20 mg / 6 mg tablets
Enalapril and hydrochlorothiazide
1. What Enalapril Comp STADA is and what it is used for
Enalapril Comp Stada is used for treating high blood pressure ( essential hypertension ). It contains a combination of two active substances, enalapril, and hydrochlorothiazide.
- Enalapril belongs to a group of medicines called ACE inhibitors (angiotensin converters). ACE inhibitors work by dilating the blood vessels and thus making it easier for the blood to flow through them. ACE inhibitors are used to treat high blood pressure ( hypertension ).
- Hydrochlorothiazide belongs to a group of medicines called diuretics ( diuretics ). Diuretics cause the kidneys to produce more urine. They are used to treat high blood pressure ( hypertension ).
Enalapril Comp Stada is used in patients whose blood pressure has not been adequately controlled on enalapril or hydrochlorothiazide alone. Therefore, one should try using drugs with only one of the active substances first.
Enalapril and hydrochlorothiazide contained in Enalapril Comp Stada 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 use Enalapril Comp STADA
Do not use Enalapril Comp STADA
- if you are allergic to
- enalapril maleate
- hydrochlorothiazide
- other sulfonamides (chemically related to hydrochlorothiazide )
- or any of the other ingredients of this medicine (listed in section 6)
- if you have previously been treated with ACE inhibitors or any other unknown cause of angioedema ( allergic reaction with symptoms such as swelling of the face, tongue, or throat, hives, difficulty swallowing and breathing)
- if someone in your family has had angioedema (because you may have hereditary predispositions).
- if you have severe renal impairment and/or need dialysis.
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren
- if you suffer from anuria (a disease in which you produce less than 100 ml of urine for 24 hours).
- if you have severe hepatic impairment.
- if you are in the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Enalapril Comp Stada, see Pregnancy and breast-feeding). 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).
Warnings and cautions
Talk to your doctor before taking Enalapril Comp Stada:
- if you are at risk of falling blood pressure due to salt and/or fluid loss, e.g. because you are taking diuretics ( diuretics, diuretics ), on a low salt diet, or as a result of severe or prolonged diarrhea or vomiting
- if there are narrowing of the heart valves in your left ventricle or other difficulties with the outflow from the left ventricle
- if you have any heart disease such as heart failure or heart disease with arterial flow difficulties (coronary heart disease). Any Enalapril Comp STADA is not used, and/or thorough check should be made
- if you suffer from difficulties with blood flow to the brain ( cerebrovascular disease, frequent drops in blood pressure may occur)
- if your kidney function is slightly impaired (increased risk of kidney failure )
- if you have narrowing of the blood vessels of the kidney (careful control is necessary)
- if you have recently had a kidney transplant ( Enalapril Comp Stada is not recommended)
- if your liver enzyme levels increase or you develop jaundice (possibly due to treatment)
- if your liver function is impaired or if you have liver disease (increased risk of developing the severe liver disease during treatment)
- if changes in the number of blood cells occur during treatment:
- the number of white blood cells decreases ( leukopenia )
- the sharp reduction in specific white blood cells associated with infection and severe general symptoms ( agranulocytosis )
- anemia (anemia; may cause weakness, fatigue, malaise, and difficulty concentrating)
- the number of platelets decreases (thrombocytopenia; may involve easy bruising and nosebleeds)
- if you suffer from connective tissue disease (collagenosis) involving blood vessels (increased risk of developing serious infections )
- if you have been treated with medicines that suppress your immune system or you are taking allopurinol (medicine for gout ) or procainamide (medicine for heart rhythm disorders). The risk of developing serious infection you
- if you are already taking lithium (a medicine for mental disorders). Concomitant treatment with lithium is not recommended
- if you have diabetes (increased risk of high blood sugar)
- if you have gout (the level of uric acid in your blood may increase as a result of treatment)
- if you have a stubborn, dry cough (may depend on the treatment)
- if you are at risk of elevated potassium levels in your blood, e.g. if you are taking special diuretics (potassium-sparing diuretics ), potassium supplements, or potassium-containing saline tablets
- if you belong to a particular ethnic group, the antihypertensive effect may be insufficient (especially in people with black skin)
- if you have swelling e.g. in arms or legs due to fluid retention (retention of fluid (edema; you may have low sodium levels in the blood)
- if you have an overproduction of aldosterone (primary hyperaldosteronism; you are not responding to treatment with Enalapril Comp Stada)
- before the parathyroid gland test. Your doctor may discontinue treatment with Enalapril Comp Stada before performing the test
- if you have previously had allergies or bronchial asthma ( hypersensitivity reactions may occur)
- if you have a disease called systemic lupus erythematosus (an immune disease; it may worsen)
- 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 taking Enalapril Comp Stada
- if you are taking any of the following medicines, the risk of angioedema (rapidly developing 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)
- vildagliptin, a medicine used to treat diabetes
- 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. This can lead to permanent visual impairment if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this.
- 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 (such as potassium ) in your blood at regular intervals.
See also more information under the heading “Do not take Enalapril Comp Stada”.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Enalapril Comp Stada is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breast-feeding.
Tell your doctor immediately if you get any of the following symptoms:
- swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing ( angioedema ). Occurs more often in black people.
- yellowing of the skin and mucous membranes.
- fever, swollen lymph nodes, and/or laryngitis.
In these cases, you should stop taking Enalapril Comp Stada and your doctor will decide on the necessary measures.
Problems such as dry mouth, thirst, weakness, numbness, muscle pain or cramps, palpitations, dizziness, nausea, vomiting, and decreased urine production can be signs of an imbalance in fluid or mineral levels. Inform your doctor.
If you need desensitization treatment against insecticides (from eg bee or wasp), your doctor must temporarily replace Enalapril Comp Stada with a suitable medicine from another substance class. Otherwise, life-threatening hypersensitivity reactions(eg drops in blood pressure, shortness of breath, vomiting, allergic skin reactions) may occur. Such reactions can also occur after insect bites (eg bee or wasp stings).
Symptoms may include flushing, nausea, and vomiting if you are treated with injectable gold while taking Enalapril Comp Stada.
If you receive dialysis during treatment with special dialysis membranes (high-flux membranes ), or if you receive special treatment for severely elevated blood fats ( LDL apheresis with dextran sulfate absorption), severe hypersensitivity reactions up to life-threatening shock may occur.
Therefore, before dialysis, haemofiltration, or LDL apheresis, your doctor should change so that you receive another medicine – not an ACE inhibitor – or use another dialysis membrane. Tell your doctor if you are being treated with Enalapril Comp Stada or if you are dependent on dialysis so that your doctor can consider this in your treatment.
If you are going to undergo surgery or anesthesia (even at the dentist), inform your doctor/dentist that you are being treated with Enalapril Comp Stada. This is because there is a risk of a rapid drop in blood pressure during anesthesia.
The use of this medicine requires regular medical check-ups, so you must go to the laboratory check-ups and examinations that you are called to.
Children and young people
The safety and efficacy of Enalapril Comp Stada in children have not been established.
Other medicines and Enalapril Comp STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor and take special care if you are taking any of the following medicines:
- other blood pressure-lowering drugs, including vasodilators, beta-blockers, renin inhibitors e.g. aliskiren
- your doctor may need to change your dose and/or ask you to take other precautions:
- if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Enalapril Comp Stada” and “Warnings and precautions”)
- diuretics ( diuretic drug) loop diuretics and thiazide s
- potassium supplements (including salt substitutes), potassium-sparing diuretic agent (diuretic), and other drugs that may increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) against infection s caused by bacteria, cyclosporine, an immunosuppressive drug which prevents the rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots)
- lithium and other drugs for the treatment of mental illness (antipsychotic drugs) or depression ( tricyclic antidepressants )
- non-steroidal anti-inflammatory drugs ( NSAIDs ) commonly used as painkillers or anti-inflammatory drugs, e.g. acetylsalicylic acid, indomethacin, and naproxen
- carbenoxolone (another anti-inflammatory drug)
- medicines for gout (eg allopurinol, brenzbromarone)
- immunosuppressive drugs that inhibit the immune system such as ciclosporin (to prevent rejection of a transplanted organ)
- amphotericin B (to treat fungal infections)
- anticancer medicines (eg cyclophosphamide, fluorouracil, methotrexate)
- diabetes drugs, both insulin,n, and drugs are taken orally to reduce blood glucose levels
- calcium and vitamin D.
- drugs to treat heart failure (impaired ability of the heart to pump sufficient blood through the body: cardiac glycosides, such as digoxin ) or to treat organ-bound heart rhythm (antiarrhythmics such as procainamide, quinidine, amiodarone sotalol)
- corticosteroids and corticotropin (ACTH) to treat inflammation, such as rheumatism
- iodinated contrast agents (substances given during certain types of X-rays; your doctor will inform you about this)
- drugs that reduce the production of prostaglandins (fats that are part of important bodily functions)
- anesthetics (eg barbiturates )
- muscle relaxants (medicines used during surgery; your anesthetist informs you of this)
- drugs and drug-classified painkillers (eg opiates)pressor amines (drugs with a powerful stimulant effect such as adrenaline )
- stimulant laxatives ( laxatives that act on the gut, such as senna)
- sympathomimetics (drugs with a stimulating effect, eg to treat asthma )
- cholestyramine and colestipol (for lowering blood cholesterol ). Cholestyramine and colestipol reduce the absorption of one of the hydrochlorothiazide components of Enalapril Comp Stada from the gastrointestinal tract. Do not take Enalapril Comp Stada later than 1 hour before or earlier than 4-6 hours after these medicines
- drugs most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other drugs belonging to the mTOR inhibitor group). See section “Warnings and Precautions”.
Alcohol potentiates the blood pressure-lowering effect of Enalapril Comp Stada.
Blood tests and other tests
Hydrochlorothiazide (in Enalapril Comp Stada) may cause a disorder in the bentiromide test (test for pancreatic function).
Thiazides can reduce serum -PBI (protein-bound iodine). Iodine is important for the thyroid gland but signs of thyroid disorder do not appear.
Enalapril Comp STADA with food, drink, and alcohol
Enalapril Comp Stada can be taken with or without food.
Avoid excessive table salt (sodium chloride) as it may reduce the effectiveness of Enalapril Comp Stada. Talk to your doctor before using potassium supplements or potassium substitutes. Alcohol increases the blood pressure-lowering effect of Enalapril Comp Stada. Concomitant use of alcohol and Enalapril Comp Stada may cause a drop in blood pressure when getting up quickly ( orthostatic hypotension ).
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will usually suggest that you stop taking Enalapril Comp Stada before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Enalapril Comp Stada should not be used during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.
Breast-feeding
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Enalapril Comp Stada is not recommended for breastfeeding mothers.
Driving and using machines
Some side effects (see section 4 below) may affect your ability to drive or use machines, especially at the beginning of treatment or when the dose is increased. Some patients may develop fatigue and dizziness during treatment. If you notice any of these symptoms, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 STADA contains lactose and sodium
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 essentially ‘sodium-free’. essentially “sodium-free”.
How to use Enalapril Comp STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
This medicine can be used to replace treatment with enalapril and hydrochlorothiazide taken as separate tablets.
Dosage
Your doctor will decide how much Enalapril Comp Stada to take. Depending on how your blood pressure is affected, your dose may need to be increased or decreased after starting treatment.
Adults
The usual dose is 1 tablet daily.
If you have kidney disease, your doctor will check your dose carefully. The lowest dose of Enalapril Comp Stada will be given and your doctor will check how your kidneys are working.
Your doctor will not prescribe Enalapril Comp Stada if you have severe kidney disease (see section 2. “Do not take Enalapril Comp Stada”).
If you are taking another diuretic for the treatment of Enalapril Comp Stada, your doctor will ask you to stop taking this medicine 2-3 days before starting treatment with Enalapril Comp Stada.
Elderly patients
The efficacy of enalapril and hydrochlorothiazide treatment has been shown in clinical trials to be as good in the elderly as in younger patients. The elderly also tolerate treatment with Enalapril Comp Stada just as well. Renal function usually deteriorates with age, with such conditions a starting dose of half a tablet daily is recommended.
Use for children and adolescents
The safety and efficacy of Enalapril Comp Stada in children have not been established and therefore the drug should not be used in children.
If you use more Enalapril Comp STADA then you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Remember to bring the pack, this leaflet, and any remaining tablets. If you have taken too many tablets, you may have severe hypotension (low blood pressure ) and fall asleep (low level of consciousness, but not unconsciousness), as well as other serious disorders (see section 4. “Possible side effects”).
If you forget to use Enalapril Comp STADA
If you forget to take a dose, take the next dose as usual and then continue as scheduled. Do not take a double dose (or larger dose ) to make up for the forgotten dose (or dose ). If you are not sure, talk to your pharmacist or doctor.
If you stop using Enalapril Comp STADA
Do not stop taking Enalapril Comp Stada without first talking to your doctor.
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 Enalapril Comp Stada and contact your doctor immediately if you experience symptoms that indicate angioedema during treatment, such as:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
- Enalapril Comp Stada can cause a decrease in different types of white blood cells ( agranulocytosis ) or other blood cells that help defend the body against bacteria ( neutropenia ). This can reduce your resistance to infection. If you get an infection with symptoms such as fever and severe deterioration of the general condition or fever with symptoms of infection such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that a lack of white blood cells ( agranulocytosis) can be ruled out through blood tests.). It is important that you then inform if you are taking Enalapril Comp Stada.
Enalapril Comp Stada contains a combination of two active substances, enalapril and hydrochlorothiazide . Thus, any possible side effect may be due to either the active substance enalapril or the active substance hydrochlorothiazide.
Very common (may affect more than 1 user in 10):
- dizziness
- dimsyn
- cough
- nausea
- impotence.
Common (may affect up to 1 in 10 people):
- changes in blood values: increase/decrease in potassium content (hyperkalemia/hypokalaemia) or creatinine, increase in cholesterol and triglyceride levels (fatty acids), increase in uric acid level in the blood
- fainting ( syncope )
- fatigue
- Depression
- headache
- taste disorders
- low blood pressure ( hypotension ) including a drop in blood pressure, which occurs when getting up quickly, with symptoms such as dizziness or fainting ( orthostatic hypotension )
- irregular heartbeat or fast heartbeat ( tachycardia )
- chest pain due to anemia and thus lack of oxygen supply to the heart muscle ( angina pectoris )
- shortness of breath
- diarrhea
- abdominal pain
- rash
- hypersensitivity reactions ( allergy ) and angioedema
- muscle cramps
- chest pain.
Uncommon (may affect up to 1 in 100 people):
- changes in blood values: anemia (aplastic and hemolytic anemia )
- low levels of sodium ( hyponatremia ) or sugar (hypoglycemia) and magnesium (hypomagnesemia), elevated urea content
- swollen joints ( gout )
- confusion, drowsiness ( somnolence ), drowsiness, difficulty falling asleep ( insomnia ), nervousness
- an ant crawls ( paresthesia )
- vertigo ( vertigo )
- decreased sexual desire
- ringing in the ears ( tinnitus )
- flushing / hot flashes
- palpitation
- severe drop in blood pressure that can lead to heart attack and/or stroke
- runny nose ( rhinorrhea )
- sore throat and hoarseness
- asthma/spasm of the trachea (feeling of tightness in the chest that makes it difficult to breathe and hissing)
- impaired intestinal motility ( ileus )
- inflammation of the pancreas ( pancreatitis )
- vomiting and/or indigestion ( dyspepsia )
- constipation
- decreased appetite ( anorexia )
- gastritis and/or stomach ulcers
- dry mouth
- weather stresses ( flatulence )
- profuse sweating (diaphoresis)
- itching ( pruritus ) or hives ( urticaria )
- hair loss ( alopecia )
- joint pain
- renal impairment or renal failure
- egg whites in the urine ( proteinuria )
- impotence
- feeling sick
- muscle twitching associated with fever.
Rare (may affect up to 1 in 1,000 people):
- decreased number of certain white blood cells ( neutropenia, leukopenia, and agranulocytosis ), hemoglobin, total red blood cell volume (low hematocrit ), platelets ( thrombocytopenia ), or all different types of blood cells (pancytopenia)
- Bone marrow depression ( bone marrow does not produce enough blood cells )
- swollen lymph nodes ( lymphadenopathy )
- diseases in which the body’s immune system can cause allergic reactions against the body’s own tissue s
- elevated blood glucose levels
- nightmares and/or difficulty sleeping
- impaired mobility (paresis)
- cold hands and feet (Raynaud’s syndrome)
- changes visible on X-ray examination of lungs ( pulmonary infiltrates)
- allergy ( hypersensitivity reactions ) in the lungs (allergic alveolitis) or lung disease ( eosinophilic pneumonia )
- rhinitis ( inflammation of the nose)
- severe lung problems (including pneumonia and fluid in the lungs)
- inflammation of the oral mucosa ( stomatitis ) or blisters in the mouth
- inflammation of the tongue ( glossitis )
- abnormal liver function, liver damage ( hepatic necrosis )
- elevated liver enzymes (seen by blood tests) or bilirubin in the blood
- liver disease (hepatitis; possibly with jaundice ie yellowing of the skin)
- increased excretion of bile by the liver (including jaundice)
- inflammation of the gallbladder (especially in patients with gallstones )
- severe changes in the skin with blisters, redness, and scaling including erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis purpura, cutaneous lupus erythematosus (an immune disease that causes inflammation of the skin), pemphigus and erythroderma (skin redness)
- decreased urinary excretion ( oliguria )
- interstitial nephritis (a kidney disease)
- breast augmentation in men ( gynecomastia )
- a group of symptoms that includes any or all of the following: fever, inflammation of body cavities such as chest and abdomen (serositis), inflammation of blood vessels ( vasculitis ), muscle pain or inflammation of the muscles, joint pain, or inflammation of joints, altered blood counts, increased white blood cell count ( eosinophilia, leukocytosis ), skin rash, hypersensitivity to light ( photosensitivity ) and other skin conditions.
Very rare (may affect up to 1 in 10,000 people):
- swelling of the intestinal walls (intestinal angioedema )
- elevated calcium levels in the blood.
Has been reported (occurs in the unknown number of users):
- increased secretion of a hormone ( antidiuretic hormone ) from tissues that do not normally secrete the hormone (may cause headache, nausea, and vomiting)
- inflammation of the salivary glands (sialoadenitis)
- inflammation of the blood vessels ( necrotizing, vasculitis, cutaneous vasculitis )
- anaphylactic (severe allergic / hypersensitivity) reactions
- restlessness, dizziness
- yellow vision
- 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 )
- sugar in the urine ( glucosuria )
- skin and lip cancer (Non- melanoma skin cancer).
5. How to store Enalapril Comp STADA
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 EXP. The expiration date is the last day of the specified month.
Store in the original package. Do not store above 25 ° C.
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 and hydrochlorothiazide.
- The active substances are enalapril maleate 20 mg and hydrochlorothiazide 6 mg.
- The other ingredients are croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized maize starch, sodium bicarbonate, and the dye indigo carmine (E132).
What the medicine looks like and the contents of the pack
Light blue, round, uncoated, biconvex tablets.
Enalapril Comp Stada is supplied as blister packs (aluminum / laminated)
OPA / Al / PVC / Al): 10, 14, 20, 28, 30, 40, 50, 56, 60, 70, 80, 90, 98, 100, 112, 200, 250, 500 and 1000 tablets.
PP container with desiccant: 100, 200, 250, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany
Other manufacturers
Actavis Ltd.
Reykjavikurvegur 76-78
220 Hafnafjörður
Iceland
Balkanpharma Dupnitsa AD
3 Samokovsko Shose Str.
Dupnitsa 2600
Bulgaria
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark