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ECONAC 100MG SUPPOSITORIES

Active substance(s): DICLOFENAC SODIUM / DICLOFENAC SODIUM / DICLOFENAC SODIUM

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Package leaflet: Information for the patient

Econac® 100mg Suppositories
Diclofenac Sodium
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
Keep this leaflet. You may need to read it again. If you have
any further questions, ask your doctor or pharmacist. This
medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness
are the same as yours. If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
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.

• 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:

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

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.

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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