Dyloject 75mg/2ml Solution for Injection
1. WHAT DYLOJECT IS AND WHAT IT IS USED FOR
Dyloject is a solution for injection. Dyloject comes in packs of 10 vials. Each vial contains 2 ml of a clear liquid. Dyloject (diclofenac sodium) is a non-steroidal anti-inflammatory analgesic drug (NSAID). NSAIDs reduce pain and inflammation. Aspirin is another NSAID (see below). Dyloject is used to treat a number of painful conditions including
• ‘Flare-ups’ of joint or back pain
• Attacks of gout
• Pain caused by kidney stones
• Pain caused by injuries, fractures or trauma
It is also used to prevent or treat pain following an operation.
2. BEFORE YOU USE DYLOJECT
Do not use Dyloject
• If you have, or have had an ulcer or bleeding in your stomach or intestines (two or more episodes)
• If you have, or have had severe heart, kidney or liver failure
• If you are allergic to diclofenac, aspirin, ibuprofen or other NSAIDs; or any of the ingredients in Dyloject. Allergic reactions include breathing difficulties, wheezing, runny nose, skin rashes.
• If you have a history of liver inflammation due to diclofenac, aspirin, or other NSAIDs
• If you have a history of bleeding in your stomach or intestines related to previous treatment with an NSAID
• If you are in the last 3 months of pregnancy
The following also apply if Dyloject is to be injected into a vein
• If you have a history of bleeding easily/blood clotting disorder
• If you have ever suffered from bleeding in your brain
• If you could be suffering from dehydration
• If you have suffered any heavy loss of blood recently
• If you have a history of asthma
• If you suffer from moderate or severe kidney problems
• If you are taking another NSAID, or medicines to thin blood Take special care with Dyloject
Tell your doctor before you are given Dyloject
• If you have, or have ever had, an ulcer in the gullet, stomach or upper bowel, or gastrointestinal bleeding, symptoms of which may include blood in vomit or when emptying bowels or black, tarry stools
• If you have, or have ever had, heart, kidney or liver disease
• If you have had a history of or suffer from any bleeding disorders, your doctor may ask you to go for regular check ups while you are being treated with Dyloject
• If you have, or have ever had, bronchial asthma
• If you have, or have ever had, a heart condition or high blood pressure
• If you suffer from any bowel disorders, for example ulcerative colitis or Crohn’s disease
• If you are taking any other medicines, either bought or prescribed, for long term use or outside a medically supervised setting
• If you have lupus (systemic lupus erythematosus or SLE) or any similar problem
• If you are planning to become pregnant, as Dyloject may interfere with your ability to become pregnant Dyloject is not suitable for children.
Because it is an anti-inflammatory medicine, Dyloject may reduce the symptoms of infection, for example headache or high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Dyloject.
Elderly patients are generally more prone to side effects associated with Dyloject.
You should take the lowest dose for the shortest possible time, particularly if you are elderly.
- Other Special Warnings
Medicines such as Dyloject may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
- Taking other medicines
Some medicines may interfere with the effects of Dyloject.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• Medicines to treat diabetes
•Anticoagulants (blood thinning tablets like warfarin or heparin)
•Antiplatelet medicines (to prevent blood clots)
• Diuretics (water tablets)
• Lithium (a medicine to treat some types of depression)
• Digoxin (a medicine for heart problems)
• Methotrexate (a medicine for some types of inflammation and cancers)
• Ciclosporin and tacrolimus (medicines for some types of inflammation and after organ transplants)
• Quinolone antibiotics (medicines used to treat some infections)
• Steroids (medicines for inflammation and for treating immune system problems)
• Any other NSAID or COX-2 (cyclooxygenase-2) inhibitor, for example aspirin or ibuprofen (medicines for inflammation or pain)
• Mifepristone (a medicine used during termination of pregnancy)
• Medicines for heart problems or high blood pressure, for example beta blockers or ACE inhibitors
• Medicines used to treat anxiety and depression known as serotonin re-uptake inhibitors (SSRIs)
• Zidovudine (a medicine for human immunodeficiency virus (HIV) infection) Pregnancy
Ask your doctor or pharmacist for advice before taking any medicines. You must tell your doctor if you are pregnant or planning to become pregnant as then your doctor will consider whether Dyloject should be used. During the late phase (last 3 months) of pregnancy Dyloject may affect the baby’s circulation.
Dyloject may make it more difficult to become pregnant.
You must tell your doctor if you are breast-feeding. If you are breast-feeding, your doctor will consider whether Dyloject should be used.
- Driving and using machines
Dyloject makes some people feel dizzy, drowsy, tired or have blurred vision. If you are affected after taking
Dyloject do not drive or operate machinery until its effects have worn off.
3. HOW TO USE DYLOJECT
Your doctor will decide when and how to treat you with Dyloject, usually in a hospital or medical centre. Your doctor or nurse will take the contents of the Dyloject vial into a syringe and give it to you by an intravenous injection (an injection into a vein) or an intramuscular injection (an injection into a muscle, usually into the buttock). The usual dose is:
Adults: One or two vials (75 to 150 mg) each day for up to two days.
Elderly: Your doctor may give you a dose that is lower than the usual adult dose if you are elderly. Children: Not suitable for children. If you use more Dyloject than you should
If you are given more Dyloject than you should, you may experience the following symptoms: headache, nausea, vomiting, stomach pain, stomach and/or intestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible. If you think you have been given too much Dyloject, tell your doctor or nurse immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dyloject can cause side effects, although not everybody gets them. If you get any of the following, tell your doctor immediately
• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)
•Any sign of bleeding in the stomach or intestine, for example when emptying your bowels, blood in vomit or black, tarry stools, diarrhoea with blood, stomach ulcer
• Skin rash, itching, bruising or painful red areas •Wheezing, shortness of breath or trouble breathing
• Yellowing of your skin or the whites of your eyes
• Persistent sore throat or high temperature
• Signs of kidney problems which can include an unexpected change in the amount of urine produced and/or its appearance, or presence of blood in urine
• Pain, redness or lumps at the injection site
If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor as soon as possible.
Common side effects (likely to affect between 1 in 100 to 1 in 10 patients) are
• Headache, dizziness, vertigo
• Drowsiness, tiredness
• Nausea, vomiting or other stomach problems
• Diarrhoea, loss of weight or appetite, heartburn
• Skin rash, itch
• Liver problems
• Injection site pain
• Irritation of the vein in which Dyloject is injected
Very rare to uncommon side effects (reported in 1 in 100,000 to 1 in 100 people) are
• Stomach ulcers or bleeding, mouth ulcers
• Mouth or tongue disorders, trouble swallowing, tightening of the jaw muscles, taste disturbance, speech disorder
•Abdominal pain or tenderness, chest pain or tightness, stiffness
• Runny nose, watery eyes, swollen or itching eyes
• Bronchospasm (symptoms of which include wheezing or difficulty in breathing)
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)
• Liver disorders and liver pain, sometimes with jaundice (yellowing of skin and whites of eyes)
• Fluid retention, symptoms of which include swollen ankles
• Impaired balance, feeling abnormal, feeling hot
• Increased sweating, shaking, chills, malaise
• Back and neck pain
Isolated side effects (reported in less than 1 in 100,000 people) include
• Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, disorientation and loss of memory, fits, headaches together with a dislike of bright lights and a stiff neck, disturbances in sensation, mental disorders, anxiety
• Constipation, inflammation of the tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon) and worsening of Crohn’s disease
• Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), congestive heart failure, blood disorders (including anaemia)
• Kidney or liver disorders, presence of blood or protein in the urine
• Skin rashes which may be made worse by exposure to sunlight, severe skin reactions; blistering, peeling, eczema, giant wheals (burning itchy swollen skin) or itchiness, hives, includes conditions known as Stevens-Johnson syndrome and Lyell’s syndrome, hair loss
• Inflammation of the pancreas, impotence Other side effects
Medicines such as Dyloject may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
The following side effects have been reported from persons who have been treated with NSAIDs:
Allergic reactions: Including sudden life threatening allergic reaction (anaphylaxis); asthma; difficulty in breathing or shortness of breath, bronchospasm; itching of the skin; hives; unusual bleeding or bruising under the skin; swelling beneath the skin, including mouth and throat; disease of the skin/swelling of the skin.
Less common reactions that have been reported include:
Visual disturbances; disease of the nerves of the eye. Reports of inflammation of the layers lining the brain with symptoms such as stiff neck; headache; nausea; vomiting; fever or disorientation, especially in patients with lupus (SLE) and other similar diseases.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DYLOJECT
Keep Dyloject out of reach and sight of children.
The expiry date is on the box and vial label. This medicine should not be used after the expiration date shown on the pack.
Your doctor, pharmacist or nurse knows how to store Dyloject properly.
Store below 30°C.
Do not freeze.
Keep vials in the outer carton in order to protect from light.
Do not use Dyloject if crystals or precipitates are seen.
6. FURTHER INFORMATION
What Dyloject contains
– The active substance is diclofenac sodium
– The other ingredients are
• Hydroxypropylbetadex • Hydrochloric acid
• Monothioglycerol • Water for Injection
• Sodium hydroxide • Nitrogen
What Dyloject looks like and contents of the pack
The Dyloject 75 mg/2 ml Solution for Injection is a colorless solution and each pack consists of ten 2 ml vials.