DEPO-MEDRONE WITH LIDOCAINE - patient leaflet, side effects, dosage

5. how to store depo-medrone with lidocaine

. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

• Do not store above 25°C. Protect from freezing.
• For single dose use only. Your doctor or pharmacist will discard the remaining contents after use.
• Do not take this medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of that 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.

• 6. Further information

What Depo-Medrone with Lidocaine contains

• Each 1 ml vial contains 40mg of methlyprednisolone acetate and 10mg lidocaine hydrochloride as the active ingredient.
• It also contains macrogol, sodium chloride, myristyl-gamma-picolinium chloride, benzyl alcohol and sterile water for injection. It may contain sodium hydroxide and/or hydrochloric acid for pH adjustment.

What Depo-Medrone with Lidocaine looks like

Depo-Medrone with Lidocaine is a white, sterile aqueous suspension for injection contained in a glass vial fitted with a rubber cap and metal seal.

Depo-Medrone with Lidocaine is available in pack containing 1 vial, each containing 1 ml of suspension.

Manufacturer

This product is manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.

Product Licence holder

Procured from within the ELI and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HAO 1DX.

| POM | PL: 19488/1732

Leaflet revision date: 13 February 2019

Blind or partially sighted? Is this leaflet hard to see or read? Call 02087997607 to obtain the leaflet in large print, tape, CD or Braille.

Depo-Medrone is a registered trademark of Pharmacia Ltd., United Kingdom.

S1732 LEAFLET 20190213

S1732 LEAFLET 20190213

PATIENT INFORMATION LEAFLET Depo-Medrone® with Lidocaine

(methylprednisolone acetate and lidocaine hydrochloride)

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

What is in this leaflet

1. What Depo-Medrone with Lidocaine is and what it is used for

2. What you need to know before you use Depo-Medrone with Lidocaine

3. How to use Depo-Medrone with Lidocaine

4. Possible side effects

5. How to store Depo-Medrone with Lidocaine

6. Contents of the pack and other information

1. what depo-medrone with lidocaine is and what it is used for

Depo-Medrone with Lidocaine contains methylprednisolone acetate and lidocaine hydrochloride.

Methylprednisolone belongs to a group of medicines called corticosteroids or steroids. Corticosteroids are produced naturally in your body and are important for many body functions. When injected into the body, such as in or near a joint, corticosteroids help reduce symptoms caused by inflammatory or rheumatic conditions.

This medicine also contains lidocaine which is a local anaesthetic. Lidocaine helps to reduce any local pain caused by injecting this medicine.

This medicine will be injected by a doctor or nurse to help treat the symptoms caused by the following conditions:

• Bursitis: inflammation in the fluid containing spaces around the shoulder, knee and/or elbow joints. For this condition this medicine will be injected directly into one or more of these spaces.
• Osteoarthritis and rheumatoid arthritis: inflammation located in between the joints. For these conditions this medicine will be injected directly into one or more joint spaces.
• Epicondylitis, tendonitis and tenosynovitis: Tennis elbow (epicondylitis), inflammation in a tendon (tendonitis), or a tendon’s covering sheath (tenosynovitis). For these conditions this medicine will be injected into the tendon or its tendon sheath.

Your doctor may use this medicine to treat conditions other than those listed above. You must talk to your doctor, if you do not feel better or if you feel worse.

2. what you need to know before you use depo-medrone with lidocaine

Do not use Depo-Medrone with Lidocaine:

• If you think you have ever suffered an allergic reaction, or any other type of reaction after being given Depo-Medrone with Lidocaine, or any other medicine containing a corticosteroid or local anaesthetic or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a skin rash or reddening, swollen face or lips or shortness of breath.
• If you get a rash, or another symptom of an infection.
• If you have recently had, or are about to have any vaccination.
• In premature babies or neonates.

See your doctor immediately if any of the above applies to you.

Do not inject this medicine:

• into the Achilles tendon (which is located behind the ankle joint)
• directly into a vein (intravenous), the spinal cord (intrathecal), into the nostrils (intranasal), in the eye (intraocular).

Warnings and precautions

Talk to your doctor or nurse before taking Depo-Medrone with Lidocaine if you have any of the following conditions.

Your doctor may also have to monitor your treatment more closely, alter your dose or give you another medicine.

• Acute adrenal insufficiency (when your body cannot produce enough corticosteroid due to problems with your adrenal glands).
• Acute pancreatitis (inflammation of the pancreas).
• Chickenpox, measles, shingles or a herpes eye infection. If you think you have been in contact with someone with chickenpox, measles or shingles and you have not already had these illnesses, or if you are unsure if you have had them.
• Severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Depo-Medrone with Lidocaine, or having a family history of these illnesses.
• Cushing’s disease (condition caused by an excess of cortisol hormone in your body).
• Diabetes (or if there is a family history of diabetes).
• Epilepsy, fits or seizures.
• Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or infections.
• Hypertension (high blood pressure).
• Hypotension (low blood pressure).
• Hypothyroidism (an under-active thyroid).
• Joint infection – which is active and so requires treatment.
• Kidney or liver disease.
• Scleroderma (also known as systemic sclerosis, an autoimmune disorder), because the risk of a serious complication called scleroderma renal crisis may be increased. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.
• Muscle problems (pain or weakness) have happened while taking steroid medicines in the past.
• Myasthenia gravis (a condition causing tired and weak muscles).
• If you have recently had an operation.
• Osteoporosis (brittle bones).
• Peritonitis (Inflammation of the thin lining (peritoneum) around the gut and stomach).
• Pheochromocytoma (a rare tumour of adrenal gland tissue. The adrenal glands are located above the kidneys).
• Skin abscess or other disorders of the skin.
• Stomach ulcer or other serious stomach or intestinal problems (ulcerative colitis).
• Unusual stress.
• Thrombophlebitis – vein problems due to thrombosis (clots in the veins) resulting in phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered tuberculosis in the past.
• Traumatic brain injury

You must tell your doctor before you take this medicine if you have any of the conditions listed above.

Other medicines and Depo-Medrone with Lidocaine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should tell your doctor if you are taking any of the following medicines which can affect the way Depo-Medrone with Lidocaine or the other medicine works:

• Acetazolamide – used to treat glaucoma and epilepsy.
• Aminoglutethimide and cyclophosphamide- used for treating cancer.
• Antibacterials (such as isoniazid, erythromycin, clarithromycin and troleandomycin).
• Antivirals (such as ritonavir, indinavir) and pharmacokinetic enhancers (such as cobicistat) used to treat HIV infections.
• Anticoagulants – used to ‘thin’ the blood such as acenocoumarol, phenindione and warfarin.
• Anticholineste­rases – used to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine.
• Antidiabetics – medicines used to treat high blood sugar.
• Antiemetics (such as aprepitant and fosaprepitant).
• Aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamazepine, phenytoin and primidone -used to treat epilepsy.
• Carbenoxolone – used for heartburn and acid indigestion.
• Ciclosporin – used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or following an organ or bone marrow transplant.
• Digoxin – used for heart failure and/or an irregular heart beat.
• Diltiazem – used for heart problems or high blood pressure.
• Ethinylestradiol and norethindrone – oral contraceptives.
• Indinavir and ritonavir-used to treat HIV infections.
• Ketoconazole or itraconazole – used to treat fungal infections.
• Pancuronium and vecuronium – or other medicines called neuromuscular blocking agents which are used in some surgical procedures.
• Potassium depleting agents – such as diuretics (sometimes called water tablets), amphotericin B, xanthenes or beta2 agonists (e.g. medicines used to treat asthma).
• Rifampicin and rifabutin – antibiotics used to treat tuberculosis (TB).
• Tacrolimus – used following an organ transplant to prevent rejection of the organ.
• Vaccines – tell your doctor or nurse if you have recently had, or are about to have any vaccination. You must not have ‘live’ vaccines while using this medicine. Other vaccines may be less effective.

If you are taking long term medication(s)

If you are being treated for diabetes, high blood pressure or water retention (oedema) tell your doctor as he/she may need to adjust the dose of the medicines used to treat these conditions.

Before you have any operation, tell your doctor, dentist or anaesthetist that you are taking this medicine.

If you require a test to be carried out by your doctor or in hospital it is important that you tell the doctor or nurse that you are taking Depo-Medrone with Lidocaine. This medicine can affect the results of some tests.

Depo-Medrone with Lidocaine with drink

Do not drink grapefruit juice while taking this medicine.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as this medicine could slow the baby’s growth. There is a risk associated with low birth weight of the baby; this risk can be reduced by administering a lower dose of the medicine.

Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.

If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine, since lidocaine as well as small amounts of corticosteroid medicines are excreted into breast milk.

If you continue breast-feeding while you are having treatment, your baby will need extra checks to make sure he or she is not being affected by your medicine.

Driving and using machines

Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue are possible after treatment with corticosteroids. If you are affected do not drive or operate machinery.

Depo-Medrone with Lidocaine contains benzyl alcohol and sodium.

This medicine contains benzyl alcohol. The amount of benzoyl alcohol per ml is 8.7 mg. It may cause toxic and allergic reactions. This medicine should not be used in pre-term or full-term neonates unless strictly necessary because of the risk of severe toxicity including abnormal respiration (“gasping syndrome”).

Talk to your doctor or pharmacist if you have liver or kidney problems or if you are pregnant or breast-feeding as high volumes may lead to toxicity (metabolic perturbation).

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.

3. how to use depo-medrone with lidocaine

Steroid Cards

Remember to always carry a Steroid Treatment Card. Make sure your doctor or pharmacist has filled out the details of your medicine, including the dose and how long you will require steroid treatment.

You should show your steroid card to anyone who gives you treatment (such as a doctor, nurse or dentist) while you are taking this medicine, and for 3 months after your last injection.

If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking this medicine. You can also wear a medic-alert bracelet or pendant to let medical staff know that you are taking a steroid if you have an accident or become unconscious.

Dosage information

Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms.

Adults

Your doctor/nurse will tell you how many injections you will require for the condition you are being treated for, and when you will get them.

Joints - the normal dose for the injections into joint will depend on the size of the joint. Large joints (e.g. knee, ankle and shoulder) may require 20 – 80 mg (0.5 – 2 ml), medium sized joints (e.g. elbow or wrist) 10 – 40 mg (0.25 – 1 ml) and small joints (e.g. finger or toe joints) may require a 4 –10 mg (0.1 – 0.25 ml) dose.

Joint injections may be given weekly over a period of several weeks, depending on how quickly you respond to treatment.

Bursitis, epicondylitis (tennis elbow) and tendonitis - the usual dose is between 4–30 mg (0.1 – 0.75 ml). In most cases repeat injections will not be needed for bursitis and epicondylitis. Repeat injections may be necessary to treat long standing tendonitis.

Elderly

Treatment will normally be the same as for younger adults.

However your doctor may want to see you more regularly to check how you are getting on with this medicine.

Children

Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose that will be effective for your child.

If you are given more Depo-Medrone with Lidocaine than you should

If you think you have been given too many injections of this medicine please speak to your doctor immediately.

Stopping/reducing the dose of your Depo-Medrone with Lidocaine

Your doctor will decide when it is time to stop your treatment. You will need to come off this treatment slowly if you:

• have been given more than 6 mg (0.15 ml) Depo-Medrone with Lidocaine for more than 3 weeks;
• have been given high doses of Depo-Medrone with Lidocaine, over 32 mg (0.8 ml) daily, even if it was only for 3 weeks or less;
• have already had a course of corticosteroid tablets or injections in the last year;
• already have problems with your adrenal glands (adrenocortical insufficiency) before you started this treatment.

You will need to come off this medicine slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss.

If your symptoms seem to return or get worse as your dose of this medicine is reduced tell your doctor immediately.

Mental problems while taking Depo-Medrone with Lidocaine Mental health problems can happen while taking steroids like Depo-Medrone with Lidocaine (see also section 4,

Possible Side Effects).

• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped. However if the problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine) show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases mental problems have happened when doses are being lowered or stopped. If you have any further questions on the use of this medicine, ask your doctor,pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will have given you this medicine for a condition which if not treated properly could become serious.

In certain medical conditions medicines like Depo-Medrone with Lidocaine (steroids) should not be stopped abruptly. If you suffer from any of the following symptoms seek IMMEDIATE medical attention.

Your doctor will then decide whether you should continue taking your medicine:

• Allergic reactions, such as skin rash, swelling of the face or wheezing and difficulty breathing or dizziness. This type of side effect is rare, but can be serious.
• Pancreatitis, stomach pain which may spread through to your back, possibly accompanied by vomiting, shock and loss of consciousness.
• Burst or bleeding ulcers, symptoms of which are severe stomach pain which may go through to the back and could be associated with bleeding from the back passage, black or bloodstained stools and/or vomiting blood.
• Infections. This medicine can hide or change the signs and symptoms of some infections, or reduce your resistance to the infection, so that they are hard to diagnose at an early stage. Symptoms might include a raised temperature and feeling unwell. Symptoms of a flare up of a previous TB infection could be coughing blood or pain in the chest. This medicine may also make you more likely to develop a severe infection.
• Peritonitis, an inflammation (irritation) of the peritoneum, the thin tissue that lines the inner wall of the abdomen and covers most of the abdominal organs. Symptoms are, the stomach (abdomen) being very painful or tender, the pain may become worse when the stomach is touched or when you move.
• Pulmonary embolus (blood clot in the lung) symptoms include sudden sharp chest pain, breathlessness and coughing up blood.
• Raised pressure within the skull of children (pseudotumour cerebri) symptoms of which are headaches with vomiting, lack of energy and drowsiness. This side effect usually occurs after treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in a leg vein), symptoms of which include painful swollen, red and tender veins.

If you experience any of the following side effects, or notice any other unusual effects not mentioned in this leaflet, tell your doctor immediately.

The side effects may occur with certain frequencies, which are defined as follows:

• Not known: frequency cannot be estimated from the available data.

Blood, heart and circulation

Not known

• High blood pressure, symptoms of which are headaches, or generally feeling unwell.
• Slowing heart rate (bradycardia).
• Problems with the pumping of your heart (heart failure) symptoms of which are swollen ankles, difficulty in breathing and palpitations (awareness of heart beat) or irregular beating of the heart, irregular or very fast or slow pulse, cardiac arrest.
• Low blood pressure, symptoms may include dizziness, fainting, lightheadedness, blurred vision, a rapid or irregular heartbeat (palpitations).
• Increase of white blood cells (leukocytosis).
• Increased clotting of the blood.

Body water and salts

Not known

• Swelling and high blood pressure, caused by increased levels of water and salt content.
• Cramps and spasms, due to the loss of potassium from your body. In rare cases this can lead to congestive heart failure (when the heart cannot pump properly).

Digestive system

Not known

• Ulcers.
• Vomiting (being sick).
• Nausea (feeling sick).
• Thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Diarrhoea.
• Bloated stomach.
• Abdominal pain.
• Hiccups.

Ears

Not known

• A feeling of dizziness or spinning (vertigo).

Eyes

Not known

• Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches).
• Cataracts (indicated by failing eyesight).
• Swollen optic nerve (causing a condition called papilloedema, and which may cause sight disturbance).
• Increased intra-ocular pressure, with possible damage to the optic nerve (indicated by failing eyesight).
• Thinning of the clear part at the front of the eye (cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blindness, blurred or double vision.
• Blurred or distorted vision (due to disease of the retina and choroid membrane).

Hepatobiliary disorders

Not known

• Methylprednisolone can damage your liver, hepatitis and increase of liver enzymes have been reported.

General disorders

Not known

• Poor wound healing.
• Irritability.
• Feeling tired or unwell.
• Skin reactions at the site of injection.

