Biofenac

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Biofenac (Airtal), 100 mg

coated tablets
Aceclofenacum
Biofenac and Airtal are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness 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 using Biofenac
• 3. How to use 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 drug.
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 using Biofenac

When not to use Biofenac

• if the patient is allergic to aceclofenac or any of the other ingredients of this drug (listed in section 6),
• if the patient is in the last three months of pregnancy,
• if the patient has had asthma, acute rhinitis, skin rash, or other allergic reactions after taking acetylsalicylic acid (e.g., Aspirin) or other non-steroidal anti-inflammatory drugs,
• if the patient has had stomach or intestinal ulcers or gastrointestinal bleeding,
• if the patient has active bleeding or bleeding disorders,
• if the patient has severe liver or kidney disease,
• if the patient has had heart or cerebrovascular disease, such as a heart attack, stroke, transient ischemic attack (mini-stroke), or vascular occlusion of the heart or brain, or has undergone a procedure to open up blocked vessels,
• if the patient has had circulatory disorders (peripheral vascular disease).

Warnings and precautions

Before starting to use Biofenac, the patient should discuss it with their doctor.

• if the patient has had symptoms of stomach or duodenal ulcers, bleeding, or perforation, or inflammatory diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease), as they may worsen,
• if the patient has had a history of cerebral bleeding,
• if the patient has had moderate liver or kidney disease, or has a tendency to retain fluid in the body for any other reason,
• if the patient has bleeding disorders, as they may worsen,
• if the patient has a specific skin and connective tissue disease, known as systemic lupus erythematosus (SLE),
• if the patient has a specific metabolic disease, known as porphyria,
• if the patient has had asthma,
• if the patient smokes,
• if the patient has diabetes,
• if the patient has angina, blood clots, high blood pressure, high cholesterol, or high triglycerides. The use of drugs like Biofenac may be associated with an increased risk of heart attack (myocardial infarction). The risk of side effects can be reduced by using the lowest effective dose for the shortest possible time. The recommended dose should not be exceeded, and the treatment duration should not be prolonged.

Allergic reactions, including angioedema and severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of Biofenac. The risk of skin reactions is higher during the first month of treatment. At the first appearance of a skin rash, mucosal lesions, or any signs of hypersensitivity, treatment should be discontinued and medical help sought immediately (see section 4).
Biofenac should be discontinued at the first sign of a skin rash or other signs of hypersensitivity.
Biofenac should not be used 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.
If any abdominal symptoms are observed, especially in elderly patients, medical help should be sought.

Biofenac and other drugs

The patient should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Some drugs may affect the action of Biofenac. In such cases, it may be necessary to change the dose or discontinue the use of these drugs. This is particularly important if the patient is taking:

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

Biofenac with food and drink

Biofenac can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 using this drug.
The patient should inform their doctor if they plan to become pregnant or have problems getting pregnant.
NSAIDs may make it more difficult to become pregnant.
Biofenac should not be used if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. The drug may cause kidney and heart problems in the unborn child. The drug may affect the patient's and their child's tendency to bleed and may cause labor to be delayed or prolonged. Biofenac should not be used during the first six months of pregnancy, unless the doctor considers it absolutely necessary. If the drug needs to be used during this period or when planning to become pregnant, the lowest possible dose should be used for the shortest possible time. Biofenac used for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low amniotic fluid levels or constriction of the fetal ductus arteriosus. If the patient requires treatment for a longer period, the doctor may recommend additional monitoring.
The use of this drug during any period of pregnancy should be done under medical supervision.
It is not known whether Biofenac passes into breast milk. The drug is not recommended during breastfeeding, unless the doctor decides otherwise.

Driving and operating machinery

The patient should not drive or operate hazardous machinery if they experience dizziness, nausea, or other central nervous system disorders while using Biofenac.

Biofenac contains sodium

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

3. How to use Biofenac

This drug should always be used as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The tablets should be swallowed whole, with a sufficient amount of liquid.
The recommended daily dose is200 mg, i.e., one coated tablet in the morning and one in the evening (one coated tablet every 12 hours).
If the patient feels that the effect of Biofenac is too strong or too weak, they should consult their doctor or pharmacist.

Use in children

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

Elderly patients

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

Kidney and heart diseases

Dosage will be determined by the 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 the case of long-term use of Biofenac, the doctor will regularly perform laboratory tests (blood morphology, liver and kidney function tests).

Taking a higher dose of Biofenac than recommended

The patient should immediately contact their doctor or pharmacist or go to the nearest hospital emergency department. They should take this leaflet with them!

Missing a dose of Biofenac

There is no need to worry! The patient should not take a double dose to make up for the missed coated tablet. The next dose should be taken at the usual time.

Stopping the use of Biofenac

The duration of treatment is determined by the doctor. The patient should not stop the therapy prematurely, even if they feel better.
If the patient has any further doubts about the use of this drug, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all drugs, Biofenac can cause side effects, although not everybody gets them.
Most of them are mild and disappear after stopping the use of Biofenac.
Side effects may 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

The patient should immediately stop using Biofenac and seek medical help if they experience:

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

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

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

• blood in the stool (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, nausea (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.
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), visual 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, taste disturbances, oral inflammation (inflammation of the mouth lining), pancreatitis, hepatitis, dizziness (feeling of spinning), tinnitus (feeling of ringing, buzzing, and hearing other sounds without an external cause), purpura (a large number of 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the drug.

5. How to store Biofenac

The drug should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this drug after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Drugs should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. 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
Croscarmellose 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, round, biconvex coated tablets with a diameter of approximately 8 mm.
Packaging:20, 60 coated tablets in aluminum/aluminum blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish marketing authorization number:

• 723924.6
• 885285.7

Parallel import authorization number: 323/15

Date of leaflet approval: 27.05.2025

[Information about the trademark]