Biofenac

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Biofenac(Airtal)

100 mg, powder for oral suspension

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

Read the leaflet carefully before taking the medicine, 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 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 you experience any side effects, including any not listed in this leaflet, tell your 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. Contents of the pack and other information

1. What is Biofenac and what is it used for

Biofenac is a pain-relieving and anti-inflammatory medicine.
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

• if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6),
• if you are in the last three months of pregnancy,
• if you have 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 you have had stomach or intestinal ulcers or bleeding from the gastrointestinal tract,
• if you have active bleeding or bleeding disorders,
• if you have severe liver or kidney disease,
• if you have had heart disease and (or) cerebrovascular disease, such as a heart attack, stroke, transient cerebral ischemia, or vascular occlusion of the heart or brain, or have undergone a procedure to open or bypass blocked vessels,
• if you have had circulatory disorders (peripheral vascular disease).

Warnings and precautions

Before starting treatment with Biofenac, discuss it with your doctor.

• if you have had symptoms of stomach ulcers, bleeding, or perforation, or inflammatory bowel disease (ulcerative colitis, Crohn's disease), as they may worsen,
• if you have had a history of cerebral bleeding,
• if you have had moderate liver or kidney disease, or if you have a tendency to retain fluid in your body for any other reason,
• if you have bleeding disorders, as they may worsen,
• if you have a specific skin and connective tissue disease, known as systemic lupus erythematosus (SLE),
• if you have a specific metabolic disorder, known as porphyria,
• if you have had asthma,
• if you smoke,
• if you have diabetes,
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Taking medicines like Biofenac may be associated with an increased risk of heart attack (myocardial infarction). The risk of side effects can be minimized by taking the medicine in the lowest effective dose and for no longer than necessary.
Do not exceed the recommended dose or prolong treatment.
Allergic reactions, including angioedema and severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of medicines like Biofenac. The risk of skin reactions is higher during the first month of treatment. If you experience any skin rash, mucosal lesions, or signs of hypersensitivity, discontinue treatment and inform your doctor immediately (see section 4).
Treatment with Biofenac should be discontinued if you experience any skin rash or other signs of hypersensitivity.
Biofenac should not be used in the 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 you experience any abdominal symptoms, especially if you are elderly, consult your doctor.

Biofenac and other medicines

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

• lithium (used to treat mental illnesses),
• digoxin (used to treat heart failure or arrhythmia),
• diuretics (water pills),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II antagonists),
• anticoagulant medicines (blood thinners),
• medicines used to treat depression,
• antidiabetic medicines,
• methotrexate (used to treat tumors and rheumatism),
• tacrolimus and cyclosporin (medicines that weaken the immune system and are used to prevent organ rejection),
• corticosteroid anti-inflammatory medicines, such as betamethasone and prednisolone,
• acetylsalicylic acid and other pain-relieving medicines (non-steroidal anti-inflammatory drugs),
• 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 medicine.
Tell your doctor if you plan to become pregnant or if you have problems getting pregnant.
NSAIDs may make it harder to get pregnant.
Do not take Biofenac if you are in the last three months of pregnancy, as it may harm your unborn baby or cause problems during delivery. Biofenac may cause kidney and heart problems in the unborn baby. Biofenac may affect your tendency to bleed and that of your child, and may cause labor 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 medicine during this period or when planning to become pregnant, use the lowest 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 levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
Taking this medicine during any stage of pregnancy should only be done under medical supervision.
It is not known whether Biofenac passes into breast milk. Breastfeeding is not recommended, unless your doctor decides otherwise.

Driving and using machines

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

Biofenac contains sorbitol (E 420), aspartame (E 951), and sodium

The medicine contains 2.639 g of sorbitol (E 420) per sachet.
Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, consult your doctor before taking the medicine.
The medicine contains 10 mg of aspartame (E 951) per sachet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired elimination.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is considered "sodium-free".

3. How to take Biofenac

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Dissolve the contents of the sachet in approximately 40-60 ml of water and drink immediately.
The recommended daily dose is200 mg, i.e., one sachet in the morning and one in the evening (one sachet every 12 hours).
If you feel that the effect of Biofenac is too strong or too weak, consult your doctor or pharmacist.

Use in children

Use of Biofenac is not recommended in children due to the lack of data on 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 sachet per day.

Long-term treatment

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

Taking a higher dose of Biofenac than recommended

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

Missing a dose of Biofenac

No need to worry! Do not take a double dose to make up for the missed sachet. Take the next dose at the usual time.

Stopping treatment with Biofenac

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild and disappear after stopping treatment with Biofenac.
Side effects may occur with the following frequencies, defined below:

• Very common: may affect more than 1 in 10 people
• Common: may affect up to 1 in 10 people
• Uncommon: may affect up to 1 in 100 people
• Rare: may affect up to 1 in 1,000 people
• Very rare: may affect up to 1 in 10,000 people
• Frequency not known: frequency cannot be estimated from the available data

Stop taking Biofenac and seek medical help 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.

Ulcers and bleeding from the gastrointestinal tract (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 conditions, also known as lack of breath), anemia (low red blood cell count or low hemoglobin levels), 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, oral inflammation (inflammation of the mouth lining), pancreatitis, hepatitis, dizziness (feeling of spinning), tinnitus (ringing, buzzing, or other sounds without external cause), petechiae (numerous small bleeding spots in the skin), rash, edema (swelling of the legs, arms, or face), muscle cramps in the legs, kidney problems, kidney failure, palpitations (unpleasant sensation of irregular and (or) forceful heartbeat), vasculitis (inflammation of blood vessels), fatigue, sudden flushing of the face, hot flashes, difficulty breathing (bronchospasm), weight gain, intestinal perforation, worsening 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 not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 medicine.

5. How to store Biofenac

Keep the medicine out of the sight and reach of children.
There are no special storage precautions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Biofenac contains

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

Other ingredients are:

Sorbitol (E 420)
Sodium saccharin
Aspartame (E 951)
Colloidal anhydrous silica
Hypromellose
Titanium dioxide (E 171)
Milk flavor
Caramel flavor
Butter flavor

What Biofenac looks like and contents of the pack

Appearance:White or cream-white powder with a characteristic odor due to the flavor compositions used.
Packaging: 3 g of powder in a single-dose sachet Al/PE.
20 sachets packed in a cardboard box.
For more detailed information, 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:

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:686022.9

• 686030.4 Parallel import authorization number:265/15

Date of leaflet approval: 19.05.2025

[Information about the trademark]