Patient leaflet - Losartan Potassium 10 mg/ml oral solution

1. What LOSARTAN 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 which binds to receptors in blood vessels, causing them to tighten.This results in an increase in blood pressure.

Losartan prevents the binding of angiotensin‑II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

LOSARTAN is used

to treat patients with high blood pressure (hypertension) in adults and in children and adolescents
6 ‑ 18 years of age.
to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal amount of protein). ^■to treat patients with chronic heart failure when therapy with specific medicines called
angiotensin‑converting‑enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan.
in patients with high blood pressure and a thickening of the left ventricle, LOSARTAN has been shown to decrease the risk of stroke (“LIFE indication”).

2. What you need to know before you take LOSARTAN

Do not take LOSARTAN

if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6), ^■if you are more than 3 months pregnant (It is also better to avoid LOSARTAN in early pregnancy ‑ see
Pregnancy),
if your liver function is severely impaired,
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.

You must tell your doctor if you think you are (or might become) pregnant. LOSARTAN 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:

if you have had a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4
‘Possible side effects’),
if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body, ^■if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special patient groups’),
if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
if your liver function is impaired (see sections 2 “Do not take LOSARTAN” and 3 “Dosage in special patient groups”),
if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ß‑blocker concomitantly, ^■if you have problems with your heart valves or heart muscle,
if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart)
or from cerebrovascular disease (caused by a reduced blood circulation in the brain), ^■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:
o an ACE‑inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes‑related kidney problems.
o 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 LOSARTAN”. ^■if you are taking other medications that may increase serum potassium (see section 2 “Other medicines and
LOSARTAN”).

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking LOSARTAN. Your doctor will decide on further treatment. Do not stop taking LOSARTAN on your own.

Children and adolescents

LOSARTAN has been studied in children. For more information, talk to your doctor.

LOSARTAN is not recommended for use in children suffering from kidney or liver problems, as limited data are available in these patient groups. LOSARTAN is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.

Other medicines and LOSARTAN

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

Tell your doctor if you are taking potassium supplements, potassium‑containing salt substitutes, potassium‑sparing medicines such as certain diuretics (amiloride, triamteren, spironolactone), or other medicines that may increase serum potassium (e.g., heparin, trimethoprim‑containing medicines), as the combination with LOSARTAN is not advisable.

Take particular care if you are taking the following medicines while under treatment with LOSARTAN: ^■other blood pressure lowering medicines as they may additionally reduce your blood pressure. Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine,

non‑steroidal anti‑inflammatory drugs such as indomethacin, including Cox‑2‑inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood pressure lowering effect of losartan.

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” and “Warnings and precautions”).

If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.

Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

LOSARTAN with food and drink

LOSARTAN may be taken with or without food.

Grapefruit juice should be avoided while taking LOSARTAN.

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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of LOSARTAN. LOSARTAN 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. LOSARTAN 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 a new‑born, or born prematurely.

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

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. LOSARTAN is unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.

LOSARTAN oral solution contains:

Glycerol: each 5 ml of oral solution contains 5.56 grams of glycerol (1.112 g/ml). Doses of 9 ml or more may cause headache, stomach upset and diarrhoea.

Sodium benzoate: this medicine contains 2 mg sodium benzoate in each 5 ml dose which is equivalent to 0.4 mg/ml. Propylene glycol: this medicine contains 4.18 mg of propylene glycol in each 5 ml dose which is equivalent to 0.84mg/ml of propylene glycol.

Sodium: this medicinal product contains less than 1 mmol sodium (23 mg) per 15 ml maximum daily dose, that is to say essentially “sodium free”.

Potassium: this medicine contains 4.24 mg potassium per 5ml dose (0.85 mg/ml).To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

3. How to take LOSARTAN

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, depending on your condition and whether you are taking other medicines. It is important to continue taking LOSARTAN for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

Adult patients with High Blood Pressure

Treatment usually starts with 50 mg losartan (5 ml) once a day.

The maximal blood pressure lowering effect should be reached 3‑6 weeks after beginning treatment. In some patients the dose may later be increased to 100 mg losartan (10 ml) once daily.

If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.

Use in children and adolescents

Children below 6 years of age

LOSARTAN is not recommended for use in children under 6 years old, as it has not been shown to work in this age group.

Children aged 6 - 18 years old

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg (2.5 ml) of LOSARTAN).

The doctor may increase the dose if blood pressure is not controlled.

Adult patients with high blood pressure andType 2 diabetes

Treatment usually starts with 50 mg losartan (5 ml) once a day.

Package leaflet: Information for the patient

Continued overleaf L9CD1RBJ1

PLFT0310‑0‑320

JOB INFORMATION

Product Name:

Supplier Code:

EAN Code:

No. of Colours:

Page Number: Tabbed:

Folded Size:

Pack Size:

Bottle Size: Strength:

Design Icon:

Change Control No.:
	MAIN BODY TEXT

Operator:

PRINT VERSION:

Operator:

APPROVALS
Third Party Approval
Sign:
Regulatory Approval
Sign:

JOB SPEC

IFICATION

03.07.2025

CJE

Losartan Oral

Solution UK

10m

g/ml

N/A

L9CD1RBJ1

N/A

PLFT0310-0-320

CR-01149

UKL511 LFT

160W x 640Lmm N/A

320

N/A

1 of 2

Univers LT Std Roman Univers LT Std Bold

The dose may later be increased to 100 mg losartan (10 ml) once daily depending on your blood pressure response.

Losartan may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha‑ or beta‑blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

Adult patients with Heart Failure

Treatment usually starts with 12.5 mg losartan (1.25 ml) once a day.

Generally, the dose should be increased weekly step‑by‑step i.e., 12.5 mg (1.25 ml) daily during the first week, 25 mg (2.5 ml) daily during the second week, 50 mg (5 ml) daily during the third week,100 mg (10 ml) daily during the fourth week, 150 mg (15 ml) daily during the fifth week, up to the maintenance dose as determined by your physician. A maximum dose of 150 mg losartan (15 ml) once daily may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta‑blocker.

Dosage in special patient groups

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years.The use of losartan is not recommended in patients with severe hepatic impairment (see section “Do not take LOSARTAN”).

Administration

Your pack contains a bottle of medicine with a cap, a bottle adaptor and a 10ml dosing syringe (see graduation scale below).

Always use the syringes provided to take your medicine. Take with a glass of water, see step 10 below.

When you use the medicine follow the instructions below:

1.
Open the bottle: press the cap and turn it anticlockwise
(Figure 1).
2.
Insert the syringe adaptor into the bottle neck and
leave in place for future doses (Figure 2).
3.
Push the tip of the dosing syringe into the hole in
the adaptor (Figure 2).
4. Turn the bottle upside down (Figure 3).
5.
Fill the syringe with a small amount of solution
by pulling the plunger down (Figure 4A). Push the
plunger upward in order to remove any possible
bubbles (Figure 4B). Finally, pull the plunger down
to the graduation mark corresponding to the
quantity in millilitres (ml) prescribed by your doctor
(Figure 4C). If you are not sure about how much
medicine to draw into the syringe, always ask your
doctor, pharmacist or nurse for advice.
6.
Turn the bottle back the right way up and carefully
remove the syringe from the adaptor, holding it by
the barrel rather than the plunger.
7.
Gently put the tip of the syringe into your mouth
and to the inside of your cheek.
8.
Slowly and gently push the plunger down to gently
squirt the medicine into the inside of your cheek and swallow it. DO NOT forcefully push down the plunger or squirt the medicine to the back of your mouth or throat, as you may choke.
9. Remove the syringe from your mouth.

10.Swallow the dose of oral solution then drink a glass of water, making sure no medicine is left in your mouth. 11. Put the cap back on the bottle with the adaptor left in place. Ensure that the cap is tightly closed. 12.Wash the syringe with cold or warm tap water and rinse well. Hold the syringe under water and move the plunger up and down several times to make sure the inside of the syringe is clean. Let the syringe dry completely before you use that syringe again for dosing. Store the syringe in a hygienic place with the medicine.

If you take more LOSARTAN than you should

If you accidentally take too much medicine, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.

If you forget to take LOSARTAN

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

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 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 hospitalisation.

The following side effects have been reported with LOSARTAN:

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

dizziness,
low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),
dose‑related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
debility,
fatigue,
too little sugar in the blood (hypoglycaemia),
too much potassium in the blood (hyperkalaemia),
changes in kidney function including kidney failure,
reduced number of red blood cells (anaemia),
increase in blood urea, serum creatinine and serum potassium in patients with heart failure.

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

somnolence,
headache,
sleep disorders,
feeling of increased heart rate (palpitations),
severe chest pain (angina pectoris),
shortness of breath (dyspnoea),
abdominal pain,
obstipation,
diarrhoea,
nausea,
vomiting,
hives (urticaria),
itching (pruritus),
rash,
localised swelling (oedema),
cough.

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

hypersensitivity,
angioedema,
intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea,
inflammation of blood vessels (vasculitis including Henoch‑Schönlein purpura), ^■numbness or tingling sensation (paraesthesia),
fainting (syncope),
very rapid and irregular heartbeat (atrial fibrillation),
brain attack (stroke),
inflammation of the liver (hepatitis),
elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.

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

reduced number of thrombocytes,
migraine,
liver function abnormalities,
muscle and joint pain,
flu‑like symptoms,
back pain and urinary tract infection,
increased sensitivity to the sun (photosensitivity),
unexplained muscle pain with dark (tea‑coloured) urine (rhabdomyolysis),
impotence,
inflammation of the pancreas (pancreatitis),
low levels of sodium in the blood (hyponatraemia),
depression,
generally feeling unwell (malaise),
ringing, buzzing, roaring, or clicking in the ears (tinnitus),
disturbed taste (dysgeusia).

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

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 via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRAYellow 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 LOSARTAN

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton or bottle label.
The expiry date refers to the last day of that month.
After first opening of the bottle, discard any unused contents after 60 days.
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 your medicine contains

The active substance is losartan potassium.
Each 1 ml of oral solution contains 10 mg losartan potassium.
The other ingredients are glycerol (E 422), polyethylene glycol 400 (E 1521), sodium benzoate (E 211), sucralose (E 955), xanthan gum (E 414) and peppermint flavour (contains: flavouring preparations, natural flavouring substances, propylene glycol, menthofuran and pulegone). See section 2 for further information about the glycerol, sodium benzoate, propylene glycol, sodium and potassium content.

What LOSARTAN looks like and contents of the pack

This medicine is a clear colourless solution. Losartan potassium oral solution is packed in 150ml HDPE bottle with a polypropylene 28mm child resistance closure. A 10ml HDPE oral syringe with markings at 1ml, 1.25ml, 2ml, 2.5ml, 3ml, 4ml, 5ml, 6ml, 7ml, 8ml, 9ml and 10ml and graduation every 0.25ml is provided together with an LDPE adaptor.

Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd,Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

Manufacturer: LM Manufacturing Limited, Sandretto Building Cavalry Hill Industrial Park, Northampton, Northamptonshire NN7 4PP, United Kingdom

Other sources of information

The same information is also available on the following website: www.medicines.org.uk This leaflet is also available in other formats for blind and partially‑sighted patients. For large print and Braille, please go to www.xpil.medicines.org

For an audio version, please go to www.rosemontpharma.com/products

This leaflet was last revised in 07/2025.