Package leaflet: information for the user / patient oxandrolon 10 mg film-coated tablets
Read all of this leaflet carefully before you start to take 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 or nurse.
– This medicine has been prescribed for you only. You do not have to give it to others. It can harm them, even if they have the same signs of illness as yours.
– If you have any side effects, talk to your doctor or pharmacist or nurse. These include any possible side effects not mentioned in this leaflet. See section 4.
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What you find in this leaflet:
1. What Oxandrolone is and what it is used for
2. What you need to know before you use Oxandrolone
3. How to use Oxandrolone
4. Possible side effects
5. How to store Oxandrolone
6. Packaging content and other information
1. What Oxandrolone is and what it is used for
Oxandrolone tablets is used during the recovery period in pathologies accompanied by protein synthesis disorders (cachexia of various genesis, trauma, extensive burns, condition after infectious diseases and irradiation, muscular dystrophy, osteoporosis) in therapy with corticosteroids, hypoplastic and aplastic anemia, chronic hemolytic anemia.
2. What you need to know before you use Oxandrolone
Do not use Oxandrolone:
– if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Oxandrolone.
– if you are pregnant or breast-feeding.
– additional contraindications include prostate carcinoma, male breast carcinoma, female breast cancer, ovarian cancer, ischemic cardiopathy, severe atherosclerosis, liver and kidney failure, nephritis, nephrotic syndrome, acute and chronic prostatitis.
Warnings and precautions
It is forbidden to overdose recommended doses. When administering the preparation to women, the expected benefit and the possible risk of treatment should be evaluated considering the androgenic effect of the preparation. When the first signs of virilization of the patients (voice thickening, hirsutism, acne, clitoromalgia) occur, administration should be stopped to avoid irreversible changes. Preparations in this group may cause the suppression of blood coagulation factors that require careful monitoring, including concomitant use with anticoagulants.
The preparation is administered with caution to patients with impaired heart function, hypertension, impaired hepatic and renal function, epilepsy, migraine and glaucoma (intraocular tension), including a history. During treatment, systematic control of intraocular pressure is recommended due to possible retention of sodium and water ions in the body. It is possible to alter hepatic function, therefore, after a 4-week treatment schedule, hepatic function control is recommended.
An increase in the incidence of hypertrophy and prostate carcinoma in the elderly may require a rigorous control. Before initiating the treatment and later on, prostate rectal control is recommended during the treatment.
In diabetes, it is advisable to adjust the doses of anti-hyperglycaemic agents.
In patients with malignant tumors the duration of treatment will be determined individually and according to liver parameters. Systemically control lipidemia and cholesterol. During treatment with Oxandrolon it is recommended to provide adequate food intake of proteins, lipids, carbohydrates, vitamins and minerals.
Children and adolescents
Oxandrolone tablets are not recommended for children and adolescents below the age of 18 due to a lack of data on the safety and efficacy of the preparation in these age groups.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Other medicines (blood glucose lowering medicines called antidiabetic medicines and so-called coumarin derivatives used to prevent blood clotting) may influence the effect of Oxandrolone. Oxandrolone may potentiate the hepatotoxic effect of some medicines.
Also, medications in the glucocorticoid group, mineralocorticoids, sodium-containing preparations and sodium-rich foods potentiate fluid retention in the body, increase the risk of developing edema, intensify acne eruptions.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Oxandrolone should not be used during pregnancy and lactation.
Driving and using machines
Treatment with Oxandrolone has no influence on the ability to drive and use machines.
Important information about some components of Oxandrolone
Oxandrolone tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency (Lapp), or glucose-galactose malabsorption should not take this medicine.
Oxandrolone tablets contain FD @ C Yellow # 6 (E110) dye, which can cause allergic reactions.
3. How to use Oxandrolone
Oxandrolone should always be used in the dose, mode and time period prescribed by your doctor. Treatment can be varied and doses adjusted individually.
Usual doses for adults are 2.5-20 mg daily divided into 2-4 intakes. The duration of therapy is usually 2-4 weeks.
Method of administration
It is used orally. The coated tablets should be swallowed whole with a sufficient amount of liquid. The tablets should not be divided, broken or chewed.
