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Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg tablet

Active Ingredient:
hydrochlorothiazide , losartan potassium
Company:  
Ipca Laboratories UK Ltd See contact details
ATC code: 
C09DA01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 19 Mar 2026
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Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 28278/0018.

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Losartan Potassium and Hydrochlorothiazide tablets

Package leaflet: Information for the user

Losartan Potassium and Hydrochlorothiazide 50 mg /12.5 mg Film coated tablets

Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg Film coated tablets

Losartan Potassium and Hydrochlorothiazide 100 mg/ 25 mg Film coated tablets

Losartan potassium and hydrochlorothiazide

Read all of this leaflet carefully before taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Losartan Potassium and Hydrochlorothiazide is and what it is used for
2. What you need to know before you take Losartan Potassium and Hydrochlorothiazide
3. How to take Losartan Potassium and Hydrochlorothiazide
4. Possible side effects
5. How to store Losartan Potassium and Hydrochlorothiazide
6. Contents of the pack and other information

1. What Losartan Potassium and Hydrochlorothiazide is and what it is used for

Losartan Potassium and Hydrochlorothiazide is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan Potassium prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure.

Losartan Potassium and Hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before you take Losartan Potassium and Hydrochlorothiazide

Do not take Losartan Potassium and Hydrochlorothiazide

  • if you are allergic to losartan potassium, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6),
  • if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure),
  • if you have severely impaired liver function,
  • if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment,
  • if you are suffering from gout,
  • if you are more than 3 months pregnant (It is also better to avoid Losartan Potassium and Hydrochlorothiazide in early pregnancy- see Pregnancy section),
  • if you have severely impaired kidney function or your kidneys are not producing any urine,
  • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Losartan Potassium and Hydrochlorothiazide.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking Losartan potassium and Hydrochlorthiazide. Your doctor will decide on further treatment. Do not stop taking Losartan Potassium and Hydrochlorthiazide on your own.

You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium and Hydrochlorothiazide 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).

It is important to tell your doctor before taking Losartan Potassium and Hydrochlorothiazide

  • if you have previously suffered from swelling of the face, lips, throat or tongue;
  • if you take diuretics (water pills);
  • if you are on a salt-restricted diet;
  • if you have or have had severe vomiting and/or diarrhoea;
  • if you have heart failure;
  • if your liver function is impaired (see section 2 “Do not take Losartan Potassium and Hydrochlorothiazide;
  • if you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney, or you have recently had a kidney transplant;
  • if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function);
  • if you have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle);
  • if you are diabetic;
  • if you have had gout;
  • if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus);
  • if you have high calcium or low potassium levels or you are on a low potassium diet;
  • if you need to have an anaesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets;
  • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland);
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems;
    • Aliskiren.
  • If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Losartan Potassium and Hydrochlorothiazide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

if you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Losartan Potassium and Hydrochlorothiazide, seek medical attention immediately;

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 Losartan Potassium and Hydrochlorothiazide”;

  • if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartan Potassium and Hydrochlorothiazide”).
  • if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan Potassium and Hydrochlorothiazide.

Children and adolescents

There is no experience with the use of Losartan Potassium and Hydrochlorothiazide in children. Therefore, Losartan Potassium and Hydrochlorothiazide should not be given to children.

Other medicines and Losartan Potassium and Hydrochlorothiazide;

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

Diuretic agents such as the hydrochlorothiazide contained in Losartan Potassium and Hydrochlorothiazide may interact with other medicines.

Tell your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g., trimethoprim-containing medicines), as the combination with Losartan Potassium and Hydrochlorothiazide is not advisable.

Diuretic agents such as the hydrochlorothiazide contained in Losartan Potassium and Hydrochlorothiazide may interact with other medicines.

Preparations containing lithium should not be taken with Losartan Potassium and Hydrochlorothiazide without close supervision by your doctor.

Special precautionary measures (e.g. blood tests) may be appropriate if you take diuretics (“water tablets”), some laxatives, medicines for the treatment of gout, medicines to control heart rhythm or for diabetes (oral agents or insulins).

It is also important for your doctor to know if you are taking:

  • other medicines to reduce your blood pressure;
  • steroids;
  • medicines to treat cancer;
  • pain killers;
  • drugs for treatment of fungal infections;
  • arthritis medicines;
  • resins used for high cholesterol, such as colestyramine;
  • medicines which relax your muscles;
  • sleeping tablets;
  • opioid medicines such as morphine;
  • ‘pressor amines’ such as adrenaline or other drugs from the same group;
  • oral agents for diabetes or insulins;

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Losartan Potassium and Hydrochlorothiazide” and “Warnings and precautions”).

Please also inform your doctor you are taking Losartan Potassium and Hydrochlorothiazide if you will be undergoing a radiographic procedure and will be given iodine contrast media.

Losartan Potassium and Hydrochlorothiazide with food and drink

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan Potassium and Hydrochlorothiazide may increase each other’s effects.

Dietary salt in excessive quantities may counteract the effect of Losartan Potassium and Hydrochlorothiazide

Losartan Potassium and Hydrochlorothiazide may be taken with or without food.

Grapefruit juice should be avoided while taking Losartan potassium and hydrochlorothiazide tablets.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan Potassium and Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan Potassium and Hydrochlorothiazide. Losartan Potassium and Hydrochlorothiazide is not recommended during 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. Losartan Potassium and Hydrochlorothiazide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

Use in elderly patients

Losartan Potassium and Hydrochlorothiazide works equally well in and is equally well tolerated by most older and younger adult patients. Most older patients require the same dose as younger patients.

Driving and using machines

When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine.

Losartan Potassium and Hydrochlorothiazide contains lactose

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

3. How to take Losartan Potassium and Hydrochlorothiazide

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose of Losartan Potassium and Hydrochlorothiazide depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan Potassium and Hydrochlorothiazide for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

High Blood Pressure

The usual dose of Losartan Potassium and Hydrochlorothiazide for most patients with high blood pressure is 1 tablet of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once daily of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg or changed to 1 tablet daily of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg or 1 tablet daily of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg .

Administration

The tablets should be swallowed whole with a glass of water.

If you take more Losartan Potassium and Hydrochlorothiazide than you should

In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. Overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Losartan Potassium and Hydrochlorothiazide

Try to take Losartan Potassium and Hydrochlorothiazide daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

4. Possible side effects

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

If you experience the following, stop taking Losartan Potassium and Hydrochlorothiazide and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients. You may need urgent medical attention or hospitalization.

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

acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Other side effects that may occur:

The following side effects have been reported:

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

  • cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder;
  • diarrhoea, abdominal pain, nausea, indigestion;
  • muscle pain or cramps, leg pain, back pain;
  • insomnia, headache, dizziness;
  • weakness, tiredness, chest pain;
  • increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels;
  • changes in kidney function including kidney failure;
  • too low sugar in the blood (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people):

  • anaemia, red or brownish spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in white blood cells, clotting problems, reduced number of platelets;
  • loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels;
  • anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment;
  • pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting;
  • blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow;
  • ringing, buzzing, roaring or clicking in the ears, vertigo;
  • low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up, angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations;
  • inflammation of blood vessels, which is often associated with a skin rash or bruising;
  • sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion;
  • constipation, obstipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
  • jaundice (yellowing of the eyes and skin), inflammation of the pancreas;
  • hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss;
  • pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness;
  • frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary tract infection, sugar in the urine;
  • decreased sexual appetite, impotence;
  • swelling of the face, localized swelling (oedema), fever.

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

  • hepatitis (inflammation of the liver), abnormal liver function tests.
  • Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

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

  • flu-like symptoms;
  • unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis);
  • low levels of sodium in the blood (hyponatraemia);
  • generally feeling unwell (malaise);
  • disturbed taste (dysgeusia).
  • skin and lip cancer (non-melanoma skin cancer)
  • decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine 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.

5. How to store Losartan Potassium and Hydrochlorothiazide

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 container. The expiry date refers to the last day of that month.

Blisters and Bottle Pack

This medicinal product does not require any special storage conditions

Do not throw away any medicines 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 Losartan Potassium and Hydrochlorothiazide contains

The active substances are Losartan potassium and hydrochlorothiazide.

Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.

Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.

Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.

Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg contain the following other ingredients:

Lactose monohydrate

Microcrystalline cellulose (Avicel 101),

Pregelatinised starch

Maize starch

Colloidal anhydrous silica

Magnesium stearate

Film coating:

HPMC 2910/ Hypromellose

Titanium dioxide

Macrogol/PEG

Talc

Quinoline yellow aluminium lake

Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg contain the following other ingredients:

Lactose monohydrate

Microcrystalline cellulose (Avicel 101),

Pregelatinised starch

Maize starch

Colloidal anhydrous silica

Magnesium stearate

Film coating:

HPMC 2910/ Hypromellose

Titanium dioxide

Macrogol/PEG

Talc

What Losartan Potassium and Hydrochlorothiazide looks like and contents of the pack

Losartan Potassium and Hydrochlorothiazide 50mg/12.5 mg: Yellow, oval, biconvex, film coated tablets with ‘C’ debossed on one side and ‘80’ on other side.

Losartan Potassium and Hydrochlorothiazide 100mg/12.5 mg: White circular, biconvex film coated Tablets with ‘C’ debossed on one side and ‘79’ on other side.

Losartan Potassium and Hydrochlorothiazide 100mg/25mg: Yellow, circular biconvex film coated tablets with ‘C’ debossed on one side and ‘78’ on other side.

Losartan Potassium and Hydrochlorothiazide is supplied in the following pack sizes:

Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg are supplied in Opaque white PVC/PVDC blister of 10 and 14 Tablets

Pack Size: 10, 14, 28,30, 50, 56, 84 and 100 Tablets

Losartan Potassium and Hydrochlorothiazide 50mg/12.5mg are supplied in HDPE container Pack size: 30, 500 Tablets

Losartan Potassium and Hydrochlorothiazide 100 mg/12.5 mg are supplied in Opaque white PVC/PVDC blister of 10 and 14 Tablets

Pack Size: 10, 14, 28, 30, 50, 56, 84 and 100 Tablets

Losartan Potassium and Hydrochlorothiazide 100mg/12.5mg are supplied in HDPE container Pack size: 30, 500 Tablets

Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/25 mg are supplied in Opaque white PVC/PVDC blister of 10 and 14 Tablets

Pack Size: 10, 14, 28, 30, 50, 56, 84 and 100 Tablets

Losartan Potassium and Hydrochlorothiazide 100mg/25mg are supplied in HDPE container Pack size: 30, 500 Tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Ipca Laboratories UK Ltd.
Unit 97-98
Silverbriar
Sunderland Enterprise Park East
Sunderland
SR5 2TQ
United Kingdom
Telephone: +44 (0) 1915166517
Fax: +44 (0) 1915166526
Email: [email protected]

This leaflet was last revised in 06/2025

Ipca Laboratories UK Ltd
Company image
Address
Silverbriar, Enterprise Park East, Sunderland,, Tyne and Wear, SR5 2TQ, UK
WWW
http://www.ipca.com
Telephone
+44 (0)7546 801 411
Fax
+44 (0) 191 516 6 526
Medical Information Direct Line
08003685328
Medical Information e-mail
[email protected]
Customer Care direct line
08003685328
Stock Availability
+44(0)7546 801 411