Description

Product Overview

What Diclofenac is and what it is used for

Diclofenac contains diclofenac sodium as the active ingredient, which is a non-steroidal anti-inflammatory drug (NSAID).

This means that it is a painkilling medicine which reduces inflammation and swelling, but it does not contain any steroid medicine.

Diclofenac suppositories are used rectally in the symptomatic management of rheumatoid arthritis including juvenile chronic arthritis, osteoarthritis, ankylosing spondylitis, psoriatic arthropathy, low back pain and acute musculoskeletal disorders including peri-arthritis, tendonitis, tenosynovitis, bursitis, sprains, strains, dislocations and in acute gout.

It can also be used to treat pain and inflammation after orthopaedic, dental or other minor surgery.

What you need to know before you take Diclofenac Suppositories

Do not take Diclofenac if you:

•Are allergic (hypersensitive) to Diclofenac or any components of the preparation.
•Have ever had an allergic reaction (difficulty in breathing, skin rash and runny nose) to aspirin
(acetylsalicylic acid) or any other NSAID such as ibuprofen.
•Have had any gastrointestinal problems after taking any other NSAID, e.g. vomiting blood or passing black, tarry stools.
•Have or have ever suffered from a stomach ulcer or bleeding from the stomach.
•Have an inflammation of your anus, rectum or colon.
•Have severe heart failure.
•If you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages.
•If you have or have had problems with your blood circulation (peripheral arterial disease).
•Have severe kidney or liver failure.
•Are in the last three months of pregnancy – please see section on ‘Pregnancy and breastfeeding’.

If any of these apply to you, tell your doctor or pharmacist. Your doctor will decide whether this
medicine is suitable for you.

Make sure your doctor knows, before you are given Diclofenac
•If you smoke
•If you have diabetes
•If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides

Warnings and Precautions

Speak to your doctor before using Diclofenac if you:

•Have experienced asthma, allergic inflammation of the nasal airways
•If any skin rash develops such as hives or itchy skin
•Have experienced symptoms of chronic obstructive pulmonary diseases (COPD), shortness of breath, persistent cough
•Have high blood pressure
•Have heart problems
•Have mild to moderate heart failure
•Have liver or kidney problems
•Have cerebrovascular disease, this is a condition that develops as a result of problems with blood vessels in the brain. If you have a history of strokes or mini stroke please speak to your doctor.
•Are taking Diclofenac long-term or if you have severe liver impairment as you will undergo monitoring while taking Diclofenac suppositories.
•Have heart problems, previous stroke or mini 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.
•Have recently had major surgery.

If any of these apply to you, tell your doctor or pharmacist. Your doctor will decide whether this medicine is suitable for you.

Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

You may also be prescribed a medicine to protect the lining of the stomach while taking diclofenac.

Non-steroidal anti-inflammatory drugs (NSAIDs) can cover the signs and symptoms of an infection.

It is advised to use the lowest dose for the shortest time to reduce the likelihood of side-effects.

If you have asthma, hayfever (seasonal allergic rhinitis), swelling of the nasal mucosa (nasal polyps), narrowing of the airways (due to a condition known as chronic obstructive pulmonary disease) or chronic infections of the respiratory tract (e.g. chest infections and especially allergic symptoms affecting the nose) you are more likely to experience reactions to NSAIDs (e.g. diclofenac). These reactions could include worsening of asthma (often referred to as intolerance to analgesics/analgesics asthma), development of hives on the skin and swelling of the eyes and lips and mucous membranes. You may be at greater risk of developing these reactions to NSAIDs if you are already allergic to, and have had reactions to, other substances. A doctor’s supervision and extreme precaution is advised with the use of NSAIDs if you have any allergic condition as described here that could predispose you to an allergic reaction.

Side effects may be minimized by using the lowest effective dose for the shortest duration necessary.

Medicines such as diclofenac may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

If you are not sure about using Diclofenac suppositories then talk to your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking other medicines, make sure your doctor is aware of them, particularly if they are any of the following:

•Other anti-inflammatory or “painkilling” medicines (NSAIDs)
•Water tablets (diuretics)
•Steroids which are used as the main treatment for certain inflammatory conditions (corticosteroids)
•Aspirin (anti-platelet agents)
•Medicines used to thin the blood such as warfarin (anticoagulants)
•Mood stabilizing drugs such as lithium
•Immunosuppressive agents which are drugs that inhibit or prevent activity of the immune system (ciclosporine)

If you are presently taking any of these medicines and are unsure talk to your doctor or pharmacist.

