Losartan AHCL: detailed information

Package leaflet: Information for the user

Losartan AHCL 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicine
Please read 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 questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Losartan AHCL is and what it is used for
What you need to know before taking Losartan AHCL
How to take Losartan AHCL
Possible side effects
How to store Losartan AHCL
Contents of the pack and other information

1. What Losartan AHCL is and what it is used for

Losartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors on blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents the effects of angiotensin II by relaxing blood vessels, thereby lowering blood pressure. Losartan slows the decline in renal function in patients with high blood pressure and type II diabetes.

Losartan AHCL is used:

for the treatment of patients with high blood pressure (hypertension) (including adults and children and adolescents aged 6 to 18 years).
to protect the kidney in hypertensive patients with type II diabetes, who have laboratory evidence of impaired renal function and proteinuria ≥0.5 g/day (a condition in which the urine contains an abnormally high amount of protein).
for the treatment of patients with chronic heart failure, when therapy with specific medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to lower high blood pressure) is not considered suitable by the physician. If heart failure is stabilized with an ACE inhibitor, switching to losartan should not be done. In patients with high blood pressure and left ventricular hypertrophy, Losartan AHCL has been shown to reduce the risk of stroke ("LIFE indication").

2. What you need to know before taking Losartan AHCL

Do not take Losartan AHCL:

if you are allergic (hypersensitive) to losartan or to any of the excipients (listed in section 6).
if you have severely impaired liver function.
if you are pregnant, beyond 3 months (it is better to avoid using Losartan AHCL tablets even during the first trimester of pregnancy; see “Pregnancy”).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions:
Talk to your doctor, pharmacist, or nurse before taking Losartan AHCL.
You should contact your doctor if you think you may be pregnant (or could become pregnant). Losartan AHCL is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby when used at this stage (see section “Pregnancy”).
It is important to inform your doctor before starting Losartan AHCL if:

you have a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 “Possible side effects”)
you are experiencing excessive vomiting or diarrhoea leading to severe fluid and/or salt loss from your body
you are taking diuretics (medicines that increase the amount of fluid removed by the kidneys) or are on a low-sodium diet, which may lead to severe fluid and salt depletion (see section 3 “Dosage in special patient groups”)
you know you have narrowing or blockage of the blood vessels to the kidneys or have recently undergone a kidney transplant
you have impaired liver function (see section 2 “Do not take Losartan AHCL” and section 3 “Dosage in special patient groups”)
you suffer from heart failure with or without kidney damage or have life-threatening concomitant cardiac arrhythmia. Particular caution is required if you are also being treated with a ß-blocker
you have heart valve or heart muscle problems
you suffer from coronary heart disease (caused by reduced blood flow in the heart’s blood vessels) or cerebrovascular disease (caused by reduced blood circulation to the brain)
you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone from the adrenal gland due to an adrenal abnormality)
you are taking any of the following medicines for high blood pressure:
- an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren.
- Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also information under “Do not take Losartan AHCL”.
- Contact your doctor if, after taking Losartan AHCL, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Losartan AHCL on your own.

Children and adolescents
Losartan AHCL has been studied in children. Please consult your doctor for further information.
Losartan AHCL is not recommended for use in children with kidney or liver problems, as limited data are available for these patient groups.
Losartan AHCL is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Other medicines and Losartan AHCL:
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium (e.g., heparin, medicines containing trimethoprim), as concomitant use with Losartan Potassium Tablets is not recommended.
Exercise particular caution if you are taking any of the following medicines during treatment with Losartan AHCL:

other medicines that lower blood pressure, as they may further reduce blood pressure. Blood pressure may also be lowered by any of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine, non-steroidal anti-inflammatory drugs such as indometacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used for pain relief), as these may reduce the antihypertensive effect of losartan.
If your kidney function is reduced, concomitant use of these medicines may lead to worsening of kidney function.
Medicines containing lithium must not be taken in combination with losartan without strict medical supervision. Special precautionary measures (e.g., blood tests) may be required.
Your doctor may need to adjust the dose and/or take other precautions:
- if you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Losartan AHCL” and “Warnings and precautions”).

Losartan AHCL with food and drink:
Losartan AHCL can be taken with or without food.
Grapefruit juice should be avoided during treatment with Losartan Potassium Tablets.

Pregnancy and breastfeeding:
Pregnancy
Contact your doctor if you think you may be pregnant (or could become pregnant).
Taking losartan is not recommended during the first 12 weeks of pregnancy, and must not be taken after the 13th week, as its use during pregnancy may harm the unborn baby. If you become pregnant while taking losartan, inform your doctor immediately. Before planning a pregnancy, you should switch to an alternative treatment.

Breastfeeding
Talk to your doctor if you are breastfeeding or planning to breastfeed. Losartan AHCL tablets are not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if the baby is a newborn or premature infant.

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

Driving and using machines:
No studies on the ability to drive and use machines have been conducted.
It is unlikely that Losartan AHCL will affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness and drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before continuing such activities.

Important information about some excipients of Losartan AHCL
This medicine contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars (e.g., lactose), contact your doctor before taking this medicine.

3. How to take Losartan AHCL

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dosage of Losartan AHCL tablets based on your condition and whether you are taking other medicines. It is important that you continue taking Losartan AHCL tablets for the entire duration prescribed by your doctor to maintain good control of your blood pressure.

Adult patients with High Blood Pressure (Hypertension)

Treatment usually starts with 50 mg of losartan (one Losartan AHCL 50 mg tablet) once daily.

The maximum blood pressure-lowering effect should be achieved within 3–6 weeks after starting treatment. In some patients, the dose may be increased to 100 mg of losartan (two Losartan AHCL 50 mg tablets) once daily.

If you feel that the effect of losartan is too strong or too weak, speak with your doctor or pharmacist.

Adult patients with high blood pressure

Treatment usually starts with 50 mg of losartan (one losartan potassium 50 mg tablet) once daily.
The maximum blood pressure-lowering effect should be achieved 3–6 weeks after starting treatment. In some patients, the dose may subsequently be increased to 100 mg of losartan (two losartan potassium 50 mg tablets or one losartan potassium 100 mg tablet) once daily.

If you feel that the effect of losartan is too strong or too too weak, discuss this with your doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

Losartan AHCL is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Children aged 6 to 18 years

The recommended initial dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once daily (up to a maximum of 25 mg of losartan).
Your doctor may increase the dose if blood pressure is not adequately controlled.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Adult patients with high blood pressure and type II diabetes

Treatment usually starts with 50 mg of losartan (one Losartan AHCL 50 mg tablet) once daily.
The dose may subsequently be increased to 100 mg of losartan (two Losartan AHCL 50 mg tablets or one losartan potassium 100 mg tablet) once daily, depending on your blood pressure response.

Losartan AHCL tablets may be administered together with other medicines that reduce blood pressure (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally-acting agents), as well as insulin and other commonly used blood glucose-lowering medicines (e.g. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure

Treatment usually starts with 12.5 mg of losartan (one Losartan AHCL 12.5 mg tablet) once daily. In general, the dose should be increased step-by-step on a weekly basis (i.e. 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week), up to the maintenance dose as determined by your doctor. The maximum dose of 150 mg of losartan (e.g., three Losartan AHCL 50 mg tablets or one Losartan AHCL 100 mg tablet and one Losartan AHCL 50 mg tablet) may be used once daily. In the treatment of heart failure, losartan is generally used in combination with a diuretic (a medicine that increases the amount of water passing through the kidneys), and/or a digitalis glycoside (a medicine that helps make the heart stronger and more efficient), and/or a beta-blocker.

Dosage in special patient groups

Your doctor may prescribe a lower dosage, especially when starting treatment in certain patients, such as those receiving high doses of diuretics, patients with hepatic impairment, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartan AHCL").

Administration

The tablets should be swallowed with a full glass of water. You should take your daily dose at the same time each day. It is important that you continue taking Losartan AHCL for as long as prescribed by your doctor.

If you take more Losartan AHCL than you should

If you accidentally take too many tablets, or if a child ingests any, contact your doctor immediately. Symptoms of overdose include low blood pressure, increased heart rate, or decreased heart rate.

If you forget to take Losartan AHCL

If you accidentally forget to take a daily dose, take the next dose as usual. Do not take a double dose to make up for the missed tablet.

If you stop taking Losartan AHCL

Do not stop treatment without consulting your doctor, even if you feel better. It is important to continue taking Losartan AHCL for as long as prescribed by your doctor.

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

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
If any of the following occur, stop taking losartan tablets and consult your doctor immediately or go to the nearest emergency room:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing).
This is a serious but rare side effect occurring in more than 1 patient in 10,000 but less than 1 in 1,000. It may require urgent medical attention or hospitalisation.

The possible side effects are listed below by frequency according to the following classification:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

The following side effects have been reported with Losartan AHCL

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

dizziness,
low blood pressure (especially after excessive loss of fluid from the blood vessels, e.g. in patients with severe heart failure or receiving high doses of diuretics),
dose-dependent orthostatic effects such as drop in blood pressure upon standing up or changing from lying down),
weakness,
fatigue,
low blood sugar (hypoglycaemia),
high potassium levels in the blood (hyperkalaemia),
changes in kidney function including kidney failure,
reduced number of red blood cells (anaemia),
increased levels of blood urea, serum creatinine and serum potassium in patients with heart failure.

