PACKAGE LEAFLET: INFORMATION FOR THE USER
Diclofenac BMM Pharma 25 mg gastro-resistant tablets
Diclofenac BMM Pharma 50 mg gastro-resistant tablets
Diclofenac sodium
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Diclofenac BMM Pharma is and what it is used for
2.
Before you use Diclofenac BMM Pharma
3.
How to use Diclofenac BMM Pharma
4.
Possible side effects
5.
How to store Diclofenac BMM Pharma
6.
Further information
1.
WHAT DICLOFENAC BMM PHARMA IS AND WHAT IT IS USED FOR
Diclofenac BMM Pharma belongs to the group of medicines known as non-steroidal
antiinflammatory/antirheumatic drugs (NSAIDs). It has an antiinflammatory, analgesic and feverreducing effect.
Diclofenac BMM Pharma is used to treat rheumatic disorders such as rheumatoid arthritis
2.
BEFORE YOU USE DICLOFENAC BMM PHARMA
Do not use Diclofenac BMM Pharma
if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of Diclofenac
BMM Pharma.
if you have or have a history of a recurrent stomach ulcer or duodenal ulcer,bleeding or
perforation
if you have a history of gastrointestinal bleeding or perforation related to previous use of
painkillers (NSAIDs)
if you have an increased tendency to bleeding
if you have porphyria (metabolic disease)
if you have severely reduced liver function, severe heart failure or severe kidney disease.
if you previously have had an allergic reaction such as asthma, sneezing or a rash on taking
painkillers containing acetylsalicylic acid or other drugs for pain/inflammation within the group
of NSAIDs (non-steroidal anti-inflammatory drugs).
during the final three months of pregnancy.
Take special care with Diclofenac BMM Pharma
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The aim should always be to take the lowest possible dose over the shortest possible treatment period
in order to reduce the risk of side effects. Higher doses than the recommended dose are generally
associated with an increased risk of side effects.
Seek advice from your doctor before treatment if you have or have had any of the following diseases:
gastrointestinal problems or heartburn/ discomfort in the stomach or a history of gastric or
intestinal ulceration, bleeding or perforation
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heart disease, liver disease or kidney disease
asthma, chronic obstructive pulmonary diseases or chronic infections of the respiratory tract
inflammation of the nasal mucous membranes
SLE (connective tissue disease)
diseases that result in an increased tendency to bleed
high blood pressure or mild to moderate heart failure
ulcerative colitis or Crohn’s disease
Elderly persons should be aware of the greater risk of side effects that comes with increasing age.
As with other anti-inflammatory agents, allergic reactions, including anaphylactic reactions can occur
in rare cases with Diclofenac BMM Pharma without earlier exposure to the drug.
Serious skin reactions have been reported very rarely in association with the use of NSAIDs. Stop using
Diclofenac BMM Pharma if you get any skin rash or any other sign of hypersensitivity and contact a
doctor.
During varicella (chicken pox) it is advisable to avoid use of this drug.
If you get gastrointestinal problems, discontinue to take Diclofenac BMM Pharma and seek advice
from a doctor.
Prolonged use of any type of painkiller for headaches can make the headache worse. If this situation is
experienced or suspected, medical advice should be obtained and treatment should be discontinued.
Like other anti-inflammatory agents, Diclofenac BMM Pharma can mask the signs or symptoms of
infection.
Medicines such as Diclofenac BMM Pharma 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.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for
example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should
discuss your treatment with your doctor or pharmacist.
Diclofenac BMM Pharma can make it more difficult to conceive, please refer to the section pregnancy
and breast-feeding for further information.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Certain medicines may be affected by treatment with Diclofenac BMM Pharma, for example:
- medicines against blood clots (warfarin, ticlopidine, acetylsalicylic acid, heparin etc.),
- medicines against tumours and disturbances of the immune system (such as methotrexate),
- medicines for treating diabetes, except for insulin,
- lithium (used for manic depression)
- SSRIs (used for depression),
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digoxin (used for heart problems),
cyclosporin (used during transplantations, for severe psoriasis and for rheumatism),
certain medicines for high blood pressure (beta-blockers, angiotensin II receptor antagonists and
ACE inhibitors),
diuretics (agents to stimulate urine production, and used against high blood pressure),
quinolone antibiotics (used for urinary tract infection),
zidovudine (used in the treatment of HIV infection),
corticosteroids (used to treat inflammatory diseases),
colestipol or colestyramine (used to treat high levels of blood fat). These medicines can be used
together with diclofenac if diclofenac is taken at least 1 hour before or 4 to 6 hours after the intake
of colestipol/colestyramine.
tacrolimus (used to treat some inflammatory diseases and after transplants)
sulfinpyrazone (a medicine used to treat gout)
fluconazole or voriconazole (used for fungal infections),
rifampicin (an antibiotic used for tuberculosis),
carbamazepine (used for epilepsy),
barbiturates (sleeping agents),
diazepam (a sedative),
pentoxifylline (an agent to dilate blood vessels),
phenytoin (used for epilepsy).
Never take several different pain-relief medicines at the same time without first consulting your
doctor or pharmacist.
Using Diclofenac BMM Pharma with food and drink
Gastro-resistant tablets must be swallowed whole with plenty of fluid (at least 1½ glasses of water).
For maximum effect, the tablets are not to be taken with or directly after a meal.
Pregnancy and breast-feeding
Diclofenac BMM Pharma must not be used during the last three months of the pregnancy. Diclofenac
BMM Pharma should be avoided by women who are trying to become pregnant or who are pregnant.
Treatment with Diclofenac BMM Pharma during any phase of pregnancy may only take place on the
prescription of a doctor.
Diclofenac passes into the breast-milk in small amounts.Therefore, Diclofenac BMM Pharma should
not be used during breast-feeding.
Taking Diclofenac BMM Pharma can make it more difficult to conceive.Seek advice from your doctor
if you are planning to become pregnant or if you are having problems in becoming pregnant.The effect
is temporary and ceases when you stop taking these types of drugs.
Driving and using machines
Diclofenac BMM Pharma can cause visual disturbances, dizziness and drowsiness. If you experience
any of these effects, or any other central nervous system disturbances, you should avoid driving or
using machines.
Important information about some of the ingredients of Diclofenac BMM Pharma
Diclofenac BMM Pharma enteric-coated tablets contain lactose monohydrate. If you do not
tolerate certain types of sugar, you should contact your doctor before taking this medicine.
3.
HOW TO USE DICLOFENAC BMM PHARMA
Always use Diclofenac BMM Pharma exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
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Rheumatic disorders
Usual dose for adults: 75-150 mg daily divided into 2-3 doses depending on disease activity.
Note that the total dose during any 24-hour period should not exceed six 25 mg tablets or three 50 mg
tablets.
Gastro-resistant tablets must be swallowed whole with at least 1½ glass of water.
If you find that Diclofenac BMM Pharma has too strong or too weak effect, contact your doctor or
pharmacist.
If you take more Diclofenac BMM Pharma than you should:
If you have taken more Diclofenac BMM Pharma than you should, or if children have been taking
medicine by accident, please contact your doctor or the hospital to get an opinion of the risk and
advice on action to be taken.
Symptoms of an overdose can include: nausea (feeling sick), vomiting, abdominal pain,
gastrointestinal bleeding, diarrhoea, dizziness, drowsiness, headache, ringing in the ears (tinnitus),
anxiety, hallucinations, convulsions and swollenness.
If you forget to take Diclofenac BMM Pharma:
Do not take a double dose to make up for a forgotten dose.
If you have any further question on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Diclofenac BMM Pharma can cause side effects, although not everybody gets
them.
You may experience gastrointestinal problems at the beginning of treatment. These side effects
normally disappear within a few days.
Some side effects can be serious
If you suffer from any of the following at any time during your treatment STOP TAKING
DICLOFENAC BMM PHARMA and seek immediate medical help:
 Agranulocytosis (symptoms: fever, sore throat, painful mouth ulcers, anal ulcers, reduced
immune reponse, prone to bacterial infections).
 Stevens-Johnson syndrome and toxic epidermal necrolysis (Life-threatening skin diseases that
cause rash, skin peeling, and sores on the mucous membranes).
 Hypersensitivity reactions (narrowing and obstruction of the respiratory airway, hives, allergic
shock reaction with a fall in blood pressure).
 You should stop taking Diclofenac BMM Pharma and see your doctor immediately if you
experience symptoms of angioedema,such as swollen face,tongue or pharynx,difficulty to
swallow,hives and difficulties to breathe.
Common (affects 1 to 10 users in 100): Abdominal pain, nausea, vomiting, diarrhoea, digestive
problems, reduced appetite, gases in the stomach, headache, dizziness, rash and raised liver values.
