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DICLOALGAN 12.5 MG SOFT CAPSULES

Active substance(s): DICLOFENAC EPOLAMINE

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Read all of this leaflet carefully before
you start taking 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.
See section 4.
What is in this leaflet:
1. What Dicloalgan is and what it is used for
2. What you need to know before you take
Dicloalgan
3. How to take Dicloalgan
4. Possible side effects
5. How to store Dicloalgan
6. Contents of the pack and other information

Package leaflet:
Information for the user

Dicloalgan 12.5 mg
Dicloalgan 25 mg
soft capsules

FI/150 (xx) xxxx Ed. I/11.17

Diclofenac epolamine

1. WHAT DICLOALGAN IS AND WHAT IT IS
USED FOR
Diclolagan contains the active substance
diclofenac epolamine.
Dicloalgan is a medicine belonging to a group
of non-steroidal anti-inflammatory drugs
(NSAIDs). This medicine is a pain reliever which
can also reduce inflammation and swelling.
Dicloalgan is used to provide short-term relief
in the following situations:
-- mild to moderate pain (such as headache,
dental pain, period pain, rheumatic pain
and muscular pain).
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE DICLOALGAN
DO NOT take Dicloalgan if:
• you are allergic to
o diclofenac epolamine or any of the other
ingredients of this medicine (listed in
section 6)
o diclofenac, acetylsalicylic acid or any
other non-steroidal anti-inflammatory
drug (NSAID)
Signs of an allergic reaction include asthma,
breathing problems, skin rash, swelling of the
face and mouth, or a runny nose
• you currently have a gastric (stomach) or
duodenal (intestinal) ulcer, bleeding or
perforation
• you have unexplained blood-forming
disorders
• you have a history of bleeding in the
digestive tract or perforation, related to
previous NSAIDs therapy

• you have had two or more episodes of
gastric (stomach) or duodenal (intestinal)
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 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
• you have or have had problems with
your blood circulation (peripheral arterial
disease)
• you have severe kidney, liver or cardiac
failure
• you are more than six months pregnant
(see also ‘Pregnancy, breast-feeding and
fertility’)
• you are under 14 years old
If any of the above applies to you talk to your
doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Dicloalgan if you:
• suffer from or have a history of any stomach
or bowel disorders including ulcerative
colitis or Crohn’s disease
• are elderly
• have kidney or liver problems
• have a condition called porphyria
• suffer from any blood or bleeding disorder
• have ever had asthma
• are breast-feeding
• have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides
• have diabetes
• are a smoker
• have recently had surgery
• are at risk of being dehydrated (e.g. by
sickness or diarrhoea)
This is because Dicloalgan might not be the
right medicine for you.
• Because it is an anti-inflammatory medicine,
the active substance in Dicloalgan may
mask the signs and symptoms of infection.
If you feel unwell and need to see a doctor,
remember to tell him or her that you are
taking Dicloalgan.
Cardiovascular disease
Medicines such as Dicloalgan may be
associated with a small increased risk for 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.
Make sure your doctor knows, before you are
given Dicloalgan

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood
pressure, raised cholesterol or raised
triglycerides
Side effects may be minimised by using the
lowest effective dose for the shortest duration
necessary.
Children and adolescents
Children and adolescents under 14 year old
must not take Dicloalgan (see also ‘Do not
take Dicloalgan’).
Other medicines and Dicloalgan
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
medicines.
Consult your doctor before taking
Dicloalgan if you use any of the following
medicines:
-- Digoxin (a medicine for strengthening the
heart), phenytoin (a medicine for treating
epilepsy) or lithium (a medicine for treating
mental disorders). Dicloalgan can increase
the concentration of these substances in
the blood.
-- Water pills and medicines to lower blood
pressure (diuretics and antihypertensives).
Dicloalgan can weaken the effect of these
medicines.
-- Potassium-sparing water pills (certain
diuretics). Dicloalgan can increase the
potassium concentration in the blood.
-- Medicines for treating heart failure and
high blood pressure (ACE inhibitors and
angiotensin II antagonists). Dicloalgan
can weaken the effect of these medicines
and can also raise the risk for kidney
dysfunction.
-- Anticoagulant medicines such as warfarin.
Like other NSAIDs, Dicloalgan may increase
the effect of these medicines.
-- Oral antidiabetic medicines. In some cases
the dosage of the antidiabetic agents may
have to be adjusted. Blood glucose level
should be monitored as a precaution.
-- Other NSAID medicines (used for pain
and inflammation e.g. ibuprofen, COX
II inhibitors and aspirin) or medicines
containing glucocorticoids. Dicloalgan
increases the risk for gastrointestinal ulcers
or bleeding.
-- Platelet aggregation inhibitors such as
acetylsalicylic acid (aspirin) and certain
antidepressants (selective serotonin
reuptake inhibitors or SSRIs). Dicloalgan
may increase the risk for gastrointestinal
bleeding.
-- Ciclosporin and tacrolimus (medicines used
to prevent transplant rejections, but also
used in the treatment of rheumatic diseases
or severe skin diseases). NSAIDs can
increase the damaging effect on the kidneys

caused by ciclosporin and tacrolimus.
-- Methotrexate. Using Dicloalgan within 24
hours before or after methotrexate can
increase the concentration of methotrexate
in the blood and lead to an increase in the
undesirable effects of this substance.
-- Medicines for treating gout containing
sulphinpyrazone or voriconazole. This can
delay the excretion of Dicloalgan, which
can result in greater concentration of
Dicloalgan in the body and an increase in
the undesirable effects of this substance.
-- Colestipol and cholestyramine. This can
induce a delay or decrease in absorption
of Dicloalgan. It is recommended to take
Dicloalgan at least one hour before or 4 to
6 hours after the other medicine.
-- Quinolones (a type of antibiotic). There
have been isolated reports of convulsions.
-- Cardiac glycosides: Concomitant use with
NSAIDs may exacerbate cardiac failure,
reduce renal filtration and increase plasma
glycoside levels.
-- Mifepristone: NSAIDs should not be
used for 8-12 days after mifepristone
administration as NSAIDs can reduce the
effect of mifepristone.
Dicloalgan with alcohol
While taking Dicloalgan you should not
drink alcohol. Alcohol can increase possible
undesirable effects of Dicloalgan, especially
tiredness and dizziness and effects on the
gastrointestinal system.
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.
Pregnancy
If you become pregnant while using
Dicloalgan, the doctor must be informed.
During the first 6 months of pregnancy, you
may only use Dicloalgan after consultation
with the doctor. During the last 3 months
of pregnancy, Dicloalgan must not be used
because of an increased risk of complications
for mother and baby.
Breast-feeding
Dicloalgan should not be taken if you are
breast-feeding as it might be harmful for
your infant. Tell your doctor if you are breastfeeding.
Fertility
Dicloalgan belongs to a group of medicines
(NSAIDs) that may affect the fertility of
women. This effect is reversible when the
medicine is withdrawn.
Therefore the use of Dicloalgan is not
recommended for women attempting to
conceive, have difficulty conceiving or who are
undergoing investigation of infertility.

Driving and using machines
When using Dicloalgan side effects such as
visual disturbances, dizziness, drowsiness,
feeling very sleepy, or other central nervous
system disturbances can occur. This effect is
increased in conjunction with alcohol.
If you are affected in this way, you should not
drive or operate machinery.
Dicloalgan contains sorbitol (E420)
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.
3. HOW TO TAKE DICLOALGAN
Swallow whole capsule with a drink of water.
To ensure the medicine works as well as
possible, take the capsule on an empty
stomach.
Adults and children aged 14 years and over:
It is important that you use the lowest dose
that controls your pain and that you do not
take Dicloalgan for longer than necessary.
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist
have told you. Check with your doctor or
pharmacist if you are not sure.
For Dicloalgan 12,5mg: Initially take 1 or
2 soft capsules, then if needed 1 or 2 soft
capsules every 4 – 6 hours. In any case, do not
take more than 6 soft capsules (75 mg) in
24-hour period.
For Dicloalgan 25mg: Initially take 1 soft
capsule, then if needed 1 soft capsule every
4 – 6 hours. In any case, do not take more
than 3 soft capsules (75 mg) in 24-hour period.
Dicloalgan should not be taken for more than
3 days. If symptoms persist or worsen consult
your doctor.
If you take more Dicloalgan than you should
If you accidentally take too much, tell your
doctor at once or go to the nearest hospital
emergency unit immediately, taking the
medicine pack with you. You may require
medical attention.
If you forget to take Dicloalgan
If you miss a dose, take one as soon as you
remember. If it is nearly time for your next
dose, skip the missed dose and take the
next capsule at the usual time. Do not take a
double dose to make up for the one that you
missed.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

Some side effects can be serious.
Stop taking Dicloalgan and tell your doctor
at once if you notice:
• severe pain in the upper abdomen, feeling
sick, being sick
• vomiting of blood or black particles, black
stool or blood in the stool
• allergic reactions such as skin rash, itching,
bruising, painful red areas, peeling or
blistering
• wheezing or shortness of breath
(bronchospasm), difficulty in swallowing,
collapse
• swollen face, lips, hands or fingers
• yellowing of your skin or your eyes
• persistent sore throat or high temperature,
unusual bleeding or bruising
• an unexpected change in the amount of
urine produced and/or its appearance.
• Mild cramping and tenderness of the
abdomen, starting shortly after the start of
the treatment with Dicloalgan 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).
Medicines such as Dicloalgan may be
associated with an increased risk of heart
attack (“myocardial infarction”) or stroke.
The side effects listed below have also been
reported:
Common (may affect up to 1 in 10 people)
• Headache, dizziness, vertigo
• Nausea, vomiting, diarrhoea, digestive
disorders (dyspepsia), abdominal pain,
flatulence, loss of appetite
• Skin rash and itching.
Uncommon (may affect up to 1 in 100
people)
• Increase in liver enzyme values in the blood
Rare (may affect up to 1 in 1,000 people)
• Hypersensitivity, anaphylactic and
anaphylactoid reactions (severe allergic
reactions including fall in blood pressure
and shock)
• Allergic swelling including face oedema
(angioneurotic oedema)
• Drowsiness
• Constriction of the airways (asthma)
including shortness of breath (dyspnoea)
• Inflammation of the stomach (gastritis),
gastric (stomach) or duodenal (intestinal)
ulcer (with or without bleeding or
perforation)
• Hepatitis (liver inflammation), jaundice
• Hives (urticaria)
• Oedema (fluid retention in the body)

Very rare (may affect up to 1 in 10,000
people)
• Disorders of red and white blood cell
formation
• Disorientation, depression, insomnia,
nightmare, irritability, psychotic disorder
• Sensitivity disorders (paraesthesia), memory
impairment, fits or spasms, anxiety, tremor,
meningitis unrelated to an infection, taste
disturbances,
• Visual disturbance, blurred or double vision
• Noises in the ear (tinnitus), hearing impaired
• Palpitations, chest pain, heart muscle
weakness (heart failure),
• High blood pressure (hypertension),
inflammation of the blood vessels (vasculitis)
• Inflammation of the lungs (pneumonitis),
• Inflammation of the large bowel (colitis),
including bleeding and worsening of
Crohn’s disease or ulcerative colitis,
constipation
• Inflammation of the oral mucosa
(stomatitis), inflammation of the tongue,
oesophageal lesions (damage to the gullet),
formation of membrane-like constrictions
in the bowel, inflammation of the pancreas
(pancreatitis)
• Liver failure
• Skin rash (including eczema and blisters),
sensitivity to light, small areas of bleeding in
the skin, severe skin reactions such as rash
with blister formation (e.g. Stevens-Johnson
syndrome, toxic epidermal necrolysis /
Lyell’s syndrome), loss of hair
• Acute kidney dysfunction (renal failure),
blood in the urine (haematuria), protein in
the urine (proteinuria), nephrotic syndrome
(fluid retention in the body and high
levels of protein leaking into the urine),
kidney tissue damage (interstitial nephritis,
papillary necrosis).
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme; website www.mhra.gov.uk/
yellowcard or search for MHRA Yellow Card
in the Google Play or Apple App Store. By
reporting side effects you can help provide
more information on the safety of this
medicine.
5. HOW TO STORE DICLOALGAN






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 and
blister after “EXP”. The expiry date refers
to the last day of that month.
Store below 25°C.
Store in the original package in order to
protect from light and moisture.

6. CONTENTS OF THE PACKS AND OTHER
INFORMATION
What Dicloalgan contains
The active substance is diclofenac epolamine.
For Dicloalgan 12,5mg: Each soft capsule
contains diclofenac as 15.38 mg diclofenac
epolamine equivalent to 12.5 mg diclofenac
potassium.
For Dicloalgan 25mg: Each soft capsule
contains diclofenac as 30.76 mg diclofenac
epolamine equivalent to 25 mg diclofenac
potassium.
The other ingredients are:
Capsule content:
Macrogol 600, glycerol anhydrous, purified
water
Capsule shell:
Gelatin, glycerol anhydrous, sorbitol
liquid partially dehydrated (E420),
hydroxypropylbetadex, sodium hydroxide,
purified water.
What Dicloalgan looks like and contents of
the pack
For Dicloalgan 12,5mg: Clear, yellowish
coloured, oval gelatin soft capsule with a size
of about 0.8 cm containing a slightly viscous
solution.
For Dicloalgan 25mg: Clear, yellowish
coloured, oval gelatin soft capsule with a size
of about 1 cm containing a slightly viscous
solution.
The soft capsules are packed in blisters.
For Dicloalgan 12,5mg:
Pack sizes: 10, 20, 30 or 40 soft capsules.
For Dicloalgan 25mg:
Pack sizes: 10 or 20 soft capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder
Conventia Medical LLP,
First Floor St Peter’s House
Market Place, Tring
Hertfordshire HP23 5AE
United Kingdom.
Manufacturer
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia 2
26900 Lodi, Italy
This leaflet was last revised in 07.2017.

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