20 mg / 12.5 mg, tablets
enalapril maleate and hydrochlorothiazide
What Enalapril comp Ratiopharm is and what it is used for
Enalapril comp Ratiopharm belongs to the group of combination medicines used to treat high blood pressure ( hypertension ). It contains two active ingredients, enalapril (an ACE inhibitor ) and hydrochlorothiazide (a diuretic). Enalapril prevents the formation of substances in the body that cause high blood pressure. Hydrochlorothiazide increases the removal of water and salt from the body, which also lowers blood pressure.
Enalapril comp Ratiopharm is used in patients who have achieved blood pressure control with the same amounts of each ingredient in Enalapril comp Ratiopharm when taken as separate tablets.
Enalapril and hydrochlorothiazide contained in Enalapril comp Ratiopharm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Enalapril comp Ratiopharm
Do not take Enalapril comp Ratiopharm
- if you are allergic to enalapril maleate, other ACE inhibitors, thiazides (medicines to increase urine production), sulfonamide derivatives (certain antibiotics and medicines for diabetes ), or any of the other ingredients of this medicine (listed in section 6)
- if you or any of your biological relatives for any reason have previously suffered from swelling of your extremities, face, lips, neck, mouth, or tongue ( angioedema)
- If you have been taking or are taking sacubitril/valsartan, a medicine used to treat a type of chronic ( chronic ) heart failure in adults, as it increases the risk of angioedema (rapidly developing swelling under the skin in areas such as the throat).
- if you are pregnant and your pregnancy has lasted for more than 3 months (use of this medicine should preferably also be avoided earlier in the pregnancy, see section “Pregnancy and breast-feeding”)
- if you have severe kidney or liver problems
- if you can not urinate
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
Warnings and cautions
Talk to your doctor or pharmacist before taking Enalapril comp Ratiopharm.
The doctor who has prescribed this medicine must be aware of the following:
- if you are taking diuretics (“diuretic tablets”)
- if you are on a low salt diet or if you are currently or during treatment suffering from severe diarrhea or vomiting
- if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance)
- if you have heart failure
- if you have narrowing of the arteries are (atherosclerosis) or cerebrovascular disease (such as stroke )
- if you have heart muscle disease ( hypertrophic cardiomyopathy ), a narrowing of the vessels that mainly carry blood from the heart, aorta (aortic stenosis), or other forms of heart problems called outflow obstruction
- undergoes LDL apheresis (removal of cholesterol from your blood using a machine)
- if you have kidney problems, or if you have narrow vessels leading to the kidneys (renal artery stenosis) or have only a functioning kidney, or if you receive dialysis
- if you have recently had a kidney transplant
- if you have diabetes
- if you have any collagen vascular disease, such as systemic lupus erythematosus ( SLE ) or scleroderma, or if you are being treated with immunosuppressive drugs, allopurinol or procainamide, or a combination of these.
- if your liver function is impaired
- if you are receiving insecticide insecticide
- if you have allergies or asthma
- if you need surgery during treatment, as some anesthetics used during surgery may cause excessive lowering of blood pressure in combination with Enalaprilcomp Ratiopharm
- if you have elevated potassium levels in your blood
- 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.
- if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is higher:
- sirolimus, everolimus, temsirolimus, and other medicines belonging to the group mTOR inhibitors (used to prevent rejection of transplanted organs and against cancer)
- racecadotril, a medicine used to treat diarrhea;
- vildagliptin, a medicine used to treat diabetes.
- if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while using the Enalapril comp Ratiopharm.
- if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Enalapril comp Ratiopharm. Without treatment, this can lead to permanent visual impairment. The risk of developing these symptoms may be greater if you have previously had an allergy to penicillin or sulfonamides.
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 comp Ratiopharm”.
You must tell your doctor if you suspect you are (or might become) pregnant. Enalapril comp Ratiopharm is not recommended during early pregnancy and should not be used after the third month of pregnancy, as this may cause serious birth defects (see section “Pregnancy and breast-feeding”).
Sudden swelling of the tongue, lips, and face, neck, possibly even the hands, and feet, or wheezing or hoarseness may occur at any time during treatment. This condition is called angioedema. If this happens, stop taking Enalapril comp Ratiopharm and contact your doctor. ACE inhibitors cause a higher incidence of angioedema in colored patients than in non-colored patients.
If a dry cough occurs during treatment, consult your doctor, who will decide whether to continue treatment.
Children and young people
Do not give Enalapril comp Ratiopharm to children under 18 years of age. There is limited information on the safety and efficacy of Enalapril comp Ratiopharm in children.
Kidneys
If you have impaired kidney function, you mustn’t take potassium supplements or potassium-sparing diuretics during treatment with enalapril/hydrochlorothiazide, as they may raise potassium levels too much.
Other medicines and Enalapril comp Ratiopharm
The use of Enalapril comp Ratiopharm with other medicines may affect the efficacy and safety of this medicine, and Enalapril comp Ratiopharm may affect the efficacy and safety of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, herbal medicines, or natural medicines. Remember to tell your doctor about Enalapril comp Ratiopharm if he/she prescribes you another medicine during or shortly after treatment.
