PACKAGE LEAFLET: INFORMATION FOR THE USER
Diclofenac Na CF 25 mg, gastro-resistant tablets
Diclofenac Na CF 50 mg, gastro-resistant tablets
Diclofenac Sodium
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 Diclofenac Na CF is and what it is used for
2. What you need to know before you take Diclofenac Na CF
3. How to take Diclofenac Na CF
4. Possible side effects
5. How to store Diclofenac Na CF
6. Contents of the pack and other information
1. WHAT DICLOFENAC NA CF IS AND WHAT IT IS USED FOR
This medicine is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines are used to reduce pain and inflammation.
This medicine relieves the symptoms of an inflammation such as pain, swelling and also reduces
fever. It does not affect the cause of the inflammation or fever.
The medicine is active against the disorders listed below:
• inflammation and deterioration of the function of the joints caused by rheumatism
• inflammation of one or more joints (arthritis)
• deterioration of joints (arthrosis) including joints in the spine
• attrition of the shoulder joint, known as frozen shoulder
• pain and swelling caused by an accident or after dental or orthopaedic surgery
• treatment of painful or irregular periods
• diseases accompanied by fever, particularly for infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOFENAC NA CF
Do not take Diclofenac Na CF
• if you are allergic to any of the ingredients of this medicine. You can find these ingredients in
section 6;
• if you have a stomach or gastrointestinal ulcer;
• have a gastrointestinal haemorrhage (indications: blood in your faeces or black, tarry excrement);
• if you have ever had gastrointestinal problems such as an ulcer, haemorrhage or black faeces or,
when in the past, after taking NSAIDs, you have had stomach problems or heartburn;
• if you are in the last 3 months of pregnancy;
• if you have had an asthma attack, rash with severe itching and hives (urticaria) after taking other
NSAIDs such as acetylsalicylic acid (aspirin) or ibuprofen;
• if you have haemorrhages or other bleeding disorders;
• if you have been diagnosed with a heart or cerebrovascular disorder; for instance, you have had a
heart attack, stroke, mini-stroke (TIA), blocked heart or brain arteries, or you have undergone surgery
for this (such as bypass surgery);
• if you have, or have had, problems with your blood circulation (peripheral arterial disease);
• if you have a blood picture disorder;
• if you have reduced production of blood cells in your bone marrow (bone marrow depression);
• if you have a serious liver disorder;
• if you have seriously reduced heart function;
• if you have a serious kidney disorder.
When you have any of the disorders listed above or when there are issues you are not sure about,
contact your doctor or pharmacist.
Warnings and precautions
• at the first signs of rash, damage to the mucous membrane, or any other sign of allergy;
• in case of gastroenteritis (colitis ulcerosa or Crohn's disease);
• in case of asthma, hay fever or other persistent problems of the respiratory system such as nasal
polyps, chronic obstructive lung disease of chronic infection of the respiratory tract;
• in case of reduced function of liver or kidney;
• if you think you are dehydrated, for instance because of diarrhoea, illness or major surgery;
• in case of coagulation or other blood disorders such as the rare liver disorder porphyria;
• in case of the inflammatory disease systemic lupus erythematosus or another connective tissue
disorder;
• in case of chickenpox (varicella).
Medicines such as Diclofenac Na CF might be associated with a slightly increased risk of a heart
attack (heart infarct) or stroke. Do not take more than the prescribed dose and do not take the
medicine for longer than the prescribed treatment.
Before starting to use diclofenac, tell your doctor:
• if you smoke
• if you have diabetes mellitus
• if you have an oppressive, painful feeling in the chest (angina), blood clots, high blood pressure or
an increased concentration of cholesterol or triglycerides (particular fats) in your blood.
The risk of side effects can be reduced by taking the lowest possible dose for the shortest time
possible.
Talk to your doctor or pharmacist if one of the warnings above applies to you.
Older patients can be more sensitive to the effects of this drug than other adults. If you are over 65
years of age, it is important to take the lowest dose that still is effective against your disorder.
Especially for elderly patients it is important to immediately inform their doctor of any side effects.
Diclofenac can reduce or mask symptoms of infections such as headaches or high body temperatures.
This can make it harder to detect or treat the infection. If you do not feel well and visit your doctor, do
not forget to mention you are taking this medicine.
Other medicines and Diclofenac Na CF
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
This also applies to medication for which you do not need a prescription.
