Package leaflet: Information for the user
Methylprednisolon Eurogenerics 4 mg tabletten
Methylprednisolon Eurogenerics 16 mg tabletten
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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Methylprednisolon Eurogenerics is and what it is used for
2.
What you need to know before you take Methylprednisolon Eurogenerics
3.
How to take Methylprednisolon Eurogenerics
4.
Possible side effects
5.
How to store Methylprednisolon Eurogenerics
6.
Contents of the pack and other information
1.
What Methylprednisolon Eurogenerics is and what it is used for
Methylprednisolon Eurogenerics contains methylprednisolone. Methylprednisolone belongs to a group of
medicines called corticosteroids.
Methylprednisolone inhibits local signs of inflammation (fever, swelling, pain, redness) and hypersensitivity
reactions. It also acts on several organs and metabolic processes.
Therefore, it is used to treat a wide range of conditions, including:
- rheumatic conditions of a variety of origins;
- allergic conditions: including hay fever, asthma, drug allergies;
- skin conditions;
- eye conditions of allergic or inflammatory origin;
- certain types of inflammation of the digestive tract;
- certain disorders of the airways;
- certain severe blood diseases;
- abnormal adrenal function;
- organ transplantation.
2.
What you need to know before you take Methylprednisolon Eurogenerics
Do not take Methylprednisolon Eurogenerics:
if you are allergic to methylprednisolone or any of the other ingredients of this medicine (listed in
section 6)
if you have a viral or fungal infection
if you have a gastric or duodenal ulcer
if you have a tropical worm infection
if you are receiving certain vaccines or did receive them in the past 3 months.
Warnings and precautions
1
Your doctor will observe you closely. It is important that you discuss all effects you experience during or
after the treatment with your doctor or nurse.
Regular medical supervision is necessary if:
you belong to one of the special risk groups (see section 4. Possible side effects).
you have had or are currently suffering from tuberculosis, gastrointestinal disorders, a heart condition
or infections.
long-term treatment with this medicine is required.
a shot (vaccination) is absolutely necessary.
Talk to your doctor or pharmacist before taking Methylprednisolon Eurogenerics:
- Certain adrenocorticotropic hormones (glucocorticosteroids), such as methylprednisolone, can mask the
symptoms of an infection. This could also reduce your resistance, making you more susceptible to
infections. Your doctor will pay attention to this.
- If you use medicines that suppress the immune system, you could be more susceptible to infections than
healthy people.
- If you have septic shock. This is a condition caused by an infection that is characterised by a sharp drop
in blood pressure, paleness, restlessness, weak rapid pulse, clammy skin and reduced consciousness.
Routine use of methylprednisolone is not recommended in that case.
- If you have had an allergic reaction to a drug previously. Because the chances of a severe allergic
reaction to methylprednisolone are greater in that case, extra precautionary measures will need to be
taken.
- If you are under heavy stress while using methylprednisolone (such as surgery or an accident), you may
need to receive higher doses.
- If you have Cushing's disease (disease caused by excess levels of the hormone cortisol in the blood).
- If you have reduced thyroid function (hypothyroidism).
- If you have diabetes.
- If you have a disease associated with seizures/convulsions (such as epilepsy).
- If you have a certain type of muscle disease (myasthenia gravis).
- There have been reports of accumulation of fat in the spine with long-term use of corticosteroids.
- If you have a herpes infection of the eye. There is a chance of damage to the cornea during treatment
with methylprednisolone.
- Treatment with corticosteroids can cause the accumulation of fluid under the retina, possibly leading to
detachment of the retina from the eye.
- If you have a pre-existing risk factor for heart and vascular diseases, you may be at an increased risk for
additional heart and vascular conditions with high doses and long-term use of methylprednisolone.
- If you suffer from reduced pumping power of the heart (congestive heart failure).
- When you suffer from or have an increased risk of thrombosis (blood clots within the veins).
- If you suffer from chronic gastroenteritis (nonspecific ulcerative colitis), inflammation of intestinal
pouches (diverticulitis), have recently had a certain type of intestinal surgery (intestinal anastomosis) or
have an ulcer of the digestive tract.
- If you use certain painkillers with inflammation-preventing and fever-reducing effect (NSAIDs).
- If you have an inflammation of the pancreas (pancreatitis) with strong pain in the upper stomach
radiating towards the back, and nausea and vomiting.
- If you have osteoporosis.
- If your kidneys do not work properly (renal insufficiency).
- If you have swelling of the adrenal medulla (pheochromocytoma).
During use of methylprednisolone, you may experience mental disorders, ranging from light-heartedness,
insomnia, irritability, personality change, severe depression and delusions (psychotic symptoms). Existing
mental disorders may also worsen.
Acute muscle disease (myopathy) and Kaposi's sarcoma (a certain form of cancer) could occur.
If methylprednisolone is used in certain eye conditions, your eyes will be checked regularly.
Tell your doctor that you are using this medicine before having a laboratory test.
2
The risk of certain side effects may be increased in the elderly and in children with long-term use.
Talk to your doctor if one of the warnings above applies or has in the past.
Other medicines and Methylprednisolon Eurogenerics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines ,
including medicines obtained without a prescription.
Some medicines may increase the effects of Methylprednisolon Eurogenerics and your doctor may wish to
monitor you carefully if you are taking these medicines. Different medicines can also affect how other
medicines work and/or affect their side effects.
- Isoniazid: used to treat bacterial infections.
- Rifampicin: antibiotic used to treat tuberculosis.
- Substances that counteract blood coagulation (anticoagulants) (oral).
- Barbiturates, carbamazepine and phenytoin used to treat epilepsy.
- Substances used to treat certain nervous system diseases (anticholinergics).
- Substances used for the muscle disease myasthenia gravis (anticholinesterases).
- Substances used to treat diabetes (antidiabetics).
- Aprepitant and fosaprepitant: used to prevent nausea and vomiting.
- Itraconazole and ketoconazole: used to treat fungal infections.
- Substances used to treat HIV infections (cobicistat and protease inhibitors such as indinavir and
ritonavir).
- Aminoglutethimide and cyclophosphamide: used to treat cancer.
- Tacrolimus: substance used following an organ transplant to prevent rejection of the organ.
- Diltiazem: used to treat heart problems or high blood pressure.
- Ethinylestradiol and norethindrone: substances to prevent pregnancy (contraceptives, "the pill").
- Ciclosporin: used to treat conditions such as severe joint inflammation (rheumatoid arthritis), severe
skin conditions associated with scaly, dry skin rashes (psoriasis) and to prevent rejection of a
transplanted organ.
- Clarithromycin, erythromycin and troleandomycin: substances used to prevent/fight certain infections.
- Aspirin (acetylsalicylic acid) and a certain group of painkillers that also have inflammation-preventing
and fever-reducing action (NSAID’s).
- Potassium-lowering substances, such as diuretics and amphotericin B.
Methylprednisolon Eurogenerics with food and drink
Talk to your doctor or pharmacist about drinking grapefruit juice together with methylprednisolone.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use of Methylprednisolon Eurogenerics during pregnancy is generally not advised, unless in consultation
with your doctor. If you become pregnant while using this medicine, you must see your doctor.
Breast-feeding
Corticosteroids pass into breast milk. Therefore, lactation during treatment with corticosteroids is not
recommended, unless this happens in consultation with your doctor.
Fertility
There are no data on the effect of methylprednisolone on fertility.
Driving and using machines
3
The possibility of muscle weakness, muscle atrophy and mood changes should be taken into consideration
when driving and using machines. If you have side effects such as dizziness, visual disorders and fatigue,
you may not drive vehicles or use machines.
Methylprednisolon Eurogenerics contains lactose monohydrate and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3.
How to take Methylprednisolon Eurogenerics
The recommended dose and duration of treatment depend on the condition. Your doctor will determine how
much of this medicine you should use and for how long. Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Methylprednisolon Eurogenerics should be taken with a sufficient amount of water or milk.
The tablets can be divided into equal doses.
If you take more Methylprednisolon Eurogenerics than you should
If you take more Methylprednisolon Eurogenerics than you should, contact your doctor or pharmacist
immediately.
