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, powder for oral suspension

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 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 the patient is allergic to aceclofenac or any of the other ingredients of this medicine (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 disease and (or) cerebrovascular disease, such as after a heart attack, stroke, transient ischemic attack (temporary cerebral ischemia), or vascular occlusion of the heart or brain, or after a procedure to open up blocked vessels,
• if the patient has had circulation disorders (peripheral vascular disease).

Warnings and precautions

Before starting to take Biofenac, you should discuss it with your 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 cerebral bleeding in their medical history,
• if the patient has had moderate liver or kidney disease, or if they have a tendency to retain fluids in the body for any other reason,
• if the patient has coagulation 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 bronchial asthma,
• if the patient smokes,
• if the patient has diabetes,
• if the patient has angina pectoris, thrombosis, hypertension, increased cholesterol levels, or increased triglyceride levels.

Taking medicines 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 medicine in the smallest effective dose and for no longer than necessary.
Do not increase the recommended dose and prolong the treatment time.
Allergic reactions, including anaphylactic shock and angioedema, and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of medicines like 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 a doctor should be informed immediately (see section 4).
Treatment with Biofenac should be discontinued in case of the first appearance of a skin rash or other symptoms 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.
In case of observing any abdominal symptoms, especially if the patient is elderly, a doctor should be consulted.

Biofenac and other medicines

You should 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 the use of 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 (diuretic medicines),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II antagonists),
• anticoagulant medicines (blood-thinning medicines),
• 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, you should consult your doctor or pharmacist before taking this medicine.
You should inform your doctor if you plan to become pregnant or if you have problems with becoming pregnant.
NSAIDs may make it more difficult to become pregnant.
Biofenac should not be used if you are in the third trimester of pregnancy.
The use of this medicine during any period of pregnancy should only be done under the supervision of a doctor.
It is not known whether Biofenac passes into breast milk. It is not recommended to use during breastfeeding, unless a doctor decides otherwise.

Driving and using machines

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

Biofenac 100 mg, powder for oral suspension contains sorbitol (E 420), aspartame (E 951), and sodium

The medicine contains 2.64 g of sorbitol in each 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 the body does not break down fructose, you should consult your doctor before taking the medicine.
The medicine contains 10 mg of aspartame in each 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 excretion.
The medicine contains less than 1 mmol (23 mg) of sodium in each sachet, which means the medicine is considered "sodium-free".

3. How to take Biofenac

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The contents of the sachet should be dissolved in approximately 40-60 ml of water and taken 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, you should consult your doctor or pharmacist.

Use in children

The 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 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

You should immediately consult your doctor or pharmacist or go to the nearest hospital emergency department. You should take this leaflet with you!

Missing a dose of Biofenac

There is no reason to worry! You should not take a double dose to make up for a missed sachet. The next dose should be taken at the usual time.

Stopping treatment with Biofenac

The duration of treatment is determined by your doctor. You should not stop therapy prematurely, even if you feel better.
If you have any further doubts about the use of this medicine, you should 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 the use of Biofenac.
Side effects may occur with the following frequency, defined below:

• 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

You should immediately stop taking Biofenac and seek medical help 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:

• 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.
Rare:high blood pressure, heart failure, shortness of breath (difficulty breathing or shortness of breath, usually associated with certain types of heart or lung disease, 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, taste disturbances, 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), 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 you experience any side effects, including any side effects not listed in this leaflet, you should 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
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Biofenac

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storage.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines 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 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, cream flavor.

What Biofenac looks like and what the package contains

Appearance:White or cream-white powder with a characteristic odor due to the used flavor compositions.
Packaging:3 g of powder in a single-dose sachet. 20 single-dose sachets 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:

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 export authorization number: 686030.4

• 686022.9

Parallel import authorization number: 419/22 Date of leaflet approval: 28.11.2022

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