If you used more Oxandrolone than you should
If you have taken or think you have taken more Oxandrolone than you should (overdose), tell your doctor straight away or get to your nearest medical unit. Bring the package or the medicines left with you.
Cases of overdose have not been reported. In the case of abuse of preparations containing oxandrolone (administration of high doses as anabolic remedy) severe endocrine, metabolic and psychiatric adverse reactions are reported.
If you forget to take Oxandrolone
If you forget to take a dose, take the missed dose as soon as you remember. However, if time for next dose approaches, stop taking the omitted dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on this medicine, ask your doctor or pharmacist.
If you stop taking Oxandrolone
You should continue to use Oxandrolone as long as your doctor tells you. Do not stop taking the medicine without first talking to your doctor or pharmacist.
If you have any further questions on this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Oxandrolone can cause side effects, although not everybody gets them.
Oxandrolone tablets in therapeutic doses are unlikely to cause side effects. During the prolonged treatment, the following side effects (no frequency data available) were observed:
– liver tumors in the elderly hypertrophy and/or prostate carcinoma;
– changes in blood analysis, low blood clotting with bleeding tendency;
– hypersensitivity reactions; – excitation, insomnia, depression, confusion;
– suppressing sexual stimulation hormone secretion;
– in women – the appearance of signs of virilization (for example, acne, hirsutism, male alopecia, irreversible thickening of the voice of the voice, dysmenorrhea, clitoral hypertrophy), hasting may be the first sign of a tonality change that may be long lasting, and sometimes irreversible;
– lack of menstrual cycle and inhibition of spermatogenesis;
– enlargement of mammary glands in men;
– libido modification;
– fluid retention with peripheral edema, hypercalcemia (increased calcium ions in the blood) in men and women – progress of atherosclerosis (pathology of fat deposition on intima vessels called arteries);
– nausea, vomiting, decreased appetite;
– liver dysfunction, cholestasis (difficulty in releasing the bile), jaundice (yellowing of the tegument);
– acne, hirsutism (abnormal hair growth) insignificant;
– retention of sodium and water ions in the body;
– increased blood biochemical parameters (blood urea, positive nitrate balance, hypercalcemia), especially in patients who follow a strict bedtime regimen, and in patients with metastatic breast cancer;
– change (increase) of liver function indices;
– pain in the bones;
– bladder irritation;
– priapism.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting adverse reactions
If you experience any side effects, talk to your doctor or pharmacist. These include any possible side effects not mentioned in this leaflet.
By reporting side effects, you can help provide additional information on the safety of this medicine.
5. How to store Oxandrolone
Keep out of the reach and sight of children.
Keep protected from light and temperatures below 25 °C.
Do not use Oxandrolone after the expiry date which is stated on the pack after “EXP”. The expiration date refers to the last day of that month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.
6. Packaging content and other information
What Oxandrolon contains
The active substance is oxandrolone.
1 film-coated tablet contains 10 mg oxandrolone;
The other ingredients are:
Core
Magnesium stearate, Kollidon CL (crospovidone), Kollidon 25 (polyvinylpyrrolodone), Ludipress (lactose monohydrate, polyvidone, crospovidone).
Coat
Copolymer of polyvinyl alcohol and polyethylene glycol, talc, titanium dioxide, mono and diglycerides of fatty acids, polyvinyl alcohol, FD & C colorant Yellow No. 6 (E110), FD & C dye Blue No. 1, FD & C dye Blue No. 2
What Oxandrolon looks like and contents of the pack
Blue, biconvex, film-coated tablets. In cross section, the internal contents of the tablet are white.
The contents of the packaging
Oxandrolone 10 mg film-coated tablets
Twenty-five (25) PVC/Al blister film-coated tablets.
Four (4) blister packs together with the patient leaflet are placed in a carton.
CERTIFICATE OF REGISTRATION
SC Balkan Pharmaceuticals SRL N. Grădescu str., 4, MD-2002, or. Chisinau, Republic of Moldova.
The manufacturer
SC Balkan Pharmaceuticals SRL Industrial Street, 7 / A, MD-2091, or. Singera, Republic of Moldova.
This product you can buy here.
