Linatil comp | Enalapril maleate and hydrochlorothiazide uses, dose and side effects


20 mg / 12.5 mg tablets
enalapril maleate and hydrochlorothiazide

What Linatil comp is and what it is used for

Linatil comp tablets contain a combination of enalapril and hydrochlorothiazide and are used in the treatment of high blood pressure when treatment with enalapril alone is not sufficient.

Your doctor may also prescribe Linatil comp tablets instead of separate tablets with the same dose of enalapril and hydrochlorothiazide.

This fixed-dose 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 belongs to a group of medicines called angiotensin-converting enzyme inhibitors ( ACE inhibitors ) and they lower blood pressure by dilating the blood vessels.

Hydrochlorothiazide belongs to a group of medicines called diuretics ( diuretics ) and they lower blood pressure by increasing the amount of urine.

Enalapril and hydrochlorothiazide contained in Linatil comp may also be authorized 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

Do not take Linatil comp:

  • if you are allergic to enalapril maleate, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to sulfonamides (mainly antibiotics , eg sulfamethoxazole).
  • if you have previously had swelling in your arms and legs, face, lips, throat, mouth or tongue ( angioedema ) when you have been treated with medicines that belong to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
  • if you have previously had swelling in your arms and legs, face, lips, neck, mouth or tongue ( angioedema ) for any other reason.
  • if any of your relatives have previously had swelling in their arms and legs, face, lips, neck, mouth or tongue ( 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 or a neurological disease as a result of severe liver damage ( hepatic encephalopathy ).
  • if you are pregnant and have been pregnant for more than 3 months. (It is also better to avoid Linatil comp 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:

  • if narrowing of the artery engines (atherosclerosis), disorders of blood flow to the brain, such as stroke or transient ischemic attack ( TIA , a “mini-stroke”)
  • if you suffer from a disease that involves reduced blood flow to the heart muscle, usually due to disease of the coronary arteries (ischemic heart disease)
  • if you have heart failure
  • if you have low blood pressure , follow a low salt diet or use diuretics ( diuretics )
  • if you have abnormal levels of water and minerals in your body (disturbed fluid / electrolyte balance), which manifests as nausea, stomach cramps and / or vomiting, headache, edema (swelling), muscle weakness and / or tremors
  • if you have heart muscle disease ( hypertrophic cardiomyopathy ), a narrowing of the vessels that mainly carry blood from the heart, aorta (aortic stenosis) or a narrowing of the artery that leads to your only functioning kidney, have a transplanted kidney or have other forms of heart problems such as called outflow obstruction
  • if you are undergoing LDL apheresis (removal of cholesterol from your blood using a machine) 
  • if you are undergoing desensitization treatment to reduce the effects of allergy to insecticides such as bee or wasp stings 
  • if you have diabetes 
  • if you have gout , have high levels of uric acid in your blood or are being treated with allopurinol
  • if you need to get anesthesia or anesthesia 
  • if you have recently had prolonged, severe vomiting and / or severe diarrhea 
  • if you are going to test your parathyroid function 
  • if you have or have had liver or kidney problems or if you have narrow vessels leading to the kidneys (renal artery stenosis) or have only one functioning kidney or if you are undergoing dialysis
  • if you have any collagen vascular disease, such as systemic lupus erythematosus ( SLE ) or scleroderma, which may be associated with skin rash, joint pain and fever
  • if you are taking a medicine that can weaken the immune system or procainamide , which is used, among other things, to treat heart rhythm disorders
  • 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 Linatil comp.
  • if you have allergies or asthma
  • if you are taking lithium, which is used to treat certain mental illnesses
  • 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:
    • racekadotril, a drug used to treat diarrhea;
    • drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus and other drugs belonging to the group mTOR inhibitors);
    • 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.
    Your doctor may need to check your kidney function, blood pressure and the amount of electrolytes (eg potassium ) in your blood at regular intervals.See also the information under the heading “Do not take Linatil comp”.

If you think you may be pregnant ( or may become pregnant ), consult your doctor. Linatil comp is not recommended during the first 3 months of pregnancy and should not be used during the last 6 months of pregnancy as it may cause serious birth defects, see section Pregnancy and breast-feeding. Breast-feeding is not recommended when taking Linatil comp.

Linatil comp is usually not recommended if 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 a high potassium value are e.g. impaired renal function, age (over 70 years), dehydration, acute heart failure , acidification of the blood (metabolic acidosis ), diabetes , concomitant use of potassium-sparing diuretics ( potassium diuretics ), potassium supplements or potassium-containing salt substitutes, or taking blood potassium-boosting medicines . You can also get low potassium in the blood which gives i.a. high blood pressure , disturbed heart rhythm (eg caused by different drugs interacting with each other, large amounts of urine).

