Valdyne 100 mg/200 mg Capsules

VALDYNE treats pain, inflammation and fever and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and specifically a sub-group called cyclooxygenase 2 (COX-2) inhibitors. VALDYNE is used in the treatment of inflammation and pain in osteoarthritis and rheumatoid arthritis. VALDYNE is also used in the treatment of pain following an operation, including dental surgery, musculoskeletal pain, primary dysmenorrhoea and helps to relieve the signs and symptoms of progressive stiffening of the spine known as ankylosing spondylitis. Your body makes substances called prostaglandins. Some prostaglandins cause pain and swelling, whilst others help protect the stomach lining. VALDYNE works by reducing the number of prostaglandins which produce pain and swelling without reducing the protective prostaglandins in the stomach.

Do not take VALDYNE:

• If you are hypersensitive (allergic) to celecoxib or any of the other ingredients of VALDYNE (listed in section 6).
• If you have had an allergic reaction to a group of medicines called sulphonamides (e.g. some antibiotics used to treat infections).
• If you have severe liver or kidney disease.
• If you have asthma, or an allergic reaction such as an itchy skin rash, swelling, or wheezing after taking aspirin or another anti-inflammatory medicine, including other cyclooxygenase 2 inhibitors.
• If you have heart disease or if you have had a stroke.
• If you have problems with your blood circulation (peripheral arterial disease), a condition in which a build-up of fatty deposits in the arteries restricts blood supply to leg muscles.
• If you are about to have coronary artery bypass graft surgery.
• If you are pregnant.
• If it is possible that you could become pregnant during ongoing treatment, you should discuss methods of contraception with your doctor.

Warnings and precautions

Take special care with VALDYNE. Some people will need special care from their doctors when they are taking VALDYNE. Make sure that your doctor knows before you start taking VALDYNE:

• If you have high blood pressure.
• If you suffer from diabetes.
• If you smoke.
• If you have high cholesterol.
• If you currently have or have had an ulcer, bleeding or perforation of the gastrointestinal tract.
• If you have had a serious allergic reaction or a serious skin reaction to any medicines.
• If you develop symptoms of a serious hypersensitivity reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of the internal organs; stop taking VALDYNE immediately if these symptoms occur.
• If you have oedema (fluid retention).
• If you have liver or kidney disease.
• If you could be dehydrated, for example by sickness or diarrhoea or the use of diuretics.
• If you have an infection, as VALDYNE may hide a fever or other signs of infection.

Other medicines and VALDYNE

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Before you start taking VALDYNE, make sure your doctor knows if you are taking:

• Other anti-inflammatory medicines.
• Aspirin.
• Corticosteroids.
• Diuretics (used to treat fluid retention).
• Warfarin or warfarin-type anticoagulants, apixaban, dabigatran or rivaroxaban (used to prevent blood from clotting).
• Rifampicin (used to treat bacterial infections).
• Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression).
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders).
• Anti-hypertensive medicines including ACE inhibitors, angiotensin II receptor antagonists and beta-blockers (e.g. metoprolol) (used for high blood pressure and heart failure).
• Ciclosporin (used for immune system suppression e.g. after transplants).
• Fluconazole (used to treat fungal infections).
• Dextromethorphan (used to treat coughs).
• Lithium (used to treat depression).

VALDYNE with alcohol

The consumption of alcohol and VALDYNE may increase the risk of gastrointestinal problems.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. VALDYNE may make it more difficult to become pregnant. You should tell your doctor if you are having problems becoming pregnant. VALDYNE must not be used by women who are pregnant or can become pregnant (i.e. women of childbearing potential who are not using adequate contraception) during ongoing treatment. If you become pregnant during treatment with VALDYNE, you should discontinue the treatment and contact your doctor for alternative treatment. VALDYNE must not be used during breastfeeding.

Driving and using machines

If you feel dizzy or tired after taking VALDYNE, do not drive or use machinery until you are feeling normal again. It is not always possible to predict to what extent VALDYNE may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which VALDYNE affects them.

VALDYNE contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Do not share medicines prescribed for you with any other person. Always take VALDYNE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Use the lowest effective dose for the shortest possible time. Take the capsules with a sufficient quantity of liquid e.g. one glass of water. VALDYNE may be taken with or without food.

The recommended dose for osteoarthritis is 200 mg taken as a single dose or as two divided doses. The recommended dose for rheumatoid arthritis is 100 mg or 200 mg twice per day. The recommended dose for pain following dental surgery is 100 mg or 200 mg twice per day. The recommended dose for pain following an operation is 200 mg once daily. The recommended dose for musculoskeletal pain is 200 mg twice daily. The recommended dose for primary dysmenorrhoea is 400 mg initially, followed by an additional 200 mg on the first day if needed. On subsequent days, the recommended dose is 200 mg twice daily. The recommended dose for ankylosing spondylitis is 200 mg daily, taken as a single dose or as 100 mg twice per day.

If you have liver problems, or you are over 65 years of age and weigh less than 50 kg, do not take more than 100 mg per day for osteoarthritis and 200 mg per day for rheumatoid arthritis. If you have liver problems, your doctor will introduce VALDYNE at the lowest recommended dose for pain post dental surgery. Your doctor will tell you how long your treatment with VALDYNE will last. If you have the impression that the effect of VALDYNE is too strong or too weak, tell your doctor or pharmacist.

If you take more VALDYNE than you should

In the event of overdosage or if you accidentally take too many capsules, consult your doctor or pharmacist as soon as possible. If neither is available, contact the nearest hospital or poison centre.

If you forget to take VALDYNE

If you miss a dose, either take it as soon as you remember or wait until the next scheduled dose. Do not take a double dose to make up for forgotten individual doses.

VALDYNE can have side effects. Not all side effects reported for VALDYNE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VALDYNE, please consult your health care provider for advice. VALDYNE may cause the following reactions. If any of the following happens, stop taking VALDYNE and tell your doctor immediately or go to the casualty department at your nearest hospital.

• If you have cardiac symptoms such as shortness of breath or difficulty breathing, sudden chest pain, cramping or tingling sensation up the left arm.
• If you experience dizziness and headache.
• If you have an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing.
• If you have blistering or peeling of the skin.
• If you have any sign of bleeding in the stomach or intestines, such as passing black or blood-stained bowel movements, or vomiting blood. These are all very serious side effects. If you have them, you may have had a serious reaction to VALDYNE. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Bronchitis.
• Sore throat.
• Blocked or runny nose, sneezing and post-nasal drip (rhinitis).
• Sinus inflammation, sinus infection, blocked or painful sinuses (sinusitis).
• Chest infection.
• Urinary tract infection.
• Worsening of existing allergies.
• Difficulty sleeping.

Less frequent side effects:

• Anaemia (changes in red blood cells that can cause fatigue and breathlessness).
• Low levels of platelets in the blood.
• Hypersensitivity.
• Swelling in the face, lips, tongue or throat, difficulty swallowing, breathing problems, nettle rash. These could be symptoms of a serious allergic reaction such as angioedema.
• Anxiety.
• Feeling confused.
• Sleepiness or drowsiness.
• Blurred vision.
• Ringing in the ears.
• Irregular heartbeat.
• Palpitations (awareness of your heartbeat).
• Fast heart rate.
• Heart failure.
• Flushing.
• Ulcers in your oesophagus, stomach and small intestine.
• Inflammation of the pancreas.
• Ruptured intestine.
• Increased liver enzymes.
• Hair loss.
• Bruising of the skin.
• Face swelling.

Other side effects:

• Hallucination.
• Bleeding in the brain.
• Loss of taste.
• Impaired sense of smell.
• Meningitis (inflammation of the membrane around the brain and spinal cord).
• Stroke.
• Inflammation of the eye.
• Heart attack.
• Blood clot inside a blood vessel of the heart.
• Inflammation of the blood vessels.
• Blood clot in the lungs.
• Inflammation of the lungs.
• Inflammation of the liver.
• Liver failure.
• Liver disease.
• Jaundice (yellowing of the skin and eyes).
• Increased sensitivity to light.
• Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalised exanthematous pustulosis (symptoms include the skin becoming red with swollen areas covered in numerous small pustules).
• A serious hypersensitivity reaction called DRESS, including skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of the internal organs.
• Kidney failure.
• Inflammation of the kidneys and other kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as water retention, foamy urine, fatigue and loss of appetite).
• Low levels of sodium in the blood (a condition known as hyponatraemia).
• Menstrual disturbances.
• Decreased fertility in females.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VALDYNE.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original package. Keep the blister strip in the outer carton. Protect from light/moisture. Do not store in a bathroom. Do not use after the expiry date stated on the blister and carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).