Biofenac

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is 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 using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor and should not be given to anyone else. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any side effects not listed in this leaflet, you should 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 package 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 gastrointestinal bleeding,
• 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 ischemic attack (mini-stroke), or vascular occlusion of the heart or brain, or have undergone vascular surgery or bypass grafting,
• if you have had circulatory disorders (peripheral vascular disease).

Warnings and precautions

You should discuss the use of Biofenac with your doctor before starting treatment.

• if you have had symptoms of stomach or duodenal ulcers, bleeding, or perforation, or inflammatory bowel disease (ulcerative colitis, Crohn's disease), as they may worsen,
• if you have had cerebral bleeding in the past,
• 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 bronchial asthma,
• if you smoke,
• if you have diabetes,
• if you have angina pectoris, thrombosis, hypertension, 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 using the medicine in the lowest effective dose and for no longer than necessary.
Do not exceed the recommended dose and duration of treatment.
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 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, you should stop 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 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, you should contact your doctor.

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 disorders),
• 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),
• zidovudine (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 baby, 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 getting pregnant.
NSAIDs may make it more difficult to become pregnant.
You should not take Biofenac if you are in the last three months of pregnancy, as the medicine may harm your unborn baby or cause problems during delivery. The medicine may cause kidney and heart problems in the unborn baby. The medicine may affect your tendency to bleed and that of your child, and may cause the delivery to be delayed or prolonged. You should 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, you should take 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, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct 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 pregnancy period should be done under medical supervision.
It is not known whether Biofenac passes into breast milk. It is not recommended to take the medicine during breastfeeding, unless your doctor decides otherwise.

Driving and using machines

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

Biofenac 100 mg, powder for oral suspension contains sorbitol, aspartame, and sodium

The medicine contains 2639 mg 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 your body does not break down fructose, you should contact 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 improper 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 exactly 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 disease

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

Liver disease

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 perform regular laboratory tests (blood morphology, liver and kidney function tests) at regular intervals.

Taking a higher dose of Biofenac than recommended

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

Missing a dose of Biofenac

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

Stopping treatment with Biofenac

The duration of treatment is determined by your doctor. You should not stop treatment 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 frequencies, 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 heart or lung diseases, also known as breathlessness), anemia (low red blood cell count or low hemoglobin level), vision disturbances.
Very rare:abnormally low white blood cell count and platelet count, elevated potassium levels, and elevated liver enzyme activity in the blood, depression, sleep disturbances, abnormal 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 (ringing in the ears), petechiae (numerous small hemorrhages in the skin), urticaria, edema (swelling of the legs, arms, or face), muscle cramps, kidney function disorders, 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, 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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
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 the medicine.

5. How to store Biofenac

The medicine should be stored out of sight and reach of children.
There are no special storage precautions.
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. Contents of the package 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 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 Al/PE. 20 single-dose sachets packaged in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the 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:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska 14/1
02-202 Warsaw
Marketing authorization number in Spain, the country of export:

• 686022.9
• 686030.4

Parallel import authorization number: 243/20
Date of leaflet approval: 21.04.2023
[Information about the trademark]