Tri – Plen 2,5 mg Film-Coated Tablets

TRI - PLEN and TRI - PLEN FORTE are used to lower high blood pressure.

Do not take TRI - PLEN or TRI - PLEN FORTE :

• if you are hypersensitive (allergic) to felodipine, ramipril, any other ACE inhibitor or any of the inactive ingredients in TRI - PLEN or TRI - PLEN FORTE, which are listed above.
• if you have severe liver problems.
• if you have or had heart problems such as heart failure, unstable angina, heart attack, stroke or atrioventricular block II and III.
• if you have problems or conditions affecting the flow of blood in and out of your heart (e.g. aortic or valvular stenosis).
• if you have severe kidney problems or a condition called ‘renal artery stenosis’.
• if you have kidney problems and are taking fluoroquinolones (used to treat bacterial infections) at the same time ( Other medicines and TRI - PLEN and TRI - PLEN FORTE).
• if you are pregnant, trying to get pregnant or breastfeeding: taking TRI - PLEN or TRI - PLEN FORTE could harm your baby.
• if you have ever had any swelling for example of the lips, eyes, tongue or throat, itching, hives, difficulty breathing and swallowing (angioedema).
• if you have porphyria.
• if you are taking certain medicines such as spironolactone, triamterene, amiloride, diuretics and lithium you undergo dialysis using certain high - flux membranes.
• if you have heart problems and are taking sacubitril/valsartan.
• if you are taking aliskiren - containing medicines (used to treat high blood pressure).
• if you are taking angiotensin receptor blockers (ARB’s) (used to treat high blood pressure and heart failure).

Warnings and precautions

Take special care with TRI - PLEN and TRI - PLEN FORTE: Tell your doctor or health care provider if:

• you are going to have general anaesthestic or surgery.
• you are going to have treatment to lower the effect of an allergy to bee or wasp stings (desensitisation).
• you have kidney problems, or you are on dialysis.
• you are an elderly patient.
• you have liver problems.
• you have heart problems.
• you have low blood pressure, which you may notice as dizziness or light - headedness.
• you have low blood cell counts.
• you have high levels of potassium in your blood.
• you have systemic lupus erythematosus (SLE), scleroderma or other autoimmune conditions.
• you are following a very low or very high salt diet.
• you are dehydrated or have had a recent bout of vomiting or diarrhoea.

You might need to have your blood pressure and/or kidneys checked more often if you have:

• severe high blood pressure.
• heart failure.
• kidney disease or are an elderly patient.

Your blood potassium may have to be measured from time to time, especially if your kidneys are not working properly. Also, you may need blood tests to check the number of white blood cells. You may also need blood tests from time to time so that your doctor can monitor your serum sodium levels. Some patients experienced enlarged gum tissue (mild gingival enlargement). This enlargement can be avoided or reversed by practicing careful dental hygiene.

Children

No experience is available. TRI - PLEN and TRI - PLEN FORTE should not be given to children.

Do not share medicines prescribed for you with any other person. Your doctor will decide what dose you will receive. This depends on your condition and other factors Always take TRI - PLEN or TRI - PLEN FORTE exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is: One TRI - PLEN tablet once a day. Later on, your doctor may prescribe a higher dose. The maximum recommended dose is one tablet of TRI - PLEN FORTE once a day. Swallow TRI - PLEN or TRI - PLEN FORTE with about half a glass of water or other drink. Do not break, crush or chew the tablets. If you have the impression that the effect of TRI - PLEN or TRI - PLEN FORTE is too strong or too weak, talk to your doctor or pharmacist.

If you take more TRI - PLEN or TRI - PLEN FORTE than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take TRI - PLEN or TRI - PLEN FORTE

If you forgot to take a dose and remember on the same day:

• take it as soon as you remember

one the next day, take the usual dose of TRI - PLEN or TRI - PLEN FORTE. If you forget to take a dose and remember this on the next day:

• take only the usual dose of TRI - PLEN or TRI - PLEN FORTE
• do not take a double dose to make up for a forgotten individual dose.

TRI - PLEN and TRI - PLEN FORTE can have side effects. Not all side effects reported for these medicines are included in this leaflet. Should your general health worsen while taking these medicines, please consult your doctor, pharmacist or other health care professional for advice. Stop taking TRI - PLEN and TRI - PLEN FORTE if you notice any of the following and seek medical attention immediately:

• swelling of the face, lips or throat which makes it difficult to swallow or breathe, as well as itching and rashes. These could be signs of a severe allergic reaction to TRI - PLEN or TRI - PLEN FORTE
• severe skin reactions including rashes, ulcers in your mouth, worsening of pre - existing skin disease, reddening, blistering or detachment of skin (such as Stevens - Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• faster heart rate, uneven or forceful heartbeat, tightness of the chest
• shortness of breath or a cough
• severe stomach pain which may reach through to your back. This could be a sign of pancreatitis
• fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of the skin and eyes. These are signs of liver problems or liver damage
• bruising easily, bleeding longer than normal, purple spots, blotching on the skin or getting infections more easily than usual, sore throat, feeling faint, fever and pale skin are all signs of blood and bone marrow problems.

Other side effects include:

Frequent:

• headache and feeling dizzy
• dry cough, inflammation of the sinuses or bronchitis, shortness of breath
• stomach pain, indigestion, nausea, vomiting and diarrhoea
• rash
• cramps and pain in muscles
• fainting, low blood pressure
• chest pain, tiredness
• flush
• swollen arms and legs.

Less frequent:

• balance problems
• itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin
• loss or change in the way you taste things
• sleep problems
• feeling depressed, anxious, more nervous than usual or restless
• blocked nose, difficulty breathing or worsening of asthma
• a swelling in your gut presenting with symptoms like abdominal pain, vomiting and diarrhoea
• heartburn, constipation or dry mouth
• passing of more urine than normal
• sweating more than usual
• loss of appetite
• increased or irregular heartbeats
• blurred vision
• pain in your joints

Other side effects:

• difficulty concentrating
• swollen mouth
• fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up
• breast enlargement in men
• burning sensations
• hair loss
• slowed or impaired reactions
• change in the way things smell.

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. By reporting side effects, you can help provide more information on the safety of TRI - PLEN and TRI - PLEN FORTE.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Do not use after the expiry date stated on the pack. Do not dispose of unused medicine in drains or sewerage systems. Return all unused medicine to your pharmacist. Keep this blister pack in the outer carton until required for use.