Sartoc – Co Film-Coated Tablets

Losartan and hydrochlorothiazide is a combination medicine used to treat high blood pressure (hypertension). Losartan belongs to a class of medicines called angiotensin ll receptor blockers. It works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, losartan relaxes blood vessels. This lowers blood pressure. Hydrochlorothiazide helps reduce the amount of salt and water in the body by acting on the kidneys to increase the flow of urine. This also helps lower blood pressure. SARTOC - CO is given for high blood pressure when your doctor has prescribed losartan and hydrochlorothiazide as separate tablets and you have responded well.

Do not take SARTOC - CO:

• If you are hypersensitive (allergic) to losartan, to hydrochlorothiazide, other thiazide diuretics, to sulphonamide - type medicines or to any of the other ingredients of SARTOC - CO tablets.
• If you have previously suffered from angioedema (swelling of the face, lips or tongue).
• If you have severe liver problems.
• If you have severe kidney problems including a kidney transplant, or your kidneys are not producing any urine.
• If you have any form of kidney disease and use in addition with SARTOC - CO other medicines such as fluoroquinolones for infection, contact your doctor to re-evaluate your treatment.
• If you are using lithium or certain diuretics (water tablets, like spironolactone, triamterene or amiloride) (see Other medicines and SARTOC - CO).
• If you have heart problems which you are aware of, you must make sure you have discussed these with your doctor before starting treatment.
• If you have Addison’s disease (a disorder in which the adrenal glands situated on top of your kidney do not produce enough hormones).
• If you suffer from an inherited disorder of blood pigment metabolism where there is a build-up of natural chemicals that produce porphyrin in your body known as porphyria with symptoms such as rashes, blisters, muscle cramps and weakness.
• If your healthcare provider has told you that you have low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm known as hypokalaemia.
• If your healthcare provider has told you that you have too much calcium in your blood which can cause increased thirst and urination, stomach pain, nausea, bone pain, muscle weakness, confusion and fatigue known as hypercalcaemia.
• If your healthcare provider has told you that you have low sodium which can cause nausea, headache, confusion and fatigue known as hyponatraemia.
• If you have increased levels of uric acid in the blood that causes attacks of gout (see Take special care with SARTOC - CO).
• If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren (see Other medicines and SARTOC - CO).
• If you have previously had or currently have cancer of the skin and/or lip.
• If you are pregnant. SARTOC - CO must not be used in pregnancy and should be discontinued if pregnancy occurs.
• If you are breastfeeding your baby. SARTOC - CO has not been tested in children and must not be used in children.

Do not share medicines prescribed for you with any other person. Always take SARTOC - CO exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are not sure. SARTOC - CO may be taken alone or in combination with other certain other medicines for high blood pressure. Adults: The usual dose of SARTOC - CO 50/12,5 is one tablet daily. Your doctor may increase the dose to one SARTOC CO 100/25 mg tablet daily, if needed. Your doctor will tell you how long your treatment with SARTOC - CO will last. The maximum dose is one tablet of SARTOC CO 100/25 mg once daily. You should not take SARTOC - CO if you are dehydrated or if you have severe kidney or liver problems. If you have the impression that the effect of SARTOC - CO is too strong or too weak, talk to your doctor or pharmacist.

If you take more SARTOC - CO 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 forget to take SARTOC - CO

Take your missed dose as soon as you remember, if within a few hours after missing a dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking SARTOC - CO

SARTOC - CO helps control high blood pressure. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke or kidney disease.

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

• Swelling of the hands, feet, ankles, face, lips, tongue, mouth or throat which may cause difficulty in swallowing or breathing,
• fever, flu-like symptoms, a painful red rash (may include purplish spots) that spreads and blisters follows where the top part of the skin dies and peels off known as toxic epidermal necrolysis (TEN),
• erythroderma which is an intense and widespread reddening of the skin, often associated with exfoliation (skin peeling off in scales or layers), when it may also be known as exfoliative dermatitis (ED),
• an inflammation of blood vessel walls (vasculitis) with symptoms such as a skin rash, chills, fever, fatigue and weight loss (necrotising angiitis vasculitis), a disorder causing inflammation and bleeding in the small blood vessels (Henoch-Schönlein purpura),
• skin rash, itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SARTOC - CO. 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:

• heart problems with symptoms such as chest pain or tightness in the chest, slower, faster or irregular heartbeat,
• trouble walking, speaking and understanding as well as paralysis or numbness in the face, arm or leg which could affect only one side of the body. This may be a stroke,
• bleeding into the skin (ecchymosis),
• blood disorders where you could be feeling tired, weak, breathless, bruising or bleeding easily and more prone to infections e.g. anaemia. Blood tests will need to be done by your doctor,
• inflammation of the liver (hepatitis), gallbladder (cholecystitis) or pancreas (pancreatitis), with symptoms such as yellowing of the skin or the whites of the eyes (jaundice), severe pain and swelling in the stomach, pale or fatty stools, nausea and vomiting, swelling in the legs and ankles, itchy skin, tiredness, loss of appetite and a tendency to bruise,
• kidney problems with symptoms such as muscle aches, weakness, shortness of breath, tiredness, fever, blood in the urine, dark or reddish urine, swelling, painful urination, increased urge to urinate, decreased amount of urine, confusion and problems with passing urine,
• the rupture or destruction of red blood cells with symptoms such as dark urine, increased heart rate and swelling of stomach (haemolysis),
• inflammation of the lungs which causes breathlessness, cough and raised temperature (pneumonitis) and fluid accumulation in the lungs (pulmonary oedema),
• skin and lip cancer (skin cancer may be a sore that does not heal or comes back after healing, pale, white or yellow flat areas that look like scars, raised and scaly red patches, small, smooth and shiny lumps that are pearly white, pink or red, pink growths with raised edges and indents in the centre or growths that has small blood vessels on the surface) (non-melanoma skin cancer),
• decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

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:

• headache,
• lack of energy, unusual tiredness,
• sleeplessness (insomnia),
• dizziness,
• cough, stuffy/blocked nose, sinus congestion or sinus problems,
• stomach pain, diarrhoea, heartburn, nausea,
• muscle cramps/spasms or pain, back pain, leg pain,
• electrolyte imbalances which can cause tiredness and confusion, muscle twitching, fits and coma,
• chronic headache with pain in the region of the neck (cephalalgia),

Less frequent side effects:

• decreased sexual drive, impotence or the inability to have or maintain an erection during sexual intercourse,
• dry skin, hair loss, flushing or redness of the skin, sensitivity to light, sweating, fever,
• severe headaches caused by local blood vessel problems (migraine), nervousness, unintentional muscle movements or trembling (tremor), fainting,
• ringing in the ears (tinnitus), sense of spinning (vertigo),
• increased levels of uric acid in the blood that causes attacks of gout in some patients (hyperuricemia), sugar in the urine, too much sugar in the blood with symptoms such as increased thirst, headaches, increased urination and blurred vision (hyperglycaemia), low blood sugar with symptoms such as excess sweating, excessive hunger, fainting, fatigue or shakiness (hypoglycaemia),
• increase in enzymes or changes in levels from blood tests which show changes in the way the liver and kidneys are working,
• restlessness; feeling of unease, such as worry or fear (anxiety), reoccurring unexpected panic attacks (panic disorder), confusion, feelings of sadness, worthlessness, thoughts of suicide or death (depression), abnormal dreams, sleep disorder, sleepiness, trouble with memory,
• Inflammation of the air passages of the lung (bronchitis), nose bleeds and infections of the nose and throat (upper respiratory infections) with cold or flu-like symptoms such as sore or hoarse throat, cough, runny or blocked nose, post-nasal drip, swelling and inflammation of the nose (rhinitis), throat (pharyngitis), and your voice box (laryngitis),
• a fall in blood pressure on standing up which causes dizziness or fainting (postural hypotension), low blood pressure,
• vomiting, constipation, tooth pain, dry mouth, excess amount of air/gas in the stomach (flatulence), stomach pain, nausea and vomiting (gastritis), inflammation of a salivary gland, loss of appetite,
• muscle weakness, joint and bone pain due to inflammation,
• numbness or tingling in an arm or leg (paraesthesia),
• a disorder of the nerves which can cause weakness, tingling or numbness (peripheral neuropathy),
• changes in vision, blurred or yellow vision, burning/stinging in the eye, inflammation or infection of the membrane of the eyeball (conjunctivitis),
• distortion of the sense of taste (dysgeusia),
• a general feeling of being unwell (malaise),

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

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