20 mg / 6 mg tablets
enalapril maleate / hydrochlorothiazide
What Linatil comp mite is and what it is used for
Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors ( ACE inhibitors ) and lowers blood pressure by dilating blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics ( diuretics ) and lowers blood pressure by increasing the amount of urine.
Lentil comp mite contains a combination of enalapril and hydrochlorothiazide and is used in the treatment of high blood pressure when treatment with enalapril alone is not sufficient.
Your doctor may also prescribe this medicine instead of separate tablets containing the same dose of enalapril and hydrochlorothiazide.
This solid combination is not suitable for initial treatment.
You need to talk to a doctor if you do not feel better or if you feel worse.
Enalapril and hydrochlorothiazide contained in Linatil comp mite 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 taking Linatil comp mite
Do not use Linatil comp mite:
- if you are allergic to enalapril , hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other medicines belonging to the same group of medicines ( ACE inhibitors ) or sulfonamides (mainly antibiotics , eg sulfamethoxazole)
- if you have previously been treated with another medicine that belongs to the same group of medicines as this ( ACE inhibitor ) and then had an allergic reaction with swelling of the face, lips, tongue and / or throat and difficulty swallowing or breathing. You should not take this medicine if you have had these types of reactions for no known reason or if any of your relatives have had such an allergic reaction before (ie you have been diagnosed with hereditary or idiopathic angioedema ).
- if you have severe kidney 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
- if you have severe liver problems
- if you are pregnant and have been pregnant for more than 3 months. (It is also better to avoid Linatil comp mite during early pregnancy – see section “Pregnancy”.)
- if you have taken or are taking sakubitril / 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 Linatil comp mite, if you:
- narrowing of the artery engines (arteriosclerosis), disorders of blood flow to the brain such as stroke or transient ischemic attack ( TIA , a “mini-stroke”)
- suffers from a disease that involves reduced blood flow to the heart muscle, usually due to disease of the coronary arteries (ischemic heart disease)
- have heart failure
- have low blood pressure , follow a low-salt diet or take diuretics ( diuretics )
- have abnormal levels of water and minerals in your body (disturbed fluid / electrolyte balance), which manifests itself as nausea, abdominal cramps and / or vomiting, headaches, swelling, muscle weakness and / or tremors
- have heart muscle disease ( hypertrophic cardiomyopathy ), a narrowing of the largest artery one that carries 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)
- undergoes treatment of allergy to insecticides such as bee or wasp stings (so-called hyposensitization )
- have diabetes and are taking medicines for diabetes (you should monitor your blood sugar levels and pay attention to low values, especially during the first month of treatment)
- have gout , have high levels of uric acid in their blood or are treated with allopurinol
- need to have anesthesia or anesthesia (even at the dentist)
- have recently had prolonged, severe vomiting and / or severe diarrhea
- should test your parathyroid function
- have or have had liver or kidney problems, or if you have narrow arteries you leading to your kidneys (renal artery stenosis) or only have one functioning kidney, or you are undergoing dialysis
- have any collagen vascular disease, such as systemic lupus erythematosus ( SLE ) or scleroderma that may be associated with skin rash, joint pain and fever
- receive any treatment that weakens the immune system or takes procainamide , which is used, among other things, to treat disorders of the heart rhythm
- 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 Linatil comp mite
- have allergies or asthma
- takes lithium, which is used to treat certain mental illnesses
- Taking any of the following medicines may increase the risk of angioedema (rapidly developing swelling under the skin in areas such as the throat):
- racekadotril, 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 .
- take 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
- You must contact your doctor if you think you are ( or might become ) pregnant. Linatil comp mite is not recommended during early pregnancy and should not be used if you are pregnant and more than 3 months pregnant, as it may cause serious birth defects if used after the third month of pregnancy (see section Pregnancy).
Lentil comp mite is usually not recommended unless the following applies, so talk to your doctor before taking this medicine:
- if you have recently had a kidney transplant
- if you have high levels of potassium in your blood. Your potassium levels should be monitored during treatment. Risk factors that can give high potassium value are impaired kidney function, age (over 70 years), dehydration, acute heart failure , acidification of the blood (metabolic acidosis ), diabetes , concomitant use of potassium-sparing diuretics ( diuretics ), potassium supplements or potassium-containing salt substitutes, or taking drugs that increase the level of potassium in the blood. You can also get low potassium in the blood, which gives i.a. high blood pressure , disturbed heart rhythm (eg due to different drugs interacting with each other, large amounts of urine).
See also “Other medicines and Linatil comp mite” below.
Elderly (over 70 years of age) and malnourished patients should be especially careful when using this medicine.
This drug may be less effective in black patients.
If you develop any of the following symptoms during treatment with this medicine, talk to your doctor immediately:
- You feel dizzy after the first dose . A small number of people react to the first dose one or to increase the dose one with dizziness, feeling weak, fainting and nausea.
- Sudden swelling of the lips and face, neck, possibly also hands and feet, or wheezing or hoarseness. This condition is called angioedema . This can occur at any time during treatment. ACE inhibitors cause a higher number of angioedema cases in black patients than in other patients.
- Fever, sore throat or cold sores (this may be a symptom of an infection caused by a decrease in the number of white blood cells ).
- Yellowing of the skin and whites of the eyes (jaundice) which may be a sign of liver disease.
- Dry cough for a long time. Cough has been reported with the use of ACE inhibitors but may also be a symptom of other diseases of the upper respiratory tract.
- Sudden myopia.
- If you experience impaired vision or eye pain with redness and sudden blurred vision.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 Linatil comp mite . Untreated, it can lead to permanent visual impairment. If you have previously had a penicillin and sufonamide allergy, you may be at a higher risk for this.
Children and young people
Lentil comp mite is not recommended for children and adolescents.
Other medicines and Linatil comp mite
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Linatil comp mite with the following medicines:
- potassium supplements (including salt substitutes), diuretics ( diuretics ) used to lower blood pressure , such as furosemide or potassium-sparing diuretics such as spironolactone , eplerenone, triamterene or amiloride, and other medicines that may increase the amount of potassium in your blood (eg trimethoprim and cotrimoxazole [trimethoprim / sulfamethoxazole] for infection caused by bacteria; cyclosporine, an immunosuppressive drug that prevents rejection of transplanted organs; and heparin , a drug used to thin the blood to prevent blood clots).
- other antihypertensive drugs
- anesthetics, medicines for the treatment of mental illness or depression ( tricyclic antidepressants ), medicines for psychosis or sedatives
- lithium (drug for the treatment of mental illness)
- analgesic or anti-inflammatory drugs, such as acetylsalicylic acid (> 300 mg / day), indomethacin and selective cyclooxygenase-2 inhibitors ( COX-2 inhibitors)
- gold injections (sodium aurothiomalate), a medicine injected for rheumatoid arthritis
- medicines such as ephedrine , which are found in some medicines for coughs and colds, or norepinephrine and adrenaline used for low blood pressure , shock , heart failure , asthma or allergies
- blood sugar lowering drugs such as insulin and those taken orally
- cholestyramine and cholestipol, active substances for lowering blood fats
- corticosteroids , anti-inflammatory hormone-like substances
- corticotropin (ACTH), which is mainly used to test the function of your adrenal glands
- muscle relaxants (eg tubocurarine chloride, muscle relaxants used in surgery)
- anticancer drugs, such as cyclophosphamide or methotrexate
- drugs that inhibit the body’s immune system, drugs that prevent rejection in organ or bone marrow transplants, such as ciclosporin
- cardiac glycosides (eg digoxin , heart-strengthening drugs)
- laxatives , drugs that promote bowel movements
- barbiturates , drugs that inhibit the central nervous system and have a calming effect
- opioid analgesics, strong analgesics without anti-inflammatory effect
- carbenoxolone, an anti- inflammatory drug in the gut
- medicines most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the group mTOR inhibitors). See section “Warnings and precautions”.
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 use Linatil comp mite” and “Warnings and precautions”).
Linatil comp mite with alcohol
Drinking alcohol with this medicine can increase the blood pressure-lowering effect (and can then, among other things, cause dizziness when standing up).
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.
Pregnancy
If you think you are ( or might become ) pregnant, consult your doctor. Usually, your doctor will advise you to stop taking Linatil comp mite before you become pregnant or as soon as you know you are pregnant and instead recommend another medicine. Lentil comp mite is not recommended during early pregnancy and should not be used if the pregnancy lasts longer than 3 months, as the medicine may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Lentil comp mite is not recommended for breastfeeding mothers.
Driving and using machines
Dizziness and tiredness have been reported by people taking this medicine. If you experience any of these, do not drive or use machines (see also section 4. “Possible side effects”).
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.
Linatil comp mite 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.
Lentil comp mite contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Linatil comp mite
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
The usual dose is 1 tablet once a day.
Impaired renal function
Your doctor will adjust the dose of enalapril and hydrochlorothiazide carefully.
If you are being treated with diuretics ( diuretics )
Ongoing treatment with another diuretic should be discontinued 2-3 days before starting treatment with this medicine.
Method of administration
The tablets are swallowed together with water.
This medicine can be taken with food or on an empty stomach.
The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following, stop taking this medicine and contact a doctor immediately or go to the emergency department at the nearest hospital:
- A severe allergic reaction called angioedema (rash, itching , swelling of the arms and legs, face, lips, mouth or throat, which may make it difficult to swallow or breathe).This is a serious and common side effect (may affect up to 1 in 10 people). You may need urgent medical attention or be hospitalized.
- Jaundice (yellowing of the skin and whites of the eyes).This is a potentially serious but rare side effect (may affect up to 1 in 1,000 people) that indicates liver problems ( inflammation of the liver, liver failure which can be fatal). You may need urgent medical attention or be hospitalized.
- Sudden myopia (side effect with unknown frequency).
- Decreased vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and mucous membranes) or acute narrow-angle glaucoma ). If you have a sudden painful red eye, contact your doctor immediately; you may need treatment to avoid permanent vision loss. The frequency of this side effect is unknown (can not be calculated from the available data).
It is common (may affect up to 1 in 10 people) that this medicine causes low blood pressure, which can be associated with a feeling of dizziness and weakness. In some patients, this may occur after the first dose or when dose one is increased. If you experience these symptoms, contact your doctor immediately.
This drug can reduce the number of white blood cells so that the defense of infection is weakened. If you get an infection with symptoms such as fever and severe general deterioration, or fever with local infection symptoms such as sore throat/throat/mouth or problems urinating, you should see a doctor immediately. A blood test will be performed to check for a possible decrease in the number of white blood cells ( agranulocytosis ). You must tell your doctor that you are taking this medicine. This side effect is rare (may affect up to 1 in 1,000 people).
This medicine can in rare cases (may affect up to 1 in 1,000 people) cause severe allergic reactions with high fever, skin rashes that look like targets (erythema multiforme), Stevens-Johnson syndrome, and toxic epidermal necrolysis (severe skin diseases with redness and peeling of the skin and blisters on the skin, in the mouth, in the eyes and on the genitals), skin that looks burnt and flaky, photosensitivity in the skin, skin diseases with red scaly spots on the nose and cheeks (lupus erythematosus), pemphigus (a disease that causes blisters and skin changes that usually begin in the mouth, hives, hair loss, and itching ). If you experience these symptoms, contact your doctor immediately.
Dry cough, which can last for a long time, has been reported in very common cases (may occur in more than 1 in 10 users) when using this medicine and other ACE inhibitors, but can also be a symptom of any other disease in the upper respiratory tract. You should contact your doctor if you develop this symptom.
The following side effects have also been reported:
Very common (may affect more than 1 user in 10):
- dimsyn
- dizziness
- nausea
- impotence
- cough.
Common (may affect up to 1 in 10 people):
- headache, depression
- low levels of potassium in the blood, which can cause muscle weakness, muscle twitching or abnormal heart rhythm
- high levels of cholesterol or fats in the blood, high levels of uric acid in the blood
- fainting, angina or chest pain, abnormal heart rhythm, very fast heartbeat ( tachycardia )
- respiratory distress
- diarrhea, abdominal pain, taste change
- rash
- fatigue
- high levels of potassium in the blood, which can cause abnormal heart rhythms
- increase in the amount of creatinine in the blood
- low blood pressure , even in connection with a change in the position of the body (such as dizziness or weakness when you stand up after lying down).
