What Divido is and what it is used for

Diclofenac sodium, the active ingredient in Divido 75 mg capsules, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation. Some of the pellets inside the Divido capsule shell release diclofenac quickly to give a rapid effect (gastro-resistant pellets).

The remainder of the pellets dissolve more slowly to produce a longer lasting effect (prolonged release pellets). Divido can be used for the treatment of pain and inflammation due to:

- Acute attacks of gout.

- Acute musculo-skeletal disorders (for example frozen shoulder, inflamed tendons).

- Dental or other minor surgery.

- Joint disorders (such as ankylosing spondylitis, osteoarthritis, rheumatoid arthritis).

- Traumatic conditions (including sprains, strains, dislocations, fractures).

- Low back pain.

Before you take Divido

Do not take Divido 

- If you have had an allergic reaction to any of the ingredients in Divido 75 mg capsules.

- If you have had an allergic reaction to ibuprofen, aspirin or other NSAIDs.

- If you have severe liver, kidney or heart failure.

- If you have established heart disease and /or cerebrovascular disease e.g.

- if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages.

- If you have or have had problems with your blood circulation (peripheral arterial disease)

- If you are in the last three months of pregnancy.

- If you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach (for example, passed black tarry or bloody stools or vomited blood or dark particles that look like coffee grounds), or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.

If you think any of these apply to you, or you are unsure, do not take the capsules. Talk to your doctor first and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking Divido, particularly if you have any of the following health problems:

- Smoking.

- Diabetes.

- Angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.

Talk to your doctor before taking Divido if you are also taking other NSAIDs, as Divido should not be used at the same time as other NSAIDs.

If you have any of the following health problems, you may need to take special care while taking the medicine as your condition could get worse:

- Asthma, hayfever or other allergies, polyps in your nose, difficulty breathing (COPD), long term respiratory infections.

- Crohn's disease or ulcerative colitis.

- SLE (Systemic Lupus Erythematosus), an inflammation of the connective tissue.

- Heart, kidney or liver problems (your doctor may want to carry out some tests while you are taking the capsules).

- High blood pressure.

- Acute porphyria.

- Blood clotting problems.

Tell your doctor if you are about to have major surgery. Because Divido is a NSAID, it can make the symptoms of an infection (such as fever, pain) less noticeable. Medicines such as Divido may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Elderly patients

If you are elderly (65 years and over), your doctor may want to monitor you carefully while you are taking Divido.

Children and adolescents

Divido is not recommended for children and adolescents under the age of 18.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor or pharmacist about any of the following:

- Other painkillers or anti-inflammatory drugs (NSAIDs), including aspirin, or any other medicines used to prevent platelet clumping.

- Medicines to lower blood pressure (anti-hypertensives).

- Anti-coagulants, such as warfarin (to "thin" the blood).

- Anti-diabetic tablets.

- Certain antibiotics, such as ciprofloxacin.

- Ciclosporin or tacrolimus (immunosuppressive medicines, used to dampen down the body's immune reactions).

- Corticosteroids.

- Mifepristone (for early termination of pregnancy).

- Heart drugs, such as digoxin.

- Diuretics ("water tablets"), including the potassium-sparing type.

- Lithium (a medicine used to treat mood swings and some types of depression).

- Selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat some types of depression).

- Methotrexate (a medicine used to treat arthritis and some types of cancer).

- Zidovudine (a medicine used to treat HIV and AIDs).

- Phenytoin (used to treat epilepsy).

- Colestipol or cholestyramine (medicines used to lower cholesterol levels).

- Voriconazole (used to treat fungal infections).

- Sulfinpyrazone (used to treat gout).

Taking Divido with food and drink

Divido is best taken with or after food.

Pregnancy and breast feeding

Tell your doctor before taking Divido if you are pregnant or breast feeding. As with other non-steroidal anti-inflammatory drugs, Divido 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.

