Fluoxetine: Interactions with Other Medicines and Possible Side Effects | Study notes Medicine

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Package leaflet: Information for the patient

Fluoxetine 60 mg Capsules, Hard

fluoxetine

Eight important things you need to know about Fluoxetine.

Please read all of this leaflet. It includes a lot of additional important information about this medicine.

• 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. See section 4 'Possible side effects', inside

this leaflet.

• Fluoxetine is not for use in children under 8 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 have started feeling better. See section 3, ‘How to take

Fluoxetine’.

• 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 ‘What you need to know before you take Fluoxetine’.

• 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, ‘If you stop taking

Fluoxetine’.

• 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’.

• If you are pregnant or planning to become 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 is and what it is used for

2. What you need to know before you take Fluoxetine

3. How to take Fluoxetine

4. Possible side effects

5. How to store Fluoxetine

6. Contents of the pack and other information

1. What Fluoxetine is and what it is used for

Fluoxetine is one of a type of antidepressants known as Selective Serotonin Reuptake Inhibitors

(SSRIs). Fluoxetine is used to treat:

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Package leaflet: Information for the patient Fluoxetine 60 mg Capsules, Hard fluoxetine Eight important things you need to know about Fluoxetine. Please read all of this leaflet. It includes a lot of additional important information about this medicine.

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. See section 4 'Possible side effects', inside this leaflet.
Fluoxetine is not for use in children under 8 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 have started feeling better. See section 3 , ‘How to take Fluoxetine’.
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 ‘What you need to know before you take Fluoxetine’.
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, ‘If you stop taking Fluoxetine’.
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’.
If you are pregnant or planning to become 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

What Fluoxetine is and what it is used for
What you need to know before you take Fluoxetine
How to take Fluoxetine
Possible side effects
How to store Fluoxetine
Contents of the pack and other information 1. What Fluoxetine is and what it is used for Fluoxetine is one of a type of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs). Fluoxetine is used to treat:

Adults:

The symptoms of depression and feelings of anxiety
The symptoms of a condition called obsessive-compulsive disorder (OCD)
The eating disorder bulimia nervosa Children and adolescents aged 8 years and above (Under specialist supervision only):
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 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.
if you are taking any medicines known specifically as irreversible, non-selective monoamine oxidase inhibitors (MAO inhibitors). An example of such a medicine is iproniazid, which is used to treat depression.
if you are taking the medicine metoprolol, used to treat heart failure. Warnings and precautions Talk to your doctor or pharmacist before taking Fluoxetine if any of the following applies to you:
if you are diabetic
if you suffer from epilepsy or have ever had a fit. Treatment should be discontinued in any patient who develops a fit or who has more fits
• if you have a history of bleeding disorders, or if you are pregnant (see ‘Pregnancy, breast- feeding and fertility’)
if you suffer from kidney, liver or heart problems
if you have disturbances in heart rhythm called QT prolongation (delayed conduction of electrical signals which can be seen on an ECG, an electrical recording of the heart), or a family history of such conditions.
if you suffer from any conditions that may make you more prone to experiencing changes in your heart beat (e.g. low blood potassium or magnesium levels, a slow heart beat)
if you suffer from manic phases (overactive behaviour or thoughts). Fluoxetine should be discontinued if you enter a manic phase
if you are having electro-convulsive treatment (ECT)
if you have increased pressure in the eye (glaucoma)
if you start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Fluoxetine may make this worse
if you get unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (these are symptoms of ‘serotonin syndrome’) – see section 4. Medicines like Fluoxetine (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. 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.

