Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Biofenac, 100 mg, coated tablets
Aceclofenacum
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, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What is Biofenac and what is it used for
Important information before taking Biofenac
How to take Biofenac
Possible side effects
How to store Biofenac
Contents of the pack 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 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 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, transient ischaemic attack (mini-stroke), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass blocked 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, 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 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 reduced by using the lowest effective dose for the shortest duration necessary.
Do not exceed 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 Biofenac. The risk of skin reactions is higher during the first month of treatment. If a skin rash, mucosal damage, or any symptoms of hypersensitivity occur, treatment should be discontinued and a doctor should be consulted immediately (see section 4).
Treatment with Biofenac should 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 abdominal symptoms occur, especially in elderly patients, contact a doctor immediately.

Biofenac and other medicines
Inform your doctor or pharmacist about all medicines currently or 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 adjust the dose or discontinue the use of these medicines. 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 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 may be taken with or without food.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Inform your doctor if you are planning a pregnancy or have difficulty becoming pregnant.
NSAIDs may make it more difficult to become pregnant.
Do not use Biofenac if you are 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 tendencies 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 needed, your doctor may recommend additional monitoring tests.
Use of this medicine during any stage of pregnancy should only occur 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 while taking Biofenac.

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

3. How to use Biofenac

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a 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
Biofenac should not be used in children due to lack of data on efficacy and safety of use.
Elderly patients
Dosage will be determined by the doctor. Regular check-up visits will be necessary.
Kidney and heart disorders
Dosage will be determined by the doctor. Regular check-up visits will be necessary.
Liver disorders
The recommended initial daily dose should be reduced to one coated tablet per day.
Long-term treatment
During long-term use of Biofenac, the doctor will periodically perform control 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 coated tablet.
Take the next dose at the usual time.
Stopping Biofenac treatment
The duration of treatment is determined by the doctor. Do not discontinue therapy prematurely, even if your condition improves.
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 experiences them.
Most of these 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 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, kidney 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 breathlessness), 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 sensation), 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 haemorrhages), rash, oedema (swelling of legs, arms or face), leg muscle cramps, kidney function disorders, renal failure, palpitations (unpleasant 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 a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 effects helps to provide more information on the safety of the medicine.

5. How to store Biofenac

Keep this medicine out of sight and reach of children.
Do not store above 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 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 package and other information

What Biofenac contains
The active substance in Biofenac is aceclofenac.
Each coated tablet contains 100 mg of aceclofenac.
Other ingredients are:
Core:
Microcrystalline cellulose
Sodium croscarmellose
Glyceryl palmitostearate
Povidone.
Coating:
Hypromellose
Microcrystalline cellulose
Polyoxyl 40 stearate
Titanium dioxide (E 171).
What Biofenac looks like and contents of the pack
Appearance: White, round coated tablets with a diameter of 8 mm.
Pack: 20, 60 coated tablets in blisters within a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, the country of export:
GALENICA A.E
Eleftherias 4, 145 64 Kifissia
Greece
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
Marketing authorisation number in Greece, the country of export: 8524/6-2-2007
Parallel import licence number: 294/23