Kafenac

Package leaflet: Information for the user

KAFENAC 100 mg film-coated tablets, 100 mg powder for oral suspension

Aceclofenac
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What KAFENAC is and what it is used for

KAFENAC contains the active substance aceclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and anti-rheumatic drugs (medicines used for conditions affecting bones, cartilage, and muscles).
This medicine is indicated in adults for the treatment of:

• Inflammatory rheumatic diseases such as osteoarthritis (a disease affecting the joints), rheumatoid arthritis (a progressive and chronic autoimmune disease affecting the joints), and ankylosing spondylitis (a severe disabling rheumatic disease that may lead to joint fusion).
• Extra-articular rheumatism such as periarthritis (an inflammatory disease involving fibrous tissues surrounding a joint), bursitis (inflammation of the fluid-filled sacs that act as cushions between bones and tendons and/or muscles around a joint), tendinitis (inflammation of tendons), and enthesitis (inflammation at the site where a muscle inserts into a bone).
• Acute painful conditions of various origin such as sciatica (a sensation of intense leg pain caused by irritation of the sciatic nerve), lumbago (back pain), myalgia (muscle pain), primary dysmenorrhea (painful menstruation), pain following trauma of various kinds, and odontalgia (toothache).

2. What you need to know before taking KAFENAC

Do not take KAFENAC

• If you are allergic to the active substance, to other NSAIDs (including acetylsalicylic acid), or to any of the other ingredients of this medicine (listed in section 6).
• If in the past you have experienced asthma attacks or other allergic reactions such as urticaria (skin reaction), rhinitis (inflammation of the nasal mucosa), edema (fluid accumulation), rash (sudden reddening of the skin), or bronchospasm (narrowing of the bronchial lumen) after taking acetylsalicylic acid or other NSAIDs. This applies to all non-steroidal anti-inflammatory drugs.
• If you have a heart and/or cerebrovascular disease (affecting blood vessels in the brain), for example, if you have had a heart attack, a stroke (brain damage occurring when blood flow to the brain suddenly stops), a mini-stroke (TIA), blockages in blood vessels of the heart or brain, or if you have undergone surgery to remove these blockages or a coronary bypass (a procedure creating an artificial shunt to bypass a circulation obstruction).
• If you have or have had circulatory problems (peripheral arterial disease).
• If you currently have a gastroduodenal ulcer (erosion of the inner lining of the stomach or intestinal mucosa) or gastrointestinal bleeding (hemorrhage).
• If you have active bleeding or bleeding disorders (blood loss).
• If you have previously experienced gastrointestinal hemorrhage or perforation caused by prior treatment with non-steroidal anti-inflammatory drugs, or if you have had recurrent peptic ulcer/bleeding in the past (two or more distinct episodes of proven ulceration or bleeding).
• If you suffer from impaired liver function (severe hepatic impairment).
• If you suffer from impaired kidney function (renal impairment).
• If you are pregnant, especially during the third trimester, or breastfeeding, unless there are compelling reasons to use it. In such cases, the lowest effective dose should be used (see "Pregnancy, breastfeeding and fertility").

KAFENAC must not be administered to children (see "Children and adolescents").
Warnings and precautions
Talk to your doctor or pharmacist before taking KAFENAC.
Do not take KAFENAC in combination with other NSAIDs, including selective COX-2 inhibitors.
Use KAFENAC with caution:

• If you smoke.
• If you have diabetes (elevated blood sugar levels).
• If you suffer from angina (chest pain caused by insufficient oxygen supply to the heart).
• If you have blood clots.
• If you suffer from hypertension (high blood pressure).
• If you have high cholesterol or triglyceride levels (fats) in the blood.
• In case of hepatic dysfunction (liver malfunction).
• In case of heart or kidney failure.
• If you have undergone major surgery.
• If you are elderly.

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 3 "How to take KAFENAC").
If you are elderly, be aware that the frequency of adverse effects, particularly gastrointestinal bleeding and perforation, is higher and may be fatal (see section 3 "How to take KAFENAC").
Gastrointestinal system (stomach and intestine)
During treatment with all NSAIDs, gastrointestinal bleeding, ulceration, or perforation—potentially fatal—have been reported at any time, with or without warning symptoms or prior history of serious gastrointestinal events (diseases of the stomach or intestine).
Immediately discontinue treatment with KAFENAC and consult your doctor if gastrointestinal bleeding or ulceration occurs while taking the medicine.
As with all NSAIDs, you should take KAFENAC with particular caution and under close medical supervision if you have symptoms indicating disorders of the upper or lower gastrointestinal tract, if you have previously had gastric or intestinal ulcers, bleeding, perforation, ulcerative colitis, or Crohn's disease (inflammatory bowel diseases), or hematological disorders (blood-related conditions), as these conditions may worsen (see section 4 "Possible side effects").
If you are elderly or have previously had an ulcer, especially complicated by hemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher, particularly with increased NSAID doses. In such cases, initiate treatment with the lowest effective dose to reduce the risk of gastrointestinal toxicity.
If you are taking low-dose acetylsalicylic acid or other medications that may increase the risk of gastrointestinal events (such as other NSAIDs or corticosteroids—see "Other medicines and KAFENAC"), consider concomitant use of gastroprotective agents (e.g., misoprostol or proton pump inhibitors).
If you have experienced gastrointestinal toxicity (i.e., stomach or intestinal problems), especially if you are elderly, report any abdominal symptoms (particularly gastrointestinal bleeding) to your doctor, especially during the initial stages of treatment.
Be cautious when taking KAFENAC if you are concurrently using medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors (SSRIs) (see "Other medicines and KAFENAC").
Cardiovascular system (heart vessels) and cerebrovascular system (brain vessels)
Undergo adequate monitoring and take KAFENAC with caution:

• If you have previously had hypertension and/or mild to moderate congestive heart failure (inability of the heart to supply adequate blood to meet the body's needs), as fluid retention and edema have been observed with NSAID treatment.
• If you have significant risk factors for cardiovascular events (high blood pressure, high blood fat levels, diabetes) or if you smoke.
• If you have previously experienced cerebrovascular bleeding.

The use of KAFENAC may be associated with an increased risk of myocardial infarction (heart attack) (see section 4 "Possible side effects").
Since the cardiovascular risks of KAFENAC may increase with dose and duration of treatment, use the lowest effective daily dose for the shortest necessary period. Response to therapy and the need for symptom improvement should be periodically reassessed.
Hypersensitivity reactions (allergy) and skin reactions
Avoid using KAFENAC if you have chickenpox; in some cases, chickenpox may lead to severe skin and soft tissue infections, and the role of NSAIDs in worsening these infections cannot be excluded (see section 4 "Possible side effects").
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions (rapid-onset allergic reactions), may rarely occur, even without prior exposure to aceclofenac (see section 4 "Possible side effects").
Severe skin reactions, some of which have been fatal, including exfoliative dermatitis (skin irritation with peeling), Stevens-Johnson syndrome (lesions of the skin and mucous membranes), and toxic epidermal necrolysis (a serious skin disease where the epidermis detaches in sheets), have very rarely been reported in association with NSAID use (see section 4 "Possible side effects"). The risk appears higher in the early stages of therapy, as most reactions occur within the first month of treatment.
Discontinue KAFENAC at the first appearance of a skin rash, mucosal lesions, or any other sign of hypersensitivity (allergy).
Renal function
Take KAFENAC with caution:

• In case of mild to moderate renal impairment, as NSAID use may lead to deterioration of kidney function. In such cases, take the lowest effective dose and undergo regular monitoring of renal function.
• If you are concurrently taking diuretics (medications that increase urine production).

