Information för alternativet: Fluoxetin Sandoz 20 Mg Dispergerbar Tablett, visar 2 alternativ

Välj alternativ:

1. Fluoxetin Sandoz 20 Mg Kapsel, Hård
2. Fluoxetin Sandoz 20 Mg Dispergerbar Tablett
3. Fluoxetin Sandoz 40 Mg Dispergerbar Tablett Fluoxetin Sandoz 10 Mg Dispergerbar Tablett

Document: Fluoxetin Sandoz dispersible tablet ENG PL change

• Fluoxetin Sandoz dispersible tablet PL
• Fluoxetin Sandoz dispersible tablet ENG PL

---

PACKAGE LEAFLET

Package leaflet: Information for the patient

Fluoxetin Sandoz 20 mg dispersible tablets

Fluoxetine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Fluoxetin Sandoz is and what it is used for

2. What you need to know before you take Fluoxetin Sandoz

3. How to take Fluoxetin Sandoz

4. Possible side effects

6. Contents of the pack and other information

Fluoxetin Sandoz is an antidepressant that influences the central nervous system. Fluoxetin Sandoz contains the active substance fluoxetin.

Fluoxetin Sandoz is used for:

Adults:

Children and adolescents aged 8 years and above:

How Fluoxetin Sandoz 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 Fluoxetin Sandoz 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.

Note that the doctor may have prescribed this medicine for a different purpose and/or at a different dosage from that given in the package leaflet. You must always follow the doctor’s prescription and the instructions given on the label of the pack.

Do not use Fluoxetin Sandoz

• If you are taking a medicine that belongs to the group of so called irreversible, non-selective monoamine oxidase inhibitors such as iproniazid, since serious or even fatal reactions can occur.

• If you are taking metoprolol used in cardiac failure.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluoxetin Sandoz

• If you have or have had mania

• If you have a low resting heart-rate and/or if you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)

• If you have a tendency to bleed

• If you have glaucoma (increased pressure in the eyes)

• If you have an ongoing treatment with diuretics (water tablets), especially if you are older;

• If you have a history of bleeding disorders or appearance of bruises or unusual bleeding

• If you have an ongoing treatment with medicines that thin the blood (see ‘Other medicines and ’ Fluoxetin Sandoz)

• If you have an ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘Other

Medicines and Fluoxetin Sandoz”)

Thoughts of suicide and worsening of your depression

If youare depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, sincethese medicines all take time to work, usually about two weeks but sometimes longer.

Youmay be more likely to think like this:

- If you are ayoung adult.Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourselfat any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friendthat you are depressedand ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Restlessness like difficulties to sit or stand still, allergic reactions or a combination of severe symptoms, the so called serotonin syndrome, may occur during treatment with Fluoxetin Sandoz, please see section 4.

Weight lossmay occur during the treatment with Fluoxetin Sandoz.

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.Fluoxetin Sandoz 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 in other indications. Additionally, only limited information concerning the long-term safety of Fluoxetin Sandozon growth, puberty, mental, emotional and behavioural development in this age group is available. Despite this, your doctor may prescribe Fluoxetin Sandoz for patients under 18 for moderate to severe major depressive episode in combination with psychological therapybecause he/she decides that this is in your best interests. If your doctor has prescribed Fluoxetin Sandoz 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 Fluoxetin Sandoz.

Fluoxetin Sandozshould not be used in the treatment of children under the age of 8 years.

Withdrawal symptoms seen on discontinuation of Fluoxetin Sandoz

When you stop taking Fluoxetin Sandoz, especially if it is abruptly, you may feel discontinuation symptoms (see “How to take Fluoxetin Sandoz”).

Other medicines and Fluoxetin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Certain medicines can affect or be affected by Fluoxetin Sandoz. These are:

If your doctor changes your medicine from a so called irreversiblenon-selective MAO inhibitor (e.g. iproniazid) to Fluoxetin Sandoz, there must be an interval of at least 2 weeks between the treatments.

If you cease taking Fluoxetin Sandoz and the medication is changed to an irreversible non-selective MAO inhibitor, there must be an interval of at least 5 weeks before you start taking the MAO inhibitor.

