Biofenac

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Biofenac (Airtal), 100 mg, effervescent powder for oral suspension
Aceclofenacum
Biofenac and Airtal are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Biofenac is and what it is 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 Biofenac is and what it is used for

Biofenac is a pain-relieving and anti-inflammatory medicine.
Biofenac is used in the treatment of chronic joint diseases associated with persistent pain and inflammation, such as: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. Important information before using the drug Biofenac

When not to use 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 experienced asthma, acute inflammation of the nasal mucosa, skin rash or other allergic reactions after taking acetylsalicylic acid (e.g. Aspirin) or another non-steroidal anti-inflammatory drug,
• if the patient has or 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 heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, mini-stroke (transient ischaemic attack), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass blocked blood vessels,
• if the patient has or has had circulatory disorders (peripheral vascular disease).

Warnings and precautions
Before starting treatment with Biofenac, discuss this with your doctor.

• if the patient has had symptoms of peptic ulcer, gastrointestinal bleeding or perforation, or inflammatory bowel diseases (ulcerative colitis, Crohn's disease), as these may worsen,
• if the patient has a history of cerebral haemorrhage,
• if the patient has had or has moderately severe liver or kidney disease or has a tendency to fluid retention for any other reason,
• if the patient has coagulation disorders, as these may worsen,
• if the patient has a specific skin and connective tissue disease, so-called SLE (systemic lupus erythematosus),
• if the patient has a specific metabolic disorder, so-called porphyria,
• if the patient has had or still has bronchial asthma,
• if the patient smokes tobacco,
• if the patient has diabetes,
• if the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol levels or elevated triglyceride levels.

Use of medicines such as Biofenac may be associated with an increased risk of heart attack (myocardial infarction). The occurrence of adverse effects can be minimized by using the medicine at the lowest effective dose and for no longer than necessary.
Do not increase the recommended dose or extend the duration of treatment.
Hypersensitivity reactions, including angioedema and severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in connection with the use of medicines such as Biofenac. The risk of skin reactions is higher during the first month of treatment. At the first appearance of skin rash, mucosal damage or any symptoms of hypersensitivity, treatment must be discontinued and the doctor must be informed immediately (see section 4).
Treatment with Biofenac must be discontinued at the first signs of 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 may occur at any time during treatment, with or without warning symptoms.
If any gastrointestinal symptoms are observed, especially if the patient is elderly, contact a doctor.
Biofenac and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the action of Biofenac. In such cases, a dose adjustment or discontinuation of these medicines may be necessary. This is particularly important if the patient is taking:

• lithium (used in the treatment of psychiatric disorders),
• digoxin (used in the treatment of heart failure or arrhythmia),
• diuretics (water tablets),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II antagonists),
• anticoagulants (blood thinners),
• medicines used to treat depression,
• antidiabetic medicines,
• methotrexate (used in the treatment of tumours and rheumatism),
• tacrolimus and cyclosporine (immunosuppressive medicines used to prevent rejection of transplanted organs),
• corticosteroid anti-inflammatory medicines, such as betamethasone and prednisolone,
• acetylsalicylic acid and other painkillers (so-called non-steroidal anti-inflammatory drugs),
• zidovudine (used in the treatment of 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Inform the doctor if the patient plans pregnancy or has difficulty becoming pregnant.
NSAIDs may make it more difficult to become pregnant.
Do not use Biofenac if the patient is in the third trimester of pregnancy.
The use of this medicine during any period of pregnancy should be under medical prescription only.
It is not known whether Biofenac passes into breast milk. Use during breastfeeding is not recommended unless the doctor decides otherwise.
Driving and operating machinery
Do not drive or operate dangerous tools or machinery if dizziness, nausea or other central nervous system disturbances occur during treatment with 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 the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which fructose accumulates in the body, the patient should contact a 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 improper excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to take Biofenac

This medicine should always be taken according to the instructions given 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 is 200 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
Use of Biofenac is not recommended in children due to lack of data on 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 sachet per day.
Long-term treatment
If Biofenac is used for a prolonged period, your doctor will periodically perform laboratory tests (blood count, liver and kidney function tests).
Taking more Biofenac than recommended
Seek immediate medical advice from your doctor or pharmacist or go to the nearest hospital emergency department.
Take this leaflet with you!
Missed dose of Biofenac
There is no cause for concern! Do not take a double dose to make up for the missed sachet. Take the next dose at the usual time.
Stopping Biofenac treatment
The duration of treatment is determined by the doctor. Do not stop treatment prematurely, even if you feel better.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most of these are mild and resolve after discontinuation of Biofenac treatment.
Adverse reactions 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 available data

Immediately discontinue use of Biofenac and seek medical help if the patient experiences:
Allergic reactions, including anaphylactic shock and angioedema (rare), with symptoms such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• urticaria and breathing difficulties,
• drop in 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 resembling 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, skin redness, inflammation, pain, and formation of blisters.

Common: dizziness, dyspepsia (indigestion), abdominal pain, nausea, diarrhoea, and changes in liver function tests.
Uncommon: flatulence, gastritis (inflammation of the stomach lining), constipation, vomiting, oral ulceration, pruritus (itching) and skin rash, renal function disorders.
Rare: hypertension, heart failure, dyspnoea (difficulty breathing or shortness of breath, usually associated with certain forms of heart or lung disease, also referred to as breathlessness), anaemia (deficiency in red blood cells or low haemoglobin concentration), visual disturbances.
Very rare: abnormally low white blood cell and platelet counts, elevated potassium levels, increased liver enzyme activity in blood, depression, sleep disorders, unusual dreams, paresthesia (tingling sensations), tremor (rhythmic, involuntary movements), headache, taste disturbances, stomatitis (inflammation of the mucous membrane of the mouth), pancreatitis, hepatitis, vertigo (sensation of spinning), tinnitus (ringing, buzzing, or other sounds in the ears without external cause), purpura (numerous small skin hemorrhages), rash, edema (swelling of legs, arms, or face), leg muscle cramps, renal function disorders, renal failure, palpitations (unpleasant sensation of irregular and/or forceful heartbeat), vasculitis (inflammation of blood vessels), fatigue, sudden facial flushing, hot flushes, breathing difficulties (bronchospasm), weight gain, intestinal perforation, exacerbation of inflammatory bowel diseases (Crohn's disease, ulcerative colitis).
Severe skin infections have been observed in individual cases during chickenpox.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Biofenac

Keep the medicine out of the sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 in Biofenac is aceclofenac.
Each sachet contains 100 mg of aceclofenac.
Other ingredients are:
Sorbitol (E 420), sodium saccharin, aspartame (E 951), anhydrous colloidal silicon dioxide,
hypromellose, titanium dioxide (E 171), milk flavour, caramel flavour, cream flavour.
What Biofenac looks like and contents of the pack
Appearance: White or creamy-white powder with an odour characteristic of the flavouring components used.
Pack: 3 g of powder in a single-dose sachet. 20 single-dose sachets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish marketing authorisation number, country of export: 686030.4
686022.9
Parallel import authorisation number: 419/22