Package leaflet: information for the user / patient
Strombafort 10 mg film-coated tablets
Strombafort 50 mg film-coated tablets
stanozolol
Read all of this leaflet carefully before you start using 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 you or your 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 Strombafort is and what it is used for
2. What you need to know before using Strombafort
3. How to use Strombafort
4. Possible side effects
5. How to store Strombafort
6. Packaging content and other information
1. What Strombafort is and what it is used for
Strombafort tablets may be used during recovery therapy in pathologies accompanied by disorders of protein synthesis, cachexia of various genesis, trauma, burns, pre- and postoperative periods, infectious diseases and irradiation, renal and adrenal insufficiency, toxic tooth, muscular dystrophy, osteoporosis, negative nitrate balance in corticosteroid therapy, hypo- and aplastic anemia. Adjuvant in the treatment of tuberculosis, osteomyelitis, bronchial asthma, hepatitis.
2. What you need to know before using Strombafort
Do not use Strombafort:
– If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Strombafort.
– If you are pregnant or breast-feeding.
– Additional contraindications are prostate carcinoma or male breast carcinoma, ischemic cardiopathy, severe atherosclerosis, hepatic and renal impairment, acute and chronic prostatitis. Strombafort tablets are not recommended for children and adolescents below the age of 18 due to a lack of data on safety and efficacy.
Take special care with Strombafort tablets
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. At the first signs of virilization of the patients (voice thickening, hirsutism, acne, clitoromalgia) administration should be stopped to avoid irreversible changes.
The preparation is cautiously administered to heart function, hypertension, impaired liver and kidney 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 is recommended. 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.
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) can affect the effect of Strombafort. Strombafort can also potentiate the hepatotoxic effect of some drugs.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Strombafort should not be used during pregnancy and lactation.
Driving and using machines
Treatment with Strombafort has no influence on the ability to drive and use machines.
Important information about some Strombafort components
Strombafort tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency (Lapp), or glucose-galactose malabsorption should not take this medicine.
3. How to use Strombafort
Strombafort should always be used in the dose, in the manner and for the time period prescribed by your doctor.
The usual dose is the following:
Adults – initial dose 10-20 mg / day.
The maintenance dose is 5-10 mg / day.
Maximum dose – 50 mg / 24 hours.
In some patients, for decreasing the frequency and severity of hereditary angioedema, the doses are adjusted individually, depending on the clinical response.
The starting dose is 2 mg 3 times a day. When a favorable response is obtained, the dose is reduced gradually over a period of 1 to 3 months to 2 mg per day.
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Out of stock
Balkan Pharmaceuticals
Mode of administration
It is given 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 Strombafort than you should
If you have taken or think you have taken more Strombafort 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 methandienone (administration of high doses as anabolic remedy) severe endocrine, metabolic and psychiatric adverse reactions are reported.
If you forget to take Strombafort
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 Strombafort
You must continue to use Strombafort 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, Strombafort can cause side effects, although not everybody gets them.
Strombafort 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 haemorrhagic tendency.
Hypersensitivity reactions.
Suppression of gonadotropin secretion (sex stimulation hormones).
In women – virilization signs (for example, acne, hirsutism, male alopecia, irreversible thickening of the voice stamp, dysmenorrhea, clitoral hypertrophy). Craving can be the first sign of tonality change, which can be long lasting and sometimes irreversible.
Amenorrhoea and inhibition of spermatogenesis. Gynaecomastia (breast enlargement) in men.
Changes libido.
In pre-puberty boys, frequent erections and penis enlargement can be observed; the presence of pubic hair and clitoral hypertrophy has been observed in girls.
Liquid retention with peripheral edema, hypercalcemia (elevation of calcium ions in the blood) in men and women – progression of atherosclerosis (pathology of fat deposition on intima vessels called arteries).
Nausea, vomiting, loss of appetite.
Dysplasia of liver function, cholestasis (difficulty in releasing the bile), jaundice (yellowing of the tegument).
Acne, hirsutism (abnormal hair growth) insignificant.
The retention of sodium and water ions in the body.
Increased levels of 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 (positive) of liver function indices.
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 undesirable side effects in this leaflet. By reporting side effects, you can help provide additional information on the safety of this medicine.
5. How to store Strombafort
Keep out of the reach and sight of children.
Keep protected from light and temperatures below 25 °C.
Do not use Strombafort 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 Strombafort contains
The active substance is stanozolol.
1 film-coated tablet contains 10 mg or 50 mg of stanozolol.
The other ingredients are:
Core
Magnesium stearate, Kollidon CL (crospovidone), microcrystalline cellulose, sodium, 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 blue color No. 1, FD & C dye Blue 2.
What Strombafort looks like and contents of the packaging
Round, biconvex, light blue, film-coated tablets. In cross section, the internal contents of the tablet are white.
Contents of the pack
Strombafort 10 mg
Twenty-five (25) film-coated tablets in PVC / Al blister. Four (4) blister packs together with the patient leaflet are placed in a carton.
Strombafort 50 mg
Twenty (20) film-coated tablets in PVC / Al blister. Three (3) 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.
