20 mg / 12.5 mg tablets
enalapril maleate / hydrochlorothiazide
What Renitec comp is and what it is used for
Renitec comp is used to treat high blood pressure.
The active substances enalapril and hydrochlorothiazide both have antihypertensive effects and complement each other. Enalapril, which is a so-called ACE inhibitor, dilates blood vessels and makes it easier for the heart to pump blood to all parts of the body. Hydrochlorothiazide, which is a diuretic, lowers blood pressure through the salt and diuretic effect.
Enalapril maleate and hydrochlorothiazide contained in Renitec comp may also be authorized 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 taking Renitec comp
Do not take Renitec comp
- if you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
- if you have severe hepatic or renal impairment
- if you have gout
- if you have previously been treated with another preparation belonging to the same group of medicines as Renitec Comp ( ACE inhibitor ) and then had an allergic reaction in the form of swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing ( angioedema )
- if you have hereditary angioedema or angioedema without a known cause (idiopathic)
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren
- pregnant women should not use Renitec comp during the last 6 months of pregnancy (even earlier in pregnancy it is good to avoid Renitec comp, see Pregnancy and breast-feeding)
- if you have taken or are currently 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 or pharmacist before taking Renitec comp:
- if you have or have had any medical conditions or allergies
- if you have impaired kidney function
- if you have a kidney transplant
- if you are undergoing dialysis treatment
- if you are on diuretic treatment ( diuretics )
- if you have recently had severe vomiting or diarrhea
- if you have any vascular disease
- if you have any liver disease
- if you have or have had other heart disease (eg some defects in the heart valves, heart failure )
- if you have lupus erythematosus ( SLE )
- if you are on a low-salt diet
- if you are being treated with potassium supplements, potassium-sparing agents, potassium-containing salt substitutes, or other medicines that may increase the potassium level in your blood (eg heparin [a medicine used to prevent blood clots], products containing trimethoprim such as the combination trimethoprim/sulfamethoxazole [medicines used to treat infection er])
- if you have diabetes
- if you have previously had an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty breathing or swallowing ( angioedema ). You should be aware that black patients are at greater risk of developing these types of reactions when treated with ACE inhibitors.
- if you are being treated with drugs that weaken the immune system ( immunosuppressive treatment eg after organ transplantation)
- 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 Renitec comp
- if you are taking any of the following medicines, as the risk of angioedema may be increased:
- racecadotril, a medicine used to treat diarrhea
- drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
- vildagliptin, a medicine used to treat diabetes
- 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 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 Renitec comp. This can lead to permanent visual impairment if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing this
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.
If you have diabetes and are taking insulin or diabetes medication in tablet form, you should be careful to monitor your blood sugar levels. This is especially important during the first month of taking Renitec comp.
Serious allergic reactions may occur if Renitec comp is used in the treatment of hypersensitivity to bee or wasp venom ( hyposensitization ) or so-called LDL -apheresis. Therefore, tell your doctor that you are using Renitec comp if you are going to undergo such treatment.
Before surgery and anesthesia (also applies to the dentist), the doctor/dentist should know that you are being treated with Renitec comp, as there is a risk that your blood pressure may drop suddenly.
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Renitec comp 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 breastfeeding.
Children and young people
Renitec comp should not be given to children as lack experience.
Other medicines and Renitec comp
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of the treatment can be affected if Renitec comp is taken at the same time as certain other medicines. Your doctor may need to change your dose and/or take other precautions.
Doctors need to know if you are already being treated with
- an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Renitec comp” and “Warnings and precautions”)
- other antihypertensive drugs
- certain lipid-lowering agents so-called resins (eg cholestyramine, colestipol)
- other diuretics including potassium-sparing agents
- remedy for angina
- potassium supplements (including salt substitutes), potassium-sparing diuretics, and other drugs that can increase the amount of potassium in your blood (eg trimethoprim and the combination trimethoprim/sulfamethoxazole for infection caused by bacteria; ciclosporin, an immune-boosting drug used to prevent rejection of transplanted organs, and heparin, a blood-thinning drug used to prevent blood clots).
See also information under the heading “Warnings and precautions”. - antidiabetic drugs ( insulin and tablets)
- corticosteroid is (eg cortisone )
- certain antidepressants (ie lithium, tricyclic antidepressants )
- digitalis (heart medicine)
- antiarrhythmics (eg amiodarone )
- certain remedies for pain and inflammation called NSAIDs
- opioid analgesics (painkillers)
- gold (for the treatment of rheumatism)
- remedies for schizophrenia
- sympathomimetics (eg ephedrine found in some cough medicines and adrenaline in some medicines for low blood pressure, shock, heart failure, asthma, or allergies )
- an inhibitor of mTOR (eg temsirolimus, sirolimus, everolimus – medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ). See also information under the heading “Warnings and Precautions”)
- a drug containing a neprilysin inhibitor such as sacubitril (available as a combination with valsartan), racecadotril, or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing) may increase. See also the information under the headings “Do not take Renitec comp” and “Warnings and precautions”.
- cytostatics (anti-cancer agents).
Renitec comp with alcohol
Alcohol may potentiate the antihypertensive effect of ACE inhibitors.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Usually, your doctor will suggest that you stop taking Renitec comp before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Renitec comp should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects. If you become pregnant during treatment with Renitec comp, consult a doctor.
Renitec comp is not recommended for breastfeeding mothers.
Driving and using machines
Some patients may experience blurred vision, dizziness, or fatigue when taking Renitec comp. This can affect the ability to drive and use machines. Be observant of how you react (see Possible side effects ).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Renitec comp contains lactose and sodium
Renitec comp contains lactose
Renitec comp 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.
Renitec comp contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is almost “sodium-free”.
How to take Renitec comp
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
The recommended dose is one tablet daily with a glass of water. Do not change the dosage without consulting your doctor.
If you take more Renitec comp than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, always contact a doctor or hospital for risk assessment.
If you forget to take Renitec comp
Do not take a double dose to make up for a forgotten tablet. Return to the regular schedule the next day.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Renitec comp and contact a doctor immediately if you get any of the following symptoms:
- Renitec comp can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
- Swelling of hands, feet or ankles, face, lips, tongue, and/or throat; difficulty swallowing; hives or difficulty breathing ( angioedema ). This is a serious and common side effect.
Other side effects:
Very common (may affect more than 1 user in 10):
Dizziness, blurred vision, cough, nausea, and weakness.
The characteristic of the cough that may occur is that it is dry and stubborn and disappears when the preparation is discontinued (consult a doctor).
Common (may affect up to 1 in 10 people):
Muscle cramps, headaches, depression, low blood pressure (including a sudden drop in blood pressure), fainting, chest pain, angina, changes in heart rate, rapid heartbeat, shortness of breath, diarrhea, abdominal pain, taste changes, rash, allergic reactions, fatigue, high or low levels of potassium, high levels of creatinine or uric acid in the blood, increase in cholesterol, increase in triglyceride.
Uncommon (may affect up to 1 in 100 people):
Anemia, low blood sugar, confusion, sleep disturbances, nervousness, tingling/numbness, dizziness, palpitations, runny nose, sore throat, hoarseness, asthma, intestinal upset, inflammation of the pancreas, vomiting, indigestion, constipation, loss of appetite, dry mouth, dry mouth, itching, hives, hair loss, joint pain, impaired kidney function, impotence, decreased sex drive, redness, tinnitus, malaise, fever, low levels of magnesium or sodium in the blood, increase in urea in the blood, gout. Myocardial infarction or stroke is possibly due to low blood pressure in high-risk patients (patients with blood flow disorders in the heart and/or brain).
Rare (may affect up to 1 in 1,000 people):
Change in the blood picture, eg reduced number of red and white blood cells and reduced number of platelets. Effects on the immune system and lungs, pneumonia, dream disorders, cold hands and feet, inflammation of the tongue and oral mucosa, hepatic impairment, inflammation of the liver, jaundice, severe skin and mucosal reactions, kidney inflammation, decreased urine output, enlargement of the mammary glands (muscle), muscle weakness, nasal congestion, high blood sugar, difficulty sleeping.
Very rare (may affect up to 1 in 10,000 people) :
Swelling of the intestinal mucosa increased the amount of calcium in the blood.
Has been reported (occurs in an unknown number of users):
Skin and lip cancer (non-melanoma skin cancer), increased secretion of ADH (a hormone that regulates urinary excretion) which often leads to a decrease in the salinity of the blood and increased amount of water in the body as a result (a condition with inadequate secretion of antidiuretic hormone, SIADH), impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina)).
A group of symptoms has been reported which may include some or all of the following: fever, inflammation of blood vessels, muscle pain, muscle inflammation, and joint pain. Rash, photosensitivity, or other skin problems may occur.
How to store Renitec comp
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. that ”. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
Content declaration
- The active substances are enalapril maleate 20 mg and hydrochlorothiazide 12.5 mg.
- The other ingredients are lactose monohydrate, sodium bicarbonate, magnesium stearate, maize starch, pregelatinized starch, and yellow iron oxide (dye E172).
What the medicine looks like and the contents of the pack
The tablets are yellow, round, wavy, diameter 8.7 mm, single cut, marked MSD 718.
Renitec comp is available in the following pack sizes:
Aluminum / PVC blister pack containing 28 (4×7), 98 (14×7) or 49 (49×1) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
NV Organon
Kloosterstraat 6
5349 AB Oss
Netherlands
Manufacturer
Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Netherlands
or
Schering-Plow Labo NV
Industrial Park 30
Heist-op-den-Berg, 2220
Belgium