FLOGOFENAC 100 mg Капсулы Твердые, Пролонгированного Действия

Содержание инструкции

1. FLOGOFENAC 100 mg prolonged-release hard capsules
   1. WHAT IS FLOGOFENAC AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING FLOGOFENAC
   3. HOW TO TAKE FLOGOFENAC
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FLOGOFENAC
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

FLOGOFENAC 100 mg prolonged-release hard capsules

Diclofenac sodium

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FLOGOFENAC is and what it is used for
• 2. What you need to know before you take FLOGOFENAC
• 3. How to take FLOGOFENAC
• 4. Possible side effects
• 5. How to store FLOGOFENAC
• 6. Contents of the pack and other information

1. WHAT IS FLOGOFENAC AND WHAT IS IT USED FOR

FLOGOFENAC contains the active ingredient diclofenac sodium, belonging to the category of non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is indicated in adults and adolescents over 14 years of age for the treatment of:

• rheumatic and degenerative inflammatory diseases (a group of various conditions that most frequently affect the joints, but can also affect other organs and systems of the body) such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, non-articular rheumatism;
• painful conditions caused by inflammation (phlogosis) of non-rheumatic origin or occurring following trauma;
• primary dysmenorrhea (painful menstrual cycle).

2. WHAT YOU NEED TO KNOW BEFORE TAKING FLOGOFENAC

Do not take FLOGOFENAC

• if you are allergic to the active ingredient, or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances closely related from a chemical point of view;
• if you suffer from confirmed congestive heart failure (the heart's inability to provide blood in an adequate quantity to the needs of the whole organism) (class II-IV of the NYHA);
• in case of ischemic heart disease (insufficient blood and oxygen supply to the heart), peripheral arteriopathy (circulatory problem consisting of obstruction of the arteries of the lower limbs) and/or cerebral vasculopathy (disease characterized by reduced or absent blood supply to an area of the brain, which can manifest with stroke, brain damage that occurs when blood flow to the brain is suddenly interrupted, or a transient ischemic attack - TIA);
• if you have a peptic ulcer (erosion of the inner lining of the stomach or intestine), bleeding or perforation of the stomach or intestine in progress;
• if you have had gastrointestinal bleeding (bleeding from the stomach or intestine) or perforation caused by previous treatments with NSAIDs or have had recurrent peptic ulcer bleeding/ulceration (two or more distinct episodes of demonstrated ulceration or bleeding);
• if you suffer from severe hepatic insufficiency (reduced liver function);
• if you suffer from severe renal insufficiency (reduced kidney function);
• if you have had asthma attacks, urticaria (skin rash characterized by the appearance of raised lesions generally accompanied by itching) or acute rhinitis (inflammation of the nasal mucosa) after taking acetylsalicylic acid (belonging to the category of NSAIDs) or other non-steroidal anti-inflammatory drugs;
• if you are undergoing intensive diuretic therapy (taking medications that increase urine production);
• in case of alterations in the production and maturation of blood cells (hematopoiesis);
• if you are in the last trimester of pregnancy or during breastfeeding (see “Pregnancy, breastfeeding and fertility”).

Some people MUST NOT use FLOGOFENAC. Consult your doctor if:

• you think you are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any other component of FLOGOFENAC. (The list of components is available at the bottom of the package) angioedema (swelling of the face, tongue or throat), breathing problems, chest pain, runny nose, rash or any other type of allergic reaction. Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using FLOGOFENAC, as FLOGOFENAC may sometimes worsen wound healing in the intestine following surgery.

FLOGOFENAC should not be administered to children under 14 years of age (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before taking FLOGOFENAC.
Do not take FLOGOFENAC in conjunction with other systemic NSAIDs (i.e. taken orally, intramuscularly or intravenously and with effects throughout the body) due to the lack of any evidence demonstrating additional benefits and based on potential additional adverse effects.
Due to the importance of prostaglandins (whose synthesis is inhibited by NSAIDs) for maintaining renal blood flow, take FLOGOFENAC with extreme caution or avoid taking diclofenac if possible:

• in case of renal hypoperfusion (decreased blood flow to the kidneys);
• in case of heart or kidney failure;
• in case of high blood pressure;
• if you have had thromboembolic events (formation of a blood clot in the vascular system and/or its possible migration in the blood);
• if you are being treated with diuretics;
• if you have undergone major surgery;
• if you are elderly; in this case, use the lowest effective dose, especially if you are frail or have a low body weight.

