25 mg and 50 mg enteric tablets are 
Diclofenac sodium

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.
  • 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Diclofenac Orifarm is and what it is used for 
2. What you need to know before you use Diclofenac Orifarm 
3. How to use Diclofenac Orifarm 
4. Possible side effects 
5. How to store Diclofenac Orifarm 
6. Package contents and other information

1. What Diclofenac Orifarm is and what it is used for

Diclofenac Orifarm belongs to the group of non-steroidal anti-inflammatory / anti-rheumatic drugs ( NSAIDs ). It has an anti-inflammatory, analgesic,c, and antipyretic effect.

Diclofenac Orifarm is used to treat rheumatic diseases such as osteoarthritis, rheumatoid arthritis, and Bechterew’s disease and to reduce menstrual pain.

Diclofenac contained in Diclofenac Orifarm 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 Orifarm

Do not use Diclofenac Orifarm

  • if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
  • if you have previously had asthma, hives, or runny nose while taking painkillers containing acetylsalicylic acid or other pain/inflammation medicines in the NSAID group .if you have stomach ulcers or duodenal ulcers
  • if you 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 an increased tendency to bleed.
  • if you have porphyria (metabolic disease)
  • if you have liver failure or severe kidney failure.
  • 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)
  • during the last three months of pregnancy (third trimester).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Diklofenak Orifarm.

  • if you think you may be allergic to diclofenac sodium, aspirin, ibuprofen, or any other NSAIDs, or any of the ingredients of Diclofenac Orifarm. [These are listed at the end of this leaflet.] Signs of a hypersensitivity reaction may be swelling of the face and mouth ( angioedema ), difficulty breathing, chest pain, runny nose, skin rash, or any other type of allergic reaction.


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 Orifarm:

  • gastric ulcer or duodenal ulcer
  • inflammatory bowel diseases (such as ulcerative colitis, Crohn’s disease )
  • asthma, seasonal allergy, nasal polyps, chronic obstructive pulmonary disease(COPD), or chronic infection of the respiratory tract
  • heart failure
  • angina
  • blood clots
  • high blood pressure
  • liver or kidney disease
  • diseases with an increased tendency to bleed
  • diabetes
  • SLE (connective tissue disease)


Before you are given diclofenac, tell your doctor

  • if you smoke
  • if you have high cholesterol or triglyceride levels (blood fats).


Tell your doctor if you have recently had or are about to have surgery on your stomach or intestinal tract before taking Diclofenac Orifarm, as Diclofenac Orifarm may sometimes impair the healing of the intestines after surgery.


Elderly patients should be aware of the increased risk of side effects that occur in old age.


NSAIDs including Diclofenac Orifarm 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 anti-inflammatory drugs, Diclofenac Orifarm may mask signs or symptoms of infection.


Diclofenac Orifarm may in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.


Like other anti-inflammatory drugs, Diclofenac Orifarm may in rare cases cause allergic reactions, including allergic shock reactions. This can also happen when taking diclofenac for the first time.


Stop taking Diclofenac Orifarm and contact a doctor immediately if swelling of e.g. a. face, tongue, and/or throat and/or difficulty swallowing or hives appearing with difficulty breathing.


Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Diclofenac Orifarm and consult a doctor if you get a rash or damage to the mucous membranes.


Medicines such as Diclofenac Orifarm 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.


For chickenpox, this medicine should not be used.


The use of Diclofenac Orifarm (as well as all medicines that inhibit cyclooxygenase/prostaglandin synthesis) may make it more difficult to get pregnant. 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.

Other medicines and Diclofenac Orifarm

The effect of the treatment can be affected if this medicine and some other medicines are taken at the same time.


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

The doctor needs to know if you are already being treated with:

  • Lithium (antidepressant)
  • Digoxin (means for heart disease)
  • Other NSAIDs (painkillers and anti-inflammatory drugs)
  • Anticoagulants (eg warfarin, ticlopidine, acetylsalicylic acid, heparin )
  • Medicines for diabetes, except insulin
  • Methotrexate (used in psoriasis, rheumatism, and certain cancers)
  • Cyclosporine (used in transplants, in severe psoriasis, rheumatism that suppresses the immune system)
  • Cholestyramine and colestipol (antihypertensive agents)
  • Blood pressure-lowering agents (eg so-called beta-receptor blockers, diuretics, ACE inhibitors, angiotensin II inhibitors)
  • Certain antibiotics (quinolone-type, eg ciprofloxacin )
  • Corticosteroids (anti-inflammatory drugs, eg prednisolone )
  • Certain antidepressants (so-called SSRIs )
  • Phenytoin (anti-epileptic seizures and epilepsy )
  • Tacrolimus (used in liver, kidney, and heart transplants and eczema )
  • Sulfinpyrazone (used to treat gout )
  • Rifampicin ( antibiotics for tuberculosis )
  • Carbamazepine (used in epilepsy )
  • St. John’s wort ( Hypericum perforatum )
  • Voriconazole or fluconazole (used for fungal infections)
  • Amiodarone (used for arrhythmias in the heart)
  • Trimethoprim (used to prevent or treat urinary tract infection)

Diclofenac Orifarm with food and drink:

The entero-tablets should be swallowed whole with plenty of drink (at least 1 glass of water).

For maximum effect, it is recommended that the tablets not be taken with a meal.

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.


Pregnancy

Pregnant women should not use Diclofenac Orifarm during the last three months of pregnancy. Taking Diclofenac Orifarm should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.

Breast-feeding

Diclofenac passes into breast milk. Diclofenac Orifarm should not be taken during breast-feeding.


Fertility

Like all medicines that inhibit cyclooxygenase/prostaglandin synthesis, diclofenacOrifarm may make it harder for you to get pregnant. Tell your doctor if you are planning to become pregnant or if you have problems getting pregnant.

Driving and using machines

Diclofenac Orifarm can cause side effects such as visual disturbances, dizziness, and drowsiness, which should be taken into account when sharpened attention is required, such as when driving and when working with precision. 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 Orifarm contains lactose

Diclofenac Orifarm contains 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.

How to use Diclofenac Orifarm

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Rheumatic diseases

The usual dose for adults: 75-150 mg daily in 2-3 divided doses depending on the disease activity.

The usual dose for children over 6 years: 25 mg morning and evening. For children over 50 kg, an adult dose is given.

Menstrual pain

The usual dose for adults: 50-150 mg divided into 1-3 doses if needed. Initially, a dose of 50-100 mg is recommended. Treatment is started at the first sign of menstrual pain. Maximum 150 mg per day.

Gastro-resistant is to be swallowed whole by at least 1½ glasses of water.

For maximum effect, it is recommended that the tablets not be taken with a meal. The tablets should not be divided or chewed.

If you use more Diclofenac Orifarm then you should

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Diclofenac Orifarm

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, pharmacist, or nurse.

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 taking Diclofenac Orifarm and tell your doctor immediately if you notice any of the following symptoms:

  • 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 Orifarm 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).
  • 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 cramping and tenderness in the abdomen, which begins shortly after starting treatment with Diclofenac Orifarm and is 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, elevated liver values.


Uncommon (may affect up to 1 in 100 people) :

spasm of the trachea,


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

Fatigue, swelling in the body due to fluid retention, hypersensitivity reactions ( hives, allergic shock reaction with a drop in blood pressure), gastritis, stomach ulcers, gastric bleeding (blood-mixed vomiting, blood in the stool, bloody diarrhea), impotence(connection uncertain), liver dysfunction (dysfunction), 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 (such as 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 , decreased white blood cells ), eczema , itching, reddening of the skin, 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, inflammation of the intestine with 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.

5. How to store Diclofenac Orifarm

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 which is stated on the carton after EXP. dat.

The expiration date is the last day of the specified month.

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 sodium diclofenac 25 mg and 50 mg respectively per enteric-tablet.
  • The other ingredients are for both strengths: lactose monohydrate 50 mg and 65 mg, respectively, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, corn starch, macrogol, methacrylic acid ethyl acrylate copolymer, simethicone emulsion (or ethyl sulfonate); ), yellow iron oxide (E 172).
  • Diclofenac Orifarm 50 mg also contains red iron oxide (E 172).

What the medicine looks like and the contents of the pack

Diclofenac Orifarm 25 mg enteric tablets:

Gold-plated tablets with the inscription D25.

Diclofenac Orifarm 50 mg enteric-coated tablets:

Well-coated tablets with the inscription D50.

Diclofenac Orifarm 25 mg and 50 mg enteric tablets are available in the following pack sizes:

Blister pack: 10, 14, 20, 28, 30, 50, 56, 98, 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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