Fluoxetine hydrochloride commonly known as fluoxetine is an antideppresant medicine belonging to the selective serotonin reuptake inhibitors class used, like other SSRIs, for the treatment of psychiatric disorders such as major depression, anxiety disorders (panic attacks, generalized anxiety, disturbances obsessive-compulsive) and bulimia. Flouxetine is marketed and produced under the brand name of Prozac. There are some other generic versions of Flouxetine such as Sarafem and zedprex too. Flouxietine can be used offlabel also for other pathologies such as premenstrual dysphoric disorder, and premature ejaculation just to name a few.
PROZAC 20 mg hard capsules
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT PROZAC
Prozac 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.
Prozac is not for use In children and adolescents under 18. See section 2, Children and adolescents aged 8 to 18 years.
Prozac 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 Prozac hard 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 Prozac without talking to your doctor. If you stop taking Prozac 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 Prozac may make these feelings worse. See section 4, Possible side-effects.
Taking some other medicines with Prozac can cause problems. You may need to talk to your doctor. See section 2, Taking other medicines.
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.
What is in this leaflet:
1. What Prozac hard capsules are and what they are used for
2. What you need to know before you take Prozac hard capsules
3. How to take Prozac hard capsules
4. Possible side effects
5. How to store Prozac hard capsules
6. Content of the pack and other information
Prozac 20 mg hard capsules contain the active substance fluoxetine which is one of a group of medicines called selective serotonin re-uptake inhibitors (SSRI) antidepressants.
This medicine is used to treat the following conditions:
Children and adolescents aged 8 years and above:
How Prozac 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 Prozac 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.
Do not take Prozac if you are:
Treatment with Prozac 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 Prozac. If Prozac has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prozac if any of the following applies to you:
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 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. Prozac 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 Prozac 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 Prozac 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 Prozac 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 Prozac.
Prozac should not be used in the treatment of children under the age of 8 years.
Other medicines and Prozac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Prozac with:
Prozac may affect the way the following medicines work (interaction):
Prozac with food, drink and alcohol
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.
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 studies describing 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 Prozac 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 Prozac.
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.
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.
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
Psychotropic drugs such as Prozac may affect your judgment or co-ordination. Do not drive or use machinery until you know how Prozac affects you.
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.
The recommended dose is:
Use in children and adolescents aged 8 to 18 years with depression:
Treatment should be started and be supervised by a specialist. The starting dose is 10 mg/day (given as 2.5 ml of Prozac oral solution). After 1 to 2 weeks, your doctor may increase the dose to 20 mg/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.
Your doctor will increase the dose with more caution and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.
If you have a liver problem or are using other medication that might affect Prozac, your doctor may decide to prescribe a lower dose or tell you to use Prozac every other day.
If you take more Prozac than you should
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 Prozac
If you stop taking Prozac
You may notice the following effects (withdrawal effects) when you stop taking Prozac: 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 Prozac are mild and disappear within a few weeks. If you experience symptoms when you stop treatment, contact your doctor.
When stopping Prozac, 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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:
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 Prozac:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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.
In children and adolescents (8-18 years) – In addition to the possible side effects listed above, Prozac 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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store your capsules above 30°C.
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 to protect the environment.
What Prozac hard capsules contains
The active substance is fluoxetine hydrochloride. Each capsule contains 20 milligram (mg) of fluoxetine (as fluoxetine hydrochloride).
The other ingredients are: maize starch flowable and dimeticone.
The capsule shell is made of gelatin, patent blue V (E131), yellow iron oxide (E172), titanium dioxide (E171) and black edible printing ink, which contains shellac, black iron oxide (E172), propylene glycol and may contain ammonium hydroxide and potassium hydroxide.
What Prozac hard capsules looks like and contents of the pack
The capsules are yellow and green, and marked ‘Lilly 3105’. The capsules are available in PVC/aluminium blister packs of 2, 7, 12, 14, 20, 28, 30, 50, 56, 70, 98, 100 and 500. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is
The manufacturer is
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: Prozac, Fontex
Czech Republic: Prozac
Luxembourg: Prozac, Fontex
United Kingdom: Prozac