2.5 mg, 5 mg, 10 mg, 25 mg tablets
prednisolone
What Prednisolone Actavis is and what it is used for
Prednisolone is a corticosteroid ( glucocorticoid ) that is used to treat a variety of immune diseases as well as inflammatory and allergic diseases. Examples of such diseases are rheumatoid arthritis, certain blood diseases, inflammation of the blood vessels ( vasculitis ), connective tissue diseases, asthma, allergic diseases, kidney diseases, diseases of the gastrointestinal tract, certain cancers, diseases that affect the immune system and conditions that occur after transplantation.
Prednisolone contained in Prednisolone Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Prednisolone Actavis
Do not use Prednisolone Actavis
- if you are allergic to prednisolone or any of the other ingredients of this medicine (listed in section 6).
- if you have a fungal infection, except local fungal infection, such as on the skin or in the mouth.
In conditions where prednisolone can save lives, there is generally no reason to avoid using prednisolone.
Warnings and cautions
Talk to your doctor or pharmacist before using Prednisolone Actavis if you have:
- diabetes, as you may develop an increased need for insulin or other medical treatment
- hypothyroidism (underactive thyroid gland which may cause fatigue or weight gain)
- liver problem
- viral infection of the eye ( herpes simplex)
- gastric ulcer
- an inflammatory bowel disease such as Crohn’s disease, ulcerative colitis, and diverticulitis
- underwent abdominal surgery recently
- tuberculosis or have ever been treated for tuberculosis (TB)
- high blood pressure
- a heart disease
- osteoporosis (osteoporosis)
- extreme muscle weakness ( myasthenia gravis )
- an adrenal tumor ( pheochromocytoma )
- lymphoma (lymphoid tumors )
- mood swings or psychotic tendencies, as these can be exacerbated
- Scleroderma (also called systemic sclerosis, an autoimmune disease) because daily doses of 15 mg or more can increase the risk of a serious complication called acute kidney crisis. Signs of acute kidney crisis include high blood pressure and decreased urine production. Your doctor may advise you to check your blood pressure and urine levels regularly.
You must be aware of the following:
- Contact a doctor if you experience blurred vision or other visual disturbances (especially in children). Long-term treatment can cause cataracts (especially in children) and glaucoma (increased pressure in the eye) with possible damage to the optic nerve and the risk of fungal or viral infection in the eye. Your doctor may want to check your vision if you are being treated for an extended period.
- Tell your doctor if you need to be vaccinated.
- You must avoid being exposed to or infected with chickenpox or measles during the time you are being treated with Prednisolone Actavis. If you are exposed to this, consult your doctor. This is especially important when treating children.
- Long-term treatment can inhibit the development and growth of infants and children.
- Contact your doctor if you get an infection. Prednisolone Actavis can hide signs of infection and aggravate an existing infection due to its ability to reduce the body’s natural resistance to infection.
- Your doctor may recommend a low-salt, high-potassium diet, as Prednisolone Actavis may affect your salt and potassium balance.
- Prednisolone Actavis can hurt the way calcium circulates in the skeleton. Therefore, your doctor must assess the risk of you developing osteoporosis (osteoporosis), especially if bone fractures are in your family history, if you do not exercise regularly, are a woman undergoing or have had menopause, or if you are older.
If you are going to have surgery, you must always tell them that you are being treated with Prednisolone Actavis.
If you are being treated with Prednisolone Actavis for a long time, you should carry a card with information about when the treatment was started, what dose you are taking, what medicine you are taking, and the name of the doctor or hospital that prescribed the treatment. Such a card ensures that you receive your glucocorticoid treatment if you are hospitalized or have a serious accident, and do not have the opportunity to say that you are undergoing this treatment. You must carry the card with you for up to 1 year after the end of treatment.
Prednisolone is on a doping list and can lead to exclusion from sporting events. Always state that you are using Prednisolone Actavis when leaving blood or urine samples.