Effects on renal function are generally reversible upon discontinuation of aceclofenac.
Hepatic function (liver)
Discontinue treatment with KAFENAC if liver function tests remain persistently abnormal or worsen, if clinical signs or symptoms suggestive of liver disease develop, or if other manifestations such as eosinophilia (elevated white blood cell count) or rash occur. Hepatitis (liver inflammation) without warning symptoms may occur with KAFENAC use.
Use KAFENAC cautiously if you have hepatic porphyria (a rare disease involving deficiency of liver enzymes), as an attack may be triggered.
Undergo regular medical check-ups if you have mild to moderate impairment of liver function.
Hematological problems (blood-related)
Aceclofenac may temporarily inhibit platelet aggregation (see "Other medicines and KAFENAC").
Respiratory disorders
Exercise particular caution when taking KAFENAC if you currently suffer or have previously suffered from bronchial asthma (a disease caused by bronchial obstruction), as NSAIDs may worsen bronchospasm.
Long-term treatments
As a precautionary measure, if you are undergoing long-term treatment with NSAIDs, regular monitoring of blood cell counts and renal and liver function parameters is recommended.
Children and adolescents
Currently, no clinical data are available on the use of this medicine in children; therefore, its administration is not recommended (see "Do not take KAFENAC").
Other medicines and KAFENAC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exercise caution when taking KAFENAC with:

• Diuretics (medications used to increase urine production); aceclofenac, like other NSAIDs, may inhibit diuretic activity. When administered concomitantly with potassium-sparing diuretics, blood potassium levels should be monitored.
• Antihypertensives (medications used to lower blood pressure); NSAIDs may reduce the effectiveness of antihypertensive drugs. If your renal function is impaired (e.g., if you are dehydrated or elderly), co-administration of antihypertensives such as ACE inhibitors or angiotensin II antagonists with NSAIDs may increase the risk of acute renal failure, usually reversible. In such cases, you should be adequately hydrated, and renal function should be monitored after starting concomitant therapy and periodically thereafter.
• Corticosteroids (anti-inflammatory drugs); there may be an increased risk of stomach and intestinal ulceration or bleeding (gastrointestinal hemorrhage) (see "Warnings and precautions").
• Anticoagulants; like other NSAIDs, aceclofenac may enhance the effect of anticoagulant drugs such as warfarin (see "Warnings and precautions"), and therefore close monitoring is required during combination therapy.
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs); concomitant use with NSAIDs may increase the risk of gastrointestinal bleeding (see "Warnings and precautions").
• Antidiabetics. Isolated cases of hypoglycemic (reduced blood sugar levels) and hyperglycemic (increased blood sugar levels) effects have been reported; therefore, adjustment of antidiabetic drug dosage should be considered when used concomitantly with aceclofenac.
• Methotrexate (an antineoplastic and antirheumatic drug used to treat conditions such as leukemia, lymphoma, rheumatoid arthritis, lupus, and psoriasis); possible interactions between NSAIDs and methotrexate should be considered even with low-dose methotrexate, especially if renal function is reduced. Renal function should be monitored when combination therapy is administered. Exercise particular caution when taking NSAIDs and methotrexate within 24 hours of each other, as this may lead to increased blood concentrations of the antitumor agent and consequently increased toxicity.
• Lithium (a mood-stabilizing drug used in the treatment of depression and bipolar disorder) and digoxin (a drug that enhances heart function); several NSAIDs inhibit the elimination of lithium and digoxin, leading to increased blood concentrations. The combination should therefore be avoided unless frequent monitoring of lithium and digoxin levels is possible.
• Other NSAIDs; concomitant use of acetylsalicylic acid and other NSAIDs may increase the frequency of adverse effects.
• Cyclosporine and tacrolimus (immunosuppressive drugs); co-administration of NSAIDs with cyclosporine or tacrolimus is believed to increase the risk of nephrotoxicity (kidney toxicity). Close monitoring of renal function is therefore essential during combination therapy.
• Zidovudine (an antiviral drug); when NSAIDs are administered with zidovudine, the risk of hematological toxicity (blood-related) increases; there are indications of increased risk of hemarthrosis (bleeding into a joint) and hematoma in HIV-positive hemophiliacs receiving concomitant treatment with zidovudine and ibuprofen (a drug belonging to the NSAID class).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take KAFENAC
during the last 3 months of pregnancy, as it may harm the fetus or cause delivery complications. It may cause heart, lung, or kidney problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take KAFENAC during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, KAFENAC may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Inhibition of prostaglandin synthesis caused by NSAIDs may negatively affect pregnancy and/or embryonic and fetal development. Epidemiological studies suggest an increased risk of miscarriage and cardiac malformations and gastroschisis (an abdominal wall defect where the intestine, and sometimes other organs, develop outside the fetus's abdomen) following use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. It is believed that the risk increases with dose and duration of therapy.
Breastfeeding
Do not take KAFENAC while breastfeeding to avoid adverse effects in the infant, unless the potential benefit to the mother outweighs the possible risk to the infant (see "Do not take KAFENAC").
Fertility
NSAIDs may impair fertility, and their use is not recommended in women attempting to conceive. Administration of aceclofenac should be discontinued in women with fertility problems or undergoing fertility investigations.
If you take KAFENAC in these cases, the dose should be kept as low as possible and the duration of treatment as short as possible.
Driving and operating machinery
Administration of aceclofenac, as with other NSAIDs and in particularly susceptible patients, may cause dizziness, vertigo, or other central nervous system disturbances. You should be informed of these possible effects before driving or operating machinery requiring full alertness.
KAFENAC 100 mg oral suspension powder contains sorbitol.
This medicine contains 2639 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition where patients cannot properly metabolize fructose, consult your doctor before taking this medicine.
KAFENAC 100 mg oral suspension powder contains aspartame.
This medicine contains 10 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body's inability to properly eliminate it.
KAFENAC 100 mg oral suspension powder. This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., essentially "sodium-free".
KAFENAC 100 mg coated tablets. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take KAFENAC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

