5 mg tablets
prednisolone

What Prednisolone EQL Pharma is and what it is used for

Prednisolone EQL Pharma 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.

Prednisolone contained in Prednisolone EQL Pharma 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 using Prednisolone EQL Pharma

Do not use Prednisolone EQL Pharma

  • 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 using Prednisolone EQL Pharma 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
  • Or have had seizures
  • Myasthenia gravis (a disease that causes muscle weakness)
  • Tuberculosis or has ever been treated for tuberculosis
  • Gastric ulcer, duodenal ulcer, or an inflammatory bowel disease (eg ulcerative colitis or diverticulitis )
  • Diabetes
  • Heart disease. for example heart failure or high blood pressure
  • Have had blood clots before (eg venous thrombosis ) or are prone to blood clots
  • Mood swings or psychotic tendencies
  • Some drug allergy
  • Osteoporosis _ _
  • Newly constructed blood vessels or intestinal connectionsAdrenal tumor ( pheochromocytoma )
  • 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 increased blood pressure and decreased urine production. Your doctor may advise you to check your blood pressure and urine levels regularly. 

Contact a doctor if you during treatment

  • Gets 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 the 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 EQL Pharma

Tell your doctor or pharmacist if you have recently taken or might be taking other medicines.

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 (used to treat tuberculosis )

– blood-thinning drugs (drugs that affect the blood’s ability to coagulate)

– carbamazepine, phenobarbital, phenytoin (antiepileptic drugs )

– 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 medicines in the form of tablets. Cortisone preparations may impair the blood sugar lowering effect of diabetes medicines.

– cobicistat (anti-HIV drug)

– estrogen (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 EQL Pharma.

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

There is a risk that the fetus is affected.

Breast-feeding

Prednisolone EQL Pharma 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 prednisone. If you get such symptoms, do not drive or use any 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 EQL Pharma 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 EQL Pharma

Always use 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 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 has a score line on one side and can be divided into two equal doses.

If you use more Prednisolone EQL Pharma 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 use Prednisolone EQL Pharma

Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.

If you stop using Prednisolone EQL Pharma

If you have been taking Prednisolone EQL Pharma 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 EQL Pharma. 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 EQL Pharma.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Prednisolone EQL Pharma 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 side effects ( may affect up to 1 in 10 people) :

  • Infection, the immunosuppressive effect of prednisolone can also cause the 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
  • Thinner skin, impaired wound healing
  • Muscle loss

Uncommon side effects (may affect up to 1 in 100 people):

  • Activation of mental disorder (at high doses )
  • Cataract
  • Cataract

Rare side effects ( may affect up to 1 in 1,000 people):

  • Depression
  • Mania in patients without a previous mental illness
  • The benign pressure increase in the skull
  • Degradation of bone tissue
  • Tendon rupture

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, 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 change, confusion, anxiety, mood swings, abnormal behavior, sleep problems, irritability
  • Seizures, memory problems, intellectual disorders, dizziness, headache, increased fat around the spinal cord
  • Visual impairment (central serous chorioretinopathy), protruding eyes, blurred vision
  • Heart failure (in sensitive patients)
  • 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, reddened 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, feeling sick
  • 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 EQL Pharma

Keep this medicine out of the sight and reach of children.

Blister pack: Do not store above 25 ° C.

Jar: No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton, label, and blister after “EXP:”. 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 5 mg.
  • The other ingredients are:
    Lactose monohydrate
    Maize starch
    Magnesium stearate

What the medicine looks like and the contents of the pack

White, round, flat tablet with a diameter of 7 mm.

PVC / PVdC / aluminum blister pack: 25 tablets.

HDPE jar with PP screw cap and safety seal: 105 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

EQL Pharma AB

Stortorget 1

222 23 Lund

info@eqlpharma.com

Manufacturer

Balkanpharma-Razgrad AD

68, Aprilsko, Vastanie Blvd

Razgrad

Bulgaria

Muhammad Nadeem

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