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DICLOFENAC SODIUM (SOLARAZE)

Brand Name(s) : Brands: Dicloflex, Dicloflex SR, Dicloflex Retard, Diclomax SR, Diclomax Retard, Dyloject, Econac, Fenactol, Fenactol Retard, Motifene, Rheumatac Retard, Rhumalgan SR, Rhumalgan XL, Solaraze, Volsaid Retard, Voltarol Ophta, Voltarol Tablets, Voltarol suppositories, Voltarol Active cutaneous spray
Warnings
Uses
Side Effects
Precautions
Interactions
Overdose

DICLOFENAC SODIUM WARNINGS

Diclofenac sodium should be used with caution in: the elderly (over 65), asthma or allergic disease, reduced heart, kidney or liver function, history of gastrointestinal disease such as ulcerative colitis or Crohn’s disease, blood clotting problems, acute porphyria, uncontrolled high blood pressure, heart problems, systemic lupus erythematosus (SLE - a condition of the immune system that causes joint pain, skin changes and other organ problems), previous stroke, patients at risk of heart attacks or strokes including those with diabetes, high blood pressure, high cholesterol or smokers; women who are pregnant or breast feeding, women who are planning to become pregnant or who are having difficulty becoming pregnant, patients treated with other non-steroidal anti-inflammatory drugs (NSAIDs), eye infection (applies to eye drops), patients using other eye drops (applies to eye drops).

It should not be used in: patients who are allergic to diclofenac sodium or to any other ingredients contained in the medicine, those who have or have ever had a peptic ulcer (ulcer in the stomach or duodenum), tear (perforation) or bleeding in the stomach, patients with severe liver, kidney or heart disease, patients who experience asthma, hives, allergic rash, itchy runny nose (rhinitis) when taking ibuprofen, aspirin or other similar NSAIDs, patients with acute porphyria (a disorder of the blood cells), the last trimester (last 3 months) of pregnancy, severe heart failure.

Also see list of precautions and interactions

STORAGE

Do not store above 25ºC and store in the original packaging (tablets).

Store below 25ºC (Solaraze)

Store below 25ºC (suppositories)

DICLOFENAC SODIUM USES

Diclofenac sodium is a painkiller and an anti-inflammatory which works by blocking the action of some of the body chemicals responsible for causing pain, swelling, tenderness, inflammation and high temperature.

It belongs to a group of drugs called non-steroidal anti-inflammatory drugs or NSAIDs.

It is usually used to relieve pain, inflammation and fever.

In general this drug is used to reduce pain and inflammation in the following conditions: sprains, strains and other injuries, pain following surgery, gout, lower back pain, migraine attacks, tendonitis (inflammation of the tendons), bursitis, painful conditions which affect the joints and muscles such as osteoarthritis (a condition caused by wear and tear of the cartilage in the joints), rheumatoid arthritis, ankylosing spondylitis (a type of arthritis that affects the spine) and pyrophosphate arthropathy (a condition similar to gout caused by the deposition of calcium crystal in the large joints).

Diclofenac sodium eye drops are used before surgery to keep the pupils open during surgery, after eye surgery or injury to control pain and inflammation and to reduce hayfever symptoms of the eye e.g. red, runny or itchy eyes.

Diclofenac sodium gel is used for the treatment of actinic keratosis, a skin problem caused by long-term exposure to the sun.

Benefits of being on this drug can include relief of pain, swelling, inflammation and fever.

Listed below are the typical uses of diclofenac sodium:

  • Sprains, strains and other injuries
  • Pain and inflammation following surgery
  • Rheumatic pain
  • Muscular pain
  • Osteoarthritis
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Acute gout
  • Backache
  • Pain relief in fractures
  • Dental pain
  • Period pain
  • Fever
  • Migraine
  • Inflammation of the eye (eye drops)
  • Actinic keratosis (gel only)

On occasion your doctor may prescribe this medicine to treat a condition not on the above list.

HOW TO USE/TAKE

This medication is available to take orally as tablets or capsules, as intravenous (directly into the vein) or intra-muscular (injection into the muscle, usually into the buttock area) injections and to use via the rectal route (back passage) as suppositories. It is also available as eye drops and as a topical preparation to use directly on the skin as a gel or a spray.

How often do I take it?