KAFENAC 100 mg film-coated tablets
Adults
The recommended dose is 2 tablets per day (200 mg per day), 1 tablet every 12 hours.
Swallow the tablets with a sufficient amount of water.
Take the medicine preferably during meals.

KAFENAC 100 mg oral suspension powder
The recommended dose is 2 sachets per day (200 mg per day), 1 sachet every 12 hours.
Dissolve the contents of one sachet in a glass of water (40–60 ml) and take immediately.
Take the medicine preferably during meals.

Elderly
Dosage adjustment is not considered necessary.

Patients with hepatic impairment
In patients with liver problems (hepatic insufficiency), it is advisable to reduce the initial dose to 100 mg per day.

However, as with other NSAIDs, use KAFENAC with caution if you are elderly or have impaired renal or hepatic function, cardiovascular disorders, or are undergoing concomitant pharmacological treatments.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see “Warnings and precautions”).

If you take more KAFENAC than you should
In case of accidental ingestion/overdose of KAFENAC, contact your doctor immediately or go to the nearest hospital.
Currently, there is insufficient information available regarding the clinical picture resulting from overdose with KAFENAC.

Therapeutic measures to be taken in case of acute poisoning with oral aceclofenac are those commonly used in acute NSAID poisoning:

• Absorption should be prevented as soon as possible by gastric lavage (stomach emptying and washing) and administration of activated charcoal.
• Supportive and symptomatic treatments should be implemented in case of complications such as hypotension (low blood pressure), renal failure, seizures, gastrointestinal irritation, and respiratory depression.
• Specific therapies such as forced diuresis (a method used to increase the elimination of already absorbed substances), dialysis (a treatment that replaces kidney function), or hemoperfusion (passing blood through a column of absorbent resin to remove a substance) are not effective in eliminating non-steroidal anti-inflammatory drugs due to their high degree of plasma protein binding and extensive metabolism.