You must tell your doctor if you use any of the following:
- potassium-sparing diuretics (” diuretic tablets”), such as spironolactone, triamterene or amiloride, potassium or calcium supplements, dietary or salt supplements containing potassium or calcium. The combination can lead to dangerously high levels of potassium or calcium in the blood
- other antihypertensive agents or high-dose diuretics (” diuretic tablets”). The combination can cause your blood pressure to drop dangerously low
- angiotensin II receptor blocker (ARB) or aliskiren (antihypertensive agent): 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 heading “Do not take Enalapril comp Ratiopharm ”and“ Warnings and Precautions ”)
- allopurinol (medicine for gout ), procainamide (medicine to treat heart rhythm problems), cytostatic medicines (cancer medicines), or medicines affecting the body’s immune system (such as cyclosporine)
- lithium (a medicine used to treat mental health problems). The combination can cause the body to store too much lithium and increase the risk of side effects s
- antipsychotic drugs, certain drugs used to treat depression ( tricyclic antidepressants ), or drugs that stimulate the central nervous system
- certain anesthetic drugs, barbiturates, or strong painkillers. The combination can make you feel dizzy when you get up.
- other drugs that can increase the amount of potassium in the body (such as heparin, a drug used to prevent blood clots; cyclosporine, an immunosuppressive drug used to prevent rejection of transplanted organs; trimethoprim, an antibiotic for urinary tract infections and the combination trimethoprim / sulfamethox)
- anti-inflammatory painkillers ( NSAIDs )
- carbenoxolone (used to relieve stomach ulcers ) corticosteroids, corticotropin(ACTH, used to treat epilepsy ), or laxatives. The combination can lead to abnormal levels of water and minerals in the body, especially a lack of potassium.
- cardiac glycosides (such as digitoxin) or tubocurarine (muscle relaxants). The effect of these drugs can be enhanced
- insulin or diabetes medicines taken by mouth
- cholestyramine and colestipol (cholesterol-binding drugs)
- medicines most commonly used to prevent the rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the mTOR inhibitor group). See section “Warnings and Precautions”.
- racecadotril (a medicine used to treat diarrhea)
Enalapril comp Ratiopharm with food and drink
Enalapril comp Ratiopharm tablets can be taken with liquid on an empty stomach or with food.
You should be aware that alcohol consumption may enhance the effects of this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will usually advise you to stop taking Enalapril comp Ratiopharm before you become pregnant, or at the latest when pregnancy is diagnosed. Your doctor will advise you to take another medicine instead of Enalapril comp Ratiopharm. Enalaprilcomp Ratiopharm is not recommended during early pregnancy and should not be used at all after the third month of pregnancy, as it may cause serious birth defects.
Breast-feeding
Enalapril comp Ratiopharm is not recommended for breastfeeding mothers.
Driving and using machines
Enalapril comp Ratiopharm may cause fatigue or dizziness, which may affect the ability to drive or use machines that require sharp attention.
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 comp Ratiopharm contains lactose and sodium
This medicine 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.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to take Enalapril comp Ratiopharm
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet once a day.
Children and young people
Children should not take this medicine as it has not been studied in children.
Elderly
Your doctor will decide on a dose that takes into account your kidney function.
Patients with kidney problems
Dosage one depends on kidney function. Follow your doctor’s instructions.
Previous treatment with diuretics
Treatment with diuretics other than hydrochlorothiazide should be stopped 2 or 3 days before starting treatment with Enalapril comp Ratiopharm. Follow your doctor’s instructions.
Do not change the dose and do not stop taking the medicine without first consulting your doctor.
If you take more Enalapril comp Ratiopharm then you should
Always contact your doctor or nearest hospital if you have taken more medicines than you should (ie an overdose). An overdose is likely to cause low blood pressure, excessive or slow heart rate, palpitations (a feeling of excessively fast or irregular heartbeat), shock, rapid breathing, cough, nausea and vomiting, cramps, dizziness, feeling sleepy and confused or anxious, urination or inability to urinate.
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Enalapril comp Ratiopharm
Take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Enalapril comp Ratiopharm
Treatment of high blood pressure is a long-term treatment and interruptions in treatment must be discussed with a doctor. Interrupting or completely interrupting your treatment can cause your blood pressure to rise.
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.
Stop taking this medicine and see a doctor or hospital immediately
- you get swelling of your hands, feet, ankles, face, lips, or throat, which can cause difficulty swallowing or breathing, itchy skin, and hives This is a serious and common side effect called angioedema (may affect up to 1 in 10 people).
- you get red, swollen,n and hot skin with blisters on the lips, eyes, mouth, nose, and/or genitals. You may also have a high fever, swollen glands, or joint pain. This can be an unusual condition called Stevens-Johnson syndrome (may affect up to 1 in 1,000 people).
This may mean that you have an allergic reaction to the Enalapril comp Ratiopharm.
Talk to your doctor immediately if you notice any of the following serious side effects.
These are less common or rare (may affect up to 1 in 100 people):
- bloating and stomach cramps (abdomen), nausea (vomiting), indigestion, heartburn, stomach pain, constipation, loss of appetite, dry mouth. This may be a sign of constriction or blockage in the intestine ( ileus )
- severe abdominal pain radiating to the back. This may be a sign of pancreatitis
- blood disorders including bone marrow problems and anemia. The symptoms of this are a greater tendency to get bruises, longer bleeding time after an injury, bleeding from the gums or other places, purple-red spots or spots on the skin (caused by damage to small blood vessels), increased susceptibility to infection
- lung problems including pneumonia which means you may feel sick or less hungry or have a high fever for two or three days, difficulty breathing, shortness of breath, cough
- high fever, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These are symptoms of hepatitis (inflammation of the liver) that can lead to liver failure.
- a condition that may include some or all of the following: high fever, inflamed blood vessels, painful inflamed muscles and joints, blood problems detected with a blood test, rash, high sensitivity to sunlight, other effects on the skin.
Other possible side effects:
Very common (may affect more than 1 in 10 people):
- dizziness
- dimsyn
- nausea
- cough
- weakness
Common (may affect up to 1 in 10 people):
- headache
- fatigue
- chest pain
- fainting
- altered and/or irregular heartbeats
- low blood pressure, including postural hypotension with associated symptoms (dizziness, weakness, blurred vision)
- diarrhea
- distortion or decrease in taste
- abdominal pain
- exanthema (rash)
- muscle cramps
- altered potassium levels in the blood
- increased levels of creatinine and fat in the blood
- too high uric acid levels in the blood
- Depression
- difficulty breathing
Uncommon (may affect up to 1 in 100 people):
- vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, ulcers, flatulence
- kidney problems, protein in the urine
- impotence
- a decrease in the number of red blood cells, which may make the skin pale and cause weakness or shortness of breath ( anemia )
- palpitations (a feeling of rapid or particularly strong or irregular heartbeat)
- myocardial infarction or cerebrovascular event (“mini-stroke”) (mainly in patients suffering from low blood pressure )
- confusion, drowsiness, insomnia, nervousness, the feeling of tingling, stinging, or numbness ( paresthesia )
- fraud (dizziness)
- joint pain, malaise, fever
- flushing, ringing in the ears ( tinnitus )
- itching, hives, hair loss
- runny nose, sore throat, and hoarseness wheezing
- excessive sweating
- gout
- low sodium and/or magnesium levels in the blood decreased blood sugar levels
- inflammation of the gallbladder, especially in patients with gallstones
Rare (may affect up to 1 in 1,000 people):
- altered blood picture, disease of the lymph nodes, an autoimmune disease where the body attacks itself
- stomatitis, glossitis
- allergic skin reactions (eg multiforme erythema, redness, scaling or blistering of the skin, epidermal necrolysis [a serious condition with a detachment of the outermost layer of the skin], purpura), skin condition with red scaly patches over the nose and cheeks (lupus erythematosus)
- inflammation of the lining of the nose which causes a runny nose ( rhinitis )
- decreased urine production
- inflammation of the kidneys (interstitial nephritis)
- breast augmentation, even in men
- abnormal dreams, sleep disorders
- decreased muscle movements (due to low potassium levels in the blood)
- Raynaud’s syndrome (symptoms include fingers changing color when exposed to cold or pressure, pain in fingers or toes when cold, tingling or pain when warm)
- increase in the number of enzymes and residues produced by the liver
Very rare (may affect up to 1 in 10,000 people)
- a condition called “intestinal angioedema”. The symptoms are abdominal pain with or without nausea or vomiting
- increase in calcium levels in the blood
No known frequency (cannot be calculated from the available data)
- inflammation of a salivary gland
- elevated blood sugar, glucose in the urine
- restlessness
- feeling drunk
- visual disturbances
- impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma )
- inflammation of the blood vessels
- anaphylactic reactions (allergic hypersensitivity that develops rapidly, with general symptoms)
- syndrome of abnormal antidiuretic hormone secretion (symptoms include headache, nausea, vomiting, agitation, or confusion and may develop into seizures and coma if left untreated).
- Skin and lip cancer (Non- melanoma skin cancer)
5. How to store Enalapril comp Ratiopharm
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 after “Ed. that. ” or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 substances are enalapril maleate and hydrochlorothiazide . Each tablet contains 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide .
- The other ingredients are lactose monohydrate, corn starch, sodium bicarbonate, pregelatinized starch, talc, and magnesium stearate.
What the medicine looks like and the contents of the pack
Round, white, flat tablet with a scoreline on one side and with a beveled edge. Diameter 8 mm.
The tablet can be divided into two halves.
Available in blister packs of 14, 20, 28, 28 x 1, 30, 30 x 1, 56, 60, 98, 98 x 1, 100, 100 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco Strasse 3, D-89079 Ulm, Germany
Manufacturer
Merckle GmbH, Ludwig-Merckle Strasse 3, D-89143 Blaubeuren, Germany