METHYLPREDNISOLONE ORION 4 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Methylprednisolone Orion 4 mg tablets EFG

methylprednisolone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Methylprednisolone Orion and what is it used for
2. What you need to know before you take Methylprednisolone Orion
3. How to take Methylprednisolone Orion
4. Possible side effects
5. Storing Methylprednisolone Orion
6. Contents of the pack and other information

1. What is Methylprednisolone Orion and what is it used for

Methylprednisolone Orion contains methylprednisolone as the active substance. Methylprednisolone is a corticosteroid that, among other things, reduces the symptoms of inflammation and allergic symptoms.

Methylprednisolone is used, for example, in endocrine, rheumatic, collagen, skin, allergic, eye, gastrointestinal, respiratory, blood, and nervous system diseases, as well as swelling, tumors, and organ transplantation.

Often other medicines are combined with cortisone therapy.

Your doctor will inform you for which disease or symptom this medicine has been prescribed for you.

2. What you need to know before you take Methylprednisolone Orion

Do not takeMethylprednisolone Orion

• if you have a systemic mycosis (infection caused by fungi that affects the whole body)
• if you are allergic to methylprednisolone or other corticosteroids or to any of the other ingredients of this medicine (listed in section 6).

For vaccines, see the "Warnings and precautions" section.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Methylprednisolone Orion if you have:

• a known allergy to the active substance (see also the section "Do not take Methylprednisolone Orion"). Allergic reactions have occurred, in rare cases even life-threatening allergic reactions (anaphylactic shock), related to this medicine. The symptoms can be, for example, constriction of the airways, low blood pressure, difficulty speaking, rapid or weak pulse, bluish discoloration of the skin, lips, and nails, diarrhea, nausea, and vomiting).
• a parasitic infection, or suspect that you may have such an infection.
• a disease caused by an excess of the hormone cortisol in your body (Cushing's syndrome). This medicine may cause it or worsen it.
• an underactive thyroid gland (hypothyroidism), as it may potentiate the effects of this medicine.
• if you have hyperthyroidism (overactive thyroid gland)
• seizures (epilepsy).
• a neuromuscular disease called myasthenia gravis, as it may predispose you to acute generalized myopathy.
• a cardiovascular disease (e.g., heart failure, high blood pressure, recent heart attack) or cardiovascular risk factors (e.g., obesity, high cholesterol levels).
• gastric, duodenal, or esophageal ulcer, inflammatory bowel disease.
• intestinal anastomosis (part of the intestine has been surgically removed).
• blood clots in blood vessels or susceptibility to blood clot formation.
• adrenal gland tumor (pheochromocytoma).
• severe depression, manic depression (bipolar disorder), or psychosis. This includes having suffered from depression or psychosis before or during the use of corticosteroids like methylprednisolone, or having a family history of these diseases.
• scleroderma (also known as systemic sclerosis, an autoimmune disorder) because corticosteroids, including methylprednisolone, may increase the risk of a serious complication called scleroderma renal crisis. The signs of a scleroderma renal crisis include high blood pressure and decreased urine production. Your doctor may advise you to periodically check your blood pressure and urine.

Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps, and stiffness while using methylprednisolone. These can be symptoms of a disease called thyrotoxic periodic paralysis that can occur in patients with hyperthyroidism (overactive thyroid gland) treated with methylprednisolone. You may need additional treatment to alleviate this condition.

Tumor lysis syndrome may occur when corticosteroids are used in the treatment of cancer. Inform your doctor if you have cancer and have symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, irregular heartbeat, vision loss or visual disturbances, and shortness of breath.

Also, inform your doctor if

• you have tuberculosis
• you have diabetes. This medicine may raise blood sugar levels, exacerbate diabetes, or predispose to diabetes with long-term use
• you have a diagnosis of emotional instability or psychosis
• you have kidney disease or kidney failure
• you are suffering from shock due to a severe infection
• you have used this medicine together with acetylsalicylic acid or non-steroidal anti-inflammatory drugs (also called NSAIDs)
• you have symptoms of steroid withdrawal that include loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, skin peeling, muscle pain, weight loss, and/or decreased blood pressure
• you have hepatobiliary disorders
• you have a nervous system disease that causes, for example, numbness, intense fatigue, or muscle weakness
• you have glaucoma (increased intraocular pressure) or if you have a family history of glaucoma
• you have a herpes eye infection
• you have any damage to the optic nerve or cataracts (indicated by lack of vision)
• you have a serious eye disease called central serious retinopathy that causes visual impairment
• you have a head injury.