If you forget to take KAFENAC
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with KAFENAC and contact your doctor immediately if you experience any of the following side effects:

• Gastrointestinal bleeding (bleeding in the stomach and intestines)
• Stomach lesions (peptic ulcers)
• Persistently abnormal or worsening liver function tests, clinical signs or symptoms suggestive of liver disease, or other manifestations such as eosinophilia
• Skin rash (sudden reddening of the skin), mucosal lesions, or any other sign of allergy

Possible side effects that may occur after taking KAFENAC are:

Common side effects (may affect up to 1 in 10 people)

• Dizziness (giddiness)
• Increased levels of certain liver enzymes
• Nausea, diarrhoea, abdominal pain, dyspepsia (indigestion)

Uncommon side effects (may affect up to 1 in 100 people)

• Gastritis (inflammation of the stomach), mouth ulcers (aphthae), flatulence (intestinal gas), constipation, vomiting
• Urticaria (skin condition), rash (sudden reddening of the skin), pruritus (itching), dermatitis (inflammation of the skin)
• Increased blood levels of urea and creatinine
• Constipation

Rare side effects (may affect up to 1 in 1,000 people)

• Anaemia (reduced concentration of haemoglobin in the blood)
• Angioedema (sudden swelling of the skin or mucous membranes)
• Visual disturbances
• Hypertension (high blood pressure)
• Anaphylactic reaction (rapid-onset allergic reaction), including shock, allergy
• Heart failure (inability of the heart to supply sufficient blood flow to meet the body's needs)
• Dyspnoea (difficulty breathing)
• Melena (passage of blood in stools), ulcer and gastrointestinal bleeding (peptic ulcers, gastrointestinal perforation or haemorrhage may occur, sometimes fatal, especially in elderly patients – see "Warnings and precautions")

Very rare side effects (may affect up to 1 in 10,000 people)

• Thrombocytopenia (reduced number of platelets in the blood), haemolytic anaemia (reduced haemoglobin concentration due to destruction of red blood cells), granulocytopenia (severe reduction in the number of granulocytes in the blood), bone marrow depression (reduced function of the bone marrow responsible for blood cell production)
• Depression, insomnia, abnormal dreams
• Paresthesia (altered sensation), dysgeusia (taste disturbances), headache, somnolence (drowsiness)
• Tinnitus (ringing in the ears), vertigo
• Palpitations
• Flushing
• Vasculitis (inflammation of blood vessels), hot flushes
• Bronchospasm (narrowing of the bronchial lumen)
• Worsening of ulcerative colitis or Crohn’s disease (inflammatory bowel diseases), stomatitis (inflammation of the oral mucosa), pancreatitis (inflammation of the pancreas), intestinal perforation, haematemesis (vomiting blood)
• Stevens-Johnson syndrome (acute allergic reaction affecting skin and mucous membranes), toxic epidermal necrolysis (or "Lyell’s syndrome", a severe skin disease induced by an allergic reaction to certain drugs, characterized by destruction of the skin epithelium and mucous membranes), purpura (bruise-like lesion resulting from capillary rupture under the skin), exanthema (skin eruption)
• Renal failure, nephrotic syndrome (a set of clinical symptoms and signs caused by glomerular damage leading to protein loss in urine)
• Hepatic injury (liver damage), including hepatitis (liver inflammation), increased alkaline phosphatase levels in blood
• Edema (fluid retention), fatigue
• Weight gain

Clinical trials and epidemiological data indicate that there may be an increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) associated with the use of aceclofenac, particularly at high doses and with long-term treatment (see "Warnings and precautions").
Exceptionally, severe skin and soft tissue infections have been reported during varicella (chickenpox) in patients receiving NSAID treatment. At present, a potential role of NSAIDs in worsening these infections cannot be ruled out (see "Warnings and precautions").
If any of the above side effects occur, it is recommended to discontinue treatment with aceclofenac and contact your doctor.
Following the instructions provided in this leaflet helps reduce the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KAFENAC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month and to the product in its original packaging, correctly stored.
KAFENAC 100 mg film-coated tablets
Store at a temperature not exceeding 30°C.
KAFENAC 100 mg oral suspension powder
No special storage precautions are required.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What KAFENAC contains
KAFENAC 100 mg film-coated tablets
One film-coated tablet contains:
Active substance: aceclofenac 100 mg.
Other components: microcrystalline cellulose, sodium croscarmellose, glyceryl palmitostearate,
povidone, hypromellose, polyoxyethylene(40) stearate, titanium dioxide.

KAFENAC 100 mg oral suspension powder
One sachet contains:
Active substance: aceclofenac 100 mg.
Other components: sorbitol, sodium saccharin, caramel flavour, cream flavour, milk flavour, anhydrous colloidal silica, aspartame, hypromellose, titanium dioxide.

Description of the appearance of KAFENAC and package contents
KAFENAC 100 mg film-coated tablets
White, circular, film-coated tablets.

• Blister pack of 10 film-coated tablets in a cardboard carton.
• Blister pack of 40 film-coated tablets in a cardboard carton.

KAFENAC 100 mg oral suspension powder
White or cream-white powder for oral suspension.
Pack of 30 sachets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ALMIRALL S.A.
Ronda General Mitre 151
08022 Barcelona, Spain

Manufacturer
Industrias Farmacéuticas Almirall S.A. (Planta de Sant Andreu de la Barca)
Ctra. de Martorell, 41-61, 08740 Sant Andreu de la Barca – Barcelona (SPAIN).

Package leaflet: Information for the user

KAFENAC 1.5 g/100 g cream

Aceclofenac
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What KAFENAC is and what it is used for
2. What you need to know before using KAFENAC
3. How to use KAFENAC
4. Possible side effects
5. How to store KAFENAC
6. Contents of the pack and other information

1. WHAT KAFENAC IS AND WHAT IT IS USED FOR

KAFENAC contains the active substance aceclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and anti-rheumatic agents (medicines used for disorders affecting bones, cartilage, and muscles).
This medicinal product is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting joints, muscles, tendons, and ligaments, such as tendinitis (inflammation of tendons), tenosynovitis (inflammation of the membrane covering the tendon), sprains, contusions, periarthritis (inflammatory diseases involving the fibrous tissues surrounding a joint), dislocations (joint dislocations), lumbago (back pain), torticollis, bursitis (inflammation of the fluid-filled sacs that act as cushions between bones and tendons and/or muscles around a joint), strains, and trauma-related sequelae.

2. WHAT YOU SHOULD KNOW BEFORE USING KAFENAC

Do not use KAFENAC

• If you are allergic to the active substance, to other NSAIDs (including acetylsalicylic acid) or to any of the other ingredients of this medicine (listed in section 6).
• If in the past you experienced worsening of asthma attacks, acute rhinitis (inflammation of the nasal mucosa), or urticaria (skin redness with intense itching) after taking acetylsalicylic acid or other NSAIDs.
• If you have or have previously had hypersensitivity reactions (allergy) to diclofenac, even if cross-allergenicity with this medicine has not been demonstrated.
• If you are in the last 3 months of pregnancy or during breastfeeding (see "Pregnancy, breastfeeding and fertility").

KAFENAC is contraindicated in paediatric patients (see "Children and adolescents").
Warnings and precautions
Talk to your doctor or pharmacist before using KAFENAC.
Use KAFENAC cream for external use only.
During treatment with KAFENAC, avoid:

• Inappropriate exposure of the treated area to sunlight without adequate protection, to prevent photosensitivity reactions (immune system reaction to sunlight).
• Applying the cream on sores or open wounds.
• Contact with eyes, mucous membranes, or any other application site with ongoing skin lesions.

