Naklofen duo 75 mg modified-release capsules – diclofenac for pain and inflammation

Naklofen duo is a medicine in the form of modified-release hard capsules containing diclofenac sodium – a non-steroidal anti-inflammatory drug (NSAID) that relieves pain and inflammation.

One capsule contains 75 mg diclofenac sodium in two types of pellets: 25 mg in gastro-resistant pellets and 50 mg in prolonged-release pellets. As a result, the medicine works quickly and its effect lasts longer.

What is Naklofen duo used for and how should it be taken?

Basic information about the medicine

What is Naklofen duo used for?

According to the patient information leaflet, Naklofen duo relieves pain and inflammation in adults in a wide range of conditions, including:

• inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, psoriatic arthropathy, painful spine syndrome, non-articular rheumatism;
• acute musculoskeletal disorders: periarthritis (e.g. "frozen shoulder"), tendinitis, tenosynovitis, bursitis;
• painful conditions after trauma – fractures, lower back pain, strains, sprains, dislocations; orthopaedic, dental and other minor surgical procedures;
• post-traumatic and post-operative pain, inflammation and swelling;
• painful and/or inflammatory gynaecological conditions, e.g. painful periods (primary dysmenorrhoea), adnexitis and heavy menstrual bleeding (menorrhagia);
• acute gout attack.

How is Naklofen duo used and dosed?

Always take the medicine exactly as your doctor has prescribed. According to the leaflet:

• Adults: the usual dose is 75 mg (one capsule) once or twice daily.
• Maximum daily dose: 150 mg diclofenac, i.e. two capsules.
• Take the capsule with or after a meal and swallow it whole with enough water; do not break or chew it, as this affects the modified release of the medicine.
• If symptoms are worst at night or in the morning, it is preferable to take the medicine in the evening.
• Your doctor may also prescribe a stomach-protecting medicine at the same time – especially if you have had stomach problems before, are elderly or take other medicines.

Special patient groups

• Children and adolescents: the medicine is not suitable for children and adolescents.
• Elderly patients and people with low body weight: they may be more sensitive to the medicine – the doctor may prescribe a lower dose; the lowest dose for the shortest time is needed and side effects, especially stomach problems, must be reported promptly.
• Impaired liver or kidney function: liver or kidney failure is a contraindication; in milder impairment caution and regular blood tests are needed.

Contraindications – when the medicine must not be used

• allergy to diclofenac sodium or any of the excipients (e.g. swelling of the face and tongue, breathing problems, runny nose, rash, chest pain);
• stomach or duodenal ulcer or bleeding in the digestive tract, current or past (including after previous NSAID use);
• the last trimester of pregnancy (after the sixth month);
• liver or kidney failure;
• an allergic reaction (asthma, wheezing, rash, swelling of the face, tongue, lips or throat, runny nose) after acetylsalicylic acid or another NSAID;
• heart disease (e.g. previous heart attack, angina, blocked heart blood vessels) and severe cardiovascular disease;
• cerebrovascular disease (stroke, mini-stroke) and peripheral arterial disease.

Precautions and warnings

• diabetes, smoking, high blood pressure, raised triglycerides or cholesterol, angina or blood clotting problems – the doctor prescribes the lowest effective dose for the shortest time;
• bowel disease (ulcerative colitis, Crohn's disease) or any stomach or bowel problems, current or past;
• impaired kidney or liver function, blood disorders or a tendency to bleed – regular blood tests;
• porphyria, asthma, chronic obstructive pulmonary disease, chronic respiratory infections, allergic rhinitis or nasal polyps, previous allergic reactions;
• dehydration; planned or recent stomach or bowel surgery (the medicine may impair wound healing);
• the medicine may mask signs of infection (e.g. headache and fever) – tell your doctor you are taking it;
• the medicine contains sucrose (sugar spheres in the pellets).

Interactions with other medicines, food and drink

• medicines for diabetes; anticoagulants (e.g. warfarin); diuretics;
• lithium, methotrexate, ciclosporin and tacrolimus, trimethoprim;
• quinolone antibiotics, voriconazole, rifampicin, phenytoin;
• other NSAIDs or COX-2 inhibitors (e.g. acetylsalicylic acid, ibuprofen);
• cardiac glycosides (e.g. digoxin), beta blockers, ACE inhibitors and other heart and blood pressure medicines;
• SSRI antidepressants and oral corticosteroids;
• colestipol and colestyramine – reduce the effect of the medicine; take Naklofen duo at least 1 hour before or 4–6 hours after them.

Pregnancy and breastfeeding

• Pregnancy: the medicine must not be taken in the last trimester. It should not be taken in the first 6 months unless the doctor considers it necessary – then at the lowest dose for the shortest possible time. Use for more than a few days from week 20 of pregnancy may cause kidney problems in the unborn baby (reduced amniotic fluid) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
• Fertility: the medicine may make it harder to conceive – talk to your doctor if you are planning a pregnancy.
• Breastfeeding: diclofenac passes into breast milk in small amounts; use during breastfeeding is not recommended.

Driving and using machines

• The medicine may cause tiredness, dizziness, drowsiness and visual problems. If you notice these effects, do not drive or use machines.

Possible side effects

• Serious – stop taking the medicine and contact a doctor immediately: chest pain or tightness, shortness of breath, difficulty breathing when lying down, swelling of feet and legs; vomiting blood or black stools; sudden slurred speech, weakness or disorientation; allergic reactions (rash, blisters, peeling skin, wheezing, swelling of the face, lips or hands, fainting); abdominal cramps with bloody stools (ischaemic colitis); chest pain as a sign of an allergic reaction (Kounis syndrome).
• Common: abdominal pain, nausea, vomiting, diarrhoea, indigestion, wind, reduced appetite; headache, dizziness, vertigo; rash; raised liver enzymes.
• Uncommon: palpitations, chest pain, heart failure.
• Rare: stomach ulcer or stomach bleeding; drowsiness, tiredness; hives; fluid retention.
• Very rare: numbness, tremor, blurred vision, double vision, ringing in the ears, insomnia, mood disorders; mouth ulcers, colitis; vasculitis, pneumonitis, blood disorders; liver or kidney dysfunction; rash that worsens in sunlight, hair loss.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor or the nearest healthcare facility immediately and take the medicine in its original pack. Possible symptoms are vomiting, stomach bleeding, diarrhoea, dizziness, ringing in the ears or convulsions; severe overdose may cause kidney or liver problems.
• Missed dose: take it as soon as you remember; if it is nearly time for the next dose, continue with your usual schedule. Do not take a double dose.
• Stopping treatment: take the medicine for as long as prescribed unless you have problems – in that case talk to your doctor.

Related information

For additional care and support with joint, bone and muscle pain, see also the category Bones, joints and muscles – products in this category do not replace the medicine prescribed to you.

Composition, pack and manufacturer

• Active substance: diclofenac sodium 75 mg per capsule (25 mg in gastro-resistant pellets and 50 mg in prolonged-release pellets).
• Excipients in the pellets: sugar spheres; hydroxypropylcellulose; hypromellose; heavy magnesium carbonate; methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%; triethyl citrate; talc; titanium dioxide (E171); macrogol; sodium hydroxide; ammonio methacrylate copolymer (type A and B); carmellose sodium.
• Capsule: titanium dioxide (E171); indigo carmine (E132); gelatin. Appearance: white to almost white pellets in a hard gelatin capsule with a blue cap and white body.
• Pack: blister with 10 capsules; 2 blisters (20 capsules) per carton.
• Marketing authorisation holder: KRKA-FARMA d.o.o. Belgrade, Jurija Gagarina 26/V/II, Belgrade; manufacturer: Krka, d.d., Novo mesto, Šmarješka cesta 6, Slovenia.
• Authorisation number: 515-01-01900-21-001 of 13 December 2022.

Storage

• Store below 30 °C in the original package to protect from moisture.
• Shelf life: 3 years.
• Do not use after the expiry date stated on the pack.
• Keep out of the sight and reach of children.

Frequently asked questions

What does "duo" mean in Naklofen duo?

The capsule contains two types of pellets: 25 mg diclofenac in gastro-resistant pellets and 50 mg in prolonged-release pellets. That is why the capsule must be swallowed whole, without opening or chewing.

How many Naklofen duo capsules may I take per day?

The usual dose is one capsule (75 mg) once or twice daily, and at most two capsules (150 mg) per day. The exact dose is set by your doctor.

Can Naklofen duo be combined with ibuprofen or aspirin?

Not without medical advice. Concomitant use with other NSAIDs, including acetylsalicylic acid and ibuprofen, is listed in the leaflet as an interaction and increases the risk of side effects, particularly on the stomach.

Is Naklofen duo safe for the heart?

With diclofenac there is a slightly increased risk of heart attack or stroke, especially with high doses and longer use. The medicine must not be used in heart and cerebrovascular disease, and if risk factors are present the doctor prescribes the lowest effective dose for the shortest time.

Sources

• ALIMS – Patient information leaflet Naklofen duo (PIL)
• ALIMS – Summary of product characteristics Naklofen duo (SmPC)

Sources checked on: 25 October 2026.