Acute overdose with this medicine does not result in immediately visible signs. However, chronic overdose
does lead to typical symptoms such as moon face, swelling and fluid retention. Your doctor will take
appropriate measures in the event of overdose.
Methylprednisolone is dialysable.
If you forget to take Methylprednisolon Eurogenerics
Contact your doctor. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Methylprednisolon Eurogenerics
Your doctor will tell you how long to use this medicine. Medical supervision is recommended when stopping
long-term treatment and the treatment should be stopped gradually. Your doctor must watch for symptoms of
insufficient adrenal function including weakness, drop in blood pressure when standing up from a lying
position, depressed mood.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported at unknown frequencies, which means that the frequency
cannot be determined based on available data:
Contamination with germs (bacteria, viruses, etc.) (infection)
Infections that are normally rare may occur (opportunistic infections)
Masking of infections, activation of latent infections
Inflammation of the peritoneum (peritonitis)
More white blood cells in the blood than normal (leucocytosis)
Severe allergic reaction to certain substances, involving a sharp drop in blood pressure, paleness,
restlessness, weak rapid pulse, clammy skin and reduced consciousness following a sudden, important
dilation of the vessels (anaphylactic shock)
Hypersensitivity reaction (anaphylactic reaction)
Hypersensitivity to medicines
Appearance of fat growths (head, chest), moon face and high blood pressure (Cushing’s syndrome)
Shortage of one or more pituitary hormones (hypopituitarism)
4
-
-
Steroid withdrawal syndrome
Abnormal ability to tolerate glucose (impaired glucose tolerance)Retention of sodium in the kidney (sodium retention)
Retention of excess fluid in the body (fluid retention)
Increased need for insulin (or oral sugar level-lowering medicines in people with diabetes)
Abnormal fat metabolism (dyslipidaemia)
Increased appetite (which may result in weight gain)
Fat growths (lipomatosis)
Mood disorders such as severe depression, euphoria, emotional lability, psychological dependence,
suicidal thoughts
Mood swings
Abnormal behaviour
Psychotic disorders, such as excess light-heartedness associated with having a great deal of energy
(mania), delusions, observation of things that are not there (hallucinations) and (worsening of) a severe
mental illness (schizophrenia) characterised by a gradual change of personality
Confusion
Mental disorder
Anxiety
Personality change
Insomnia
Irritability
Accumulation of fat in the spine (epidural lipomatosis)
Increased pressure in the brain with swollen mucous membranes (benign intracranial hypertension)
Seizures/fits (convulsions)
Memory loss (amnesia)
Disturbance of cognitive functions such as perception, attention, concentration, memory, orientation,
language use and skills (cognitive disorder)
Dizziness
Headache
Fluid accumulation under the retina (central serous chorioretinopathy)
Cloudy lens (cataract)
Increased pressure inside the eye (glaucoma)
Abnormal bulging of the eye (exophtalmia)
Dizziness (Vertigo)
The pumping power of the heart could be reduced in at-risk patients (congestive heart failure)
Accelerated heart beat (at high doses)
Increased blood pressure (hypertension)
Decreased blood pressure (hypotension)
Persistent hiccups
Ulcer in the digestive tract (peptic ulcer) with possible perforation and bleeding
Stomach bleeding
Bleeding and injury of the intestinal wall (intestinal perforation)
Inflammation of the pancreas with strong pain in the upper stomach radiating towards the back, and
nausea and vomiting (pancreatitis)
Inflammation of the stomach lining (ulcerative oesophagitis)
Inflammation of the oesophagus with or without ulcers (oesophagitis)
Stomach pain (abdominal pain)
Swollen stomach (abdominal distension)
Diarrhoea
Disturbed digestion with a full feeling in the upper stomach, pain in the stomach, burping, nausea,
vomiting and heart burn (dyspepsia)
Nausea
Small spots of bruising in a mucous membrane (ecchymoses)
(Youth) pimples (acne)
5
-
Sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), breathing
difficulties and/or itching and skin rash, often as an allergic reaction (angioedema)
Fluid accumulation in the arms and legs (peripheral oedema)
Small spots of bruising under the skin (petechiae)
Thin, fragile, wrinkly skin (skin atrophy)
Streaks on the skin (striae)
Increased pigmentation of the skin (hyperpigmentation)
Decreased pigmentation of the skin (hypopigmentation)
Excess hair growth in women (hirsutism)
Rash
Redness of the skin (erythema)
Itching (pruritus)
Skin rash with severe itching and formation of bumps (urticaria)
Excess sweating (hyperhidrosis)
Osteoporosis
Muscle weakness
Bone breakdown (osteonecrosis)
Broken bone
Reduction of muscle tissue because a muscle is not used or can no longer be used due to a nervous
system disease (muscle atrophy)
Muscle disease (myopathy)
Chronic joint disease (neuropathic arthropathy)
Joint pain (arthralgia)
Muscle pain (myalgia)
Growth retardation in children
Irregular menstruation
Impaired wound healing
Tiredness
Feeling unwell (malaise)
Reduced potassium level in the blood
Abnormal blood test results (increased alanine aminotransaminase, aspartate aminotransaminase or
blood alkaline phosphatase)
Reduced ability to process sugars (carbohydrates), leading to a possible increased need for insulin or
another substance to reduce blood sugar levels.