• Tramadol used in pain treatment or triptans used to treat migraine. There is an increased risk of serotonin syndrome. Triptans may also cause narrowed heart blood vessels and raised blood pressure when used concomitantly.Class IA and III antiarrhythmics or other medicines that may affect the heart’s rhythm; antipsychotics used to treat schizophrenia such asphenothiazines, pimozide, haloperidol; tricyclic antidepressants used to treat depression; certain antimicrobial agents used to treat infections such as. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine: halofantrine used to treat malaria;astemizole and mizolastine and mequitazine used to treat allergies

• Diuretics, desmopressin, carbamazepine, oxcarbazepine and other medicines that can cause low sodium levels in your blood.

• Tricyclic antidepressants, other selective serotonin reuptake inhibitors, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol and other medicines that may lower the seizure threshold.

• St. John’s wort (Hypericum perforatum, a natural herbal remedy to treat depression), MAO-A inhibitors (such as linezolid or methylthioninium chloride (methylene blue)), selegilin and other medicines with a serotonergic effect. Concomitant treatment with Fluoxetin Sandoz can cause a severe side effect (serotonin syndrome).

• Flecainide, propafenone or nebivolol used to treat heart problems; carbamazepine used to treat epilepsy; tricyclic antidepressants such as imipramine, desipramine and amitriptyline; atomoxetine used to treat attention-deficit hyperactivity disorder; risperidone used to treat psychotic disorders.If taken together with Fluoxetin Sandoz, the blood levels of these medicines may change and your doctor may need to lower their dose.

• Tamoxifen used to treat breast cancer.Fluoxetin Sandoz may change the blood levels of this drug and a reduction of the effect of tamoxifen cannot be excluded. Your doctor may need to consider different antidepressant treatments.

• Cyproheptadine, used to treat allergy, may reduce the antidepressant activity of fluoxetine.

Fluoxetin Sandoz with food,drink and alcohol

The tablets may be taken with or without food.

The combination of Fluoxetin Sandoz and alcohol is not recommended.

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.

Fluoxetin Sandoz should not be used during pregnancy or breastfeeding unless your doctor has weighed the risks of not using to be greater than using the medicine.

Both intake of Fluoxetin Sandoz during pregnancy and breastfeeding may affect the unborn child/breastfed infant.

Pregnancy

In babies whose mothers took fluoxetine during the first few months of pregnancy, there have been some reports suggesting 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. You and your doctor may decide that it is better for you to gradually stop taking Fluoxetin Sandoz while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Fluoxetin Sandoz.

Make sure your midwife and/or doctor knows you are on Fluoxetin Sandoz. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Fluoxetin Sandoz 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.

If you take Fluoxetin Sandoz especially during late pregnancy or just before giving birth you baby might have some symptoms when it is born. These symptoms include: irritability, tremor, muscle weakness, persistent crying, and difficulty in sucking or in sleeping. These symptoms may indicate so called serotonergic effects or withdrawal reactions.If your baby has any of these symptoms when it is born, contact your midwife or doctor who will be able to advice you.

Breast-feeding

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.

Fertility

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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Fluoxetin Sandoz can impair judgement, thinking capacity and motor skills. This should be taken into account in situations where increased alertness is necessary, e.g. when driving or operating hazardous machinery.

Fluoxetin Sandoz contains lactose

Fluoxetin Sandoz contains lactose. If you do not tolerate certain types of sugar, you should contact your doctor before taking this medicine.

3. How to use Fluoxetin Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Fluoxetine can be taken as a single dose or divided into several doses.

Fluoxetin Sandoz dispersible tablets can be dissolved in a glass of water, divided, or swallowed whole.

The recommended dose is:

Depression:

The recommended dose is 20 mg daily.

Your doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment. When appropriate the dosage can be gradually increased up to a maximum of 60 mg.

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 a period of at least 6 months.

Obsessive thoughts and obsessive actions (OCD):

The recommended dose is 20 mg daily.

Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment. When appropriate the dosage can be gradually increased up to a maximum of 60 mg daily. If no improvement is noted within 10 weeks, treatment with Fluoxetin Sandoz should be reconsidered.

Bulimia:

The recommended dose is 60 mg daily.

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. After one to two 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.

Your doctor should review the need for continuing treatment beyond 6 months. If you have not improved, your treatment should be reassessed.

