DEALGIC 75 mg Капсулы Твердые Пролонгированного Действия

Содержание инструкции

1. DEALGIC 75 mg prolonged-release hard capsules, 100 mg prolonged-release hard capsules
   1. What is DEALGIC and what is it used for
   2. What you need to know before taking DEALGIC
   3. How to take DEALGIC
   4. Possible side effects
   5. How to store DEALGIC
   6. Package contents and other information

DEALGIC 75 mg prolonged-release hard capsules, 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 they have the same symptoms as you, as it may 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 DEALGIC is and what it is used for
• 2. What you need to know before you take DEALGIC
• 3. How to take DEALGIC
• 4. Possible side effects
• 5. How to store DEALGIC
• 6. Contents of the pack and other information

1. What is DEALGIC and what is it used for

DEALGIC contains the active ingredient diclofenac sodium, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac sodium is used to reduce pain and inflammation.
DEALGIC is used to treat:

• joint diseases such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis;
• diseases characterized by pain and inflammation affecting the tissues surrounding the joints, such as tendons and ligaments (extra-articular rheumatism);
• pain due to inflammation of non-rheumatic origin or following a trauma;
• pain associated with the menstrual cycle (primary dysmenorrhea).

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking DEALGIC

Do not take DEALGIC

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you have previously suffered from liver diseases;
• if you suffer from ulcer, bleeding or perforation at the level of the stomach or intestine;
• if you have suffered from bleeding or perforation at the level of the stomach or intestine following treatments with NSAIDs or if you have suffered from recurrent peptic bleeding/ulcer (two or more episodes);
• if you are in the third trimester of pregnancy or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you suffer from a severe impairment of liver or kidney function (severe hepatic and renal insufficiency);
• if you suffer from confirmed heart disease and/or cerebrovascular disease, e.g. have had a heart attack, stroke, mini-stroke (TIA) or blockage of blood vessels leading to the heart or brain or surgery to eliminate or prevent such blockages;
• if you have ongoing bleeding or if you are predisposed to bleeding;
• if you have ever had an allergic reaction (asthma, runny nose, skin redness) after taking anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin);
• if you are taking high doses of medicines that increase urine production (diuretics);
• if you have an alteration in the production of blood cells (hematopoiesis);
• if you are under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking DEALGIC.
To reduce the risk of developing side effects associated with the use of this medicine, use the
lowest effective dose for the shortest duration of treatment necessary to control the symptoms.
Do not take DEALGIC together with other non-steroidal anti-inflammatory drugs (NSAIDs), including
selective COX-2 inhibitors, as this may increase the risk of developing serious side effects.
If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of
Dealgic.
Stop treatment and contact your doctor immediately if you experience the following serious
side effects:

• Skin rashes, itching, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands, feet, eyes, lips, tongue and/or face (angioedema). These may be signs of allergic reactions, even serious (anaphylactic shock);
• Abdominal pain, at the beginning of treatment with diclofenac, followed by rectal bleeding or bloody diarrhea usually within 24 hours of the onset of abdominal pain;
• Other symptoms and disorders at the level of the abdomen, especially at the beginning of treatment, and particularly if you are elderly or have previously had side effects at the level of the stomach or intestine due to the use of medicines. These may be symptoms of bleeding, perforations or ulcerations in the stomach or intestine;
• Changes in blood tests for liver function, or other signs of liver disease, such as a high concentration of white blood cells in the blood (eosinophilia) or skin rash. These may be symptoms of liver inflammation, even serious;
• Chest pain, shortness of breath, weakness and difficulty speaking. These may be symptoms of serious thrombotic events (problems due to the formation of blood clots);
• Excessive accumulation of fluid in your body (edema); this condition is reversible with discontinuation of treatment;
• If you are a woman who has fertility problems;
• If you are a woman who intends to become pregnant.

