NAKLOFEN 75 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Naklofen Duo, 75 mg, prolonged-release capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Naklofen Duo and what is it used for
4. Important information before taking Naklofen Duo
   1. When not to take Naklofen Duo
   2. Warnings and precautions
   3. Children and adolescents
   4. Naklofen Duo and other medicines
   5. Naklofen Duo with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Naklofen Duo contains sucrose and sodium
5. How to take Naklofen Duo
   1. Taking a higher dose of Naklofen Duo than recommended
   2. Missing a dose of Naklofen Duo
   3. Stopping treatment with Naklofen Duo
6. Possible side effects
   1. Reporting side effects
7. How to store Naklofen Duo
8. Contents of the pack and other information
   1. What Naklofen Duo contains
   2. What Naklofen Duo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Naklofen Duo, 75 mg, prolonged-release capsules

Diclofenac sodium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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 effects. The main mechanism of action of the drug is to inhibit the synthesis of prostaglandins.
Naklofen Duo is used to treat:

• inflammatory or degenerative forms of rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, extra-articular rheumatism (including tendonitis, ligamentitis, bursitis, periarticular soft tissue);
• pains caused by post-traumatic and post-operative inflammatory conditions, e.g. after surgical or orthopedic procedures;
• painful conditions in primary dysmenorrhea.

2. Important information before taking Naklofen Duo

When not to take Naklofen Duo

• if the patient is allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity symptoms include facial and lip edema (angioedema), difficulty breathing, chest pain, rhinitis, rash, or any other allergic reactions.
• if the patient has active or a history of stomach or duodenal ulcers, bleeding, or perforation,
• if the patient has bleeding or perforation of the gastrointestinal tract associated with previous use of non-steroidal anti-inflammatory drugs,
• 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. after a heart attack, stroke, transient ischemic attack (TIA), or vascular surgery, or angioplasty,
• if the patient has circulatory disorders (peripheral vascular disease).

Warnings and precautions

Before starting to take Naklofen Duo, discuss it with your doctor.
Taking diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (with possible fatal outcome). This effect may be particularly dangerous in cases of high doses of diclofenac and in the elderly or patients with a history of gastrointestinal ulcers. If any unusual abdominal symptoms occur (especially gastrointestinal bleeding), the medicine should be discontinued immediately and a doctor consulted.
In patients with ulcerative colitis or Crohn's disease, diclofenac may exacerbate the disease.
Taking diclofenac may, in very rare cases (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, and toxic epidermal necrolysis with skin and mucous membrane lesions, high fever, and severe general condition. At the first signs of rash, mucous membrane lesions, or other symptoms of an allergic reaction, the medicine should be discontinued and a doctor consulted.
The medicine may mask symptoms of infection (e.g. headache, increased body temperature) and make it difficult to diagnose. During medical examinations, the doctor should be informed about the use of the medicine.
Patients with asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections are more likely to experience an allergic reaction to diclofenac (exacerbation of asthma symptoms, angioedema, or urticaria). This warning also applies to patients allergic to other substances (e.g. those who experience skin reactions, itching, or urticaria). In these patients, the medicine should be administered with caution (preferably under medical supervision).
In patients with liver function disorders, diclofenac may worsen the course of the disease. The doctor's recommendations regarding regular liver function tests should be strictly followed.
Particular caution should be exercised when using Naklofen Duo:

• in patients with porphyria, as diclofenac may cause a porphyria attack.
• if the patient smokes.
• if the patient has diabetes.
• if the patient has angina pectoris, thrombosis, hypertension, increased cholesterol levels, or increased triglyceride levels.

Before taking Naklofen Duo, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Naklofen Duo may sometimes cause impaired wound healing in the intestines after surgery.
The occurrence of side effects can be reduced by using the medicine in the smallest effective dose and for no longer than necessary.
Naklofen Duo should not be taken simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
Before taking the medicine, the patient should inform their doctor or pharmacist about the presence of the above-mentioned diseases.
Taking such medicines 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 of the medicine. The patient should not take higher doses or use the medicine for longer than recommended.
If, at any time during treatment with Naklofen Duo, the patient experiences any signs or symptoms of heart or vascular disease, such as chest pain, shortness of breath, weakness, or speech disorders, they should immediately consult a doctor.
The medicine may temporarily inhibit platelet aggregation.

Children and adolescents

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

Naklofen Duo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
The patient should tell their doctor about any chronic diseases or metabolic disorders.
As a result of interactions with some other medicines, the effect of Naklofen Duo or those medicines may be enhanced or weakened.
The patient should particularly inform their doctor about taking the following medicines:

• Lithium or antidepressant medicines (selective serotonin reuptake inhibitors);
• Digoxin (a medicine used to treat heart diseases);
• Angiotensin-converting enzyme inhibitors, beta-adrenergic blockers (a group of medicines used to treat hypertension and heart failure);
• Diuretics (medicines that increase urine production);
• Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids;
• Trimethoprim (a medicine used to prevent or treat urinary tract infections);
• Anticoagulant medicines and platelet inhibitors;
• Antidiabetic medicines (except insulin);
• Methotrexate (a medicine used to treat certain cancers or arthritis);
• Cyclosporine and tacrolimus (medicines used in organ transplantation);
• Quinolone antibacterials and some medicines used to treat infections.
• Phenytoin (a medicine used to treat epileptic seizures);
• Colestyramine and colestipol (medicines that lower cholesterol levels in the blood);
• Sulfinpyrazone and probenecid (medicines used to treat gout);
• Voriconazole (a medicine used to treat fungal infections).

Naklofen Duo with food and drink

The capsules should be swallowed whole, with a liquid, during or immediately after a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Naklofen Duo should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Naklofen Duo may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Naklofen Duo should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Naklofen Duo may cause kidney disorders in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for a longer period than a few days, the doctor may recommend additional monitoring.
Naklofen Duo should not be taken during breastfeeding.
The medicine may make it difficult to conceive. If the patient plans to conceive or has problems conceiving, they should inform their doctor.

Driving and using machines

Naklofen Duo has a mild or moderate effect on the ability to drive and use machines. If dizziness and/or other central nervous system disorders occur, the patient should not drive vehicles or operate machines.

Naklofen Duo contains sucrose and sodium

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

3. How to take Naklofen Duo

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The general recommendation is for the doctor to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible period.
The daily dose for adults is usually 1 capsule twice a day, and the maintenance dose is 1 capsule once a day. The total daily dose should not exceed 150 mg of diclofenac. In cases of severe symptoms (especially in the morning), the patient may, for a short period, take the entire daily dose of Naklofen Duo (2 capsules) at once.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Naklofen Duo than recommended

Overdose of Naklofen Duo does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions.
In case of significant poisoning, acute kidney failure and liver damage may occur.
If the patient has accidentally taken more tablets than recommended, they should immediately consult a doctor, pharmacist, or go to the hospital emergency department.

Missing a dose of Naklofen Duo

The patient should not take a double dose to make up for a missed dose.
If a dose is missed, the patient should take it as soon as they remember.
However, if more than half of the time between two doses has passed, the missed dose should not be taken, and the next dose should be taken according to the previous schedule.

Stopping treatment with Naklofen Duo

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Naklofen Duo can cause side effects, although not everybody gets them.
Some side effects can be serious.
The patient should stop taking Naklofen Duo and immediately consult their doctor if they notice:

• mild painful abdominal cramps and tenderness, starting soon after taking Naklofen Duo, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency not known - cannot be estimated from available data),
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome,
• discomfort in the stomach, heartburn, or pain in the upper abdomen,
• bloody vomiting, blood in stool, blood in urine,
• skin disorders such as rash or itching,
• shortness of breath or wheezing,
• yellowing of the skin or whites of the eyes,
• prolonged sore throat or high fever,
• swelling of the face, feet, or ankles,
• severe migraine,
• chest pain accompanied by coughing.

Side effects are ranked according to frequency of occurrence using the following terms:

• 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, loss of appetite; headache, dizziness; increased liver enzyme activity; rash.
Rare: gastritis, gastrointestinal bleeding, bloody vomiting, black stools, bloody diarrhea, stomach or duodenal ulcers (with or without bleeding and perforation); jaundice, liver function disorders (asymptomatic liver inflammation, acute liver inflammation, chronic active liver inflammation), bile duct obstruction; drowsiness, fatigue; urticaria; hypersensitivity reactions (including bronchospasm, angioedema, hypotension, anaphylactic shock), fluid retention (edema), breathing difficulties (asthma, dyspnea).
Very rare: changes in blood cell count (anemia, thrombocytopenia, leukopenia, agranulocytosis); facial edema (angioedema); disorientation, depression, insomnia, fatigue, nightmares, irritability, psychotic disorders; paresthesia (tingling sensation), memory disorders, convulsions, anxiety, tremors, aseptic meningitis, taste disorders, ischemic stroke; vision disorders, blurred vision, double vision; ringing in the ears, hearing disorders; heart rhythm disorders (palpitations), chest pain, heart failure, myocardial infarction; hypertension, vasculitis; pneumonia; ulcerative colitis (including bloody diarrhea and exacerbation of ulcerative colitis or Crohn's disease), constipation, oral mucositis (including ulcerative oral mucositis), glossitis, esophageal disorders, formation of diaphragm-like strictures in the intestines, pancreatitis; liver function disorders (fulminant hepatitis, liver necrosis, liver failure); kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis; blistering rash, urticaria, erythema, erythema multiforme, Stevens-Johnson syndrome (severe blistering rash affecting the skin, mucous membranes, eyes, genitals), toxic epidermal necrolysis (severe, widespread blistering rash of the skin with mucous membrane lesions, high fever, and severe general condition), exfoliative dermatitis, hair loss, photosensitivity, red or purple spots on the skin (purpura), itching.
Frequency not known: confusion, hallucinations, malaise.
If Naklofen Duo is taken for more than a few weeks, the patient should regularly consult their doctor to ensure that no side effects have occurred.
Taking such medicines as Naklofen Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Naklofen Duo

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Naklofen Duo contains

• The active substance of the medicine 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).
• The other ingredients are: enteric pellets: sucrose, starch, hydroxypropylcellulose, hypromellose, heavy magnesium carbonate, methacrylic acid, and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, talc, titanium dioxide (E171), sodium carmellose, macrogol 6000, sodium hydroxide; prolonged-release enteric pellets: sucrose, starch, hydroxypropylcellulose, ammonium methacrylate copolymer (type 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

The prolonged-release capsules are white-blue in color, filled with pellets in a shade from white to cream.
Packaging:20 prolonged-release capsules in blisters, in a cardboard box.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information about the medicine, the patient should contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: 22 57 37 500

Date of last revision of the leaflet: