Biofenac

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Biofenac, 100 mg, coated tablets

Aceclofenac

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 using Biofenac
• 3. How to use Biofenac
• 4. Possible side effects
• 5. How to store Biofenac
• 6. Package contents 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 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 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 the patient 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 had heart disease and (or) cerebrovascular disease, such as after a heart attack, stroke, transient ischemic attack (temporary cerebral ischemia), or vascular occlusion of the heart or brain, or after a procedure to open up blocked vessels,
• if the patient has had circulation disorders (peripheral vascular disease).

Warnings and precautions

Before starting to use Biofenac, the patient should discuss it with their doctor.

• if the patient has had symptoms of stomach or duodenal ulcers, bleeding, or perforation, or inflammatory diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease), as they may worsen,
• if the patient has had cerebral bleeding in their medical history,
• if the patient has had moderate liver or kidney disease, or if they have a tendency to retain fluid in the body for any other reason,
• if the patient has bleeding disorders, as they may worsen,
• if the patient has a specific skin and connective tissue disease, known as SLE (systemic lupus erythematosus),
• if the patient has a specific metabolic disease, known as porphyria,
• if the patient has had asthma,
• if the patient smokes,
• if the patient has diabetes,
• if the patient has angina pectoris, thrombosis, hypertension, high cholesterol, or high triglycerides.

The use of medicines like Biofenac may be associated with an increased risk of heart attack (myocardial infarction). The occurrence of side effects can be limited by using the medicine in the smallest effective dose and for no longer than necessary.
Do not increase the recommended dose and prolong the treatment time.
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 Biofenac. The risk of skin reactions is higher during the first month of treatment. At the first appearance of a skin rash, mucosal damage, or any symptoms of hypersensitivity, treatment should be discontinued and medical attention should be sought immediately (see section 4).
Biofenac should be discontinued in case of the first appearance of a 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 can occur at any time during treatment, with or without warning symptoms.
In case of observing any abdominal symptoms, especially in elderly patients, medical attention should be sought.

Biofenac and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 particularly important if the patient is taking:

• lithium (used to treat mental illnesses),
• digoxin (used to treat heart failure or arrhythmia),
• diuretics (diuretic medicines),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II antagonists),
• anticoagulant medicines (blood-thinning medicines),
• 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The patient should inform their doctor if they plan to become pregnant or if they have problems with becoming pregnant.
NSAIDs may make it more difficult to become pregnant.
Biofenac should not be used if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. Biofenac may cause kidney and heart problems in the unborn child. Biofenac may affect the patient's and their child's tendency to bleed and may cause the delivery to be delayed or prolonged.
Biofenac should not be used during the first six months of pregnancy, unless the doctor considers it absolutely necessary. If it is necessary to use the medicine during this period or when planning to become pregnant, the smallest possible dose should be used for the shortest possible time. Biofenac used for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low amniotic fluid levels or narrowing of the arterial duct in the child's heart. If the patient requires treatment for a longer period, the doctor may recommend additional check-ups.
The use of this medicine during any pregnancy period should be done under medical supervision.
It is not known whether Biofenac passes into breast milk. Biofenac should not be used during breastfeeding, unless the doctor decides otherwise.

Driving and using machines

The patient should not drive vehicles or operate hazardous tools or machines if they experience dizziness, nausea, or other central nervous system disorders while using Biofenac.

Biofenac contains sodium

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

3. How to use Biofenac

This medicine should always be used as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The tablets should be swallowed whole, with a sufficient amount of liquid.
The recommended daily dose is200 mg, i.e., one coated tablet in the morning and one in the evening (one coated tablet every 12 hours).
If the patient feels that the effect of Biofenac is too strong or too weak, they should consult their doctor or pharmacist.

Use in children

The use of Biofenac is not recommended in children due to the lack of data on its 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 coated tablet per day.

Long-term treatment

In the case of long-term use of Biofenac, the doctor will perform regular laboratory tests (blood morphology, liver and kidney function tests) at regular intervals.

Taking a higher dose of Biofenac than recommended

The patient should immediately contact their doctor or pharmacist or go to the nearest hospital emergency department. They should take this leaflet with them!

Missing a dose of Biofenac

There is no reason to worry! The patient should not take a double dose to make up for the missed coated tablet. The next dose should be taken at the usual time.

Stopping the use of Biofenac

The duration of treatment is determined by the doctor. The patient should not stop the therapy prematurely, even if they feel better.
If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Biofenac 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 frequency, 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

The patient should immediately stop using Biofenac and seek medical attention if they 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.

Gastrointestinal ulcers and bleeding (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, kidney function disorders.
Rare:high blood pressure, heart failure, shortness of breath (difficulty breathing or shortness of breath, usually associated with certain types of heart or lung disease, also known as lack of breath), anemia (low red blood cell count or low hemoglobin level), vision disturbances.
Very rare:abnormally low white blood cell and platelet counts, elevated potassium levels, and elevated liver enzyme activity in the blood, depression, sleep disturbances, unusual dreams, paresthesia (tingling sensation), tremors (rhythmic, involuntary movements), headaches, oral inflammation (inflammation of the oral mucosa), pancreatitis, hepatitis, dizziness (feeling of spinning), tinnitus (feeling of ringing, buzzing, and hearing other sounds without an external cause), purpura (numerous small bleeding spots in the skin), rash, edema (swelling of the legs, arms, or face), muscle cramps, kidney function disorders, kidney failure, palpitations (unpleasant feeling of irregular and (or) strong heartbeat), vasculitis (inflammation of blood vessels), fatigue, sudden flushing of the face, hot flashes, breathing difficulties (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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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
Al. Jerozolimskie 181C
PL-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, it is possible to gather 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.
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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Biofenac contains

The active substance of Biofenac is aceclofenac.
Each coated tablet contains 100 mg of aceclofenac.

Other ingredients are:

Core:
Microcrystalline cellulose
Sodium carmellose
Glycerol palmate
Povidone.
Coating:
Hypromellose
Microcrystalline cellulose
Polysorbate 40
Titanium dioxide (E 171).

What Biofenac looks like and what the package contains

Appearance: White, round, coated tablets with a diameter of 8 mm.
Packaging: 20, 60 coated tablets in blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Greece, the country of export: 8524/6-2-2007

Parallel import authorization number: 294/23

Date of leaflet approval: 19.12.2023

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