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

drowsiness,
headache,
sleep disorders,
sensation of rapid heartbeat (palpitations),
acute chest pain (angina pectoris),
shortness of breath (dyspnoea),
abdominal pain,
constipation,
diarrhoea,
nausea,
vomiting,
urticaria,
itching,
rash,
localized swelling (oedema),
cough.

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

hypersensitivity,
angioedema,
inflammation of blood vessels (vasculitis, including Henoch-Schönlein purpura),
numbness or tingling sensation (paraesthesia),
fainting (syncope),
fast and irregular heartbeat (atrial fibrillation),
stroke,
liver inflammation (hepatitis),
elevated levels of alanine aminotransferase (ALT) in the blood, usually resolving upon discontinuation of treatment,
intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

reduced number of platelets (thrombocytopenia),
migraine,
liver function abnormalities,
muscle and joint pain,
influenza-like symptoms, back pain, urinary tract infection, increased sensitivity to sunlight (photosensitivity), unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis), impotence, inflammation of the pancreas (pancreatitis), low sodium levels in the blood (hyponatraemia), depression, general feeling of being unwell (malaise), ringing, buzzing, roaring or crackling sounds in the ears (tinnitus), taste disturbance (dysgeusia).

Side effects in children are similar to those observed in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan AHCL

Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of the month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Losartan AHCL contains:
The active substance is Losartan Potassium.
For 25 mg: Each film-coated tablet contains 25 mg of losartan potassium, equivalent
to 22.9 mg of losartan.
For 50 mg: Each film-coated tablet contains 50 mg of losartan potassium, equivalent
to 45.8 mg of losartan.
For 100 mg: Each film-coated tablet contains 100 mg of losartan potassium, equivalent
to 91.7 mg of losartan.

The excipients are:
Tablet core: Lactose, pregelatinized maize starch, povidone K-90 (E1201), silicon dioxide (E551), talc (E553b), magnesium stearate (E572).
Film coating: Hydroxypropyl-cellulose (E463), hydroxypropyl-methylcellulose (E464), polyethylene glycol 400, titanium dioxide (E171), talc (E553b).

Description of the appearance of Losartan AHCL and package contents:
Losartan AHCL 25 mg: White to almost white, round, biconvex film-coated tablets, with a breakline on one side and an embossed "25" on the other side.
The breakline is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing into equal doses.

Losartan AHCL 50 mg: White to almost white, round, biconvex film-coated tablets, with a breakline on one side and an embossed "50" on the other side.
The breakline is intended only to facilitate breaking the tablet for easier swallowing and is not intended for dividing into equal doses.

Losartan AHCL 100 mg: White to almost white, round, biconvex, flat on one side and with an embossed "100" on the other side.

Losartan AHCL tablets are packaged in blisters made of clear polyvinyl chloride (PVC) 250μ with polyvinylidene chloride (PVdC) 90 gsm and an aluminum foil 25μ, or in HDPE bottles.
Pack sizes:
Blister packs: 21, 28, 30, 90 or 98 tablets
HDPE bottles for 50 mg and 100 mg: 250, 500 and 1000 tablets (for hospital use only)

Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Responsible for batch release:
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare single member S.A.
64 Km National Road Athens, Lamia,
Schimatari, 32009,
Greece

This medicinal product is authorized in the EEA Member States under the following names:

| Member State | Medicinal Product Name | |------------------|----------------------------| | Belgium | Losartan Potassium Accord 25/50/100 mg, comprimes pellicules / filmomhulde tabletten / Filmtabletten | | Estonia | Losartan Accord, 25/50/100 mg õhukese polümeerikattega tabletid | | Germany | Losartan-Kalium Accord 25/50/100 mg Filmtabletten | | Hungary | Losartan Potassium Accord 25/50/100 mg Filmtabletta | | Italy | Losartan AHCL 25/50/100 mg compresse rivestite con film | | Ireland | Losartan Potassium 25/50/100 mg Film-coated Tablets | | Latvia | Losartan Potassium Accord 25/50/100 mg apvalkotās tablets | | Malta | Losartan Potassium 25/50/100 mg Film-coated Tablets | | Netherlands | Losartan Potassium Accord 25/50/100 mg filmomhulde tabletten | | Portugal | Losartan Potassium Accord | | Spain | Losartan Accord 25/50/100 mg comprimidos recubiertos con película EFG | | United Kingdom | Losartan Potassium 25/50/100 mg Film-coated Tablets |

This patient information leaflet was last approved in 02/2026.