See also “Other medicines and Linatil comp” below. 

Elderly (over 70 years of age) and malnourished patients should be especially careful when using Linatil comp. 

Linatil comp may be less effective in black patients.

If you develop any of the following symptoms during treatment with Linatil comp, talk to your doctor immediately: 

  • You feel dizzy after the first dose . A small number of people react to the first dose one or increase of dose one with dizziness, weakness, 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. 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. Untreated, it can lead to permanent visual impairment. If you have previously had a penicillin and sulfonamide allergy, you may be at a higher risk for this.

Children and young people

This medicine is not recommended for children.

Other drugs and Linatil comp

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Linatil comp at the same time as the following medicines:

  • potassium supplements (including salt substitutes), diuretics ( diuretics ) used to lower blood pressure , including potassium-sparing diuretics such as spironolactone , triamterene or amiloride and other medicines that may increase the amount of potassium in your blood (eg trimethoprim and cotrimoxazole [trimethoprim / sulfamethoxazole] against infections 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.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 Linatil comp” and “Warnings and precautions”).
  • anesthetics and medicines to treat mental illness or depression, medicines for psychosis , tricyclic antidepressants or sedatives.
  • lithium (drug for the treatment of mental illness).
  • analgesic or anti-inflammatory drugs, such as acetylsalicylic acid , indomethacin and selective cyclooxygenase -2 inhibitors ( COX-2 inhibitors).
  • gold injections (sodium aurothiomalate), a drug 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 resin and cholestipol, active substances to lower cholesterol.
  • 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, used in surgery).
  • allopurinol, probenecid, sulfinpyrazone, gout medicines .
  • drugs such as atropine or biperiden used to treat a number of different disorders such as gastrointestinal cramps, bladder spasm , asthma , motion sickness, muscle spasms and as an aid in anesthesia .
  • 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).
  • drugs that have a side effect that can cause abnormal impulse transmission in the heart such as drugs for irregular heartbeat, certain drugs for psychosis and other drugs e.g. for the treatment of bacterial infection er.
  • calcium salts and vitamin D, which can increase calcium levels in the blood (may lead to gastrointestinal disturbances, strong thirst, excessive urination, fatigue, weakness and weight loss).
  • carbamazepine, a drug mainly used in epilepsy and bipolar disorder .
  • amphotericin B, to treat fungal infections.
  • laxatives , drugs that promote bowel movements.
  • iodinated contrast agents that improve the visibility of vascular structures and organs by X-ray.
  • 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.
  • salicylates, painkillers and / or inflammatory diseases.
  • 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”.

Linatil comp with food, drink and alcohol 

Linatil comp can be taken independently of meals. 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.


If you think you may be pregnant (or may become pregnant), consult your doctor. Usually, your doctor will advise you to stop taking Linatil comp before pregnancy or as soon as you know you are pregnant and instead recommend another medicine. Linatil comp is not recommended in 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.


Tell your doctor if you are breastfeeding or planning to start breastfeeding. Linatil comp is not recommended for breastfeeding mothers.

Driving and using machines

Dizziness and tiredness have been reported by people using Linatil comp. 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 contains lactose and sodium

Linatil 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.

L initial comp contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to take Linatil comp

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:


The recommended dose is 1 tablet once a day.

On older

Your doctor may need to adjust the dose of enalapril and hydrochlorothiazide.

Impaired renal function

Your doctor will adjust the dose of enalapril and hydrochlorothiazide. 

If you are taking other diuretic tablets

If you are currently taking other diuretic tablets, your doctor will tell you to stop taking them 2-3 days before you start taking Linatil comp.

Method of administration

The tablets are swallowed together with a glass of water.

Linatil comp can be taken with food or on an empty stomach.

The breaker is not there to divide the tablet into equal doses, but only to facilitate swallowing.

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 Linatil comp 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.
  • A severe allergic reaction called anaphylactic reaction and causes difficulty breathing or dizziness. This is a rare side effect (may affect up to 1 in 1,000 people).
  • Severe blisters, Stevens-Johnson syndrome (blisters on the skin, mouth, eyes and genitals), skin that looks burnt and flaky, photosensitivity of the skin, skin diseases with red flaky spots on the nose and cheeks (lupus erythematosus), pemphigus ( a condition that causes blisters and skin changes that usually begin in the mouth, hives , hair loss and itching ). These side effects are rare (may affect up to 1 in 1,000 people).
  • 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 inflammation of the liver. 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 retina) or acute narrow-angle glaucoma ) (side effect with unknown frequency).

