2.5 mg, 5 mg, 10 mg and 20 mg tablets of
enalapril maleate
What Enalapril Sandoz is and what it is used for
- Enalapril Sandoz contains enalapril maleate. Enalapril belongs to a group of medicines called ACE inhibitors. The effect of these drugs is that they lower blood pressure by dilating the blood vessels.
- Enalapril Sandoz is used to treating high blood pressure ( hypertension ).
- It is also used to treat a heart problem that is sometimes called heart failure. This means that your heart is not working as well as it used to when it comes to pumping blood around the body, leading to fatigue after light physical activity, shortness of breath, and swelling in the ankles and feet. Enalapril Sandoz may help treat these symptoms.
- In many patients with a damaged heart muscle, but who have no symptoms, Enalapril Sandoz can help prevent the onset of symptoms such as shortness of breath and swelling.
Enalapril maleate contained in Enalapril Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Enalapril Sandoz
Do not take Enalapril Sandoz:
- if you are allergic to
- enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
- other ACE inhibitorsSigns of this may have been itching, hives, wheezing, or swelling of the hands, throat, mouth, or eyelids.
- if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).
- if you are more than three months pregnant. (It is also better to avoid EnalaprilSandoz in early pregnancy – see section Pregnancy).
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
Do not take Enalapril Sandoz if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Enalapril Sandoz.
Warnings and cautions
Talk to your doctor or pharmacist before taking Enalapril Sandoz:
- if you have kidney problems, have recently had a kidney transplant, are on dialysis, or are taking diuretics ( diuretics )
- if you have dietary salt restrictions or have recently had severe vomiting or diarrhea
- if you have heart problems called “aortic stenosis”, “hypertrophic cardiomyopathy” or “obstruction”
- if you have a collagen disease in the blood vessels, undergo treatment with immunosuppressive agents (used to treat autoimmune diseases such as rheumatoid arthritis or after transplant surgery)
- if you are taking allopurinol (used to treat gout ) or procainamide (used to treat abnormal heart rhythms). If you develop an infection (symptoms may be fever), tell your doctor immediately. Your doctor may take blood samples from time to time to check your white blood cells.
- if you have previously had “angioedema” while taking other medicines. Signs may have been itching, hives, wheezing, or swelling of the hands, throat, mouth, or eyelids
- if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
- racecadotril, a medicine used to treat diarrhea
- medicines used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors)
- vildagliptin, a medicine used to treat diabetes.
- if you have diabetes and are taking diabetes medication, including insulin, to control your diabetes (you should check your blood for low blood sugar, especially during the first month of treatment)
- if you are taking potassium supplements, potassium-sparing diuretics ( diuretics ), potassium-containing salt substitutes, or other medicines that may increase the amount of potassium in your blood (eg trimethoprim and cotrimoxazole against infections caused by bacteria; ciclosporin, an immunosuppressive drug that prevents rejection transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots)
- if you are taking lithium, which is used to treat certain mental illnesses
- if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
- aliskiren.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals. See also the information under the heading “Do not take Enalapril Sandoz”.
- if your doctor has told you that you do not tolerate certain sugars
If you develop any of the following symptoms while taking Enalapril Sandoz, tell your doctor immediately:
- jaundice (yellowing of the skin and whites of the eyes)
- prolonged dry cough
If you are going to undergo any of the following procedures or any of the following treatments, tell your doctor that you are taking Enalapril Sandoz:
- any form of surgery or if you are given anesthetics (also applies to the dentist)
- a treatment called LDL apheresis, to remove cholesterol from your blood using a machine
- hyposensitization, to reduce the effect of hypersensitivity to bee or wasp stings.
Routine tests
When you start taking Enalapril Sandoz for the first time, your doctor will check your blood pressure more often to make sure you have received the correct dose. For some patients, the doctor may also want to measure potassium, creatinine, and liver enzyme levels.
Pregnancy
Talk to your doctor or pharmacist before taking Enalapril Sandoz if you think you may be (or might become) pregnant. Enalapril Sandoz is not recommended in early pregnancy and should not be taken if you are pregnant for more than three months as it may seriously harm your baby if used at this stage of pregnancy (see section Pregnancy).
Children and young people
Information on the use of Enalapril Sandoz in children over 6 years of age with high blood pressure is limited, but no information is available for children with heart problems. Enalapril Sandoz should not be used in infants or children with renal impairment.
Other medicines and Enalapril Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some other medicines may affect each other’s effects.
- potassium-sparing diuretic agents ( diuretics ) as spironolactone, eplerenone, triamterene or amiloride, potassium supplements (including salt substitutes), or other drugs which can increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole (the combination of trimethoprim/sulfamethoxazole) against infection you that caused by bacteria; ciclosporin, an immunosuppressive drug that prevents rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots). EnalaprilSandoz can increase the levels of potassium in your blood, leading to high potassium levels. This gives few signs and is usually detected by blood tests
- diuretic agents ( diuretics ) as thiazide s, furosemide, bumetanide
- medicines most commonly used to prevent the rejection of transplanted organs ( sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors). See section “Warnings and Precautions”
- the second drug that lowers blood pressure, et, as nitroglycerine, nitrates, and vasodilator
- lithium, is used to treat certain mental illnesses. Enalapril Sandoz should not be taken with this medicine
- tricyclic antidepressant agents, as amitriptyline, used for depression, antipsychotics, phenothiazines, used for severe anxiety
- painkillers such as morphine or anesthetics because your blood pressure may be too low
- medicines used to treat stiffness and inflammation associated with pain, especially those affecting muscles, bones and joints:
- including treatment with gold, which may lead to flushing, nausea, vomiting, and low blood pressure when taken with Enalapril Sandoz
- non-steroidal anti-inflammatory drugs ( NSAIDs ), such as diflunisal or diclofenac including COX-2 inhibitors. These drugs can prevent your blood pressure from being properly controlled and can increase the level of potassium in your blood.
- acetylsalicylic acid (used as pain relief)
- medicines such as ephedrine, used in certain cough and cold medicines, or norepinephrine and adrenaline used for low blood pressure, shock, heart failure, asthma, or allergies. If these medicines are used together with EnalaprilSandoz, they can keep your blood pressure high
- allopurinol (used to treat gout )
- procainamide (used to treat abnormal heart rhythms)
- diabetes medications such as insulin. Enalapril Sandoz may lower your blood sugar even more if you are taking this medicine with medicines for diabetes.
Your doctor may need to change your dose and/or take other precautions:
If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Enalapril Sandoz” and “Warnings and precautions”).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Enalapril Sandoz.
Enalapril Sandoz with alcohol
If you drink alcohol while taking Enalapril Sandoz, your blood pressure may drop too much and you may experience dizziness or dizziness or fainting. You should limit your alcohol intake to a minimum.
Pregnancy, breastfeeding, and fertility
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Normally, your doctor will advise you to stop taking Enalapril Sandoz before you become pregnant or as soon as you know you are pregnant and advise you to take another medicine instead of Enalapril Sandoz. Enalapril Sandoz is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Breast-feeding of infants (during the first weeks after birth), and especially for premature infants, is not recommended while you are taking Enalapril Sandoz. In the case of an older infant, your doctor will talk about the benefits and risks of taking EnalaprilSandoz while breast-feeding, compared to other treatments.
Driving and using machines
Some side effects, such as dizziness and fatigue, have been reported with EnalaprilSandoz. This may affect some patients’ ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Enalapril Sandoz contains lactose and sodium
Enalapril Sandoz contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Enalapril Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Enalapril Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How to take the medicine
- Always take the medicine by mouth.
- The number of tablets you should take each day depends on your condition.
- Enalapril Sandoz can be taken with or without food.
Dosage for high blood pressure
The starting dose is 5 mg per day up to 20 mg per day depending on your blood pressure. In patients with blood pressure levels that are slightly above normal, the recommended dose is 5-10 mg per day. For patients with kidney problems, heart problems, low salt or fluid levels, a starting dose of 5 mg or less should be used.
If you are currently taking a high dose you the diuretic agent, your doctor may ask you to stop taking these agents 2-3 days before you start taking Enalapril Sandoz. A starting dose of 5 mg or less is recommended.
Once your blood pressure is under control, the usual maintenance dose is 20 mg daily, up to a maximum of 40 mg daily.
Dosage for heart problems
In patients with heart problems, Enalapril Sandoz is used as an adjunct to diuretics and, if necessary, with digitalis (a medicine used to treat heart failure due to congestion or irregular heartbeat) or beta-blockers (medicines used to treat high blood pressure, angina, and heart problems). The starting dose is 2.5 mg and should be increased gradually to the usual maintenance dose of 20 mg, given either once a day or divided into two doses, over a period of 2 to 4 weeks. The maximum daily dose is 40 mg, divided into two divided doses.
Impaired renal function
In patients with renal impairment, the dose of enalapril will need to be adjusted depending on how well the kidneys are functioning. Renal function is calculated by measuring the amount of creatinine (a residual product) in the urine and also by blood tests. If you are on dialysis, your daily dose will vary. Your doctor will tell you which dose to take.
Use for the elderly
Your dose is determined by your doctor based on how well your kidneys are working.
Use for children and adolescents
Experience with the use of Enalapril Sandoz in children and adolescents with high blood pressure is limited. If the child can swallow the tablet, the dose will be determined based on the child’s weight and blood pressure response. The recommended starting dose is 2.5 mg for children weighing between 20 kg and less than 50 kg, and 5 mg for children weighing 50 kg or more. Enalapril Sandoz is given once a day. Dosage one should be adjusted according to the child’s needs, up to a maximum of 20 mg per day in children weighing between 20 kg and less than 50 kg, and 40 mg per day in children weighing 50 kg or more.
Infants and children with kidney problems
Enalapril Sandoz should not be used by infants or children with kidney problems.
If you take more Enalapril Sandoz then you should
If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. The most common signs and symptoms of an overdose are drops in blood pressure and stupor (a condition with almost complete unconsciousness). Other symptoms may include dizziness or dizziness due to a drop in blood pressure, severe and rapid heartbeat, rapid heart rate , anxiety, cough, kidney failure and rapid breathing.
If you forget to take Enalapril Sandoz
If you forget 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 tablet.
If you stop taking Enalapril Sandoz
Do not stop taking your medicine unless your doctor tells you to. If you stop taking the medicine, your blood pressure may increase. If your blood pressure gets too high, it can affect your heart and kidneys.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
The following side effects may occur when using this medicine:
It is important to stop taking this medicine and see a doctor immediately if you start to get the following symptoms:
- Allergic reaction . You may experience itching , shortness of breath or wheezing and develop swelling in your hands, mouth, throat, face or eyes.
Stop taking Enalapril Sandoz immediately and contact your doctor if you get any of the following side effects:
- Severe dizziness, fainting sensation, especially at the beginning of the treatment or when the dose is increased or when you get up, severe redness of the skin, blisters, flaking of the skin in layers.
Other side effects are
Very common (may affect more than 1 user in 10)
- Blurred vision, cough, nausea, weakness.
Common (may affect up to 1 in 10 people)
- Headache, depression, low blood pressure , fainting
- Chest pain, changes in heart rhythm, angina, rapid heartbeat, shortness of breath
- Diarrhea, abdominal pain, taste change, feeling tired
- Skin rash, allergic reactions with swelling of arms and legs, face, lips, tongue or throat with difficulty swallowing or breathing
- Increased potassium levels in the blood, increases in serum creatinine (both usually detected by blood tests)
Uncommon (may affect up to 1 in 100 people)
- Anemia , anxiety, a feeling of increased consciousness or shaky feeling (caused by low blood sugar), confusion, drowsiness, difficulty sleeping, nervousness, tingling sensation in the skin or numbness, feeling that everything is spinning around (dizziness)
- Low blood pressure (which can make you dizzy when you get up), irregular heartbeat, heart attack or stroke (in high-risk patients)
- Runny nose, sore throat and hoarseness, difficulty breathing or asthma
- Intestinal upset ( ileus ), inflammation of the pancreas, vomiting, digestive problems, constipation, decreased appetite, stomach irritation, dry mouth