Pay particular attention and contact your doctor:

• if you smoke;
• if you have diabetes;
• if you suffer from angina, blood clots, high blood pressure, high cholesterol or high triglycerides;
• if you have asthma;
• if you have seasonal allergies (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps);
• if you have chronic obstructive pulmonary diseases or chronic respiratory tract infections;
• if you suffer from or have suffered from gastrointestinal disorders such as gastric or intestinal ulcer, bleeding or perforations;
• if you are taking, concurrently with DEALGIC, medicines that may increase the risk of ulceration or bleeding (such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (antidepressants) or antiplatelet agents such as aspirin);
• if you suffer from or have suffered from gastrointestinal diseases such as ulcerative colitis or Crohn's disease because these conditions may worsen;
• if you have undergone major surgery;
• if you have liver problems (e.g. hepatic insufficiency, hepatitis);
• if you suffer from a disease called hepatic porphyria, characterized by a deficiency of liver enzymes;
• if you have kidney problems (e.g. renal insufficiency);
• if you have or have had high blood pressure, heart or brain diseases (e.g. congestive heart failure, confirmed heart disease, peripheral arterial disease and/or stroke);
• if you are taking medicines that increase urine production (diuretics) or other medicines that may alter the function of your kidneys;
• If you have blood coagulation defects (hemostasis defects).

It is possible that, depending on your state of health and based on your response to the medicine, your
doctor may prescribe you periodic checks and blood tests to monitor the function of your
heart, liver and kidneys, and therefore to assess your response to diclofenac therapy and
improvement in your health condition.
At any time during treatment with NSAIDs, including diclofenac, as gastrointestinal bleeding, ulcerations or perforations may occur, which may also
cause death. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk
of gastrointestinal toxicity and may also prescribe you medicines (e.g. misoprostol or
proton pump inhibitors) to protect the gastrointestinal mucosa.

Elderly patients
If you are elderly, especially if you are frail and underweight, you are more likely to experience
side effects that are generally more serious, especially bleeding and perforations in the stomach
or intestine, which may even be fatal.
Your doctor will prescribe the minimum effective dose.
As a precaution, your doctor may have your kidney function checked and prescribe you
medicines that act by protecting the gastrointestinal mucosa such as misoprostol or
proton pump inhibitors.
Inform your doctor of any unusual symptoms in the stomach or intestine, especially at the beginning
of treatment with this medicine.

Children and adolescents
DEALGIC should not be used in children and adolescents under 14 years of age.

Other medicines and DEALGIC
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines.
Pay particular attention and inform your doctor if you are taking any of the following medicines:

• Other NSAIDs (Non-steroidal anti-inflammatory drugs) and corticosteroids: the concomitant use of this medicine with other non-steroidal anti-inflammatory drugs or corticosteroids may increase the incidence of side effects at the gastrointestinal level;
• Anticoagulants and platelet agents: you should be careful because the concomitant use of DEALGIC with medicines used to thin the blood, such as warfarin, may increase the risk of bleeding: the concomitant use with this medicine, as with other NSAIDs, may temporarily prevent some blood cells (platelets), responsible for stopping any bleeding, from functioning properly (may inhibit platelet aggregation);
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression: the concomitant use of DEALGIC with these medicines may cause an increased risk of gastrointestinal bleeding;
• Diuretics, ACE inhibitors and angiotensin II antagonists,used for the treatment of high blood pressure: the concomitant use with DEALGIC, as with other NSAIDs, may cause a decrease in the therapeutic action exerted by these categories of medicines;
• Digoxin,used for the treatment of heart disorders: the concomitant use with DEALGIC may cause an increase in the concentration of this medicine in the blood;
• Lithium,used for the treatment of some mental disorders: the concomitant use with DEALGIC may cause an increase in the concentration of this medicine in the blood (increased lithemia);
• Methotrexate,used for the treatment of some forms of cancer and some autoimmune diseases: the concomitant use with DEALGIC may increase the toxicity exerted by this medicine. The doctor will carefully assess whether or not to administer you diclofenac within 24 hours before and after taking methotrexate;
• Antidiabetics:generally diclofenac can be administered together with oral antidiabetics without affecting their clinical effect. However, concomitant intake may cause an increase or decrease in the therapeutic action of these medicines and it may be necessary to adjust the dosage of antidiabetics. The doctor, in this case, will prescribe you the analysis for monitoring blood glucose levels.
• Cyclosporine,used to counter organ rejection after a transplant: the concomitant use with DEALGIC may increase the kidney toxicity of cyclosporine. In case of concomitant use, the doctor will prescribe you lower doses than normally prescribed.
• Quinolone antibacterial agents,antibiotic drugs: the concomitant use with DEALGIC may determine the onset of convulsions;
• Phenytoin,used for the treatment of epilepsy: the concomitant use with DEALGIC causes an increase in the concentrations of phenytoin in the blood. The doctor will prescribe you the analysis for monitoring the concentration of phenytoin in the blood.
• Cholestyramine and colestipol,used for the treatment of cholesterol: the concomitant use may cause an increase or decrease in the absorption of diclofenac and therefore its therapeutic action. Your doctor will tell you to take diclofenac at least one hour before or 4-6 hours after taking cholestyramine/colestipol.
• Potent CYP2C9 inhibitors,such as sulfinpyrazone and voriconazole: the concomitant use may cause an increase in the toxicity of diclofenac.
• CYP2C9 inducers (such as rifampicin):the concomitant use may cause a decrease in blood concentrations and exposure to diclofenac.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take DEALGIC in the last 3 months of pregnancy as it may harm the fetus or cause
problems during childbirth. It may cause problems with the fetus's kidneys, lungs and heart. It may
affect your and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take DEALGIC in the first 6 months of pregnancy unless absolutely
necessary and under the advice of a doctor. If treatment is needed during this period or during
attempts to conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, DEALGIC may 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 a narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If
treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not take this medicine if you are breastfeeding, as diclofenac passes into breast milk.
Fertility
Do not take this medicine if you are a woman of childbearing potential, if you intend to become
pregnant, if you have difficulty conceiving, or if you have undergone fertility tests, because
diclofenac may impair female fertility.