Like other NSAIDs, FLOGOFENAC may mask the signs and symptoms of infections due to its mechanism of action.
Gastrointestinal effects
Immediately stop treatment with diclofenac and consult your doctor if you experience manifest or occult (dark stools) gastrointestinal bleeding or ulceration while taking FLOGOFENAC.
Take FLOGOFENAC with particular caution and undergo close medical supervision:

• if you have symptoms indicative of gastrointestinal disorders or if you have had gastric or intestinal ulcerations, bleeding or perforation in the past (see section 4 “Possible side effects”). The risk of gastrointestinal bleeding is higher with high doses of NSAIDs and if you have had an ulcer in the past, especially if complicated by bleeding or perforation. Start and maintain treatment with the lowest effective dose to reduce the risk of gastrointestinal toxicity, especially if you have had an ulcer in the past, particularly if complicated by bleeding or perforation, and if you are elderly. During treatment with all NSAIDs, at any time, with or without warning symptoms or previous episodes of serious gastrointestinal events (pathologies of the stomach or intestine), the possible occurrence of bleeding in the stomach and intestine, ulceration or perforation has been reported, which can be fatal. In the elderly, these adverse effects (especially bleeding and perforation) are more frequent and generally have more serious consequences (they can be fatal).
• if you are concomitantly treated with medications that could increase the risk of ulceration or bleeding such as systemic corticosteroids, anticoagulants, antiplatelet agents or selective serotonin reuptake inhibitors (SSRIs) (see "Other medicines and FLOGOFENAC").
• if you have ulcerative colitis or Crohn's disease (inflammatory bowel diseases) as these conditions may worsen (see section 4 “Possible side effects”).

If you are taking low doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal events (such as other NSAIDs, corticosteroids), you may consider using protective agents (e.g. misoprostol or proton pump inhibitors) at the same time.
If you have suffered from gastrointestinal toxicity (i.e. problems with the stomach and intestines caused by the use of certain drugs, including NSAIDs), especially if you are elderly, you should report any abdominal symptoms (especially gastrointestinal bleeding) to your doctor, particularly in the early stages of treatment.
Hepatic effects
Take FLOGOFENAC with caution:

• if you have hepatic insufficiency, as your condition may worsen. Discontinue treatment if liver function parameters are persistently altered or worsened, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations such as eosinophilia (high concentration of certain types of white blood cells in the blood) or rash (sudden redness of the skin) occur. Hepatitis (inflammation of the liver) can occur with the use of diclofenac without prodromal symptoms (characteristic symptoms of the disease). Undergo regular liver function checks during prolonged treatments with diclofenac. Treatment with diclofenac, like other NSAIDs, may lead to increased levels of one or more liver enzymes;
• if you have hepatic porphyria (rare disease in which there is a deficiency of liver enzymes), as it could trigger an acute attack characterized by abdominal pain, fever, increased white blood cells, vomiting, constipation, increased heart rate and blood pressure, urinary retention, profuse sweating, decreased reflexes, low blood sodium, loss of sensitivity, emotional instability, up to coma, paralysis, hallucinations, behavioral disorders, respiratory paralysis, death in the most severe cases.

Renal effects
In association with therapy with NSAIDs, including diclofenac, fluid retention and edema have been reported.
Therefore, take FLOGOFENAC with caution:

• in case of heart or kidney failure;
• if you suffer from high blood pressure;
• if you are elderly;
• if you are being treated concomitantly with diuretics or with medications that may significantly affect kidney function;
• if you have a marked decrease in extracellular volume due to any cause (e.g. before or after major surgery - see “Do not take FLOGOFENAC”); in such cases, when taking FLOGOFENAC, monitoring of renal function is recommended as a precaution.

Discontinuation of therapy is normally followed by a return to pre-treatment conditions.
Skin effects
Stop taking FLOGOFENAC at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity (allergy).
Very rarely, severe skin reactions, some of which have been fatal, including exfoliative dermatitis (skin irritation with scaling), Stevens-Johnson syndrome (a serious skin disease caused by an acute allergic reaction, often to drugs, and characterized by the formation of blisters and areas of scaling) and toxic epidermal necrolysis (a serious skin disease in which the epidermis detaches in sheets) have been reported in association with the use of NSAIDs (see section 4 “Possible side effects”). The risk appears to be higher in the early stages of therapy as the onset of the reaction occurs in most cases within the first month of treatment.
Cardiovascular and cerebrovascular effects
Medicines like FLOGOFENAC may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.
Take FLOGOFENAC with caution if you have heart problems or a history of stroke, if you have suffered from high blood pressure and/or congestive heart failure in the past, or if you think you may be at risk for these conditions, you should discuss your therapy with your doctor or pharmacist.
The doctor will periodically evaluate the response to therapy and the improvement of symptoms.
Since the cardiovascular risks of diclofenac may increase with dose and duration of exposure, use the shortest possible duration and the lowest effective daily dose.
Hematological effects
During prolonged treatments with diclofenac, like other NSAIDs, undergo frequent checks of the blood count (ratio between the various components of the blood).
Undergo careful monitoring if you have hemostasis defects (blood coagulation) as, like other NSAIDs, FLOGOFENAC may temporarily inhibit platelet aggregation.
Pre-existing asthma
Pay particular attention when taking FLOGOFENAC if you suffer from asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps), chronic obstructive pulmonary diseases (long-lasting) or chronic respiratory tract infections (especially if connected to symptoms similar to allergic rhinitis), as reactions to NSAIDs such as worsening of asthma (“analgesic intolerance” or “aspirin-exacerbated respiratory disease”), angioedema (rapid swelling of tissues at the level of face, hands, feet, genitals and mucous membranes), urticaria and possibly shock are more frequent in these patients.
Be careful if one of the situations just described applies to you as you may be more predisposed to the onset of clinical emergencies.
Pay particular attention also if you are allergic to other substances, e.g. other drugs, for which you experience skin reactions, itching or urticaria.
As with other NSAIDs, severe allergic reactions, including anaphylactic/anaphylactoid reactions (allergic reactions with rapid onset), can occur in rare cases, even without a previous exposure to diclofenac (see section 4 “Possible side effects”).

Children and adolescents
The use of FLOGOFENAC is not recommended in children under 14 years of age (see “Do not take FLOGOFENAC”).

Other medicines and FLOGOFENAC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pay particular attention when taking FLOGOFENAC with:

• lithium (mood stabilizer, used in the treatment of depression and bipolar disorder),
• digoxin (drug that stimulates heart function),
• diuretics and antihypertensive agents (drugs used to lower blood pressure),
• other NSAIDs and corticosteroids (anti-inflammatory drugs),
• drugs that inhibit blood coagulation (such as heparin and warfarin) and drugs that prevent platelet aggregation (antiplatelet agents such as ticlopidine and clopidogrel),
• SSRIs, selective serotonin reuptake inhibitors (neurotransmitter produced mostly by nerve cells and mainly involved in mood regulation),
• Antidiabetics,
• methotrexate (anti-cancer and anti-rheumatic drug, used for the treatment of some pathologies such as leukemia, lymphoma, rheumatoid arthritis, lupus and psoriasis),
• cyclosporine (immunosuppressant drug),
• quinolone antibacterial agents,
• phenytoin (anticonvulsant),
• cholestyramine and colestipol (drugs used to lower cholesterol levels in the blood),
• potent CYP2C9 inhibitors (enzyme that metabolizes diclofenac) such as sulfinpyrazone and voriconazole.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not take FLOGOFENAC in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth (see “Do not take FLOGOFENAC”).
This medicine can cause problems with the kidneys and heart of the fetus. It may affect your and your
baby's tendency to bleed and delay or prolong labour more than expected. You should not take
FLOGOFENAC in the first 6 months of pregnancy unless absolutely necessary and under the advice of
your doctor. If you need treatment during this period or during attempts to conceive, the lowest dose
should be used for the shortest possible time. From the 20th week of pregnancy, FLOGOFENAC can cause
kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid
surrounding the baby (oligohydramnios) or causing the narrowing of a blood vessel (ductus arteriosus)
in the baby's heart. If you need treatment for more than a few days, your doctor may advise additional
monitoring.
Breastfeeding
Do not take FLOGOFENAC if you are breastfeeding, to avoid undesirable effects in the infant (see “Do not
take FLOGOFENAC”).
Like other NSAIDs, diclofenac passes into breast milk in small amounts.
Fertility
Stop taking FLOGOFENAC if you have fertility problems or if you are undergoing investigations into
fertility.

Driving and operating machinery
If you have experienced visual disturbances, dizziness, vertigo, drowsiness or other central nervous system
disorders with the use of diclofenac, avoid driving vehicles or operating machinery.

FLOGOFENAC 100 mg prolonged-release hard capsules containssucrose. If your doctor has
diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.

3. HOW TO TAKE FLOGOFENAC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended initial daily dose of diclofenac is 100-150 mg.
In milder cases and in long-term therapies, 75-100 mg per day are usually sufficient.
The daily dosage should be divided into 2-3 administrations.
In primary dysmenorrhea, the recommended daily dose, which should be individually adjusted, is 50-150
mg. Initially take a dose of 50-100 mg and, if necessary, increase it during subsequent
menstrual cycles, up to a maximum of 150 mg per day. Start treatment at the onset of the first symptoms and, in
based on the symptoms, continue it for a few days. Divide the daily dosage into 2-3
administrations.
Swallow the capsules whole with a little liquid.
Undesirable effects can be minimized by administering the lowest effective dose for the
shortest duration necessary to control the symptoms (see paragraph 4 “Possible side effects”).
In the treatment of elderly patients, the dosage must be carefully established by the doctor who will have to
consider a possible reduction of the above dose.

If you take more FLOGOFENAC than you should
In case of taking an excessive dose of the drug, consult your doctor immediately.
There is no typical clinical picture resulting from taking an excessive dose of diclofenac.
Symptoms may include vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus (ringing in the ears)
or convulsions. In the case of significant poisoning, acute renal failure and liver damage are possible.
.

If you forget to take FLOGOFENAC
Do not take a double dose to make up for forgetting the tablet.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Side effects can be minimised by using the lowest effective dose for the shortest duration necessary (see section 3 “How to take FLOGOFENAC”).
Stop taking FLOGOFENAC and tell your doctor immediately if you notice:

• manifest or occult gastrointestinal bleeding or ulceration occurs;
• liver function parameters are persistently altered or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations such as eosinophilia occur;
• skin rash, mucous membrane lesions or any other sign of hypersensitivity develops.
• mild abdominal cramps and tenderness occur shortly after starting treatment with FLOGOFENAC, followed by rectal bleeding or bloody diarrhoea within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Possible side effects that may occur following the intake of FLOGOFENAC are:

Common side effects (may affect up to 1 in 10 people)

• headache, dizziness;
• vertigo;
• increased transaminases (liver enzymes);
• rash;
• nausea, vomiting, diarrhoea, dyspepsia (feeling of discomfort in the stomach), abdominal pain, flatulence (presence of gas in the intestine), anorexia (loss of appetite).

Rare side effects (may affect up to 1 in 1,000 people)

• hypersensitivity (allergy), anaphylactic and anaphylactoid reactions (serious allergic reactions with rapid onset including hypotension and shock);
• somnolence;
• asthma, including dyspnoea (difficulty breathing);
• gastritis (inflammation of the stomach), gastrointestinal bleeding, haematemesis (vomiting blood), bloody diarrhoea (presence of blood in liquid stools), melena (blood in stools), gastrointestinal ulcer (with or without bleeding) or perforation;
• oedema;
• urticaria;
• hepatitis (inflammation of the liver), jaundice (yellowing of the skin), liver disorders.

Very rare side effects (may affect up to 1 in 10,000 people)

• thrombocytopenia (decrease in the number of platelets in the blood), leucopenia (decrease in the number of white blood cells in the blood), anaemia (decrease in haemoglobin concentration in the blood) including haemolytic and aplastic anaemia, agranulocytosis (severe decrease in the number of granulocytes in the blood);
• disorientation, depression, insomnia, nightmares, irritability, psychotic reactions;
• paresthesia (altered sensitivity), memory impairment, convulsions, anxiety, tremors, aseptic meningitis (inflammation of the meninges), altered taste, cerebrovascular accidents (diseases resulting from damage to the vessels of the brain);
• angioedema (rapid swelling of the subcutaneous and submucosal tissues);
• visual disturbances, blurred vision, diplopia (double vision);
• tinnitus, worsening of hearing;
• palpitations, chest pain, heart failure, myocardial infarction;
• hypertension, vasculitis (inflammation of the veins);
• pneumonia;
• colitis (inflammation of part of the intestine), including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease, constipation, stomatitis (inflammation of the oral mucosa), including ulcerative stomatitis, glossitis (inflammation of the tongue), oesophageal disorders, diaphragm-like intestinal stenosis, pancreatitis (inflammation of the pancreas);

If one or more of the side effects described above occur, stop treatment with diclofenac and
contact your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE FLOGOFENAC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to the last day of that month and to the product in intact packaging, correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What FLOGOFENAC contains
Each 100 mg capsule contains:

Active ingredient:Diclofenac sodium 100 mg.

Other components:Sucrose, corn starch, polyvinylpyrrolidone, ethylcellulose, talc.
Capsule composition: Titanium dioxide (E171), erythrosine (E127), indigotine (E132), iron oxide
yellow (E172), gelatin, glycerol, purified water.

Description of the appearance of FLOGOFENAC and contents of the pack
Hard prolonged-release capsules.
Pack of 21 capsules (3 blisters of 7 capsules each).

Marketing Authorisation Holder
A.Menarini Industrie Farmaceutiche Riunite s.r.l.- Via Sette Santi, 3- 50131 Firenze.

Manufacturer
A.Menarini Manufacturing Logistics and Services s.r.l.- Via Campo di Pile – L’Aquila.