- Burning aching pain with feeling of emptiness and hunger, especially when the stomach is empty (caused by stomach ulcers ), heavy sweating, itching , hives ( urticaria ), hair loss, protein in the urine (usually detected by a test)
- Impotence , muscle cramps, redness , ringing in the ears, drowsiness, elevated body temperature
- Impaired renal function
- Kidney failure , increases in blood urea and decreases in sodium levels in the blood (usually detected by a test)
Rare (may affect up to 1 in 1,000 people)
- Strange dreams, sleep problems
- Reduction in the number of white blood cells , red blood cells , platelets , bone marrow depression (all are usually detected by blood tests)
- Swelling of the face and disorders of lymph node function ( lymphadenopathy )
- Low blood flow to your fingers and toes, causing redness and pain (Raynaud’s phenomenon), fluid in the lungs, runny nose or sore nose
- Increased immune response ( autoimmune disease)
- Eosinophilic pneumonia (signs may include cough, fever and difficulty breathing)
- Pain, swelling or sores in the mouth, infection or pain and swelling in the tongue, kidney problems such as decreased amount of urine that you urinate
- Liver failure or hepatitis , this can cause yellowing of your skin (jaundice)
- Severe redness of the skin, blisters, flaking of the skin in layers
- Breast development in men
- Increased liver enzymes or bilirubin (usually detected by a blood test), decreased blood sugar
Very rare (may affect up to 1 in 10,000 people)
- “Angioedema” in the intestines. Signs may include abdominal pain, nausea and vomiting, increased calcium levels in the blood
Has been reported (occurs in unknown number of users)
- Feeling sick, confusion and / or weakness, nausea, decreased appetite, irritability. This can be something called inadequate secretion of antidiuretic hormone(SIADH).
- A complex side effect has also been reported which may include some or all of the following signs:
- Fever, inflammation of the blood vessels, pain and inflammation of muscles or joints
- Disorders of the blood picture, which affects the various components of the blood (usually detected by blood tests)
- Rash, hypersensitivity to sunlight and other effects on your skin.
5. How to store Enalapril Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister / can after EXP. dat. or EXP. The expiration date is the last day of the specified month.
Aluminum / OPA / Aluminum / PVC blister:
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
HDPE can:
Do not store above 30 ° C. Shelf life: 6 months after opening.
Close the jar tightly. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is enalapril maleate. One tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg enalapril maleate.
Other ingredients are:
[For 2.5 mg and 5 mg]
Hydroxypropylcellulose, lactose monohydrate , magnesium stearate, corn starch, sodium bicarbonate and talc.
[For 10 mg]
Lactose monohydrate , magnesium stearate, corn starch, sodium bicarbonate, red iron oxide (E172) and talc.
[For 20 mg]
Lactose monohydrate , magnesium stearate, corn starch, sodium bicarbonate, red iron oxide (E172), yellow iron oxide (E172) and talc.
What the medicine looks like and contents of the pack
Enalapril Sandoz 2.5 mg tablets are round, flat, white tablets with bevelled edges.
The tablets are packaged in aluminum / OPA / aluminum / PVC blisters containing 28, 30, 49, 50, 100, 100 x 1 or 300 tablets.
Enalapril Sandoz 5 mg tablets are round, flat, white tablets with bevelled edges and a notch on one side.
The tablets are packaged in aluminum / OPA / aluminum / PVC blisters containing 10, 20, 28, 30, 50, 60, 98, 100, 100 x 1, 300 or 500 tablets.
Enalapril Sandoz 10 mg tablets are round, flat, reddish-brown tablets with bevelled edges and a notch on one side and white spots on the surface and inside the tablet.
The tablets are packaged in aluminum / OPA / aluminum / PVC blisters containing 28, 30, 50, 98, 100 or 100 x 1 tablets.
Enalapril Sandoz 20 mg tablets are round, flat, light orange tablets with bevelled edges and a notch on one side and white spots on the surface and inside the tablet.
The tablets are packaged in aluminum / OPA / aluminum / PVC blisters containing 10, 14, 28, 30, 50, 56, 60, 98, 100, 100 x 1 or 500 tablets.
The breaker is not for dividing the tablet into equal doses but only for easier swallowing.
HDPE jar with PP lid, seal and desiccant:
[For 2.5 mg]
Pack sizes: 30, 100 or 250 tablets
[For 5 mg, 10 mg and 20 mg]
Pack sizes: 30, 100, 125 or 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Verovskova ulica 57, Ljubljana, 1526, Slovenia