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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 and inflammation, and bring down a high temperature.

Econac Suppositories are used to treat a number of painful conditions affecting the joints and muscles, fractures, dislocation, back pain, dental and other minor surgeries.

This medicine is a suppository which works when it is placed in your back passage (rectum). It should never be taken by mouth.

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, any other NSAIDs or any of the other ingredients of this medicine (listed in section 6)

•    You have ever had a peptic ulcer or bleeding in your gut

•    You suffer from any gut disorders, for example ulcerative or inflammatory disease of the bowel, rectum (back passage) or anus

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

•    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.

Take special care with Econac Suppositories and check

with your doctor or pharmacist before using your

medicine if:

•    You are pregnant or you are breast feeding

•    You have ever had a peptic ulcer or any other disease of the stomach or intestine

•    You suffer from bronchial asthma or any allergic disease

•    You suffer from any disorder of the liver or kidneys

•    You have excessive fluid loss (e.g. through vomiting or diarrhoea), salt restriction or heart failure

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

•    You smoke

•    You have diabetes

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

•    You have a condition called porphyria

•    You are an elderly patient

•    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. Medicines such as Econac Suppositories 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.

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:

•    Anticoagulant tablets (to prevent blood clots, e.g. warfarin)

•    Antihypertensives (for the treatment of high blood pressure for example betablockers or ACE inhibitors)

•    Diuretics (to make you pass more water)

•    Lithium (for depression)

•    Medicines for the treatment of heart failure (e.g. digoxin)

•    Corticosteroids (e.g. for asthma and various inflammatory conditions)

•    Antibiotics (for an infection, e.g. quinolone)

•    Any other NSAID (for painful or inflammatory conditions e.g. aspirin)

•    Medicines for the treatment of diabetes

•    Mifepristone (used to terminate pregnancies)

•    Methotrexate which can be used to treat certain tumours and other diseases including psoriasis and rheumatoid arthritis

•    Ciclosporin or Tacrolimus (used to suppress the body’s immune system, e.g. following transplants or in diseases such as psoriasis and rheumatoid arthritis)

•    Zidovudine (an anti-viral drug)

•    SSRIs such as fluoxetine or sertaline (for depression). Pregnancy, breast-feeding and fertility:

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:

NSAIDs like this medicine may sometimes cause symptoms such as drowsiness which could make it unsafe to drive or use machines. If you notice any such symptoms, do not drive or operate machinery and ask your doctor or pharmacist for advice.

3. HOW TO USE ECONAC SUPPOSITORIES

Suppositories are designed for insertion into the back passage (rectum). Never take them by mouth.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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:

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.

Gently 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 melt 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) uses too many Econac Suppositories, 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:

•    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. Up to 1 in 10 people have experienced:

•    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.

Between 1 in 100,000 and 1 in 100 people have experienced:

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

•    Drowsiness, tiredness

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

•    Skin rash and itching

•    Fluid retention, symptoms of which include swollen ankles

•    Liver function disorders, including hepatitis and jaundice. Isolated side-effects, reported in less than 1 in 100,000 people include:

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). 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).

Effects on the liver or kidneys:

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

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

Other effects:

Inflammation of the pancreas, impotence.

Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.

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.

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 Authorisation 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 September 2014.    100059/LF/5

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

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