Pregnancy<\/em><\/p>\n\n\n\nTell your doctor as soon as possible that you are pregnant, think you may be pregnant, or are planning to become pregnant.
<\/p>\n\n\n\n
There have been reports of an increased risk of heart defects in infants whose mothers used Fluoxetine Accord during the first months of pregnancy. In the population, approximately 1 in 100 babies is normally born with heart defects. This malformation increased in frequency to about 2 in 100 when mothers were treated with Fluoxetine Accord. You and your doctor may decide to gradually stop treatment if you are pregnant. Depending on the circumstances, however, your doctor may suggest that you should continue using Fluoxetine Accord.
<\/p>\n\n\n\n
Tell your midwife or doctor that you are using Fluoxetine Accord. When drugs such as Fluoxetine Accord are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
<\/p>\n\n\n\n
However, caution should be exercised when using during pregnancy, especially during the later part of pregnancy or shortly before delivery as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, breastfeeding, and difficulty sleeping.
<\/p>\n\n\n\n
Breast-feeding<\/em><\/p>\n\n\n\nFluoxetine is excreted in human milk and may cause side effects in breast-fed infants. You should only breast-feed if necessary. If you continue to breast-feed, your doctor may prescribe a lower dose of fluoxetine.
<\/p>\n\n\n\n
Fertility<\/em><\/p>\n\n\n\nIn animal studies, fluoxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but no such reducing effect of fluoxetine on fertility has yet been demonstrated in humans.
<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Your medicine may affect your judgment and coordination. Do not drive or use machines until you know how Fluoxetine Accord affects you.<\/p>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
<\/p>\n\n\n\n
How to take Fluoxetine Accord<\/h2>\n\n\n\n
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Do not take more capsules than your doctor advised.
<\/p>\n\n\n\n
Swallow the capsules together with a glass of water. Do not chew the capsules.
<\/p>\n\n\n\n
Adults:<\/strong><\/p>\n\n\n\nThe recommended dose is:<\/p>\n\n\n\n
- Depression: The<\/strong> recommended dose is 1 capsule (20 mg) daily. Your doctor will review and, if necessary, adjust the dose 3-4 weeks after starting treatment. If necessary, dose one can be increased gradually up to a maximum dose of 3 capsules (60 mg) daily. Dose one should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately after you start taking the medicine. This is common as an improvement in depressive symptoms may take a few weeks. Patients with depression should be treated for at least 6 months.<\/li>
- Bulimia nervosa: The<\/strong> recommended dose is 3 capsules (60 mg) daily.<\/li>
- Obsessive-compulsive disorder: The<\/strong> recommended dose is 1 capsule (20 mg) daily. Your<\/em> doctor will review and, if necessary, adjust the dose one after 2 weeks of treatment. If necessary, dose one can be gradually increased up to a maximum dose of 3 capsules (60 mg) daily. If no improvement has occurred within 10 weeks, treatment should be reconsidered.<\/li><\/ul>\n\n\n\n
Use in children <\/strong>and adolescents aged 8 to 18 years with depression:<\/strong><\/p>\n\n\n\nTreatment should be initiated and supervised by a specialist. The starting dose is 10 mg\/day.<\/p>\n\n\n\n
After 1 to 2 weeks, the doctor may increase the dose by one to 20 mg\/day. Dose one should be increased carefully to ensure that you receive the lowest effective dose. Children with low body weight may need a lower dose. Your doctor will assess the need for further treatment after 6 months. If no improvement is seen, the treatment should be reconsidered.
<\/p>\n\n\n\n
Older:<\/strong><\/p>\n\n\n\nThe doctor will increase the dose with greater caution and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.
<\/p>\n\n\n\n
Hepatic impairment:<\/strong><\/p>\n\n\n\nIf you have liver disease or are taking other medicines that may affect Fluoxetine Accord, your doctor may decide to prescribe a lower dose or you should take Fluoxetine Accord every other day.<\/p>\n\n\n\n
If you take more Fluoxetine Accord then you should<\/h2>\n\n\n\n
Do not take more capsules than your doctor has prescribed. If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the pack and the remaining tablets to your doctor.
<\/p>\n\n\n\n
Symptoms of overdose include nausea, vomiting, seizures, heart problems (such as irregular heartbeat and cardiac arrest), lung problems, and mental changes ranging from anxiety to unconsciousness.<\/p>\n\n\n\n
If you forget to take Fluoxetine Accord<\/h2>\n\n\n\n- If you miss a dose, do not worry. Take the next dose the next day at the usual time. Do not take a double dose to make up for a forgotten dose.<\/li>
- Taking the medicine at the same time each day may help you remember to take it regularly.<\/li><\/ul>\n\n\n\n
If you stop taking Fluoxetine 20 mg capsule<\/h2>\n\n\n\n- Do not stop<\/strong> taking Fluoxetine Accord without first asking your doctor, even if you feel better. You must continue to take your medicine.<\/li>
- Make sure you never run out of capsules.<\/li><\/ul>\n\n\n\n
You may experience the following when you stop taking Fluoxetine Accord: dizziness, tingling sensation such as ant crawling, difficulty sleeping (vivid dreams, nightmares, insomnia), feeling of restlessness or anxiety, unusual tiredness or weakness, anxiety, nausea\/vomiting (nausea), tremors and headache.<\/p>\n\n\n\n
Most people who stop taking Fluoxetine Accord experience that the symptoms are mild and go away on their own within a few weeks. If you get symptoms when treatment stops, contact your doctor.<\/p>\n\n\n\n
When you stop taking Fluoxetine Accord, your doctor will help you reduce the dose slowly over one to two weeks to reduce the risk of withdrawal symptoms.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Like all medicines, Fluoxetine Accord can cause side effects, although not everybody gets them.<\/p>\n\n\n\n
- Contact a doctor as soon as possible or go to the nearest hospital<\/strong> if you have thoughts of injuring yourself or committing suicide (see section 2).<\/li>
- If you get a rash or allergic reaction such as itching, swollen lips\/tongue, or wheezing\/shortness of breath, stop taking Fluoxetine Accord capsules immediately and contact your doctor immediately.<\/strong><\/li>
- If you get a rash or an allergic reaction such as itching, swollen lips\/tongue, or wheezing when breathing\/shortness of breath – stop taking fluoxetine immediately and tell your doctor immediately. <\/strong>If you feel restless and can not sit still, you may have something called akathisia. Increasing the dose of Fluoxetine Accord may make you feel worse. If this happens, consult your doctor<\/strong>.<\/li>
- Contact your doctor immediately<\/strong> if the skin turns red or you get another skin reaction or blisters form and the skin flakes or comes off. This is very rare.<\/li><\/ul>\n\n\n\n
The most common side effects (very common side effects that may affect more than 1 in 10 people are insomnia, headache, diarrhea, nausea, and fatigue).
<\/p>\n\n\n\n
Some patients have had:<\/p>\n\n\n\n
- a collection of symptoms (so-called serotonergic syndrome) which i.a. includes unexplained fever with rapid breathing or rapid pulse, sweating, muscle stiffness or tremors, confusion, extreme anxiety, or fatigue (rare only)<\/li>
- feeling weak, drowsy, or confused, especially in the elderly and (elderly) people taking diuretics ( diuretics )<\/li>
- prolonged and painful erection<\/li>
- irritability and extreme anxiety<\/li>
- heart problems, e.g. rapid or irregular heartbeat, fainting, collapse, or dizziness when you get up and which may indicate a heart rate with abnormal function.<\/li><\/ul>\n\n\n\n
If you get any of the above side effects, talk to your doctor immediately.<\/strong>
<\/p>\n\n\n\nThe following side effects have also been reported in patients taking Fluoxetine capsules:
<\/p>\n\n\n\n
Common <\/strong>( <\/strong>may <\/strong>affect <\/strong>up <\/strong>to <\/strong>1 <\/strong>in <\/strong>10 people <\/strong>)<\/strong><\/p>\n\n\n\n- poor appetite, weight loss<\/li>
- nervousness, anxiety<\/li>
- restlessness, difficulty concentrating<\/li>
- feel tense<\/li>
- decreased sexual drive or sexual problems (including difficulty maintaining an erection before sexual activity)<\/li>
- difficulty sleeping, unusual dreams, fatigue, or drowsiness<\/li>
- dizziness<\/li>
- taste change<\/li>
- uncontrolled shaking movements<\/li>
- dimsyn<\/li>
- the feeling of fast and irregular heartbeat<\/li>
- hot flashes<\/li>
- yawning<\/li>
- indigestion, vomiting<\/li>
- dry mouth<\/li>
- rash, hives, itching<\/li>
- profuse sweating<\/li>
- joint pain<\/li>
- frequent urination<\/li>
- unexplained vaginal bleeding<\/li>
- feel shaky or shivering<\/li><\/ul>\n\n\n\n
Uncommon <\/strong>( <\/strong>may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n- feel isolated from oneself<\/li>
- strange thoughts<\/li>
- abnormal elation<\/li>
- orgasm problem<\/li>
- suicidal thoughts or thoughts of harming yourself<\/li>
- grind teeth<\/li>
- muscle twitching, involuntary movements, or problems with balance and coordination<\/li>
- memory impairment<\/li>
- enlarged (dilated) pupil s<\/li>
- earring<\/li>
- low blood pressure<\/li>
- shortness of breath<\/li>
- nosebleed<\/li>
- difficulty swallowing<\/li>
- hair loss<\/li>
- increased tendency to get bruises<\/li>
- unexplained bruising or bleeding<\/li>
- cold sweats<\/li>
- difficulty urinating<\/li>
- feel hot or cold<\/li>
- abnormal liver function<\/li><\/ul>\n\n\n\n
Rare <\/strong>( <\/strong>may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n- low levels of salt in the blood<\/li>
- decreased platelet count, which increases the risk of bleeding or bruising<\/li>
- decreased white blood cell count<\/li>
- violent behavior<\/li>
- hallucinations<\/li>
- agitation<\/li>
- panic attacks<\/li>
- confusion<\/li>
- stuttering<\/li>
- aggression<\/li>
- attack<\/li>
- vasculitis ( inflammation of a blood vessel)<\/li>
- rapid swelling of the tissues around the neck, face, mouth, and\/or throat<\/li>
- sore throat<\/li>
- liver inflammation ( hepatitis )<\/li>
- lung problem<\/li>
- sensitivity to sunlight<\/li>
- muscle pain<\/li>
- problems urinating<\/li><\/ul>\n\n\n\n
Bone Fractures<\/strong> – An increased risk of bone fractures has been seen in patients taking this type of medicine.
<\/p>\n\n\n\nMost of these side effects disappear with continued treatment.
<\/p>\n\n\n\n
In children and adolescents (8-18 years)<\/strong> – In addition to the possible side effects listed above, fluoxetine may reduce growth or possibly delay sexual maturity. Suicide-related behaviors (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds have also been reported as common in children.
<\/p>\n\n\n\n5. How to store Fluoxetine Accord<\/h2>\n\n\n\n
Keep out of sight and reach of children.<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Do not store above 30 \u00b0 C.<\/p>\n\n\n\n
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n
The active substance is fluoxetine hydrochloride. Each capsule contains 22.4 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
<\/p>\n\n\n\n
The other ingredients are pregelatinized starch (corn), purified talc, anhydrous silica, and magnesium stearate.
<\/p>\n\n\n\n
The capsule shell contains quinoline yellow (E104), erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), and gelatin.
<\/p>\n\n\n\n
The printing ink contains shellac (E904), black iron oxide (E172), propylene glycol, and ammonium hydroxide.<\/p>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Fluoxetine Accord is a hard capsule. Each capsule contains 20 mg of fluoxetine.<\/p>\n\n\n\n
The capsules are light green\/yellow opaque, hard gelatin capsules, marked \u201cBJ\u201d on the top and \u201cF20\u201d on the bottom, containing a white to off-white powder.<\/p>\n\n\n\n
Fluoxetine hydrochloride 20 mg capsules are packaged in PVC \/ aluminum blisters. Blister cards with 10, 14, 20, 28, 30, 50, 56, 60, 70, 90, 98 or 100 capsules.
<\/p>\n\n\n\n
Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/em><\/p>\n\n\n\nAccord Healthcare BV<\/p>\n\n\n\n
Winthontlaan 200<\/p>\n\n\n\n
3526 KV Utrecht<\/p>\n\n\n\n
Netherlands
<\/p>\n\n\n\n
Manufacturer<\/em><\/p>\n\n\n\nAccord Healthcare Ltd.<\/p>\n\n\n\n
Sage House, 319 Pinner Road<\/p>\n\n\n\n
North Harrow, Middlesex<\/p>\n\n\n\n
HA1 4HF,<\/p>\n\n\n\n
UK
<\/p>\n\n\n\n
Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n
ul. Lutomierska 50,95-200 Pabianice, Poland
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20 mg capsule, hard
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