - an increased risk of bone fractures has been observed in patients
taking this type of medicines.

Most of these side effects are likely to disappear with continued treatment.
Additional side effects in children and adolescents
In children and adolescents (8-18 years) – In addition to the possible side effects
listed above, Fluoxetine may slow growth or possibly delay sexual maturity. Nose
bleeds were also commonly reported in children.
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 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 Fluoxetine Capsules
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use the capsules after the expiry date (EXP.) which is stated on the label.
The expiry date refers to the last day of that month.
• 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 Fluoxetine Capsules contain
Each Fluoxetine 20mg capsule contains 20mg of fluoxetine as fluoxetine hydrochloride.
Each Fluoxetine 60mg capsule contains 60mg of fluoxetine as fluoxetine hydrochloride.
Fluoxetine 20mg capsules:Each capsule contains Pregelatinised maize starch and Dimeticone.
The capsule shell is made of gelatin, brilliant blue (E133), quinoline yellow (E104),
sunset yellow (E110), titanium dioxide (E171), and purified water.
Fluoxetine 60mg capsules:Each capsule contains Pregelatinised maize starch, and Dimeticone.
The capsule shell is made of gelatin, quinoline yellow (E104), sunset yellow (E110),
titanium dioxide (E171), Sodium lauril sulfate and purified water.
What Fluoxetine Capsules look like and contents of the pack
Fluoxetine 20mg capsules: - Green/cream coloured size “4” hard gelatin capsules,
filled with white to off-white powder.
Fluoxetine 60mg capsules: - Cream/cream coloured size “1” hard gelatin capsules,
filled with white to off-white powder.
This product is available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 70, 90, 98,
100 or 500 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom
Telephone:
0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
Email:
info@bristol-labs.co.uk
This medicinal product is authorised in the Member States of the EEA under
the following names:
UK- FLUOXETINE 20mg and 60mg CAPSULES
ES- FLUOXETINA BRILL PHARMA 20mg CÁPSULAS DURAS EFG
FLUOXETINA BRILL PHARMA 60mg CÁPSULAS DURAS
IE- FLUOXETINE 20mg and 60mg HARD CAPSULES
Fluoxetine 20mg Capsules; PL 17907/0386
Fluoxetine 60mg Capsules; PL 17907/0387
This leaflet was last revised in June 2016.
To request a copy of this leaflet in Braille, large print or audio format, please contact
the licence holder at the address (or telephone, fax, email) above.
V6 23-06-16 D0

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• The colourant sunset yellow (E 110) in the capsule shell can cause allergic type
reactions.

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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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