Hormones and metabolic system

Not known

• Slowing of normal growth in infants, children and adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid facies).
• Diabetes or worsening of existing diabetes.
• Irregular or no periods in women.
• Increased appetite and weight gain.

S1732 Physician LEAFLET 20190213

PHYSICIAN LEAFLET Depo-Medrone® with Lidocaine (methylprednisolone acetate and lidocaine hydrochloride)

FOR FURTHER INFORMATION PLEASE REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS.

Posology and method of administration

Depo-Medrone with Lidocaine should not be mixed with any other preparation as flocculation of the product may occur. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever suspension and container permit. Depo-Medrone with Lidocaine may be used by any of the following routes: intra-articular, periarticular, intrabursal, and into the tendon sheath. It must not be used by the intrathecal, or intravenous routes.

Adults

Intra-articular: Rheumatoid arthritis, osteo-arthritis. The dose of Depo-Medrone with Lidocaine depends on the size of the joint and the severity of the condition. Repeated injections, if needed, may be given at intervals of one to five or more weeks depending upon the degree of relief obtained from the initial injection. A suggested dosage guide is: large joint (knee, ankle, shoulder), 0.5 – 2 ml (20 –80 mg of steroid); medium joint (elbow, wrist), 0.25 – 1 ml (10 – 40 mg of steroid); small joint (metacarpopha­langeal, interphalangeal, sternoclavicular, acromioclavicular), 0.1 – 0.25 ml (4 – 10 mg of steroid).

Periarticular: Epicondylitis. Infiltrate 0.1 – 0.75 ml (4 – 30 mg of steroid) into the affected area.

Intrabursal: Subdeltoid bursitis, prepatellar bursitis, olecranon bursitis. For administration directly into bursae, 0.1 – 0.75 ml (4 – 30 mg of steroid). In most acute cases, repeat injections are not needed.

Into the tendon sheath: Tendinitis, tenosynovitis, epicondylitis. For administration directly into the tendon sheath, 0.1 – 0.75 ml (4 – 30 mg of steroid). In recurrent or chronic conditions, repeat injections may be necessary.

Paediatric population

For infants and children, the recommended dosage should be reduced, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight.

Elderly

When used according to instructions, there is no information to suggest that a change in dosage is warranted in the elderly. However, treatment of elderly patients, particularly if long-term, should be planned bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age and close clinical supervision is required.

Special precautions should be observed when administering DepoMedrone with Lidocaine: Intra-articular injections should be made using precise, anatomical localisation into the synovial space of the joint involved. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal and hip joints. The spinal joints, unstable joints and those devoid of synovial space are not suitable. Treatment failures are most frequently the result of failure to enter the joint space. Intra-articular injections should be made with care as follows: ensure correct positioning of the needle into the synovial space and aspirate a few drops of joint fluid. The aspirating syringe should then be replaced by another containing Depo-Medrone with Lidocaine. To ensure position of the needle synovial fluid should be aspirated and the injection made.

After injection the joint is moved slightly to aid mixing of the synovial fluid and the suspension. Subsequent to therapy care should be taken for the patient not to overuse the joint in which benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial effects of the steroid.

Intrabursal injections should be made as follows: the area around the injection site is prepared in a sterile way and a wheal at the site made with 1 percent procaine hydrochloride solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place and the aspirating syringe changed for a small syringe containing the desired dose. After injection, the needle is withdrawn and a small dressing applied. In the treatment of tenosynovitis and tendinitis, care should be taken to inject Depo-Medrone with Lidocaine into the tendon sheath rather than into the substance of the tendon. Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with Depo-Medrone with Lidocaine.

The usual sterile precautions should be observed with each injection.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Special precautions for storage

Do not store above 25°C. Protect from freezing. For single dose use only. Your doctor or pharmacist will discard the remaining contents after use.

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

POM | PL: 19488/1732

Leaflet revision date: 13 February 2019

S1732 Physician LEAFLET 20190213