Dicloreum: the package leaflet

Dicloreum is an anti-inflammatory medicine used to relieve pain due to inflammation of the joints and muscles. The drug contains the active ingredient diclofenac sodium: find out the indicated dosage and timing of intake.Dicloreum contains the active substance diclofenac sodium, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac sodium is used to reduce pain and inflammation.

Dicloreum is used to treat:

• joint diseases such as rheumatoid arthritis and osteoarthritis;
• diseases of the muscles, tendons and bones such as periarthritis, bursitis, tendinitis, myositis, lumbosciatica;
• inflammation and swelling following trauma.

Talk to your doctor if you do not feel better or if you feel worse after the prescribed treatment period.

What you need to know before you take Dicloreum

DO NOT take Dicloreum

• if you are allergic to diclofenac sodium, or to other non-steroidal anti-inflammatory drugs (NSAIDs) and in particular to acetylsalicylic acid, or to medicines used to reduce pain (analgesics), lower fever (antipyretics), or to any of the other ingredients of this medicine (listed in section 6);
• if you have had liver problems (for example severe liver failure);
• if you have an ulcer, bleeding or perforation of the stomach or intestines;
• if you have ever had stomach or bowel bleeding (haemorrhage) or perforation after previous treatment with NSAIDs;
• if you have had recurrent stomach or duodenal bleeding / ulcer (two or more distinct episodes of
  proven ulceration or bleeding);
• if you are in the last trimester of pregnancy (see section “Pregnancy, breast-feeding and fertility”);
• if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”);
• if you have severe kidney problems (severe kidney failure);
• if you have confirmed heart or blood vessel problems in the brain (cerebral vasculopathy), for example if you have had a heart attack, stroke, mini-stroke (also called transient ischemic attack, TIA);
• if you have an obstruction in the blood vessels to your heart or brain or have had an operation to clear or avoid these obstructions;
• if you have or have ever had problems with blood circulation (peripheral arterial disease);
• if you have ongoing bleeding or are prone to bleeding;
• if you have had asthma attacks, hives or acute rhinitis after taking acetylsalicylic acid or other NSAIDs;
• if you have an alteration in the production of blood cells;
• if you are taking high doses of medicines that increase urine production (diuretics) (see section “Other medicines and Dicloreum”).

Do not give Dicloreum to children under the age of 14.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Dicloreum.

Tell your doctor before taking Dicloreum:

• if you have or have had high blood pressure;
• if you have heart, brain or blood vessel problems (e.g. congestive heart failure, known cardiomyopathy, peripheral arterial disease and / or stroke);
• if you have risk factors for adverse events affecting the heart, brain or blood vessels (e.g. high blood pressure, diabetes, smoking, high cholesterol or triglycerides, etc.);
• if you have chest pains (angina), blood clots;
• if you have ever had blood clots or emboli;
• if you have blood clotting defects (haemostasis defects);
• if you have kidney problems (eg kidney hypoperfusion, kidney failure), unless you have had severe kidney problems (severe kidney failure) because you should not take Dicloreum (see section “DO NOT take Dicloreum”);
• if you are taking medicines that increase urine production (diuretics) or other medicines which can affect the way your kidneys work;
• if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (eg aspirin), corticosteroids given by mouth, by injection or rectally (eg cortisone), anticoagulants (eg warfarin), selective inhibitors reuptake of serotonin (antidepressants) (see section “Other medicines and Dicloreum”);
• if you have or have had stomach or bowel problems (e.g. ulcer) or if you have ever had stomach or bowel ulceration, bleeding or perforation, as Dicloreum may not be suitable for you;
• if you have ulcerative colitis or Crohn’s disease as these conditions may get worse;
• if you have asthma or are predisposed because this medicine can cause narrowing of the airways (bronchospasm crisis) and in some cases shock and other allergic phenomena;
• if you have allergic-based seasonal colds (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps);
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
• if you have or have had liver problems (eg liver failure) except if you have had severe liver problems (severe liver failure) because you should not take Dicloreum (see section “DO NOT take Dicloreum”);
• if you have liver porphyria;
• if you have undergone major surgery;
• if you have a low volume of body fluids (for example before or after major surgery);
• if you are underweight because you will be prescribed a low dose of dicloreum;
• if you are elderly, particularly if you are weak and underweight, because you will be prescribed a low dose of dicloreum (see section “Elderly patients”).

In these cases, your doctor will closely monitor you and possibly re-evaluate the need for treatment with Dicloreum. In addition, your doctor may order periodic tests to evaluate your condition during treatment with Dicloreum.

Tell your doctor if you develop during treatment with Dicloreum:

• even severe skin reactions, as severe skin reactions which can be fatal have been reported very rarely;
• fluid retention and swelling from fluid accumulation (edema);
• signs and symptoms of liver problems or if your liver function parameters are abnormal (blood test results);
• unusual symptoms in the stomach and intestines especially at the start of treatment with dicloreum.

In these cases, the doctor will decide whether to continue or stop treatment with Dicloreum.

Also, pay special attention:

• Bleeding from the gastrointestinal tract, ulceration or perforation, which can even cause death, can occur at any time during treatment with NSAIDs, including diclofenac. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines to protect the gastrointestinal mucosa (e.g. misoprostol or proton pump inhibitors).
• Undesirable effects can be minimized by using the lowest effective dose for the shortest possible time (see section 3 “How to take Dicloreum”).
• Avoid the use of diclofenac during treatment with other NSAIDs given by mouth, by injection and rectally, including selective cyclo oxygenase-2 inhibitors, as it increases the chance of side effects.
• Dicloreum can hide the signs and symptoms of an infection.

Elderly patients

Elderly patients are more likely to experience adverse reactions, especially stomach or bowel bleeding and perforation, which are usually more serious and can be fatal. Tell your doctor about any unusual stomach and bowel symptoms especially at the start of treatment with this medicine.

If you are elderly, particularly if you are weak and underweight, your doctor will prescribe a low dose of dicloreum.

Other medicines and Dicloreum

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The blood concentration of the following medicines may increase when used together with Dicloreum:

• lithium;
• digoxin;
• methotrexate;

Your doctor will have you checked to check the blood concentrations of these medicines.

The effect on blood pressure of the medicines listed below may be diminished when used together with Dicloreum:

• medicines used to lower blood pressure:
  – medicines that increase urine production (diuretics)
  – beta blockers
  – angiotensin converting enzyme inhibitors (ACE inhibitors)

Your doctor will monitor you and carefully evaluate the administration of these medicines with Dicloreum, particularly if you are elderly.

Your doctor will monitor and test you if you need to take one or more of the medicines listed below with Dicloreum:

• blood pressure lowering medicines
  – ACE inhibitors and angiotensin II antagonists and if you have kidney problems
  – potassium-sparing (e.g. spironolactone);
• other non-steroidal anti-inflammatory drugs;
• corticosteroids (hormonal medicines used for example to reduce inflammation);
• medicines to thin the blood (anticoagulants or antiplatelet agents);
• serotonin reuptake inhibitors (antidepressants);
• medicines for diabetes;
• cyclosporine (immunosuppressant to change the response of the body’s immune system)
• medicines to fight bacterial infections of the quinolone class
• colestipol and cholestyramine, as they can delay or reduce the absorption of diclofenac. Your doctor will tell you when to take these medicines, usually diclofenac should be taken 1 hour before or 4-6 hours after taking colestipol and cholestyramine;
• potent inhibitors of CYP2C9 eg. sulfinpyrazone and voriconazole.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

• Do not use diclofenac during the first and second trimester of pregnancy unless clearly necessary because it can increase the risk of miscarriage and malformations in the newborn. The risk increases with increasing dose and duration of diclofenac therapy.If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, your doctor will prescribe the lowest dose of diclofenac for the shortest time possible.
• Do not use diclofenac during the third trimester of pregnancy because it can cause damage to the heart, lungs,
  kidneys of the fetus. It can also cause a prolongation of bleeding time in the mother and
  newborn, which can occur even at very low doses and an inhibition of contractions of the uterus in the
  mother with delay or prolongation of delivery.

Feeding time

Diclofenac passes into breast milk in small amounts, so do not use Dicloreum while breastfeeding to avoid adverse effects on the baby.

Fertility

As with other NSAIDs, do not use Dicloreum if you are planning to become pregnant as this medicine can impair fertility. Your doctor will consider the need to stop treatment with dicloreum if you have difficulty getting pregnant or need to have fertility tests.

Driving and using machines

Diclofenac may cause visual disturbances, dizziness, vertigo, somnolence or other disturbances which may affect the ability to drive and use machines.

If you have these symptoms, avoid driving a vehicle or using machines.

Dicloreum contains lactose

The gastro-resistant tablets contain lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

How to take dicloreum

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Dicloreum tablets should be taken whole with some liquid and should not be crushed, split or chewed.

Use in adults

Initial therapy: the recommended dose is 1 tablet 3 times a day.

