Methylprednisolone Hikma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Methylprednisolone Hikma 40 mg, 125 mg, 500 mg and 1000 mg

Powder for injectable solution
Generic Medicine
Please read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What Metilprednisolone Hikma is and what it is used for

Metilprednisolone is the active substance in Metilprednisolone Hikma powder for
injectable solution.
Metilprednisolone Hikma contains Metilprednisolone Sodium Succinate.
Metilprednisolone belongs to a group of medicines called corticosteroids (steroids).
Corticosteroids are naturally produced in your body and are important for many bodily functions.
Stimulating your body with additional corticosteroids, such as Metilprednisolone Hikma, can be helpful following surgery (e.g., organ transplantation), during relapses of multiple sclerosis symptoms, and in other stress conditions.
Metilprednisolone may be used to treat the following conditions:

Allergic conditions:

• Bronchial asthma
• Acute non-infectious swelling of the throat
• Severe perennial allergic rhinitis
• Swelling of the mouth, tongue, and trachea that may cause breathing difficulties (angioneurotic edema)
• Severe allergic reaction (anaphylaxis)

Skin disorders:

• Severe inflammatory skin diseases

Critical phases of gastrointestinal disorders:

• Inflammation of the colon and inflammation of the small intestine (Crohn's disease)

Neurological disorders:

• In some cases of cerebral edema, acute spinal cord trauma, worsening or relapse of multiple sclerosis

Respiratory disorders:

• Aspiration of gastric contents
• Severe inflammatory lung diseases

Other disorders:

• In some cases of meningitis caused by the tuberculosis-causing pathogen
• To reduce immune system reactions in organ transplantation

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Metilprednisolone Hikma

Do not take Metilprednisolone Hikma:

• if you are allergic to methylprednisolone (or to any other corticosteroid) or to any of the other ingredients of this medicine (listed in section 6).
• if you have a fungal infection at a site other than the skin that is not being treated.
• if you have had fever, seizures, or loss of consciousness related to malaria (cerebral malaria).
• if you have had a head injury or stroke.

In addition to the above, do not use Metilprednisolone Hikma 40 mg:

• if you are allergic or suspect you may be allergic to cow's milk.

Warnings and precautions
Talk to your doctor or nurse before using Metilprednisolone Hikma.
Contact your doctor or nurse immediately if any of the following situations apply to you:

• If you have never had chickenpox, measles, shingles, or an eye infection caused by herpes. If you develop any of these conditions while taking methylprednisolone, they could become very serious. If you are not immune, or if you are the parent of a child taking this medicine, avoid close contact with anyone who has these infections. Contact your doctor immediately if you think you have been exposed to any of these infections or if a member of your family develops one of them.
• If you are taking digoxin (a medicine for heart failure).

You must inform your doctor before being administered Metilprednisolone Hikma if you have:

• fragile bones (osteoporosis) or if you are a postmenopausal woman
• mood disorders, either currently or in the past, including severe depression, manic depression (bipolar disorder), or problems such as delusions, hallucinations, or disorganized speech after taking steroids
• high blood pressure (hypertension)
• weakened heart muscle (heart failure)
• a recent heart attack
• diabetes, either yourself or a close family member. If you have diabetes, you must carefully monitor your blood sugar levels during treatment with methylprednisolone
• tuberculosis, either currently or in the past
• glaucoma, either yourself or a close family member
• muscle pain or weakness after previous treatment with corticosteroid medicines
• liver problems such as jaundice
• poor kidney function
• epilepsy
• ulcer in the small intestine
• recent fistula (abnormal connections within the intestine)
• ulcerative colitis and diverticulitis (intestinal disorders)
• inflammation and blood clots in the veins of the legs (thrombophlebitis)
• skin abscesses
• myasthenia gravis (a debilitating muscle disease)
• underactive thyroid gland (hypothyroidism)
• Kaposi's syndrome (a type of skin cancer).

Contact your doctor if you experience blurred vision or other visual disturbances.
Metilprednisolone Hikma 40 mg contains milk proteins.
If you are allergic or suspect you may be allergic to cow's milk, you must not take this medicine as it may contain traces of cow's milk proteins. Severe allergic reactions have been reported in patients allergic to cow's milk.
Before undergoing any surgery, inform your doctor, anaesthetist, or dentist that you are taking methylprednisolone, as your body's response to stress is reduced.
Inform your doctor that you are taking methylprednisolone if you are due to have any medical test, whether performed by your general practitioner or in hospital, as this medicine may affect test results.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Metilprednisolone Hikma
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may be harmful when taken together with methylprednisolone, or they may alter the way methylprednisolone or other medicines work. Your doctor may need to adjust the dose of your medicines if you are taking other medicines.
Some medicines may increase the effects of Metilprednisolone Hikma, and your doctor may wish to monitor you closely if you are taking any of these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
Inform your doctor or nurse if you are taking any of the following medicines:

• acetazolamide for glaucoma, epilepsy, and fluid retention
• aminoglutethimide for Cushing's syndrome and breast cancer
• antibiotics: rifampicin, rifabutin, troleandomycin, or erythromycin
• anticoagulants such as warfarin, acenocoumarol, and phenindione used to thin the blood. Your doctor may request blood tests to ensure your blood clotting is normal
• aspirin, sodium salicylate, and non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen, and diclofenac used to treat mild to moderate pain
• carbamazepine for epilepsy, pain, and manic depression
• antipsychotics
• carbenoxolone for stomach ulcers and heartburn
• cyclosporine to prevent organ rejection
• cimetidine for stomach ulcers and heartburn
• diltiazem and mibefradil for heart and circulation problems such as hypertension and angina
• digoxin and similar cardiac glycosides
• diuretics for fluid retention such as hydrochlorothiazide, furosemide, and ethacrynic acid
• methotrexate
• insulin and other diabetes medicines such as metformin. If you have diabetes, you must monitor your blood sugar levels more closely when using methylprednisolone
• ketoconazole and itraconazole for fungal infections
• salbutamol
• medicines for high blood pressure such as lisinopril and losartan
• pancuronium or other medicines used for muscle relaxation during surgical operations and dental extractions
• phenobarbital, phenytoin, and primidone for epilepsy
• pyridostigmine and neostigmine for myasthenia gravis
• vaccinations: inform your doctor before receiving live vaccines such as the polio vaccine if you are currently using or have recently used corticosteroids, as there is a risk of infections and poor immune response to the vaccine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine.
This medicine will only be administered during pregnancy and breastfeeding if your doctor considers that the benefit of treatment outweighs the potential risks to the embryo/fetus or newborn.
It has not been shown that corticosteroids affect fertility.

Metilprednisolone Hikma contains sodium
Each vial of Metilprednisolone Hikma 40 mg contains less than 1 mmol of sodium (23 mg) per 40 mg, i.e., it is essentially "sodium-free".
Each vial of Metilprednisolone Hikma 125 mg contains less than 1 mmol of sodium (23 mg) per 125 mg, i.e., it is essentially "sodium-free".
Each vial of Metilprednisolone Hikma 500 mg contains 53.18 mg of sodium per 500 mg.
Each vial of Metilprednisolone Hikma 1000 mg contains 167.59 mg of sodium per 1000 mg.
Inform your doctor if you are on a low-sodium (salt) diet, as your sodium intake may need to be adjusted.

3. How to use Metilprednisolone Hikma

The recommended dose is:
Adults
The initial dose is generally 10–500 mg, depending on the condition being treated. Higher doses may be required for the short-term management of severe acute conditions. The initial dose up to 250 mg should be administered intravenously as a bolus over a period of at least 5 minutes. Doses exceeding 250 mg must be administered by infusion over a period of at least 30 minutes.
Elderly
You will receive the same treatment as younger adults, although your doctor may decide to monitor more closely for any adverse effects of the treatment (see section 4).
Use in children
During infancy, childhood, and adolescence, corticosteroids may cause growth retardation. This effect may be irreversible. The doctor must limit treatment to the lowest possible dose for the shortest possible duration.
If you use more Metilprednisolone Hikma than you should
If you think you have been given too many injections, contact your doctor immediately.
If you stop treatment or reduce the dose of Metilprednisolone Hikma
Your doctor will decide the appropriate time to stop treatment.
The dose should be reduced gradually if:

• you have been treated with corticosteroid injections for more than 3 weeks
• less than a year has passed since you stopped long-term treatment (months or years) with corticosteroid tablets
• you have Addison’s disease or conditions in which the adrenal glands do not produce enough natural corticosteroids
• you have received treatment with more than 32 mg of methylprednisolone per day
• the injections were administered in the evening.

It is important to reduce the dose gradually to avoid withdrawal symptoms.
Withdrawal symptoms may include:

• skin itching
• sweating
• fever
• muscle and joint pain
• runny nose
• sticky eyes
• weight loss.

If your symptoms return or worsen due to dose reduction, inform your doctor immediately.
Mental health problems during use of Metilprednisolone Hikma
Mental health problems may occur when taking steroids such as methylprednisolone (see also section 4). Corticosteroids, especially at high doses, may affect mood and behaviour. Some patients become confused, irritable, and may experience delusions and suicidal thoughts, particularly at the beginning of treatment. This is especially true if you have previously suffered from or are susceptible to mental disorders. These effects may also occur when stopping treatment with methylprednisolone.
Contact your doctor if you or someone close to you is concerned about psychological changes.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
Metilprednisolone Hikma is used to treat conditions that may worsen if not
adequately treated. Side effects are more common at high doses or during
prolonged treatment. Your doctor will prescribe the lowest effective dose for the shortest
possible time to minimize side effects. Please consult your doctor if
you need further information.
Serious side effects
Seek immediate medical attention if you experience any of the following
symptoms:

• Sudden, life-threatening allergic reaction (anaphylaxis) with symptoms such as rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing
• Infections, which may be more severe and frequent, although symptoms may be less evident
• Stomach ulcers that may lead to perforation and bleeding. Symptoms include stomach pain, black tarry stools, or vomiting blood
• Acute pancreatitis causing severe abdominal and back pain.
• Increased intracranial pressure (pseudotumor cerebri) in children, usually after discontinuation of methylprednisolone treatment. Symptoms include headache, vomiting, lack of energy, and drowsiness.
• Blood clots in the veins (thromboembolism), which may cause pain, tenderness or swelling in one leg; or pulmonary clots with symptoms such as sudden sharp chest pain, shortness of breath, and coughing up blood.
• Heart failure in pumping blood properly, causing severe breathlessness and swelling of the ankles (congestive heart failure)

Other side effects
Inform your doctor if any of the following side effects worsen:
Effects on the haematopoietic system:

• Increase in white blood cells (this adverse effect has been reported with unknown frequency, i.e. frequency cannot be estimated from the available data).

Effects on the gastrointestinal system:

• Indigestion, bloating, fungal infections or ulcers in the oesophagus
• Feeling unwell, nausea, vomiting and bad taste in the mouth
• Methylprednisolone may damage the liver. Cases of hepatitis and increased liver enzymes have been reported (these adverse effects have been reported with unknown frequency, i.e. frequency cannot be estimated from the available data).

Effects on the immune system:

• Increased susceptibility to infections
• Some skin tests may give abnormal results and inactive tuberculosis may reactivate.

Effects on bones, muscles and joints:

• Weakness of shoulder and hip muscles
• Thinning of bones (osteoporosis) and bone fractures, especially in the spine, arms and legs. Bone thinning generally requires additional treatment (particularly if you are a woman over 60 years of age) to prevent breaks and fractures.
• Reduced blood supply to bones at joint level may cause knee and hip pain.
• Tendon rupture in muscles causing pain or swelling.

Effects on kidney function:

• Fluid and sodium retention, potassium loss, possibly leading to abnormal alkalinity of the blood, which in rare cases may cause congestive heart failure (see serious side effects).

Effects on the skin:

• Development of light and dark patches on the skin
• Slow wound healing, pinpoint spots under the skin, bruising, redness, thinning of the skin, stretch marks, acne. Kaposi's sarcoma (a type of skin cancer). These effects may improve if the dose of the medicine is reduced.

Hormonal effects:

• Reduced activity of the hypothalamus, pituitary gland and adrenal glands, which control responses to stress, digestion, immune system and emotions
• Slowed growth in newborns and children
• Menstrual cycle disturbances
• Rounded face ("moon face") typical of Cushing's syndrome
• Excessive hair growth
• Reduced ability to digest sugars and starches, increasing the need for diabetes medication
• Muscle and bone weakness
• Increased appetite and weight gain.

Effects on metabolism and nutrition:

• Accumulation of fatty tissue in specific body areas.

Mental state changes:
Steroids, including methylprednisolone, can cause serious mental health
problems. These reactions are common in both adults and children. Approximately one in twenty adults may be severely affected.

• Mood changes such as irritability, extreme happiness (euphoria), depression, and sudden mood swings, including withdrawal symptoms such as anxiety.
• Suicidal thoughts
• Delusions, hallucinations, mania, worsening of schizophrenia
• Behavioural disorders, sleep disturbances, seizures (convulsions)
• Cognitive impairment including confusion and memory loss.

Eye-related effects:

• Increased intraocular pressure, glaucoma
• Swelling of the optic nerve with possible damage
• Blurred vision (this adverse effect has been reported with unknown frequency, i.e. frequency cannot be estimated from the available data) or difficulty seeing (cataract), thinning of the cornea and whites of the eyes
• Worsening of existing viral or fungal eye infections
• Retinal and choroidal membrane disease (this adverse effect has been reported with unknown frequency, i.e. frequency cannot be estimated from the available data).

Effects on the heart, lungs and blood circulation:

• Rupture of heart muscle following heart attack
• High blood pressure which may cause headache or general malaise
• Sudden drop in blood pressure leading to collapse
• Heart attack
• Irregular heartbeat
• Increased levels of white blood cells in the blood
• Wheezing or cough
• Increased blood clotting (this adverse effect has been reported with unknown frequency, i.e. frequency cannot be estimated from the available data).

Effects on the nervous system:

• Seizures and increased pressure in the head.

Other effects

• Persistent hiccups, feeling unwell.

Withdrawal symptoms
A "withdrawal syndrome" may occur; see section 3 for more
information.
If you experience any side effect, including those not listed in this
leaflet, consult your doctor or nurse.
Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, consult your doctor or nurse. You may also report side
effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store Metilprednisolone Hikma

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep the vial in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the label of the vial and the carton after EXP. The expiry date refers to the last day of that month.

6. Package contents and other information

What Metilprednisolone Hikma contains

• The active substance is methylprednisolone (as sodium succinate).
• The other components are disodium hydrogen phosphate dihydrate, anhydrous disodium phosphate, and sodium hydroxide. The 40 mg vial also contains lactose.

Description of the appearance of Metilprednisolone Hikma and contents of the pack
Metilprednisolone is a white or almost white powder, packaged in a transparent glass vial sealed with a rubber stopper and an aluminium crimp cap.
Each vial of Metilprednisolone Hikma 40 mg contains 53.0 mg of methylprednisolone sodium succinate, equivalent to 40 mg of methylprednisolone.
Each vial of Metilprednisolone Hikma 125 mg contains 165.8 mg of methylprednisolone sodium succinate, equivalent to 125 mg of methylprednisolone.
Each vial of Metilprednisolone Hikma 500 mg contains 663.0 mg of methylprednisolone sodium succinate, equivalent to 500 mg of methylprednisolone.
Each vial of Metilprednisolone Hikma 1000 mg contains 1,326.0 mg of methylprednisolone sodium succinate, equivalent to 1000 mg of methylprednisolone.

Marketing Authorisation Holder and Responsible Person for Batch Release
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó 8, 8A and 8B – Fervença
2705-906 Terrugem SNT
Portugal
[email protected]

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Czech Republic: Methylprednisolone Hikma, 40 mg, 125 mg, 250 mg, 500 mg and 1000 mg, Prášek pro injekční roztok
France: Méthylprednisolone Hikma, 40 mg, 500 mg et 1000 mg, Poudre pour solution injectable
Germany: Methylprednisolone Hikma, 250 mg und 1000 mg, Pulver zur Herstellung einer Injektionslösung
Italy: Metilprednisolone Hikma, 40 mg, 125 mg, 500 mg e 1000 mg, Polvere per soluzione iniettabile
Portugal: Metilprednisolona Hikma, 40 mg, 125 mg, 250 mg, 500 mg e 1000 mg, Pó para solução injetável
Slovakia: Methylprednisolone Hikma, 40 mg, 125 mg, 250 mg, 500 mg e 1000 mg, Prášok na injekčný roztok
United Kingdom: Methylprednisolone, 40 mg, 500 mg and 1000 mg, Powder for solution for injection

This leaflet was last approved on

The following information is intended exclusively for healthcare professionals:

Route of administration:
Methylprednisolone may be administered intravenously or intramuscularly.
The preferred method of administration in emergency situations is intravenous injection
given over an appropriate period of time.
a) Preparation of the injectable solution (reconstitution):
The injectable solution of Methylprednisolone must be prepared by dissolving the
powder in an appropriate volume of water for injections, as described in the table below.

b) Preparation of the infusion solution
For intravenous infusion, the initially prepared solution may be diluted with
5% dextrose in water for injections, 0.9% sodium chloride in water for injections (isotonic saline solution), or 5% dextrose in isotonic saline solution.
To avoid compatibility issues with other drugs, methylprednisolone should be administered separately, only in the solutions mentioned above.
Parenteral medications must be inspected visually for the presence of particulate matter or discoloration prior to administration.
After reconstitution as recommended, use immediately and discard any unused portion.
From a microbiological standpoint, the product should be administered immediately. If not administered immediately, storage times and conditions prior to administration are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.