Discontinue treatment with KAFENAC and seek appropriate medical treatment if you experience symptoms of local irritation.
Prolonged use of dermatological products may lead to sensitization phenomena (allergy).
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions (rapid-onset allergic reactions), may occur, even without prior exposure to aceclofenac (see section 4 "Possible side effects").
Severe skin reactions, some of which have been fatal, including exfoliative dermatitis (skin irritation with peeling), Stevens-Johnson syndrome (skin and mucous membrane lesions), and toxic epidermal necrolysis (a serious skin disease in which the epidermis detaches in sheets), have been very rarely reported in association with NSAID use (see section 4 "Possible side effects"). The risk appears to be higher in the early stages of therapy, as the reaction usually occurs within the first month of treatment.
Discontinue KAFENAC at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity (allergy).
Avoid using KAFENAC in case of chickenpox; in some cases, chickenpox may lead to serious skin and soft tissue infections, and the role of NSAIDs in worsening these infections cannot be excluded (see section 4 "Possible side effects").
Children and adolescents
Currently, there are no data available on the safety and efficacy of aceclofenac in children up to 14 years of age; therefore, its use is not recommended (see "Do not use KAFENAC").
Other medicines and KAFENAC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exercise caution when using KAFENAC with:

• Lithium (a mood-stabilizing medicine used in the treatment of depression and bipolar disorder).
• Digoxin (a medicine that enhances heart function).
• Oral anticoagulants (medicines that increase blood fluidity).
• Diuretics (medicines used to increase urine production).
• Analgesics (medicines used to relieve pain).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Oral formulations (e.g., tablets) of aceclofenac may cause adverse effects in the newborn.
It is not known whether the same risk applies to KAFENAC.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine. Do not use KAFENAC during the last 3 months of pregnancy.
You must not use KAFENAC during the first 6 months of pregnancy unless strictly necessary and advised by your doctor. If treatment is required during this period, use the lowest effective dose for the shortest possible duration.
Breastfeeding
Do not use KAFENAC if you are breastfeeding.
Fertility
The use of KAFENAC, as with any drug inhibiting prostaglandin synthesis and cyclooxygenase (anti-inflammatory drugs), is not recommended in women attempting to conceive.
KAFENAC administration should be discontinued in women with fertility problems or undergoing fertility investigations.
Driving and using machines
KAFENAC does not impair the ability to drive or operate machinery.
KAFENAC 15 mg/g cream contains propylparahydroxybenzoate and methylparahydroxybenzoate.
These may cause allergic reactions (including delayed reactions).

3. HOW TO USE KAFENAC

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1.5 g - 2 g of KAFENAC cream, equivalent to 4-5 cm, to be applied three times daily to the affected area, or as prescribed by a physician.
If you use more KAFENAC than you should
Cases of overdose are not known. In case of improper use or ingestion of an excessive dose, general therapeutic measures normally adopted in poisoning with non-steroidal anti-inflammatory drugs should be undertaken.
If you forget to use KAFENAC
Do not use a double dose to compensate for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Possible adverse reactions that may occur following the use of KAFENAC are:
Mild or moderate skin irritation accompanied by redness and mild itching, which disappear upon discontinuation of treatment.

Uncommon adverse reactions (may affect up to 1 in 100 patients)

• Photosensitivity in cases where treated skin areas have been exposed to strong sunlight without adequate protection (see "Warnings and precautions").
• Erythema (skin irritation).
• Itching.

Very rare adverse reactions (may affect up to 1 in 10,000 patients)
Bullous eruption (including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Exceptionally, severe infectious complications of the skin and soft tissues have been reported during chickenpox in association with NSAID treatment (see "Warnings and precautions").
Following the instructions provided in this leaflet reduces the risk of adverse reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. HOW TO STORE KAFENAC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month and applies to the product in its original, unopened packaging, properly stored.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What KAFENAC contains
100 g of cream contain:
Active substance: aceclofenac 1.5 g.
Other components: emulsifying wax, liquid paraffin, propyl 4-hydroxybenzoate,
methyl 4-hydroxybenzoate, purified water.

Description of the appearance of KAFENAC and contents of the pack
White cream.
Tube containing 50 g of cream.

Marketing Authorization Holder
ALMIRALL S.A.
Ronda General Mitre 151
08022 Barcelona, Spain

Manufacturer
Industrias Farmacéuticas Almirall, S.A. (Planta de Sant Andreu de la Barca), Ctra. de Martorell, 41-61 -
08740 Sant Andreu de la Barca - Barcelona (Spain) (solely for batch control and release).
Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek (Germany).