Pregnancy<\/strong><\/p>\n\n\n\nStudies have shown an increased risk of heart defects in infants whose mothers used fluoxetine 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 ratiopharm.
<\/p>\n\n\n\n
When drugs such as fluoxetine 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
If possible, this medicine should not be used during pregnancy unless the benefit outweighs the potential risk. Thus, you and your doctor may decide to gradually stop taking Fluoxetine ratiopharm if you are pregnant or planning to become pregnant. However, depending on your situation, your doctor may suggest that you should continue treatment with Fluoxetine ratiopharm.
<\/p>\n\n\n\n
Caution should be exercised when using during pregnancy, especially during the latter part of pregnancy or just before delivery as the following effects have been observed in newborns: irritability, tremors, muscle weakness, persistent crying, and difficulty in sucking or sleeping.<\/p>\n\n\n\n
If you take Fluoxetine ratiopharm at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Fluoxetine ratiopharm so that they can advise you on this.
<\/p>\n\n\n\n
Breast-feeding<\/strong><\/p>\n\n\n\nFluoxetine passes into breast 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<\/strong><\/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
Psychotropic drugs such as Fluoxetine ratiopharm may impair judgment and coordination. Do not drive or use machines until you know how Fluoxetine ratiopharm affects you. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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
Fluoxetine ratiopharm contains sodium<\/h2>\n\n\n\n
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
<\/p>\n\n\n\n
3. How to take Fluoxetine ratiopharm<\/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 tablets than your doctor has prescribed.
<\/p>\n\n\n\n
Adults<\/strong><\/p>\n\n\n\nThe recommended dose is<\/p>\n\n\n\n
- Depression<\/strong>The recommended dose is 20 mg per day. Your doctor will review and, if necessary, adjust the dose 3-4 weeks after starting treatment. If necessary, the dose can be increased gradually up to a maximum dose of 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. Treatment for depression should last for at least 6 months.<\/li>
- Bulimia<\/strong>The recommended dose is 60 mg daily.<\/li>
- Obsessive-compulsive disorder<\/strong> recommended dose is 20 mg per day. Your doctor will review and, if necessary, adjust the dose one after 2 weeks of treatment. If necessary, the dose can be increased gradually up to a maximum dose of 60 mg daily. If no improvement has occurred within 10 weeks, treatment with Fluoxetine ratiopharm should be reconsidered by your doctor.<\/li><\/ul>\n\n\n\n
Use in children and adolescents aged 8 to 18 years with depression<\/h2>\n\n\n\n- Treatment should be initiated and supervised by a specialist. The starting dose is 10 mg per day. After 1 to 2 weeks, your doctor may increase the dose by one to 20 mg per 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. If the treatment gives good results, your doctor should assess the need for continued treatment after 6 months. If you have not improved within 9 weeks, the treatment should be reconsidered.<\/li><\/ul>\n\n\n\n
Older<\/strong><\/p>\n\n\n\n- Your doctor will be more careful with the dose increase if you are older. The daily dose should generally not exceed 40 mg. The maximum dose is 60 mg per day.<\/li><\/ul>\n\n\n\n
Hepatic impairment<\/strong><\/p>\n\n\n\n- If you have liver disease or are taking medicines that may affect fluoxetine, your doctor may prescribe a lower dose or you should take Fluoxetine ratiopharm every other day.<\/li><\/ul>\n\n\n\n
How to take Fluoxetine ratiopharm<\/strong><\/p>\n\n\n\nWhen you take half or a whole tablet, you should swallow the medicine with a glass of water. Alternatively, you can dissolve the medicine in \u00bd to 1 glass of water. Once the tablet has dissolved, you must drink everything in the glass as soon as possible.<\/p>\n\n\n\n
If you take more Fluoxetine ratiopharm then you should<\/h2>\n\n\n\n- 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.<\/strong><\/li>
- Bring the Fluoxetine ratiopharm pack if you can.<\/li><\/ul>\n\n\n\n
Symptoms of overdose include: nausea, vomiting, seizures, heart problems (eg irregular heartbeat and cardiac arrest), lung problems and mental changes in everything from severe anxiety to unconsciousness.<\/p>\n\n\n\n
If you forget to take Fluoxetine ratiopharm<\/h2>\n\n\n\n- Do not worry if you forgot to take a dose. 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>
- Take your medicine at the same time each day and it will be easier for you to remember to take it.<\/li><\/ul>\n\n\n\n
If you stop taking Fluoxetine ratiopharm<\/h2>\n\n\n\n- Do not stop<\/strong> taking Fluoxetine ratiopharm without first asking your doctor, even if you feel better. You must take the medicine without interruption. Make sure you always have medicine at home.<\/li><\/ul>\n\n\n\n
The following symptoms (withdrawal symptoms) may occur when you stop taking Fluoxetine ratiopharm:<\/p>\n\n\n\n
dizziness, tingling of needles, difficulty sleeping (vivid dreams, nightmares, insomnia), feeling of restlessness or anxiety, unusual tiredness or weakness, anxiety, nausea \/ vomiting (feeling sick), tremors and headache. Most people who stop taking Fluoxetine ratiopharm experience that the symptoms are mild and disappear within a few weeks. If you get symptoms when you stop taking Fluoxetine ratiopharm contact your doctor.<\/p>\n\n\n\n
When treatment with Fluoxetine ratiopharm is stopped, your doctor will help you reduce the dose slowly over one to two weeks so that the risk of withdrawal symptoms is reduced.
<\/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, this medicine 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 \/ difficulty breathing, stop taking the tablets immediately and contact your doctor immediately<\/strong> .<\/li>
- If you feel anxious and cannot stand or sit still, you may have experienced akathisia . An increase in Fluoxetine ratiopharm dose one can make you feel worse. If this happens, consult your doctor.<\/strong><\/li>
- Contact your doctor immediately<\/strong> if the skin turns red and blisters then form and the skin flakes or loosens. This is 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”) that include unexplained fever with rapid breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme anxiety, or drowsiness (occurs only rarely)<\/li>
- feeling weak, drowsy, or confused, especially in the elderly and (elderly) people taking diuretics ( diuretic tablets)<\/li>
- prolonged and painful erection<\/li>
- irritability and extreme anxiety.<\/li>
- heart problems, such as rapid or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate heart rhythm disturbances.<\/li><\/ul>\n\n\n\n
If you get any of the side effects listed above, contact your doctor immediately.<\/strong>
<\/p>\n\n\n\nThese side effects have also been reported in patients taking fluoxetine:
<\/p>\n\n\n\n
Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n- poor appetite, weight loss<\/li>
- nervousness, anxiety<\/li>
- restlessness, difficulty concentrating<\/li>
- feel tense<\/li>
- reduce sexual desire or sexual problems (including difficulty maintaining an erection before sexual activity)<\/li>
- sleep problems, 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>
- unexpected vaginal bleeding<\/li>
- feel shaky or have chills<\/li><\/ul>\n\n\n\n
Uncommon<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n- feel isolated from oneself<\/li>
- strange thoughts<\/li>
- abnormal elation<\/li>
- sexual problems, including orgasm problems, which occasionally persist after stopping treatment<\/li>
- suicidal thoughts or thoughts of harming oneself<\/li>
- grind teeth<\/li>
- muscle twitching, involuntary movements, or problems with balance and coordination<\/li>
- impaired memory<\/li>
- enlarged (dilated) pupil s<\/li>
- ringing in the ears<\/li>
- low blood pressure<\/li>
- respiratory distress<\/li>
- nosebleeds<\/li>
- difficulty swallowing<\/li>
- hair loss<\/li>
- increased tendency to get bruises<\/li>
- bleeding in the gastrointestinal tract<\/li>
- cold sweats<\/li>
- difficulty urinating<\/li>
- general malaise<\/li>
- feel abnormal<\/li>
- feel hot or cold<\/li>
- abnormal liver test values.<\/li><\/ul>\n\n\n\n
Rare<\/strong> (may affect up to 1 in 1,000 people)<\/p>\n\n\n\n- low levels of salt in the blood<\/li>
- reduction in the number of platelets which increases the risk of bleeding or bruising<\/li>
- decreased white blood cell count<\/li>
- violent behavior<\/li>
- hallucinations<\/li>
- stark oro<\/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>
- pain in the esophagus<\/li>
- inflammation of the throat<\/li>
- hepatitis (jaundice)<\/li>
- lung problem<\/li>
- sensitivity to sunlight<\/li>
- bleeding in the skin<\/li>
- muscle pain<\/li>
- difficulty urinating<\/li>
- milk flow from the breasts<\/li>
- bleeding in mucous membranes.
<\/li><\/ul>\n\n\n\nHas been reported<\/strong> (occurs in an unknown number of users)<\/p>\n\n\n\n- severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see \u201cPregnancy, breast-feeding and fertility\u201d in section 2 for more information.<\/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
Children and adolescents (8-18 years)<\/strong><\/p>\n\n\n\nIn addition to the side effects listed above, fluoxetine may slow the growth rate and possibly delay puberty. Suicide-related behaviors (suicide attempts and suicidal thoughts), hostility, mania and nosebleeds were also reported as common side effects in children.
<\/p>\n\n\n\n
5. How to store Fluoxetine ratiopharm<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.
<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
<\/p>\n\n\n\n
No special storage instructions.
<\/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. Each soluble tablet contains 10 mg of fluoxetine (as hydrochloride).
<\/p>\n\n\n\n
The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and anhydrous colloidal silica.<\/p>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
White, round tablet
<\/p>\n\n\n\n
Pack sizes: 10, 10×1, 30, 30×1, 100 and 100×1 tablets.
<\/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 Authorization Holder:<\/strong>
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
<\/p>\n\n\n\nManufacturer:<\/strong>
Merckle GmbH
Ludwig-Merckle-Stra\u03b2e 3
89143 Blaubeuren
Germany
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