Provimed 50 mg film-coated tablets

Package leaflet: information for the user / patient


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 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 is Provimed and what it is used for
2. What you need to know before you are using Provimed
3. How to use Provimed
4. Possible side effects
5. How to keep Provimed
6. Packaging content and other information

1. What is Provimed and what it is used for
Provimed film-coated tablets contain the active substance mesterolone. It is used during androgen deficiency (male hormone) or male infertility when associated with primary or secondary male hypogonadism (primary gonads).
2. What you need to know before you are using Provimed
Do not use Provimed:
– if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Provimed;
– if you have prostate cancer or breast enlargement in men;
– if you have or have had liver tumors.
Take special care with treatment with Provimed tablets
Before you start treatment with Provimed, your doctor will perform an examination of your prostate. Your doctor will also note your medical history and perform other tests, including some blood tests.
Tell your doctor if you have or have had any of the following symptoms:
• Prostate diseases;
• liver disease;
• heart disease or blood vessels;
• high blood pressure;
• kidney disease;
• difficulties in removing urine;
• migraine;
• epilepsy;
• Diabetes;
• Sleep apnea (abnormal breathing breaks during sleep);
• polycythemia (a blood disorder in which too many cells are produced red blood cells);
• Porphyria (a rare metabolic disorder).
If you have not told your doctor about any of the above, tell them before you start taking Provimed.
Tell your doctor if you have allergies to other medicines, foods, preservatives or dyes.
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 affect the effect of Provimed. Also, Provimed can potentiate the hepatotoxic effect of some drugs.
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. Provimed should not be used during pregnancy and breast-feeding.
Driving and using machines
Treatment with Provimed has no influence on the ability to drive and use machines.
Important information about some of the ingredients of Provimed
Provimed 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 Provimed
Provimed should always be used in the dose, in the manner and for the time period prescribed by your doctor.
The following doses are recommended:
For adults:
Initiation of treatment – 75-100 mg daily for several months.
In maintenance therapy – 50 – 75 mg per day.
Mode of administration
It is taken 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 Provimed than you should
If you have taken or think you have taken more tablets 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 mesterol (high doses as anabolic remedies) severe endocrine, metabolic and psychiatric adverse reactions are reported.
If you forget to take Provimed
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 Provimed
You must continue to use Provimed as long as your doctor has told 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, Provimed can cause side effects, although not everybody gets them.
Provimed tablets in therapeutic doses are unlikely to cause side effects. During the prolonged treatment, the following reactions were observed adverse (frequency data not available):
Benign, malignant and unspecified tumors (including cysts and polyps)
Liver tumors. In the elderly – hypertrophy and / or prostate carcinoma.
Blood and lymphatic disorders
Changes in the leucocyte, hypocoagular pattern with haemorrhagic tendency.
Immune system disorders
Hypersensitivity reactions.
Nervous system disorders
Psychiatric disorders
Depression, aggression, irritability.
Endocrine disorders
Suppression of gonadotrophin secretion, amenorrhea and inhibition of spermatogenesis, gynecomastia in men. Change libido. In prepubertal boys, frequent erections and penis enlargement can be observed.
Metabolic and nutritional disorders
Fluid retention with peripheral edema, hypercalcemia, progress of atherosclerosis.
Gastrointestinal disorders
Nausea, vomiting, severe pain or stomach sensitivity, which do not disappear in a short time.
Hepatobiliary disorders
Dysplasia of liver function, cholestasis, jaundice.
Skin and subcutaneous tissue disorders
Acne, insignificant hirsutism.
Diagnostic Investigations
Increased blood urea concentration, positive nitrate balance, hypercalcemia (especially in bed care patients and metastatic breast cancer patients). Change (positive) of liver function indices.
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 keep Provimed
Keep out of the reach and sight of children.
Keep protected from light and temperatures below 25 °C.
Do not use Provimed 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 Provimed contains
The active substance is mesterolone.
1 film-coated tablet contains 50 mg of dinaron.
The other ingredients are:
Magnesium stearate, Kollidon CL (crospovidone), Kollidon VA-64 (copovidone), Ludipress (lactose monohydrate, polyvidone, crospovidone).
Copolymer of polyvinyl alcohol and polyethylene glycol, talc, dioxide titanium, mono and diglycerides of fatty acids, polyvinyl alcohol, FD & C Blue Color No.1, yellow iron oxide dye, black iron oxide dye.
What Provimed looks like and contents of the pack
Round, biconvex green film-coated tablets. In cross section, the internal contents of the tablet are white.
The contents of the packaging
Twenty (20) film-coated tablets in PVC/Al blister.
Three (3) blister packs together with the patient leaflet are placed in a carton.

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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