Prednisolone Actavis may affect blood sugar (glucose) tests.
Other medicines and Prednisolone Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
- ciclosporin is used to treat rheumatic diseases and skin disorders or after a transplant
- antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin used to treat epilepsy
- drugs used to treat tuberculosis (rifampicin)
- non-steroidal anti-inflammatory drugs ( NSAIDs ) such as aspirin, ibuprofen, and indomethacin used to relieve pain or to treat rheumatic diseases
- birth control pills
- thiazide diuretics (“liquid tablets”) such as bendroflumethiazide used for water retention or high blood pressure
- cardiac drugs ( digoxin )
- antifungals such as amphotericin B used to treat fungal infections
- anti- infective drugs ( fluoroquinolones )
- antidiabetic drugs
- cytotoxic drugs such as methotrexate used to treat cancer
- muscle relaxants
- drugs for the treatment of mental disorders (quetiapine)
- Some medicines may increase the effect of Prednisolone Actavis and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).
Prednisolone Actavis with food, drink, and alcohol
Prednisolone Actavis should be swallowed with water. You can take Prednisolone Actavis before or after a meal.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, you should not normally use Prednisolone Actavis. Talk to your doctor. Long-term treatment with Prednisolone Actavis has led to reduced placenta and birth weight. Long-term treatment has also been associated with impaired adrenal function in the fetus.
Breast-feeding
Prednisolone Actavis passes into breast milk but is unlikely to affect breastfed infants.
Fertility
Prednisolone Actavis may reduce male fertility.
Driving and using machines
Prednisolone Actavis does not affect your ability to drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Prednisolone Actavis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Prednisolone Actavis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to use Prednisolone Actavis
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Prednisolone Actavis is dosed specifically for you and the dose depends on your illness.
The tablet can be divided into two equal doses.
If you use more Prednisolone Actavis than you should
If you (or someone else) has ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Show any remaining medicines or the empty medicine package to your doctor. Frequently repeated doses for a long time can cause thinning of the skin, swelling of the face, high blood pressure, diabetes, increased hair growth, muscle weakness, mood swings, osteoporosis, and missed periods in women.
If you forget to use Prednisolone Actavis
If you miss a dose, take it as soon as you remember and then take the next dose at the usual time. Never take a double dose to make up for a forgotten dose.
If you stop taking Prednisolone Actavis
If you stop taking the tablets suddenly, you may develop fever, muscle or joint pain, headache, and poor general condition. The disease you were treated for with Prednisolone Actavis can flare up again.
Talk to your doctor before stopping treatment and follow their advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects depend on the dose and the duration of treatment. Most side effects disappear when treatment is stopped and usually weaken if the dose is reduced.
Stop using Prednisolone Actavis and contact a doctor immediately if any of the following serious side effects occur:
Very common (may affect more than 1 user in 10):
High pressure in the eye can cause headaches, nausea, and halo effects (rings around light sources in the dark).
Uncommon (may affect up to 1 in 100 people):
Breathing difficulties
Very rare (may affect up to 1 in 10,000 people), including Has been reported (affects an unknown number of users):
High blood sugar with decreased consciousness or unconsciousness, seizures in people with no previous history of epilepsy, inflammation of the pancreas which causes severe stomach pain and fever after long-term use with high dose, severe skin diseases with rash, skin discharge, blisters, and inflammation, especially on hands and feet and in and around the mouth and fever ( Stevens-Johnson syndrome, toxic epidermal necrolysis ).
Acute renal crisis in patients already suffering from scleroderma (an autoimmune disease). Signs of acute kidney crisis include high blood pressure and decreased urine production.
Other side effects are
Very common (may affect more than 1 user in 10):
Pulmonary abscesses in people with lung cancer, growth retardation in children, decreased number of certain white blood cells, increased risk of infection, difficulty in detecting or aggravating existing infections, signs of impaired adrenal function (headache, nausea, dizziness, anorexia, weakness, emotional changes, apathy, inappropriate stress reactions), osteoporosis during long-term treatment (may be severe), muscle weakness (at high doses ), cataracts (cloudy vision) with long-term treatment, diabetes, high blood sugar (in diabetics).
