ACEKLIK 100 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Aceklik, 100 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Aceklik and what is it used for
4. Important information before taking Aceklik
   1. When not to take Aceklik:
   2. Warnings and precautions
   3. Aceklik with food and drink
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Excipients
5. How to take Aceklik
   1. Elderly patients
   2. Taking a higher dose of Aceklik than recommended
   3. Missing a dose of Aceklik
   4. Stopping treatment with Aceklik
6. Possible side effects
   1. Other side effects that have been reported for this type of medicine (NSAIDs) include:
   2. Reporting side effects
7. How to store Aceklik
8. Contents of the packaging and other information
   1. What Aceklik contains
   2. What Aceklik looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Aceklik, 100 mg, coated tablets

Aceclofenac

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

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

Table of contents of the leaflet

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

1. What is Aceklik and what is it used for

Aceklik contains the active substance aceclofenac. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Aceklik is used to relieve pain and inflammation in patients with:

• arthritis (degenerative joint disease). This disease often occurs in people over 50 years of age and is the cause of cartilage and bone tissue degeneration in the joint.
• an autoimmune disease that causes chronic joint inflammation (rheumatoid arthritis).
• spinal joint inflammation, which can lead to spinal fusion (ankylosing spondylitis).

2. Important information before taking Aceklik

When not to take Aceklik:

• if the patient is allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to acetylsalicylic acid or any other NSAIDs (such as ibuprofen, naproxen, or diclofenac)
• if the patient has experienced any of the following symptoms after taking acetylsalicylic acid or another NSAID:
• asthma attack
• bronchospasm
• rhinitis, itching, and (or) sneezing (nasal irritation)
• a bulging, red rash with round lesions, which may cause itching, stinging, or burning
• severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing, wheezing, unusual pain, and vomiting
• if the patient has a history of, currently has, or suspects they have stomach or intestinal ulcers
• if the patient has severe kidney disease
• if the patient has liver failure
• if the patient is pregnant or breastfeeding (unless the doctor considers it necessary)
• if the patient has active bleeding or coagulation disorders
• if the patient has heart disease and (or) cerebrovascular disease, such as if the patient has had a heart attack, stroke, mini-stroke (transient ischemic attack), or has had surgery to clear or bypass blocked blood vessels
• if the patient has circulatory problems (peripheral arterial disease)

Aceklik is not recommended for use in children.

Warnings and precautions

Before starting to take Aceklik, the patient should discuss it with their doctor:

• if the patient has any kidney or liver disease or tends to retain fluid in the body, or if the patient is being treated with diuretics
• if the patient has any of the following gastrointestinal diseases:
• inflammatory bowel disease (ulcerative colitis)
• chronic inflammatory bowel disease (Crohn's disease)
• ulceration, bleeding, or perforation
• blood disorders
• if the patient has asthma or other breathing difficulties
• if the patient has a blood disease known as porphyria
• if the patient has chickenpox or shingles, they should avoid taking this medicine, as there is a risk of rare, severe skin infections associated with taking aceclofenac
• if the patient has recently undergone major surgery
• if the patient is elderly (the doctor should prescribe the smallest effective dose for the shortest possible time).

There may be hypersensitivity reactions and, very rarely, severe allergic reactions (see section 4 "Possible side effects"). The risk is higher during the first month of treatment. The patient should stop taking Aceklik if they experience the first symptoms of a skin rash, mucosal damage, or any symptoms of hypersensitivity.
Taking medicines like Aceklik may be associated with an increased risk of heart attack ("myocardial infarction").
Before starting to take aceclofenac, the patient should inform their doctor if:

• the patient smokes
• the patient has diabetes
• the patient has angina pectoris, blood clots, high blood pressure, elevated cholesterol or triglycerides in the blood.

Side effects can be limited by taking the smallest effective dose for the shortest possible time.
The risk associated with taking the medicine is more likely when taking high doses and long-term treatment.
Do not exceed the recommended dose or duration of treatment.

Aceklik with food and drink

Aceklik should be taken preferably during a meal or after a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they plan to become pregnant or if they have problems getting pregnant.
NSAIDs may make it harder to get pregnant.
Aceklik should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. Aceklik may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the patient and their baby and may cause the delivery to be delayed or prolonged. Aceklik should not be taken during the first 6 months of pregnancy, unless the doctor considers it absolutely necessary. If it is necessary to take the medicine during this period or when planning to become pregnant, the smallest effective dose should be taken for the shortest possible time. Taking Aceklik for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn baby, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If the patient requires treatment for a longer period, the doctor may recommend additional check-ups.
Breastfeeding
Aceklik should not be taken during breastfeeding. It is not known whether this medicine passes into breast milk. It is not recommended to take this medicine during breastfeeding, unless the doctor considers it necessary.

Driving and using machines

If the patient experiences dizziness, drowsiness, fatigue, or any visual disturbances after taking Aceklik, they should not drive or operate machinery.

Excipients

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Aceklik

This medicine should always be taken as directed by the doctor. The doctor will prescribe the smallest effective dose for the shortest possible time to limit side effects. If in doubt, the patient should consult their doctor or pharmacist.
The recommended daily dose for adults is 200 mg (two 100 mg Aceklik tablets). One 100 mg tablet should be taken in the morning and the second in the evening.
The tablet should be swallowed whole, with a large amount of water, during or after a meal. The tablet should not be crushed or chewed.
Do not exceed the established daily dose.

Elderly patients

Elderly patients are more likely to experience severe side effects (listed in section 4 "Possible side effects").
If the doctor prescribes Aceklik, the patient will receive the smallest effective dose for the shortest possible time.

Taking a higher dose of Aceklik than recommended

In case of accidental ingestion of too many Aceklik tablets, the patient should immediately contact their doctor or go to the nearest hospital emergency department. The patient should take this leaflet or the Aceklik packaging with them, so the medical staff knows what medicine the patient has taken.

Missing a dose of Aceklik

If a dose is missed, there is no need to worry, the patient should simply take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Aceklik

Do not stop taking Aceklik unless the doctor advises it.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aceklik can cause side effects, although not everybody gets them.
The patient should stop taking the medicine and seek medical help immediately if they experience any of the following side effects:

• severe allergic reaction (anaphylactic shock). Symptoms can develop quickly and be life-threatening if not treated immediately and may include: fever, difficulty breathing, wheezing, abdominal pain, vomiting, swelling of the face and throat.
• severe skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. These conditions are potentially life-threatening, develop quickly, and involve the formation of large blisters and skin peeling. The rash may also appear in the mouth, throat, or eyes. It is usually accompanied by fever, headache, and joint pain.
• meningitis. Symptoms include high fever, headache, vomiting, rash, stiff neck, sensitivity to light, or intolerance to light.

and

• blood in the stool (feces)
• black, tarry stools. Vomiting blood or dark particles that look like coffee grounds.
• medicines like Aceklik may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
• kidney failure.

The patient should stop taking the medicine and consult their doctor if they experience:

• indigestion or heartburn
• abdominal pain (stomach pain) or other unusual symptoms related to the stomach
• blood disorders, such as reduced production of certain blood cells (bone marrow suppression), abnormal breakdown of red blood cells, known as hemolytic anemia, low iron levels in the blood, low white blood cell count, low platelet count, elevated potassium levels in the blood, which can irritate blood vessels, causing inflammation known as vasculitis. These disorders can cause extreme fatigue, shortness of breath, joint pain, recurrent infections, and bruising on the skin.

If any of the following side effects get worse or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
Common (may affect up to 1 in 10 people):

• dizziness
• nausea (nausea)
• diarrhea
• increased liver enzyme activity in the blood.

Uncommon (may affect up to 1 in 100 people):

• gas (bloating)
• inflammation or irritation of the stomach lining (gastritis)
• constipation
• vomiting
• mouth ulcers
• itching
• rash
• skin inflammation
• bulging, red rash with round lesions, which may cause itching, stinging, or burning (hives)
• increased urea levels in the blood
• increased creatinine levels in the blood.

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

• low iron levels in the blood
• hypersensitivity (allergic reaction)
• visual disturbances
• heart failure
• high blood pressure
• shortness of breath
• gastrointestinal bleeding
• stomach and intestinal ulcers

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

• depression
• unusual dreams
• insomnia
• tingling, stinging, or numbness of the skin
• uncontrolled shaking (tremors)
• drowsiness
• headaches
• taste disturbances in the mouth
• feeling of spinning while standing still
• ringing in the ears (tinnitus)
• rapid or forceful heartbeat (palpitations)
• hot flashes
• breathing difficulties
• mouth inflammation
• perforation of the stomach, intestine, or gut wall
• worsening of ulcerative colitis and Crohn's disease
• pancreatitis
• hepatitis
• spontaneous bleeding into the skin (appearing as a rash)
• blisters
• fluid retention and swelling
• fatigue
• leg cramps
• increased alkaline phosphatase activity in the blood
• weight gain.

Other side effects that have been reported for this type of medicine (NSAIDs) include:

• hallucinations
• confusion
• blurred vision, partial or complete loss of vision
• eye pain when moving the eyes
• worsening of asthma
• skin reaction to sunlight
• kidney inflammation
• general malaise

In individual cases, during chickenpox, severe skin infections have been observed.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Aceklik

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aceklik contains

• The active substance of Aceklik is aceclofenac. Each tablet contains 100 mg of aceclofenac.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, copovidone K28, talc, colloidal anhydrous silica, glycerol distearate (type I). The tablet coating contains hypromellose 2910 - 5mPas, microcrystalline cellulose, titanium dioxide (E 171), macrogol stearate (type I).

What Aceklik looks like and contents of the pack

White, round, biconvex, film-coated tablet with a diameter of 8 mm and a height of 4 mm.
Aceklik is available in blisters, in a carton containing 20, 30, 40, 50, 60, 70, 80, 90, 100, or 180 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Lithuania:
Aceclofenac Orion
Poland:
Aceklik

Date of last revision of the leaflet: