Enalapril Actavis

Enalapril Actavis

enalapril

Manufacturer:

Teva

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Enalapril maleate.
Description
Enalapril Actavis Tablets contains an active substance called enalapril maleate.
Excipients/Inactive Ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinised maize starch, sodium hydrogen carbonate.
Tab 10 mg and 20 mg: Iron oxide red (E172) and iron oxide yellow (E172).
Action
Enalapril Actavis Tablets belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).
Enalapril Actavis Tablets works by widening the blood vessels. This lowers the blood pressure. The medicine usually starts to work within an hour, and the effect lasts for at least 24 hours. Some people will require several weeks of treatment until the best effect on the blood pressure is seen.
Indications/Uses
Enalapril Actavis Tablets is used: to treat high blood pressure (hypertension).
To treat heart failure (weakening of heart function). It can lower the need to go to hospital and can help some patients live longer.
To prevent the signs of heart failure. The signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet.
Dosage/Direction for Use
Always take Enalapril Actavis Tablets exactly as the doctor has told. Check with the doctor or pharmacist if the patient is not sure.
It is very important to continue taking Enalapril Actavis Tablets for as long as the doctor prescribes it.
Do not take more tablets than prescribed.
High Blood Pressure: The usual starting dose ranges from 5 to 20 mg taken once a day.
Some patients may need a lower starting dose.
The usual long term dose is 20 mg taken once a day.
The maximal long term dose is 40 mg taken once a day.
Heart Failure: The usual starting dose is 2.5 mg taken once a day.
The doctor will raise this amount step by step until the dose that is right for the patient has been achieved.
The usual long term dose is 20 mg each day, taken in one or two doses.
The maximal long term dose is 40 mg each day, divided in two doses.
Patients with kidney problems: The dose of medicine will be changed depending on how well the kidneys are working: Moderate kidney problems: 5 mg to 10 mg each day.
Severe kidney problems: 2.5 mg each day.
If having dialysis: 2.5 mg each day. On days the patient is not having dialysis, the dose may be changed depending on how low the blood pressure is.
Elderly patients: The dose will be decided by the doctor, and will be based on how well the kidneys are working.
Children: Experience in the use of Enalapril Actavis Tablets in children with high blood pressure is limited. If the child can swallow tablets, the dose will be worked out using the child's weight and blood pressure. The usual starting doses are: Between 20 kg and 50 kg: 2.5 mg each day.
More than 50 kg: 5 mg each day.
The dose can be changed according to the needs of the child: A maximum of 20 mg daily can be used in children who are between 20 kg and 50 kg.
A maximum of 40 mg daily can be used in children who are more than 50 kg.
Enalapril Actavis Tablets is not recommended in newborn babies (first few weeks after birth) and in children with kidney problems.
If the patient forgets to take Enalapril Actavis Tablets: If the patient forgets to take a tablet, skip the missed dose.
Take the next dose as usual.
Do not take a double dose to make up for a forgotten dose.
If the patient stops taking Enalapril Actavis Tablets: Do not stop taking the medicine unless the doctor tells to stop. If the patient has any further questions on the use of the product, ask the doctor or pharmacist.
Overdosage
If the patient takes more Enalapril Actavis Tablets than he/she should, talk to the doctor or go to a hospital straight away. Take the medicine pack. The following effects may happen: feeling of light-headed or dizziness. This is due to a sudden or excessive drop in blood pressure.
Contraindications
Do not take Enalapril Actavis Tablets if: Allergic (hypersensitive) to enalapril maleate or any of the other ingredients of Enalapril Actavis Tablets (listed in Description).
Have ever had an allergic reaction to a type of medicine similar to Enalapril Actavis Tablets called an ACE inhibitor.
Have ever had swelling of the face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited.
More than 3 months pregnant (it is also better to avoid Enalapril Actavis Tablets in early pregnancy-see Use in Pregnancy & Lactation).
Do not take Enalapril Actavis Tablets if any of these applies. If not sure, talk to the doctor or pharmacist before taking Enalapril Actavis Tablets.
The concomitant use of Enalapril Actavis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
Special Precautions
Check with the doctor or pharmacist before taking the medicine if: the patient has a heart problem.
The patient has a condition involving the blood vessels in the brain.
The patient has a blood problem such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or a decreased number of red blood cells (anaemia).
The patient has a liver problem.
The patient has a kidney problem (including kidney transplantation). These may lead to higher levels of potassium in the blood which can be serious. The doctor may need to adjust the dose of Enalapril Actavis Tablets or monitor the blood level of potassium.
The patient is having dialysis.
The patient has been very sick (excessive vomiting) or had bad diarrhoea recently.
The patient is on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes.
The patient is over 70 years of age.
The patient has diabetes: Monitor the blood for low blood glucose levels, especially during the first month of treatment. The level of potassium in the blood can also be higher.
The patient has ever had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing. Be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.
The patient has low blood pressure (the patient may notice this as faintness or dizziness, especially when standing).
The patient has collagen vascular disease (e.g. lupus erthematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses the immune system, are taking the drugs allopurinol or procainamide, or any combinations of these.
The patient thinks she is (or might become) pregnant: Enalapril Actavis Tablets is not recommended in early pregnancy, and must not be taken if she is more than 3 months pregnant, as it may cause serious harm to the baby if used at that stage (see Use in Pregnancy & Lactation).
The patient is breast-feeding or about to start breast-feeding (see Use in Pregnancy & Lactation): She should be aware that Enalapril Actavis Tablets lowers the blood pressure in black patients less effectively than in non-black patients.
If not sure if any of these applies, talk to the doctor or pharmacist before taking Enalapril Actavis Tablets.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
If the patient is about to have a procedure: If the patient is about to have any of the following, tell the doctor that he/she is taking Enalapril Actavis Tablets: Any surgery or receive anaesthetics (even at the dentist); a treatment to remove cholesterol from the blood called 'LDL apheresis'; a desensitisation treatment, to lower the effect of an allergy to bee or wasp stings.
Important information about some of the ingredients of Enalapril Actavis Tablets: Enalapril Actavis Tablets contains lactose, which is a type of sugar. If the patient has been told by the doctor that he/she has intolerance to some sugars, talk to the doctor before taking this medicine.
Driving and using machinery: The patient may feel dizzy or sleepy while taking Enalapril Actavis Tablets. If this happens, do not drive or use any tools or machines.
Use In Pregnancy & Lactation
Pregnancy: Tell the doctor if the patient thinks she is (or might become) pregnant. The doctor will normally advise the patient to stop taking Enalapril Actavis Tablets before she becomes pregnant or as soon as she knows she is pregnant and will advise her to take another medicine instead of Enalapril Actavis Tablets. Enalapril Actavis Tablets is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding: Tell the doctor if the patient is breast-feeding or about to start breast-feeding. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Enalapril Actavis Tablets. In the case of an older baby the doctor should advise on the benefits and risks of taking Enalapril Actavis Tablets whilst breast-feeding, compared to other treatments.
Side Effects
Like all medicines Enalapril Actavis Tablets can cause side effects, although not everybody gets them. The following side effects may happen with the medicine: Stop taking Enalapril Actavis Tablets and talk to a doctor straight away, if the patient notice any of the following: Swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing.
Swelling of the hands, feet or ankles.
If the patient develops a raised red skin rash (hives).
Be aware that black patients are at increased risk of these types of reactions. If any of these happen, stop taking Enalapril Actavis Tablets and talk to a doctor straight away.
When the patient starts taking Enalapril Actavis Tablets he/she may feel faint or dizzy. If this happens, it will help to lie down. This is caused by the blood pressure lowering. It should improve as the patient continues to take the medicine. If worried, talk to the doctor.
Other side effects include: Very Common (affects more than 1 in 10 people): Feeling dizzy, weak or sick; blurred vision; cough.