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.
medicines that affect the heart’s rhythm e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazines, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin given through a vein, pentamidine), antimalarial treatment particularly halofantrine, certain antihistamines used to treat allergies (astemizole, mizolastine) because taking one or more of these medicines with fluoxetine may increase the risk of changes in the electrical activity of the heart.
mequitazine or cyproheptadine, medicines used to treat allergies.
warfarin, NSAID or other medicines which can thin the blood (including clozapine, used to treat certain mental disorders, and aspirin); 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.
monoamine oxidase inhibitors A (MAOI-A) including moclobemide, linezolid (an antibiotic) and methyylthioninium chloride (also called methylene blue, used for the treatment of a blood disorder (methemoglobinemia)) due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with fluoxetine can be started the following 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 medicine.
medicines that lower sodium levels in the blood e.g.desmopressin (used to treat certain hormone problems), oxcarbazepine (used for epilepsy), diuretics (water tablets).
medicines that can increase the chance of seizures, such as other SSRI antidepressants (e.g. sertraline, citalopram, paroxetine), medicines for nausea and vertigo (e.g. perphenazine, prochlorperazine, chlorpromazine), certain medicines for mental illness called butyrophenones (e.g. benperidol, haloperidol), mefloquine or chloroquine (for malaria), or bupropion (for depression or nicotine dependence). It is important that you consult your doctor or pharmacist if you are taking these or any other medicine, as he/she may need to monitor you more closely or adjust your dose. Fluoxetine with food, drink and alcohol
- This medicine may be taken with or without food.
- Do not drink alcohol while 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 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 in100 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. Make sure your midwife and/or doctor know you are on 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. If you take Fluoxetine near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Fluoxetine so they can advise you. 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 Do not drive or use machines if you feel that your abilities are affected. Medicines for the treatment of mental illnesses may decrease your ability to perform tasks requiring precision or close attention. Fluoxetine contain lactose If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3. How to take Fluoxetine Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You should swallow your capsules whole with a glass of water. This medicine may be taken with or without food. Your doctor may need to start you on the lower strength Fluoxetine 20 mg capsules which are available. Adults Depression (with or without anxiety symptoms) The recommended starting dose is 20 mg once a day. Your doctor may decide to gradually increase the dose up to a maximum of 60 mg per day. Obsessive-compulsive disorder (OCD) The recommended starting dose is 20 mg once a day. Your doctor may decide to gradually increase the dose up to a maximum of 60 mg per day. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment. Bulimia nervosa The recommended dose is 60 mg daily. Elderly The daily dose should generally not exceed 40 mg. The maximum recommended dose is 60 mg per day. Patients with liver problems If you have liver problems or are using another medicine that might affect fluoxetine, your doctor may

heart condition known as torsades de pointes. This can result in a very fast heartbeat causing a sudden loss of consciousness

restlessness and an inability to sit or stand still, you may have ‘akathisia’
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)
liver problems causing feeling or being sick, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin or whites of the eyes (jaundice), dark urine, pale stools
skin reddening or if you develop a varied skin reaction or your skin starts to blister or peel particularly around the mouth, nose, eyes and genitals.
a lower than normal level of sodium in the blood, which may make you feel weak and confused with aching of muscles. This may be due to inappropriate ADH secretion, a hormone that causes the body to retain water and dilute the blood, reducing the amount of sodium
frequent infections with fever, chills, sore throat or mouth ulcers (reduced number of white blood cells)
lung problems, scarring and thickening in the lungs with shortness of breath
prolonged and painful erection Other possible side effects Very common (may affect more than 1 in 10 people)
difficulties in sleeping
headache
feeling sick
diarrhoea
feeling tired or drowsy Common (may affect up to 1 in 10 people)
loss of appetite
weight loss
tiredness
sleepiness
feeling anxious or nervous
restlessness
difficulty concentrating
feeling tense
decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity) abnormal or vivid dreams
feeling dizzy
changes in taste
shaking
blurred vision
rapid and irregular heartbeat sensations
other changes to the electrical activity of the heart called QT prolongation, which can be seen on an ECG, an electrical recording of the heart).
feeling flushed
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)
mood changes
feeling detached
strange thinking
memory problems
feel high (euphoria)
inability to orgasm
teeth grinding
muscle twitching, involuntary movements or problems with balance or coordination
enlarged (dilated) pupils
low blood pressure
shortness of breath
swallowing problems
abdominal bleeding
ringing in the ears
nose bleeds
hair loss
increased tendency to bruising
cold sweat
pain when passing urine
feeling hot or cold
generally feeling unwell/abnormal
increase in liver enzymes seen in a blood test Rare (may affect up to 1 in 1,000 people)
low levels of salt in the blood
untypical wild behaviour
hallucinations (see, hear or feel things that are not there)
feel agitated
panic attacks
confusion
aggression
stuttering or stammering
widening of blood vessels
pain in the tube that takes food or water to your stomach
sensitivity to sunlight
leaking of milk from the breast
sore throat and discomfort when swallowing
aching muscles, muscle tenderness or weakness, not caused by exercise
difficulty passing urine
unusual bleeding or bruising, frequent infections with fever, chills, sore throat or mouth ulcers (reduced number of white blood cells)
high prolactin levels in the blood
bleeding from the mucosal lining of areas such as the mouth and nose Not known (frequency cannot be estimated from the available data)
heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy, breast- feeding, fertility in section 2 for more information Bone fractures - an increased risk of bone fractures has been observed in patients taking this type of medicine. Additional side effects in children and adolescents (8- 18 years): Fluoxetine may slow growth or

Fluoxetine: Interactions with Other Medicines and Possible Side Effects, Study notes of Medicine

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