Common (may affect up to 1 in 10 people):
Deterioration of existing cardiac dysfunction, psychosis, skin changes in the form of red streaks, spots, varicose veins, wounds, rash on the body and face, increased hair growth, Cushing’s syndrome (moon face and increased body fat – at continued high doses ), too low potassium levels ( muscle weakness, general weakness and heart rhythm disturbances that may be severe), missed periods in women, decreased salt secretion, edema, agitation, depression, high blood pressure, worsening symptoms of intestinal inflammation, sweating, urination at night, impaired wound healing ability, cod, fungal or fungal infection skin, increased number of certain white blood cells, increased number of platelets, elevated levels of cholesterol, triglycerides and lipoproteins in the blood (high dose ).
Uncommon (may affect up to 1 in 100 people):
Gastric ulcer and bleeding from the gastrointestinal tract or holes in the intestine when used with non-steroidal anti-inflammatory drugs ( NSAIDs ) such as aspirin or ibuprofen, changes in bone mass, allergic reactions, diabetes (low dose ), insomnia, mood swings, personality changes, mania, mania, kidney stones, elevated levels of cholesterol, triglycerides and lipoproteins in the blood (low dose ).
Rare (may affect up to 1 in 1,000 people):
Increased risk of blood clots, memory loss, formation of adipose tissue in the spinal cord, decreased thyroid function, increased pressure in the eye ( glaucoma ) after long-term treatment, tendon rupture, and decreased reaction to skin tests.
Very rare (may affect up to 1 in 10,000 people), including Has been reported (affects an unknown number of users):
High pressure in the brain (especially in children), heart muscle diseases that cause shortness of breath, feeling of tightness in the chest and tumor light syndrome, stiff posture, changes in the eyes, blurred vision, irregular heartbeat, slow pulse, inflammation of tendons (heel tendons and bursitis ), protruding eyes (long-term treatment), increased production of parathyroid hormones, pheochromocyte-related crisis (high blood pressure, headache, high heart rate, sweating), attacks of porphyria (rare hereditary metabolic disease), heartburn and worsening of existing gastric ulcers.
How to store Prednisolone Actavis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or jar. The expiration date is the last day of the specified month.
2.5 mg:
Do not store above 30 ° C.
5 mg:
Jar: Close the jar tightly. Moisture sensitive.
Blister pack and other strengths:
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is prednisolone
- The tablet also contains lactose monohydrate, pregelatinized starch, sodium starch glycolate (type A), iron oxide yellow (E172), iron oxide red (E172), and glycerol behenate, magnesium stearate.
What the medicine looks like and the contents of the pack
2.5 mg tablet
Yellow, 7 mm, round, flat tablet with a scoreline on one side and marked with “A610” on one side and “2.5” on the other side.
5 mg tablet
White, 7 mm, round, flat tablet with a scoreline on one side and marked with “A620” on one side and “5” on the other side.
10 mg tablet
Red, 7 mm, round, flat tablet with a scoreline on one side and marked with “A630” on one side and “10” on the other side.
25 mg tablet
White, 9 mm, round, flat tablet with a scoreline on one side and marked with “A650” on one side and “25” on the other side.
2.5 mg:
Available in blister packs containing 7, 10, 14, 25, 28, 30, 50, 56, 90, 98, 100 and 105 tablets.
5 mg:
Available in blister packs containing 7, 10, 14, 25, 28, 30, 50, 56, 90, 98, 100 and 105 tablets.
Also available in a jar, with desiccant, containing 25, 100, or 300 tablets.
Other strengths:
Available in jars containing 25 and 100 tablets. The 25 mg tablet is available in a jar of 10 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria