Triplixam 5 mg Film-Coated Tablets

Triplixam is a combination of three active ingredients: perindopril, indapamide and amlodipine. It is an anti-hypertensive medicine used in the treatment of high blood pressure (hypertension).

If you are already taking perindopril/indapamide as fixed dose combination and amlodipine from separate tablets you may instead receive one tablet of Triplixam which contains the three active ingredients in the same strength.

Each of the active ingredients reduces blood pressure and they work together to control your blood pressure:

• Perindopril belongs to a class of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by widening the blood vessels, which makes it easier for your heart to pump blood through them.
• Indapamide is a diuretic (which is a sulphonamide derivative). Diuretics increase the amount of urine produced by the kidneys. However, indapamide only causes a slight increase in the amount of urine produced.
• Amlodipine is a calcium channel blocker s (which belongs to a class of medicines called dihydropyridines). It works by relaxing blood vessels, so blood passes through easily.

Do not take Triplixam

• if you are hypersensitive (allergic) to perindopril or other ACE-inhibitors, indapamide or other sulphonamides, amlodipine or other dihydropyridines, or any of the other ingredients of Triplixam (listed in section 6),
• if you have experienced symptoms such as wheezing, with difficult breathing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE-inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema),
• if you have a liver disease with moderate to severe impairment of your liver function or suffer from a condition called hepatic encephalopathy (disease of the brain caused by liver illness),
• if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing),
• if you are treated with medicines that may cause serious heart rhythm disturbances,
• if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body),
• if you suffer from heart failure after a heart attack,
• if you have severe low blood pressure (hypotension),
• if you have a low blood potassium level,
• if you have severe kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis),
• if you have only one kidney
• if you are receiving dialysis or any other type of blood filtration. Depending on the machine that is used, Triplixam may not be suitable for you,
• if you have moderate or severe impairment of your kidney function,
• if you are pregnant or planning to become,
• if you are breastfeeding your baby,
• if you have porphyria,
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren,
• if you are being treated with sacubitril/valsartan, a medicine for heart failure as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased (see “Warnings and Precautions” and “Other medicines and Triplixam”).
• If you are treated with lithium,
• If you are treated with potassium sparing diuretics (water pills that increase your blood potassium e.g. spironolactone, triamterene),
• If you are taking a fluoroquinolone (an antibiotic).

Warnings and precautions

Tell your doctor or healthcare professional before taking Triplixam. Take special care with Triplixam:

• if you have hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),
• if you have heart failure or any other heart problems,
• if you have a severe increase in blood pressure (hypertensive crisis),
• if you have liver disease/disorder,
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,
• if you have atherosclerosis (hardening of the arteries),
• if you need to have a test to check how well your parathyroid gland is working,
• if you suffer from gout,
• if you have diabetes mellitus,
• if you are on a salt restricted diet or use salt substitutes which contain potassium (a well- balanced potassium blood level is essential),
• if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Triplixam should be avoided (see “Taking other medicines”),
• if you are elderly and your dose needs to be increased,
• if you have had photosensitivity reactions,
• if you are of black origin the blood pressure lowering effect may be less and you may have a higher incidence of angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing),
• if you are on haemodialysis dialysed with high-flux membranes,
• if you have a kidney disease/disorder or if you are receiving dialysis,
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Triplixam. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy, you can be at higher risk of developing this,
• if you have muscle disorders including muscle pain, tenderness, weakness or cramps,
• if you have increased levels of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have too much acid in blood, which may cause an increased rate of breathing,
• if you have cerebral circulatory insufficiency (low blood pressure and blood flow in the brain),
• if you have swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), which can occur at any time during treatment, stop your treatment immediately and directly contact your doctor.

Do not share medicines prescribed for you with any other person.

Always take Triplixam exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Swallow the tablet with a glass of water preferably in the morning and before a meal. Your doctor will decide on the correct dose for you. This will be one tablet once a day.

If you take more Triplixam than you should

Taking too many tablets may cause you blood pressure to become low or even dangerously low sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria (passing less urine than is normal), anuria (no production or passing of urine). You may feel lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical care if you take too many Triplixam tablets.

Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24 - 48 hours after intake.

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take Triplixam

It is important to take your medicine every day as regular treatment is more effective. However, If you forget to take a dose of Triplixam, take the next dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Triplixam

As the treatment for high blood pressure is usually life-long, you should discuss your treatment with your doctor before stopping Triplixam.

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

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

Stop taking Triplixam and see a doctor immediately, if you experience any of the following side effects:

• sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing (bronchospasm),
• swelling of eyelids, face or lips,
• swelling of the mouth, tongue and throat, which causes great difficulty breathing,
• severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions,
• severe dizziness or fainting,
• heart attack, unusual fast or abnormal heart beat, or life-threatening irregular beat.
• inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell.
• muscle weakness, cramps, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown.

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

Tell your doctor if you notice any of the following:

Frequent side effects

Oedema, low potassium in the blood, headache, dizziness, palpitations (awareness of your heartbeat), flushing, vertigo, pins and needles, vision disturbances (including double vision), tinnitus (sensation of noises in the ears), light-headedness due to low blood pressure, cough, shortness of breath, gastro-intestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation, change of bowel habit), allergic reactions (such as skin rashes, itching), muscle spasms, cramps, feeling of tiredness, weakness, somnolence, ankle swelling (oedema).

Less frequent side effects

Mood swings, anxiety, depression, sleep disturbances, trembling, hives, fainting, loss of pain sensation, irregular and/or rapid heartbeat, rhinitis (blocked up or runny nose), altered bowel habits, hair loss, purpura (red pinpoints on skin), skin discoloration, itchy skin, sweating, chest pain, joint or muscle pain, back pain, pain, feeling unwell (malaise), kidney problems, disorder in passing urine, increased need to urinate at night, increased number of times of passing urine, impotence (inability to obtain or maintain an erection), fever or high temperature, discomfort or enlargement of the breasts in men, weight increase or decrease, increase in some white blood cells, high potassium levels in the blood, hypoglycaemia (very low blood sugar level), low sodium levels in the blood that may lead to dehydration and low blood pressure, rapid heartbeat, vasculitis (inflammation of blood vessels), photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA, blister clusters over the skin, swelling of hands, ankles or feet, blood creatinine increased and blood urea increase, fall, dry mouth.

Confusional state, changes in laboratory parameters: low chloride in the blood, low magnesium in the blood, increased level of liver enzymes, high level of serum bilirubin and psoriasis worsening, decrease or absence urine output, acute renal failure.

Dark urine, feeling sick (nausea) or being sick (vomiting), muscle cramps, confusion and seizures (fits). These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).

Decreased numbers of white blood cells, decrease in the number of platelets (which causes easy bruising and nasal bleeding), anaemia (decrease in red blood cells), cardiovascular disorders (irregular heartbeat, angina pectoris (pains to the chest, jaw and back, brought on by physical effort, and due to problems with the blood flow to the heart), stroke, eosinophilic pneumonia (a rare type of pneumonia), swelling of the gums, severe skin reactions including intense skin rash, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, erythema multiforme (a skin rash which often starts with red itchy patches on your face, arms or legs), bleeding, tender or enlarged gums, abnormal liver function, inflammation of the liver (hepatitis), severe kidney problems, yellowing of the skin (jaundice), abdominal bloating (gastritis), disorder of the nerves which can cause weakness, tingling or numbness, increased muscle tension, hyperglycaemia, high level of calcium in the blood, cerebrovascular accident (stroke) possibly secondary to excessive low blood pressure.

Hepatic encephalopathy (disease of the brain caused by liver illness), abnormal ECG heart tracing, low potassium levels in the blood, if you suffer from systemic lupus erythematous (a type of collagen disease), this might get worse.

Short sightedness (myopia), vision blurred, 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).

Trembling, rigid posture, mask like face, slow movements and a shuffling, unbalanced walk.

Discoloration, numbness and pain in fingers or toes (Raynaud’s phenomenon).

Changes in laboratory parameters (blood tests) can occur. Your doctor may request blood tests to monitor your condition.

If you have these symptoms contact your doctor as soon as possible. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 30 °C.

Store all medicine out of reach of children.

Keep the bottle well closed to protect the tablets from moisture.

Do not store in bathrooms.

Do not use after the expiry date on the carton and the bottle. The expiry date refers to the last day of that month.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).