Naklofen SR 100 mg. 20 tablets

What is Naklofen SR and what it is used for
What is Naklofen SR?
Naklofen SR is a non-steroidal, anti-inflammatory medicinal product with anti-inflammatory, analgesic and temperature-reducing effects. Its main mechanism of action is the suppression of the synthesis of prostaglandins. It is used to treat all forms of rheumatic diseases and to relieve various types of pain.
Prolonged-release tablets are used to treat chronic conditions.

What is Naklofen SR used for?
Doctors prescribe this medicinal product to treat diseases that require anti-inflammatory and / or analgesic action:
Inflammatory rheumatic diseases (rheumatoid arthritis, seronegative spondyloarthritis, other arthritis);
Degenerative diseases of joints and spine (arthrosis, spondyliosis);
Arthritis caused by crystals (gout, pseudosupport);
Excessive rheumatism (periarthritis, bursitis, myositis, tendinitis, synovitis);
Gynecological diseases (pain and menstrual cramps, after birth when mother does not breastfeed);
Other pain syndromes (in injury, after dental and other surgical procedures, in renal and biliary colic).

2. What you need to know before you take Naklofen SR
Tell your doctor if you suffer from any chronic disease, metabolic disorder, if you are hypersensitive or if you are taking any other medicines
Do not use Noklofen SR:

if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6), to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
if you have problems with breathing (bronchial asthma), rash (urticaria), inflammation of the nose (allergic rhinitis) or hypersensitivity reactions with sudden swelling of the lips and face, neck, it is possible to use a non-steroidal medicinal product or acetylsalicylic acid also on the hands and feet, or when there is a suffocation and sizzle;
if you have or have had a stomach or duodenal ulcer, gastrointestinal bleeding;
if you have stomach or intestinal problems after taking other non-steroidal anti-inflammatory drugs;
if you suffer from severe liver or kidney failure;
if you are pregnant in the last trimester of pregnancy;
if you have a history of heart disease and / or cerebrovascular disease, for example if you have had a heart attack, stroke, microinvest (PIP) or blockages of the heart or brain vessels, or a blood vessel or bypass operation;
if you have or have had problems with your blood circulation (peripheral arterial disease).
Tipping SR should not be given to children.

Warnings and precautions
Talk to your doctor or pharmacist before taking Naklofen SR:

if you suffer from gastrointestinal disease or have suffered in the past, you should be carefully monitored by a doctor;
if you have severe renal or hepatic insufficiency or are elderly;
if you are being treated for epilepsy or if you suffer from impaired exchange of blood pigments (porphyria);
if you have blood clotting disorders or are being treated with medicinal products that prevent the formation of thrombi (anticoagulants) or medicines that decompose existing blood clots (fibrinolytics);
if you smoke;
if you have diabetes;
if you have angina, blood clots, high blood pressure, elevated cholesterol or elevated triglycerides;
if you have asthma, allergic rhinitis, nasal mucosal edema, chronic obstructive pulmonary disease, or chronic respiratory tract irritation, you should discuss this with your doctor before using Naklofen SR;
if you have ever had serious skin reactions.
Adverse reactions can be minimized by using the lowest effective dose for the shortest amount of time.

Other medicines and Naklofen SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tracer SR may interact with some other medicines and the effect of other medicines may be increased or weakened. This happens with some medicines that are used to:

treatment of psychiatric problems (lithium);
treatment of heart problems (digoxin);
medicines to increase the amount of urine (diuretics);
analgesics (acetylsalicylic acid or other non-steroidal anti-inflammatory drugs);
medicines to prevent blood clotting (warfarin);
treatment of depression (medicines known as SSRIs);
medicines to treat diabetes;
to suppress the immune system (cyclosporin);
treatment of malignancies (methotrexate);
treatment of infections (quinolone antibiotics);
treatment of seizures (phenytoin);
treatment of high blood pressure (ACE inhibitors, beta-blockers);
for the treatment of inflammation (corticosteroids);
lowering of cholesterol (of colestipol / cholestyramine);
If you have the impression that the effect of Noklofen SR is too strong or too weak, talk to your doctor or pharmacist.

If you take more Naklofen SR than you should
Ingestion of many tablets causes primarily increased adverse reactions - gastrointestinal, renal, hepatic and central nervous system.

If you forget to take the Naklofen SR
Do not take a double dose to make up for forgotten.
Take the medicine every day at the same time. If you forget to take the medicine, take it as soon as you remember. You never double the dose.

If you stop taking  Naklofen SR
If you are taking diclofenac for a short relief of pain, you can stop taking it as soon as you do not need it anymore. For prolonged treatment, you should consult a doctor before stopping treatment.

If you have any further questions on this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common (may affect up to 1 in 10 people): nausea, diarrhea, constipation, abdominal pain, dyspepsia (difficulty digestion), flatulence, headache, dizziness, increased hepatic enzyme activity, rash;
Rare (may affect up to 1 in 1,000 people): bleeding, ulcers, perforation, jaundice, liver function disorder (asymptomatic hepatitis, acute hepatitis, chronic active hepatitis), impaired normal bile flow from the liver to the intestine (cholestasis) , drowsiness, fatigue, kidney failure, blood in the urine (haematuria), hives (urticaria), hypersensitivity reactions (bronchospasm, angioedema, anaphylactic shock), fluid retention (edema), breathing disorders (asthma, dyspnoea);
Very rare (may affect up to 1 in 10,000 people): Changes in the number of blood cells (anemia, thrombocytopenia, leucopenia, agranulocytosis), swelling of the face (angioneurotic edema), disorientation, depression, sleep disturbances , irritability, psychotic disorder, paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident, vision impairment, blurred vision, double vision (diplopia) , impaired hearing, pulse abnormalities (e.g. lpitatsii), chest pain, heart failure, myocardial infarction; high blood pressure, inflammation of the blood vessels and lung tissue, inflammation of the colon (non-specific haemorrhagic colitis, recurrence or worsening of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), inflammation of the tongue (glossitis) inflammation of the lining of the stomach, pancreas and intestinal stricture, hepatic disorders (fulminant hepatitis, hepatic failure and necrosis), urinary tract (interstitial nephritis, nephrotic syndrome, papillary necrosis, bruising, including Stevens-Johnson syndrome (severe rash that affects the skin, mouth, eyes and genital area) and toxic epidermal necrolysis (severe rash affecting large blisters and scaling), hair loss, sensitivity to sunlight (phototoxic reactions), red or purple stains on the skin (purpura), itching (pruritus);
Not known (frequency can not be estimated from the available data): confusion, hallucinations, general discomfort (malaise).
Clinical trials and epidemiological data consistently indicate that the use of diclofenac sodium, especially at high doses (150 mg daily) and in prolonged treatment, may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke) .
How to Naklofen SR
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton 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 moisture.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What's Naklofen SR?
The active substance is diclofenac sodium. Each prolonged-release tablet contains 100 mg diclofenac sodium.
The other ingredients are sucrose, hypromellose (E464), cetyl alcohol, colloidal anhydrous silica, talc (E553b), povidone, magnesium stearate (E572), titanium dioxide (E171), iron oxide (E172), macrogol 6000, polysorbate 80 (E433).

What Naklofen SR looks like in the packaging
Prolonged-release tablets are round, strongly biconvex, smooth, reddish-brown tablets. They are available in 20-pack blister packs. Each box contains 2 blisters of 10 tablets.

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