DICLAC retard 75 mg. 50 tablets
Diclac 75 ID is the product that relieves pain and inhibits inflammation (non-steroidal anti-inflammatory / analgesic).
It is used to treat:
rheumatic joint pain (arthritis);
back pain syndrome, "frozen shoulder", "tennis elbow" and other forms of rheumatism;
attacks of gout;
sprains, strains or other injuries;
pain and swelling after surgery;
painful gynecological inflammatory conditions, including painful menstrual cramps;
infections of the ear, nose or throat.
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE DICLAC 75 ID
Do not take Diclac 75 ID
if you are allergic to the active ingredient diclofenac or any of the other ingredients of this medicine (listed in section 6);
if you have ever had an allergic reaction (rash, difficulty breathing) after taking medicines containing diclofenac or similar substances such as acetylsalicylic acid, ibuprofen and others. Reactions can be asthma, runny nose, rash, swelling of the face. If you think you may be allergic, ask your doctor;
if you have a stomach ulcer and duodenal ulcer;
if you have or have previously had gastrointestinal haemorrhage (blood in stools or black stools);
if you suffer from severe kidney or liver disease;
if you suffer from severe heart disease;
if you are in the last three months of pregnancy;
in children and adolescents.
Warnings and Precautions
If you are taking other anti-inflammatory drugs or painkillers, including aspirin, corticosteroids, anticoagulants or some antidepressants (selective serotonin reuptake serotonin);
If you suffer from asthma, seasonal allergic rhinitis (hay fever), swelling of the lining of the nose (polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, reactions to NSAIDs such as exacerbation of asthma (ie. Intolerance to analgesics / analgesic asthma), swelling of the throat and facial or urticaria are more frequent;
If you have or have ever had gastrointestinal problems such as stomach ulcers, bleeding or black stools, stomach discomfort or heartburn after taking NSAIDs should report any unusual signs in the abdomen (especially bleeding) your doctor and stop taking of Diclac;
If you have inflammation of the colon (ulcerative colitis) or the small intestine (Crohn's disease);
If you have or had heart problems or high blood pressure;
If you have kidney or liver disease;
If you are dehydrated (from disease, diarrhea, before or after surgery);
If you have swollen feet;
If you have increased bleeding or other blood disorders, including rare liver disease called porphyria.
Diclac can suppress symptoms of infection (fever), make it hard to find and difficult to treat it.
Very rarely in association with NSAID therapy, severe skin hypersensitivity reactions. At the first sign of a skin rash or other hypersensitivity reactions Diclac treatment should be discontinued.
Drugs such as diclofenac may be associated with a slightly increased risk of heart attack (myocardial infarction), or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose and duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
If you are elderly and you are taking other medicines or basic groups are underweight, it is advisable for your doctor to prescribe the lowest effective dose.
Diclac is not suitable for children and adolescents under 18 years.
Other medicines and Diclac 75 ID
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Lithium or selective inhibitors of serotonin reuptake (SSRI) (the drugs used to treat certain types of depression);
Digoxin (used to treat heart disease);
Diuretics (medicines that increase the amount of urine, often used to treat high blood pressure);
ACE inhibitors or beta-blockers (used to treat high blood pressure and heart failure);
Other anti-inflammatory drugs such as acetylsalicylic acid, ibuprofen, etc .;
Corticosteroids (anti-inflammatory medicines);
Medicines that inhibit blood clotting and thrombus formation;
Medicines to treat diabetes (except insulin);
Methotrexate (used to treat certain types of cancer or arthritis);
Ciclosporin (a medicine used in patients undergoing transplantation);
Some antibacterial agents (quinolone) used to treat infections;
Phenytoin and medicines containing phenytoin (for epilepsy);
Colestipol and cholestyramine and medicinal products containing them (for lowering blood cholesterol). These drugs can cause a delay or reduction in the absorption of diclofenac. It is therefore recommended intake of diclofenac to it at least one hour before or 4 to 6 hours after taking cholestyramine colestipol;
Sulfinpyrazone (to treat gout)
Voriconazole or medicinal products containing voriconazole (to treat fungal infections);
Drugs that can increase the level of potassium in your blood. These are potassium-sparing diuretics (increasing urine flow), cyclosporine, tacrolimus (medicines that suppress the immune system) and trimethoprim (used to treat infections). It is frequent monitoring of potassium level in your blood.
Fertility, pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Women of childbearing age
There is no evidence to suggest recommendations for women of childbearing age.
If pregnancy is detected during continuous administration of Diclac 75 ID is necessary advice. In the first and second trimester of pregnancy Diclac 75 ID should be used only after consulting a doctor as the dose should be as low and duration of intake as short as possible, since it is considered that the possible risk to the fetus increases with dose and duration of administration. The product should not be administered during the last trimester of pregnancy due to the risk of complications for mother and child at birth.
The active ingredient diclofenac and its breakdown products pass into breast milk in small quantities. Because of possible negative consequences for the child, breast-feeding should be discontinued.
Diclac can complicate pregnancy and is therefore not recommended for use in women trying to conceive. When women get pregnant and those who conduct research about infertility, you should consider discontinuation of treatment with diclofenac.
Diclac 75 ID contains lactose
Diclac 75 ID contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
Each modified-release tablet (bilayer) contains less than 0.01 carbohydrate units.
3. HOW TO TAKE DICLAC 75 ID
Always take Diclac 75 ID exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Do not exceed the prescribed dosage. It is important to take the lowest effective dose for the shortest possible period.
The recommended dose for adults is between 100 and 150 mg of diclofenac daily. Adults should take one modified-release tablet (corresponding to 75 mg of diclofenac sodium). Can be considered a total daily dose of 2 modified-release tablets (corresponding to 150 mg of diclofenac sodium).
The maximum daily dose of 150 mg should not be exceeded.
In painful menstruation start treatment with a single dose of 50 to 100 mg at first onset of symptoms. Continue with the dosage of 150 mg daily. If necessary, if the dosage is not effective, your doctor may advise you to 200 mg / day. Do not take more than 200 mg / day.
Children and adolescents
Diclac is not suitable for use in children and adolescents.
No dose adjustment is required in elderly patients.
Patients with renal impairment
No dose adjustment is necessary in patients with renal impairment.
Patients with hepatic impairment
No dose adjustment is necessary in patients with hepatic impairment.
Method of administration
Tablets Diclac 75 ID must be swallowed whole and not chewed and with enough liquid, preferably before meals.
A two-layer tablet contains a portion which immediately released active ingredient (12,5 mg) and the part which frees a longer period of time the active ingredient (62,5 mg). Thus is achieved a rapid onset of action and prolonged duration of effect.
The duration of use is determined by your doctor.
If you take more dose Diclac 75 ID
Overdose no typical clinical picture. Symptoms of overdose may be disorders of the central nervous system such as headaches, dizziness, tinnitus, drowsiness and unconsciousness, and also seizures, abdominal pain, nausea and vomiting, diarrhea. Bleeding may occur in the gastrointestinal tract, and functional disorders of the liver and kidneys.
There is no known specific antidote. After uptake of potentially life-threatening dose can be applied and activated charcoal to induce gastric emptying (eg. By emesis, gastric lavage).
Please tell your doctor overdose with 75 Diclac ID. He / she will decide what action to take depending on the severity of the overdose.
If you forget to take Diclac 75 ID
If you forget to take your medicine, do not take a double dose to make up.
If you stop taking Diclac 75 ID
Please consult your doctor if you have stopped treatment prematurely.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Diclac 75 ID can cause side effects, although not everybody gets them.
Adverse reactions are described with the following frequencies:
Very common: occurring in more than 1 in 10 patients treated;
Common: at least 1 in 10 but more than 1 in 100 patients treated;
Uncommon: at least 1 in 100 but more than 1 in 1000 patients treated;
Rare: in less than 1 in 1000, but more than 1 in 10 000 patients treated;
Very rare: in less than 1 in 10,000;
Not known: from the available data can not be estimated.
Below mentioned side effects include those reported following both transient and after prolonged treatment with diclofenac in various formulations. Serious side effects are:
abnormal bleeding at the injury;
fever or sore throat constantly;
allergic reaction with swelling of the face, lips, mouth, tongue or throat, often accompanied by a rash and itching, which leads to difficulty in swallowing, low blood pressure and fainting; wheezing in the chest or shortness of breath (asthma symptoms);
chest pain (symptoms of a heart attack);
sudden and severe headache, nausea, dizziness, numbness, difficulty or inability to speak, paralysis (symptoms of stroke);
stiffness of the neck (symptoms of viral meningitis);
high blood pressure;
red or purple skin (possible sign of inflammation of blood vessels), skin rash with blisters on the lips, eyes and mouth, skin irritation with blistering and peeling;
severe stomach pain, bloody or black stools; vomiting blood;
yellowing of the skin or eyes (signs of hepatitis);
blood in the urine, excess protein in the urine, seriously reducing the amount of urine (signs of renal impairment).
Drugs such as diclofenac may be associated with a slightly increased risk of heart attack (myocardial infarction), or stroke.
Other common side effects:
Headache, dizziness, vertigo, nausea, vomiting, diarrhea, indigestion, abdominal pain, flatulence, loss of appetite, changes in liver function (values of certain enzymes are elevated), skin rash.
Other rare side effects:
Hypersensitivity, drowsiness, difficulty breathing (asthma), stomach pain, gastritis, bleeding from the gastrointestinal tract, vomiting blood, bloody diarrhea, stomach or intestinal ulcer, hepatitis, jaundice, liver disorders, hives, swelling of hands and feet (edema ).
Other rare side effects:
Reducing the number of platelets, reducing the number of white blood cells, anemia, swelling of the soft tissues of the face, disorientation, depression, difficulty sleeping, nightmares, irritability, mental disorders, tingling, memory impairment, convulsions, anxiety , tremor, meningitis, taste disturbances, cerebrovascular accident, vision or hearing, double vision, ringing in the ears, colitis, including exacerbation of ulcerative colitis and Crohn's disease, constipation, inflammation of the mouth, including the occurrence of ulcers, inflammation the vocal cords, oesophageal ulcer, pancreatitis, heart rhythm disturbances, chest pain, heart failure, heart attack, high blood pressure, blood vessel inflammation, hair loss, redness, dark red-purple rash, swelling of the skin (due to increased sensitivity to the sun), severe rash with blisters, eczema, dermatitis, pruritus, syndrome Stevens-Johnson, toxic epidermal necrolysis (syndrome Lyell), fast flowing hepatitis, liver failure and other serious liver problems, acute renal failure, blood in urine, protein in the urine, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DICLAC 75 ID
Keep out of the reach and sight of children.
Do not use Diclac ID 75 after the expiry date stated on the packaging. The expiry date refers to the last day of that month.