DealGic

Package leaflet: Information for the patient

DEALGIC 75 mg prolonged-release hard capsules, 100 mg prolonged-release hard capsules

diclofenac sodium
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 DEALGIC is and what it is used for

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

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

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

2. What you should know before taking DEALGIC

Do not take DEALGIC

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously suffered from liver disease;
• if you currently have a stomach or intestinal ulcer, bleeding, or perforation;
• if you have previously experienced stomach or intestinal bleeding or perforation following treatment with NSAIDs, or if you have had recurrent bleeding/peptic 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 severe impairment of liver or kidney function (severe hepatic or renal insufficiency);
• if you have established heart disease and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, transient ischemic attack (TIA), or obstruction of blood vessels supplying the heart or brain, or have undergone surgery to remove or prevent such blockages;
• if you currently have active bleeding or have a predisposition to bleeding;
• if you have ever had an allergic reaction (asthma, runny nose, skin redness) after taking anti-inflammatory medicines (NSAIDs) or acetylsalicylic acid (aspirin);
• if you are taking high doses of medicines that increase urine production (diuretics);
• if you have a disorder in blood cell production (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 adverse effects associated with the use of this medicine, use the lowest effective dose for the shortest duration necessary to control your 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 serious adverse effects.
If you are elderly, particularly if you are frail or underweight, your doctor will prescribe a lower dose of Dealgic.
Stop treatment and contact your doctor immediately if you experience any of the following serious adverse 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 ones (anaphylactic shock);
• Abdominal pain at the beginning of treatment with diclofenac, followed by rectal bleeding or hemorrhagic diarrhea usually within 24 hours of the onset of abdominal pain;
• Other abdominal symptoms or disturbances, especially at the start of treatment, particularly if you are elderly or have previously experienced adverse gastrointestinal effects from medicines. These could be signs of gastrointestinal bleeding, perforation, or ulceration;
• Abnormal liver function tests or other signs of liver disease, such as elevated white blood cell count (eosinophilia) or skin rash. These may indicate liver inflammation, even severe;
• Chest pain, shortness of breath, weakness, or speech difficulties. These may be symptoms of serious thrombotic events (problems due to blood clot formation);
• Excessive fluid accumulation in the body (edema); this condition is reversible upon discontinuation of treatment;
• If you are a woman experiencing fertility problems;
• If you are a woman planning to become pregnant.

Take particular care 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 allergic rhinitis, nasal mucosa swelling (e.g., nasal polyps);
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
• if you currently suffer or have previously suffered from gastrointestinal disorders such as gastric or intestinal ulcers, bleeding, or perforations;
• if you are taking, concomitantly with DEALGIC, medicines that may increase the risk of ulceration or bleeding (such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents like aspirin);
• if you currently suffer or have previously suffered from gastrointestinal diseases such as ulcerative colitis or Crohn’s disease, as these conditions may worsen;
• if you have recently undergone major surgery;
• if you have liver problems (e.g., liver insufficiency, hepatitis);
• if you suffer from a condition called hepatic porphyria, characterized by a deficiency of liver enzymes;
• if you have kidney problems (e.g., renal insufficiency);
• if you currently have or have had high blood pressure, or heart or brain disorders (e.g., congestive heart failure, established heart disease, peripheral arterial disease, and/or stroke);
• if you are taking diuretics or other medicines that may affect kidney function;
• if you have blood coagulation disorders (hemostasis defects).

Depending on your health status and your response to the medicine, your doctor may periodically prescribe check-ups and blood tests to monitor the function of your heart, liver, and kidneys, and to assess your response to diclofenac therapy and improvement in your health condition.
At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can even be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to minimize the risk of gastrointestinal toxicity and may also prescribe protective medicines (e.g., misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
Elderly patients
If you are elderly, especially if frail and underweight, you are at higher risk of experiencing adverse effects, which are generally more severe, particularly gastrointestinal bleeding and perforation, which may even be fatal.
Your doctor will prescribe the lowest effective dose.
As a precaution, your doctor may monitor your kidney function and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
Children and adolescents
DEALGIC must not be used in children and adolescents under 14 years of age.
Other medicines and DEALGIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take particular care and inform your doctor if you are taking any of the following medicines:

• Other NSAIDs (non-steroidal anti-inflammatory drugs) and corticosteroids: concomitant use of this medicine with other NSAIDs or corticosteroids may increase the risk of gastrointestinal adverse effects;
• Anticoagulants and platelet agents: you should be cautious, as concomitant use of DEALGIC with blood-thinning medicines such as warfarin may increase the risk of bleeding; concomitant use with this medicine, as with other NSAIDs, may temporarily impair the function of blood platelets responsible for stopping bleeding (may inhibit platelet aggregation);
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), used to treat depression: concomitant use of DEALGIC with these medicines may increase the risk of gastrointestinal bleeding;
• Diuretics, ACE inhibitors, and angiotensin II antagonists, used to treat high blood pressure: concomitant use with DEALGIC, as with other NSAIDs, may reduce the therapeutic effect of these medicines;
• Digoxin, used to treat heart disorders: concomitant use with DEALGIC may increase the blood concentration of this medicine;
• Lithium, used to treat certain mental disorders: concomitant use with DEALGIC may increase the blood concentration of lithium (increased serum lithium levels);
• Methotrexate, used to treat certain cancers and autoimmune diseases: concomitant use with DEALGIC may increase the toxicity of this medicine. Your doctor will carefully evaluate whether or not to administer diclofenac within 24 hours before or after methotrexate;
• Antidiabetics: generally, diclofenac can be administered with oral antidiabetics without affecting their clinical effect. However, concomitant use may increase or decrease the therapeutic effect of these medicines, and dosage adjustments may be necessary. In such cases, your doctor will prescribe blood glucose monitoring.
• Cyclosporine, used to prevent organ rejection after transplantation: concomitant use with DEALGIC may increase cyclosporine-induced kidney toxicity. If used together, your doctor will prescribe lower doses than normally recommended.
• Quinolone antibiotics: concomitant use with DEALGIC may lead to seizures;
• Phenytoin, used to treat epilepsy: concomitant use with DEALGIC increases phenytoin blood levels. Your doctor will prescribe blood tests to monitor phenytoin levels.
• Colestipol and cholestyramine, used to treat cholesterol: concomitant use may increase or decrease diclofenac absorption and thus its therapeutic effect. Your doctor will advise you to take diclofenac at least one hour before or 4–6 hours after colestipol/cholestyramine.
• Potent CYP2C9 inhibitors, such as sulfinpyrazone and voriconazole: concomitant use may increase diclofenac toxicity.
• CYP2C9 inducers (e.g., rifampicin): concomitant use may decrease diclofenac blood concentrations and exposure.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take DEALGIC during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney, lung, and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor more than expected. You should not take DEALGIC during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used.
From week 20 of pregnancy, DEALGIC may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction of 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 age, planning to become pregnant, experiencing difficulty conceiving, or undergoing fertility investigations, as diclofenac may impair female fertility.
Driving and using machines
DEALGIC may affect your ability to drive vehicles or operate machinery, especially when combined with alcohol, as it may cause visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders. Therefore, avoid driving 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 exactly as prescribed by your doctor. If in doubt, 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 daily; or
• 1 capsule of DEALGIC 75 mg prolonged-release hard capsules once daily.

If necessary, your doctor may increase your daily dose up to 150 mg, by taking 1 capsule of DEALGIC 75 mg prolonged-release hard capsules twice daily, or 2 capsules as a single dose, in case of particularly severe symptoms, especially in the morning.
Swallow the medicine without chewing and with sufficient liquid.
Taking the medicine after meals may delay the absorption of the active substance into the bloodstream; therefore, in case of acute pain, take DEALGIC before meals.
The duration of treatment varies depending on the individual case.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Use in children and adolescents
DEALGIC must not be used in children and adolescents under 14 years of age.
Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will advise you on how much DEALGIC you should take.
If you take more DEALGIC than you should
If you take more DEALGIC than prescribed, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose include: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, ringing in the ears (tinnitus), or seizures.
In more severe cases, impaired kidney function (acute renal failure) and liver damage may occur.
If you forget to take DEALGIC
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact your doctor immediately if you experience any of 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 ones (anaphylactic shock);
• Abdominal pain, at the beginning of treatment with diclofenac, followed by rectal bleeding or bloody diarrhoea usually within 24 hours after the onset of abdominal pain;
• Other abdominal symptoms and disturbances, especially at the beginning of treatment, and particularly if you are elderly or have previously experienced side effects on the stomach or intestine due to medicines. These could be symptoms of bleeding, perforation or ulceration of the stomach or intestine;
• Abnormal liver function blood tests, or other signs of liver disease, such as high levels 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 speech difficulties. These may be symptoms of serious thrombotic events (problems due to blood clots);
• Excessive accumulation of fluid in the body (oedema); this condition is reversible upon discontinuation of treatment.

Other possible side effects include:
Common (may affect up to 1 in 10 people)

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

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

• Allergic reactions (hypersensitivity), severe and rapidly occurring allergic reactions (anaphylaxis), including hypotension and collapse (shock);
• Drowsiness;
• Asthma, including breathing difficulty (dyspnoea);
• Gastritis, gastrointestinal haemorrhage, presence of blood in vomit (haematemesis), bloody diarrhoea, passage of blood with stools (melena), gastrointestinal ulcer (with or without haemorrhage and perforation);
• Changes in liver function (hepatitis and liver disorders), yellowing of the skin and whites of the eyes (jaundice);
• Urticaria;
• Skin swelling due to fluid accumulation (oedema).

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

• Rapid swelling (edema) of the skin, mucosa, and submucosal tissues (angioedema including facial swelling)
• Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions
• Altered sensation in limbs or other body parts (paresthesia)
• Memory impairment, seizures, anxiety, tremors
• Central nervous system disorder characterized by inflammation of the meninges (aseptic meningitis), taste disturbances, stroke (cerebrovascular accidents), restlessness
• Vision 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 intestinal inflammation characterized by episodes of diarrhea (colitis, including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, inflammation of the oral mucosa (stomatitis, including ulcerative stomatitis), inflammation of the tongue mucosa (glossitis), esophageal disorders, narrowing of certain intestinal segments (intestinal stenosis), inflammation of the pancreas (pancreatitis)
• Impaired liver function (fulminant hepatitis, hepatic necrosis, liver failure)
• Bullous skin eruptions, 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 purplish spots spread over the skin, with or without joint pain, muscle pain, weakness, and fever; these may be symptoms of inflammation of the blood vessel walls known as purpura (including Schönlein-Henoch purpura), itching
• Impaired kidney function (acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis), presence of blood in urine (hematuria), excretion of protein in urine (proteinuria)
• Feeling of lack of energy (asthenia) Not known (frequency cannot be estimated from the available data)
• Specific type of allergic coronary spasm (Kounis syndrome)
• Reduced blood flow to the intestine (ischemic colitis).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 above 25°C.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DEALGIC contains

• The active substance is diclofenac. DEALGIC 75 mg prolonged-release hard capsules: Each capsule contains 75 mg of sodium diclofenac, equivalent to 69.6 mg of diclofenac.

DEALGIC 100 mg prolonged-release hard capsules:
Each capsule contains 100 mg of sodium diclofenac, equivalent to 92.80 mg of diclofenac.

• The other components 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 contents of the pack
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), Italy

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