Description

Product Overview

WHAT DICLOFENAC IS AND WHAT IT IS USED FOR

The name of this medicine is Diclofenac SR 75mg Capsules or Diclofenac Retard 100mg Capsules. The active substance in them is diclofenac sodium which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
They are used to relieve pain and inflammation or swelling and can be used in the treatment of painful conditions affecting the joints and muscles, e.g. rheumatoid arthritis, osteoarthrosis, low back pain and sprains or broken bones, or to control pain and inflammation following orthopaedic, dental and other minor surgery.

BEFORE YOU TAKE DICLOFENAC

Do not take Diclofenac if

• You are allergic (hypersensitive) to diclofenac sodium or any of the other ingredients of Diclofenac
• You are allergic to aspirin, ibuprofen or any other anti-inflammatory medicines used to treat painful conditions
• You currently have, or have ever had, ulcers in the stomach or small intestine (peptic ulceration) or bleeding in your stomach or intestines
• Your doctor has told you that you have intolerance to sugars called lactose or sucrose
• Your doctor has told you that you have acute porphyria
• You have severe liver, kidney or heart failure
• You are taking any other NSAIDs (non-steroidal anti-inflammatory drugs)
• You are pregnant or breast-feeding

Diclofenac Capsules are not recommended for children.

Talk to your doctor before taking this product if any of the above apply to you.

Take special care with Diclofenac
• If you have asthma
• If you have, or have ever had, bloody diarrhoea
• If you are elderly

Or if you suffer from any of the following conditions:
• Heart, liver or kidney disease
• Systemic lupus erythematosus (SLE) (a chronic inflammatory disease affecting many systems of the body) or other mixed connective tissue disorders (if so you may have an increased risk of aseptic meningitis if you take this medicine)
• Crohn’s disease or ulcerative colitis (bowel disorders) any blood disorders where you bleed or bruise easily

If any of the above apply to you, it is important that you tell your doctor or pharmacist before taking this medicine and they will decide what to do. It may still be safe for you to take Diclofenac.

If you go into hospital or visit a dentist or any other doctor, tell them that you are taking this medicine.

Warnings

Medicines such as Diclofenac Capsules 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

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

This is especially important if you are taking any of the following:

• Quinolone antibiotics (such as ciprofloxacin) used to treat certain bacterial infections
• Warfarin (to thin the blood) or any other anticoagulant medicines
• Methotrexate – used in cancer and certain inflammatory diseases like rheumatoid arthritis
• Lithium – a medicine for depression
• Zidovudine – a medicine used to treat HIV
• A group of medicines called selective serotonin reuptake inhibitors that are commonly referred to as SSRIs and used to treat depression
• Steroids (e.g. prednisolone)
• Other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin and ibuprofen)
• Water tablets (diuretics)
• Medicines that affect your immune system (e.g. ciclosporin or tacrolimus)
• Medicines for diabetes (e.g. hypoglycaemic agents)
• Medicines to treat heart problems (e.g. digoxin)
• Medicines to treat high blood pressure
• A medicine called mifepristone used for the termination of pregnancy. It is important to tell your doctor if you have taken mifepristone within the last 12 days.

Taking Diclofenac with food and drink
Diclofenac should be taken with or after food.

Pregnancy and breast-feeding
If you are pregnant, think you might be or are breast-feeding you should ask your doctor or pharmacist for advice before taking Diclofenac.

Diclofenac may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines
It is safe to drive while taking Diclofenac; however, you may experience dizziness, tiredness or problems with your sight. If you are affected by any of these, do not drive or operate machinery.

Important information about some of the ingredients of Diclofenac Capsules
These capsules contain lactose and sucrose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE DICLOFENAC

Always take Diclofenac exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how many capsules you should take and when.

Diclofenac SR 75mg Capsules:
The normal dose of Diclofenac SR for adults is one or two 75mg capsules daily, swallowed whole with or after food. Do not chew the capsule(s) or remove the contents.

Diclofenac Retard 100mg Capsules:
The normal dose of Diclofenac Retard for adults is one 100mg capsule daily, swallowed whole with or after food. Do not chew the capsule or remove the contents.

If you take more Diclofenac than you should
If you take too many capsules contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any remaining capsules with you.

If you forget to take Diclofenac
If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

POSSIBLE SIDE EFFECTS

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

If you get any of the following side effects after taking Diclofenac, stop taking them and contact your doctor immediately:

• Difficulty in breathing
• Starting to wheeze
• Any unusual swelling or a blistering skin
• Vomiting blood or dark coffee ground like material
• Passing bloody or black tar like stools
• Bloody diarrhoea
• Swelling of the face, lips, tongue or throat

If you get any of the following symptoms contact your doctor as soon as possible:

• Heartburn (indigestion)
• Pains in your stomach or any other unusual stomach problems
• Small red or purple spots on your skin
• Stiff neck, headache, nausea and/or vomiting associated with fever

The following side effects have been reported most commonly:

• Stomach ulcers
• Stomach pain or irritation
• Nausea
• Vomiting
• Skin rash or itching
• Diarrhoea
• Flatulence (excess wind)
• Constipation
• Oedema (water retention/swelling)

The following side effects have also been reported less commonly:

• Certain blood disorders which may increase the risk of bleeding, bruising or infections
• Headache
• Problems with sight
• Depression
• Confusion
• Hallucination (imagining something that is not really there)

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

HOW TO STORE DICLOFENAC

Keep out of the reach and sight of children.
Store Diclofenac SR 75mg Capsules between 10oC and 25oC. Do not refrigerate. Store in the original packaging to protect the capsules from moisture.
Diclofenac Retard 100mg Capsules do not require any special storage conditions.
Do not use Diclofenac after the expiry date which is stated on the carton and blister foil. The expiry date refers to the last day of that month.
Do not use Diclofenac if you notice that the packaging or any of the capsules are damaged.
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.