Biofenac

Package leaflet: information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Biofenac (Airtal), 100 mg
film-coated tablets
Aceclofenacum
Biofenac and Airtal are different trade names for the same medicine.
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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 an analgesic and anti-inflammatory medicine.
Biofenac is used in the treatment of 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 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 been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (mini-stroke), or arterial embolism in the heart or brain, or undergone 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 gastric or duodenal ulcer, 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 moderate 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 connective tissue and skin disease, known as SLE (systemic lupus erythematosus),
• if the patient has a specific metabolic disorder, known as porphyria,
• if the patient has had or still has 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. Use of medicines such as Biofenac may be associated with an increased risk of heart attack (myocardial infarction). The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary. Do not increase the recommended dose or prolong the duration of treatment.

Hypersensitivity reactions, including angioedema and severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of Biofenac. The risk of skin reactions is highest during the first month of treatment. At the first sign of skin rash, mucosal lesions or any symptoms of hypersensitivity, treatment must be discontinued and a doctor must be consulted immediately (see section 4).
Treatment with Biofenac must be discontinued at the first appearance of skin rash or other symptoms of hypersensitivity.
Biofenac should not be used in cases 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 abdominal symptoms occur, especially in elderly patients, medical advice should be sought immediately.

Interaction of Biofenac with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of Biofenac. In such cases, a dose adjustment or discontinuation of one of the 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 cardiac arrhythmias),
• diuretics (water tablets),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor 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 may 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 baby, she should consult her doctor or pharmacist before using this medicine.
Inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
NSAIDs may impair fertility.
Do not use Biofenac if the patient is in the last three months of pregnancy, as the medicine may harm the unborn child or cause problems during delivery. The medicine may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both the mother and the child and may cause delayed or prolonged labour. Do not use Biofenac during the first 6 months of pregnancy unless your doctor considers it absolutely necessary. If use during this period or when planning pregnancy is required, the lowest possible dose should be used for the shortest possible time. Biofenac used for longer than a few days beyond the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, your doctor may recommend additional monitoring tests.
Use of this medicine during any stage of pregnancy should only be under medical supervision and prescription.
It is not known whether Biofenac passes into breast milk. Use during breastfeeding is not recommended unless otherwise decided by a doctor.

Driving and operating machinery
Do not drive or operate dangerous tools or machinery if dizziness, nausea or other central nervous system disturbances occur while taking Biofenac.

Biofenac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use Biofenac

This medicine should always be used as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The tablets should be swallowed whole, with an adequate amount of liquid.
The recommended daily dose is 200 mg, i.e. one coated tablet in the morning and one in the evening (one
coated tablet 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 lack of data on efficacy and safety.
Elderly patients
Dosage will be determined by the doctor. Regular follow-up visits will be necessary.
Kidney and heart diseases
Dosage will be determined by the doctor. Regular follow-up visits will be necessary.
Liver diseases
The recommended initial daily dose should be reduced to one coated tablet per day.
Long-term treatment
If Biofenac is used long-term, your doctor will periodically perform laboratory tests (blood count, liver and kidney function tests).
Taking more Biofenac than recommended
Contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.
Bring this leaflet with you!
Missed dose of Biofenac
There is no cause for concern! Do not take a double dose to make up for a missed coated tablet. Take the next dose at the usual time.
Stopping Biofenac treatment
The duration of treatment is determined by the doctor. Do not stop therapy 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 them are mild and resolve after discontinuation of Biofenac.
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 the available data

Biofenac must be discontinued immediately and medical help sought 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, redness, inflammation and pain of the skin, and formation of blisters.

Common: dizziness, dyspepsia (indigestion), abdominal pain, nausea, diarrhoea, and changes in liver function tests.

Uncommon: bloating (gas), gastritis (inflammation of the stomach lining), constipation, vomiting, oral ulceration, skin itching and rash, renal function disorders.

Rare: arterial hypertension, heart failure, dyspnoea (difficulty breathing or shortness of breath, usually associated with certain forms of heart or lung disease, also known as shortness of breath), anaemia (low number of red blood cells or low haemoglobin concentration), visual disturbances.

Very rare: abnormally low white blood cell and platelet counts, elevated potassium levels and increased liver enzyme activity in blood, depression, sleep disorders, unusual dreams, paraesthesia (tingling sensations), tremors (rhythmic, involuntary movements), headache, taste disturbances, stomatitis (inflammation of the oral mucosa), pancreatitis, hepatitis, vertigo (spinning sensation), tinnitus (ringing, buzzing or other sounds in the ears without external cause), purpura (numerous small skin haemorrhages), rash, oedema (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 flushing of the face, 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 isolated cases during chickenpox.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring 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 the medicine.

5. How to store the medicine Biofenac

Keep the medicine out of sight and reach of children.
Store below 30°C.
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 sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Biofenac contains
The active substance in Biofenac is aceclofenac.
Each coated tablet contains 100 mg of aceclofenac.
Other ingredients are:
Glyceryl palmitostearate
Sodium croscarmellose
Povidone
Microcrystalline cellulose
Coating:
Sepifilm:
Polyoxyl 40 stearate
Titanium dioxide (E 171)
Microcrystalline cellulose
Hypromellose

What Biofenac looks like and contents of the pack
Appearance: White, round, biconvex coated tablets with a diameter of approximately 8 mm.
Packaging: 20, 60 coated tablets in aluminium/aluminium blisters, packed in a cardboard box.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation 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
Poland

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

Spanish Marketing Authorisation Numbers (country of export): 723924.6
885285.7
Parallel Import Authorisation Number: 323/15