Muscle symptoms

High doses of corticosteroids can cause a severe muscle disease that affects the whole body and can even cause complete paralysis. Therefore, you should inform your doctor immediately if you experience any symptoms during treatment.

Susceptibility to infections

This medicine may increase your susceptibility to infections or mask the symptoms of infections. To avoid serious consequences due to this, inform your doctor immediately if you experience any symptoms of infection during treatment.

Stress

If you are or will be exposed to exceptionally high stress during treatment, talk to your doctor. It may be necessary to adjust your treatment.

Psychiatric disorders

Psychiatric disorders, such as euphoria, insomnia, mood changes, personality changes, deep depression, or defined psychotic symptoms, may occur or increase in severity due to the use of this medicine. These effects usually appear after a few days or weeks of starting treatment. Such psychiatric effects can also occur when reducing the dose or immediately after stopping treatment. If you have these symptoms, consult your doctor because it may be necessary to adjust your treatment.

Eye symptoms

This medicine can cause various eye disorders, including increased eye pressure. If you experience any eye symptoms, eye infection, or vision disorders (experience blurred vision or other visual disturbances) during this treatment, contact your doctor.

Vaccination

If you receive this medicine in doses that suppress your immune system, you cannot be given any live or attenuated vaccine. Consult your doctor about the vaccines available to you during corticosteroid therapy.

Effects on blood pressure and laboratory values

In rare cases, high doses or long-term use of this medicine may increase blood pressure, increase sodium and water retention in the body (swelling), increase potassium and calcium excretion, or raise blood lipid values. To control these side effects, your doctor may review your diet.

Hormonal effects

Excess corticosteroids in the body, especially in the long term, can cause symptoms of Cushing's syndrome: a fatty hump between the shoulders, a rounded face, and reddish-purple stripes on the skin. Cushing's syndrome can also cause high blood pressure, bone loss, and occasionally diabetes. You will be monitored, and if necessary, your doctor will adjust the treatment.

Long-term use of this medicine can also suppress the adrenal function and cortisol production in your body. Therefore, treatment will be discontinued by gradually reducing the dose. If cortisol production in your body is suppressed, sudden discontinuation of this medicine can cause withdrawal symptoms and even a potentially life-threatening situation with intense vomiting and diarrhea, low blood pressure, and loss of consciousness.

Others

High-dose or long-term treatment with corticosteroids can also cause acute pancreatitis (inflammation of the pancreas), osteoporosis (bone fragility), malignant vascular tumors (Kaposi's sarcoma), or epidural lipomatosis (accumulation of fatty tissue in the spinal canal area).

This medicine increases the risk of tendon rupture when used with antibiotics called fluoroquinolones, especially in elderly patients.

You will be monitored to detect these effects, and if necessary, your doctor will adjust the treatment.

Elderly patients

The common side effects of this medicine may be more severe in elderly patients.

Children

Prolonged use of high doses of this medicine can cause growth and development disorders in children, increased intracranial pressure (symptoms: headache, nausea/vomiting, balance disturbances, decreased consciousness), or pancreatitis (symptom: pain in the upper abdomen). You should carefully observe your child to detect signs and symptoms of these disorders.

Use in athletes:

This medicine contains methylprednisolone, which can produce a positive result in doping tests (see references in section 4.4 of the summary of product characteristics).

Other medicines and Methylprednisolone Orion

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

The efficacy of some medicines or that of methylprednisolone may change or you may experience side effects if you use methylprednisolone and the following medicines concomitantly. Your doctor may closely monitor you if you are taking these medicines:

• antibiotics such as fluoroquinolones, erythromycin, clarithromycin, and troleandomycin (used to treat bacterial infections)
• antifungals such as itraconazole, amphotericin B (used to treat fungal infections)
• ketoconazole except shampoo (used to treat Cushing's syndrome, when the body produces an excess of cortisol)
• medicines such as distigmine and neostigmine (used to treat myasthenia gravis, a muscle disease)
• isoniazid, rifampicin (for the treatment of tuberculosis)
• aprepitant, fosaprepitant (for the prevention of nausea)
• medicines such as diltiazem or mibefradil (for the treatment of coronary artery disease and high blood pressure) or any other medicine for the treatment of high blood pressure
• medicines used for the treatment of heart failure such as digoxin
• certain HIV medicines such as indinavir, ritonavir, and cobicistat
• cyclosporin (to prevent organ transplant rejection)
• estrogen (for contraception or menopausal symptoms)
• oral medicines, e.g., warfarin (to prevent blood clotting)
• antidiabetics (medicines used to treat high blood sugar levels)
• medicines such as tacrolimus (used after organ transplantation to prevent organ rejection)
• medicines such as sirolimus, leflunomide, adalimumab, canakinumab, azathioprine (used to reduce the activity of the immune system)
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs such as ibuprofen (used to treat mild to moderate pain)
• aminoglutethimide (for the treatment of Cushing's syndrome and metastatic breast cancer)
• diuretics also called water pills (for the treatment of a variety of conditions, such as high blood pressure and edema)
• laxatives (used to treat and prevent constipation)
• antiepileptics such as carbamazepine, phenobarbital, phenytoin, and primidone (used to treat epilepsy).

