Lisinopril 2.5 mg Tablets – patient leaflet, side effects, dosage

1. What Lisinopril is and what it is used for

Lisinopril is used to treat:

• high blood pressure
• reduced heart pumping ability
• patients recovering from a heart attack
• kidney disease resulting from diabetes and high blood pressure.

Lisinopril is recommended in children (above 6 years old) only for the treatment of high blood pressure (hypertension).

Lisinopril contains a medicine called Lisinopril. This belongs to the ACE inhibitor medicine group (angiotensin-converting enzyme inhibitors). Lisinopril expands your blood vessels. This reduces your blood pressure and makes it easier for your heart to pump blood to all body parts.

2. What you need to know before you take Lisinopril

Do not take Lisinopril

• if you are allergic to lisinopril or to any of the other ingredients of this medicine (listed in section 6) or to other ACE inhibitors.

• if during earlier ACE inhibitor use you had swelling of the face, lips, tongue and/or throat with difficulty swallowing, breathing or with joints.

  Do not take Lisinopril if you had any of these reactions

  • without a known cause or
  • if it has been confirmed that you have a hereditary or
  • other form of fluid accumulation (angiooedema).
• 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 the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• if you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early pregnancy – see pregnancy section.)

Warnings and precautions

Talk to your doctor before taking Lisinopril

• if you suffer from dehydration due to treatment with “water tablets” (diuretics), dialysis, a low salt diet, vomiting or diarrhoea.

If this applies to you, on starting medication you may frequently have a large drop in blood pressure.

• if you suffer from heart disorders such as heart failure, narrowing of the aortic or mitral valves (aortic or mitral stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy or ‘HOCM’) or if you have a condition involving the blood vessels in the brain.
• if you have kidney problems

• if you are undergoing dialysis treatment

  • with high flux membranes
  • blood separation treatment to remove cholesterol from your blood by machine with dextran sulphate

or desensitisation treatment to reduce the effects of an allergy to a bee or wasp sting. In these cases tell your doctor that you are taking Lisinopril. He may wish to interrupt your Lisinopril treatment to prevent a possible allergic reaction.

• if you have been diagnosed with a condition called hypoaldosteronism (a decreased levels of the hormone aldosterone in your blood)
• if you have liver problems. If you develop jaundice during use of Lisinopril stop taking it and consult your doctor.
• if you have blood vessel disease, known as collagen vascular disease

• if you are Black of Afro Caribbean origin have a higher risk of having:

  • sudden fluid accumulation in the skin and mucous membranes such as throat or tongue
  • breathing difficulties
  • itching and rash, often as an allergic reaction
  • a reduction of the effect of Lisinopril.

• if you have a cough.

  • Inform your doctor if this becomes worse.
• if you need to have surgery or an anaesthetic, remind your doctor or dentist that you are taking Lisinopril.

• if taking other medicines, such as potassium supplements, lithium (for mental disorders)

  or medicines against diabetes.

• if you are taking any of the following medicines used to treat high blood pressure:

  • an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
  • aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Lisinopril”.

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in area such as the throat) may be increased:

  • racecadotril, a medicine used to treat diarrhoea

• medicines used to prevent organ transplant rejection and for cancer (e.g.

  temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors)

• vildagliptin, a medicine used to treat diabetes
• medicines to break up blood clots (usually given in hospital)
• if you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately If you are unsure if any of the above apply to you, please discuss this with your doctor.

You must tell your doctor if you think that you are (or might become) pregnant. Lisinopril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Pregnancy section).

Children and adolescents

Lisinopril has been studied in children. For more information, talk to your doctor. This medicine is not recommended in children under 6 years of age or in any child with severe kidney problems.

Other medicines and lisinopril

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

This particularly applies to:

• Diuretics (“water tablets”) which are used to treat high blood pressure.
• Other medicines used to treat high blood pressure.

Your doctor may need to change your dose and/or 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 Lisinopril” and “Warnings and precautions”).

• Medicines that reduce inflammation and treat pain or arthritis , such as aspirin

  (acetylsalicylic acid) (if you are taking more than 3 grams each day), ibuprofen, indomethacin or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors)

• Medicines for mental disorders or depressions such as

  • lithium
  • medicines to treat psychoses
  • tricyclic antidepressants, such as amitriptiline
• Potassium supplements (including salt substitutes), potassium sparing diuretics (such as spironolactone, triamterene or amiloride) and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots.

• Medicines which are most often used to avoid rejection of transplanted organs

  (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

• Blood sugar lowering medicines, such as insulin or those taken orally (including vildagliptin). The antidiabetic medicine dose may need adjusting. See section “Warnings and precautions”.
• Medicines to break up blood clots (usually given in hospital). See section “Warnings and precautions”.
• Racecadotril, a medicine used to treat diarrhoea. See section “Warnings and precautions”.

• Sacubitril/valsartan (used to treat long-term heart failure). See section “Do not take

  Lisinopril”.

• Central nervous system stimulative medicines, such as

  • ephedrine or pseudoephedrine, which could be included in decongestants or cough/cold remedies or
  • salbutamol, a medicine for treating asthma.
• Medicines to suppress the body’s immune system
• Allopurinol, a medicine to treat gout
• Procainamide, used to treat abnormal heartbeats
• Beta-blocker medicines, used to regulate heart rhythm
• Nitrate medicines, used for heart problems (such as angina pectoris)
• Gold injections (sodium aurothiomalate), a medicine to injection against rheumatic arthritis

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines.

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking Lisinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril. Lisinopril is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Dizziness or tiredness may occur when using Lisinopril. Do not drive or operate machinery if this affects you.

Lisinopril tablets contain sodium

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

3. How to take Lisinopril

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Lisinopril should be taken once daily preferably every morning. Take the tablets with a glass of water independent of meal.

The tablets are not intended to be broken.

There are products with dose higher than 2.5 mg available.

Taking your first dose

• Take special care when you have your first dose of this medicine or if your dose is increased. It may cause a greater fall in blood pressure than later doses.

• This may make you feel dizzy or light-headed. If this happens, it may help to lie down.

  If you are concerned, please talk to your doctor as soon as possible

Adults

Your dose depends on your medical condition and whether you are taking any other medicines. Your doctor will tell you how many tablets to take each day. Check with your doctor or pharmacist if you are unsure.

• For high blood pressure

The recommended starting dose is 10 mg once a day.

For severe conditions your doctor may decide to start you on between 2.5mg and 5mg once a day.

Once optimal control of blood pressure has been reached, the usual effective maintenance dose is 20mg once a day.

Diuretic-Treated Patients

If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with lisinopril. Patients with high blood pressure who cannot discontinue the diuretic therapy, should begin Lisinopril treatment with 5mg once a day.

• Heart conditions such as heart failure

The recommended starting dose is 2.5mg once a day.

The usual long-term dose is 5 to 35 mg once a day.

• After a heart attack

The recommended starting dose is 5 mg within 24 hours of your attack and 5 mg one day later. The usual long-term dose is 10 mg once a day.

• Diabetic patients with kidney problems

The recommended dose is either 10mg or 20mg once a day.

Use in children and adolescents (6 to 16 years old) with high blood pressure

• This medicine is not recommended for children under 6 years or in any children with severe kidney problems.
• The doctor will work out the correct dose for your child. The dose depends on the child’s body weight.
• For children who weigh between 20 kg and 50 kg, the recommended starting dose is 2.5 mg once a day. The dose can be increased to a maximum of 20 mg once daily.
• For children who weigh more than 50 kg, the recommended starting dose is 5 mg once a day. The dose can be increased to a maximum of 40 mg once daily.

Patients with reduced kidney function

If you suffer from a kidney disorder, the doctor should prescribe the lowest possible dose and monitor your kidney function.

Patients following recent kidney transplant

The use of Lisinopril tablets is not recommended.

Elderly, over 65 years

No special dose adjustment is necessary. In case of reduced kidney function the dose should be adjusted carefully.

If you take more Lisinopril than you should

Contact your doctor or the nearest hospital casualty department immediately.

Take this leaflet or some tablets with you so that people will know what you have taken.

If you forget to take Lisinopril

Take the missed dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lisinopril

Do not stop treatment before talking to your doctor, as this will reduce the treatments effect.

If you have any further questions on the use of this medicine, 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 Lisinopril and seek medical advice immediately, if you develop any of the following reactions:

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people). The signs may include sudden onset of:

  • swelling of the face, lips, tongue and/or throat
  • difficulties in breathing and swallowing, dizziness
  • severe or sudden swelling of hands, feet and ankles
  • severe itching skin (with raised lumps).
• Severe skin disorders including Stevens-Johnson Syndrome and pemphigus (the symptoms include a sudden, unexpected rash or burning, red skin, blistering of the lips, eyes or mouth, genitals, skin peeling, fever) and aggregate of mature or abnormal looking lymphocytes in the dermis (cutaneous pseudolymphoma) (very rare, may affect up to 1 in 10,000 people).
• Inhibition of the formation of blood in the bone marrow which can cause weakness, bruising or make infections more likely. Other symptoms may include sudden sore throat, fever, tiredness, paleness, mouth sores (very rare, may affect up to 1 in 10,000 people).
• An infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth, abnormalities of the lymph glands or urinary problems (very rare, may affect up to 1 in 10,000 people).
• Inflammation of the liver (hepatitis). This can cause loss of appetite, yellowing of the skin and eyes, and dark coloured urine (very rare, may affect up to 1 in 10,000 people).
• Inflammation of the pancreas. This causes moderate to severe pain in the stomach (very rare, may affect up to 1 in 10,000 people).
• Possible heart attack (chest pressure or ache) or stroke (weakness or paralysis of limbs or face, difficulty speaking) in high risk patients, increased heart rate and quick and irregular heart beat (palpitations) (uncommon, may affect up to 1 in 100 people).

• not going to the toilet (low urine output) which can also occur with a high temperature

  (fever), nausea, tiredness, pain in your sides, swelling of your legs, ankles, feet, face and hands or blood in your urine. These are due to a severe kidney problem (sudden kidney failure) (rare, may affect up to 1 in 1,000 people).

Other possible side effects:

Common: may affect up to 1 in 10 people

• dizziness
• headache
• fall in blood pressure as a result e.g. of standing up rapidly from a sitting or lying position, sometimes accompanied by dizziness
• a dry cough that does not go away

• diarrhoea
• vomiting
• kidney problems

Uncommon: may affect up to 1 in 100 people

• mood changes
• spinning sensation (vertigo)
• taste abnormalities
• difficulty in sleeping
• seeing, feeling or hearing things that are not there (hallucinations)
• change of colour in your fingers or toes (pale blue followed by redness) or numbness or tingling in your fingers or toes
• runny nose
• feeling sick (nausea)
• abdominal pain
• indigestion
• skin rash and/or itching
• inability to maintain an erection (impotence)
• tiredness
• general weakness
• change in blood tests that show how well your liver and kidneys are working
• too much potassium in the blood, sometimes manifesting itself as muscle cramps, diarrhoea, nausea, dizziness, headache (hyperkalaemia)

Rare: may affect up to 1 in 1,000 people

• decrease of the red blood pigment haemoglobin and number of red blood cells

  (haematocrit)

• mental confusion
• dry mouth
• nettle rash
• hair loss
• psoriasis, a skin disorder
• kidney failure leading to excessive urea in the blood
• enlargement of one or both breasts in men
• increase of bilirubin, a substance produced in the liver
• low sodium level in the blood (signs are tiredness, confusion and muscle twitching)
• changes in the way things smell
• feeling unwell, confused, irritable or weak, loss of appetite. This could be a sign of a build up of fluid in the body and low concentration of salt in the blood (SIADH, syndrome of inappropriate antidiuretic hormone secretion),

Very rare: may affect up to 1 in 10,000 people

• low blood sugar levels
• difficulty in breathing, inflammation of nasal sinuses, certain forms of pneumonia
• allergic reaction in the small intestine (intestinal angioedema)
• changes in your lymph glands
• autoimmune disease, a condition when your immune system attacks your own healthy tissues
• yellowing of the skin and/or the whites of the eyes (jaundice)
• excessive sweating
• passing less water (urine) than normal and/or passing urine less frequently.

Not known: frequency cannot be estimated from the available data

• symptoms of depression
• fainting

Skin reactions may be accompanied by fever, inflammation of a blood vessel (vasculitis) , muscle pains (myalgia), pains in the joints (arthralgia) and inflammation of the joints (arthritis), increased quantity of antibodies (ANA), increased blood sedimentation rate, rash and increase in the number of white blood cells (eosinophilia and leukocytosis), photosensitive to light or other skin reactions can occur.

Children

Safety data from clinical studies suggest that lisinopril is generally well tolerated in hypertensive children, and that the safety profile in this age group is comparable to that seen in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Lisinopril

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 on the carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lisinopril contains

The active substance is lisinopril

Each tablet contains 2.5 mg of lisinopril (as dihydrate).

The other ingredients are calcium hydrogen phosphate dihydrate, mannitol, maize starch, croscarmellose sodium and magnesium stearate.

What looks like and contents of the pack

Round, biconvex and uniformly white with a smooth surface.

The tablets are packed in polyvinylchloride/aluminium blisters which are inserted in a carton folder.

Pack sizes: 14, 28, 30, 50 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sandoz Limited

Maxis 1 Western Road Bracknell

United Kingdom

RG12 1RF

Manufacturer

Lek Pharmaceuticals d.d Verovskova 57

1526 Ljubljana, Slovenia

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 391179 Barleben, Germany

Rowa Pharmaceuticals d.d Newtown

Bantry

Co.Cork, Ireland

This leaflet was last approved in 05/2026