“You can’t beat a healthy heart.”
High Blood Pressure Medication
Scheduling Status S3
Proprietary name, Strength and Pharmaceutical Form
PEARINDA 2 mg tablets (each tablet contains 2 mg perindopril)
PEARINDA 4 mg tablets (each tablet contains 4 mg perindopril)
PEARINDA 8 mg tablets (each tablet contains 8 mg perindopril)
Please read this patient information leaflet carefully before taking PEARINDA tablets.
- Keep this information. You may need to read it again.
- If you have any further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
WHAT PEARINDA CONTAINS
Perindopril tert-butylamine salt
Lactose monohydrate, microcrystalline cellulose, silica colloidal anhydrous & magnesium Stearate.
WHAT PEARINDA IS USED FOR
PEARINDA belongs to a class of medicines called ACE inhibitors. ACE stands for angiotensin converting enzyme. It works by blocking ACE, an enzyme involved in narrowing blood vessels and causing sodium and fluid retention by the kidneys. This causes blood vessels to relax, allowing blood to flow more freely and at a lower pressure, and increasing the heart’s ability to pump blood in some types of heart failure.
PEARINDA is used to treat:
- Mild to moderate high blood pressure (hypertension).
- Congestive heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs), not adequately controlled by conventional therapy.
BEFORE YOU TAKE PEARINDA
Do not use PEARINDA
- if you are hypersensitive (allergic) to PEARINDA or any other ACE inhibitor, or to any of the other ingredients in the tablet;
- if you had symptoms such as swelling of the face, tongue or throat, wheezing, skin rashes, intense itching, dizziness or fainting with previous ACE inhibitor or angiotensin receptor blocker (ARB) treatment or have had these symptoms in any other circumstances (this is a condition called angioedema);
- if you have narrowing of the main blood vessel leading from the heart, heart muscle disease or narrowing of the artery supplying the kidney with blood;
- if you have any other heart or kidney problems;
- if you have porphyria;
- if you are pregnant or breast-feeding, or intend becoming pregnant.
PEARINDA tablets should not be given to children.
The presence of other medical problems may affect the use of PEARINDA. Talk to your doctor, pharmacist or healthcare professional before taking PEARINDA:
- if you have blood vessel problems in your brain (cerebrovascular disease) or ischaemic heart disease;
- if you become dehydrated (volume depleted), e.g. if you were vomiting, or had diarrhoea or heavy sweating, if you are on dialysis, or if you follow a salt restricted diet or use diuretics;
- if you have high blood potassium, low blood sodium, or are on a sodium-restricted diet or use salt substitutes which contain potassium;
- if you suffer from a collagen disease such as systemic lupus erythematosus or scleroderma;
- if you have bone marrow depression;
- if you have any other heart, liver or kidney problems;
- if you suffer from diabetes which is not well controlled;
- if you are allergic to lactose.
You should inform you doctor, pharmacist or healthcare professional that you are taking PEARINDA:
- if you are going to have an operation or anaesthesia;
- if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
- if you are to undergo a procedure to remove cholesterol from your blood by a machine (LDL apheresis).
What about pregnancy and breast-feeding?
You should not take PEARINDA:
- if you are pregnant, planning to become pregnant or if you suspect you are pregnant;
- if you are breast-feeding.
Can you take your tablets with other medicines?
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of PEARINDA with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.
In particular, you should check with your doctor, pharmacist or other healthcare professional if you are taking any of the following to be sure that it is safe to take PEARINDA at the same time:
- other medicines for treating high blood pressure including diuretics (water tablets);
- other medicines that could cause lowering of the blood pressure;
- potassium supplements, potassium-containing salt substitutes and potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride);
- lithium (for mania or depression);
- non-steroidal anti-inflammatory medicines.
Taking your medicine with food and alcohol:
It is recommended that PEARINDA should be taken once daily before a meal.
Avoid drinking alcohol. Drinking alcohol with PEARINDA may further lower your blood pressure and may make you feel dizzy or light-headed.
What about driving and using machines?
You may experience dizziness or light-headedness while taking PEARINDA. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react on PEARINDA.
Before you begin using any new medicine (prescription or non prescription) or if you develop any new medical problem while you are using this medicine, check with your doctor, pharmacist or other healthcare professional.
HOW TO USE PEARINDA
Always take PEARINDA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of PEARINDA is too strong or too weak, tell your doctor or pharmacist. Do not share medicines prescribed for you with any other person.
It is recommended that PEARINDA is taken once daily in the morning before a meal.
Mild to moderate high blood pressure (hypertension)
The recommended starting dose is 4 mg once daily, which can be increased to a single dose of 8 mg if necessary after one month of treatment.
In elderly patients and if you have certain other conditions, a starting dose of 2 mg will be used, which can be increased according to response to a maximum of 8 mg once daily.
Insulin and non-insulin dependent diabetics can be treated with the usual doses.
Congestive heart failure
The treatment should be initiated at a low dose under close medical supervision. The initial dose is 2 mg as a single dose in the morning. This may be increased to 4 mg once daily as a maintenance dose.
If you are taking water tablets (diuretics), your doctor may decide to reduce or even discontinue these at the beginning of your treatment with PEARINDA.
Speak to your doctor if you suffer from kidney disease for information on how this medicine should be taken as the above dosages may not be appropriate for you.
PEARINDA is not suitable for use in children.
If you take more tablets 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. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.
If you forget to take your tablets:
It is important to take your medicine every day. However, if you forget to take one or more doses, take another as soon as you remember and then go on as prescribed on a normal daily dose. Do not take a double dose.
POSSIBLE SIDE EFFECTS
Get emergency medical help if you have any of these signs of an allergic reaction:
- severe stomach pain;
- difficulty in breathing; swelling of your face, lips, tongue, or throat;
- dizziness or fainting;
- unusually fast or irregular heart beat. These could be signs of angioedema which is a serious reaction that can occur with all medicines of this type (ACE inhibitors). It must be treated immediately, usually in hospital.
The following common side-effects may occur:
- shortness of breath,
- light-headedness due to low blood pressure,
- pins and needles,
- diarrhoea, nausea, abdominal pain, indigestion, vomiting, constipation,
- taste disturbances,
- muscle cramps and weakness,
- skin rash,
- vision disturbances,
- ringing sound in the ears.
The following side-effects occur less frequently:
- Changes in your blood (your doctor may decide to carry out blood tests at regular intervals to monitor for this),
- irregular heart beat,
- heart attack,
- chest pain,
- changes in mood or sleep,
- dry mouth,
- inflammation of the pancreas,
- sexual disorders,
- kidney problems,
- jaundice, inflammation of the liver,
- tightening of the chest, wheezing and shortness of breath,
- blocked or runny nose, sinusitis,
- eosinophilic pneumonia (a rare type of pneumonia),
Not all side-effects reported for PEARINDA are included in this leaflet. Should your general health worsen while taking PEARINDA, please consult your doctor, pharmacist or other health care professional for advice.
STORING AND DISPOSING OF PEARINDA
- Store below 25°C.
- Keep the blisters in the carton until required for use.
- Do not store your medicine in the bathroom.
- Do not take this medicine after the expiry date which is clearly marked on the blister and outside of the box.
- Return any expired or unused medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
- KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
PRESENTATION OF PEARINDA
PEARINDA 2: The tablets are available in PA-Alu-PVC/Alu foil blister packs of 30’s.
PEARINDA 4: The tablets are available in PA-Alu-PVC/Alu foil blister packs of 30’s.
PEARINDA 8: The tablets are available in PA-Alu-PVC/Alu foil blister packs of 30’s.
IDENTIFICATION OF PEARINDA
PEARINDA 2: A white round convex tablet with a diameter of approx 5 mm.
PEARINDA 4: A white capsule shaped tablet, with dimensions of 8 x 4 mm approx., bearing a breakline on both sides.
PEARINDA 8: A white round convex tablet, with a diameter of 8 mm approx., bearing a breakline on one side.
PEARINDA 2: 41/7.1.3/0648
PEARINDA 4: 41/7.1.3/0649
PEARINDA 8: 41/7.1.3/0650
NAME AND ADDRESS OF REGISTRATION HOLDER
Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Cape Town, South Africa
DATE OF PUBLICATION