40 mg / ml + 10 mg / ml solution for injection suspension 
for methylprednisolone acetate and lidocaine hydrochloride

What Depo-Medrol cum lidocaine is and what it is used for

Depo-Medrol cum lidocaine contains methylprednisolone acetate and lidocaine hydrochloride.

Methylprednisolone acetate belongs to a group of medicines called corticosteroids. Corticosteroids are produced naturally in the body and counteract and alleviate allergic problems, inflammation, and rheumatic problems. 

This medicine also contains lidocaine hydrochloride, which is a local anesthetic. Lidocaine hydrochloride helps relieve any local pain that occurs when this medicine is injected.

Depo-Medrol cum lidocaine is given as an injection near a joint, to treat local symptoms caused by inflammatory diseases.

Talk to your doctor if you are not sure why you are taking Depo-Medrol cum lidocaine.

What you need to know before you use Depo-Medrol cum lidocaine

Do not use Depo-Medrol cum lidocaine

  • if you are allergic to methylprednisolone acetate, lidocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).

Depo-Medrol cum lidocaine should not be used in a place where you have a local virus – or bacterial infection e.g. tuberculosis and gonorrhea.

Talk to a doctor if you have any of the above conditions.

Do not inject this medicine:

  • directly in a vein ( intravenously ) or in the spinal cord (intrathecally). 

Warnings and cautions

Talk to your doctor before giving Depo-Medrol cum lidocaine if you have or get any of the following diseases or conditions: 

  • An infection
  • Mental illness
  • Diabetes
  • Epilepsy (seizures)
  • Glaucoma (increased pressure in the eye)
  • Heart failure
  • Neuromuscular diseases e.g. Multiple Sclerosis (MS), Parkinson’s disease
  • High blood pressure
  • Hypothyroidism (underactive thyroid gland )
  • Impaired renal function
  • Scleroderma (also called systemic sclerosis, an autoimmune disease)
  • Osteoporosis
  • Stomach ulcers or other serious gastrointestinal problems
  • Diseases of the liver and bile ducts
  • Ulcerative colitis (inflammation of the colon)
  • Tuberculosis
  • An adrenal tumor ( pheochromocytoma )
  • Recently underwent bowel surgery

Your doctor may need to monitor your treatment more closely, change your dose or give you another medicine.

Contact a doctor if you experience blurred vision or other visual disturbances.

Tell your doctor that you have received Depo-Medrol cum lidocaine if you are going to undergo a skin test, e.g. spot test for allergy or tuberculin test.

Depo-Medrol cum lidocaine may affect the growth of children.

Other medicines and Depo-Medrol cum lidocaine

Tell your doctor, pharmacist, or nurse 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 Depo-Medrol cum lidocaine and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

Depo-Medrol cum lidocaine may be affected by or affect the effect of many other medicines. The attending physician must therefore be aware of any other medication. This applies to both prescription and over-the-counter medicines. 

Always tell Depo-Medrol cum lidocaine to the doctor who prescribes another medicine for you.

Tell your doctor or nurse if you have recently been or should be vaccinated. Some vaccines are not suitable for treatment with Depo-Medrol cum lidocaine.

Depo-Medrol cum lidocaine with food, drink, and alcohol

Intake of grapefruit juice may affect treatment with Depo-Medrol cum lidocaine. If you consume grapefruit or grapefruit juice, discuss this with your doctor.

Pregnancy, breastfeeding, 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

There is a risk that the fetus is affected. In long-term treatment, low birth weight, withdrawal symptoms, and isolated cases of cataracts have been seen in infants. Do not use Depo-Medrol cum lidocaine during pregnancy except on certain prescriptions from the doctor.

Breast-feeding

There is a risk that a breastfed baby is affected, as small amounts of methylprednisolone pass into breast milk. Do not use Depo-Medrol cum lidocaine during lactation except on certain prescriptions from the doctor.

Driving and using machines

Depo-Medrol cum lidocaine does not usually affect your ability to drive or use machines. However, you may experience side effects such as dizziness, visual disturbances, and fatigue that may affect your ability to drive.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Depo-Medrol cum lidocaine contains excipients

Depo-Medrol cum lidocaine contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is next to “sodium-free”.

How to use Depo-Medrol cum lidocaine

Depo-Medrol cum lidocaine is given as an injection. Your doctor will decide where the injection one should be, how much medicine, and how many injections, you will get, depending on the condition being treated. Your doctor will inject as low a dose for as short a time as possible to effectively relieve your symptoms.

If you are given too much Depo-Medrol cum lidocaine

As this medicine will be given to you by your doctor, it is unlikely that you will be given too much medicine.

If you stop using Depo-Medrol cum lidocaine

When you stop taking Depo-Medrol cum lidocaine, you should do so step by step to avoid withdrawal symptoms.

If, after stopping Depo-Medrol cum lidocaine, you develop signs of urgency

failure of the adrenal cortex an e.g. fatigue, chills, or dizziness, you should contact a doctor immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

Stop taking Depo-Medrol cum lidocaine and contact your doctor immediately if you get any of the following symptoms:

  • Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing ( angioedema or anaphylactic reaction )
  • Severe abdominal pain that may be a sign of bleeding or a hole in the intestine
  • Symptoms of infection such as fever and chills and malaise. This medicine may reduce your resistance to infection or hide or alter the signs and symptoms of certain infections which may make them more difficult to detect.

Side effects are methylprednisolone

Common (may affect up to 1 in 10 people)

Low potassium levels may cause fatigue, emotional symptoms (eg depression, feelings of happiness), mood swings, abnormal behavior, insomnia, irritability, glaucoma (increased pressure in the eye), stomach ulcers, acne, fluid retention (in the ankles, feet, and legs), increased pain in the inflamed area.

Uncommon (may affect up to 1 in 100 people)

Allergic reactions increased pressure in the central nervous system that can cause headaches and blurred vision, stretch marks in the skin, and soft parts.

Has been reported (occurs in an unknown number of users)

Infection , increased white blood cell count ( leukocytosis ), drug hypersensitivity, severe allergic reaction , pheochromocyte-related crisis (symptoms such as palpitations, headache and sweating), withdrawal symptoms on tapering, lipid disorders, increased appetite (which may result in weight gain) , accumulation of adipose tissue in isolated places on the body, emotional symptoms (eg rapidly changing emotions, drug addiction or suicidal thoughts), mental disorders, personality changes, confusion, anxiety, memory problems, intellectual disorder, dizziness, headache, visual disturbance, blurred vision, dizziness, increased tendency to get blood clots, low blood pressure , hiccups, stomach ulcers, intestinal perforation, esophagitis, bloating, abdominal pain, diarrhea, heartburn, nausea, increase in liver enzymes, local loss of muscles, short-term and limited swelling (mainly in skin) which is often allergic, increased male body hair in women, redness , excessive sweating, stretch marks, rash, itching , hives , muscle aches, muscle weakness, joint swelling, joint pain, fatigue, malaise, increased urinary calcium , increased urea in the blood (blood test value), decreased tolerance to carbohydrates.

The risk of suffering from the above-mentioned side effects is lower with short-term treatment than with long-term treatment.

Side effects are lidocaine

Common (may affect up to 1 in 10 people)

Feelings of happiness, confusion, anxiety, worry, unconsciousness, seizures, tremors, increased sensitivity to e.g. touch, dizziness, drowsiness, double vision, blurred vision, tinnitus, slow heartbeat, low blood pressure, respiratory arrest, difficulty breathing, vomiting, muscle twitching, fluid retention, coldness, feeling hot.

Has been reported (occurs in an unknown number of users)

Severe allergic (anaphylactic) reaction with symptoms such as hives and difficulty breathing, cardiac arrest, circulatory collapse, hives, skin changes.

Reporting of side effects

5. How to store Depo-Medrol cum lidocaine

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Opened packaging is durable for 7 days.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substances are methylprednisolone acetate and lidocaine hydrochloride. 1 ml solution for injection contains 40 mg methylprednisolone acetate and 10 mg lidocaine hydrochloride.
  • The other ingredients are benzyl alcohol, macrogol 3350, sodium chloride, miripirium chloride, hydrochloric acid/sodium hydroxide (for pH adjustment), and water for injections.

What the medicine looks like and the contents of the pack

Vials of a glass of 1 ml, 1×2 ml, 1 × 10 ml, 25×1 ml, 50 ml × 1.

Not all pack sizes may be marketed.

Muhammad Nadeem

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