Driving and operating machinery
DEALGIC may impair the ability to drive and operate machinery, especially under
the influence of alcohol, as you may experience visual disturbances, dizziness,
vertigo, drowsiness or other central nervous system disorders. Therefore, refrain from driving
vehicles and operating machinery.

DEALGIC contains propylene glycol.
This medicine contains 1 mg of propylene glycol per capsule.

3. How to take DEALGIC

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Adults
Depending on the severity of the condition, the recommended dose is:

• 1 capsule of DEALGIC 100 mg prolonged-release hard capsules once a day; Or:
• 1 capsule of DEALGIC 75 mg prolonged-release hard capsules once a day.

If necessary, your doctor may increase your daily dose up to 150 mg, taking 1 capsule of
DEALGIC 75 mg prolonged-release hard capsules twice a day, or 2 capsules in a single
administration, in cases of particularly severe disorders, especially in the morning.
Swallow the medicine whole with sufficient liquid.
Taking it after meals may delay the passage into circulation of the active ingredient, therefore, in case of
acute pain, take DEALGIC before meals.
The duration of treatment varies depending on the case.
Undesirable effects can be minimized by taking the lowest effective dose for the
shortest duration necessary to control the symptoms.

Use in children and adolescents
DEALGIC should not be used in children and adolescents under 14 years of age.

Use in the elderly
In the elderly, it may be necessary to reduce the dose of diclofenac. Your doctor will tell you how much Dealgic
you should take.

If you take more DEALGIC than you should
If you take more DEALGIC than you should, contact your doctor immediately or go to the nearest
hospital.
Symptoms of overdose are: vomiting, bleeding from the stomach and intestines, diarrhea,
dizziness, ringing in the ears (tinnitus) or convulsions.
In the most severe cases, it may manifest alterations in kidney function (acute renal failure) and
liver damage.

If you forget to take DEALGIC
Do not take a double dose to make up for a missed dose.
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.

Stop treatment and contact your doctor immediatelyif you experience the following serious side effects:

• Skin rashes, itching, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands, feet, eyes, lips, tongue and/or face (angioedema). These may be signs of allergic reactions, even severe (anaphylactic shock);
• Abdominal pain, at the beginning of treatment with diclofenac followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain;
• Other symptoms and disturbances at the abdominal level, especially at the beginning of treatment, and particularly if you are elderly or have previously experienced stomach or intestinal side effects due to the use of medicines. These could be symptoms of bleeding, perforations or ulcerations in the stomach or intestine;
• Changes in blood tests for liver function, or other signs of liver disease, such as a high concentration of white blood cells in the blood (eosinophilia) or skin rash. These could be symptoms of liver inflammation, even severe;
• Chest pain, shortness of breath, weakness and difficulty speaking. These may be symptoms of serious thrombotic events (problems due to blood clot formation);
• Excessive fluid build-up in your body (edema); this condition is reversible with discontinuation of treatment.

