Pregnancy<\/strong><\/p>\n\n\n\nThere have been reports of an increased risk of heart defects in infants whose mothers used Fluoxetine Stada 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 approximately 2 in 100 when mothers were treated with Fluoxetine Stada. You and your doctor may decide to gradually stop treatment if you are pregnant. However, depending on the circumstances, your doctor may suggest that you continue to use Fluoxetine Stada.
<\/p>\n\n\n\n
Tell your midwife or doctor that you are using Fluoxetine Stada. When drugs such as Fluoxetine Stada 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
Your doctor may decide if you can take fluoxetine during pregnancy, but caution should be exercised, especially during the latter part of pregnancy and before delivery. However, the following symptoms have been reported in newborns: irritation, tremors, hypotension (low blood pressure ), muscle weakness, persistent crying, difficulty in sucking or sleeping.
<\/p>\n\n\n\n
If you take Fluoxetine Stada 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 Stada 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. Side effects have been reported from breast-fed infants. Your doctor may advise you not to breast-feed while taking Fluoxetine Stada. Alternatively, it may be possible to take the lowest effective dose of Fluoxetine Stada and continue breast-feeding. This reduces the side effects to a minimum.
<\/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
You should avoid driving or using dangerous machines until you are reasonably sure that your ability to perform these tasks is not affected. Fluoxetine Stada, like other antidepressants, may affect your judgment or the reactivity required to perform these activities.
<\/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 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 STADA contains lactose (milk sugar)<\/h2>\n\n\n\n
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
<\/p>\n\n\n\n
How to use Fluoxetine STADA<\/h2>\n\n\n\n
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
<\/p>\n\n\n\n
The usual dosage for adults and the elderly:<\/strong>
<\/p>\n\n\n\nTreatment of major depression:<\/strong><\/p>\n\n\n\nThe recommended dose is 20 mg daily.<\/p>\n\n\n\n
Your doctor may increase the dose one to three to four weeks if you do not respond to treatment. If needed, the dose can be gradually increased up to a maximum of 60 mg. Dose one should be increased carefully to ensure that you receive the lowest effective dose.
<\/p>\n\n\n\n
You may not feel better right away when you start taking your antidepressant. This is common because an improvement in depressive symptoms may not come until after the first few weeks.
<\/p>\n\n\n\n
Patients with depression should be treated for a period of at least 6 months.
<\/p>\n\n\n\n
Treatment of the obsessive-compulsive disorder<\/strong><\/p>\n\n\n\nThe recommended dose is 20 mg daily. Your doctor may increase the dose one after two weeks if you do not respond to treatment. If necessary, the dose can be increased gradually up to a maximum of 60 mg per day.
<\/p>\n\n\n\n
If your condition does not improve within 10 weeks, your doctor will evaluate whether to continue treatment with fluoxetine. If you have had a good effect, your doctor may continue your treatment beyond 10 weeks. Dose one will be adjusted individually for you so that you get the lowest effective dose one. At regular intervals, your doctor will evaluate whether you need further treatment.
<\/p>\n\n\n\n
Bulimia<\/strong><\/p>\n\n\n\nFor adults and the elderly, a dose of 60 mg daily is recommended.
<\/p>\n\n\n\n
For the treatment of all the above conditions:<\/strong><\/p>\n\n\n\nThe recommended dose can be increased or decreased. The safety and efficacy of treatment with doses of more than 80 mg per day have not been properly studied. High doses will therefore only be prescribed when your doctor feels that the benefits outweigh the risks.
<\/p>\n\n\n\n
Use in children and adolescents older than 8 years:<\/strong><\/p>\n\n\n\nTreatment of moderate to severe major depression:<\/em><\/strong><\/p>\n\n\n\nThe treatment must be initiated and checked by a specialist.
<\/p>\n\n\n\n
The starting dose is 10 mg per day. Your doctor may prescribe a lower dose for you with low-weight children.
<\/p>\n\n\n\n
The treating physician will adjust the dose one carefully and individually so that the child or adolescent receives the lowest effective dose one. After one to two weeks, the doctor may increase the dose to one to 20 mg per day.
<\/p>\n\n\n\n
He will examine the need for continued treatment with Fluoxetine Stada after 6 months, and reconsider treatment if the condition has not improved within 9 weeks of treatment.
<\/p>\n\n\n\n
Older:<\/em><\/p>\n\n\n\nCaution is advised when increasing dose one and the daily dose one should not exceed 40 mg. The maximum recommended dose is 60 mg.
<\/p>\n\n\n\n
Patients with hepatic impairment or patients with other medicines that may affect the levels of Fluoxetine Stada (your doctor knows these):<\/strong><\/p>\n\n\n\nYour doctor may prescribe a lower dose or recommend a longer time between dosing sessions.
<\/p>\n\n\n\n
How to take the drug<\/strong><\/p>\n\n\n\nYou can take the tablet with or between meals. Fluoxetine Stada can be swallowed whole with water or dissolved in water. Swallow the reconstituted tablet immediately and completely. If you need to take more than one tablet a day, you can take them as a single dose or all at the same time as a single dose.
<\/p>\n\n\n\n
The tablet can be divided into two equal doses.<\/p>\n\n\n\n
If you take more Fluoxetine STADA then you should<\/h2>\n\n\n\n
Symptoms of overdose include nausea, vomiting, seizures, heart problems from irregular heartbeat without symptoms to a heart attack; lungs that do not function properly which can cause difficulty breathing, changes in the brain and spinal cord such as arousal, and an altered level of consciousness or unconsciousness.<\/p>\n\n\n\n
<\/p>\n\n\n\n
If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital,l or the Poison Information Center for risk assessment and advice. Bring the Fluoxetine Stada pack if you can.<\/p>\n\n\n\n
If you forget to take Fluoxetine STADA<\/h2>\n\n\n\n
If you miss a dose, do not worry. Take your next dose the next day as usual. Do not take a double dose to make up for a forgotten dose.<\/p>\n\n\n\n
If you stop taking Fluoxetine STADA<\/h2>\n\n\n\n
Do not stop taking Fluoxetine Stada unless your doctor tells you to. At the end of treatment, your dose of Fluoxetine Stada should be gradually reduced over several weeks or months to reduce withdrawal symptoms (see section 4. \u201cPossible side effects\u201d).<\/p>\n\n\n\n
<\/p>\n\n\n\n
Withdrawal symptoms<\/strong><\/p>\n\n\n\nYou may experience withdrawal symptoms when you stop taking Fluoxetine Stada. These are common especially if you abruptly stop taking Fluoxetine Stada. Withdrawal symptoms include dizziness, sensory disturbances (including tingling and numbness), sleep disturbances, including the inability to sleep ( insomnia ) and intense dreams, weakness, agitation or anxiety, nausea and\/or vomiting, tremors, and headache.
<\/p>\n\n\n\n
Usually, these symptoms are mild to moderate. However, they can be difficult. They usually occur in the first few days after the end of treatment and get better within two weeks. However, they can be for 2-3 months or longer. Tell your doctor if any of these symptoms become severe or affect your daily life. He or she may ask you to start taking your tablets again and then reduce the dose even slower.
<\/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
Undesirable effects may occur less frequently and become less severe as your treatment continues. These side effects do not always mean that you have to stop treatment.
<\/p>\n\n\n\n
Like other medicines such as Fluoxetine Stada, the following side effects have been reported:
<\/p>\n\n\n\n
A very common side effect is<\/strong> (can occur in more than 1 in 10):<\/p>\n\n\n\n- sleep disorders ( insomnia )<\/li>
- headache<\/li>
- loose stools (diarrhea), malaise (nausea)<\/li>
- mental or physical fatigue (exhaustion),<\/li><\/ul>\n\n\n\n
Common side effects are<\/strong> (may affect up to 1 in 10):<\/p>\n\n\n\n- poor appetite<\/li>
- weight loss<\/li>
- nervousness, anxiety<\/li>
- feel tense<\/li>
- restlessness<\/li>
- sleep problems (sleep disorders), e.g. unusual dreams<\/li>
- fatigue ( somnolence )<\/li>
- poor concentration (attention deficit disorder), dizziness, lethargy<\/li>
- taste change ( dysgeusia )<\/li>
- uncontrolled shaking movements ( tremor )<\/li>
- dimsyn<\/li>
- the feeling of fast and irregular heartbeat (palpitations)<\/li>
- Sudden redness of the face ( flush )<\/li>
- yawning<\/li>
- nausea (vomiting), indigestion ( dyspepsia )<\/li>
- dry mouth<\/li>
- skin rash, hives ( urticaria ), itching ( pruritus )<\/li>
- profuse sweating ( hyperhidrosis )<\/li>
- joint pain ( arthralgia )<\/li>
- frequent urination<\/li>
- unexpected vaginal bleeding<\/li>
- sexual problems such as difficulty maintaining an erection for sexual activity ( erectile dysfunction ), premature ejaculation or delayed ejaculation (ejaculation disorder), decreased sex drive (decreased libido )<\/li>
- feel shaky or have chills.<\/li><\/ul>\n\n\n\n
Uncommon side effects<\/strong> (may affect up to 1 in 100 people):<\/p>\n\n\n\n- feel isolated from oneself<\/li>
- strange thoughts<\/li>
- abnormal exhilaration (elevated mood, euphoric mood)<\/li>
- orgasm problem<\/li>
- grind teeth<\/li>
- suicidal thoughts or thoughts of harming oneself<\/li>
- a painful restlessness with a constant need to move ( psychomotor hyperactivity)<\/li>
- muscle twitching ( myoclonus ), involuntary movements ( dyskinesia ), or problems with balance and coordination ( ataxia )<\/li>
- enlarged pupils ( mydriasis )<\/li>
- difficulty remembering things (impaired memory)<\/li>
- ringing in the ears ( tinnitus )<\/li>
- low blood pressure ( hypotension )<\/li>
- shortness of breath ( dyspnoea )<\/li>
- epistaxis ( epistaxis )<\/li>
- difficulty swallowing ( dysphagia )<\/li>
- intestinal bleeding ( gastrointestinal bleeding)<\/li>
- hair loss ( alopecia )<\/li>
- increased tendency to get bruises<\/li>
- cold sweats<\/li>
- difficulty emptying the bladder ( dysuria )<\/li>
- sexual incapacity (sexual dysfunction )<\/li>
- general discomfort (feeling sick), abnormal feeling, feeling cold, feeling hot.<\/li><\/ul>\n\n\n\n
Rare side effects are<\/strong> (may affect up to 1 in 1000 people):<\/p>\n\n\n\n- decreased platelet count, increasing the risk of bleeding or bruising ( thrombocytopenia )<\/li>
- the low number of certain white blood cells ( neutropenia )<\/li>
- decreased number of white block bodies ( leukopenia )<\/li>
- allergic reaction (anaphylactoid reaction)<\/li>
- rash with or without itching along with any of the following symptoms: fever, joint pain, muscle aches, swollen lymph nodes, and\/or flu-like symptoms (serum sickness)<\/li>
- Low sodium levels in the blood ( hyponatremia ) including sodium levels below 110 mmol \/ l blood serum. This may in some cases be due to excessive secretion of antidiuretic hormone. This side effect is most likely if you are elderly and also taking diuretics. It usually gets better when you stop the treatment.<\/li>
- extremely elevated mood, a lot of energy, and unusual thought patterns (mania); persistent elated or irritable mood ( hypomania )<\/li>
- to see or feel something that does not exist (hallucinations)<\/li>
- stark oro<\/li>
- panic attacks<\/li>
- confusion<\/li>
- stuttering (dysphemia)<\/li>
- aggression<\/li>
- seizures (convulsions)<\/li>
- inability to sit still ( akathisia, see section 2 \u201cWarnings and Precautions\u201d)<\/li>
- uncontrollable movements of the mouth, tongue, and limbs (buccoglossal syndrome)<\/li>
- serotonergic syndrome, a reaction caused by an excess of the body’s own substance serotonin (for symptoms see section 2. “Warnings and precautions”)<\/li>
- life-threatening irregular heartbeat ( ventricular arrhythmia including torsades de pointes ), abnormal heart activity shown by ECG ( QT prolongation on ECG )<\/li>
- inflammation of a blood vessel ( vasculitis )<\/li>
- dilation of blood vessels ( vasodilation )<\/li>
- sore throat ( pharyngitis )<\/li>
- lung problems including pneumonia and fibrosis (the formation of fibrous tissue in the lungs). You may get shortness of breath before you get these signs of illness.<\/li>
- pain in the esophagus<\/li>
- rapid swelling of the throat, face, mouth, and\/or throat ( angioedema )<\/li>
- bleeding under the skin ( ecchymosis )<\/li>
- sensitivity to sunlight (photosensitivity)<\/li>
- purple or red pin-sized dots on the skin (purple)<\/li>
- severe and life-threatening skin reactions including rash, redness, blisters on the lips, eyes, or mouth, dandruff, fever. This may be a sign of Erythema Multiforme and may develop into Stevens-Johnson syndrome or toxic epidermal necrolysis ( Lyell’s syndrome ). For symptoms of these side effects, see section 2. “Warnings and precautions”)<\/li>
- muscle pain ( myalgia )<\/li>
- difficulty urinating ( urinary retention, disorders of urination)<\/li>
- a persistent, painful erection (priapism)<\/li>
- high levels of a hormone called prolactin ( hyperprolactinemia ), excessive production of breast milk ( galactorrhea )<\/li>
- mucosal bleeding (mucosal bleeding)<\/li>
- yellowing of the skin and whites of the eyes are signs of hepatic impairment\/hepatitis<\/li>
- abnormal liver function values \u200b\u200b( transaminases, elevated gamma-glutamyltransferase).<\/li><\/ul>\n\n\n\n
Has been reported<\/strong> (occurs in an unknown number of users):<\/p>\n\n\n\n- impaired concentration<\/li>
- Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see \u201cPregnancy\u201d in section 2 for more information.<\/li><\/ul>\n\n\n\n
Other possible side effects:<\/strong><\/p>\n\n\n\nAn increased risk of bone fractures has been seen in patients taking this type of drug.
