Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Biofenac (Airtal)
100 mg, powder for oral suspension
Aceclofenacum
Biofenac and Airtal are different trade names for the same medicine.
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 questions, please 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 someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Biofenac is and what it is used for
What you need to know before taking Biofenac
How to take Biofenac
Possible side effects
How to store Biofenac
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 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 (TIA), 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 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, 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,
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 risk of adverse effects can be minimized 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 in association with the use of drugs such as Biofenac. The risk of skin reactions is higher during the first month of treatment. At the first sign 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 sign 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 occur, especially if the patient is elderly, contact a doctor.

Biofenac with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan 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 arrhythmias),
diuretics (water tablets),
certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
anticoagulants (blood-thinning medicines),
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 baby, she should consult a doctor or pharmacist before using this medicine.
Inform your doctor if you are planning 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 affect bleeding tendency in both the patient and her 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 of the medicine is required during this period or when planning pregnancy, 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 the patient requires treatment for longer than a few days, the doctor may recommend additional monitoring tests.
Use of this medicine during any stage of pregnancy should only be done on prescription by a doctor.
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 during treatment with 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 the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking this 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 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 use Biofenac

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a 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, consult your doctor or pharmacist.
Use in children
The 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 sachet per day.
Long-term treatment
If Biofenac is used long-term, the doctor will periodically perform laboratory tests (blood count, liver and kidney function tests).
Taking more Biofenac than recommended
Contact a 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 the missed sachet. Take the next dose at the usual time.
Stopping Biofenac
The duration of treatment is determined by the doctor. Do not discontinue 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most of them are mild and resolve after discontinuation of Biofenac. Adverse 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 1000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: frequency cannot be estimated from available data

Discontinue Biofenac immediately 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, redness of the skin, 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 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 known as shortness of breath), anaemia (low red blood cell count 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, paresthesia (tingling sensations), tremors (rhythmic, involuntary movements), headache, taste disturbances, stomatitis (inflammation of the mucous membrane of the mouth), pancreatitis, hepatitis, vertigo (spinning sensation), tinnitus (ringing, buzzing, or hearing other sounds without external cause), purpura (numerous small skin hemorrhages), rash, edema (swelling of legs, arms, or face), leg muscle cramps, renal dysfunction, renal failure, palpitations (uncomfortable sensation of irregular and/or strong 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).
In isolated cases during chickenpox, severe skin infections have been observed.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can 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, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309;
website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps 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.
No special storage instructions are required.
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 packaging 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.
Packaging: 3 g of powder in a single-dose Al/PE sachet.
20 sachets packed in a cardboard box.

For further information, please contact the responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation numbers in Spain, the country of export: 686022.9
686030.4

Parallel import licence number: 265/15