Divido must not be taken during the last three months of pregnancy.

It is not usually recommended at other stages of pregnancy, but you may be able to take it if your doctor advises that it is necessary for you.

Divido should be avoided if you are breast feeding, as small amounts of the medicine may pass into breast milk.

Driving and using machines

These capsules can cause some people to feel dizzy or giddy, drowsy or sleepy, tired or have problems with their vision. If you are affected, do NOT drive or operate or use machinery until the symptoms wear off. Ask your doctor for advice.

How to take Divido

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is ONE capsule of Divido, ONCE or TWICE a day as prescribed.

It is important that the second dose is taken 8-12 hours after the first dose and that no more than two Divido 75 mg capsules are taken in any 24 hour period. 

Divido 75 mg capsules must be swallowed whole with a drink of water (about half a glass). Do not chew or break open the capsules. The capsules are best taken with or after food. It may help you to remember to take your capsules if you take them at the same time every day, perhaps with breakfast or an evening meal.

Tell your doctor if you have any concerns about your treatment.

If you take more Divido than you should

If you take more capsules than you should or if a child accidentally swallows some, go to your doctor or nearest emergency department immediately and take your medicine pack with you.

If you forget to take Divido.

If it is a little more than 12 hours since your previous dose, take the missed dose and then adjust the timing of your next dose to 8-12 hours later. Do not take a double dose to make up for the one you forgot and do not take more than two capsules in 24 hours.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Serious side effects 

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Divido is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. 

 Possible side effects

Like all medicines, Divido can cause side effects, although not everybody gets them. Taking the lowest effective dose for the shortest possible time will minimise side effects.

Some side effects can be serious. STOP taking Divido 75 mg capsules and tell your doctor immediately if you notice any of the following symptoms:

- Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Divido and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).

- Stomach ulcer or duodenal ulcer.

- Passing blood in your feces (stools/motions).

Bleeding from the stomach or intestines (e.g. passing black ‘tarry’ stools).

- Vomiting blood or dark particles that look like coffee grounds.

- Stomach pains or other abnormal stomach symptoms.

- Indigestion or heartburn.

- Worsening of Crohn’s disease or of ulcerative colitis.

- Allergic reactions, which can include sudden wheeziness, difficulty in breathing, swelling of the face, lips, hands or fingers, skin rash, itching, bruising, painful red areas, peeling or blistering.

These are the other side effects known about so far with diclofenac sodium:

Common side effects (may affect up to 1 in 10 people):

Headache, dizziness or giddiness, vertigo, sickness, feeling sick, flatulence, diarrhoea, loss of appetite, changes in blood test results, skin rashes.

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

Liver problems including hepatitis and jaundice (yellowing of the skin or whites of the eyes), sleepiness, rashes and spots, swelling caused by a build-up of fluid (known as ‘oedema’).

Very rare side effects (may affect up to 1 in 10,000 people):

Memory problems, pins and needles, disorientation, impaired hearing, insomnia, irritability, fits, anxiety, nightmares, tremor, mood changes, psychotic reactions, changes in taste, stiff neck, depression, confusion, hallucinations, bleeding in the brain, feeling unwell, tiredness, tinnitus (ringing in the ears), blurred vision, double vision, eye pain, constipation (including blockages), problems swallowing, hair loss, eczema, unusual bruising, kidney problems, urinary problems (e.g. any change in the usual amount or colour of the urine), severe liver problems including liver failure, sensitivity to light, flaky skin, blisters on the skin and sore mouth/eyes, inflammation of the pancreas, swelling of the tongue, high blood pressure, inflammation of the blood vessels, chest pain, palpitations, heart failure, inflammation of the lungs, changes in blood cell levels.

Medicines such as Divido may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Divido

Keep out of reach of children.

Store below 30°C.

Do not use beyond the expiry date or if the product shows any signs of deterioration.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away the medicines you no longer use.

These measures will help to protect the environment.