Naklofen duo

Package leaflet: Information for the patient

Naklofen Duo, 75 mg, modified-release capsules
Diclofenacum natricum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What is Naklofen Duo and what is it used for
2. Important information before taking Naklofen Duo
3. How to take Naklofen Duo
4. Possible side effects
5. How to store Naklofen Duo
6. Contents of the pack and other information

1. What is Naklofen Duo and what is it used for

Naklofen Duo is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory,
analgesic, and antipyretic properties. The main mechanism of action of the drug is the
inhibition of prostaglandin synthesis.
Naklofen Duo is used in the treatment of:

• inflammatory or degenerative forms of rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, extra-articular rheumatism (including tendinitis, ligamentitis, bursitis, and other periarticular soft tissue disorders);
• pain caused by inflammatory conditions following trauma or surgery, e.g., after surgical or orthopedic procedures;
• pain associated with primary dysmenorrhea.

2. Important information before using Naklofen Duo

When not to use Naklofen Duo

• if the patient is allergic to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity include facial and lip swelling (angioedema), difficulty breathing, chest pain, nasal congestion, rash, or any other allergic-type reactions.
• if the patient has active or a history of peptic ulcer disease of the stomach and (or) duodenum, gastrointestinal bleeding or perforation,
• if the patient has gastrointestinal bleeding or perforation related to previous use of non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient is in the last trimester of pregnancy,
• if the patient has severe liver or kidney failure,
• if the patient has heart disease and (or) cerebrovascular disease, e.g. following myocardial infarction, stroke, transient ischemic attack (TIA), or arterial embolism in the heart or brain, or following procedures to unblock or bypass obstructed blood vessels,
• if the patient has current or previous circulatory disorders (peripheral vascular disease).

Warnings and precautions
Before starting treatment with Naklofen Duo, discuss it with your doctor.
Use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). Such effects may be particularly dangerous when high doses of diclofenac are used, and in patients with a history of gastrointestinal ulcers or in elderly patients.
If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Naklofen Duo, the medicine should be discontinued immediately and the patient should contact their doctor.
In patients with ulcerative colitis or Crohn's disease, diclofenac may worsen the course of the disease.
Talk to your doctor before starting treatment with Naklofen Duo if the patient has ever experienced severe skin rash, skin peeling, blistering, or oral ulceration after taking Naklofen Duo or other pain-relieving medicines.
Use of diclofenac may very rarely (especially at the beginning of treatment) cause life-threatening skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever, and severe general condition. If early signs of rash, mucosal changes, or other symptoms of allergic reaction occur, the medicine should be discontinued immediately and the patient should contact their doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and may interfere with accurate diagnosis. Inform your doctor about using this medicine during medical examinations.
Patients with asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease (COPD), or chronic respiratory infections are at higher risk of allergic reactions to diclofenac (worsening asthma symptoms, Quincke's edema, or urticaria). This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching, or hives). In such patients, the medicine should be administered with particular caution (preferably under medical supervision).
In patients with impaired liver function, diclofenac may worsen the course of the disease. Strictly follow your doctor's recommendations regarding regular liver function tests.
Special caution is required when using Naklofen Duo:

• in patients with hepatic porphyria, as diclofenac may trigger an attack of porphyria.
• if the patient smokes tobacco.
• if the patient has diabetes.
• if the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglyceride levels.

Before using Naklofen Duo, inform your doctor if the patient has recently undergone or is scheduled for stomach or gastrointestinal surgery, as Naklofen Duo may occasionally impair intestinal wound healing after surgical procedures.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Do not use Naklofen Duo simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors.
Before using the medicine, inform your doctor or pharmacist about any of the above-mentioned conditions.
Taking medicines such as Naklofen Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended.
If any signs or symptoms of heart or blood vessel disease occur at any time during treatment with Naklofen Duo—such as chest pain, shortness of breath, weakness, or speech disturbances—contact your doctor immediately.
The medicine may transiently inhibit platelet aggregation.

Children and adolescents
Naklofen Duo is not suitable for use in children and adolescents.

Naklofen Duo and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use, including those available without a prescription.
Inform your doctor about any chronic diseases or metabolic disorders.
The effect of Naklofen Duo or other medicines may be enhanced or diminished due to interactions with certain other drugs.
Specifically inform your doctor if you are taking any of the following medicines:

• Lithium or antidepressants (selective serotonin reuptake inhibitors);
• Digoxin (a medicine used in heart disease treatment);
• Angiotensin-converting enzyme (ACE) inhibitors, beta-blockers (medicines used in treating hypertension and heart failure);
• Diuretics (medicines that increase urine output);
• Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids;
• Trimethoprim (a medicine used to prevent or treat urinary tract infections);
• Anticoagulants and antiplatelet agents;
• Antidiabetic medicines, except insulin;
• Methotrexate (a medicine used in treating certain cancers or arthritis);
• Cyclosporine and tacrolimus (medicines used in organ transplant recipients);
• Antibacterial quinolones and certain medicines used to treat infections;
• Phenytoin (a medicine used to treat epileptic seizures);
• Colestipol and cholestyramine (medicines that lower blood cholesterol levels);
• Sulfinpyrazone and probenecid (medicines used in treating gout);
• Voriconazole (a medicine used to treat fungal infections).

Naklofen Duo with food and drink
Swallow the capsules whole, with liquid, during or immediately after a meal.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take Naklofen Duo if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Naklofen Duo may cause kidney and heart dysfunction in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor. Naklofen Duo should not be used during the first six months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Naklofen Duo may cause kidney dysfunction in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Do not use Naklofen Duo during breastfeeding.
The medicine may impair fertility. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
Naklofen Duo has a mild or moderate effect on the ability to drive and operate machinery. If dizziness or other central nervous system disturbances occur, do not drive or operate machinery.

Naklofen Duo contains sucrose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free."

3. How to use Naklofen Duo

This medicine should always be used according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
The general recommendation is for the doctor to individually adjust the dose for each patient
and to use the lowest effective dose for the shortest possible duration.
The usual daily dose for adults is 1 capsule twice daily, and the maintenance dose is 1 capsule once daily. The total daily dose of 150 mg of diclofenac should not be exceeded. In cases of severe symptoms (especially in the morning hours), the patient may, for a short period, take the entire daily dose of Naklofen Duo (2 capsules) at once.
If the effect of the medicine seems too strong or too weak, consult your doctor.

Taking a higher than recommended dose of Naklofen Duo
Overdose with Naklofen Duo does not produce characteristic symptoms, but the following may occur:
vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions.
In cases of severe poisoning, acute kidney failure and liver damage may occur.
If an excessive amount of tablets has been taken by accident, seek immediate medical advice from your doctor or pharmacist, or go to a hospital emergency department.

Missing a dose of Naklofen Duo
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as remembered.
However, if more than half of the interval between two doses has passed, do not take the missed dose; instead, take the next dose according to the original schedule.

Stopping treatment with Naklofen Duo
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious.
You should stop taking Naklofen Duo and contact your doctor immediately if you notice any of the following:

• mild abdominal cramps and tenderness occurring soon after starting treatment with Naklofen Duo, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency not known – cannot be estimated from available data),
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome,
• stomach discomfort, heartburn or upper abdominal pain,
• vomiting blood, blood in the stool, or blood in the urine,
• skin reactions such as rash or itching,
• wheezing or shortness of breath,
• yellowing of the skin or whites of the eyes,
• persistent sore throat or high fever,
• swelling of the face, feet or legs,
• severe migraine,
• chest pain associated with cough,
• severe allergic skin reaction, which may present as widespread red and (or) dark spots, skin swelling, blisters and itching (generalized fixed bullous eruption).

Adverse effects are listed below according to their frequency using the following categories:

• Very common: may occur in more than 1 in 10 patients
• Common: may occur in up to 1 in 10 patients
• Uncommon: may occur in up to 1 in 100 patients
• Rare: may occur in up to 1 in 1,000 patients
• Very rare: may occur in up to 1 in 10,000 patients
• Frequency not known: frequency cannot be estimated from available data.

Common: nausea, vomiting, abdominal pain, indigestion, bloating with gas release, loss of appetite; headache, dizziness; increased liver enzyme activity; rash.
Rare: gastric mucosal inflammation, gastrointestinal bleeding, vomiting blood, tarry stools, haemorrhagic diarrhoea, peptic ulcer disease of the stomach and (or) duodenum (with or without bleeding and perforation); jaundice, liver function disorders (asymptomatic hepatitis, acute hepatitis, chronic active hepatitis), cholestasis; somnolence, fatigue; urticaria; hypersensitivity reactions (including bronchospasm, angioedema, hypotension, anaphylactic shock), fluid retention (oedema), breathing difficulties (asthma, dyspnoea).
Very rare: changes in blood cell counts (anaemia, thrombocytopenia, leukopenia, agranulocytosis); facial swelling (angioedema); disorientation, depression, insomnia, fatigue, nightmares, irritability, psychotic disorders; paraesthesia (pricking and tingling sensations), memory disturbances, seizures, restlessness, tremor, aseptic meningitis, taste disturbances, ischaemic stroke; visual disturbances, blurred vision, double vision; tinnitus, hearing disturbances; cardiac rhythm disorders (palpitations), chest pain, heart failure, myocardial infarction; hypertension, vasculitis; pneumonia; colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, oral mucosal inflammation (including ulcerative stomatitis), glossitis, oesophageal disorders, formation of diaphragm-like strictures in the intestines, pancreatitis; liver function disorders (fulminant hepatitis, hepatic necrosis, liver failure); renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis; bullous rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome (severe blistering rash affecting the skin, oral mucosa, eyes, genitals), toxic epidermal necrolysis (severe, widespread blistering skin rash with redness and skin peeling), exfoliative dermatitis, hair loss, photosensitivity, red or purple spots on the skin (purpura), itching.
Frequency not known: confusion, hallucinations, malaise; allergic skin reaction, which may present as round or oval red areas and skin swelling, blisters and itching (fixed erythema). The skin in affected areas may also become darker, which may persist after healing. Upon re-exposure to the medicine, fixed erythema usually reappears in the same locations.

If Naklofen Duo is taken for longer than a few weeks, regular contact with a doctor is recommended to ensure no adverse effects have occurred.
Taking medicines such as Naklofen Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Naklofen Duo

Keep this medicine out of sight and reach of children.
Store below 30°C.
Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton following: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Naklofen Duo contains

• The active substance is diclofenac sodium. Each prolonged-release capsule contains 75 mg of diclofenac sodium (25 mg in the form of enteric pellets and 50 mg in the form of prolonged-release enteric pellets).
• Other ingredients are: enteric pellets: sucrose, cores, hydroxypropylcellulose, hypromellose, heavy magnesium carbonate, polymethacrylic acid copolymer and ethyl acrylate (1:1) dispersion 30%, triethyl citrate, talc, titanium dioxide (E171), sodium carboxymethylcellulose, macrogol 6000, sodium hydroxide; prolonged-release enteric pellets: sucrose, cores, hydroxypropylcellulose, ammonio methacrylate copolymer (types A and B), triethyl citrate, talc; capsule cap: titanium dioxide (E171), indigo carmine (E132), gelatin; capsule body: titanium dioxide (E171), gelatin. See section 2 "Naklofen Duo contains sucrose and sodium".

What Naklofen Duo looks like and contents of the pack
Modified-release capsules are white-blue in colour, filled with pellets ranging from white to cream-coloured.
Pack: 20 modified-release capsules in blister packs, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
tel. 22 57 37 500