Millipred

Call your doctor for instructions if you miss a dose or forget to take your medicine.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while using prednisolone. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid drinking alcohol while you are taking prednisolone.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prednisolone in children. However, pediatric patients are more likely to have slower growth and bone problems if prednisolone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prednisolone in the elderly. However, elderly patients are more likely to have age-related kidney and bone problems, which may require caution and an adjustment in the dose for elderly patients receiving prednisolone.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Asparaginase
• Bemiparin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clonixin
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olaparib
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sorafenib
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Amobarbital
• Aspirin
• Atracurium
• Desogestrel
• Dienogest
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Levonorgestrel
• Licorice
• Medroxyprogesterone Acetate
• Mestranol
• Metocurine
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Phenytoin
• Primidone
• Rifampin
• Saiboku-To
• Vecuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Eye infection or
• Glaucoma or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Infection (e.g., bacterial, virus, or fungus) or
• Mood changes, including depression or
• Myasthenia gravis (severe muscle weakness) or
• Osteoporosis (weak bones) or
• Peptic ulcer, active or history of or
• Personality changes or
• Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or
• Tuberculosis, inactive—Use with caution. May make these conditions worse.

• Fungal infections or
• Herpes simplex eye infection—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain prednisolone. It may not be specific to Millipred. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

This medicine comes with a patient instruction insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

This medicine should be taken with food to avoid stomach irritation.

Measure the oral liquid with the special oral syringe that comes with the package. The average household teaspoon may not hold the right amount of liquid.

If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution, suspension, syrup, tablets):
  • Dose depends on medical condition:
    • Adults—At first, 5 to 60 milligrams (mg) per day. Your doctor may adjust your dose as needed.
    • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.14 to 2 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day. Your doctor may adjust your dose as needed.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine. Blood or urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while taking this medicine.

This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

While you are being treated with prednisolone, do not have any immunizations (vaccines) without your doctor's approval. Prednisolone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

• Aggression
• agitation
• anxiety
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mental depression
• mood changes
• nervousness
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• shortness of breath
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• Abdominal cramping and/or burning (severe)
• abdominal pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of skin
• decrease in height
• decreased vision
• diarrhea
• dry mouth
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fatigue
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn and/or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sleeplessness
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

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:

• Increased appetite

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take Millipred. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have your eye pressure checked if you are on this medicine for a long time. Talk with your doctor.
• If you have been taking Millipred for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like Millipred. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• This medicine may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Talk with your doctor before you drink alcohol.
• You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
• If you are 65 or older, use Millipred with care. You could have more side effects.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped Millipred (prednisolone tablets).
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Chest pain or pressure.
• Period (menstrual) changes.
• Bone or joint pain.
• Change in eyesight.
• Change in the way you act.
• Low mood (depression).
• Seizures.
• A burning, numbness, or tingling feeling that is not normal.
• Any unexplained bruising or bleeding.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Not able to sleep.
• Restlessness.
• Sweating a lot.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.