BIOFENAC 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Biofenac, 100 mg, Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Biofenac and what is it used for
4. Important information before taking Biofenac
   1. When not to take Biofenac
   2. Warnings and precautions
   3. Biofenac and other medicines
   4. Biofenac with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Biofenac contains sodium
5. How to take Biofenac
   1. Use in children
   2. Elderly patients
   3. Kidney and heart diseases
   4. Liver diseases
   5. Long-term treatment
   6. Taking a higher dose of Biofenac than recommended
   7. Missing a dose of Biofenac
   8. Stopping treatment with Biofenac
6. Possible side effects
   1. Stop taking Biofenac and seek medical attention immediately if you experience:
   2. Reporting side effects
7. How to store Biofenac
8. Contents of the pack and other information
   1. What Biofenac contains
   2. Other ingredients are:
   3. What Biofenac looks like and contents of the pack
   4. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Biofenac, 100 mg, Coated Tablets

Aceclofenac

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 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 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 taking Biofenac

When not to take Biofenac

• if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6),
• if you are in the last three months of pregnancy,
• if you have 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 you have had stomach or intestinal ulcers or bleeding from the gastrointestinal tract,
• if you have active bleeding or bleeding disorders,
• if you have severe liver or kidney disease,
• if you have had heart disease and (or) cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia (mini-stroke), or vascular occlusion of the heart or brain, or after a procedure to open blocked vessels,
• if you have had circulatory disorders (peripheral vascular disease).

Warnings and precautions

Before starting treatment with Biofenac, discuss it with your doctor:

• if you have 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 you have had cerebral bleeding in your medical history,
• if you have had moderate liver or kidney disease, or if you have a tendency to retain fluid in your body for any other reason,
• if you have bleeding disorders, as they may worsen,
• if you have a specific skin and connective tissue disease, known as SLE (systemic lupus erythematosus),
• if you have a specific metabolic disease, known as porphyria,
• if you have had asthma,
• if you smoke,
• if you have diabetes,
• if you have angina pectoris, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Taking medicines like Biofenac may be associated with an increased risk of heart attack (myocardial infarction).
The occurrence of side effects can be reduced by taking the medicine in the smallest effective dose and for no longer than necessary.
Do not exceed the recommended dose and duration of treatment.
Allergic reactions, including angioedema and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of Biofenac. The risk of skin reactions is higher during the first month of treatment. At the first sign of a skin rash, mucosal damage, or any signs of hypersensitivity, treatment should be discontinued and medical attention should be sought immediately (see section 4).
Treatment with Biofenac should be discontinued in case of the first signs of skin rash or other signs 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 the elderly, contact your doctor.

Biofenac and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have 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 change the dose or discontinue the use of these medicines. This is especially important if you are taking:

• lithium (used to treat mental illnesses),
• digoxin (used to treat heart failure or arrhythmia),
• diuretics (water pills),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II antagonists),
• anticoagulant medicines (blood thinners),
• 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you are planning to become pregnant or if you have problems getting pregnant.
NSAIDs may make it more difficult to become pregnant.
Do not take Biofenac if you are in the last three months of pregnancy, as it may harm your unborn baby or cause problems during delivery. Biofenac may cause problems with the kidneys and heart of the unborn baby. Biofenac may affect the ability to clot and cause prolonged delivery. Do not take Biofenac during the first 6 months of pregnancy, unless your doctor considers it absolutely necessary. If it is necessary to take the medicine during this period or when planning to become pregnant, use the lowest possible dose for the shortest possible time. Taking Biofenac for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn baby, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a longer period, your doctor may recommend additional check-ups.
Treatment with this medicine during any pregnancy period should be done under medical supervision.
It is not known whether Biofenac passes into breast milk. Breastfeeding is not recommended, unless your doctor decides otherwise.

Driving and using machines

Do not drive or operate hazardous machinery if you experience dizziness, nausea, or other central nervous system disorders while taking Biofenac.

Biofenac contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially 'sodium-free'.

3. How to take Biofenac

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets 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 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 the lack of data on efficacy and safety.

Elderly patients

Dosage will be determined by your doctor. Regular check-ups will be necessary.

Kidney and heart diseases

Dosage will be determined by your 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 case of long-term use of Biofenac, your doctor will regularly perform laboratory tests (blood morphology, liver and kidney function tests).

Taking a higher dose of Biofenac than recommended

Contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Take this leaflet with you!

Missing a dose of Biofenac

Do not worry! Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time.

Stopping treatment with Biofenac

The duration of treatment is determined by your doctor. Do not stop treatment prematurely, even if you feel better.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of them are mild and disappear after stopping treatment with Biofenac.
Side 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

Stop taking Biofenac and seek medical attention immediately if you 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.

Ulcers and bleeding from the gastrointestinal tract (rare) with symptoms such as:

• blood in the stool (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.
Rare:high blood pressure, heart failure, shortness of breath (difficulty breathing or shortness of breath, usually associated with certain heart or lung diseases, 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 count and platelet count, elevated potassium levels, and elevated liver enzyme activity in the blood, depression, sleep disturbances, unusual dreams, paresthesia (tingling sensation), tremors (rhythmic, involuntary movements), headaches, taste disturbances, oral inflammation (inflammation of the oral mucosa), pancreatitis, hepatitis, dizziness (feeling of spinning), tinnitus (feeling of ringing, buzzing, and hearing other sounds without 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help 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.
Store the medicine at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month.
Medicines should 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 of Biofenac is aceclofenac.
Each coated tablet contains 100 mg of aceclofenac.

Other ingredients are:

Core:
Glycerol distearate,
Croscarmellose sodium,
Povidone (K-30),
Microcrystalline cellulose (type 101),
Microcrystalline cellulose (type 102).
Coating:
Sepifilm 752:
Magnesium 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 8 mm, with the inscription "A" on one side, and the other side is smooth.
Pack:20, 60 coated tablets in PA/Aluminum/PVC//Aluminum blisters and a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information about the medicine and its names in other EU member states, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]
Date of last revision of the leaflet:February 2023
((logo of the marketing authorization holder))