Dynarb 150 mg Tablets

DYNARB belongs to a group of medicines called angiotensin-II receptor antagonists. DYNARB is used

• to treat hypertension (high blood pressure), either alone or in combination with other antihypertensive medicines
• to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Do not take DYNARB :

• if you are hypersensitive (allergic) to irbesartan or any of the other ingredients of DYNARB (see section 6)
• if you take lithium for mood disorders. This may lead to toxic blood concentrations of lithium
• if you have a history of angioedema (swellings similar to hives beneath the surface of the skin) related to previous therapy with DYNARB or other medicines containing the same active ingredient as DYNARB or with certain medicines used to treat heart conditions, called ACE inhibitors (angiotensin-converting enzyme inhibitors) or ARBs (angiotensin receptor blockers). If this is the case, you may never use these medicines again
• if you have hereditary angioedema (swelling around your face, throat or tongue)
• if you suffer from hypertrophic obstructive cardiomyopathy (HOCM) (thickening of the muscle of the heart)
• if you have severe kidney disease, narrowing of the blood vessels of both kidneys, or you have only one kidney left, of which the blood vessels are narrowed, or you have a transplanted kidney
• contact your doctor to re-evaluate your treatment if you are treated with ACE inhibitors/angiotensin receptor blockers together with a fluoroquinolone antibiotic such as ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin and norfloxacin
• if you have kidney problems and are taking fluoroquinolones (used to treat bacterial infections) at the same time (see Other medicines with DYNARB)
• if you have a disease of the heart valves called aortic stenosis in which the opening is narrowed
• if you are also being treated with medicines called potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride) that increase the rate of urination
• if you suffer from severe liver problems
• if you are, or think you may be, pregnant or if you are planning to become pregnant or if you are breastfeeding
• if you have porphyria (a rare hereditary blood disease)
• if you are taking a medicine called aliskiren to treat high blood pressure.

DYNARB should not be given to children.

Warnings and precautions

Take special care with DYNARB: If you become pregnant while taking DYNARB, you should stop taking DYNARB immediately and inform your doctor. Your doctor should switch you to a different medicine.

Tell your doctor:

• if you are being treated with a diuretic (water tablet) or are on a salt restricted diet as you may experience a serious drop in blood pressure (hypotension)
• if you suffer from excessive vomiting or diarrhoea
• if you have kidney problems
• if you have heart failure
• if you suffer from diabetes
• if you experience fatigue or muscle weakness as these may be symptoms of a condition called hyperkalaemia
• if you are taking other medicines to treat high blood pressure, including aliskiren
• if you have kidney disease or are an elderly patient and are taking fluoroquinolones (used to treat bacterial infections)
• if you are taking medicine containing lithium
• if you receive DYNARB for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
• if you suffer from a hormonal disorder called primary aldosteronism
• if you suffer from heart problems
• if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes
• if you are a black patient as DYNARB may not effectively lower your blood pressure. Your doctor may request tests to monitor your condition before or during treatment.

Children and adolescents

DYNARB should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Do not share medicines prescribed for you with any other person. Always take DYNARB exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is

Adults

The usual dose is 150 mg once daily, with or without food. The dose of DYNARB can be increased to 300 mg once daily, depending on your blood pressure response. Your doctor will decide on the dose depending on your condition.

Children

DYNARB should not be given to children under 18 years of age. Your doctor will tell you how long your treatment with DYNARB will last. Do not stop treatment early because your high blood pressure may return.

If you have the impression that the effect of DYNARB is too strong or too weak, tell your doctor or pharmacist.

If you take more DYNARB than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include

• fever, faintness, flushing, hypotension (low blood pressure), drowsiness, agitation and seizures.

If you forget to take DYNARB

If you forget to take DYNARB, take as soon as you remember, then continue to take DYNARB at the usual times. Do not take a double dose to make up for forgotten individual doses.

If you stop taking DYNARB

It is important that you continue the course of treatment even if you begin to feel better after a few days.

DYNARB can have side effects. Not all side effects reported for DYNARB are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using DYNARB, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using DYNARB and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DYNARB. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• jaundice (yellowing of the skin and eyes)
• pancreatitis (inflammation of the pancreas with symptoms such as stomach pain, increased heart rate and fever)
• increased or fast heart beat (tachycardia)
• weakness, fatigue, weight loss, headache (symptoms of a condition called vasculitis)
• hepatitis (inflammation of the liver with symptoms such as loss of appetite and fatigue)
• leukocytoclastic vasculitis (causing rash, joint pains and increasing size of lymph nodes)
• Henoch-Schonlein purpura (inflammation of small blood vessels, with symptoms such as rash or many small bruises)
• rhabdomyolysis (a condition affecting the muscles with symptoms such as dark urine and difficulty moving arms or legs)
• kidney problems (passing less urine than is normal for you)
• hyperkalaemia - too high levels of potassium in your blood - (a condition that causes fatigue, weakness, feeling of numbness, chest pain and palpitations or skipped heart beats)

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• dizziness, light-headedness, headache
• sudden internal or external spinning sensation (vertigo)
• low blood pressure or fainting when getting up from a lying or sitting position (orthostatic hypotension/dizziness)
• nausea, vomiting
• pain in muscle, pain in joints
• unusual tiredness
• abnormal blood test results in diabetic patients with advanced kidney disease
• increases in blood levels of creatine kinase (enzyme that measures the muscle and heart function)

Less frequent side effects:

• increased risk of infections (signs of infection include fever/chills or a sore throat)
• face becoming red and hot
• cough and common cold, chest infection
• diarrhoea, stomach discomfort, heartburn, taste disturbances, indigestion
• abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite, yellow eyes or skin)
• skin disorders including rash, hives, itching
• problems with sexual performance
• chest pain (angina), back pain

The following side effects have been reported but the frequency for them to occur is not known:

• blood disorders including anaemia and a deficiency of platelets in the blood, which causes bleeding into the tissues, bruising, and slow blood clotting after injury
• a decrease of blood sugar in patients suffering from diabetes (high blood sugar)
• migraine
• ringing sound in the ear (tinnitus)
• muscle weakness, muscle cramps, abnormal physical weakness or lack of energy
• swelling caused by excess fluid trapped in your body's tissues
• potential teratogenic effects (giving birth to a baby with birth defects)

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, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of DYNARB. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 25 °C. Keep blisters in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).