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Package leaflet: Information for the patient

Econac® 100mg Suppositories

Diclofenac Sodium

The name of your medicine is Econac 100mg Suppositories, it will be referred to as Econac Suppositories for ease here after.

What is in this leaflet:

1.    What are Econac Suppositories and what they are used for

2.    What you need to know before you use Econac Suppositories

3.    How to use Econac Suppositories

4.    Possible side effects

5.    How to store Econac Suppositories

6.    Contents of the pack and other information

1. WHAT ARE ECONAC SUPPOSITORIES AND WHAT ARE THEY USED FOR

Econac Suppositories contain diclofenac and belong to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs). These medicines reduce pain, swelling and ease inflammation, in conditions affecting the joints, muscles and tendons including:

-    Rheumatoid arthritis, osteoarthritis, acute gout, ankylosing spondylitis

-    Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures

-    Tendonitis, tenosynovitis, bursitis.

They are also used to treat pain and inflammation associated with dental and minor surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ECONAC SUPPOSITORIES

DO NOT use Econac Suppositories if:

•    you know that you are allergic to Diclofenac Sodium, aspirin, ibuprofen or any other NSAIDs or any of the other ingredients of this medicine (listed in section 6)

•    signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, runny nose, skin rash or any other allergic type reaction

-    you have now, or have ever had a stomach (gastric) or duodenal (peptic) ulcer or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)

-    you have had stomach or bowel problems after you have taken other NSAIDs

-    you have severe heart, kidney or liver failure

•    you have established heart disease and/or cerebrovascular disease e.g. if you have had a heart attack, stroke, ministroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages

•    you have or have had problems with your blood circulation (peripheral arterial disease)

•    you are more than six months pregnant

•    you suffer from ineffectual straining to empty the bowels, diarrhoea or rectal bleeding

TbkB special care with Econac Suppositories and check with your

doctor or pharmacist before using your medicine If:

•    you suffer from any stomach or bowel disorders including

ulcerative colitis or Crohn's disease

•    you suffer from any disorder of the liver or kidneys

•    you have a condition called porphyria

•    you suffer from haemophilia (a disorder of blood clotting) or any other bleeding disorder

•    you suffer from bronchial asthma or any allergic disease

•    you are breast feeding

•    you have angina, blood clots, high blood pressure or raised cholesterol or raised triglycerides

•    you have heart problems, or have you had a stroke, or do you think 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 smoke

-    you have diabetes

-    you have Lupus (systemic lupus erythematosus) or any similar condition.

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

If you are having a medical examination, tell the doctor that you are using Econac Suppositories as they reduce the signs of fever and inflammation which would otherwise be noticed.

Other medicines and Econac suppositories:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Econac Suppositories may affect or be affected by the following medicines:

•    medicines for the treatment of diabetes

-    anticoagulant tablets (blood thinning tablets like warfarin)

•    diuretics (water tablets)

-    lithium (used to treat some mental problems)

•    methotrexate (for some inflammatory diseases and some cancers)

-    ciclosporin or Tacrolimus (used to treat some inflammatory diseases and after transplants)

-    trimethoprim (a medicine used to prevent or treat urinary tract infections)

•    quinolone antibiotics (for infections)

•    any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen

•    mifepristone (a medicine used to terminate pregnancy)

•    cardiac glycosides (for example digoxin), used to treat heart problems

•    medicines known as SSRIs used to treat depression

•    oral steroids (an anti-inflammatory drug)

•    medicines used to treat heart conditions or high blood pressure, for example betablockers or ACE inhibitors

•    voriconazole (a medicine used to treat fungal infections)

-    phenytoin (a medicine used to treat seizures)

•    colestipol/cholestyramine (used to lower cholesterol).

Pregnancy, breast-leeding and fertility:

Pregnancy:

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. Although not common, abnormalities have been reported in babies whose mothers have taken NSAIDs during pregnancy. You should not use Econac Suppositories during the last 3 months of pregnancy as it may affect the baby’s circulation.

•    Are you trying for a baby? Using Econac Suppositories may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.

Driving and using machines:

Very occasionally people have reported that Econac Suppositories have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.

Other special warnings

•    you should take the lowest dose of Econac Suppositories for the shortest possible time, particularly if you are underweight or elderly

•    there is a small increased risk of heart attack or stroke when you are taking any medicine like Econac Suppositories. The risk is higher if you are taking high doses for a long time. Always follow the doctors instructions on how much to take and how long to take it for

-    whilst you are taking these medicines your doctor may want to give you a check-up from time to time

-    if you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms

•    because it is an anti-inflammatory medicine, Econac Suppositories may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Econac Suppositories.

Econanc suppositories are not recommended for use in children.

3. HOW TO USE ECONAC SUPPOSITORIES

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose will be on the pharmacist's label. Check the label carefully. If you are not sure, ask your doctor or pharmacist.

Keep using the suppositories for as long as you have been told,

unless you have any problems. In that case, check with your doctor. Suppositories are designed for insertion into the back passage (rectum). Never take them by mouth.

The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.

Adults: One Econac Suppository may be inserted as a once daily treatment, usually at night. As a general principle, the smallest effective dose should be used, and for the shortest time. Side effects can worsen with increased use.

Elderly: If you are elderly, your doctor may want to reduce the usual adult dosage and to check that the medicine is suiting you, especially during the first four weeks of treatment. Make sure to follow your doctor’s instructions carefully and to keep your appointments.

Use In children and adolescents Children: Econac Suppositories are not recommended for use in children. Where necessary, you can use other medicines (tablets taken by mouth) with your suppository. Econac Suppositories may be combined with oral (to be taken by mouth) tablets.

Your doctor may want to monitor you.

INSERTING YOUR MEDICINE:

Empty your bowels before inserting a suppository.

Wash your hands.

Tear the foil wrapping apart at notch and take out the suppository.

Lie on one side with your knees pulled up towards your chest.

Gentiy push the suppository pointed end first into your back passage (rectum) with your finger. Push the suppository up as far as possible. Lower your legs, and if possible, remain still for a few minutes.

If you feel your body wanting to expel the suppository, try to resist this. Lie still and press your buttocks together. It is important to keep the suppository in the rectum to allow it to meit and the medicine to be absorbed. Pushing the suppository high into the rectum with your finger will help to reduce this feeling.

Wash your hands.

If you use more Econac Suppositories than you should:

If you (or someone else) use too many Econac Suppositories, you may experience headache, feeling sick, vomiting, stomach pain, black colored stools, diarrhea, fainting, seizures or even kidney or liver damage in sever cases. In such situations contact your doctor, or nearest hospital, immediately for advice. Bring the remaining suppositories with you.

If you forget to use Econac Suppositories:

If you miss a dose, leave it out and use the next dose whenever it is due. After that, just carry on as before.

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

4. POSSIBLE SIDE EFFECTS

Econac Suppositories are suitable for most people, but, like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious.

Stop using the suppositories and tell your doctor straight away If you notice:

•    mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Econac Suppositories and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data)

•    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 faeces

•    allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering

•    wheezing or shortness of breath (bronchospasm)

•    swollen face, lips, hands or fingers

•    yellowing of your skin or the whites of your eyes

•    persistent sore throat or high temperature

•    an unexpected change in the amount of urine produced and/or its appearance.

If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.

Econac Suppositories may also occasionally cause itching or burning in your back passage or make any haemorrhoids (piles) worse.

The side effects listed below have also been reported.

Common side effects (may affect up to 1 in 10 people):

•    stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite

•    headache, dizziness, vertigo

•    skin rash or spots

•    raised levels of liver enzymes in the blood.

Rare side effects (may affect up to 1 In 1,000 people):

•    stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly)

•    gastritis (inflammation, irritation or swelling of the stomach lining)

- vomiting blood

•    diarrhoea with blood in it or bleeding from the back passage

•    black, tarry faeces or stools

•    drowsiness, tiredness

•    skin rash and itching

•    fluid retention, symptoms of which include swollen ankles

•    liver function disorders, including hepatitis and jaundice

•    irritation where the suppository is inserted.

Very rare side effects (may affect up to 1 in 10,000 people): Effects on the nervous system:

Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, confusion, hallucinations, malaise, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation.

Effects on the stomach and digestive system:

Constipation, inflammation of the tongue, mouth ulcers, taste changes, lower gut disorders (including inflammation of the colon, or worsening of ulcerative colitis or Crohn’s disease).

Effects on the heart, chest or blood:

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).

Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness).

Effects on the liver or kidneys:

Kidney or severe liver disorders, presence of blood or protein in the urine. Effects on skin or hair:

Serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight. Hair loss.

Effects on reproductive system:

Impotence

Other side effects that have also been reported Include:

Inflammation of the pancreas, facial swelling, inflammation of the lining of the brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye, disturbances of sensation.

Do not be alarmed by this list - most people use Econac Suppositories without any problems.

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

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. You can also report side effects dinectiy via the Yellow Card Scheme at www.mhra.gov.uktyellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ECONAC SUPPOSITORIES

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

Do not use this medicine after the expiry date which is stated on the Carton after ‘Expiry date’. The Expiry date refers to last day of that month. Do not store above 25°C. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Econac Suppositories contain:

The active substance is diclofenac sodium. The other ingredient is hard fat.

What Econac Suppositories look like and contents of the pack:

Econac Suppositories are white, torpedo shaped with a uniform white surface. One suppository contains 100mg diclofenac sodium. One package contains 10 suppositories for rectal use only.

Marketing Authorization Holder:

Mercury Pharma Group Ltd.,

Capital House, 85 King William Street,

London EC4N 7BL, UK Manufacturer:

Dr. R. Pfleger Chemische Fabrik GmbH,

Dr.-Robert-Pfleger-Str., Bamberg, 96052, Germany.

This leaflet was last revised in August 2016.

Econac is a registered bade mark of Mercury Pharma Group Ltd.

100059/LF/038/05 259130 004