Pregnancy, breastfeeding and fertility

Do not use Diclofenac if you are pregnant or breast-feeding unless it is considered essential by your physician.
Diclofenac may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
This medicine must not be used by women who are in the last three months of pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Diclofenac should not affect your ability to drive or operate machinery. If in the unlikely event you have dizziness or blurred vision, do not drive or operate machinery

How to use Diclofenac 100mg Suppositories

Always use Diclofenac exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
It is important that you use the lowest dose that controls your pain and you should not use Diclofenac for longer than necessary.

Diclofenac suppositories are for rectal use only.

Adults:

The usual dosage is one suppository inserted into the rectum in the evening.
Your doctor will decide how long you will take this medicine. Your doctor has carefully chosen the correct dosage for you taking into account the severity of your condition, your age and any other reasons special to you; therefore you should always take the dose prescribed.

Elderly:

The dosage should be kept as low as possible.

Children:

Diclofenac suppositories are not suitable for children.

If you use more Diclofenac than you should

If you use too many suppositories, tell your doctor or hospital emergency department at once.
Take your medicine with you.

If you forget to use Diclofenac

If you forget to use Diclofenac use one as soon as you remember, and then go on as before. Do not insert two suppositories at the same time. No more than one suppository should be used daily. Do not take more than 150 mg in 24 hours.

If you stop using Diclofenac

Your doctor will decide how long you will take this medicine. Your doctor has carefully chosen the correct dosage for you taking into account the severity of your condition, your age and any other reasons special to you. Therefore, you should always take the dose prescribed.

Possible side effects

Like all medicines, Diclofenac can cause side effects, although not everybody gets them. These may occur in the initial stages of treatment and may be more serious if they occur in the elderly.

If the following happens at any time during your treatment, tell your doctor immediately:

•An allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives).
•Passing blood in your faeces (stools/motions).
•Passing black tarry stools.
•Vomiting any blood or dark particles that look like coffee grounds.
•A serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
•Indigestion or heartburn.
•Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

Very common (≥1/10);

Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to < 1/100) Rare ( ≥ 1/10,000 to <1/1,000) Very Rare (<1/10,000) Not Known (cannot be estimated from available data). Common:

•Headache, dizziness
•Vertigo
•Nausea, vomiting, diarrhoea, indigestion, flatulence, abdominal pain, loss of appetite
•Skin rash
•Irritation at area of insertion
•Increased levels of serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvioc transaminase (SGTP), enzymes that are normally present in liver and heart cells, SGOT and SGTP are released into blood when the liver or heart are damaged.

Rare:

•Allergic action (e.g. difficulties in breathing, wheezing or low blood pressure)
•Drowsiness, tiredness
•Asthma, shortness of breath
•Inflammation of the lining of the stomach
•Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels
•Gastro-intestinal ulcers with or without bleeding
•Hives
•Yellowing of your skin or the whites of your eyes (hepatitis or liver function disorders)
•Fluid Retention

Very Rare:

•Decrease of platelets in the blood, signs of this can be bleeding inside the body or bleeding from the skin
•Decrease of white blood cells in the blood
•Anaemia, abnormal bleeding
•Rapid swelling, including swelling of the face
•Disorientation, depression, insomnia, nightmares, irritability, psychotic disorder.
•Sensation of tingling, pricking, or numbness of skin
•Impaired memory
•Convulsions, tremors
•Anxiety
•Symptoms of aseptic meningitis with neck stiffness, headaches, nausea, vomiting or clouding of consciousness
•Skin diseases known as Steven Johnson syndrome and Lyell’s, which are the detachment of top layers of skin from bottom layers
•Kidney failure, signs and symptoms of this are bloody stools, fatigue, bruising easily and fluid retention
•Nephrotic syndrome, which is a disorder in which the kidneys can become damaged the most common signs of this are weight gain due to excess fluid retention, swelling, urine foamy
•Interstitial nephritis, which is a kidney disorder in which the spaces between the kidney tubules become swollen (inflamed). Some symptoms of this condition may be blood in urine, fever, nausea and vomiting
•Renal papillary necrosis, which is a disorder of the kidneys, symptoms of this may be back pain blood in urine, cloudy urine

Gastrointestinal bleeding associated with this product can be fatal
Medicines such as Diclofenac 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

How to store Diclofenac Suppositories

Keep out of the reach and sight of children.
Do not store above 25° C.
Do not use Diclofenac suppository after the expiry date as stated on the label and carton.
The expiry date refers to the last day of the 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.