Aceclofenac Kern Pharma 100 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Aceclofenac Kern Pharma 100 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Aceclofenaco Kern Pharma is and what it is used for

Aceclofenac is a medicine effective in reducing pain and inflammation.

Aceclofenaco Kern Pharma is used in adults for the treatment of inflammatory and painful conditions such as low back pain (lumbago), toothache (odontalgia), and joint pain (shoulder periarthritis and extra-articular rheumatism). Aceclofenac is also used in the long-term treatment of chronic pain and inflammation associated with chronic joint disorders: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. What you need to know before taking Aceclofenac Kern Pharma

It is important that you use the lowest dose that relieves/controls your pain and that you do not take aceclofenac for longer than necessary to control your symptoms.

Do not take Aceclofenac Kern Pharma

• if you are allergic to aceclofenac or to any of the other ingredients of this medicine (listed in section 6),
• if you are in the third trimester of pregnancy or if you are breastfeeding,
• if acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) have caused you asthma, rhinitis, urticaria, or another allergic reaction,
• if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract,
• if you have bleeding disorders or coagulation problems (you bleed easily),
• if you have severe liver or kidney disease,
• if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the blood vessels of the heart or brain, or have undergone surgery to remove an obstruction or coronary bypass,
• if you have or have had circulatory problems (peripheral arterial disease).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine

• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protecting medicine.

Elderly patients have a higher incidence of adverse effects, particularly gastrointestinal bleeding and perforation (in some cases fatal).

• if you have liver disease,
• if you have renal insufficiency,
• if you have heart problems or have suffered a stroke (cerebral hemorrhage),
• if you smoke,
• if you have diabetes,
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides,
• if you have blood disorders,
• if you are taking concomitant medications that affect blood coagulation, such as oral anticoagulants like warfarin, or antiplatelet agents such as acetylsalicylic acid, inform your doctor. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants,
• if you have Crohn's disease or ulcerative colitis, as medicines like aceclofenac may worsen these conditions,
• if you are recovering from major surgery,
• if you have had or still suffer from bronchial asthma,
• in case of chickenpox, the use of this medicine should be avoided, as serious skin infections may rarely occur related to its use,
• hypersensitivity reactions may occur and, very rarely, severe allergic reactions (see section 4. Possible side effects). The risk is higher during the first month of treatment. Discontinue treatment immediately at the first signs of skin rash, mucosal lesions, or other signs of hypersensitivity.

Medicines such as aceclofenac may be associated with an increased risk of heart attacks ("myocardial infarction"). Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration. Do not exceed the recommended dose or duration of treatment.

In addition, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Consult your doctor, even if any of the circumstances mentioned above have occurred to you in the past.

Other medicines and Aceclofenac Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medicines may interact with aceclofenac. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

This is especially important if you are taking lithium, digoxin, diuretics, antihypertensives, anticoagulants, antiplatelet agents, hypoglycemic agents, methotrexate, corticosteroids, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRI antidepressants), cyclosporine, tacrolimus, or zidovudine.

Taking Aceclofenac Kern Pharma with food and drink

Aceclofenac may be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take aceclofenac during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's ability to bleed and may delay or prolong labor more than expected. You should not take aceclofenac during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, aceclofenac may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Aceclofenac film-coated tablets must not be taken during breastfeeding.

For women of childbearing age, it should be noted that medicines like aceclofenac have been associated with a reduced ability to conceive.

Driving and using machines

If you experience dizziness, fainting, vertigo, or other central nervous system disturbances while taking aceclofenac, do not drive or operate any tools or machinery.

3. How to take Aceclofenac Kern Pharma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will prescribe the lowest effective dose for the shortest possible time to minimize side effects.

This medicine is taken orally.

The tablets should be swallowed whole with a sufficient amount of water.

The recommended dose in adults is 200 mg per day, i.e., one tablet in the morning and one at night (1 tablet every 12 hours), taken either before or after meals (see section “Taking Aceclofenac Kern Pharma with food and drink”).

The duration of treatment will be determined by your doctor. Do not stop treatment earlier than advised, even if you feel well.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents:

Not recommended.

Use in elderly patients:

Your doctor will determine the dose to be taken and will carry out periodic checks.

Use in patients with renal impairment or heart failure:

Your doctor will determine the dose to be taken and will carry out periodic checks.

Use in patients with hepatic impairment:

The dose should be reduced to 1 tablet per day.

Long-term treatment:

If you take aceclofenac for a prolonged period, your doctor should perform quarterly check-ups, for example on kidney and liver function, and blood tests.

If you take more Aceclofenac Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Aceclofenac Kern Pharma

Take your missed dose as soon as possible. If it is almost time for your next dose, wait and take the next tablet at the scheduled time.

Do not take a double dose to make up for the forgotten dose. Take the following dose according to the usual schedule.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The adverse effects that may occur are:

Frequent (may affect up to 1 in 10 patients)

• Gastric discomfort, abdominal pain, nausea, and diarrhea.
• Dizziness.
• Increased liver enzymes.

Uncommon (may affect up to 1 in 100 patients)

• Flatulence, stomach inflammation, constipation, vomiting, and mouth ulcers.
• Itching, skin rash, skin inflammation (dermatitis), and urticaria.
• Increased urea, increased creatinine.

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

• Blood in stools, gastrointestinal bleeding, gastrointestinal ulcer.
• Facial swelling.
• Heart failure, high blood pressure.
• Anemia.
• Severe allergic reaction, allergies.
• Vision abnormalities.
• Difficulty breathing.

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

• Inflammation of the mucosa of the mouth, pancreatitis, intestinal perforation, vomiting blood.
• Worsening of ulcerative colitis and Crohn's disease has also been observed.
• Purple spots on the skin, severe skin reactions.
• Medicinal products such as aceclofenac may, very rarely, be associated with very serious mucocutaneous reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
• Palpitations, flushing, feeling of warmth, inflammation of blood vessels (vasculitis).
• Liver injury (including hepatitis), increased alkaline phosphatase.
• Medicinal products such as aceclofenac may be associated with liver disorders causing yellowing of the skin and eyes, sometimes accompanied by high fever or swelling and tenderness in the upper abdomen. If any of the following reactions occur: yellowing of the skin or eyes, stop treatment IMMEDIATELY and inform your doctor.
• Decrease in white blood cells, decrease in platelets, bone marrow suppression, haemolytic anaemia.
• Increased blood potassium levels.
• Depression, sleep disturbances, difficulty falling asleep.
• Tingling, drowsiness, headache, taste disturbances, tremors.
• Dizziness, ringing in the ears (tinnitus).
• Noisy breathing, bronchospasm.
• Leg cramps.
• Kidney function impairment (nephrotic syndrome), renal failure.
• Fatigue, fluid retention (oedema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aceclofenac Kern Pharma

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aceclofenac Kern Pharma:

• The active substance is aceclofenac. Each tablet contains 100 mg of aceclofenac.
• The other components (excipients) are: Tablet core: microcrystalline cellulose, povidone, stearic acid, sodium croscarmellose, magnesium stearate. Coating: OPADRY I YS-1R-7003 (titanium dioxide (E-171), hypromellose 3cp (E-464), hypromellose 5cp (E-464), macrogol 400 and polysorbate 80 (E-433)).

Appearance of the product and contents of the pack

Film-coated tablets, round, white or almost white, slightly convex on both sides, packed in OPA-Aluminum-PVC/Aluminum blisters.

Available in packs of 20 or 40 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/