Other side effects may be:

Common (may affect up to 1 in 10 people)

• Headache, dizziness;
• Vertigo;
• Nausea, vomiting, diarrhoea, indigestion (dyspepsia), abdominal pain, flatulence, eating disorder leading to refusal of food (anorexia);
• Increased levels of certain liver enzymes (transaminases);
• Skin rash.

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

• allergic reactions (hypersensitivity), severe, rapid-onset allergic reactions (anaphylaxis) including hypotension and collapse (shock);
• Drowsiness;
• Asthma, including difficulty breathing (dyspnea);
• Gastritis, gastrointestinal bleeding, presence of blood in vomit (hematemesis), bloody diarrhoea, passage of blood with stools (melena), gastrointestinal ulcer (with or without bleeding and perforation);
• Changes in liver function (hepatitis and liver disorders), yellowing of the skin and whites of the eyes (jaundice);
• Urticaria;
• Swelling of the skin due to fluid accumulation (edema).

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

• Rapid swelling (edema) of the skin, mucous membranes and submucosal tissues (angioneurotic edema including facial edema)
• Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions
• Alteration of the sensitivity of the limbs or other parts of the body (paresthesia)
• Impairment of memory, convulsions, feeling of anxiety, tremors
• Disease of the central nervous system characterized by inflammation of the meninges (aseptic meningitis), changes in taste, stroke (cerebrovascular accidents), excitement
• Visual disturbances, blurred vision, double vision (diplopia)
• Ringing in the ears (tinnitus), worsening of hearing
• Palpitations, chest pain, heart failure, myocardial infarction
• High blood pressure (hypertension), inflammation of blood vessels (vasculitis)
• Pneumonia
• Severe inflammation of the intestine characterized by episodes of diarrhoea (colitis, including haemorrhagic colitis and worsening of ulcerative colitis or Crohn's disease), constipation, inflammation of the oral mucosa (stomatitis, including ulcerative stomatitis), inflammation of the tongue mucosa (glossitis), disorders at the level of the esophagus, narrowing of some parts of the intestine (intestinal stenosis), inflammation at the level of the pancreas (pancreatitis)
• Alteration of liver function (fulminant hepatitis, liver necrosis, liver failure)
• Blistering skin rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, skin rash caused by sunlight (photosensitivity reactions), small red or purple spots widespread on the skin associated or not with joint pain, muscle pain, weakness and fever, these may be symptoms of inflammation of the walls of blood vessels called purpura (including Schönlein Henoch purpura), itching
• Alteration of kidney function (acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis), presence of blood in the urine (hematuria), excretion of protein in the urine (proteinuria)
• Feeling of lack of energy (asthenia) Not known (frequency cannot be estimated based on available data)
• Particular type of allergic coronary spasm (Kounis syndrome)
• Reduced blood flow to the intestine (ischemic colitis).

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 DEALGIC

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

6. Package contents and other information

What DEALGIC contains

• The active ingredient is diclofenac. DEALGIC 75 mg capsulesEach capsule contains 75 mg of diclofenac sodium, equivalent to 69.6 mg of diclofenac

DEALGIC 100 mg capsules
Each capsule contains 100 mg of diclofenac sodium, equivalent to 92.80 mg of diclofenac

• The other ingredients are: DEALGIC 75 mg prolonged-release hard capsules and DEALGIC 100 mg prolonged-release hard capsules: gastro-resistant pellets:microcrystalline cellulose; polyvinylpyrrolidone; anhydrous colloidal silica; methacrylic acid copolymer, type C; propylene glycol; talc;

delayed-release pellets:microcrystalline cellulose; polyvinylpyrrolidone; anhydrous colloidal silica; Eudragit RS
100; Eudragit RL 100; dibutyl phthalate; talc; gelatin capsule components - cap:indigotine
E132; titanium dioxide E171; purified water; gelatin; gelatin capsule components - body:
purified water; gelatin.

Description of the appearance of DEALGIC and package contents
20 prolonged-release hard capsules of 100 mg in PVC/aluminum blisters
20 prolonged-release hard capsules of 75 mg in PVC/aluminum blisters
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Farma Group S.r.l.
Via Farfisa, 18
60021 Camerano (AN)

Manufacturers
Swiss Caps GmbH, Grassingerstraβe 9, 83043 Bad Aibling, Germany
Doppel Farmaceutici S.r.l., via Volturno 48 - 20089 Quinto de' Stampi- Rozzano (MI)