2.5 mg, 5 mg and 10 mg tablets
prednisolone
What Prednisolone Alternova is and what it is used for
Prednisolone Alternova is a cortisone preparation that counteracts and alleviates allergic problems, inflammation, and rheumatic problems.
The drug is used in conditions where you need to dampen the body’s reaction, such as the inflammatory reaction in rheumatoid arthritis ( rheumatoid arthritis ). Other examples that can be mentioned are connective tissue disease ( SLE ), inflammation of the vessel walls, connective tissue changes, asthma, severe inflammation of the colon ( ulcerative colitis ), certain blood diseases, severe allergic conditions, and tumor treatment.
The prednisolone contained in Prednisolone Alternova may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 take Prednisolone Alternova
Do not take Prednisolone Alternova:
- 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.
You should not be vaccinated with a live vaccine while taking an immunosuppressive dose of cortisone.
Warnings and cautions
Talk to your doctor or pharmacist before taking Prednisolone Alternova if you have:
- an infection or getting an infection while being treated with prednisolone
- underactive thyroid gland (also called hypothyroidism )
- liver disease or kidney failure
- had seizures
- myasthenia gravis (a disease that causes muscle weakness)
- tuberculosis or has ever been treated for tuberculosis
- gastric ulcer, if you have a duodenal ulcer or inflammatory bowel disease (eg ulcerative colitis or diverticulitis )
- diabetes
- heart disease, e.g. heart failure or high blood pressure
- a mental illness
- have had blood clots before (eg venous thrombosis ) or are prone to blood clots
- mood swings or psychotic tendencies
- any drug allergy
- osteoporosis _ _
- an adrenal tumor ( pheochromocytoma )
- newly constructed blood vessels or intestinal connections
- 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.
Contact a doctor during treatment:
- get serious psychological side effects, e.g. depression and suicidal thoughts. These can also occur when you stop taking prednisolone.
- experiencing blurred vision or other visual disturbances.
- exposed to an unusually severe physical or mental strain of any kind (eg infection, surgery, trauma) while you are being treated with prednisolone. Dose one may need to be increased.
Prednisolone treatment can reduce your resistance to infection, making it easier for you to become infected during treatment. Chickenpox and measles can become more serious when taking cortisone preparations. If you have not had these diseases before, you should therefore avoid exposure to chickenpox or measles during treatment and talk to a doctor if this should happen anyway.
If you need to be vaccinated during prednisolone treatment, tell your doctor about your treatment before getting vaccinated.
Corticosteroids can cause growth retardation in infants, children, and adolescents and long-term use should therefore be avoided. If long-term use is necessary, the growth of infants and children will be closely monitored by your doctor.
Other medicines and Prednisolone Alternova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
The treatment effect may be affected if this medicine is taken at the same time as certain other medicines. Your doctor must tell you if you are taking any of the following medicines:
- rifampicin, isoniazid (a medicine used to treat tuberculosis )
- blood-thinning drugs (drugs that affect the blood’s ability to coagulate).
- phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines )
- anticholinergics (drugs that counteract the effect of the body’s substance acetylcholine , used to treat eg Parkinson’s disease and asthma )
- cholinesterase inhibitors (used to treat myasthenia gravis and Alzheimer’s disease )
- insulin and diabetes drugs in the form of tablets. Cortisone preparations may impair the blood sugar lowering effect of diabetes medicines.
- cobicistat (medicines for HIV – infection )
- estrogen er (used in birth control pills, among other things )
- acetylsalicylic acid and other non-steroidal anti-inflammatory drugs ( NSAIDs ) (used to treat pain and inflammation ). The risk of stomach ulcers may increase when combined with cortisone preparations.
- thiazides, furosemide , ethacrynic acid (potassium lowering diuretics )
- xanthines (eg theophylline, used to treat asthma )
- beta-2-stimulators (eg salbutamol, terbutaline, salmeterol , formoterol, used to treat asthma )
- amphotericin B ( antibiotics for fungal infection).
If you need to be vaccinated, tell your doctor that you are taking Prednisolone Alternaova.
Your doctor may want to monitor you closely if you are taking these medicines.
Pregnancy and breastfeeding
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
There is a risk that the fetus is affected.
Breast-feeding
Prednisolone Alternova passes into breast milk but is unlikely to affect breastfed infants.
Driving and using machines
Dizziness, visual disturbances, and fatigue may occur with the use of prednisolone. If you get such symptoms, do not 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 Alternova 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.
How to use Prednisolone Alternova
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
Usually, the treatment is started with a higher dose which is then reduced to a certain maintenance dose when a satisfactory effect is obtained. When the treatment is to be stopped, the dose should be slowly reduced to eventually stop completely.
Do not stop treatment without consulting a doctor.
Doctors should be contacted in the event of stress such as fever and stress as dose changes may be necessary.
The tablet can be divided into two equal doses. The division of the 2.5 mg and 5 mg tablets can be done by placing the tablet on a flat surface with the notch facing up. Then divide the tablet by pressing down with one thumb on each side of the dividing slot.
The tablet should be swallowed with water. Do not crush, chew or dissolve in water.
If you take more Prednisolone Alternova than you should
If you have 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.
If you forget to take Prednisolone Alternova
Do not take a double dose to make up for a forgotten dose.
If you stop taking Prednisolone Alternova
If you have been taking Prednisolone Alternova for a long time, the treatment must be phased out according to your doctor’s instructions. It must not be stopped suddenly, as it can lead to severe side effects.
“Steroid withdrawal syndrome” may occur after abrupt discontinuation of Prednisolone Alternova. This syndrome includes symptoms such as loss of appetite, nausea, vomiting, fatigue, headache, fever, joint pain, flaky skin, muscle aches, weight loss, and/or low blood pressure. Contact your doctor if you experience any of these symptoms after stopping Prednisolone Alternova.
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.
Side effects occur mainly with long-term treatment but also depend on dose size and individual sensitivity.
Contact a doctor immediately if the following serious side effects occur:
Severe allergic reaction, including angioedema
(occurs in an unknown number of users).
Symptoms may include:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
- fever
- drop in blood pressure
Pheochromocytosis-related crisis (occurs in an unknown number of users).
Symptoms may include:
- attack headache
- palpitation
- sweating
- pallor
Acute renal crisis (in patients already suffering from scleroderma, an autoimmune disease, see section 2, Warnings and precautions) (occurs in an unknown number of users).
Symptoms may include:
- high blood pressure and decreased urine production
Suicidal ideation (see section 2, Warnings and precautions) (occurs in an unknown number of users).
Other side effects:
Common (may affect up to 1 in 10 people):
- infection, the immunosuppressive effect of prednisolone may also cause your infection to flare up again (eg tuberculosis )
- lower concentration of certain hormones, Cushing-like appearance, growth retardation in children
- low levels of potassium, accumulation of sodium in the body, elevated blood sugar and urine levels, osteoporosis
- swelling due to fluid retention, high blood pressure
- skin thinning, impaired wound healing
- muscle wasting
Uncommon (may affect up to 1 in 100 people) :
- glaucoma
- cataract
- increased tendency for blood clots
- at high doses your activation of mental disorder
Rare (may affect up to 1 in 1,000 people ):
- the benign pressure increase in the skull
- degradation of bone tissue, tendon rupture
- Depression
- mania in patients without a previous mental illness
Has been reported (occurs in an unknown number of users):
- increased white blood cell count ( leukocytosis )
- hypersensitivity to the drug
- withdrawal syndrome during tapering (see section 3)
- decreased pH in the blood, decreased amount of potassium in the blood, increased blood fats, impaired glucose tolerance, impaired diabetes, accumulation of adipose tissue in secreted places in the body, and increased appetite (which can lead to weight gain)
- emotional symptoms (such as elation, emotional instability, drug dependence), mental disorders (such as delusions, hallucinations, and schizophrenia), personality changes, confusion, anxiety, mood swings, abnormal behavior, sleep problems, irritability
- seizures, memory problems, intellectual disorder, dizziness, headache, increased fat around the spinal cord
- visual impairment (central serous chorioretinopathy), protruding eyes, blurred vision
- heart failure (in sensitive patients), slow pulse
- blood clots
- hiccup
- gastric ulcer, perforation in the intestine, inflammation of the pancreas, inflammation, and ulcers in the esophagus, swollen abdomen, abdominal pain, diarrhea, digestive problems, nausea
- increased hair in women, bleeding in the skin, bruising, reddening of the skin, sweating, stretch marks (blue-red marks on the chest and abdomen), itching, hives , acne
- muscle weakness, muscle aches, bone fractures without previous trauma, joint breakdown, joint pain
- irregular menstruation
- fatigue, malaise
- the increased amount of calcium in the urine; elevated liver values ( alanine aminotransferase, aspartate aminotransferase ), elevated alkaline phosphatase in the blood, elevated blood urea (seen in blood samples), and weaker reaction to skin tests.
How to store Prednisolone Alternova
2.5 and 5 mg: Do not store above 30 ° C.
10 mg: No special storage instructions.
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 and blister. The expiration date is the last day of the specified month.
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 2.5 mg, 5 mg, and 10 mg respectively per tablet.
- The other ingredients are Magnesium stearate, gelatin, talc, lactose monohydrate, and potato starch.
What the medicine looks like and the contents of the pack
Appearance
2.5 mg: Diameter 6 mm, white, round, flat tablet with a scoreline on one side. The tablet can be divided into two equal doses.
5 mg: Diameter 8 mm, white, round, flat tablet with a scoreline on one side. The tablet can be divided into two equal doses.
10 mg: Diameter 10 mm, white, round, convex tablet with a scoreline on one side. The tablet can be divided into two equal doses.
Pack sizes
2.5 mg:
Blister (PVC / PVDC / Alu.): 25, 49 x 1 (single dose) and 100 tablets.
Tablet jar (HDPE): 25, 100, 105, 200 and 300 tablets.
5 mg:
Blister (PVC / PVDC / Alu.): 25, 49 x 1 (single dose), 50 and 100 tablets.
Tablet jar (HDPE): 25, 50, 100, 105, 200 and 300 tablets.
10 mg:
Blister (PVC / PVDC / Alu.): 25, 49 x 1 (single dose) and 100 tablets.
Tablet jar (HDPE): 25, 100 and 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark
Manufacturer
Viminco A / S, Lodshusvej 11, 4230 Skælskør, Denmark