LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE 100/25 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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Jubilant Pharmaceuticals nv

Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
PILE – p. 1/8
June 2013

PACKAGE LEAFLET: INFORMATION FOR THE USER
Losartan Potassium/Hydrochlorothiazide 100/25 mg, film-coated tablets
losartan potassium and hydrochlorothiazide
Read all of this leaflet carefully before you start 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 or your pharmacist.

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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1.
What Losartan Potassium/Hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Losartan
Potassium/Hydrochlorothiazide
3.
How to take Losartan Potassium/Hydrochlorothiazide
4.
Possible side effects
5.
How to store Losartan Potassium/Hydrochlorothiazide
6.
Contents of the pack and other information

1.

What Losartan Potassium/Hydrochlorothiazide is and what it is used for

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

2.

What you need to know before you take Losartan
Potassium/Hydrochlorothiazide

Do not take Losartan Potassium/Hydrochlorothiazide



if you are allergic to losartan, hydrochlorothiazide or any of the other
ingredients of this medicine (listed in section 6)
if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.
g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your
doctor if you are not sure)

Jubilant Pharmaceuticals nv







Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
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June 2013

if you are more than 3 months pregnant. (It is also better to avoid Losartan
Potassium/Hydrochlorothiazide in early pregnancy - See Pregnancy.)
if you have severely impaired liver function
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.

Warnings and precautions
You must tell your doctor if you think you are (or might become) pregnant. Losartan
Potassium/ 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).
Talk to your doctor or pharmacist before taking Losartan
Potassium/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/
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 erythematodus)
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).

Jubilant Pharmaceuticals nv

Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
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June 2013

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.
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.
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 measures (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

other agents for diabetes or insulins
Please also inform your doctor if you are taking Losartan
Potassium/Hydrochlorothiazide if and you will be undergoing a radiographic
procedure and will be given iodine contrast media.

Jubilant Pharmaceuticals nv

Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
PILE – p. 4/8
June 2013

Losartan Potassium/Hydrochlorothiazide with food, drink and alcohol
You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan
Potassium/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 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
Potassium/Hydrochlorothiazide is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast
feed. Especially if your baby is a newborn, or born prematurely.
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/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 medicines.

3.

How to take Losartan Potassium/ Hydrochlorothiazide

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

Jubilant Pharmaceuticals nv

Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
PILE – p. 5/8
June 2013

High Blood Pressure
The usual dose of Losartan Potassium/Hydrochlorothiazide for most patients with
high blood pressure is 1 tablet of Losartan Potassium/Hydrochlorothiazide 50/12,5 mg
per day to control blood pressure over the 24-hour period. This can be increased to 2
tablets (once daily of Losartan Potassium/Hydrochlorothiazide 50 mg/12,5 mg filmcoated tablets or changed to one tablet daily of Losartan
Potassium/Hydrochlorothiazide 100 mg/25 mg film-coated tablets (a stronger
strength) per day. The maximum daily dose is 2 tablets per day of Losartan
Potassium/Hydrochlorothiazide 50/12.5mg film-coated tablets or 1 tablet daily of
Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg film-coated tablets.
Method of administration
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of
water).
The tablets should be taken with breakfast.
If you take more Losartan Potassium/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/Hydrochlorothiazide
Try to take Losartan Potassium/Hydrochlorothiazide daily as prescribed. However, if
you miss a dose, do not take an extra dose.
Just resume your usual schedule.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

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/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.

Jubilant Pharmaceuticals nv

Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
PILE – p. 6/8
June 2013

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, localised swelling (oedema), fever

Jubilant Pharmaceuticals nv

Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
PILE – p. 7/8
June 2013

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-colored) urine (rhabdomyolysis)

Low levels of sodium in the blood (hyponatraemia)

Generally feeling unwell (malaise)
If you get any side effects, talk to your doctor or pharmacist. This includes any side
effect not listed in this leaflet.

5.

How to store Losartan Potassium/ 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 carton after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
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/Hydrochlorothiazide contains
The active substances are losartan potassium and hydrochlorothiazide.
Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide
(HCT).
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinised
maize starch, magnesium stearate (E572).
Tablet film-coating: titanium dioxide (E171), hypromellose 6cP (E464),
hydroxypropylcellulose (E463), quinoline yellow (E104) aluminium lake.

Jubilant Pharmaceuticals nv

Losartan Potassium/Hydrochlorothiazide100/25 mg
film-coated tablets
PILE – p. 8/8
June 2013

What Losartan Potassium/Hydrochlorothiazide looks like and contents of the
pack
Losartan Potassium/Hydrochlorothiazide 100/25 mg tablets are yellow coloured, oval
shaped film-coated tablets, debossed with ‘J’ on one side and ‘100+’ on the other.
14, 28, 30, 50, 56 and 98 film-coated tablets in Al/Al blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturers
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Distributed by
Aspire Pharma Ltd,
Antrobus House,
18 College Street,
Petersfield, Hampshire,
GU31 4AD,
United Kingdom
This medicinal product is authorised in the EEA under the following
names:
The Netherlands:
United Kingdom:
Sweden:
Denmark:
Germany:

Losartankalium/HCT 100/25 mg Jubilant, filmomhulde
tabletten
Losartan Potassium/Hydrochlorothiazide 100/25 mg
film-coated tablets
Losartan/hydroklortiazid Jubilant 100 mg/25 mg, filmdragerad
tablett
Losartan/hydroklortiazid Jubilant 100 mg/25 mg,
filmovertrukket tablet
Losartan-Kalium/Hydrochlorothiazid Jubilant Pharmaceuticals
100 mg/25 mg, Filmtabletten

This leaflet was last revised in 06/2013.

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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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