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DICLOALGAN 12.5 MG SOFT CAPSULES

Active substance(s): DICLOFENAC EPOLAMINE

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Package leaflet: Information for the user
Dicloalgan 12.5 mg soft capsules
Dicloalgan 25 mg soft capsules

Diclofenac epolamine

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

1. What Dicloalgan is and what it is used for
Dicloalgan 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 symptomatic 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)
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 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:
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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). This 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: Concommitant 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.
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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 breast-feeding.
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 12.5 mg
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 25 mg
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
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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
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)
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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 12.5 mg
Each soft capsule contains diclofenac as 15.38 mg diclofenac epolamine equivalent to 12.5 mg diclofenac
potassium.
For Dicloalgan 25 mg
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

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For Dicloalgan 12.5 mg
Clear, yellowish coloured, oval gelatin soft capsule with a size of about 0.8 cm containing a slightly viscous
solution.
For Dicloalgan 25 mg
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 12.5 mg
Pack sizes: 10, 20, 30 or 40 soft capsules.
For Dicloalgan 25 mg
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
UK
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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Expand Transcript

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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