Olmetec Plus Film-Coated Tablets

OLMETEC PLUS contains two active substances, olmesartan medoxomil and hydrochlorothiazide. Olmesartan medoxomil belongs to a group of medicines called angiotensin II - receptor antagonists. It lowers blood pressure by relaxing the blood vessels. Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (“water tablets”). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. OLMETEC PLUS is used for treating high blood pressure in patients whose blood pressure is not effectively controlled on olmesartan medoxomil alone.

Do not take OLMETEC PLUS:

• If you are hypersensitive (allergic) to olmesartan medoxomil or hydrochlorothiazide or any of the other ingredients of OLMETEC PLUS (listed in section 6).
• If you are pregnant or you are breastfeeding your baby (see section 2 “Pregnancy and breastfeeding”).
• If you have a history of swelling related to previous therapy with ACE inhibitors or angiotensin receptor blockers (ARBs) you must never again be given these medicines.
• If your heart muscle becomes thickened and stiff, making it harder for your heart to pump blood out of your heart and around your body [hypertrophic obstructive cardiomyopathy (HOCM)].
• If you have a problem with your kidneys, particularly if it is a blockage of the blood vessel which supplies oxygen - rich blood to your kidneys (renal artery stenosis), and/or you have a single kidney.
• If you have narrowing or blockage of your heart valves (aortic stenosis).
• If you are taking “water pills” (diuretics) that cause your body to retain potassium (such as spironolactone, triamterene or amiloride).
• If you suffer from porphyria.
• If you are taking medication which contains aliskiren, used for treatment of high blood pressure.
• If you are taking lithium, used for treatment of mental health problems, such as bipolar disorder, depression and schizophrenia (see section 2 “Other medicines and OLMETEC PLUS”).
• If you suffer from severe kidney problems or the inability to pass urine normally.
• If you suffer from severe liver problems or yellowing of the skin and eyes (jaundice) or problems with drainage of the bile from the gallbladder (biliary obstruction, e.g. gallstones).
• If you have low potassium, low sodium, high calcium or high levels of uric acid levels in the blood that do not get better when treated.
• If you have previously had or currently have cancer of the skin and/or lip.

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

Warnings and precautions

Take special care with OLMETEC PLUS:

• If you are taking ACE inhibitors, angiotensin II receptor blockers (ARBs) or aliskiren (used to treat high blood pressure) as it may increase the risk of low blood pressure, increased blood potassium levels and decreased kidney function.
• If you are dehydrated or have diarrhoea or vomiting, then your water and sodium levels need to be corrected before you take OLMETEC PLUS.
• If you have mild to moderate kidney problems, ensure that you regularly monitor your potassium, creatinine and uric acid levels.
• If you suffer from high cholesterol, then monitor your cholesterol levels regularly while on treatment with OLMETEC PLUS.
• If you are taking medication used to treat diabetes, (either oral or injection), please consult your doctor as your diabetic medication dose may need to be adjusted.
• If you experience persistent dryness of the mouth and thirst, weakness, tiredness, drowsiness, restlessness, muscle pain or cramps, this can be the result of salt (such as potassium, sodium and calcium) and water imbalances caused by OLMETEC PLUS. Your doctor will monitor the amount of salts in your blood at regular intervals.

Do not share medicines prescribed for you with any other person. Always take OLMETEC PLUS exactly as your doctor or pharmacist has instructed you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults: OLMETEC PLUS is taken once daily, with or without food. A maximum dose of OLMETEC PLUS 20/25 should not be exceeded.

Elderly: In elderly patients the same dosage of the combination is recommended as for adults.

Swallow the tablet with water. If possible, you should take your dose at the same time each day, for example at breakfast time.

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

If you take more OLMETEC PLUS 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. If you take more tablets than you should, or if a child accidentally swallows one or more, go to your doctor or nearest accident and emergency department immediately and take your medicine pack with you.

If you forget to take OLMETEC PLUS

If you forget to take a dose, take your normal dose on the following day as usual. Do not take any extra tablets to make up for the missed dose. Do not take a double dose of OLMETEC PLUS to make up for forgotten individual doses.

If you stop taking OLMETEC PLUS

It is important to continue to take OLMETEC PLUS unless your doctor tells you to stop.

OLMETEC PLUS can have side effects. Not all side effects reported for OLMETEC PLUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using OLMETEC PLUS, please consult your health care provider for advice.

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

• Swelling of your hands, feet, ankles, face, lips and mouth or throat which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.
• Toxic epidermal necrolysis (TEN), a life-threatening skin condition where top layer of the skin peels off, usually the mucous membranes (eye, mouth, vagina) are affected.

These are all very serious side effects. If you have them, you may have had a serious reaction to OLMETEC PLUS. 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:

• Skin and lip cancer (non-melanoma skin cancer); the appearance of a lump or discoloured patch on the skin that persists after a few weeks.
• Yellowing of the skin and eyes, also called jaundice.
• Decrease in vision or eye pain, possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma.
• Angina (pain or uncomfortable feeling in the chest, known as angina pectoris).
• Changes in the way your heart beats, for example, if you notice it beating faster.
• Blood clots (thrombosis or embolism).
• Severe shortness of breath, difficulty breathing, infection that inflames lungs (pneumonia), infection of the lungs or fluid build-up in the lungs (acute respiratory distress syndrome).
• Convulsions (also known as fits or seizures).
• Signs of frequent infections such as fever or sore throat, coughing, stuffy and runny nose, painful urination or burning urine as a sign of urinary tract infection, infection of salivary glands with mumps-like symptoms (e.g. swollen face, abnormal taste, dry mouth, pain in the mouth or face).
• Kidney failure or poor functioning of the kidneys.
• Reduction of amount of urine.
• Red discolouration of urine or presence of blood in the urine.
• Severe and chronic diarrhoea with substantial weight loss, as well as abdominal pain, fatigue, bloating, nausea, vomiting, and anemia (sprue-like enteropathy) (see section 4.4).

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

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Rise in blood fat levels, rise in blood urea or uric acid, rise in creatinine.
• Electrolyte imbalances (decrease in magnesium and sodium levels).
• Rise in blood sugar, rise in blood calcium levels, increase of serum amylase (hyperamylasaemia).
• Dizziness or light-headedness.
• Headache.
• Feeling confused.
• Vertigo (a sensation of feeling off balance or dizzy).
• Cough or coughing up thickened mucus and shortness of breath (bronchitis).
• Sore throat (pharyngitis) or stuffy nose (rhinitis).
• Abdominal cramps or stomach pains.
• Diarrhoea or nausea.
• Vomiting.
• Upset stomach or accumulation of gas (meteorism).
• Constipation.
• Bloatedness or indigestion.
• Flatulence.
• Stomach flu (gastroenteritis).
• Pain in the joints (arthritis) or bones, back pain.
• Haematuria (blood in the urine).
• Urinary tract infection.
• Chest pain.
• Cold or flu symptoms.
• Pain.
• Tiredness.
• Decreased muscle strength.
• Increase in levels of liver function.
• Abnormal kidney function tests.

Less frequent side effects:

• Changes to your cell counts (decreased number of white blood cells, decreased number of blood platelets, anaemia, bone marrow damage).
• Anorexia, a condition where you may restrict your eating habits due to fear of gaining weight.
• Decrease in blood chloride.
• Restlessness, feeling ‘down’ or depressed, problems sleeping.
• Feeling un-interested (apathy).
• Drowsiness.
• Disturbances in consciousness, including loss of consciousness.
• Loss of appetite.
• Partial loss of voluntary movement.
• Objects you look at appearing yellow, transient blurred vision, dry eyes, reduced tears.
• Having colour vision problems.
• Low blood pressure or experiencing low blood pressure when you suddenly stand up after sitting or lying down (orthostatic hypotension).
• Inflammation of the blood vessels (vasculitis).
• Inflammation of the pancreas.
• Infection in the gall bladder.
• Skin reaction induced by sunlight.
• Muscle spasm or pain.
• Muscle cramps, pain in limbs or joint stiffness.
• A feeling of numbness, tingling or burning.
• Erectile or sexual dysfunction.
• Fever.
• Feeling weak or ill (malaise).
• Increase or decrease in blood potassium levels.
• Rise in blood urea nitrogen, decrease in haemoglobin and haematocrit values.

If you notice any side effects not mentioned in the 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 “Adverse Drug Reaction 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 OLMETEC PLUS.

Store at or below 30 ºC. Keep blister in carton until required for use. Do not use after the expiry date printed on the outer container and blister. KEEP OUT OF REACH OF CHILDREN.