KAFENAC 100 mg Coated Tablet

Зміст інструкції

1. KAFENAC 100 mg coated tablets, 100 mg oral suspension powder
   1. What is KAFENAC and what is it 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
2. KAFENAC 1.5 g/100 g cream
   1. WHAT IS KAFENAC 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

KAFENAC 100 mg coated tablets, 100 mg oral suspension powder

Aceclofenac

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is KAFENAC and what is it used for

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

• Rheumatic inflammatory diseases such as osteoarthritis (a disease affecting the joints), rheumatoid arthritis (a progressive and chronic autoimmune disease affecting the joints), ankylosing spondylitis (a severe disabling rheumatic disease that can cause fusion of the joints).
• 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 a cushion between bones and tendons and/or muscles surrounding a joint), tendinitis (inflammation of the tendons), enthesitis (inflammation of the insertion of a muscle onto a bone).
• Acute painful conditions of different causes such as sciatica (a sensation of intense pain in the leg caused by irritation of the sciatic nerve), lumbago (back pain), myalgia (muscle pain), primary dysmenorrhea (painful menstrual cycle), pain following trauma of various kinds, odontalgia (toothache).

2. What you need to know before taking KAFENAC

Do not take KAFENAC

• If you are allergic to the active ingredient, to other NSAIDs (including acetylsalicylic acid) or to any of the other components of this medicine (listed in paragraph 6).
• If you have experienced in the past, after taking acetylsalicylic acid or other NSAIDs, asthma attacks or other allergic reactions such as urticaria (skin reaction), rhinitis (inflammation of the nasal mucosa), edema (fluid accumulation), rash (sudden redness of the skin)

or bronchospasm (narrowing of the bronchi). This applies to all non-steroidal anti-inflammatory drugs.

• If you have a heart and/or cerebrovascular condition (at the level of the brain vessels), for example if you have had a heart attack, a stroke (brain damage that occurs when the blood flow to the brain is suddenly interrupted), a mini-stroke (TIA), blockages of the blood vessels of the heart or brain or if you have undergone surgery to remove these blockages or a coronary bypass (surgery that creates an artificial bridge that allows bypassing an obstacle to blood flow).
• If you have or have had problems with blood circulation (peripheral arterial disease).
• If you have an active gastroduodenal ulcer (erosion of the inner lining of the stomach or intestinal mucosa) or bleeding (hemorrhages) in the gastrointestinal tract.
• If you have active bleeding and bleeding disorders (blood loss).
• If you have had gastrointestinal bleeding or perforation in the past caused by previous treatments with non-steroidal anti-inflammatory drugs or if you have had a recurrent gastric/peptic ulcer/bleeding in the past (two or more distinct episodes of demonstrated ulceration or bleeding).
• If you suffer from decreased liver function (severe hepatic impairment).
• If you suffer from decreased kidney function (renal impairment).
• If you are pregnant, especially in the third trimester and during breastfeeding, unless there are valid reasons to take it. In this case, the minimum effective dosage must be used (see “Pregnancy, breastfeeding and fertility”).

KAFENAC should not be administered to children (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before taking KAFENAC.
Do not take KAFENAC in combination with other NSAIDs, including selective COX-2 inhibitors.
Take KAFENAC with caution:

• If you smoke.
• If you have diabetes (increased blood sugar concentration).
• 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 a high level of cholesterol or triglycerides (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.

Adverse effects can be minimized by using the minimum effective dose for the shortest possible duration necessary to control the symptoms (see paragraph 3 “How to take KAFENAC”).
If you are elderly, be aware that the frequency of adverse effects, especially gastrointestinal bleeding and perforation, which can be fatal, is higher (see paragraph 3 “How to take KAFENAC”).
Gastrointestinal tract (stomach and intestines)
During treatment with all NSAIDs, at any time, with or without warning symptoms or after serious gastrointestinal events (pathologies at the level of the stomach or intestines), bleeding in the stomach and intestines, ulceration or perforation have been reported, which can be fatal.

Immediately stop treatment with KAFENACand consult your doctor if you experience gastrointestinal bleeding or ulceration while taking the medicine.
As with all NSAIDs, you must take KAFENAC with particular caution and under strict medical supervision if you have symptoms indicative of disorders relating to the upper or lower gastrointestinal tract, if you have had gastric or intestinal ulcers in the past, bleeding, perforation, ulcerative colitis or Crohn's disease (inflammatory bowel diseases), hematological alterations (at the level of the blood) as these conditions may be worsened (see paragraph 4 “Possible side effects”).
If you are elderly or if you have had an ulcer in the past, especially if complicated by bleeding or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is greater, especially with increased doses of NSAIDs. In these cases, start treatment with the lowest effective dose in order to reduce the risk of gastrointestinal toxicity.
If you are taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (such as other NSAIDs or corticosteroids - see “Other medicines and KAFENAC”) you may consider using protective agents for the stomach (e.g. misoprostol or proton pump inhibitors) at the same time.
If you have suffered from gastrointestinal toxicity (i.e. problems with the stomach and intestines), in particular if you are elderly, you should report any abdominal symptoms (especially gastrointestinal bleeding) to your doctor, particularly in the early stages of treatment.
Be careful when taking KAFENAC if you are being treated concomitantly with medicines that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents or selective serotonin reuptake inhibitors (see “Other medicines and KAFENAC”).
Cardiovascular (at the level of the heart vessels) and cerebrovascular (at the level of the brain vessels) system
Undergo adequate monitoring and take KAFENAC with caution:

• If you have had hypertension and/or congestive heart failure (inability of the heart to provide blood in adequate quantities to the needs of the body) from mild to moderate, as fluid retention and edema have been found in association with treatment with NSAIDs.
• If you have significant risk factors for cardiovascular events (high blood pressure, high levels of fats in the blood, diabetes) or if you smoke.
• If you have had cerebrovascular bleeding in the past.

The use of KAFENAC may be associated with an increased risk of myocardial infarction (heart attack) (see paragraph 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 period necessary. The response to therapy and the need for improvement of symptoms should be re-evaluated periodically.
Hypersensitivity (allergy) and skin reactions (of the skin)
Avoid the use of KAFENAC in case of chickenpox; in some cases, chickenpox can cause serious infectious complications of the skin and soft tissues and the role of NSAIDs in worsening these infections cannot be excluded (see paragraph 4 “Possible side effects”).
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions (rapidly occurring allergic reactions), even without previous exposure to aceclofenac, may occur in rare cases (see paragraph 4 “Possible side effects”).
Serious skin reactions (at the level of the skin), some of which fatal, including exfoliative dermatitis (skin irritation with scaling), Stevens-Johnson syndrome (lesions at the level of the skin and mucous membranes) and toxic epidermal necrolysis (severe skin disease in which the epidermis detaches in sheets), have been very rarely reported in association with the use of NSAIDs (see paragraph 4 “Possible side effects”). The risk appears to be higher in the early stages of therapy as the onset of the reaction occurs in most cases within the first month of treatment.
Stop taking KAFENAC at the first appearance of skin rash, mucous membrane lesions or any other sign of hypersensitivity (allergy).
Renal function
Take KAFENAC with caution:

• In case of mild to moderate renal impairment as the use of NSAIDs may determine a deterioration of renal function. In these cases, take the minimum effective dose and undergo regular checks of renal function.
• If you are being treated concomitantly with diuretics (drugs that increase urine production).

The effects on renal function are generally reversible with the discontinuation of aceclofenac.
Hepatic function (liver)
Stop treatment with KAFENAC if liver function parameters are persistently altered or worsened, if clinical or symptomatic signs of hepatopathy (liver disease) develop, or if other manifestations such as eosinophilia (elevated concentration of white blood cells in the blood) or rash (sudden redness of the skin) occur. Hepatitis (inflammation of the liver) can occur with the use of KAFENAC without warning symptoms.
Take KAFENAC with caution if you have hepatic porphyria (rare disease in which there is a deficiency of liver enzymes), as it may trigger an attack.
Undergo regular medical check-ups in case of mild-moderate impairment of liver function.
Hematological problems (at the level of the blood)
Aceclofenac may temporarily block platelet aggregation (see “Other medicines and KAFENAC”).
Respiratory disorders
Pay particular attention when taking KAFENAC if you suffer or have suffered in the past from bronchial asthma (disease caused by obstruction of the bronchi) as NSAIDs may worsen bronchospasm.
Long-term treatments
As a preventive measure, if you are undergoing long-term treatment with NSAIDs, you should be monitored for blood cell count and renal and hepatic function parameters.