Uncommon (may affect up to 1 in 100 people):
- decrease in the number of red blood cells , which can make the skin pale and cause weakness or shortness of breath ( anemia )
- heart attack or cerebrovascular event (“mini-stroke”) possibly due to low blood pressure in high-risk patients (patients with blood flow disorders in the heart and / or brain)
- low levels of magnesium in the blood
- hypoglycaemia (too low blood sugar), (see “Warnings and precautions” in section 2)
- confusion, drowsiness, difficulty sleeping, nervousness, restlessness, tingling or numbness, dizziness
- visual disturbances where the environment is perceived as mainly yellow due to yellowing of the optical parts of the eye (xanthopsia)
- palpitations (a feeling of fast or very strong or irregular heartbeat)
- runny nose, sore throat, hoarseness, difficulty breathing, wheezing
- intestinal obstruction, inflammation of the pancreas, causing severe pain in the abdomen and back ( pancreatitis ), vomiting, digestive problems, constipation, loss of appetite, pain and irritation in the stomach, dry mouth , stomach ulcers
- sweating, itching , hives , hair loss
- increased photosensitivity of the skin
- problems with the kidneys, such as kidney failure , protein in the urine
- impotence
- inflammation of the salivary gland
- hot flashes, ringing in the ears, malaise, fever
- muscle cramps
- low levels of sodium in the blood, which can cause fatigue and confusion, muscle twitching, seizures or coma and also lead to dehydration and low blood pressure , which makes you dizzy when you stand up
- increase in the amount of urea in the blood.
Rare (may affect up to 1 in 1,000 people):
- reduction in the number of white blood cells , which increases the risk of infection, reduction in the number of other blood cells , including platelets , altered blood composition, poor bone marrow production , swollen lymph nodes in the throat, armpit or groin, autoimmune disease in which the body attacks itself
- strange dreams, sleep disorders
- muscle weakness, sometimes due to low potassium (paresis)
- Raynaud’s syndrome, a disease of the blood vessels that causes tingling in your fingers and toes and also makes them pale, then bluish and finally reddish
- problems with the lungs, including pneumonia , inflammation of the nasal mucosa , causing the nose to run ( rhinitis )
- cold sores, inflammation of the tongue
- liver problems, gallbladder inflammation
- purple or red spots on the skin (purple)
- decreased urine production
- inflammation of the kidneys (interstitial nephritis)
- enlarged breasts in men
- increase in the amount of enzymes and residues produced in the liver
- high blood sugar.
Very rare ( may affect up to 1 in 10,000 people):
- swelling of the intestines
- high levels of calcium in the blood (see “Other medicines and Linatil comp mite” in section 2).
Has been reported (occurs in the unknown number of users):
- abnormal secretion of antidiuretic hormone (so-called SIADH) which, among other things, causes general symptoms such as confusion, nausea, mood swings, seizures and unconsciousness
- a complex side effect that may include some or all of the following symptoms: fever, severe inflammation , inflammation of the blood vessels, muscle aches and / or joint pain, changes in blood composition and increased lowering (a blood test used to detect inflammation ), rash, hypersensitivity to sunlight and other skin problems
- skin and lip cancer (non- melanoma skin cancer).
Other side effects are only seen with the higher doses of hydrochlorothiazide than 6 mg (12.5 mg and 25 mg):
- muscle cramps (common)
- uric acid crystals in the joints ( gout ) (less common)
- decreased sex drive (less common)
- gas problems (less common)
- joint pain (less common).
How to store Linatil comp mite
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 blister and the outer carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package.
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 and hydrochlorothiazide .
Each tablet contains 20 mg enalapril maleate and 6 mg hydrochlorothiazide .
The other ingredients are lactose monohydrate, magnesium stearate, corn starch, sodium bicarbonate, talc.
What the medicine looks like and contents of the pack
Lentil comp mite tablets are white, oval, biconvex with a scoreline on one side and a scoreline and the marking “EN20” on the other side.
The tablets are packaged in aluminum/aluminum blisters that are packaged in cardboard.
Linatil comp mite tablets are available in pack sizes of: 14, 20, 28, 30, 49, 49 x 1, 50, 50 x 1, 98, 100 and 100 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany