What Prozac is and what it is used for
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: Adults:
• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Prozac 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. Prozac should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy. How Prozac works Everyone has a substance called serotonin in their brain. People who are depressed or have obsessivecompulsive 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.
How to take Prozac
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 3 capsules (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 3 capsules (60 mg) 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 3 capsules (60 mg) daily. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment. 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. Elderly: 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. Liver impairment: 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
• 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 Prozac 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 Prozac
• 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 Prozac
• Do not stop taking Prozac 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 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.
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 Prozac 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. 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 Prozac:
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
• change in taste
• uncontrollable shaking movements
• blurred vision
• rapid and irregular heartbeat sensations
• 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
• thoughts of suicide or harming yourself
• teeth grinding
• muscle twitching, involuntary movements or problems with balance or co-ordination
• memory impairment
• enlarged (dilated) pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nose bleeds
• difficulty swallowing
• hair loss
• increased tendency to bruising
• unexplained bruising or bleeding
• cold sweat
• difficulty passing urine
• feeling hot or cold
• abnormal liver test results
Rare (may affect up to 1 in 1,000 people)
• low levels of salt in the blood
• reduction in blood platelets, which increases risk of bleeding or bruising
• reduction in white blood cell count
• untypical wild behaviour
• panic attacks
• 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
• lung problems
• sensitivity to sunlight
• muscle pain
• problems urinating
• 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. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Prozac
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.
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