BIOFENAC 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.
3. Biofenac (Airtal)
4. 100 mg, Coated Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
5. What is Biofenac and What is it Used For
6. Important Information Before Taking Biofenac
   1. When Not to Take Biofenac
   2. Warnings and Precautions
   3. Biofenac and Other Medications
   4. Biofenac with Food and Drink
   5. Pregnancy, Breastfeeding, and Fertility
   6. Driving and Operating Machines
   7. Biofenac Contains Sodium
7. How to Take Biofenac
   1. Use in Children
   2. Elderly Patients
   3. Kidney and Heart Diseases
   4. Liver Diseases
   5. Long-Term Treatment
   6. Taking More Than the Recommended Dose of Biofenac
   7. Missing a Dose of Biofenac
   8. Stopping Biofenac Treatment
8. Possible Side Effects
   1. Stop Taking Biofenac and Seek Medical Attention Immediately if You Experience:
   2. Reporting Side Effects
9. How to Store Biofenac
10. Package Contents and Other Information
    1. What Biofenac Contains
    2. Other Ingredients Are:
    3. What Biofenac Looks Like and What the Package Contains
    4. Marketing Authorization Holder in Spain, the Country of Export:
    5. Manufacturer:
    6. Parallel Importer:
    7. Repackaged by:
    8. Date of Leaflet Approval: 20.05.2025

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Biofenac (Airtal)

100 mg, Coated Tablets

Aceclofenac
Biofenac and Airtal are different trade names for the same drug.

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not give it to others. The medication 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Biofenac and What is it Used For
• 2. Important Information Before Taking Biofenac
• 3. How to Take Biofenac
• 4. Possible Side Effects
• 5. How to Store Biofenac
• 6. Package Contents and Other Information

1. What is Biofenac and What is it Used For

Biofenac is a pain-relieving and anti-inflammatory medication.
Biofenac is used to treat chronic joint diseases associated with chronic pain and inflammation, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. Important Information Before Taking Biofenac

When Not to Take Biofenac

Warnings and Precautions

Before starting to take Biofenac, discuss it with your doctor.

Taking medications like Biofenac may be associated with an increased risk of heart attack (myocardial infarction).
The occurrence of side effects can be limited by taking the medication in the smallest effective dose and for no longer than necessary.
Do not increase the recommended dose or prolong the treatment duration.
Allergic reactions, including angioedema and severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Biofenac. The risk of skin reactions is higher during the first month of treatment. At the first appearance of a skin rash, mucosal damage, or any symptoms of hypersensitivity, treatment should be discontinued and medical attention should be sought immediately (see section 4).
Biofenac should be discontinued in case of the first appearance of a skin rash or other symptoms of hypersensitivity.
Biofenac should not be taken in case of chickenpox.
Biofenac may rarely cause gastrointestinal ulcers and bleeding. This can occur at any time during treatment, with or without warning symptoms.
In case of observing any abdominal symptoms, especially in elderly patients, medical attention should be sought.

Biofenac and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Some medications may affect the action of Biofenac. In such cases, it may be necessary to change the dose or discontinue the use of these medications. This is especially important if you are taking:

• lithium (used to treat mental illnesses),
• digoxin (used to treat heart failure or arrhythmia),
• diuretics (diuretic medications),
• certain medications used to treat high blood pressure (ACE inhibitors and angiotensin II antagonists),
• anticoagulant medications (blood thinners),
• medications used to treat depression,
• antidiabetic medications,
• methotrexate (used to treat tumors and rheumatism),
• tacrolimus and cyclosporin (medications that weaken the immune system and are used to prevent organ rejection),
• corticosteroid anti-inflammatory medications, such as betamethasone and prednisolone,
• acetylsalicylic acid and other pain-relieving medications (non-steroidal anti-inflammatory medications),
• zydovudine (used to treat HIV infection).

Biofenac with Food and Drink

Biofenac can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Tell your doctor if you plan to become pregnant or if you have problems getting pregnant.
NSAIDs may make it more difficult to become pregnant.
Do not take Biofenac if you are in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. Biofenac may cause kidney and heart problems in the unborn baby. Biofenac may affect the tendency to bleed in the mother and her child and may cause the delivery to be delayed or prolonged. Do not take Biofenac during the first six months of pregnancy, unless your doctor considers it absolutely necessary. If it is necessary to take the medication during this period or while planning to become pregnant, use the smallest possible dose for the shortest possible time. Taking Biofenac for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn baby, leading to low amniotic fluid levels or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If you require treatment for a longer period, your doctor may recommend additional check-ups.
Taking this medication during any period of pregnancy should be done under medical supervision.
It is not known whether Biofenac passes into breast milk. It is not recommended to take during breastfeeding, unless your doctor decides otherwise.

Driving and Operating Machines

Do not drive vehicles or operate hazardous tools or machines if you experience dizziness, nausea, or other central nervous system disorders while taking Biofenac.

Biofenac Contains Sodium

The medication contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to Take Biofenac

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets whole with a sufficient amount of liquid.
Recommended Daily Doseis 200 mg, i.e., one coated tablet in the morning and one in the evening (one coated tablet every 12 hours).
If you feel that the action of Biofenac is too strong or too weak, consult your doctor or pharmacist.

Use in Children

Biofenac is not recommended for children due to the lack of data on its efficacy and safety.

Elderly Patients

Dosage will be determined by your doctor. Regular check-ups will be necessary.

Kidney and Heart Diseases

Dosage will be determined by your doctor. Regular check-ups will be necessary.

Liver Diseases

The recommended initial daily dose should be reduced to one coated tablet per day.

Long-Term Treatment

In case of long-term use of Biofenac, your doctor will regularly perform laboratory tests (blood count, liver and kidney function tests).

Taking More Than the Recommended Dose of Biofenac

Immediately contact your doctor or pharmacist or go to the nearest hospital emergency department. Take this leaflet with you!

Missing a Dose of Biofenac

There is no reason to worry! Do not take a double dose to make up for the missed coated tablet. Take the next dose at the usual time.

Stopping Biofenac Treatment

The duration of treatment is determined by your doctor. Do not stop the therapy prematurely, even if you feel better.
If you have any further doubts about taking this medication, consult your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Biofenac can cause side effects, although not everybody gets them. Most of them are mild and disappear after stopping the medication.
Side effects can occur with the following frequency:

• Very Common: may occur in more than 1 in 10 people
• Common: may occur in up to 1 in 10 people
• Uncommon: may occur in up to 1 in 100 people
• Rare: may occur in up to 1 in 1,000 people
• Very Rare: may occur in up to 1 in 10,000 people
• Frequency Not Known: frequency cannot be estimated from the available data

Stop Taking Biofenac and Seek Medical Attention Immediately if You Experience:

Allergic reactions, including anaphylactic shock and angioedema (rare) with symptoms such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing,
• low blood pressure and fever.

Gastrointestinal ulcers and bleeding (rare) with symptoms such as:

• bloody stools (very rare),
• black tarry stools (rare),
• vomiting blood or dark particles that look like coffee grounds (very rare).

Potentially life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare) with symptoms such as:

• itching, rash, redness of the skin, inflammation, pain, and blistering.

Common:dizziness, indigestion (upset stomach), abdominal pain, nausea, diarrhea, and changes in liver function tests.
Uncommon:bloating (gas), gastritis (inflammation of the stomach lining), constipation, vomiting, oral ulcers, itching, and rash, kidney function disorders.
Rare:high blood pressure, heart failure, shortness of breath (difficulty breathing or shortness of breath, usually associated with certain heart or lung diseases, also known as lack of breath), anemia (low red blood cell count or low hemoglobin level), vision disturbances.
Very Rare:abnormally low white blood cell and platelet counts, elevated potassium levels, and elevated liver enzyme activity in the blood, depression, sleep disturbances, unusual dreams, paresthesia (tingling sensation), tremors (rhythmic, involuntary movements), headaches, oral inflammation (inflammation of the oral mucosa), pancreatitis, hepatitis, dizziness (feeling of spinning), tinnitus (feeling of ringing, buzzing, and hearing other sounds without an external cause), petechiae (numerous small bleeding spots in the skin), rash, edema (swelling of the legs, arms, or face), muscle cramps, kidney function disorders, kidney failure, palpitations (unpleasant feeling of irregular and (or) strong heartbeat), vasculitis (inflammation of blood vessels), fatigue, sudden flushing of the face, hot flashes, breathing difficulties (bronchospasm), weight gain, intestinal perforation, exacerbation of inflammatory bowel diseases (Crohn's disease, ulcerative colitis).
In individual cases, during chickenpox, severe skin infections have been observed.

Reporting Side Effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl .
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Biofenac

Keep the medication out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Biofenac Contains

The active substance of Biofenac is aceclofenac.
Each coated tablet contains 100 mg of aceclofenac.

Other Ingredients Are:

Glycerol palmitostearate
Crosscarmellose sodium
Povidone
Microcrystalline cellulose
Coating:
Sepifilm:
Polysorbate 40
Titanium dioxide (E 171)
Microcrystalline cellulose
Hypromellose

What Biofenac Looks Like and What the Package Contains

Appearance:White, biconvex, round coated tablets with a diameter of approximately 8 mm.
Packaging: 20 or 60 coated tablets in aluminum/aluminum blisters in a cardboard box.

Marketing Authorization Holder in Spain, the Country of Export:

Almirall, S.A.
General Mitre, 151, 08022 – Barcelona, Spain

Manufacturer:

Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell, 41-61, 08740 Sant Andreu de la Barca, Barcelona, Spain

Parallel Importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Spanish Marketing Authorization Number:885285.7

• 723924.6 Parallel Import Authorization Number:266/15

Date of Leaflet Approval: 20.05.2025

[Information about the trademark]