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LOSARTAN HYDROCHLOROTHIAZIDE 100MG/25MG FILM-COATED TABLET

Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM

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PATIENT INFORMATION LEAFLET

LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
50mg/12.5mg AND 100mg/25mg 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. Do not pass it on to others. It may
harm them, even if their symptoms 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 your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of pack and other information

1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
The name of your medicine is Losartan potassium/Hydrochlorothiazide 50mg/12.5mg or
100mg/25mg Film-coated Tablets. Your medicine is referred to as Losartan
potassium/Hydrochlorothiazide Tablets or “your medicine” throughout this leaflet.
Losartan potassium/Hydrochlorothiazide Tablets are a combination of an angiotensin II
receptor (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 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/Hydrochlorothiazide Tablets are indicated for the treatment of essential
hypertension (high blood pressure).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YOUR MEDICINE
DO NOT take Losartan potassium/Hydrochlorothiazide Tablets:
 if you are allergic (hypersensitive) to losartan potassium, hydrochlorothiazide or to
any of the other ingredients of this medicine (listed in section 6),
 if you are allergic (hypersensitive) to other sulphonamide-derived substances (e.g.
other thiazides, some anti-bacterial drugs such as co-trimoxazole - ask your doctor if
you are not sure),
 if you have severely impaired liver function,
 if you are more than 3 months pregnant (It is also better to avoid Losartan
potassium/Hydrochlorothiazide Tablets in early pregnancy – see “Pregnancy and
breast-feeding” section)
 if you have severely impaired kidney function or your kidneys are not producing any
urine,
 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 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
Losartanpotassium/Hydrochlorothiazide Tablets.
You must tell your doctor if you think you are (or might become) pregnant. Losartan
potassium/Hydrochlorothiazide Tablets are 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 this medicine if you:
















have previously suffered from swelling of the face, lips, throat or tongue
take diuretics (“water tablets”)
are on a salt-restricted diet
have or have had severe vomiting and/or diarrhoea
have heart failure
liver function is impaired (see section 2 “Do not take Losartan
potassium/Hydrochlorothiazide Tablets”)
have narrow arteries to your kidneys (renal artery stenosis) or only have one
functioning kidney, or you have recently had a kidney transplant
have narrowing of the arteries to the heart (atherosclerosis), or suffer from angina
pectoris (chest pain due to poor heart function
have ‘aortic or mitral valve stenosis’ (narrowing of the valves of the heart) or
‘hypertrophic cardiomyopathy’ (a disease causing thickening of heart muscle)
are diabetic
have had gout
have or have had an allergic condition or asthma
have had a condition that causes joint pain, skin rashes and fever (systemic lupus
erythematosus (SLE))
have high calcium or low potassium levels
are on a low potassium diet





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.
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)
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
potassium/Hydrochlorothiazide”.
Children and adolescents
There is no experience with the use of Losartan potassium/Hydrochlorothiazide in
children. Therefore, Losartan potassium/Hydrochlorothiazide should not be given to
children.
Other medicines and Losartan potassium/ 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/Hydrochlorothiazide may interact with other medicines.
Preparations containing lithium should not be taken with Losartan potassium/
Hydrochlorothiazide without close supervision by your doctor.
Special precautionary measure (e.g. blood tests) may be appropriate if you take potassium
supplements, potassium-containing salt substitutes or potassium-sparing medicines, other
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 cholestyramine
 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/Hydrochlorothiazide” and “Warnings and
precautions”)
Please also inform your doctor you are taking Losartan
potassium/Hydrochlorothiazide if you will be undergoing a radiographic procedure
and will be given iodine contrast media.
Losartan potassium/Hydrochlorothiazide tablets with food and drink
You are advised not to drink alcohol whilst taking these tablets: alcohol and
Losartan/Hydrochlorothiazide tablets may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of Losartan
potassium/Hydrochlorothiazide tablets.
Losartan potassium/Hydrochlorothiazide tablets may be taken with or without food.

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/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/Hydrochlorothiazide.
Losartan potassium/Hydrochlorothiazide Tablets are 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/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/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 medicine, you should not perform tasks that may require
special attention (for example, driving an automobile or operating dangerous machinery) until
you know how you tolerate your medicine.

Losartan potassium/Hydrochlorothiazide Tablets contain 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 YOUR MEDICINE
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/Hydrochlorothiazide Tablets depending on your condition and whether
you are taking other medicines. It is important to continue taking your medicine 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/Hydrochlorothiazide for most patients with high blood
pressure is 1 tablet of Losartan potassium/Hydrochlorothiazide 50mg/12.5mg per day to
control blood pressure over the 24-hour period.
This can be increased to 2 tablets once daily of Losartan potassium/Hydrochlorothiazide
100mg/25mg (a stronger strength) per day.
The maximum daily dose is 2 tablets per day of Losartan potassium/Hydrochlorothiazide
50mg/12.5mg or 1 tablet daily of Losartan potassium/Hydrochlorothiazide 100mg/25mg.

If you take more of your medicine than you should
If 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 your medicine
Try to take your medicine 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, Losartan potassium/Hydrochlorothiazide Tablets can cause side effects,
although not everybody gets them.
If you experience the following, stop taking Losartan potassium/Hydrochlorothiazide Tablets
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:
Common (may affect up to 1 in 10 people):




cough, infection of the upper airways, congestion in the nose, sinusitis, sinus disorder
diarrhoea, abdominal pain, nausea (feeling sick), 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 lightheaded 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 and 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, localised swelling (oedema), feve
 Rare (may affect up to 1 in 1,000 people):
 hepatitis (inflammation of the liver), abnormal liver function tests
Not known (frequency cannot be estimated from the available data):
 Flu-like symptoms
 Unexplained muscle pain with dark (tea-coloured) urine (rhabdomylosis)
 Low levels of sodium in the blood (hyponatraemia)
 Generally feeling unwell (malaise)
 Disturbed taste (dysgeusia)

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 the yellow
card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE YOUR MEDICINE
Do not use your medicine after the expiry date which is stated on the carton. The expiry date
refers to the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
There are no special requirements to store the tablets at a particular temperature.
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 substances are losartan potassium and hydrochlorothiazide.
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg contains 50mg of losartan potassium
and 12.5mg of hydrochlorothiazide as the active ingredients.
Losartan potassium/Hydrochlorothiazide 100mg/25mg contains 100mg of losartan potassium
and 25mg of hydrochlorothiazide as the active ingredients.

Losartan potassium/Hydrochlorothiazide 50mg/12.5mg and 100mg/25mg Tablets contain the
following inactive ingredients: microcrystalline cellulose, lactose monohydrate,
pregelatinized maize starch, magnesium stearate, hydroxypropylcellulose, hypromellose,
titanium dioxide (E171), talc and yellow iron oxide (E172).
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg contains 4.24mg (0.108 mEq) of
potassium.
Losartan potassium/Hydrochlorothiazide 100 mg/25mg contains 8.48 mg (0.216 mEq) of
potassium.
What your medicine looks like and contents of the pack
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg is supplied as yellow, oblong, scored
on one side film-coated tablets.
Losartan potassium/Hydrochlorothiazide 100mg/25mg is supplied as yellow, round, scored on
one side film-coated tablets.
The score line is only to help breaking for ease of swallowing and not to divide into equal
doses.

Losartan potassium/Hydrochlorothiazide 50mg/12.5mg and 100mg/25mg are supplied in
blister packs of 28 film-coated tablets.

Marketing Authorisation Holder
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK
Losartan potassium/Hydrochlorothiazide 100mg/25mg : PL 20395/0108
And Losartan potassium/Hydrochlorothiazide 50mg/12.5mg : PL 20395/0109

This leaflet was last prepared in November 2016.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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