BIFLOX 20 mg. 28 tablets
BIFLOX 20 mg. 28 tablets
BIFLOX WHAT IS AND WHAT IT IS USED
Biflox binds to certain structures and the human brain has an antidepressant effect.
Depression with or without symptoms of anxiety, especially when not required sedation;
Premenstrual dysphoric disorder.
2 WHAT YOU NEED TO KNOW BEFORE TREATMENT WITH BIFLOX
Biflox not apply to:
Hypersensitivity (allergy) to the drug or to any of the excipients;
Concomitant medicinal products from a group called MAO inhibitors. The product should not be administered earlier than 14 days after discontinuation of MAO inhibitors or reversible MAOIs.
In the application of this product please note the following:
Thoughts of suicide and worsening of your depression or anxiety disorder.
If you are feeling depressed and / or have anxiety disorders may occasionally thoughts of harming or killing themselves.
These may be increased when first starting antidepressants, since these medicines all take time to start running - usually about two weeks but sometimes longer.
You may be more likely to think like this:
If you have previously had thoughts about killing or harming yourself;
If you are a young man. Data from clinical studies suggest an increased risk of suicidal behavior in young people under 25 years old) with psychiatric conditions who were treated with an antidepressant.
If at any time in you have thoughts of harming or killing yourself, immediately contact your doctor or go to hospital!
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or are worried about changes in your behavior.
Rashes and allergic reactions
The appearance of skin rash or hives often combined with the development of systemic reactions such as fever, increased white blood cells, joint pain, swelling, swollen glands, protein in the urine, a moderate increase in liver enzymes. In cases where, in the course of treatment with the product develop rash and / or other symptoms of hypersensitivity whose cause can not be established, require discontinuation of treatment with the product.
Seizures are a potential risk with antidepressants, so the product should be used with caution in patients with a history of seizures, or in patients with an increased risk of seizures.
The product is used with caution in patients with mania in the past. Upon entering the
manic phase treatment with the product should be discontinued.
Liver / kidney disease
Biflox is metabolized in the liver and excreted by the kidneys. In cases of substantial
hepatic dysfunction is dose reduction or acceptance
Product during the day.
Biflox be used with caution in these patients.
Some patients may experience weight loss.
It is possible to influence the blood sugar level - during the treatment was observed
hypoglycemia, and after its termination - hyperglycemia. It may be necessary to change
doses of hypoglycaemic agents.
Patients with a bleeding diathesis needs to be monitored during the treatment with the product
because of the risk of the occurrence of bleeding, especially in the case of combination therapy with
clozapine, phenothiazines, nonsteroidal anti-inflammatory drugs.
Premenstrual dysphoric disorder
This condition occurs in the last week of the menstrual cycle and include depressed mood, anxiety, emotional lability, accompanied by violation of social functions and headache, swelling of the breasts, bloating, fluid retention.
Response of symptoms occurs relatively quickly - within the first cycle of therapy. These symptoms may recur after a period usually 1 or 2 cycles after discontinuation of therapy.
Application of Biflox and intake of food and beverages
No need for a special diet during treatment with this product.
Tell your doctor if you are pregnant, may be pregnant or are planning pregnancy. This is because some studies have shown an increased risk of birth defects, particularly cardiovascular, in infants whose mothers took fluoxetine during the first few months of pregnancy. In these studies it was found that about 2 to 100 of babies (2%), whose mothers took fluoxetine in the early stages of pregnancy, cardiac defect, compared with the normal level of 1 in 100 babies (1%), which is usually observed. You and your doctor may decide that it is better to gradually stop taking Biflox while pregnant. However, depending on the circumstances, your doctor may decide that for you it is better to continue taking Biflox.
If you take Biflox should tell the midwife and / or doctor. When taken during pregnancy, especially during the last months of pregnancy H, medicines like Biflox may increase the risk of serious complications in newborns, called persistent pulmonary hypertension of the newborn, leading to shortness of breath and blueness of the baby. These symptoms usually begin-within the first 24 hours after birth. Should this occur in your baby, contact your midwife and / or doctor.
Before taking any medicine, consult your doctor or pharmacist. The product is excreted in human milk. Discontinuing breastfeeding for
the period of treatment with the product.
Incorporation in the finished dosage form azo (E110) may cause allergic reactions, incl. bronchial asthma. The product contains lactose as an excipient. Is unsuitable for people with lactase deficiency, galactosemia or glucose / galactose malabsorption.
Driving and using machines
Biflox can have a negative impact on psychomotor functions koeto.nalaga during treatment products contain the potentially dangerous types of activities requiring increased attention and rapid psychomotor reactions. Because of the slow elimination from the body, the effect of the product continue to 2-3 weeks after cessation of treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they have not been prescribed by your doctor
MAO inhibitors - when co-administered with fluoxetine is possible that serotonin syndrome manifested clinically by fever, muscle stiffness, seizures, tremors, nervousness, mental changes, diarrhea, changes in blood pressure, in some cases fatal.
The administration of an MAO inhibitor should be stopped at least two weeks prior to initiation of treatment with Biflox. On the other hand recommended treatment with MAOIs to start at least five weeks after discontinuing Biflox due to the long half-life of fluoxetine and norfluoxetine;
Other antidepressants - co-administered with Biflox leads to gain their effects and increase the risk of side effects, especially CNS due to increased plasma levels.
Lithium and tryptophan products - in their combined use with Biflox established change in plasma levels of lithium (increased or decreased). In the course of treatment is necessary monitoring of plasma lithium concentrations in order to avoid the development of toxic effects and adequate adjustment in dosage.
Benzodiazepines - The half-life of diazepam may be prolonged by coadministration with Biflox; co-administration of the product with alprazolam leads to increased plasma levels of the latter.
Medicinal products with a high degree of plasma protein binding (warfarin, digitoxin) - it is possible to increase the plasma concentrations of the latter and increase the risk of adverse reactions due to replacement by Biflox. Conversely, when co-administered with products having higher affinity for plasma proteins is possible shift of Biflox and increase its plasma concentrations.
Tryptophan - it is possible to amplify movement disorders and disturbances on the part of the gastrointestinal tract.
Anticonvulsants (phenytoin, carbamazepine) It has been observed to increase the plasma concentrations and the risk of toxic effects when administered with Biflox.
Medicinal products that have CNS depressant activity and alcohol - amplified suppressing effects and increases the risk of seizures.
Antipsychotics (haloperidol, clozapine) - coadministration Biflox may lead to toxic plasma levels of carbamazepine. In relation to the long half-life of Biflox and active metabolite norfluoxetine, there may be interactions with other drugs even 2-3 weeks after discontinuation of the product.
3 HOW TO USE BIFLOX
Always take Biflox as instructed by your doctor!
For oral use in adults only
Depression with or without anxiety symptoms - initial and maintenance dose of 20 mg;
OCD -preporachvana daily dose - 20-60 mg daily. An initial dose of 20 mg daily. If after several weeks of treatment effect has not occurred, the dose may be increased.
Bulimia nervosa - adult working and elderly - dose of 60 mg. Dose increases should be made gradually according to individual patient response.
Premenstrual dysphoric disorder - a daily dose of 20 mg as a first course of treatment for not more than six months. After this period requires assessment of the patient's condition.
For all indications, the recommended dose may be increased or reduced. Doses above 80 mg have not been evaluated systematically. The product can be taken with food or without it. After discontinuation of the body remain active drugs for weeks. This should be taken into account when initiating and ending treatment. Most patients do not need a gradual reduction in dose.
Children: Do not use in children under 18 years.
Patients with liver or kidney disease: Reduction in the dose or increase the interval between doses in patients with severe hepatic or renal impairment and in elderly patients in the presence of systemic diseases requiring medical treatment.
If you have the impression that the effect of the application of Biflox is strong or too weak, talk to your doctor or pharmacist!
If you take a large amount of medicine: When administered at the recommended dose, immediately consult a doctor!
Symptoms - nausea; vomiting, agitation, anxiety, and other symptoms hipomaniyni manifestations of CNS.
Treatment - discontinuation of the product, gastric lavage, symptomatic treatment and monitoring of indicators sardechno¬sadovata and respiratory functions. It is necessary to take account of long half-life of fluoxetine and norfluoxetine. Due to the large volume of distribution, dialysis, hemoperfusion or forcing diuresis does not affect the process of elimination of the product. There is no known specific antidote
If you forget to use Biflox
If you forget to take the next dose, take the missed it as soon as possible, but do not double the next one.
4 POSSIBLE SIDE EFFECTS
Like any other medicine, Biflox can cause adverse
Chesti- decrease in appetite, nausea, vomiting;
Rare - mouth sores, difficulty swallowing, inflammation of the esophagus and stomach,
inflammation of the gums and tongue, changes in liver enzymes, thirst;
Very rare -diariya, inflammation of the gall bladder and stone formation, colitis,
duodenal ulcer, enteritis, vomiting blood, hepatitis, enlarged liver, hyperchlorhydria, increased salivation, jaundice, stomach ulcer, discoloration of the tongue, tongue edema.
Rare - underactive thyroid gland;
Very rare -diabetna acidosis, diabetes mellitus;
Hematologic and by the lymphatic system
Rare - anemia, skin bleeding;
Very rare - hipohromna anemia, alterations in the number of white blood cells, skin bleeding,
Common - weight loss;
Rare - dehydration, generalized edema, gout, high cholesterol and fat levels in the blood
low levels of potassium and sodium, peripheral edema;
Very rare - intolerance to alcohol, increased levels of ALP and creatine phosphokinase, increased potassium and uric acid in the blood, low calcium levels, anemia, increased levels of SGPT;
Rare - arthritis, bone pain, inflammation of the periarticular tissues and tendons, cramps;
Very rare - arthritis, thinning of cartilage, muscle weakness, muscle inflammation,
osteoporosis, rheumatoid arthritis;
Established increased risk of bone fractures in patients taking drugs of the same
group to which it belongs and Biflox
Common - agitation, amnesia, emotional lability, sleep disorders;
Rare - acute brain syndrome, apathy, uncertain gait, confusion, euphoria, hallucinations, hyperkinesia, incoordination, increased libido, manic reaction, neuralgia, neuropathy, paranoid reaction, psychosis, dizziness;
Very rare - abnormal EEG, antisocial reactions, chronic brain syndrome, CNS depression, coma, speech disorders, dystonia, prickling, neuritis, hysteria, paralysis, decreased reflexes, stupor;
Rare - asthma, epistaxis, hyperventilation, pneumonia;
Very rare - respiratory failure, emphysema, decreased oxygen supply to the lungs, laryngeal edema, pulmonary edema, pneumothorax,
Skin and appendages
Rare: acne, alopecia, contact dermatitis, eczema, herpes simplex, rash, urticaria, skin ulcers;
Very rare - pustules on the skin, herpes zoster, hirsutism, skin bleeding, psoriasis, pustular rash, seborrhea;
Common - hypertension;
Rare: angina, arrhythmias, congestive heart failure, low blood pressure, migraine, myocardial infarction, vascular headache conditioned;
Very rare - atrial fibrillation, slow heart rate, cerebral embolism, cerebral ischemia, cardiac arrest, heart block, peripheral vascular disorder, phlebitis, shock, thrombophlebitis, thrombosis, vascular spasm, ventricular arrhythmia. ventricular premature complexes, ventricular fibrillation;
Common - frequent urination;
Rare - abortion albumin in the urine, absence of menstruation, breast pain, lactation, changes in urination, blood in urine, menstrual bleeding, abnormal urination, incontinence;
Very rare - glucose in the urine, a reduction of menstrual pain, kidney, small amount of urine;
Tolerance, physical and psychological dependence
Reported to have withdrawal symptoms or other symptoms of drug dependence in the use of fluoxetine. It is, however, prior to treatment with fluoxetine dosage can be turned off, or another type of dependency or known ones. Common symptoms include dizziness, tingling, headache, anxiety, nausea, most of which are mild and self-limiting. Rarely fluoxetine is connected in such symptoms.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
At temperatures below 25 ° C
Keep out of reach of children!
Do not use after the expiry date stated on the package!
Shelf life: 2 (two) years