Mylan Methylprednisolone Solution

MYLAN METHYLPREDNISOLONE is used is used for its potent anti - inflammatory (reduces swelling) effect. It lowers the immune response at high doses.

MYLAN METHYLPREDNISOLONE should not be administered to you :

• If you have chicken pox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them.
• If you have ever suffered an allergic reaction, or any type of reaction after being given MYLAN METHYLPREDNISOLONE, or any other medicine containing a corticosteroid or any of the ingredients in this medicine. An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath.
• If you have any fungal infection (such as thrush), which is not being treated.
• If you have a blood disorder or are taking medicines to make the blood thinner.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection if:

Note! If you are an athlete you are warned that the active ingredient, methylprednisolone, in MYLAN METHYLPREDNISOLONE is on the list of banned substances.

Before you receive MYLAN METHYLPREDNISOLONE, tell your doctor:

• If you have tuberculosis (TB) or if you have suffered tuberculosis in the past.
• If you currently have an infectious disease.
• If you have diverticulitis (inflammation of the bowel wall).
• If you have non-specific ulcerative colitis if there is a risk of impending perforation, abscess or other infection.
• If you have a stomach ulcer or other serious stomach or intestinal problems.
• If you have osteoporosis (brittle bones).
• If you have kidney function disorders.
• If you have high blood pressure.
• If you are psychotic (suffering from mental disorders).
• If you have diabetes.
• If you have HIV (AIDS).
• If you are elderly.

Risk of bradycardia (slower than normal heart rate), possibly unrelated to the speed of infusion, has been reported during and after administration of MYLAN METHYLPREDNISOLONE.

Do not share medicines prescribed for you with any other person. The usual dose is: Your doctor will tell you how long your treatment with MYLAN METHYLPREDNISOLONE will last.

• The correct dose of MYLAN METHYLPREDNISOLONE will be decided by your doctor and depends on the type of infection, whether you are on any other antibiotics and your weight and age.
• If your condition does not improve your doctor will review your treatment.
• MYLAN METHYLPREDNISOLONE is usually administered as an intravenous infusion or intramuscular injection at your doctor’s office, hospital or clinic.
• If the vials are cracked or damaged in any way, they must not be used.
• Keep the MYLAN METHYLPREDNISOLONE as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials, Dispose properly after use. Ask your doctor, pharmacist or health professional to explain local regulations for proper disposal.
• If you have the impression that the effect of MYLAN METHYLPREDNISOLONE is too strong or too weak, tell your doctor or pharmacist.
• If you receive more MYLAN METHYLPREDNISOLONE than you should: Since a healthcare professional will administer MYLAN METHYLPREDNISOLONE, he/she will control the dosage. However, in the event of overdose your doctor will manage the overdose.
• If you forget to receive a dose of MYLAN METHYLPREDNISOLONE Do not take a double dose to make up for forgotten individual doses. Since a healthcare professional will administer MYLAN METHYLPREDNISOLONE, it is unlikely that the dose will be missed.

MYLAN METHYLPREDNISOLONE can have side effects. Not all side effects reported for MYLAN METHYLPREDNISOLONE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MYLAN METHYLPREDNISOLONE, please consult your healthcare professional for advice.

If any of the following happens, stop taking MYLAN METHYLPREDNISOLONE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difficulty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse.
• High blood pressure, symptoms of which are headaches, or generally feeling unwell.
• Sudden swelling of the face, lips, tongue or other parts of the body.
• Skin rashes and itching. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MYLAN METHYLPREDNISOLONE. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: The following side effects have been reported frequently:

• Feeling nervous or restless; having problems sleeping.
• Gastrointestinal irritation (feeling or being sick); increase in appetite; indigestion; weight gain.

The following side effects have been reported less frequently but serious: Bradycardia (abnormally slow heart rate) Other side effects reported are:

• Diabetes or worsening of existing diabetes.
• Round or moon-shaped face (Cushingoid facies); slowing of normal growth in infants, children and adolescents which may be permanent; irregular or no periods in women.
• Cramps and spasms, due to the loss of potassium from your body.
• Difficulty in thinking or being confused; feeling high or moods that go up and down; feeling depressed; feeling, seeing or hearing things which do not exist. Have strange and frightening thoughts, changing how you act or having feelings of being alone.
• Seizures.
• Eyes: Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches); swollen optic nerve (indicated by sight disturbance); damage to the optic nerve or cataracts (indicated by failing eyesight); thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera); worsening of viral or fungal eye infections; protruding of the eyeballs; blurred or double vision.
• Congestive heart failure in susceptible individuals.
• Acne; poor wound healing; thinning of skin with stretch marks; thinning of hair; bruising; small purple/red patches on the skin; pale or darker patches on your skin, or raised patches which are an unusual colour.
• Muscle weakness; brittle bones (bones that break easily); broken bones and fractures; torn muscle tendons causing pain and/or swelling.
• Burning, numbness, pain or tingling at or near injection site. Local allergic reaction or infection at injection site (redness, swelling, pain or other signs of infection or allergic reaction); scarring at injection site.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Store in the original package/container.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label/carton/bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Before reconstitution, keep the vials in the carton to protect the contents against light until required for use. The reconstituted solution can be stored for up to 24 hours if stored in a refrigerator at 2 – 8 °C or must be used immediately if not used stored in a refrigerator. Discard any remaining solution.