Common (affects less than 1 in 10 people): Low blood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain; headache, fainting (syncope); change in sense of taste, shortness of breath; diarrhoea or abdominal pain, rash; tiredness (fatigue), depression; allergic reactions with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing; increased blood potassium level, increased levels of creatinine in the blood (both are usually detected by a test).
Uncommon (affects less than 1 in 100 people): sudden fall in blood pressure; fast or uneven heart beats (palpitations); heart attack (possibly due to very low blood pressure in certain high-risk patients, including those with blood flow problems of the heart or brain); anaemia (including aplastic and haemolytic); stroke (possibly due to very low blood pressure in high-risk patients); confusion, sleeplessness or sleepiness, nervousness; feeling the skin prickling or being numb; vertigo; ringing in the ears (tinnitus); runny nose, sore throat or hoarseness; asthma; slow movement of food through the intestine, inflammation of the pancreas; being sick (vomiting), indigestion, constipation, anorexia; irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure; increased perspiration; itching or nettle rash; loss of hair; muscle cramps, flushing, generally feeling unwell (malaise), high temperature (fever), impotence; high level of proteins in the urine (measured in a test); low level of blood sugar or sodium, high level of blood urea (all measured in a blood test).
Rare (affects less than 1 in 1,000 people): 'Raynaud's phenomenon' where the hands and feet may become very cold and white due to low blood flow; changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets; bone marrow depression; autoimmune diseases; strange dreams or sleep problems; pulmonary infiltrates; inflammation of the nose; pneumonia; inflammation of the cheeks, gums, tongue, lips, throat; lower amount of urine produced; erythema multiforme; 'Stevens-Johnson syndrome' a serious skin condition where the patient has reddening and scaling of the skin, blistering or raw sores, or detachment of the top layer of skin from bottom layers; liver problems such as lower liver function, inflammation of the liver, jaundice (yellowing of the skin or eyes), higher levels of liver enzymes or bilirubin (measured in a blood test); enlargement of the mammary glands in males.
Very Rare (affects less than 1 in 10,000 people): swelling in the intestine (intestinal angioedema).
If any of these side effects gets serious, or if the patient notices any side effects not listed, tell the doctor or pharmacist.
Drug Interactions
Tell the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Enalapril Actavis Tablets can affect the way some medicines work. Also some other medicines can affect the way Enalapril Actavis Tablets works: In particular tell the doctor or pharmacist if the patient is taking any of the following medicines: Other medicines to lower blood pressure, such as beta-blockers or water tablets (diuretics).
Medicines containing potassium (including dietary salt substitutes).
Medicines for diabetes (including oral antidiabetic medicines and insulin).
Lithium (a medicine used to treat a certain kind of depression).
Medicines for depression called 'tricyclic antidepressants'.
Medicines for mental problems called 'antipsychotics'.
Certain cough and cold medicines and weight reducing medicines which contain something called a 'sympathomimetic agent'.
Certain pain or arthritis medicines including gold therapy.
Non-steroidal anti-inflammatory drugs, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain).
Aspirin (acetylsalicylic acid).
Medicines used to dissolve blood clots (thrombolytics).
Alcohol.
If not sure if any of these applies, talk to the doctor or pharmacist before taking Enalapril Actavis Tablets.
Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (includ ing acute renal failure) compared to the use of a single RAAS-acting agent.
Taking Enalapril Actavis Tablets with food and drink: Enalapril Actavis Tablets can be taken with or without food. Most people take Enalapril Actavis Tablets with a drink of water.
Storage
Store Enalapril Actavis Tablet below 25°C. Store in the original package in order to protect from moisture.
Medicines should not be disposed of via waste water or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Keep out of the reach and sight of children.
Shelf life: 3 years.
ATC Classification
C09AA02 - enalapril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
Presentation/Packing
Tab 5 mg (circular, flat, white 8 mm, scored on both sides without markings) x 30's. 10 mg (circular, flat, peach 7 mm, scored on both sides with side score and without markings) x 30's. 20 mg (circular, flat, light orange 9 mm tablets scored on both sides with side score and without markings) x 30's.
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