The medications listed below can increase the risk of bleeding or ulcers if they are used together with
this medicine. Tell your doctor if you use one of the medications listed below:
• corticosteroids, used to treat inflamed parts of the body;
• medicines that combat blood clotting (anticoagulants and inhibitors of blood platelet aggregation);
• certain medicines against depression, the selective serotonin re-uptake inhibitors (SSRIs);
• other medications used to treat pain, swelling and other inflammation symptoms (NSAIDs), such as
acetylsalicylic acid (aspirin) or ibuprofen. Intestinal tract haemorrhaging or development of ulcers can
be side effects of all NSAIDs, including this medicine. This problem, which can be more serious in
the elderly, can occur at any time during treatment and may or may not be accompanied by warning
signs or a prior history of serious gastrointestinal tract problems.
Also inform your doctor if you are using one of the medications listed below:
• lithium, a medicine against depression;
• digoxin, a medicine used for certain heart disorders;
• certain medicines that suppress the natural immune response (methotrexate and ciclosporin);
• oral medicines that lower blood sugar level (oral anti-diabetics);
• diuretics;
• medicines that lower blood pressure (anti-hypertensives such as ACE inhibitors and beta blockers);
• the group of medicines against certain bacterial infections (quinolones);
• certain medicines that are used when blood cholesterol is too high (colestipol and cholestyramine);
• sulfinpyrazone (a medication used to treat gout) or voriconazole (a medication used to treat fungal
infections);
• phenytoin, a medicine used to treat epilepsy.
Pregnancy and breast-feeding
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.
Use of this medicine during pregnancy has not been investigated. Consequently, this medicine should
only be used exactly as indicated by your doctor.
This medicine belongs to the category of medicines (NSAIDs) known to inhibit contractions in the
last 3 months of pregnancy and able to cut off blood supply to the unborn child. Consequently, this
medicine cannot be used in the last 3 months of the pregnancy.
Like other NSAIDs, this medicine might make it more difficult to become pregnant. If you are
planning to get pregnant or have had problems getting pregnant, it is better not to use this medicine.
Also do not use diclofenac when you are breast-feeding. Small amounts of diclofenac could be
secreted in the breast milk.
Driving and using machines
Normally, this medicine does not affect your ability to drive or to operate machinery. This medicine
might have side effects such as dizziness, sleepiness or blurred vision. If that happens, you are not
allowed to drive a car or operate machinery and you should immediately contact your doctor.
Diclofenac Na CF gastro-resistant tablets contain lactose
This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars,
then contact him or her before you take this medicine.
3. HOW TO TAKE DICLOFENAC NA CF
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Your doctor will tell you how many tablets of Diclofenac Na CF you will have to take and for how
long. It is important to take the lowest possible dose, sufficient to treat the inflammation or pain
effectively, during as short a period as possible. Depending on your initial reaction to the treatment,
your doctor can prescribe a higher or lower dose. Never take more than the dose prescribed by your
doctor.
Dose
Divide your daily dose into 2 or 3 portions. The maximum daily dose is 150 mg. This daily dose can
be administered in different ways such as tablets and suppositories. Doses of 50 mg and more are not
appropriate for children younger than 12 years of age. Your doctor will give you a dosing schedule.
Rheumatic joint inflammations (rheumatoid arthritis):
For adults, the initial daily dose is 150 mg; the maintenance dose is 75 - 100 mg/day.
For children the daily dose amounts to 1½ to 2 mg per kg of bodyweight. Because of its strength,
Diclofenac Na CF 50 mg can only be used for children older than 12 years.
Joint wear (arthrosis):
Depending on the severity of the pain, the initial daily dose of diclofenac is 100 - 150 mg. The
maintenance dose generally is 75 - 100 mg/day.
Frozen shoulder (periarthritis humeroscapularis):
The initial dose depends on the pain level. Normally it is 150 mg. Based on its effect the dose can
subsequently be reduced.
Post-surgery pain and swelling after an accident:
The initial daily dose is 150 mg and can subsequently be reduced depending on the complaints
experienced.
Treatment of painful or irregular periods:
The dose is determined for each patient individually. The initial daily dose is 50-100 mg and can be
increased to a maximum of 150 mg, if needed; in exceptional cases, the dose can be increased to
200 mg.
Fever treatment:
For this purpose, low daily dosages of 0.5 mg/kg bodyweight are administered, divided over 2-3
doses. Because of these low dosages, gastro-resistant tablets are not appropriate for use in children.
Administration
Swallow tablets whole and without chewing, preferably prior to a meal.
If your kidneys no longer work well
Because of the role prostaglandins play in maintaining perfusion of the kidney, very prudent use of
diclofenac is advised for patients with reduced heart or kidney function. Regular checks of the
perfusion of these organs is advised. Patients who use diuretics and those who have undergone major
surgery also need to be checked regularly. Prudence is also advised for elderly patients. In case of
prolonged use, regular checks of liver and kidney function are recommended.
When you notice, or think, that Diclofenac Na CF is too active, or not active enough, talk to your
doctor or pharmacist.
If you take more Diclofenac Na CF than you should
If you have accidentally taken too much of this medicine, contact your doctor or pharmacist
immediately. Try to remember how many tablets, and of which strength, you took. Signs of an
overdose could be: vomiting, diarrhoea, dizziness, ringing in the ears (tinnitus), fits/convulsions,
intense stomach pain or bloody or tarry stool.
If you forget to take Diclofenac Na CF
If you have forgotten to take a dose, take it as soon as you remember. If it is nearly time to take your
next dose, do so at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Diclofenac Na CF
Do not stop taking this medicine all of a sudden. Changing or interrupting your treatment can only be
done after approval of your doctor; stopping suddenly could aggravate your situation.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be:
• very common (in more than 1 in 10 users)
• common (in 1 to 10 in 100 users)
• uncommon (in 1 to 10 in 1,000 users)
• rare (in 1 to 10 in 10,000 users)
• very rare (in fewer than 1 in 10,000 users)
Blood and lymphatic system disorders
Very rare:
Blood disorders (shortage of blood platelets) accompanied by bruises and a bleeding
tendency (thrombocytopaenia); blood disorders (shortage of blood platelets)
accompanied by an increased sensitivity to infections (leukopaenia); anaemia; very
serious blood disorders (shortage of blood platelets) accompanied by sudden high
fever, intense soreness of the throat and mouth sores (agranulocytosis).
Immune system disorders
Rare:
(Serious) allergic reactions (including low blood pressure and shock)
Very rare:
Sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue),
breathing difficulties and/or itching and rash, often as an allergic reaction
(angioneurotic oedema).
Psychiatric disorders
Very rare:
Confusion (disorientation); (serious) depression; sleeplessness; nightmares;
irritability; mental disorders including delusions, hallucinations and/or confusion;
anxiety.
Nervous system disorders
Common:
Headache; dizziness.
Rare:
Drowsiness.
Very rare:
Sensations of tickling, itching, or tingling without cause (paraesthesia); memory
disorders; fits/convulsions; shaking; stiff neck (meningitis symptoms); taste
disorders; stroke/brain haemorrhage also known as cerebrovascular accident (CVA).
Eye disorders
Very rare:
Visual defects; blurred and/or double vision.
Ear and labyrinth disorders
Common:
Imbalance problems accompanied by nausea (vertigo).
Very rare:
Ringing in the ears (tinnitus); damaged hearing.
Cardiac and vascular disorders
Very rare:
Palpitations; chest pain; insufficient pumping power of the heart (heart failure); heart
infarction; elevated blood pressure (hypertension); vascular inflammation (vasculitis).
Respiratory disorders
Rare:
Asthma (including shortness of breath).
Very rare:
Benign inflammation of lung tissue (pneumonitis).
Gastrointestinal disorders
Common:
Nausea; vomiting; diarrhoea; digestive disorders with symptoms such as a full feeling
in the upper abdomen, pain in the stomach area, burping, nausea, vomiting, heartburn
(dyspepsia); abdominal pain; wind (flatulence); no appetite (anorexia).
Rare:
Inflammation of the lining of the stomach (gastritis); bleeding of the gastrointestinal
tract; vomiting of blood; bloody diarrhoea; blood in stool; ulcer in gastrointestinal
tract (with or without bleeding or perforation).
Very rare:
Colon inflammation (colitis) including bleeding inflammation of colon and
aggravation of ulcer-like inflammation of the colon (colitis ulcerosa) or recurrent
(serious) intestinal inflammation (Crohn's disease); constipation; inflammation of
mucous membranes of mouth (stomatitis); inflammation of the tongue (glossitis);
abnormal oesophagus; narrowing of the intestine; inflamed pancreas accompanied by
intense pain of upper abdomen radiating to back and nausea and vomiting
(pancreatitis).
Hepatobiliary disorders
Common:
Increased levels of certain enzymes.
Rare:
Inflamed liver (hepatitis) (occasionally fatal); jaundice (yellow discoloration of skin
or eyes).
Very rare:
Liver disorders, necrosis of liver tissue; liver failure.
Skin disorders
Common: Rash.
Rare:
Rash with intense itching and hives (urticaria).
Very rare:
Appearance of vesicles; eczema, redness of the skin (erythema); rash with irregular,
red (moist) patches (erythema multiforme); serious hypersensitivity reaction with
(high) fever, red skin patches, joint pains and/or eye inflammation (Stevens-Johnson
syndrome); serious, sudden (hypersensitivity) reaction accompanied by high fever
and skin blisters/flaking (toxic epidermal necrolysis); serious skin inflammation with
loss of epidermis and hair (exfoliative dermatitis); hair loss; hypersensitivity to light
or sunlight; haemorrhages in skin and mucous membranes; itching.
Renal and urinary disorders
Very rare:
Acute inadequate kidney function (kidney failure); blood in the urine; excessive
protein level in urine (proteinuria); fever and pain in the flanks because of reduced
kidney function (nephrotic syndrome); kidney inflammation accompanied by blood in
the urine, fever, pain in the flanks (interstitial nephritis); kidney tissue necrosis (renal
papillary necrosis).
General disorders and administration site conditions
Rare:
Fluid accumulation (oedema).
Most side effects are gastrointestinal in nature. Stomach ulcers, bleeding or a breakthrough of the
gastrointestinal tract, sometimes fatal, especially amongst the elderly, can occur (see section 2).
Nausea, vomiting, diarrhoea, flatulence, constipation, digestive disorders, abdominal pain, blood in
the stool, blood vomiting, inflammation of the mucous membranes of the mouth, aggravation of colon
inflammations and Crohn's disease (chronic inflammation of the small intestine and/or colon) (see
section 2) have been reported after administration. Inflammation of the lining of the stomach has been
observed less often.
Medicines such as Diclofenac Na CF might be associated with a slightly increased risk of a heart
attack (heart infarct) or stroke.
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. U can also report side effects directly via the Netherlands Pharmacovigilance
Centre Lareb, website: www.lareb.nl. By reporting side effects, you can help provide more
information on the safety of the medicine.
5. HOW TO STORE DICLOFENAC NA CF
Keep this medicine out of the sight and reach of children.
Store in the original package to protect from moisture.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the outside packaging and the blister
packaging after ‘Do not use after’ or ‘EXP’. A month and a year are shown there. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste, and don't flush them down the
toilet. 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 Diclofenac Na CF contains
Diclofenac Na CF 25 mg, gastro-resistant tablets
• The active substance in this medicine is diclofenac sodium. One tablet contains 25 mg of diclofenac
sodium.
• The other ingredients are: O-acetyltriethyl citrate, cellulose, hydroxypropyl methylcellulose, red and
yellow iron oxide (E 172), lactose, corn starch, polyethylene glycol 400, polyethylene glycol 6000,
polymethyl acrylate, povidone, talcum, titanium dioxide (E 171), colloidal anhydrous silica and
magnesium stearate.
Diclofenac Na CF 50 mg, gastro-resistant tablets
• The active substance in this medicine is diclofenac sodium. One tablet contains 50 mg of diclofenac
sodium.
• The other ingredients are: O-acetyltriethyl citrate, cellulose, hydroxypropyl methylcellulose, red and
yellow iron oxide (E 172), lactose, corn starch, polyethylene glycol 400, polyethylene glycol 6000,
polymethyl acrylate, povidone, talcum, titanium dioxide (E 171), colloidal anhydrous silica and
magnesium stearate.
What Diclofenac Na CF looks like and contents of the pack
Diclofenac Na CF 25 mg, gastro-resistant tablets, are light brown, round, slightly domed and have a
diameter of 6 mm. The tablets are available in quantities of 30, 50, 100, 150, 200, 250, 300, 500,
1000, 2000, 2500 or 5000 tablets in a PP bottle with a PE lid and 10 tablets in a PVC-AI or
PVC/PVDC-AI blister, packed in multiples of 10 tablets.
Diclofenac Na CF 50 mg, gastro-resistant tablets, are light brown, round, slightly domed and have a
diameter of 8 mm. The tablets are available in quantities of 30, 50, 100, 150, 200, 250, 300, 500,
1000, 2000, 2500 or 5000 tablets in a PP bottle with a PE lid and 10 tablets in a PVC-AI of
PVC/PVDC-AI blister, packed in multiples of 10 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Authorisation holder
Centrafarm B.V.
Nieuwe Donk 3
NL-4879 AC Etten-Leur
The Netherlands
Manufacturer
Centrafarm Services B.V.
Nieuwe Donk 9
NL-4879 AC Etten-Leur
The Netherlands
Recorded in the register under:
RVG 17257 Diclofenac Na CF 25 mg, gastro-resistant tablets
RVG 17258 Diclofenac Na CF 50 mg, gastro-resistant tablets
This leaflet was last revised in December 2013.
Rev. no.. 10.0
9256341 1401
Logo: centrafarm
pharmaceutical products
Nieuwe Donk 3 NL-4879 AC Etten-Leur