Children and adolescents
There are currently no clinical data on the use of the drug in children, therefore its administration is not recommended (see “Do not take KAFENAC”).

Other medicines and KAFENAC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Be cautious when taking KAFENAC with:

• Diuretics (medicines used to increase urine production); aceclofenac, like other NSAIDs, can inhibit the activity of diuretics. In the case of concomitant administration with potassium-sparing diuretics, it is necessary to monitor potassium levels in the blood.
• Antihypertensives (medicines used to reduce blood pressure); NSAIDs can reduce the effect of antihypertensive drugs. If your kidney function is impaired (for example if you have lost a lot of fluids or if you are elderly) the co-administration of antihypertensive drugs such as ACE inhibitors or angiotensin II receptor antagonists and NSAIDs can increase the risk of acute renal failure, generally reversible. In these cases you must be adequately hydrated and monitoring of kidney function should be considered after the start of concomitant therapy and periodically thereafter.
• Corticosteroids (medicines with anti-inflammatory action); there may be an increased risk of ulceration or bleeding in the stomach and intestines (gastrointestinal bleeding) (see “Warnings and precautions”).
• Anticoagulants; like other NSAIDs, aceclofenac can increase the activity of anticoagulant drugs such as warfarin (see “Warnings and precautions”) and therefore strict control is necessary in case of combined 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 (low blood sugar) and hyperglycemic (high blood sugar) effects have been reported; it is therefore advisable to consider the possibility of adjusting the dosage of hypoglycemic agents (medicines that reduce blood sugar levels) in conjunction with aceclofenac.
• Methotrexate (antineoplastic and antirheumatic drug, used for the treatment of certain diseases such as leukemia, lymphomas, rheumatoid arthritis, lupus and psoriasis); the possible interaction between NSAIDs and methotrexate should be considered even when low doses of methotrexate are administered, especially if you have reduced kidney function. When combined therapy is to be administered, kidney function should be monitored. Use particular caution in case of concomitant administration within 24 hours of NSAIDs and methotrexate, as an increase in the concentration of the antitumor agent in the blood with consequent increase in the toxicity of the latter may occur.
• Lithium (mood stabilizer, used in the treatment of depression and bipolar disorder) and digoxin (drug that stimulates heart function); several NSAIDs inhibit the elimination of lithium and digoxin, leading to an increase in their concentration in the blood. 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 (immunosuppressant drugs); it is believed that the administration of NSAIDs in conjunction with cyclosporine or tacrolimus may increase the risk of

nephrotoxicity (toxicity at the level of the kidneys). During combination therapy it is therefore important
to carefully monitor kidney function.

• Zidovudine (antiviral drug); when NSAIDs are administered with zidovudine, the risk of hematological (blood) toxicity increases; there is evidence of increased risk of hemarthrosis (bleeding into a joint) and hematoma in HIV-positive hemophiliacs undergoing concomitant treatment with zidovudine and ibuprofen (a drug belonging to the NSAID category).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take KAFENAC
in the last 3 months of pregnancy, as it may harm the fetus or cause problems
during childbirth. It may cause problems with the heart, lungs or kidneys of 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 in the first 6 months of
pregnancy, unless absolutely necessary and under the advice of your doctor. If
treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of
pregnancy, KAFENAC may cause kidney problems in the fetus, if taken for more than a few
days, 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 needed for more than a few days, your doctor may
recommend additional monitoring.
The inhibition of prostaglandin synthesis caused by NSAIDs can negatively affect
pregnancy and/or the development of the embryo and fetus. Results of epidemiological studies suggest
an increased risk of abortion and cardiac malformation and gastroschisis (defect of the abdominal wall in which the intestine and sometimes other organs develop outside the abdomen
of the fetus) after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy.
The absolute risk of cardiac malformations increased from less than 1%, to about 1.5%. It
has been considered that the risk increases with the dose and duration of therapy.
Breastfeeding
Do not take KAFENAC if you are breastfeeding, to avoid adverse effects in the infant unless the
potential benefit to the mother outweighs the possible risk to the fetus (see “Do not take
KAFENAC”).
Fertility
NSAIDs may impair fertility and use is not recommended in women planning to become
pregnant. The administration of aceclofenac should be discontinued in women who have
fertility problems or are undergoing fertility investigations.
If you take KAFENAC in these cases, the dose should be kept as low as possible and the duration
of treatment should be as short as possible.

Driving and operating machinery
The administration of aceclofenac, as occurs with other NSAIDs and in particularly
predisposed patients, may lead to dizziness, vertigo or other central nervous system disorders.
You must be informed of these possible effects before driving a vehicle or operating
machinery requiring a degree of alertness.

KAFENAC 100 mg oral suspension powder contains sorbitol.
This medicine contains 2639 mg of sorbitol in each sachet. Sorbitol is a source of
fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients cannot
metabolize fructose, talk to your doctor before taking this medicine.

KAFENAC 100 mg oral suspension powder contains aspartame.
This medicine contains 10 mg of aspartame in each sachet. Aspartame is a source of
phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disease that
causes the accumulation of phenylalanine because the body cannot dispose of it properly.

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 following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
KAFENAC 100 mg 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.
Preferably take the medicine during meals.
KAFENAC 100 mg powder for oral suspension
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 swallow
immediately.
Preferably take the medicine during meals.

Elderly
It is not considered necessary to modify the dosage.

Patients with hepatic impairment
In patients with liver problems (hepatic impairment) it is advisable to reduce the initial dose to
100 mg per day
However, as with other NSAIDs, take KAFENAC with caution if you are elderly and have impaired
renal or hepatic function, cardiovascular dysfunction or if you are undergoing simultaneous
treatment with other pharmacological treatments.
Undesirable effects can be minimized by administering the minimum effective dose for the
minimum duration necessary to control the symptoms (see “Warnings and precautions”).

If you take more KAFENAC than you should
In case of accidental ingestion/intake of an excessive dose of KAFENAC, immediately notify
your doctor or go to the nearest hospital.
Currently, insufficient information is available regarding the clinical picture resulting from
overdose with KAFENAC.
The therapeutic measures to be adopted in case of acute poisoning with oral aceclofenac are
those commonly used in case of acute poisoning with NSAIDs:

• Absorption should be prevented as soon as possible by means of gastric lavage (stomach emptying and washing) and treatment with activated charcoal.
• Supportive and symptomatic treatments should be adopted in case of complications such as hypotension (low blood pressure), renal failure, convulsions, gastrointestinal irritation and respiratory depression.
• Specific therapies, such as forced diuresis (method used to increase the elimination of substances already absorbed), dialysis (therapy that replaces kidney function) or hemoperfusion (passage of blood through a resin column to remove a substance) do not allow the elimination of non-steroidal anti-inflammatory drugs, due to the high percentage of binding to blood proteins and their considerable metabolism.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop treatment with KAFENACand contact your doctor immediately if you experience any of the following side effects:

• Bleeding in the stomach and intestines (gastrointestinal).
• Damage to the stomach (peptic ulcers).
• Persistent or worsening liver function parameters, clinical signs or symptoms consistent with liver disease, other manifestations such as eosinophilia.
• Skin rash (sudden redness of the skin), mucous membrane lesions or any other sign of allergy.

Possible side effects that may occur following the intake of KAFENAC are:

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

• Dizziness.
• Increased levels of certain liver enzymes.
• Nausea, diarrhea, abdominal pain, dyspepsia (digestive pain).

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

• Gastritis (inflammation of the stomach), mouth ulcers (aphthae), flatulence (presence of gas in the intestines), constipation, vomiting.
• Urticaria (skin condition), rash (sudden redness of the skin), itching, dermatitis (skin inflammation).
• Increased levels of urea and creatinine in the blood.
• Constipation.

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

• Anemia (reduction in hemoglobin concentration 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 provide an adequate amount of blood for the needs of the entire body).
• Dyspnea (difficulty breathing).
• Melena (emission of blood with the stool), gastrointestinal ulcer and bleeding (peptic ulcers, perforation or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly - see “Warnings and precautions”).

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

• Thrombocytopenia (decrease in the number of platelets in the blood), hemolytic anemia (decrease in hemoglobin concentration in the blood caused by the destruction of red blood cells), granulocytopenia (severe decrease in the number of granulocytes in the blood), bone marrow depression (decrease in the functionality of the bone marrow that produces blood cells).
• Depression, insomnia, abnormal dreams.
• Paresthesia (altered sensitivity), dysgeusia (altered taste), headache, drowsiness.
• Tinnitus (ringing in the ears), vertigo.
• Palpitations.
• Flushing.
• Vasculitis (inflammation of the veins), hot flashes.
• Bronchospasm (narrowing of the bronchi).
• Worsening of ulcerative colitis or Crohn's disease (inflammatory bowel diseases), stomatitis (inflammation of the oral mucosa), pancreatitis (inflammation of the pancreas), intestinal perforation, hematemesis (emission of blood with vomiting).
• Stevens-Johnson syndrome (acute allergic reaction involving the skin and mucous membranes), toxic epidermal necrolysis (or “Lyell’s syndrome”, a serious skin disease induced by an allergy to certain drugs, characterized by the destruction of the epithelium and mucous membranes), purpura (lesion similar to a bruise, resulting from the rupture of capillaries under the surface of the skin), exanthem (skin rash).
• Renal failure, nephrotic syndrome (a set of symptoms and clinical signs caused by an alteration of the renal glomeruli that leads to protein loss in the urine).
• Liver injury (including hepatitis - liver inflammation), increased alkaline phosphatase in the 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, especially at high doses and in long-term treatments (see “Warnings and precautions”).
Exceptionally, during chickenpox, severe skin and soft tissue infections have been reported in conjunction with treatment with NSAIDs. To date, the role of NSAIDs in worsening these infections cannot be ruled out (see “Warnings and precautions”).
If one or more of the side effects described above occur, it is recommended to stop treatment with aceclofenac and contact your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging. The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
KAFENAC 100 mg coated tablets
Store at a temperature not exceeding 30°C.
KAFENAC 100 mg powder for oral suspension
No special storage precautions are necessary.
Do not dispose of any medicine in 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 pack and other information

What KAFENAC contains
KAFENAC 100 mg coated tablets
One coated tablet contains:

Active ingredient:aceclofenac 100 mg.

Other ingredients: microcrystalline cellulose, sodium croscarmellose, glyceryl palmitostearate,
povidone, hypromellose, polyethylene(40) stearate, titanium dioxide.
KAFENAC 100 mg oral suspension powder
One sachet contains:

Active ingredient: aceclofenac 100 mg.

Other ingredients: sorbitol, sodium saccharin, caramel flavour, cream flavour, milk flavour, colloidal
anhydrous silica, aspartame, hypromellose, titanium dioxide.

Description of the appearance of KAFENAC and contents of the pack
KAFENAC 100 mg coated tablets
White circular coated tablets.

• Blisters of 10 coated tablets in a cardboard box.
• Blisters of 40 coated tablets in a cardboard box.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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).

KAFENAC 1.5 g/100 g cream

Aceclofenac

Read this 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 told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better 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 IS KAFENAC AND WHAT IT IS USED FOR

KAFENAC contains the active substance aceclofenac which belongs to the category of non-steroidal anti-inflammatory drugs (NSAIDs) and antirheumatic drugs (drugs used for diseases affecting bones, cartilage and muscles).
This medicine is indicated in the local treatment of painful and inflammatory (inflammatory) conditions of rheumatic or traumatic nature of the joints, muscles, tendons and ligaments such as for example tendinitis (inflammation of the tendons), tenosynovitis (inflammation of the membrane that covers the tendon), sprains, bruises, periarthritis (inflammatory diseases involving the fibrous tissues surrounding a joint), dislocations (joint dislocations), lumbago (back pain), stiff neck, bursitis (inflammation of the fluid-filled sacs that act as a cushion between bones and tendons and/or muscles surrounding a joint), strains and post-traumatic sequelae.

2. WHAT YOU NEED TO KNOW BEFORE USING KAFENAC

Do not use KAFENAC

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

KAFENAC is contraindicated in children (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before using KAFENAC.
Use KAFENAC cream only for external use.
During treatment with KAFENAC you must avoid:

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

Stop treatment with KAFENAC and undergo appropriate therapeutic treatment if
you experience symptoms of local irritation.
Prolonged use of dermatological products can lead to sensitization phenomena
(allergy).
As with other NSAIDs, allergic reactions, including anaphylactic/ anaphylactoid reactions (rapid-onset allergic reactions), may also occur, even without previous
exposure to aceclofenac (see section 4 “Possible side effects”).
Severe skin reactions (at the skin level), some of which are fatal, including exfoliative dermatitis
(skin irritation with scaling), Stevens-Johnson syndrome (lesions at the
skin and mucous membranes) and epidermal necrolysis (severe skin disease in which the epidermis detaches in
layers), have been very rarely reported in association with the use of NSAIDs (see section
4 “Possible side effects”). The risk appears to be higher in the early stages of therapy in
as the onset of the reaction occurs in most cases within the first month of
treatment.
Stop taking KAFENAC at the first sign of skin rash, mucosal lesions or
any other sign of hypersensitivity (allergy).
Avoid using KAFENAC in case of chickenpox; in some cases, chickenpox can cause serious
infectious complications of the skin and soft tissues and it is not possible to exclude the role of NSAIDs
in exacerbating these infections (see section 4 “Possible side effects”).

Children and adolescents
Currently, there are no data regarding the safety and efficacy of aceclofenac in
children up to 14 years of age, therefore its administration is not recommended (see “Do not use KAFENAC”).

Other medicines and KAFENAC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Use KAFENAC with caution with:

• Lithium (mood stabilizer, used in the treatment of depression and bipolar disorder).
• Digoxin (a medicine that stimulates heart function).
• Oral anticoagulants (medicines that increase blood fluidity).
• Diuretics (medicines used to increase urine production).
• Pain relievers (medicines used against pain).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Oral forms (e.g., tablets) of aceclofenac can cause adverse effects in the unborn child.
It is not known whether the same risk applies to KAFENAC.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Do not
use KAFENAC if you are in the last 3 months of pregnancy.
You should not use KAFENAC during the first 6 months of pregnancy, unless it is strictly
necessary and recommended by your doctor. If you need treatment during this period,
you should use the lowest dose for the shortest possible time.
Breastfeeding
Do not use KAFENAC if you are breastfeeding.
Fertility
The use of KAFENAC, like any drug that inhibits the synthesis of prostaglandins and
cyclooxygenase (anti-inflammatory drugs), is not recommended in women who intend to start a
pregnancy.
The administration of KAFENAC should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Driving and using machines
KAFENAC does not impair the ability to drive vehicles or operate machinery.

KAFENAC 15 mg/g cream contains propylparaben and methylparaben.
They can cause allergic reactions (even delayed).

3. HOW TO USE KAFENAC

Use this medicine following exactly as stated in this leaflet or as instructed 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 a day
to the affected area or as prescribed by your doctor.

If you use more KAFENAC than you should
Cases of overdose are not known. In case of improper use or taking an excessive dose
of the medicine, it is appropriate to resort to general therapeutic measures of the type normally
adopted in case of poisoning with non-steroidal anti-inflammatory drugs.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects that may occur after taking KAFENAC are:
Mild or moderate skin irritation accompanied by redness and mild itching that
disappears with discontinuation of treatment.

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

• Photosensitivity in case the treated skin areas have been exposed to strong sunlight without adequate protection (see “Warnings and precautions”).
• Erythema (skin irritation).
• Pruritus (itching).

Very rare side effects (may affect up to 1 in 10,000 people)
Bullous eruption (including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis).
Exceptionally, severe infectious skin and soft tissue complications have been reported during chickenpox in association with treatment with NSAIDs (see “Warnings and
precautions”).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly through
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 which is reported on the packaging. The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine in 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 PACK AND OTHER INFORMATION

What KAFENAC contains
100 g of cream contains:

Active substance: aceclofenac 1.5 g.

Other components: emulsifying wax, liquid paraffin, propylparahydroxybenzoate,
methylparahydroxybenzoate, purified water.

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

Marketing Authorisation 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) (exclusively for batch control and release).
Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek (Germany).