50 mg enteric-tablet is
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
- Save this information, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4
In this leaflet:
1. What Diclofenac Mylan is and what it is used for
2. What you need to know before you take Diclofenac Mylan
3. How to take Diclofenac Mylan
4. Possible side effects
5. How to store Diclofenac Mylan
6. Contents of the packaging and other information
1. What Diclofenac Mylan is and what it is used for
Diclofenac Mylan is a drug that inhibits inflammation, relieves pain, and lowers fever by affecting the production of prostaglandins in the body. Prostaglandins can cause inflammation, pain, and fever.
Diclofenac Mylan belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines).
Diclofenac Mylan is used to treat rheumatic diseases such as osteoarthritis, rheumatoid arthritis, childhood rheumatism, and Bechterew’s disease and to reduce menstrual pain.
The diclofenac sodium contained in Diclofenac Mylan may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 take Diclofenac Mylan
Do not take Diclofenac Mylan:
- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6)
- if you have previously had allergic reactions such as swelling of the face, lips, throat, tongue and/or arms and legs (signs of angioedema ), asthma, chest pain, runny nose, or skin rash when you have taken painkillers containing acetylsalicylic acid or other medicines for pain/inflammation within the NSAID group.
- if you have severe liver disease
- if you have an increased tendency to bleed
- if you have porphyria (metabolic disease)
- if you have or have had recurrent stomach ulcers or duodenal ulcers
- if you have previously had stomach ulcers or duodenal ulcers during treatment with diclofenac or similar preparations
- if you 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
- if you have or have had problems with blood circulation ( peripheral vascular disease)
- if you have severe kidney disease
- during the last 3 months of pregnancy
Warnings and cautions
The lowest possible dose and the shortest possible treatment time should always be sought
to reduce the risk of side effects. In general, higher doses than recommended can lead to serious risks. This also means that the combination of several NSAIDs at the same dose should be avoided.
If you have or have had the following diseases, you should consult a doctor before starting treatment with Diclofenac Mylan:
- angina, blood clots, high blood pressure
- gastric ulcer or duodenal ulcer
- inflammatory bowel disease ( ulcerative colitis Crohn’s disease )
- liver disease
- heart or kidney disease
- inflammation of the nasal mucous membranes, asthma, COPD ( chronic obstructive pulmonary disease ), chronic infection of the airways, or allergic reactions such as urticaria or angioedema (periodically occurring local swellings)
- SLE (connective tissue disease)
- blood disorders and diseases with an increased tendency
to bleed Before receiving diclofenac, tell your doctor:
- if you smoke
- if you have high cholesterol or triglyceride levels (blood fats)
Elderly people, especially those with low body weight, should be aware of the increased risk of side effects that are present in old age.
Tell your doctor if you have recently had or are about to have surgery on your stomach or intestinal tract before receiving Diclofenac Mylan, as Diclofenac Mylan can sometimes impair the healing of wounds in the intestines after surgery.
NSAIDs including Diclofenac Mylan may in rare cases cause stomach ulcers which may occur at any time during treatment with or without warning symptoms. Patients who experience gastrointestinal complaints, especially elderly patients, should consult a physician in case of abdominal symptoms.
Like other NSAIDs, Diclofenac Mylan may mask signs or symptoms of infection.
For chickenpox, this medicine should not be used.
The use of Diclofenac Mylan (as well as all medicines that inhibit cyclooxygenase/prostaglandin synthesis) may make it difficult to conceive. Talk to your doctor if you are planning to become pregnant or if you have problems getting pregnant. The effect is temporary, ie ceases when you stop using these types of drugs.
Drugs such as Diclofenac Mylan may cause a small increased risk of heart attack or stroke. Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time.
You should pay attention to signs and symptoms such as. chest pain, shortness of breath, weakness, slurred speech that may occur without warning. If you get these problems, contact a doctor immediately.
Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Diclofenac Mylan and consult a doctor if you get a rash or damage to the mucous membranes.
Other medicines and Diclofenac Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diclofenac Mylan may affect or be affected by certain medicines that contain the following active substances:
- anticoagulants (eg warfarin, ticlopidine, acetylsalicylic acid, heparin )
- medicines for the treatment of diabetes, except insulin
- lithium or selective serotonin reuptake inhibitors ( SSRIs ) (used in certain types of depression)
- digoxin (used for heart problems)
- tacrolimus (used for transplants and eczema )
- cyclosporine (used for transplants, severe psoriasis, and rheumatism)
- certain medicines for high blood pressure (so-called beta-receptor blockers, angiotensin II antagonists, and ACE inhibitors )
- diuretics ( diuretics also used for high blood pressure )
- quinolone antibiotics (used in urinary tract infections)
- corticosteroids (used to treat inflammatory diseases)
- colestipol or cholestyramine (used for high blood fats)
- rifampicin ( antibiotics for tuberculosis )
- carbamazepine (used in epilepsy )
- St. John’s wort, methotrexate (used in psoriasis, rheumatism, and certain cancers)
- sulfinpyrazone (used in gout )
- voriconazole or fluconazole (used for fungal infections)
- phenytoin (used in epilepsy )
- amiodarone (used for arrhythmias in the heart)
- trimethoprim (used to prevent or treat urinary tract infection)
Concomitant use of other NSAIDs should be avoided as the risk of side effects increases.
Pregnancy and breastfeeding
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.
Taking Diclofenac Mylan may inhibit the fertility of women and should be avoided by women trying to conceive or are pregnant. Pregnant women should not use Diclofenac Mylan during the last three months of pregnancy. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Diclofenac Mylan passes into breast milk. To avoid effects on the baby, DiclofenacMylan should not be used during breast-feeding.
Driving and using machines
Diclofenac Mylan may cause side effects in some people such as visual disturbances, dizziness, or drowsiness. Avoid driving or using machines if you experience these or similar symptoms.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 Mylan contains lactose, sodium, and para-orange (E110)
Diclofenac Mylan enteric tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Diclofenac Mylan contains less than 1 mmol (23 mg) sodium per enteric-tablet, ie essentially ‘sodium-free ‘.
Diclofenac Mylan also contains para-orange (E110), which may cause allergic reactions.
How to take Diclofenac Mylan
Always take Diclofenac Mylan exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
As Dikofenak Mylan is only available in strength 50 mg enteric tablets, not all dosages are possible. If other strengths or pharmaceuticals are needed, other diclofenac products should be used.
The usual dose for adults: 75-150 mg daily, usually morning and evening.
The usual dose for adults: 50-150 mg divided into 1-3 doses when needed. Initially, 50-100 mg is recommended. Treatment is started at the first sign of menstrual pain. Maximum 150 mg per day.
Use for children and adolescents
Rheumatic diseaseThe unusual dose for children over 6 years: 25 mg morning and evening. For children over 50 kg, an adult dose is given.
The tablets should be swallowed whole. Diclofenac Mylan can be irritating to the stomach, to avoid this, the tablets are coated with a layer that dissolves only when the tablets have passed the stomach. If the tablets are split, crushed, or chewed, this layer is destroyed and it is easier to suffer from side effects in the form of stomach upset and stomach pain.
If you take more Diclofenac Mylan than 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.
If you forget to take Diclofenac Mylan
Do not take a double dose to make up for a forgotten tablet.
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.
Some side effects can be serious
Stop using Diclofenac Mylan and contact a doctor or hospital immediately if you notice the following:
- 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).
- Infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection such as sore throat/pharynx/mouth or urination. Diclofenac can affect the white blood cells so that the defense of the infection deteriorates (very rare). A blood test can rule out a lack of white blood cells ( agranulocytosis ). You must inform your doctor when contacting a doctor.
- Symptoms such as swelling of e.g. a. face, tongue, and/or pharynx and/or difficulty swallowing or hives that occur with difficulty breathing ( angioedema ) (very rare).
- Skin rash or damage to the mucous membranes. Severe skin reactions (Steven Johnson’s syndrome ( mucositis and skin inflammation with blisters and high fever) and Lyell’s syndrome (such as Steven – Johnson syndrome but also with sudden skin detachment)) when using NSAIDs have been reported (very rare).
- Palpitations or sudden chest pain (signs of a heart attack). If you become short of breath, have difficulty breathing when lying down or if your feet or legs swell (signs of heart failure ) (uncommon).
- Mild abdominal cramps and soreness, which begin shortly after starting treatment with diclofenac 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).
The following side effects have also been reported with the use of diclofenac:
Common (may affect up to 1 in 10 people): Stomach pain, nausea, vomiting, diarrhea, indigestion, decreased appetite, increased flatulence, headache, dizziness, dizziness, rash, increased liver values.
Uncommon (may affect up to 1 in 100 people): Tracheal spasm.
Rare (may affect up to 1 in 1,000 people): Fatigue, swelling of the body due to fluid retention, hypersensitivity reactions ( hives, allergic shock reaction with a drop in blood pressure), gastritis, gastric ulcer, gastric bleeding, (blood-mixed vomiting, blood in the stool, bloody diarrhea ), impotence (connection uncertain), hepatic dysfunction (hepatitis, jaundice), asthma (including shortness of breath).
Very rare (may affect up to 1 in 10,000 users including single reports) : Impact on vision (blurred vision, double vision) and hearing (hearing loss, tinnitus), difficulty falling asleep, nightmares, irritability, anxiety, depression, memory disorders, confusion, disturbed reality, tingling, tremors, convulsions, sensory loss, change in taste, impact on the vessel (e.g., high blood pressure , vascular inflammation), hematological effects (decreased number of platelets which can give small hemorrhages in the skin and mucous membranes, disintegration of red blood cells , anemia , reduced number of white blood cells ), eczema , itching, skin redness, hair loss, photosensitivity reactions, effects on the kidneys (eg decreased or stopped urine production and blood in the urine), severe liver disease, liver failure, meningitis or non-bacterial pneumonia , stroke , intestinal problems (eg constipation, inflammationof the intestine with or without bleeding), worsening of Crohn’s disease and ulcerative colitis , inflammation of the tongue, mouth or esophagus, inflammation of the pancreas.
For NSAIDs, severe skin and soft tissue infections are rarely associated with chickenpox.
Drugs such as diclofenac may have a small increased risk of heart attack or stroke, the risk increases with higher doses and long-term treatment.
Effects on vision such as visual impairment, blurred vision, or double vision are side effects caused by NSAIDs and disappear upon cessation of
treatment. In case of these symptoms, an examination of the eyes should be done to rule out
5. How to store Diclofenac Mylan
Keep out of sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton.
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
- The active substance is diclofenac sodium 50 mg.
- The other ingredients are lactose monohydrate 40 mg, microcrystalline cellulose, colloidal anhydrous silica, maize starch, povidone, magnesium stearate, carnauba wax, dyes (iron oxide (E172), titanium dioxide (E171)), talc, methacrylic acid paracetyl acrylate, triacrylate, orange aluminum lacquer (E110), quinoline yellow aluminum lacquer (E104).
What the medicine looks like and the contents of the pack
Curved, film-coated yellow-brown tablets, diameter 8 mm.
Plastic jars (rheumatism adapted) 20, 30, 50, 100, and 250 (only for dose dispensing) enteric tablets .
Not all pack sizes may be marketed.
Marketing Authorisation Holder
104 35 Stockholm
Tel: 08 555 227 50, E-mail: firstname.lastname@example.org