It is common (may affect up to 1 in 10 people) that Linatil comp causes low blood pressure, which may 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.

Linatil comp may, in rare cases (may affect up to 1 in 1,000 people), reduce the number of white blood cells and weaken your immune system. 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 sample will be taken 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.

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 Linatil comp and other ACE inhibitors but can also be a symptom of any other disease in the upper the 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
  • weakness
  • cough.

Common (may affect up to 1 in 10 people) :

  • low levels of potassium in the blood, which can cause muscle weakness, twitching or abnormal heart rhythm
  • high levels of fats or uric acid in the blood
  • headache, depression
  • fainting, low blood pressure associated with changes in body position (such as dizziness or weakness when standing up after lying down), chest pain, abnormal heart rhythm, very rapid heartbeat ( tachycardia )
  • respiratory distress
  • diarrhea, abdominal pain
  • taste change
  • rash
  • fatigue
  • high levels of potassium in the blood, which can cause abnormal heart rhythm; increase in the amount of creatinine in the blood
  • muscle cramps.

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 )
  • hypoglycaemia (too low blood sugar), (see “Warnings and precautions” in section 2)
  • low levels of magnesium in the blood
  • uric acid crystals in the joints ( gout )
  • confusion, drowsiness, difficulty sleeping, nervousness, restlessness, tingling or numbness, dizziness, decreased sex drive
  • 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)
  • heart attack or cerebrovascular event (“mini-stroke”) (especially in patients with low blood pressure )
  • inflammation of the blood vessels ( necrotizing vasculitis)
  • runny nose, sore throat, hoarseness, difficulty breathing, wheezing when breathing
  • intestinal obstruction, inflammation of the pancreas, causing severe pain in the abdomen and back ( pancreatitis ), vomiting, digestive problems, constipation, loss of appetite, irritation of the stomach, dry mouth , stomach ulcers , gas in the stomach
  • sweating, itching , hives , hair loss
  • increased photosensitivity of the skin
  • joint pain
  • kidney problems, protein in the urine
  • impotence
  • hot flashes, ringing in the ears
  • malaise, fever
  • inflammation of the salivary gland
  • deviating amount of salt in the body (disturbance of the electrolyte balance), i.a. low levels of sodium in the blood, which can cause fatigue and confusion, muscle twitching, cramps or coma , and can 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) :

  • decrease in the number of white blood cells , which increases the risk of infection, decrease in the number of other blood cells , changed composition of the blood, poor production of bone marrow , disease of the lymph nodes, autoimmune disease where the body attacks itself
  • strange dreams, sleep disorders
  • paresis (paralysis)
  • Raynaud’s phenomenon, a disease of the blood vessels that causes tingling in your fingers and toes and which 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
  • skin rash, redness of the skin
  • decreased urine production
  • inflammation of the kidneys (interstitial nephritis)
  • enlarged breasts, even in men
  • increase in the amount of enzymes and residues produced in the liver
  • elevated blood sugar level.

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” in section 2).

Has been reported (occurs in the unknown number of users) :

  • a complex side effect that may include some or all of the following signs:
    • fever, inflammation of the blood vessels, pain and inflammation of muscles or joints
    • blood diseases that affect the components of the blood (usually detected with a blood test)
    • rash, hypersensitivity to sunlight and other effects on the skin
  • abnormal release of antidiuretic hormone (so-called SIADH) which, among other things, causes general symptoms such as confusion, nausea, mood swings, seizures and unconsciousness
  • glucose in the urine ( glucosuria )
  • loss of appetite, dizziness
  • skin and lip cancer (non- melanoma skin cancer).

How to store Linatil 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 outer carton and the blister after EXP.

The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. 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. 

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 12.5 mg hydrochlorothiazide .
  • The other ingredients are sodium bicarbonate, corn starch, lactose monohydrate , calcium hydrogen phosphate dihydrate, talc, magnesium stearate.

What the medicine looks like and contents of the pack

White, oval, biconvex tablet with a notch on one side and marked “EH” on the other side.

The tablets are packaged in Al / PA / Al / PVC blisters in a carton.

Pack sizes: 10, 14, 20, 28, 30, 49, 50, 50 x 1, 56, 60, 98, 100 or 120 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


Salutas Pharma GmbH, Otto-von-Guericke-Alle 1, 39179 Barleben, German

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