Captopril tablets 25 mg – patient leaflet, side effects, dosage

1. What this medicine is and what it is used for

Captopril belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) Inhibitors. These work by helping to widen your blood vessels, which then make it easier for your heart to pump blood through them.

Captopril is used to treat the following:

• Mild to moderately high blood pressure (hypertension)
• Severely high blood pressure (hypertension) where standard treatment is ineffective or unsuitable
• Treatment or prevention of heart failure
• Short-term (4 weeks) treatment within the first 24 hours of a heart attack
• Kidney problems caused by diabetes

2. What you need to know before you take Captopril

Do not take Captopril if:

• You are allergic to Captopril, ACE Inhibitors or any of the other ingredients of this medicine (listed in Section 6)
• You are more than 3 months pregnant (it is also better to avoid Captopril in early pregnancy - see "Pregnancy and breast-feeding" section)
• You have a history of suffering from swelling of the deeper layers of the skin caused by a build-up of fluid relating to previous treatment with an ACE Inhibitor (angioedema)
• You suffer from an inherited swelling of the deeper layers of the skin caused by a build-up of fluid or without an identifiable cause (hereditary or idiopathic angioedema)
• If you are breast-feeding (see "Pregnancy and breast-feeding" section)
• If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
• If you are taking sacubitril/valsartan, a medicine used to treat heart failure, as the risk of angioedema (swelling of the deeper layers of the skin caused by a build-up of fluid) is increased. Captopril must not be started earlier than 36 hours after the last dose of sacubitril/valsartan (or vice versa)

Warnings and precautions

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 Captopril"

Talk to your doctor before taking Captopril:

• If you are due to have surgery, you should make sure that the anaesthetist is aware you are taking Captopril
• If you suffer from narrowing of the heart valves, restricting the blood flow (aortic stenosis or mitral stenosis) or thickening of the heart muscle (hypertrophic cardiomyopathy)
• If you suffer from low blood pressure (hypotension)
• If you suffer from kidney disorders
• If you have a history of suffering from swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema). This can occur at any time during treatment. If you are black, you are at higher risk of developing angioedema than in non-black patients
• If you are taking racecadotril, a medicine used to treat diarrhoea
• If you are taking mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) (see "Other medicines and Captopril")
• If you are currently suffering from a cough
• If you suffer from liver failure
• If you are taking lithium, a medicine used to treat mood disorders [antipsychotic] (see "Other medicines and Captopril")
• If you suffer from collagen vascular disease (inflammation or weakness of the connective tissue)
• If you are taking immunosuppressants, medicines used to reduce the body's immunity when receiving organ transplant (see "Other medicines and Captopril" section)
• If you are taking allopurinol, a medicine used to treat gout (see "Other medicines and Captopril" section)
• If you are taking procainamide, a medicine used to treat irregular heartbeats [digitalis/cardiac glycosides] (see "Other medicines and Captopril" section)
• If you suffer from blood disorders. You must tell your doctor if you develop any signs of an infection, such as a sore throat or fever
• If you are taking potassium-sparing diuretics (e.g. triamterene, amiloride and spironolactone), potassium-containing supplements or salt substitutes or medicines which can increase the level of potassium in the blood e.g. heparin, co-trimoxazole (see "Other medicines and Captopril")

• If you are receiving treatment to reduce the effects of an allergy (desensitisation) to a wasp or bee sting

  • If you are diabetic and being treated with oral medicines, such as vildagliptin, or insulin
  • If you are at risk of abnormally low levels of potassium in blood (hypokalaemia)
  • If you are having dialysis with high flux membranes e.g. AW69
  • If you are having a non-surgical treatment for the removal of cholesterol (LDL) from your blood by a procedure called LDL apheresis with dextran sulfate
  • If you are pregnant, think that you may be pregnant or are planning to have a baby (see "Pregnancy and breast-feeding" section)
  • If you are black, Captopril may be less effective in lowering blood pressure than in non-black patients

Other medicines and Captopril

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

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 Captopril" and "Warnings and precautions")
• If you are taking sacubitril/valsartan (see also information under the headings "Do not take Captopril" and "Warnings and precautions"). Medicines which may interact with or be affected by Captopril:
• Clonidine used to treat high blood pressure
• Lithium, a medicine used to treat mood disorders (antipsychotic)
• Tricyclic antidepressants, medicines used to treat depression
• Diuretics (medicines used to increase frequency of urination), in particular, triamterene, amiloride and spironolactone (potassium-sparing diuretics)
• Potassium-containing supplements or salt substitutes
• Heparin, co-trimoxazole (medicines which can increase the level of potassium in the blood)
• Indomethacin and other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen
• Minoxidil and other medicines used to widen the blood vessels (vasodilators)
• Allopurinol and probenicid, medicines used to treat gout
• Procainamide, a medicine used to treat irregular heartbeats
• Immunosuppressants such as ciclosporin, medicines used to reduce the body's immunity when receiving organ transplant such as azathioprine and cyclophosphamide
• Racecadotril, a medicine used to treat diarrhoea
• mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus)
• Other medicines used to treat high blood pressure (hypertension) such as beta-blockers, calcium channel blockers, alpha blockers, sympathomimetics
• Nitroglycerine and other nitrates used to treat angina and heart failure
• Medicines that may be used to treat a heart attack such as aspirin, thrombolytics, beta-blockers and/ or nitrates
• Insulin and oral diabetic medicines such as sulfonylurea, vildagliptin
• Medicines used to treat cancer (cytostatic agents)
• Captopril may cause a false-positive urine test for acetone

