50 mg enteric-tablet is
diclofenac sodium
1. What Diclofenac Sandoz is and what it is used for
Diclofenac sodium, the active substance in Diclofenac Sandoz, belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines), which are used to treat pain and inflammation.
Diclofenac Sandoz relieves inflammatory symptoms, such as swelling and pain, and is also antipyretic. Diclofenac Sandoz does not affect the cause of inflammation or fever.
Diclofenac Sandoz can be used to treat the following conditions:
- rheumatism, including joint pain ( arthritis ) and juvenile rheumatoid arthritis, joint degeneration ( osteoarthritis ), and certain types of back pain ( vertebral joint disease)
- painful, inflamed so-called “frozen” shoulder
- painful inflammation and swelling e.g. after dental surgery or after other surgery
- severe, painful menstruation
- infection is accompanied by fever, especially during short-term treatment with cytotoxic drugs
The active substance in these enteric tablets (diclofenac sodium) can be released in the body with a delay. Because of this, this medicine is not recommended if you need immediate or immediate relief of symptoms.
Diclofenac sodium contained in Diclofenac Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Diclofenac Sandoz
DO NOT use Diclofenac Sandoz if you:
- is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6)
- have stomach ulcers or a sore elsewhere in your gut
- bleeding from your stomach or intestines, signs of this may be blood in the stool or black stools
- have had bleeding or holes in the stomach or intestines in connection with previous NSAID treatment
- have had ulcers or bleeding in the stomach or intestines (at least twice)
- have severe liver or kidney failure (severe liver or kidney disease)
- is in the last three months (third trimester) of your pregnancy
- have previously had an asthma attack or breathed with wheezing, or chest pain, or extensive itchy skin rash ( hives ), or “hay fever-like” runny nose after taking other NSAIDs such as acetylsalicylic acid or ibuprofen
- currently bleeding or suffering from a bleeding disorder
- suffers from an abnormal blood condition (blood dyscrasia )
- suffer from problems with your blood status (bone marrow depression), low white blood cell count (sometimes with a serious risk of infection ), low platelet count(with an increased risk of bleeding and bruising), or low red blood cell count(dizziness, headache). This can happen after a radiation treatment
- have known heart disease and/or disease of the blood vessels of the brain, e.g. heart attack, stroke, “mini-stroke” ( transient ischemic attack, TIA ). You may also have had narrowing of the blood vessels to the heart or brain, or have had surgery for such narrowing by clearing blood vessels one or through a bypass operation
- have or have had problems with blood circulation ( peripheral vascular disease)
If any of these descriptions apply to you or if you feel unsure, ask your doctor or pharmacist.
Warnings and cautions
Talk to your doctor or pharmacist before using Diklofenak Sandoz if you:
- have previously had stomach or intestinal problems e.g. ulcers, bleeding or black stools, or have suffered from indigestion or heartburn after taking NSAIDs funds
- suffers from asthma, hay fever, or any other long-term respiratory problem such as a nasal polyp or chronic obstructive pulmonary disease
- tend to develop allergic skin rashes, itching, or hives
- have an inflammatory bowel disease, such as ulcerative colitis or Crohn’s disease
- have a bleeding disorder or any other problem with the blood including the unusual liver condition called porphyria
- have an inflammatory disease called systemic lupus erythematosus, or any related tissue disease
- have heart problems
- smokes
- have diabetes
- have angina, blood clots, high blood pressure, high cholesterol or triglyceride levels (blood fats)
- have any liver or kidney problems
- think you are dehydrated, perhaps due to diarrhea, low fluid intake or nausea, or in connection with surgery
- has the viral disease chickenpox
If any of these descriptions apply to you, your doctor may want to give you specific advice or change your treatment.
Side effects can be minimized by treating with the lowest effective dose for the shortest possible time.
Older people may be more sensitive to the effects of Diclofenac Sandoz than younger adults. If you are 65 years of age or older, it is important that you carefully follow your doctor’s instructions and take the lowest number of enteric tablets that provide satisfactory symptom relief. It is especially important for older people to promptly report adverse event’s doctor or pharmacist (see section 4 “Possible Side Effects”).
Your doctor may also prescribe the concomitant use of another medicine (such as misoprostol or proton pump inhibitor ) to protect your stomach, especially if you have had stomach problems in the past if you are elderly,y or if you are taking low- dose acetylsalicylic acid or some other medicines that are likely to increase your risk. gastrointestinal problems.
Tell your doctor if you have recently had or will have surgery on your stomach or intestinal tract before taking Diclofenac Sandoz, as Dicolofenak Sandoz may sometimes impair the healing of the intestines after surgery.
Diclofenac Sandoz may reduce or mask the symptoms of infection such as headache or fever. This can lead to an infection that can be more difficult to detect and treat. If you do not feel well and see a doctor, remember to tell them that you are taking Diclofenac Sandoz.
Other medicines and Diclofenac Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because some medicines should not be taken at the same time as Diclofenac Sandoz.
The following medicines, if taken at the same time as Diclofenac Sandoz, may increase the risk of bleeding or ulcers in the stomach or intestines, so you should tell your doctor or pharmacist if you are taking any of the following medicines:
- Oral corticosteroids are used to treat inflamed areas of the body
- anticoagulants such as warfarin or phenprocoumon used in blood thinning
- selective serotonin reuptake inhibitors ( SSRIs ), are used in the treatment of certain types of depression
- other NSAIDs, e.g. COX-2 ( cyclooxygenase -2 ) inhibitors such as acetylsalicylic acid and ibuprofen, are used to relieve inflammation/pain
Tell your doctor or pharmacist if you are taking any of the following:
- lithium is used in the treatment of certain mood disorders, such as mania or depression
- digoxin, used in the treatment of heart problems
- amiodarone used to treat irregular heartbeats
- diuretic, diuretic agents
- antihypertensive agents, such as ACE inhibitors, angiotensin II receptor antagonists, or beta-blockers, are used to treat high blood pressure (or certain other heart problems)
- blood thinners ( anticoagulants )
- oral drugs for the treatment of diabetes (oral antidiabetics)
- methotrexate is used in the treatment of severe arthritis and certain forms of cancer
- ciclosporin or tacrolimus is used to prevent rejection after an organ transplant or to treat certain inflammatory diseases
- quinolone antibiotics, used in the treatment of certain infectious s
- trimethoprim, used in the treatment of bacterial infection s
- colestipol and cholestyramine, are used in the treatment of high cholesterol in the blood
- sulfinpyrazone is used in the treatment of gout
- fluconazole and voriconazole, are used in the treatment of fungal infections
- phenytoin, used in the treatment of seizures
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.
- Do not take Diclofenac Sandoz during the first six months of pregnancy unless your doctor has advised you to do so.
- Do not take this medicine during the last three months of pregnancy as it may harm the unborn baby or cause problems during birth.
- This medicine, like other NSAIDs, may make it harder to get pregnant, so it is best not to take this medicine if you are planning to become pregnant or have previously had problems getting pregnant.
- Do not take Diclofenac Sandoz if you are breast-feeding. It can be harmful to your baby.
Driving and using machines
Diclofenac Sandoz has not been shown to affect your ability to drive or use machines.
However, if you experience side effects such as vision problems, dizziness, or drowsiness (see section 4), do not drive or use motor vehicles.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Diclofenac Sandoz contains lactose, hydrogenated polyacrylic castor oil, and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains castor oil, which may cause stomach upset and diarrhea.
This medicine contains less than 1 mmol (23 mg) sodium per enteric-tablet, ie essentially ‘sodium-free ‘.
How to use Diclofenac Sandoz
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will tell you how many tablets to take and how long to treat. It is important to take the lowest dose that relieves the inflammation/pain for the shortest possible time. Depending on how you initially respond to treatment, your doctor may suggest an increase or decrease in dose one. Never exceed the dose recommended by your doctor.
The recommended dose is:
Adults (over 18 years)
- Rheumatic joint pain ( arthritis ): Treatment is started with 150 mg diclofenac sodium daily, the maintenance dose for long-term treatment is 75 mg-100 mg daily.
- Joint degeneration ( osteoarthritis ): Treatment is started with 100 mg-150 mg daily, depending on the degree of pain. The maintenance dose for long-term treatment is 75 mg – 100 mg daily.
- Painful frozen shoulder, painful inflammation, and swelling e.g. after dental surgery or other surgery: Treatment is started with 150 mg daily, depending on the degree of pain. The maintenance dose will be gradually reduced depending on the degree of pain.
- Severe menstrual pain: Initially, 50 mg – 100 mg is recommended. Treatment is started at the first sign of menstrual pain. Continue taking 50-150 mg daily (maximum 50 mg three times a day) for a few days. If the maximum dose of 150 mg is not effective during 2-3 menstrual periods, your dose may be increased to 200 mg per day at the next menstrual period.
- Diseases associated with fever, especially with short-term treatment as a supplement when infection occurs during chemotherapy: A daily dose of 0.5 mg diclofenac sodium per kg body weight is recommended, divided into 2-3 doses.
Use for children
- Rheumatic joint pain ( arthritis ): A daily dose of 1.5-2 mg diclofenac sodium per kg body weight is recommended, divided into 2-3 doses.
Elderly (over 65 years)
Elderly people are at greater risk of side effects from NSAIDs such as DiclofenacSandoz, so older people must take the lowest possible dose of one of these drugs that affect.
Method of administration :
The enteric tablets should be swallowed whole, together with the liquid.
The tablets can be taken with a meal.
The tablets must not be crushed or chewed.
If the symptoms are more bothersome during the night or directly in the morning, your doctor may suggest that you take the enteric tablets in the evening.
If you take more Diklofenak Sandoz then you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. You may need medical attention.
Signs of overdose may include vomiting, diarrhea, dizziness, ringing in the ears ( tinnitus ), cramps or severe abdominal pain, bloody or black stools.
If you forget to take Diclofenac Sandoz
If you forget to take a dose, take it as soon as you remember to take it. If it is almost time for your next dose at the time you realize you forgot the previous dose, then take the next dose at the normal time.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
If any of the following serious side effects occur, stop taking this medicine and tell your doctor immediately or go to the emergency department of your nearest hospital. You may need urgent medical attention.
- severe pain in the stomach or intestines, bloody or black stools, vomiting of blood
- unusual bleeding or bluish, which may be a sign of decreased platelet count
- high fever or persistent sore throat (possible signs of white blood cell deficiency ( agranulocytosis ))
- the severe allergic reaction that causes difficulty breathing, dizziness, swelling of the face, lips, mouth, tongue, or throat often associated with rash and itching
- wheezing and the feeling of tightness in the chest (signs of asthma )
- stiff neck (signs of meningitis )
- seizures
- high blood pressure
- red or purple skin (possible signs of vascular inflammation), skin rash with blisters, blisters on lips, eyes, and mouth, inflammation of the skin with flaking or flaking
- yellowing of the skin or eyes (signs of hepatitis )
- blood in the urine, excess protein in the urine, a severe decrease in the amount of urine (signs of kidney effects)
- inflammation of the pancreas which leads to severe pain in the abdomen or back ( pancreatitis )
- sudden onset and severe headache, nausea, dizziness, numbness, inability or difficulty speaking, paralysis (signs of stroke )
The serious side effects mentioned above are rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 users).
- Severe heart problems such as chest pain and shortness of breath (signs of heart attack or heart failure ) are less common (may affect 1 in 100 people).
- Chest pain, which may be a sign of a potentially serious allergic reaction known as Kuoni’s syndrome ( has been reported, occurs in an unknown number of users).
- Mild abdominal cramps and soreness that begin shortly after starting treatment with Diclofenac Sandoz and are followed by rectal bleeding or bloody diarrhea, usually within 24 hours of the onset of abdominal pain ( reported, occurring in an unknown number of users).
Other side effects are
Common (may affect up to 1 in 10 people):
- headache, dizziness
- nausea, vomiting, diarrhea, indigestion, abdominal pain, flatulence, loss of appetite
- liver function (which can be shown, for example, in the level of transaminase in blood samples)
- rash
- dizziness
Uncommon (may affect 1 in 100 people):
- palpitation
Rare (may affect up to 1 in 1,000 people):
- somnolence
- abdominal pain
- itchy rash
- swelling of arms, hands, legs, and feet ( edema )
Very rare (may affect up to 1 in 10,000 people):
- reduction in red or white blood cells, with symptoms such as paleness, tiredness, dark urine, light stools, increased risk of infection s
- impaired orientation, depression, anxiety, difficulty sleeping, nightmares, irritability, lost contact with reality (mental disorders)
- an ant crawls in hands or feet, memory disorders, tremors
- changes in taste, vision, hearing (such as ringing sounds in the ears), and balance
- inflammation of the lungs causing shortness of breath and chest pain ( pneumonitis )
- constipation or other intestinal problems including colitis (with symptoms such as persistent diarrhea), or worsening of pre-existing inflammatory bowel diseases
- sore mouth, sore tongue, sore esophagus
- ulcer in the esophagus (a tube that passes food from the throat to the stomach)
- hives, itching, unusual sensitivity to sunlight, resulting in red, swollen skin with blisters
- hair loss
- severe liver problems
Drugs such as Diclofenac Sandoz may be associated with a small increased risk of heart attack (heart attack) or stroke.
5. How to store Diclofenac Sandoz
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 blister and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is diclofenac sodium.
- Each enteric- containing tablet contains 50 mg of diclofenac sodium.
The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate , magnesium stearate, maize starch, povidone K30, sodium starch glycolate type A, hypromellose, hydrogenated poloxyl castor oil, yellow iron oxide (E172), titanium dioxide ( (methacrylic acid copolymer), macrogol 8000, silicone antifoam emulsion (dimethylpolysiloxane and silica).
What the medicine looks like and contents of the pack
Light brown, round, slightly biconvex enteric tablet with rounded edges.
Pack sizes: 10, 20, 30, 40, 50, 60, 100, 100 x 1 or 500 enteric tablets in PVC / PE / PVDC / Aluminum blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria