NAKLOFEN 25 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Naklofen, 25 mg/ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Naklofen and what is it used for
4. Important information before using Naklofen
   1. When not to use Naklofen:
   2. Warnings and precautions
   3. Children and adolescents
   4. Naklofen and other medications
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Naklofen contains benzyl alcohol, sodium metabisulfite (E 223), propylene glycol, sodium
5. How to use Naklofen
   1. Dosage and administration
   2. Children and adolescents
   3. Using a higher dose of Naklofen than recommended
   4. Missing a dose of Naklofen
   5. Stopping treatment with Naklofen
6. Possible side effects
   1. If you experience any of the following side effects, stop using Naklofen and inform your doctor immediately:
   2. Reporting side effects
7. How to store Naklofen
8. Contents of the packaging and other information
   1. What Naklofen contains
   2. What Naklofen looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:
   5. Information intended for healthcare professionals only:
   6. Incompatibilities

Leaflet accompanying the packaging: information for the user

Naklofen, 25 mg/ml, solution for injection

Diclofenac sodium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Naklofen and what is it used for
• 2. Important information before using Naklofen
• 3. How to use Naklofen
• 4. Possible side effects
• 5. How to store Naklofen
• 6. Contents of the packaging and other information

1. What is Naklofen and what is it used for

Naklofen is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic effects. The main mechanism of action of the drug is based on the inhibition of prostaglandin synthesis.
Naklofen is used to treat inflammatory or degenerative forms of rheumatic disease:

• rheumatoid arthritis, ankylosing spondylitis,
• osteoarthritis,
• extra-articular rheumatism.

2. Important information before using Naklofen

When not to use Naklofen:

• if you are allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or to 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 you have active or a history of stomach or duodenal ulcers, bleeding, or perforation,
• if you have bleeding or perforation of the gastrointestinal tract associated with previous use of non-steroidal anti-inflammatory drugs,
• if you are in the last trimester of pregnancy,
• if you have severe liver or kidney failure,
• if you have heart disease and/or cerebrovascular disease, such as after a heart attack, stroke, transient ischemic attack (temporary cerebral ischemia), or vascular occlusion of the heart or brain, or after a revascularization or bypass procedure,
• if you have circulation disorders (peripheral vascular disease).

Warnings and precautions

Before starting treatment with Naklofen, 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 the case of high doses of diclofenac, as well as for people with a history of gastrointestinal ulcers or the elderly. If any unusual abdominal symptoms occur during treatment with Naklofen (especially gastrointestinal bleeding), discontinue the medication and consult a doctor immediately.
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. After the first signs of rash, mucous membrane lesions, or other symptoms of an allergic reaction, discontinue the medication and consult a doctor.
The drug may mask infection symptoms (e.g., headache, increased body temperature) and make it difficult to diagnose. During medical examinations, inform your doctor about taking the medication.
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 medication should be administered with special caution.
In patients with liver function disorders, diclofenac may worsen the disease. Follow your doctor's recommendations for regular liver function tests.
Be particularly cautious when using Naklofen:

• in patients with porphyria, as diclofenac may trigger a porphyria attack.
• if you smoke.
• if you have diabetes.
• if you have angina pectoris, thrombosis, hypertension, increased cholesterol levels, or increased triglyceride levels.

Before using Naklofen, tell your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Naklofen may sometimes cause impaired wound healing in the intestines after surgery.
To minimize the risk of side effects, use the medication in the smallest effective dose and for no longer than necessary.
Do not use Naklofen simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
Before using the medication, inform your doctor about the above-mentioned diseases.
Taking such medications as Naklofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medication. Do not use higher doses or longer treatment than recommended.
If you experience any signs or symptoms of heart or vascular disease, such as chest pain, shortness of breath, weakness, or speech disorders, consult your doctor immediately.
The medication may temporarily inhibit platelet aggregation.

Children and adolescents

Naklofen in the form of a solution for injection is not suitable for use in children and adolescents.

Naklofen and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as medications you plan to take, including those available without a prescription.
Tell your doctor about all chronic diseases and metabolic disorders.
Due to interactions with certain other medications, the effect of Naklofen or these medications may be enhanced or weakened.
Inform your doctor especially about taking the following medications:

• lithium or antidepressant medications (selective serotonin reuptake inhibitors),
• digoxin (a medication used to treat heart conditions),
• angiotensin-converting enzyme inhibitors, beta-blockers (a group of medications used to treat hypertension and heart failure),
• diuretics (medications that increase urine output),
• non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids,
• trimethoprim (a medication used to prevent or treat urinary tract infections),
• anticoagulant medications and platelet inhibitors,
• antidiabetic medications (except insulin),
• methotrexate (a medication used to treat certain cancers or arthritis),
• cyclosporine and tacrolimus (medications used in organ transplant patients),
• quinolone antibacterials and certain medications used to treat infections,
• phenytoin (a medication used to treat epileptic seizures),
• colestipol and cholestyramine (medications that lower cholesterol levels in the blood),
• sulfinpyrazone and probenecid (medications used to treat gout),
• voriconazole (a medication used to treat fungal infections).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication.
Do not use Naklofen if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Naklofen may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, do not use Naklofen unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time. From the 20th week of pregnancy, Naklofen may cause kidney disorders in the unborn child if used for more than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.
Do not use Naklofen during breastfeeding.
The medication may make it difficult to conceive. If you plan to conceive or have problems conceiving, inform your doctor.