Taking Captopril with food and drink and alcohol

• During treatment with Captopril, it is recommended not to drink alcohol
• These tablets may be taken before, during and after meals

Pregnancy and breast-feeding

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 taking this medicine. Pregnancy

Captopril is not recommended during the first 3 months of pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby.

Breast-feeding

• If you are breast-feeding, Captopril should not be taken as Captopril is passed into breast milk
• If you are breast-feeding, Captopril is not recommended for premature babies and for the first few weeks after birth because of the possible risk of effects on the heart and/or kidneys
• If the infant is older, it may be possible to use Captopril during breast-feeding if treatment is necessary for you and your child is monitored for any adverse effects

Driving and using machines

Captopril may affect your ability to drive and operate machinery. This is more likely to occur at the start of treatment, when the dose is changed or if you drink alcohol. If any symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Captopril contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Captopril

Always take Captopril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• These tablets are to be taken orally
• The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses
• The recommended maximum daily dose is 150 mg
• These tablets may be taken before, during and after meals

Adults

High blood pressure (hypertension):

• The recommended starting dose is 25-50 mg daily, given in two divided doses
• This dose may be increased by increments with intervals of at least 2 weeks
• The maximum dose is 100-150 mg daily, given in two divided doses

Heart failure:

• The recommended starting dose is 6.25-12.5 mg two or three times daily
• The usual maintenance dose is 75-150 mg per day
• The maximum dose is 150 mg per day given in divided doses
• The dose should be increased by increments with intervals of at least 2 weeks

PACKAGE LEAFLET: INFORMATION

FOR THE PATIENT

Captopril 12.5 mg, 25 mg and 50 mg

Tablets

Till-Ver.9

As stated in design

Package leaflet

Till-Ver.9

TW263197 (safety)

UK

All

NA

TBA

9 points (Reg text)

Till-Ver.8 / TW163719 06/05/2026

Following a heart attack:

Short-term treatment:

• An initial dose of 6.25 mg should be given as soon as possible
• A 12.5 mg dose should then be given after 2 hours
• A 25 mg dose should be given a further 12 hours later
• From the following day, a dose of 100 mg per day should be given in two divided doses for 4 weeks Long-term treatment:
• An initial dose of 6.25 mg should be given
• This should be followed by a dose of 12.5 mg 3 times daily for 2 days
• And then a dose of 25 mg 3 times daily
• The recommended dose for preventative treatment is 75-150 mg daily given in two or three divided doses

Diabetic patients with kidney disease:

The recommended dose is 75-100 mg daily.

Patients with kidney disorders:

The dose should be reduced or the interval between doses should be increased.

Elderly

An initial dose of 6.25 mg twice daily should be given.

Use in children

• Captopril Tablets are not recommended for use in children and adolescents.
• The recommended starting dose is 0.3 mg per kg of bodyweight. The dose may be given up to three times daily.
• For children with kidney disorders, premature babies, new-borns and infants, the recommended starting dose should only be 0.15 mg per kg of bodyweight.

If you take more Captopril than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of overdose include: slower heartbeat (bradycardia), electrolyte disturbances, severely low blood pressure (hypotension), circulatory shock, kidney failure and stupor.

If you forget to take Captopril

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Captopril

It is important that you keep taking Captopril for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Captopril can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

• Allergic reactions: swelling of the face, throat or tongue, difficulty in breathing, dizziness
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema), particularly the arms and legs, face, lips, respiratory, digestive, and urinary tracts, tongue, throat, voice box
• Blistering of the skin (pemphigoid)
• Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome)
• Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)

Common side effects

(may affect up to 1 in 10 people)

• Rashes
• Severe itching with or without a rash (pruritus)
• Hair loss (alopecia)
• Feeling (nausea) or being sick (vomiting)
• Upset stomach and/or stomach pain
• Stomach ulcer (peptic ulcer)
• Diarrhoea
• Constipation
• Dry mouth
• Changes in or loss of taste
• Dizziness
• Dry, irritating cough
• Breathlessness (dyspnoea)
• Difficulty in sleeping (insomnia)

Uncommon side effects

(may affect up to 1 in 100 people)

• Decreased appetite
• Headache
• Tingling or numbness in the hands or feet (paraesthesia)
• Low blood pressure (hypotension), low blood pressure after a change in position i.e. when standing up from a lying or sitting position (orthostatic hypotension)
• Poor blood circulation causing the toes and fingers to be numb and pale (Raynauds Syndrome)
• Redness/flushing or pale (pallor) skin
• Faster heartbeat (tachycardia or tachyarrhythmia, arrhythmia)
• Chest pain (angina pectoris)
• Feeling your heartbeat (palpitations)
• Tiredness, weakness or lack energy (fatigue)
• Generally feeling unwell (malaise)
• General weakness (asthenia)

Rare side effects

(may affect up to 1 in 1000 people)

• Loss of appetite (anorexia), weight loss
• Swelling of the intestines which may cause stomach pain, with or without being sick (intestinal angioedema)
• Inflammation and/or ulcers in the mouth (stomatitis)
• Sleepiness or drowsiness (somnolence)
• Kidney disorders including kidney failure, increase in the amount of urine produced (polyuria), a need to pass urine more frequently (pollakiuria) or a decrease in the amount of urine produced (oliguria)

Very rare side effects

(may affect up to 1 in 10,000 people)

• Looking pale and feeling tired (anaemia)
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia)
• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)

• A reduction in blood platelets, which increases risk of bruising of the skin or bleeding

  (thrombocytopenia)

• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely

  (neutropenia, agranulocytosis, pancytopenia), especially in patients with kidney problems

  • Swollen or enlarged lymph nodes

    (lymphadenopathy)

  • Auto-immune diseases
  • Positive Anti-Nuclear Antibody test (ANA), used to detect auto-immune disorders
  • Abnormally high levels of blood potassium (hyperkalaemia)
  • Abnormally low levels of salt (sodium) in blood (hyponatremia)
  • Low blood sugar levels (hypoglycaemia)
  • Skin rashes with the formation of wheals (urticaria)
  • Peeling of the skin over large areas of the body (erythroderma, exfoliative dermatitis)
  • Skin disease causing scaly pink patches (psoriasis, psoriasiform dermatitis)
  • Abnormal sensitivity of the skin to sunlight (photosensitivity)
  • Swollen tongue (glossitis)
  • Inflammation of the pancreas (pancreatitis)
  • Liver damage including jaundice (yellowing of the skin or whites of the eyes)
  • Liver problems including inflammation of liver (hepatitis), increase in liver enzymes and bilirubin (detected through blood test)
  • Problems with the blood vessels in the brain including stroke and fainting (syncope)
  • Difficulty in breathing or wheezing (bronchospasm) or chest problems
  • Runny nose (rhinitis)
  • Shortness of breath or difficulty in breathing (allergic alveolitis)
  • Collective symptoms of cough, fever, difficulty breathing and sweating at night (allergic/ eosinophilic pneumonia)
  • Confusion
  • Depression
  • Muscle (myalgia) or joint pain (arthralgia)
  • Protein in the urine (nephrotic syndrome, proteinuria)
  • Blurred vision
  • Inability to maintain an erection (impotence)
  • Enlargement of the male breast (gynaecomastia)
  • Fever
  • Increase of BUN (Blood Urea Nitrogen levels detected by a blood test)
  • Increase of creatinine in the blood
  • Decrease of haemoglobin, haematocrit, leucocytes and thrombocytes (blood cells and platelets)
  • Increase in ESR (a blood test to measure inflammation in the body)
  • Eosinophilia (frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells)
  • Heart suddenly and unexpectedly stops beating (cardiac arrest) or weakened heart (cardiogenic shock)

Not known (frequency cannot be estimated from the available data)

• Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).

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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Captopril

• 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/blister after EXP. The expiry date refers to the last date of that month.
• Store below 25◦C. Store in the original package.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Captopril contains:

• Each 12.5 mg tablet contains 12.5 mg of Captopril
• Each 25 mg tablet contains 25 mg of Captopril
• Each 50 mg tablet contains 50 mg of Captopril The other ingredients are: maize starch, microcrystalline cellulose, lactose monohydrate and stearic acid.

What Captopril looks like and content of the pack:

• Captopril 12.5 mg are round, white tablets of diameter 6.0-6.2 mm with a break mark on one side, convex on the other side
• Captopril 25 mg are round, white tablets of diameter 8.0-8.2 mm with facet and a crossed break line on each side
• Captopril 50 mg are round, white tablets of diameter 10.0-10.2 mm with facet and a crossed break line on each side

Captopril is available in:

Captopril Tablets are available in packs of 28, 56 or 100 tablets.

Not all pack sizes may be marketed.

Product Licence Numbers:

• Captopril 12.5 mg Tablets: PL 11311/0062
• Captopril 25 mg Tablets: PL 11311/0063
• Captopril 50 mg Tablets: PL 11311/0064

Marketing Authorisation Holder:

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer:

Salutas Pharma GmbH

Otto-Von-Guericke-Allee 1

D-39179 Barleben, Germany

This leaflet was last revised in May 2026

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