Long-term therapy: the recommended dose is 1 tablet twice a day taken in the morning and in the evening.

Your doctor will tell you if you can reduce the dosage further. Take Dicloreum preferably with or
after meals (breakfast and dinner).

Dicloreum is also available in suppositories, oral administration can be associated with rectal therapy: 1 suppository, preferably in the evening and 1 50 mg tablet in the morning at breakfast.

Use in the elderly

In the elderly, the dose of diclofenac may need to be reduced. Your doctor will tell you how much Dicloreum to take.

Use in children and adolescents

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

If you take more dicloreum than you should

In case of accidental ingestion of an overdose of Dicloreum, notify your doctor immediately or contact the nearest hospital.

If you take too much diclofenac you may have vomiting, bleeding from the stomach and intestines, diarrhea, dizziness, ringing or ringing in the ears or convulsions. In severe cases, severe kidney and liver damage can also occur.

Your doctor will treat acute non-steroidal anti-inflammatory drug poisoning, including diclofenac, based on your symptoms.

If you forget to take Dicloreum

Do not take a double dose to make up for a forgotten dose.

If you stop taking Dicloreum

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious.

Stop taking Dicloreum and tell your doctor immediately if you notice:

Mild abdominal cramps and tenderness occurring shortly after initiation of dicloreum
followed by rectal bleeding or bloody diarrhea usually within 24 hours of
abdominal pain onset (frequency not known, cannot be estimated from the available data).

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

• headache, dizziness;
• dizziness;
• nausea, vomiting;
• diarrhea, gas (flatulence);
• problems with digestion (dyspepsia), abdominal pain;
• lack or reduced appetite (anorexia);
• abnormal values ​​in blood tests (increase in some liver enzymes: transaminases);

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

• allergic reactions, severe allergic reactions (anaphylaxis) including hypotension and shock;
• drowsiness;
• asthma, difficulty in breathing (dyspnoea);
• inflammation of the stomach (gastritis), bleeding from the stomach or intestines, vomiting with blood, stomach or intestinal ulcer with or without bleeding and perforation;
• diarrhea accompanied by bleeding, blood in the stool;
• inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders;
• urticaria;
• edema (swelling from fluid accumulation).

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

• abnormal values ​​in blood tests: low number of platelets (thrombocytopenia), reduction in the number of leukocytes (leukopenia), reduction in the number of red blood cells (anemia, including haemolytic and aplastic anemia), reduction in the number of granulocytes (agranulocytosis);
• abnormal values ​​in urinalysis: presence of blood in the urine (haematuria), presence of protein in the urine (proteinuria);
• allergic reaction with rapid swelling of the skin and mucous membranes (angioneurotic edema) including edema of the face;
• disorientation, depression, insomnia, nightmares, irritability, severe mental changes (delirium, hallucinations);
• memory impairment, excitement, seizures, anxiety, tremors;
• tingling;
• changes in taste;
• inflammation of the membranes that line the brain (aseptic meningitis), damage to the blood vessels of the brain;
• vision disturbances, blurred vision, double vision;
• ringing or ringing in the ears, hearing impairment;
• perception of one’s heart beat (palpitations), chest pain, heart problems (heart failure), heart attack;
• high blood pressure, inflammation of the blood vessels (vasculitis);
• pneumonia;
• inflammation of the colon (colitis) including colitis accompanied by bleeding and worsening of the rectum ulcerative colitis or Crohn’s disease;
• constipation;
• inflammation of the lining of the mouth (stomatitis) including stomatitis with ulcers, inflammation of the tongue (glossitis);
• problems with the esophagus, narrowing of the intestines;
• inflammation of the pancreas (pancreatitis);
• very severe and sudden form of hepatitis (fulminant hepatitis), necrosis of the liver, impaired liver function (liver failure);
• skin reactions of various types (redness, blistering, peeling etc.) from mild to life-threatening:
• appearance of red-brown spots on the skin (purple), also as an allergic reaction;
• itch;
• hair loss;
• sensitivity of the skin to sunlight;
• kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, necrosis;
• renal papillary;

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 via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Dicloreum

This medicine does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Do not use this medicine if the pack has been opened or damaged.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Contents of the pack and other information

What Dicloreum contains

• The active ingredient is diclofenac sodium. Each tablet contains 50 mg of diclofenac sodium.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate, cellulose acetate phthalate, diethyl phthalate, titanium dioxide, povidone.

What Dicloreum looks like and contents of the pack

Each pack contains 30 tablets for oral use.