Voltaren – Diclofenac sodium uses, dose and side effects


25 mg, 50 mg enteric tablet er
diclofenac sodium

What the Voltaren is and what it is used for

Voltaren suppresses inflammation, relieves pain, and lowers fever. Voltaren belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory/anti-rheumatic drugs).

Voltaren is used to treat pain and swelling associated with rheumatic diseases. Voltaren enter tablet er reduces pain and amount of bleeding in connection with menstruation.

What you need to know before using Voltaren

Do not use the Voltaren

  • if you are allergic to diclofenac or any other ingredient in this medicine
  • 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 or have had recurrent stomach or duodenal ulcers
  • if you have previously had stomach ulcers or duodenal ulcers during treatment with diclofenac or similar preparations
  • if you have a known heart disease and/or disease in the blood vessels of the brain, e.g. heart attack, stroke, “mini-stroke” ( transient ischemic attack, TIA ). You may also have had narrowings in the blood vessels to the heart or brain, or have had surgery for such narrowings by clearing vessels or via 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 precautions

As low a dose as possible and the shortest possible treatment time should always be sought to reduce the risk of side effects. In general, a higher dose than recommended can entail serious risks. This also means combining several NSAID preparations 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 Voltaren:

  • diabetes
  • angina, blood clots, high blood pressure
  • peptic ulcer or duodenal ulcer
  • inflammatory bowel disease ( ulcerative colitis, Crohn’s disease )
  • liver disease
  • heart or kidney disease
  • inflammation of the mucous membranes of the nasal cavities, asthma, COPD ( chronic obstructive pulmonary disease ), chronic infection of the respiratory tract, or allergic reactions such as hives or angioedema (periodically occurring local swellings)
  • SLE (connective tissue disease)
  • blood diseases and diseases with an increased tendency to bleed
  • high blood pressure

Before receiving diclofenac, tell your doctor:

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

Older people, especially those with low body weight, should be aware of the increased risk of side effects that exist in older age. 

Tell your doctor if you have recently had or are going to have surgery on your stomach or intestinal tract before receiving Voltaren, as Voltaren can sometimes impair the healing of wounds in the intestines after surgery.

NSAIDs including Voltaren can rarely cause stomach ulcers which can appear at any time during treatment with or without warning symptoms. Patients who experience problems with the gastrointestinal tract, especially elderly patients, should contact a doctor in case of abdominal symptoms.

Like other NSAIDs, Voltaren can mask signs or symptoms of infection.

In the case of chickenpox, this medicine should not be used.

Use of Voltaren (as well as any drug that inhibits cyclooxygenase/prostaglandin synthesis) may make it more difficult to become pregnant. Consult a doctor if you are planning a pregnancy or if you have problems conceiving. The effect is temporary, i.e. it stops when you stop using these types of drugs.

Medicines such as Voltaren may lead to a slightly increased risk of heart attack or stroke. Such an increase in risk is more likely when using high doses and during long-term treatment. Do not exceed the recommended dose or duration of treatment.

You should pay attention to signs and symptoms such as chest pain, shortness of breath, weakness, and slurred speech that may come without warning. If you experience these symptoms, contact your doctor immediately.

Other medicines and Voltaren

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

Voltaren can affect or be affected by certain medicines that contain the following active substances:

  • anticoagulants (eg warfarin, ticlopidine, aspirin, heparin )
  • medicines for the treatment of diabetes, except insulin
  • lithium or selective serotonin reuptake inhibitors ( SSRIs ) (used in some types of depression)
  • digoxin (used for heart problems)
  • tacrolimus (used in transplants and eczema )
  • ciclosporin (used in transplants, in severe psoriasis, and rheumatism)
  • certain medicines against high blood pressure (so-called beta-receptor blocking agents, angiotensin II antagonists, and ACE inhibitors )
  • diuretics (water-reducing agents also used for high blood pressure )
  • quinolone antibiotics (used for urinary tract infections)
  • corticosteroids (used to treat inflammatory diseases)
  • colestipol or cholestyramine (used for high blood lipids)
  • rifampicin ( antibiotic for tuberculosis )
  • carbamazepine (used in epilepsy )
  • St. John’s wort
  • methotrexate (used in psoriasis, rheumatism, and some forms of cancer)
  • sulfinpyrazone (used in gout )
  • voriconazole or fluconazole (used for fungal infections)
  • phenytoin (used in epilepsy )
  • amiodarone (used for heart rhythm disorders)
  • trimethoprim (used to prevent or treat urinary tract infections)

Concomitant use of other NSAIDs should be avoided as the risk of side effects increases.

The Voltaren with food and drink

The tablets should be swallowed whole with liquid. For maximum effect, it is recommended that the tablets are not taken with a meal.

Pregnancy, breastfeeding, and fertility

Taking Voltaren can inhibit fertility in women and should be avoided by women who are trying to conceive or are pregnant. Treatment during any part of the pregnancy must only take place after a doctor’s prescription.

Voltaren passes into breast milk. Voltaren should not be used during breastfeeding to avoid effects on the child.

Driving ability and use of machinery

In some people, Voltaren can cause side effects such as visual disturbances, dizziness, or drowsiness. 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.

Voltaren contains lactose monohydrate, sodium, and macrogol glycerol hydroxy stearate

This medicine contains lactose monohydrate. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine. 

This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. it is almost ‘sodium-free’.

This medicine contains macrogol glycerol hydroxy stearate, which can cause stomach upset and diarrhea.

How to use the Voltaren

Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Rheumatic diseases

The usual dose for adults: is 75 – 150 mg daily, usually morning and evening.

The usual dose for children over 6 years: is 25 mg morning and evening. Children over 50 kg are given the adult dose.

Menstrual pain

The usual dose for adults: is 50 – 150 mg divided into 1 – 3 dosing sessions as needed. Initially, 50 – 100 mg is recommended. Treatment begins at the first sign of menstrual pain. Maximum 150 mg per day.

The tablets should be swallowed whole with liquid. For maximum effect, it is recommended that the tablets are not taken with a meal. The tablets should not be split or chewed.

If you have used too much Voltaren:

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.

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 Voltaren and tell your doctor immediately if you notice the following:

  • Chest pain, which may be a sign of a potentially serious allergic reaction called Kuoni’s syndrome (reported to occur in an unknown number of users).
  • Infection with symptoms such as fever with the greatly worsened general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or vomiting. Voltaren can affect the white blood cells so that the defense against infection deteriorates (very rare). A blood test can rule out a lack of white blood cells ( agranulocytosis ). You must inform the doctor about your medication when contacting the doctor.
  • Symptoms such as swelling of e.g. face, tongue, and/or throat and/or difficulty swallowing or hives that occur together with breathing difficulties ( angioedema ) occur (very rare).
  • Skin rash or damage to the mucous membranes. Severe skin reactions (Steven Johnson’s syndrome ( mucosa and skin inflammation with blisters and high fever) and Lyell’s syndrome (like Steven-Johnson’s syndrome but also with sudden skin peeling)) with the use of 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 you lie down or if your feet or legs swell (signs of heart failure ) (uncommon).
  • Mild cramping and tenderness in the stomach, which begins shortly after starting treatment with Voltaren and is followed by rectal bleeding or bloody diarrhea, usually within 24 hours of the onset of stomach pain (has been reported to occur in an unknown number of users).

The following side effects have also been reported when using Voltaren:

Common (may affect up to 1 in 10 people): Stomach pain, nausea, vomiting, diarrhea, indigestion, decreased appetite, increased flatulence, headache, dizziness, vertigo, skin 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 users): Fatigue, swelling of the body due to fluid retention, hypersensitivity reaction ( hives, allergic shock reaction with drop in blood pressure), gastritis, stomach ulcer, stomach bleeding (vomiting blood, blood in the stool, bloody diarrhea), impotence (uncertain relationship), liver function disorders (inflammation of the liver, jaundice), asthma (including shortness of breath).

Very rare (may affect up to 1 in 10,000 users including isolated reports): Effects on vision (blurred vision, double vision) and hearing (impaired hearing, tinnitus), difficulty falling asleep, nightmares, irritability, anxiety, depression, memory disturbances, confusion, disturbed perception of reality, crawling, tremors, convulsions, loss of sensation, changes in taste, effects on vessels (e.g. high blood pressure , vascular inflammation), blood count effects (reduced number of blood platelets which can cause small bleeding in the skin and mucous membranes, breakdown of red blood cells , anemia , reduced number of white blood cells ), eczema , itching, skin redness, hair loss, photosensitivity reactions, effects on the kidneys (e.g. reduced or stopped urine production and blood in the urine), severe liver disease, liver failure, meningitis or pneumonia without a bacterial cause, stroke , intestinal problems (e.g. constipation, inflammation of 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, serious skin and soft tissue infections occur in rare cases in connection with chickenpox.

Medicines such as diclofenac can lead to a slightly 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 when treatment is stopped. With these symptoms, an examination of the eyes should be done to rule out other causes.

How the Voltaren should be stored

Use before the expiry date on the packaging.

Store out of sight and reach of children

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

Voltaren enteric tablet er 25 mg and 50 mg

The active substance is diclofenac sodium. Each tablet contains 25 mg and 50 mg of diclofenac sodium respectively.

Other ingredients are anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, corn starch, lactose monohydrate 16 and 25 mg respectively, povidone, sodium starch glycolate, methacrylic acid-ethyl acrylate copolymer, macrogol, silicone antifoam emulsion, talc, hypromellose, macrogol glycerol hydroxy stearate, titanium dioxide (E 171), iron oxide yellow (E 172) and for 50 mg also iron oxide red (E172).

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