<\/p>\n\n\n\n
Withdrawal symptoms<\/p>\n\n\n\n
These occur especially if you suddenly stop using fluoxetine. The symptoms are:<\/p>\n\n\n\n
- ant crawling ( paresthesias ), tremors, headache<\/li>
- sleep disorders (including insomnia and intense dreams), weakness, anxiety,<\/li>
- dizziness, nau, sea, and\/or vomiting.<\/li><\/ul>\n\n\n\n
(see also section 3. “If you stop taking Fluoxetine Stada”).
<\/p>\n\n\n\n
Use in children and adolescents under 18 years of age<\/strong><\/p>\n\n\n\nIn studies in children, the following additional side effects have been reported<\/p>\n\n\n\n
- suicidal thoughts and suicidal behavior and aggression<\/li>
- manic reactions, including extremely high mood, energy, and abnormal thought patterns (mania), and persistent hilarious or irritated mood ( hypomania ).<\/li>
- growth inhibition (reduced increase in height and weight)<\/li>
- delayed sexual maturation or sexual dysfunction<\/li>
- decreased levels of alkaline phosphatase (an enzyme found in the liver).<\/li><\/ul>\n\n\n\n
5. How to store Fluoxetine STADA<\/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
Do not store above 30 \u00b0 C.
<\/p>\n\n\n\n
Medicines 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.<\/p>\n\n\n\n
One Fluoxetine Stada 20 mg dispersible tablet contains 20 mg fluoxetine.
<\/p>\n\n\n\n
The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate, 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 with a scoreline on both sides.<\/p>\n\n\n\n
The tablet can be divided into two equal doses.
<\/p>\n\n\n\n
Fluoxetine Stada 20 mg dispersible tablets are available in blister packs of plastic and aluminum foil.
<\/p>\n\n\n\n
Pack sizes: 12, 14, 20, 28, 30, 50, 60, 70, 90, 98 and 100 tablets in blisters.<\/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
STADA Arzneimittel AG<\/p>\n\n\n\n
Stadastrasse 2-18<\/p>\n\n\n\n
61118 Bad Vilbel<\/p>\n\n\n\n
Germany
<\/p>\n\n\n\n
Other manufacturers<\/strong><\/p>\n\n\n\nSTADApharm GmbH, Stadastrasse 2-18, 61118 Bad Vilbel, Germany<\/p>\n\n\n\n
STADA Arzneimittel GmbH, Muthgasse 36\/2, 1190 Vienna, Austria<\/p>\n\n\n\n
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland<\/p>\n\n\n\n
Centrafarm Services BV, Nieuwe Donk 9, 4879 Etten-Leur, The Netherlands<\/p>\n\n\n\n
Sanico NV, Industrial Zone IV, Veedijk 59, 2300 Turnhout, Belgium
<\/p>\n\n\n\n
Local representative<\/strong><\/p>\n\n\n\nSTADA Nordic ApS<\/p>\n\n\n\n
Marielundvej 46 A<\/p>\n\n\n\n
2730 Herlev<\/p>\n\n\n\n
Denmark
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20 mg dispersible tablets
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