OXANDROLONE TABLETS

NAME OF THE MEDICINAL PRODUCT

Oxandrolone  Tablet IP 10mg,

Oxandrolone  Tablet USP 10mg

Package leaflet:

Information for the patient

Oxandrolone 10mg  tablets

Read all of this leaflet carefully before you start taking 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.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.What OXANDROLONE Tablets are and what they are used for
2. What you need to know before you take OXANDROLONE Tablets
3. How to take OXANDROLONE Tablets
4. Possible side effects
5. How to store OXANDROLONE Tablets
6. Contents of the pack and other information

 WHAT OXANDROLONE TABLETS ARE AND WHAT THEY ARE USED FOR

Composition:
One tablet contains: active substance – 10 mg Oxandrolone.
Excipients: Magnesium Stearate; Crospovidone; lactose; povidone;

Form of the drug:
Round tablets of 10 mg with white color and flat surface.

Pharmacological properties:
Oxandrolone is an anabolic steroid. When it reaches the cell nucleus, it stimulates the genetic apparatus of the cell, which brings to an increased synthesis of DNA, RNA and structural protein, ATP synthase and the intrusion of the in cell macroergic. It stimulates the anabolic processes and inhibits the catabolic ones, which is caused by glucocorticoids. That brings to an increase of the muscle mass, it postpones the fat distribution, it improves the connective tissue.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXANDROLONE TABLETS

Indications:
Disorders of protein synthesis, Cachexia of different origins, Traumas, extensive burns, Infectious diseases, muscular dystrophy, Osteoporosis, Negative nitrogen balance, Corticosteroid therapy, Hypo- and aplastic anemia

HOW TO TAKE OXANDROLONE TABLETS

Dosage and route of administration:
Adults: Standard Oxandrolone doses adjustments individual. It is normally in the range 2.5-20 mg for a day.
For children: The most common dosage is ≤ 0.1 mg / kg. For 24 hours. The medical treatment is from 2-4 weeks. The course of treatment should be repeated after one or two months.

 POSSIBLE SIDE EFFECTS

Tumors of the liver, liver cancer, or peliosis hepatis, a form of liver disease, have occurred during long-term, high-dose therapy with anabolic steroids. Although these effects are rare, they can be very serious and may cause death. Discuss these possible effects with your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
For both females and males
Less common

~
Yellow eyes or skin
Rare (with long-term use)
~
Black, tarry, or light-colored stools
~
dark-colored urine
~
purple- or red-colored spots on body or inside the mouth or nose
~
sore throat and/or fever
~
vomiting of blood

Check with your doctor as soon as possible if any of the following side effects occur:
For both females and males
Less common
Bone pain
nausea or vomiting
sore tongue
swelling of feet or lower legs
unusual bleeding
unusual weight gain

Rare (with long-term use)
Abdominal or stomach pain
feeling of discomfort (continuing
headache (continuing)
hives
loss of appetite (continuing)
unexplained weight loss
unpleasant breath odor (continuing)

Incidence not known
Lack or slowing of normal bone growth

For females only
More common
Acne or oily skin
enlarging clitoris
hoarseness or deepening of voice
irregular menstrual periods
unnatural hair growth
unusual hair loss

Less common
Mental depression
unusual tiredness

For young males (boys) only
More common

Acne
enlarging penis
increased frequency of erections
unnatural hair growth

Less common
Unexplained darkening of skin

For sexually mature males only
More common
Enlargement of breasts or breast soreness
frequent or continuing erections
frequent urge to urinate

For elderly males only
Less common
>Difficult or frequent urination

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For both females and males
Less common

  • Chills
  • diarrhea
  • feeling of abdominal or stomach fullness
  • muscle cramps
  • trouble in sleeping
  • unusual decrease or increase in sexual desire

 For males only
More common

  • Acne

Less common

  • Decreased sexual ability

Contraindications: Oversensitivity to the drug, prostate cancer, breast cancer, kidney failure, prostatitis, pregnancy, atherosclerosis, lactation.

HOW TO STORE OXANDROLONE TABLETS

It should be stored in a dry place away from heat and humidity. 15° to 25° C (59° to 77° F) Keep Oxandrolone out of the reach of children and away from pets. Do not refrigerate or freeze Store in the original package in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your Pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Further Information

Expiration date: 3 years. Do not use after expiry date.
Terms of Use: By doctor’s prescription

 Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar

Related Portfolio Items

Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut Aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit.