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FLUOXETINE 20 MG HARD CAPSULES

Active substance(s): FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE

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FLUOXETINE 20 mg CAPSULES
FLUOXETINE 60 mg 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 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.
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 hydrochloride.
Fluoxetine capsules belong to a group of medicines called selective serotonin re-uptake
inhibitors (SSRI) 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.

How Fluoxetine works
Everyone has a substance called serotonin in their brain. People who are depressed or
have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin
than others. It is not fully understood how Fluoxetine and other SSRIs work but they may
help by increasing the level of serotonin in the brain.
Treating these conditions is important to help you get better. If it’s not treated, your
condition may not go away and may become more serious and more difficult to treat.
You may need to be treated for a few weeks or months to ensure that you are free from
symptoms.

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.
• taking other medicines known as irreversible, non-selective monoamine oxidase
inhibitors (MAOIs), since serious or even fatal reactions can occur (e.g. iproniazid used
to treat depression).
Treatment with Fluoxetine should only be started at least 2 weeks after discontinuation
of an irreversible, non-selective MAOI.
Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop
taking Fluoxetine. If Fluoxetine has been prescribed for a long period and/or at a high
dose, a longer interval needs to be considered by your doctor.
• taking metoprolol (to treat heart failure) since there is an increased risk of your heart
beat becoming too slow.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine, if any of the following
applies to you:
• heart problems;
• 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.
• mania now or in the past; if you have a manic episode, contact your doctor immediately
because Fluoxetine might need to be discontinued;
• 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’);
• 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;
• ongoing ECT (electro-convulsive therapy);
• 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;
• 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);
• 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);
• ongoing treatment with diuretics (water tablets), especially if you are elderly;
• glaucoma (increased pressure in the eye);
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.
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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Fluoxetine with:
• Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs, used to
treat depression). Irreversible, non-selective MAOIs must not be used with Fluoxetine
as serious or even fatal reactions (serotonin syndrome) can occur (see section “Do not
take Fluoxetine”). Treatment with Fluoxetine should only be started at least 2 weeks
after discontinuation of an irreversible, non-selective MAOI (for instance
tranylcypromine). Do not take any irreversible, non-selective MAOI. MAOIs for at
least 5 weeks after you stop taking Fluoxetine. If Fluoxetine has been prescribed for a
long period and/or at a high dose, a longer interval than 5 weeks may need to be
considered by your doctor.
• Metoprolol used in cardiac failure: there is an increased risk your heart beat becoming
too slow.
Fluoxetine may affect the way the following medicines work (interaction):
• 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.
• Monoamine oxidase inhibitors A (MAOI-A) including moclobemide, linezolid (an
antibiotic) and methylthioninium chloride (also called methylene blue, used for the
treatment of medicinal or chemical product induced methemoglobinemia): due to the
risk of serious or even fatal reactions (called serotonin syndrome). Treatment with
Fluoxetine can be started the day after stopping treatment with reversible MAOIs but
the doctor may wish to monitor you carefully and use a lower dose of the MAOI-A drug.
• Mequitazine (used to treat allergy); because taking this drug with Fluoxetine may
increase the risk of changes in the electrical activity of the heart.
• 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.
• lithium, selegiline, St. John’s Wort, tramadol (a painkiller), triptans (for
migraine) and tryptophan; there is an increased risk of mild serotonin syndrome
when these drugs are taken with Fluoxetine. Your doctor will carry out more frequent
check-ups.
• medicines that may affect the heart’s rhythm, e.g. Class IA and III antiarrhythmics,
antipsychotics (e.g. phenothiazine derviatives, pimozide, haloperidol), tricyclic
antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin,

erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine or
certain antihistamines (astemizole, mizolastine), because taking one or more of these
drugs with Fluoxetine may increase the risk of changes in the electrical activity of the
heart.
• anti-depressants such as tricyclic anti-depressants, other selective serotonin reuptake
inhibitors (SSRIs) or bupropion, mefloquineor chloroquine (used to treat malaria),
tramadol (used to treat severe pain) or anti-psychotics such as phenothiazines or
butyrophenones; because Fluoxetine may increase the risk of seizures when taken with
these medicines.
• Anti-coagulants (such as warfarin), NSAID (such as ibruprofen, diclofenac), aspirin
and 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, adjust your dose and check on you more
frequently.
• cyproheptadine (for allergies); because it may reduce the effect of Fluoxetine.
• drugs that lower sodium levels in the blood (including, drug that causes increase in
urination, desmopressin, carbamazepine and oxcarbazepine); because these drugs may
increase the risk of sodium levels in the blood becoming too low when taken with
Fluoxetine.
• flecainide, propafenone, nebivolol or encainide (for heart problems), carbamazepine
(for epilepsy), atomoxetine or tricyclic antidepressants (for example imipramine,
desipramine and amitriptyline) or risperidone (for schizophrenia); because Fluoxetine
may possibly change the blood levels of these medicines, your doctor may need to
lower their dose when administered with Fluoxetine.
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
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.
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.
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.
It is preferable not to use this treatment during pregnancy unless the potential benefit
outweighs the potential risk. Thus, you and your doctor may decide to gradually stop
taking Fluoxetine while you are pregnant or before being pregnant. However, depending
on your circumstances, your doctor may suggest that it is better for you to keep taking
Fluoxetine.
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.
IXXXXXX

PACKAGE LEAFLET: INFORMATION FOR USER

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3. How to take Fluoxetine Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure. 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 recommended 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 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, this medicine 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 very rare.
• Tell your doctor immediately if there is a reduction in blood platelets, which increases
risk of bleeding or bruising.
The most frequent sides effects (very common side effects that may affect more than
1 user in 10) are insomnia, headache, diarrhoea, feeling sick (nausea) and fatigue.
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:
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
• thoughts of suicide or harming yourself
• unexplained bruising or bleeding
• abnormal liver function tests
Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• untypical wild behaviour
• reduction in white blood cell count
• hallucinations
• agitation
• aggression
• problems urinating
• confusion
• stuttering
• lung problems
• hepatitis
• muscle pain
• 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. Suicide-related
behaviours (suicide attempt and suicidal thoughts), hostility, mania and 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.

• 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 and 60mg capsules:Each capsule contains Pregelatinised maize starch and Dimeticone.
The 20mg capsule shell is made of gelatin, brilliant blue (E133), quinoline yellow (E104),
sunset yellow (E110), titanium dioxide (E171).
The 60mg capsule shell is made of gelatin, quinoline yellow (E104), sunset yellow (E110),
titanium dioxide (E171), Sodium lauril sulfate.
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
info@bristol-labs.co.uk
Email:
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 November 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.

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.
V10 14-11-16 D0

IXXXXXX

Driving and using machines
Psychotropic drugs such as fluoxetine may affect your judgment or co-ordination. Do
not drive or use machinery until you know how fluoxetine affects you.
Fluoxetine capsules contain Sunset yellow
• 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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