Anapolon 50 ML

Package leaflet: information for the user / patient

 ANAPOLON 50 mg film-coated tablets ( Oxymetholone )

Read 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 your pharmacist or nurse.
– This medicine has been prescribed for you only. You do not have to give it to others. It can hurt them, even if they do 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.

What you find in this leaflet:
1. What Anapolon is and what it is used for;
2. What you need to know before you use Anapolon;
3. How to use Anapolon;
4. Possible side effects;
5. How to store Anapolon;
6. Packaging content and other information

 1. What Anapolon is and what it is used for
 Anapolone tablets are used during recovery therapy in pathologies:
– Decreases in protein synthesis.
– Variety of genesis.
– Trauma, burns.
– After infectious diseases and irradiation.
– Muscular dystrophy.
– Osteoporosis.
– Negative nitrate balance in corticosteroid therapy.
– Hypoplastic and aplastic anemia.

 2. What you need to know before you use Anapolon
Do not use Anapolon:
– If you are allergic (hypersensitive) to the active substance or to the medicine any of the other ingredients of Anapolon.
– If you are pregnant or breast-feeding.
– Additional contraindications are prostate carcinoma or male breast carcinoma, ischemic cardiopathy, atherosclerosis severe, hepatic and renal insufficiency, acute and chronic prostatitis.
-Anapolone tablets are not recommended for children and adolescents under the age of 18 due to a lack of safety and health data effectiveness.

Take special care with Anapolone tablets.
It is forbidden to overdose recommended doses. When using the preparation by women, it is necessary to evaluate all the expected benefits and possible risks of the treatment, given the androgenic action of the preparation. At the first signs of virilization of the patients (thickening voice, hirsutism, acne, clitoromalgia) should be stopped to avoid irreversible changes.
The preparation is cautiously administered to affect the function of the heart, hypertension, impaired liver and kidney function, epilepsy, migraine and glaucoma (intraocular tension). Regular monitoring is recommended during treatment of intraocular pressure due to the possible retention of sodium ions and water in the body. It is possible to alter liver function, that’s why after a 4-week treatment schedule control of liver function is recommended. Before initiating the treatment and then on its course, prostate rectal control is recommended. In diabetes, it is advisable to adjust the doses of anti-hyperglycaemic agents.
For patients with malignant tumors, the duration of treatment will be determined individually and according to liver parameters. It is necessary to systematically check the level of lipidemia and cholesterol.

Taking other medicines
Please tell your doctor or pharmacist if you take or have recently taken any other medicines, including of those released without a prescription.
Other medicines (medicines that lower the glucose level in called antidiabetic blood and so-called coumarin derivatives used to prevent blood clotting) may influence the effect of Anapolon. This drug may also potentiate the hepatotoxic effect of some medicines.
Also, drugs from the group of glucocorticoids, mineralocorticoids, preparations containing sodium and foods rich in sodium boosts fluid retention in the body, increases the risk of development edema, intensifies acne eruptions.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Anapolon should not be used during pregnancy and lactation.

Driving and using machines
Treatment with Anapolone has no influence on the ability to drive and operate machinery.

Important information about some of the ingredients of Anapolon
Anapolon tablets contain lactose. Patients with hereditary problems rare cases of galactose intolerance, lactase deficiency (Lapp) or glucose-galactose malabsorption should not be used this medicine.
Anapolon tablets contain colorant FD @ C Yellow No 6 (E110), which can cause allergic reactions.

3. How to use Anapolon
Anapolone should always be used in the dose, in the way and for the time period prescribed by your doctor. The recommended daily dose for adults is 1-5 mg / kg / day.
The usual effective dose is 1-2 mg / kg / day, but may also be needed large, so the doses will be individualized. The effects do not happen immediately, therefore the minimum treatment is 3-6 months. Patients with congenital aplastic anemia, requires continuous treatment with doses of maintenance.

Mode of administration
It is given orally. The film-coated tablets should be swallowed whole, with a sufficient amount of liquid. The tablets should not be broken or chewed.