  • Diclofenac sodium tablets: take this medication orally usually two to three times a day, preferably with or just after food. Diclofenac sodium tablets should be taken with a glass of water. The dispersible tablets should first be dissolved in water. Some diclofenac sodium tablets and capsules are modified release which means they release diclofenac sodium more slowly into your body and do not need to be taken as often. Modified release preparations must not be crushed or chewed and must be swallowed whole. Make sure you check the label of your medicine so that you know exactly how much diclofenac sodium to take, how to take it and how often. If you are unsure about this ask you doctor or pharmacist.
  • Diclofenac sodium suppositories are usually used daily in divided doses
  • Diclofenac sodium injections are given intravenously (directly into the vein) or intra-muscularly (injection into the muscle, usually into the buttock area) at a maximum of twice a day for no more than two days.
  • Other diclofenac sodium formulations (e.g. eye drops, gel, cutaneous spray) may need to be taken or used more or less frequently, as indicated by your doctor or pharmacist. Make sure that you carefully read the patient information leaflet provided with your medicine so that you know exactly how and how often to take or use your diclofenac sodium medicine. If you are unsure consult your doctor or pharmacist.
  • Use this medication regularly in order to get the most benefit from it.
  • Remember to use it at the same time each day - unless specifically told otherwise by your doctor.
  • Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

  • Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

  • Diclofenac sodium may cause dizziness, drowsiness, tiredness and changes in sight (visual disturbances). If these symptoms occur then you should not drive or operate machinery. Consult your doctor or pharmacist for more details.

When can I stop?

  • Always complete the full course as prescribed by your doctor.

DICLOFENAC SODIUM SIDE EFFECTS

  • Feeling sick (nausea)
  • Ulcers of the stomach or bleeding
  • Worsening of existing bowel conditions (ulcerative colitis, Crohn's disease)
  • Blood disorders (including anaemia and being prone to minor infections and bleeding)
  • Skin problems (including hives, itching, rash, irritation)
  • Small increased risk of heart attack or stroke with long-term use
  • Headache
  • Dizziness
  • Drowsiness
  • Spinning sensation
  • Gastritis (inflammation of the stomach)
  • Loss of weight
  • Poor appetite
  • Abnormal liver function tests
  • Inflammation of the liver cells (hepatitis)
  • Itching
  • Fluid retention (swollen ankles is one of the symptoms)
  • Tingling of the hands or feet
  • Ringing in the ears
  • Diarrhoea
  • Unusual sensitivity of the skin to the sun
  • Tiredness
  • Mood swings and confusion
  • Pancreatitis (inflammation of the pancreas, a gland located behind the stomach that plays a role in digestion)
If any of these persist or you consider them severe then inform your doctor or pharmacist

Stop taking diclofenac sodium and tell your doctor immediately if you develop any of the following symptoms:

  • Indigestion or heartburn
  • Unexplained pains in your stomach (abdomen) or other unusual stomach problems such as indigestion, feeling sick and or being sick
  • Allergic reactions including unexplained wheezing or shortness of breath, runny nose, watery eyes, swelling of the face or tongue, dizziness, light-headedness and unconsciousness (skin problems may also develop which can be severe with peeling and blistering of the skin and sensitivity to light)
  • Liver problems, that may be associated with yellowing of the skin and whites of the eyes and/or pale stools (motions) and dark urine (water)
  • Kidney problems which may be associated with passing less or more water (urine) than normal, cloudy urine, blood in the urine, pain in the back and/or swelling, particularly of the legs
  • Nervous system problems (severe headache, neck stiffness, disorientation, and light hurting the eyes [photophobia])
  • Persistent and severe skin rash, itching or irritation at the site of application of diclofenac sodium gel
  • Pass blood in your stools/motions (faeces)
  • Pass black tarry stools
  • Vomit any blood or black particles that look like coffee grounds.
  • Severe sore throat with a high temperature
  • Any type of fit or seizure
  • Blurred or disturbed sight (vision), or seeing/hearing strange things

If diclofenac sodium gel comes into contact with broken skin or gets into your eyes, nose or mouth it can cause irritation. If this happens wash the affected area with plenty of water. If symptoms persist then contact your doctor or pharmacist.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

DICLOFENAC SODIUM PRECAUTIONS

Before taking diclofenac sodium, tell your doctor or pharmacist if you are allergic to it or to other non-steroidal anti-inflammatory drugs (NSAIDs); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: stomach ulcer, tear (perforation) or bleeding, severe liver, kidney or heart disease, experience asthma, allergic rash, itchy runny nose when taking ibuprofen, aspirin or similar medicines, acute porphyria (a disorder of the blood cells), are in the last 3 months of pregnancy.

Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: asthma or allergic disease, heart, kidney, liver or bowel problems, blood clotting problems, high blood pressure, systemic lupus erythematosus (SLE - a condition of the immune system that causes joint pain, skin changes and other organ problems), previous stroke, pregnancy, breast feeding, you are planning or having difficulty becoming pregnant, you are at significant risk of heart problems because of diabetes, high blood pressure (hypertension), high cholesterol, hyperlipidaemia or smoking. You are being treated with other NSAIDs, have an eye infection (applies to eye drops), you are using other eye drops (applies to eye drops).

Diclofenac sodium may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

  • There is no information to suggest that diclofenac sodium is affected by alcohol.

The elderly: diclofenac sodium should be used with caution in the elderly as it may be associated with an increased risk of problems associated with side effects (particularly bleeding of the stomach and intestine).

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

Diclofenac sodium is not recommended to be used in the first 6 months of pregnancy unless the potential benefit to the patient outweighs the potential risk to the unborn baby.

Diclofenac sodium is not safe in the third trimester of pregnancy and should not be used in the last three months of pregnancy as it may cause damage to the unborn baby and reduce labour.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Diclofenac sodium appears in breast milk in very low amounts and should if possible be avoided when breast feeding.

Ask your doctor or pharmacist if you have any doubts or questions about this.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

DICLOFENAC SODIUM INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:

If you are currently using any of these medications, tell your doctor or pharmacist before starting diclofenac sodium.

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

  • Aspirin or other NSAIDs
  • Medicines for high blood pressure (e.g. ACE inhibitors, beta blockers) and water tablets (diuretics)
  • Cardiac glycosides (used to treat heart failure e.g. digoxin)
  • Ciclosporin (used to suppress the body's immune system)
  • Medicines for thinning the blood (anticoagulants)
  • Antidiabetics (medicines used to treat diabetes)
  • Corticosteroids (a type of steroid)
  • Mifepristone (for termination of pregnancy)
  • Rifampicin (used to treat tuberculosis)
  • Voriconazole (used to treat fungal infections)
  • Quinolone antibiotics (used to treat infections)
  • SSRI antidepressant drugs (such as fluoxetine)
  • Antiplatelet drugs such as clopidrogel
  • Tacrolimus (a transplant drug)
  • Methotrexate (an anticancer agent and sometimes used to treat arthritis and the skin condition psoriasis)
  • Lithium (used to treat depression)
  • Venlafaxine (used in depression)
  • Zidovudine (used to treat viral infection HIV)

This information does not contain all possible interactions. Therefore, before using diclofenac sodium, tell your doctor or pharmacist of all the products you use.

DICLOFENAC SODIUM OVERDOSE

Symptoms of overdose include headache, nausea, sickness (vomiting), stomach pain, diarrhoea, drowsiness, coma, tinnitus (ringing or buzzing noise in the ears), fainting and fits. If you take more than the recommended dose of diclofenac sodium, speak to your doctor or local hospital immediately.

Overdose with topical diclofenac sodium (applied to the skin) is unlikely. If you accidentally swallow some diclofenac sodium gel contact your doctor or local hospital straight away.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of diclofenac sodium or intentional overdose is suspected, contact your local hospital, GP or if in England call 111 or NHS Direct. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

Overdose with topical diclofenac (applied to the skin) is unlikely. If you accidentally swallow some diclofenac gel you may experience a headache, drowsiness, low blood pressure and be sick. If these symptoms occur then contact your doctor or local hospital straight away.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of diclofenac or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

MISSED DOSE

If you miss an oral (by mouth) dose of diclofenac sodium, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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Source: Selected from data included with permission and copyrighted by Boots UK Limited or TicTac Communications Ltd. This copyrighted material is sourced from a licensed data provider and is not for distribution, except as may be authorised by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse events, nor should it be construed to indicate that use of a particular medicine is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any medicine, changing any diet, or discontinuing any course of treatment.

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