Increased calcium level in the urine
Suppression of reactions to skin allergy tests
Increased blood urea
Negative nitrogen balance (due to protein catabolism)
Torn tendons, especially the Achilles tendon.
Sagging spine (spinal compression fracture)
Increase of liver enzymes
Increase of white blood cells
Accumulation of fat tissue on localized parts of the body
Increased clotting of the blood
Disease of the retina and choroid membrane
Rare cases of blindness
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix
V. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Methylprednisolon Eurogenerics
Keep this medicine out of the sight and reach of children.
6
Blister packs: This medicinal product does not require any special storage conditions.
Bottles: Do not store above 30°C.
After first opening (bottles): Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the blister/label and carton after ‘Exp’. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Methylprednisolon Eurogenerics contains
The active substance is methylprednisolone.
The other ingredients are lactose monohydrate, sucrose, sodium starch glycolate (Type A), anhydrous
colloidal silica (E551), magnesium stearate (E572).
What Methylprednisolon Eurogenerics looks like and contents of the pack
Methylprednisolon Eurogenerics 4 mg tablets: White to off white, round, biconvex tablets, plain on both
sides.
Methylprednisolon Eurogenerics 16 mg tablets: White to off white, oval, biconvex tablets, breakline on one
side and embossed ‘16’ on the other side.
Methylprednisolon Eurogenerics 4 mg tablets are available in in blister packs containing 20, 30 or 100
tablets and bottles containing 20, 30 or 100 tablets.
Methylprednisolon Eurogenerics 16 mg tablets are available in blister packs containing 20, 30, 50 or 100
tablets and bottles containing 20, 50 or 100 tablets .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Eurogenerics NV - Heizel Esplanade b22 - 1020 Brussel - België
Manufacturer
Piramal Healthcare UK Litimed - Whalton Road – Morpeth - Northumberland NE61 3YA - Verenigd
Koninkrijk
Millmount Healthcare Limited
 Units 5-7 Navan Enterprise Centre - Trim Road, Co. Meath - Ierland
 Unit 1 Donore Road Industrial Estate – Drogheda - Co. Louth - Ierland
 Block-7 - City North Business Campus – Stamullen - Co. Meath - Ierland
Sanico NV - Veedijk 59 - B- 2300 Turnhout - Belgiê
Eurogenerics NV - Heizel Esplanade B 22 - B-1020 Brussel - België
This medicinal product is authorised in the Member States of the EEA under the following names:
NL: Methylprednisolon Eurogenerics 4 mg – 16 mg tabletten
BE: Methylprednisolone EG 4 mg – 16 mg tabletten
LU: Methylprednisolone EG 4 mg – 16 mg comprimés
In het register ingeschreven onder:
Methylprednisolon Eurogenerics 4 mg tabletten: RVG 116593
Methylprednisolon Eurogenerics 16 mg tabletten: RVG 116594
Deze bijsluiter is voor het laatst goedgekeurd in februari 2017.
7