If you use more Anapolon than you should
If you have taken or think you have taken several Anapolon tablets than you should (overdose), tell your doctor immediately or get to your nearest medical unit. Bring the package or the medicines left with you.
Cases of overdose have not been reported. In case of abuse of preparations, containing oximetolone (administration of high doses as anabolic remedy) severe endocrine adverse reactions, metabolic and psychic are reported.

If you forget to take Anapolon
If you forget to take a dose, take the missed dose as soon as you remember. However, if dosing time approaches do not take the missed dose anymore. Do not take a double dose to offset a forgotten dose.
If you have any further questions on this medicine, talk to your doctor or pharmacist.

If you stop taking Anapolon
You must continue to use Anapolon as long as it is indicated your doctor. Do not stop taking the medicine without first talking to your doctor or pharmacist. If you have any further questions on this medicine, talk to your doctor or pharmacist.

4. Possible side effects
Like all medicines, Anapolon can cause side effects, although they do not appear to all people.   Anapolone tablets in therapeutic doses are unlikely to causes side effects. During prolonged treatment they have the following adverse reactions were observed (no data available frequency):

 – Liver tumors.
 – In the elderly – hypertrophy and / or prostate carcinoma.
 – Changes in blood analysis, low blood clotting with tendency to haemorrhages.
 – Hypersensitivity reactions.
 – Suppression of gonadotropin secretion (sex stimulation hormone).
 – Amenorrhoea and inhibition of spermatogenesis.
 – Gynaecomastia (breast enlargement) in men.
 – Libido changes.
 – Liquid retention with peripheral edema, hypercalcemia (increase in ions calcium in the blood) in men and women – the progression of atherosclerosis (pathology of fat deposition on intima vessels called arteries).
 – Nausea, vomiting, loss of appetite.
 – In women – the appearance of signs of virilization (acne, hirsutism, alopecia male, irreversible change of the voice tag, dysmenorrhea, clitoral hypertrophy). Voice tone change may be the first sign, which can be long and sometimes irreversible.
 – In case of use at adolescence boys, frequent erections can be observed enlargement of the penis, in girls – increased pubic hair and hypertrophy clitoral.
 – Dysplasia of liver function, cholestasis (difficulty in releasing the bile), jaundice (yellowing of teguments).
 – Acne, hirsutism (abnormal hair growth) insignificant.
 – The retention of sodium and water ions in the body.
 – Increasing the concentration of some biochemical parameters in the blood (urea in the blood, positive nitrate balance, hypercalcemia) especially in patients, who adheres to a strict bedtime regimen, and to breast cancer patients metastatic.
 – Change (positive) of liver function indices.

 If any of the side effects gets serious, or if you notice it any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Reporting adverse reactions
If you experience any side effects, talk to your doctor or pharmacist.     

5. How to store Anapolon
Keep out of the reach and sight of children.Keep protected from light and temperatures below 25°C.   Do not use Anapolon 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 do not must be disposed of by household waste or household waste.Ask your pharmacist how to dispose of medicines that you no longer have necessary. These measures will help to protect the environment.

6. Packaging content and other information
What Anapolon contains

The active substance is oximetolone. 1 film-coated tablet contains 50 mg of oximetolone.
 The other ingredients are:
 Core: Magnesium stearate, Kollidon CL (crospovidone), Ludipress (lactose monohydrate, polyvidone, crospovidone).
 Coat: Copolymer of polyvinyl alcohol and polyethylene glycol, talc, dioxide titanium, mono and diglycerides of fatty acids, polyvinyl alcohol, dye FD & C Yellow No. 6 (E110), quinoline yellow dye.

 What Anapolon looks like and contents of the pack
Yellow, biconvex, film-coated tablets. In the inner part of the tablet section content has a white color.

The contents of the packaging
Anapolon 50 mg film-coated tablets
Twenty (20) film-coated tablets in PVC / Al blister.
Three blister strips together with the patient prospectus are placed in a cardboard box.

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.

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