Impairment of the liver

If you suffer from liver impairment, the dosage may be reduced by your doctor.

If you take more Fluoxetin Sandoz than you should

If you have taken too much Fluoxetin Sandoz you should contact your doctor or a hospital.

Symptoms of overdose: 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 Fluoxetin Sandoz

• 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 Fluoxetin Sandoz

Do not stop taking Fluoxetin Sandozuntil your doctor tells you to. It is important that you keep taking your medicine.

• Do not stop taking your medicine without asking your doctor first, even when you start to feel better.

• Make sure you do not run out of tablets.

You may notice the following effects when you stop taking Fluoxetin Sandoz: dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, , inability to sleep), feeling restless or agitated, unusual tiredness or weakness, feeling anxious, feeling sick or being sick, shakiness, headaches.

Most people find that any symptoms on stopping Fluoxetin Sandozare mild and go away on their own within a few weeks. If you experience symptoms when you stop treatment, contact your doctor.

When stopping Fluoxetin Sandoz, 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctorimmediately

• 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). (uncommon, may affect up to 1 in 100 people)

• If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of breath. Allergic reaction can also include serious reaction of your skin (your skin starts to turn red and then blister or peel) or involve kidneys, liver or lung (see section 2“ ”). Stop taking the tablets straight away and tell your doctor immediately. (rare, may affect up to 1 in 1,000 people)

• If you feel restless and feel like you cannot sit or stand still you may have akathisia(rare, may affect up to 1 in 1,000 people)

• If you have severe skin reactions, including blistering, red or purple marks or peeling of the skin. It can also affect the mouth, eyes and other mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis or Erythema multiforme). (rare, may affect up to 1 in 1,000 people)

• If you experience 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; (rare, may affect up to 1 in 1,000 people)

• If you have feelings of weakness, drowsiness or confusion. This affects mostly older people and (older) people on diuretics (water tablets); (rare, may affect up to 1 in 1,000 people)

• If you have prolonged and painful erection; (rare, may affect up to 1 in 1,000 people)

• If you have irritability and extreme agitation. (rare, may affect up to 1 in 1,000 people)

• If you experience heart problems, such as fast or irregular heart rate, fainting, collapsing or dizziness upon standing which may indicate abnormal functioning of the heart rate. (rare, may affect up to 1 in 1,000 people)

The following side effects have also been reported in patients taking Fluoxetin Sandoz:

Very common (may affect more than 1 in 10 people)

- insomnia

- headache

- diarrhea

- feeling sick (nausea)

- fatigue

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

- dizziness

- change in taste

- uncontrollable shaking movements

- blurred vision

- rapid and irregular heartbeat sensations

- flushing

- yawning

- 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

- generally feeling unwell or abnormal

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

- low levels of white blood cells, which makes infections more likely

- untypical wild behaviour

- hallucinations

- agitation

- panic attacks

- confusion

- stuttering

- aggression

- fits

- 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

- hepatitis

- lung problems

- sensitivity to sunlight

- muscle pain

- problems urinating

- producing breast milk

- abnormal liver function test results

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.

Additionally in children and adolescents (8-18 years)– In addition to the possible side effects listed above, fluoxetine 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.

Withdrawal effects when stopping treatment may occur, particularly Fluoxetin Sandoz is stopped abruptly. The risk of withdrawal symptoms may be dependent on the duration of therapy and dosage and the rate of dose reduction (see “How to use Fluoxetin Sandoz”).

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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluoxetin Sandoz

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton.

The expiry date refers to the last day of that month.

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 protect the environment.

6. Contents of the pack and other information

What Fluoxetin Sandoz contains

The active substance isfluoxetine hydrochloride equivalent to 20 mg fluoxetine.

The other ingredients arelactose monohydrate, microcrystalline cellu­lose, pregelatinised maize starch, crospovidone, croscarmellose sodium, anhydrous colloidal silicon dioxide, sodium saccharin, sodium cyclamate, magnesium stearate

Flavourings: Peppermint flavour, plum flavour

What Fluoxetin Sandoz looks like and contents of the pack

[Fluoxetin Sandoz 20 mg dispersible tablets are white, round and biconvex tablets, with one sided score notch and available in blister packs of 7, 10, 14, 20, 28, 30, 60, 70, 100 and 100x1 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in

2015-07-03