Package leaflet · information for the user
Drostanolone Enanthate 200 mg/ml
Drostanolone Enanthate
Read all of this leaflet carefully before you start using this medicine
- 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.
1.What Drostanolone Enanthate is and what it is used for
Drostanolone Enanthate 200 mg/ml is a clear oily solution that is injected into a muscle. It contains drostanolone, a man-made copy of a male sex hormone of the kind men's bodies make naturally. Unlike some hormones of this family, drostanolone is not changed into the female hormone oestrogen in the body, so it does not usually cause water retention or breast swelling. The "enanthate" part is a slow-release form: one injection releases the hormone gradually over about a week. Your doctor has prescribed this medicine for you after weighing up the benefits and the risks in your particular case.
2.What you need to know before you use Drostanolone Enanthate
Some conditions make this injection unsuitable, and your doctor needs to know your full medical history before you have your first dose.
Do not use it if
- Do not use this medicine if you are allergic to drostanolone enanthate or to the oil it is dissolved in (the ingredients are listed at the end of this leaflet).
- Do not use it if you have, or your doctor thinks you may have, cancer of the prostate gland or cancer of the male breast.
- Do not use it if you have a high level of calcium in your blood, which your doctor may have found on a blood test.
- Do not use it if you are a woman. It can cause masculine changes such as a deeper voice and extra body hair, and some of these changes may not go away.
- Do not use it if you are pregnant, think you may be pregnant, or are breastfeeding.
- Do not use it if you have severe liver or kidney disease, unless your doctor has decided the treatment is still right for you.
Warnings and precautions
- Talk to your doctor before using this medicine if you have a heart problem, high blood pressure, or high cholesterol. Hormones of this type can raise your "bad" cholesterol and lower your "good" cholesterol, which over time can be hard on the heart and blood vessels.
- Talk to your doctor before using it if you are an older man or have any prostate trouble, such as a weak stream or getting up at night to pass urine. Your doctor will usually check your prostate before and during treatment.
- Talk to your doctor if you have diabetes, epilepsy, migraine, or if your kidneys or liver do not work well, as these can be affected by hormone treatment.
- Your doctor will normally arrange blood tests before you start and from time to time during treatment, to check your blood count, cholesterol, liver and, in men, your prostate. Please go to these appointments even if you feel well.
- This medicine lowers the amount of testosterone your own body makes and can reduce your sperm count and your fertility while you are using it, and for some time afterwards.
- This medicine must not be used in children or in boys who have not finished growing, as it can stop the bones growing to their full length.
- Drostanolone is on the World Anti-Doping Agency's prohibited list. If you take part in any level of organised sport, tell your doctor before you start, because a test will detect it for a long time after the last injection.
Other medicines and Drostanolone Enanthate
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including ones you bought without a prescription. This is especially important for medicines that thin the blood, such as warfarin, because this injection can strengthen their effect and increase the risk of bleeding or bruising; for medicines for diabetes, including insulin, because your blood sugar may fall and your doses may need changing; and for steroid tablets, creams or injections of the cortisone type (for example prednisolone), which together with this medicine can make your ankles and legs swell.
Pregnancy, breastfeeding and fertility
This medicine must not be used during pregnancy. It can harm an unborn baby, and a girl baby can be born with masculine changes to her body. It must not be used while breastfeeding, as it may pass into breast milk. This medicine is not for use in women at all. In men, it lowers the number and quality of sperm while it is being used, so it can make it harder to father a child; this usually improves after treatment stops, but it may take several months, and it does not always return to normal. Talk to your doctor if you and your partner are hoping to have a baby.
Driving and using machines
This medicine is unlikely to affect your ability to drive or to use tools and machines. However, some people feel dizzy or have headaches, and blood pressure can rise during treatment. If this happens to you, do not drive or use machines until you feel well again.
3.How to use Drostanolone Enanthate
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is given as an injection deep into a muscle, usually in the buttock or the thigh, by a doctor or nurse — or by you, if your doctor has shown you how. It must never be injected into a vein. The solution is oily, so it is injected slowly, and the injection site should be changed each time so that the same spot is not used twice in a row. Each ampoule is for one use only; anything left in the ampoule must be thrown away. If you miss an appointment or a dose, do not try to make up for it with an extra injection — contact your doctor, who will tell you when to have the next one. If you think you have been given too much, tell your doctor straight away.
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop and get medical help straight away
- Stop and get medical help now if you have signs of an allergic reaction: a rash, itching, swelling of the face, lips or throat, or difficulty breathing.
- Get medical help now if you have chest pain, sudden shortness of breath, weakness down one side of your body, or trouble speaking — these can be signs of a heart or blood-vessel problem.
- Get medical help now if your skin or the whites of your eyes turn yellow, if your urine goes dark, or if you have pain in the upper right of your tummy — these can be signs of a liver problem.
- Get medical help now if you cannot pass urine at all, or if you see blood in your urine.
- Get medical help now if you have an erection that is painful or lasts several hours.
- Tell your doctor promptly if you feel very low in mood, unusually aggressive, or have thoughts of harming yourself.
Other possible side effects
- Oily skin and acne, most often on the face, chest and back
- Thinning hair on the scalp or losing hair in a male pattern, and more hair on the body or face
- Pain, redness, hardness or a lump at the place where you were injected
- Difficulty sleeping, and feeling restless, irritable or unusually short-tempered
- Changes in sex drive, either more or less than usual
- Smaller testicles and a lower sperm count while you are using the medicine
- Headache, or feeling that your heart is beating hard or fast
- Changes in your cholesterol and, less often, a rise in blood pressure — usually found on a check-up rather than felt
- In men, difficulty passing urine or needing to pass urine more often at night
- Reporting of side effects: if you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly to Ergopharm at pv@ergopharm.net. By reporting side effects you can help provide more information on the safety of this medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist — including any not listed in this leaflet. You can also report them directly to us at pv@ergopharm.net or through our reporting form, and to your national reporting system. By reporting side effects you help provide more information on the safety of this medicine.
5.How to store Drostanolone Enanthate
Keep this medicine out of the sight and reach of children. Store below 25 °C. Do not freeze. Keep the ampoules in the outer carton so that they are protected from light, and take one out only when it is about to be used. Do not use this medicine after the expiry date printed on the carton and on the ampoule; the expiry date refers to the last day of that month. Do not use it if the ampoule is cracked or chipped, or if the liquid is cloudy or has bits floating in it. Never throw medicines away with household waste or down the drain. Return any unused ampoules, and any used ampoules and needles, to your pharmacist or to a sharps collection point. These measures help protect the environment.
6.Contents of the pack and other information
The active substance is drostanolone enanthate. Each 1 ml ampoule contains 200 mg of drostanolone enanthate. The other ingredient is a sterile refined oil carrier, which simply carries the active substance and allows it to be released slowly from the muscle. What it looks like and contents of the pack: a clear, slightly viscous, pale yellow oily solution in a single-use 1 ml glass ampoule (Type I amber or transparent glass). Each carton contains 10 ampoules of 1 ml, together with this leaflet. The carton carries a GS1 DataMatrix code and a verification code under a scratch-off panel, which you or your pharmacist can use to check that the pack is genuine at ergopharm.net. Manufactured under GMP conditions by Ergopharm, Vadodara, Gujarat, India.