Driving and using machines

Naklofen has a mild or moderate effect on the ability to drive and use machines. If you experience dizziness and/or other central nervous system disorders, do not drive or operate machines.

Naklofen contains benzyl alcohol, sodium metabisulfite (E 223), propylene glycol, sodium

This medication contains 120 mg of benzyl alcohol in each ampoule. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women, as well as patients with liver or kidney disease, should consult their doctor before using the medication, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
Sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.
This medication contains 630 mg of propylene glycol in each ampoule.
The medication contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to use Naklofen

Always use this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage and administration

Injections should be administered deep intramuscularly.
The solution for injection is used to treat acute conditions. Injections should be replaced with tablets or suppositories as soon as possible. The medication should not be used for more than 2 days. The medication is usually used in a dose of 75 mg - one ampoule per day, administered deep into the upper outer quadrant of the buttock. Do not use a higher dose than 150 mg per day.
Exceptionally, in severe cases, the daily dose may be increased to two injections of 75 mg, administered at an interval of several hours (one injection in each buttock).
If the effect of the medication seems too strong or too weak, consult your doctor or pharmacist.

Children and adolescents

Naklofen in the form of a solution for injection is not recommended for use in children and adolescents due to the dose size.

Using a higher dose of Naklofen than recommended

Overdose of the medication does not have characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions.
In the case of significant poisoning, acute kidney failure and liver damage may occur.
If you have accidentally taken more of the medication than recommended, consult your doctor, pharmacist, or go to the hospital emergency department immediately.

Missing a dose of Naklofen

Your doctor decides on the frequency of injections. If a planned dose is missed, inform your doctor as soon as possible.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Naklofen

Stopping treatment with the medication without consulting your doctor may be dangerous. If diclofenac is used for a short period to relieve pain, it can be safely discontinued. However, in the case of long-term use, consult your doctor before stopping the medication.
If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Naklofen can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms:

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Reactions at the injection site, including pain, redness, swelling, hardening, ulceration, and bruising. This may lead to skin and tissue necrosis around the injection site, which heals with scarring, also known as Nicolau syndrome.

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; irritation at the injection site, pain at the injection site, hardening at the injection site.
Rare: gastritis, gastrointestinal bleeding, vomiting blood, 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, shortness of breath); swelling, tissue atrophy at the injection site.
Very rare: changes in blood cell count (anemia, thrombocytopenia, leukopenia, agranulocytosis); facial edema (angioedema); disorientation, depression, insomnia, fatigue, nightmares, irritability, psychotic disorders; paresthesia (tingling and numbness), memory disorders, convulsions, restlessness, tremors, aseptic meningitis, taste disorders, ischemic stroke; vision disorders, blurred vision, double vision; tinnitus, hearing disorders; heart rhythm disorders (palpitations), chest pain, heart failure, myocardial infarction; hypertension, vasculitis; pneumonia; colitis (including bloody diarrhea and exacerbation of ulcerative colitis or Crohn's disease), constipation, oral mucositis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal stricture, 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 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, abscess at the injection site.
Frequency not known: confusion, hallucinations, malaise, tissue damage at the injection site.

If you experience any of the following side effects, stop using Naklofen and inform your doctor immediately:

• discomfort in the stomach, heartburn, or pain in the upper abdomen,
• vomiting blood, blood in stool, blood in urine,
• skin disorders such as rash or itching,
• shortness of breath or difficulty breathing,
• 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 cough.

Taking medications like Naklofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Naklofen

Keep the medication out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use this medication after the expiration date stated on the carton after: EXP. The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Naklofen contains

• The active substance of the medication is diclofenac sodium. 1 ml of the solution for injection contains 25 mg of diclofenac sodium. 3 ml of the solution for injection (1 ampoule) contains 75 mg of diclofenac sodium.
• Other ingredients are: benzyl alcohol, propylene glycol, sodium metabisulfite (E 223), sodium hydroxide, water for injection. See section 2 "Naklofen contains benzyl alcohol, sodium metabisulfite (E 223), propylene glycol, sodium".

What Naklofen looks like and what the packaging contains

The solution for injection is clear, colorless to slightly yellow.
Packaging:5 ampoules containing 3 ml of the solution for injection, 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 medication, contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
tel. 22 57 37 500

Date of the last update of the leaflet:

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Information intended for healthcare professionals only:

Incompatibilities

It is not recommended to mix the medication with other medications in the same syringe.