Uncommon (affects 1 to 10 users in 1,000): Tiredness and bronchospasm.
Rare (affects 1 to 10 users in 10,000): Hypersensitivity, anaphylactic reactions (severe
hypersensitivity reactions which may lead to breathing difficulty and shock (strong decrease in blood
pressure, paleness, agitation, weak and fast pulse, clammy skin, and decreased consciousness)),
asthma (including difficulties to breathe), drowsiness, swelling of the body as a result of fluid
retention, gastritis, bleeding or ulcers in the gastrointestinal tract, vomiting blood, black stools, liver
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function disorders (liver inflammation, yellowing of the skin), nettle rash., impotence (the association
here is uncertain).
Very rare (affects less than 1 user in 10,000): Angioneurotic oedema (rapid swelling of the skin and
mucosa), effects on vision (blurred vision, double vision) and hearing (reduced hearing, tinnitus),
effects on blood composition (a reduced number of blood platelets, which can lead to small bleeding
in the skin and mucous membranes, a reduced number of white blood cells, which can degrade the
immune response, breakdown of red blood cells and anaemia), disorientation, depression, difficulties
in sleeping, nightmares, irritability, anxiety, a disturbed sense of reality, abnormal skin sensation (i.e
tingling or numbness), memory impairment, convulsions (involuntary contraction of the muscles),
shaking movement often noticed in hands and arms (tremor), changes in the sense of taste, aseptic
meningitis, stroke, effects on the heart and blood vessels (such as chest pains, sensation of a irregular
and/or forced beating of the heart, heart failure, myocardial infarction, high blood pressure, vasculitis
(inflammation of the blood vessels)), inflammation of the lungs, problems with the large intestine,
constipation, inflammation of the oral mucosa, tongue or pancreas, intestinal strictures, lower gut
disorders (including inflammation of the colon, or worsening of ulcerative colitis or Crohn’s disease),
oesophageal disorder, liver function disorders, (including fulminant liver inflammation, hepatic
necrosis and hepatic failure), eczema, redness of the skin, exfoliative dermatitis, hair loss,
hypersensitivity to light, itching, purpura (skin bleedings), bullous skin reactions (including StevensJohnson Syndrome and toxic epidermal necrolysis), effects on the kidneys (such as kidney failure and
blood or proteins in the urine).
Stomach bleeding can occur at any time during treatment with or without warning symptoms. This
generally has more serious consequences in elderly patients. A doctor must be contacted if this occurs,
or if any other unexpected symptoms occur.
Exceptional serious infections of the skin in case of varicella (chicken pox).
Diclofenac BMM Pharma may cause a reduction in the number of white blood cells and your
resistance to infection may be decreased. If you experience an infection with symptoms such as fever
and serious deterioration of your general condition, or fever with local infection symptoms such as
sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test
will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to
inform your doctor about your medicine.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5.
HOW TO STORE DICLOFENAC BMM PHARMA
Keep out of the reach and sight of children.
Do not use Diclofenac BMM Pharma after the expiry date which is stated on the carton after EXP.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
FURTHER INFORMATION
What Diclofenac BMM Pharma contains
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The active substance is diclofenac sodium 25 mg or 50 mg
The other ingredients are lactose monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinised starch, sodium starch glycolate, maize starch, macrogol, methacrylic acid-ethyl
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acrylate copolymer, dimethicone, polysorbate 80, sorbic acid, talc and colourings (25 mg:
yellow iron oxide E172, titanium dioxide E171; 50 mg: red and yellow iron oxide E172,
titanium dioxide E171)
What Diclofenac BMM Pharma looks like and contents of the pack
25 mg gastro-resistant tablets: Domed film-coated yellow tablets, 7 mm in diameter, marked D 25.
50 mg gastro-resistant tablets: Domed film-coated brown tablets, 8 mm in diameter, marked D 50.
Blister pack:
25 mg gastro-resistant tablets: 10, 20, 30, 50 and 100
50 mg gastro-resistant tablets: 10, 20, 30, 50 and 100
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
BMM Pharma AB
Blasieholmsgatan 2
111 48 Stockholm
Sweden
Manufacturer:
Dragenopharm Apotheker Püschl GmbH & Co KG
Otto Göllstrasse 1
84529 Tittmoning
Germany
This leaflet was last approved in 2012-01-26
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