Methylprednisolone may interact with muscle relaxants that may be used during surgical procedures. If you are going to undergo surgery, inform your doctor and nurse well in advance that you are using methylprednisolone.

Taking Methylprednisolone Orion with drinks

You should avoid consuming grapefruit juice during treatment. Grapefruit juice could potentiate the adverse effects of this medicine.

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 for advice before taking this medicine, as it may delay the growth of the baby.

Cataracts have been observed in children born to mothers treated with corticosteroids for a prolonged period during pregnancy.

Only take this medicine during pregnancy and breastfeeding if your doctor considers that the benefit of treatment is greater than the possible risks to the fetus/child.

Corticosteroids pass into breast milk.

Corticosteroid therapy may affect semen quality and may cause amenorrhea (absence of menstruation in women of childbearing age).

Driving and using machines

Side effects such as dizziness, visual disturbances, and fatigue may occur in relation to the use of this medicine. If these occur, do not drive or use machines.

Methylprednisolone Orion contains lactose

Each 4 mg tablet contains 67 mg of lactose (as monohydrate).

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Methylprednisolone Orion

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

The initial doseis determined according to the disease and its severity, and is usually 4-48 mg/day. Higher doses may be used in severe acute diseases.

In long-term treatment, the lowest effective dose is used and is taken preferably on alternate mornings (every other morning).

Use in children

For children, the lowest possible doses and short treatment periods are recommended.

It is possible that your doctor has prescribed a different dose than those indicated here. Always follow the instructions of your doctor.

The tablet can be divided into equal doses.

If you takemore Methylprednisolone Orion than you should

An overdose of methylprednisolone is unlikely to cause serious effects. Chronic overdose may suppress the production of cortisol in your body (adrenal insufficiency).

If you accidentally take (or someone takes) a dose that is too high, contact your doctor.

In case of overdose, you will receive treatment to alleviate the symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

Carry this leaflet and the remaining tablets with you if you need medical attention.

If you forget to takeMethylprednisolone Orion

Take the missed dose as soon as possible. Do not take a double dose to make up for missed doses.

Before going on vacation or traveling, make sure you have enough medicine.

If you stop taking Methylprednisolone Orion

Do not stop treatment with methylprednisolone without consulting your doctor. Abrupt discontinuation of this medicine can cause withdrawal symptoms, which include loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, skin peeling, muscle pain, weight loss, and/or decreased blood pressure. To reduce the risk of such symptoms, treatment will be discontinued by gradually reducing the dose.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. The duration of treatment and the dose used will affect the appearance of adverse effects.

If you suffer a severe allergic reaction with or without a drastic drop in blood pressure, cardiac arrest, and bronchospasm (tension of the muscle of the airways that causes wheezing), stop taking this medicine and contact a doctor, health center, or hospital immediately.

Frequent (may affect up to 1 in 10 people):

• infection
• inhibition of the body's own corticotropin hormone and cortisol secretion (with long-term use)
• rounding of the face and weight gain
• accumulation of sodium and fluid in the body
• depressed mood, euphoric mood
• cataract (indicated by loss of vision)
• high blood pressure
• gastric, duodenal, or throat ulcer (which can perforate and bleed)
• inflammation in the limbs
• bruises, thinning, and fragility of the skin, acne
• osteoporosis
• muscle weakness
• impairment of wound healing
• constipation, fatigue, muscle weakness, cramps, and spasms due to low potassium levels in the blood.

The following adverse effects have also been reported:

Unknown frequency (frequency cannot be estimated from available data):

• severe metabolic disorders (tumor lysis syndrome) related to the initiation of cancer treatment
• raised brown/purple/red patches on the skin or inside the mouth (Kaposi's sarcoma)
• increased white blood cells, e.g., when you have an infection or an allergic reaction
• severe allergic reactions
• increased pressure inside the skull (accompanied by inflammation of the optic nerve), seizures, memory loss, loss of intellectual ability, dizziness, headache
• abnormal heart rhythm, heart failure (in susceptible patients), heart rupture after a heart attack, low blood pressure, arterial embolism (a sudden interruption of blood flow to an organ or part of the body due to a blood clot)
• bone fractures due to poor blood circulation, fractures, decreased muscle size, acute muscle disease, joint disorder (neuropathic arthropathy), joint pain, muscle pain
• increased liver enzymes
• lipid metabolism disorders (e.g., accumulation of fatty tissue in localized parts of the body)
• increased blood coagulation
• eye disorders (disease of the retina and inner membrane of the eye, bulging eyes, glaucoma, increased pressure in the eye, thinning of the transparent part of the front of the eye (cornea) or the white part of the eye (sclera)), blurred vision
• opportunistic infection (when the body's immune system is impaired)
• hypopituitarism
• steroid withdrawal syndrome
• increased appetite
• increased blood urea level
• higher blood sugar levels and increased need for insulin or hypoglycemic medications, hormones, or medications that regulate blood sugar levels
• a pathological condition resulting from the accumulation of base or loss of acid in the body, associated with a low serum potassium level
• too much acid accumulated in the body (metabolic acidosis)
• greater nitrogen output than input (negative nitrogen balance)
• mood changes, psychological dependence, suicidal thoughts, psychotic disorders, confusion, anxiety, mental health disorders, altered personality, abnormal behavior, insomnia, irritability
• pulmonary embolism (blood clots in the lungs), symptoms include sudden acute chest pain, shortness of breath, and coughing up blood
• stomach bleeding, hole in the intestines, pancreatitis, inflammation of the stomach lining, esophagitis, with or without ulcers, stomach pain, stomach swelling, diarrhea, digestive problems, nausea
• acute and painless blisters on the skin or swelling of the underlying tissues (angioedema), small blood spots under the skin, a vascular lesion formed by the dilation of a group of small blood vessels (telangiectasia), stretch marks, various skin colors (hypopigmentation or hyperpigmentation of the skin), excessive growth of facial or body hair in women, skin rash, skin redness, itching, slightly raised areas of the skin, excessive sweating
• irregular menstruation
• fatigue, feeling of general malaise
• altered sugar and starch tolerance
• increased calcium level in the urine
• suppressed skin test reactions
• tendon rupture (especially in the Achilles tendon), spinal fracture (vertebral fractures)
• pheochromocytoma crisis: a serious condition that can occur in patients with an adrenal gland tumor. Symptoms include very high blood pressure, heart attack, rapid or irregular heartbeats, headache, abdominal or chest pain.
• scleroderma renal crisis in patients who already suffer from scleroderma (an autoimmune disorder). Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.

Isolated cases of so-called "post-steroid paniculitis" have been reported in association with treatment discontinuation. According to reported cases, the red, firm, and burning subcutaneous nodules that appear approximately two weeks after treatment discontinuation disappear spontaneously.

The following adverse effects may also occur during therapy with corticosteroids: increased tendency to coagulate, elevated lipid levels in the blood, increased risk of atherosclerosis (hardening and narrowing of the arteries), vasculitis (red, swollen, and painful blood vessels due to inflammation). Corticosteroid therapy may affect semen quality and cause absence of menstruation.

Elderly people are more susceptible than other adults to certain adverse effects of the product, such as gastric ulcers, osteoporosis (bone fragility), or skin atrophy.

In long-term treatment, adverse effects can be reduced by using the lowest effective dose and taking the dose on alternate mornings.

Other Adverse Effects in Children

The most common adverse effects in children are mood changes, abnormal behavior, insomnia, and irritability. This medicine can also cause growth retardation.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Methylprednisolone Orion

Store below 25°C.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Methylprednisolone Orion

• The active ingredient is methylprednisolone.
• Each tablet contains 4 mg of methylprednisolone.
• The other ingredients are lactose monohydrate, cornstarch, gelatin, magnesium stearate, and talc.

Appearance of the Product and Package Contents

White or almost white, round, flat tablet with beveled edges and a score line. The diameter of the 4 mg tablet is 7 mm.

Package sizes: 10, 20, 30, 50, and 100 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Orion Pharma, S.L.

Avenida Alberto Alcocer 46B

28016 Madrid

Phone: +349 159 9 86 01

Date of the Last Revision of this Leaflet:March 2025

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/