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LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 50 MG/12.5 MG FILM-COATED TABLETS
Active substance(s): HYDROCHLOROTHIAZIDE / LOSARTAN POTASSIUM
231-30-86263-ZA LEA LOSARTAN POTASSIUM AND HCTZ A/S TAB TUK
28 September 2015
PAGE 1: FRONT FACE (INSIDE OF REEL)
What is in this leaflet:
1. What Losartan potassium and Hydrochlorothiazide tablets are
and what they are used for
2. What you need to know before you take Losartan potassium
and Hydrochlorothiazide tablets
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
Pharma code 1710
What Losartan potassium and Hydrochlorothiazide
tablets are and what they are used for
Losartan and Hydrochlorothiazide is a combination of an
angiotensin II receptor antagonist (losartan) and a diuretic
Losartan and Hydrochlorothiazide is indicated for the treatment of
essential hypertension (high blood pressure).
What you need to know before you take Losartan
potassium and Hydrochlorothiazide tablets
Do not take Losartan potassium and Hydrochlorothiazide tablets:
• if you are allergic to losartan, hydrochlorothiazide or to any of
the other ingredients in 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 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 are more than 3 months pregnant. (It is also better to
avoid Losartan potassium and Hydrochlorothiazide in early
pregnancy – see section 2: Pregnancy, breast-feeding and fertility.)
• if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan
potassium and Hydrochlorothiazide tablets:
• 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 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
• 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
• if you suffer from primary hyperaldosteronism (a syndrome
associated with increased secretion of the hormone aldesterone
by the adrenal gland, caused by an abnormality within the
• you must tell your doctor if you think you are (or might become)
pregnant. Losartan potassium and Hydrochlorothiazide is not
Other medicines and Losartan potassium and Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking or 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. 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 potassium
supplements, potassium-containing salt substitutes or
potassium-sparing medicines, other diuretics (“water tablets”),
some laxatives, glycyrrhizin (found in liquorice), 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 or 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.
Your doctor may need to change your dose and/or to take other
If you are taking an ACE-inhibitor or aliskiren (see also information
under the headings ‘Do not take ‘Losartan potassium and
Hydrochlorothiazide tablets’ and ‘Warnings and precautions’).
Please also inform your doctor when it is planned to apply iodine
contrast media about taking Losartan potassium and
Losartan potassium and Hydrochlorothiazide tablets with food
,drink and alcohol
You are advised not to drink alcohol whilst taking these tablets:
alcohol and Losartan potassium and Hydrochlorothiazide tablets
may increase each other’s effects.
Dietary salt in excessive quantities may counteract the effect of
Losartan potassium and Hydrochlorothiazide tablets.
You should avoid food and drink containing liquorice as
glycyrrhizin, which is found in liquorice, may cause abnormal
blood electrolyte levels.
Losartan potassium and Hydrochlorothiazide tablets may be taken
with or without food.
Pregnancy,breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
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 tablets 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 tablets. Losartan potassium
and 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.
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Losartan potassium and Hydrochlorothiazide
tablets are not recommended for mothers who are breast-feeding,
and your doctor may choose another treatment for you if you wish
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
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.
Page 1 of 3
Top of page cut-off to middle of registration mark: 44 mm.
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 section 2: Pregnancy,
breast-feeding and fertility).
• if you are taking any of the following medicines used to treat
high blood pressure:
PACKAGE LEAFLET: INFORMATION FOR THE USER
• an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in
particular if you have diabetes-related kidney problems.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Your doctor may check your kidney function, blood pressure, and
• Keep this leaflet. You may need to read it again.
the amount of electrolytes (e.g. potassium) in your blood at
• If you have any further questions, ask your doctor or
See also information under the heading ‘Do not take Losartan
• 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 potassium and Hydrochlorothiazide tablets’.
the same as yours.
Children and adolescents
• If you get any side effects, talk to your doctor or pharmacist. This There is no experience with the use of Losartan potassium and
includes any possible side effects not listed in this leaflet. See
Hydrochlorothiazide in children. Therefore, Losartan potassium
section 4 .
and Hydrochlorothiazide should not be given to children.
Losartan potassium and Hydrochlorothiazide
50 mg/12.5 mg Film-Coated Tablets
Losartan potassium and Hydrochlorothiazide
100 mg/25 mg Film-Coated Tablets
TEVA UK Ref:
231-30-86263-ZA LEA LOSARTAN POTASSIUM AND HCTZ A/S TAB TUK
28 September 2015
PAGE 2: REAR FACE (OUTSIDE OF REEL)
• Constipation, wind, stomach upsets, stomach spasms, vomiting,
dry mouth, inflammation of a salivary gland, toothache
• Jaundice (yellowing of the eyes and skin), inflammation of the
• 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
How to take Losartan potassium and
• Frequent urination including at night, abnormal kidney function
including inflammation of the kidneys, urinary infection, sugar
in the urine
Always take this medicine exactly as your doctor has instructed
you. Check with your doctor or pharmacist if you are not sure.Your • Decreased sexual appetite, impotence
Swelling of the face, fever
doctor will decide on the appropriate dose of Losartan potassium
Rare: may affect up to 1 in 1,000 people
and Hydrochlorothiazide depending on your condition and
• Hepatitis (inflammation of the liver), abnormal liver function
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
Not known: frequency cannot be estimated from the available
control of your blood pressure.
High blood pressure
• Abnormal muscle breakdown which can lead to kidney
The recommended dose of Losartan potassium and
Hydrochlorothiazide for most patients with high blood pressure is • Disturbed taste (dysgeusia)
1 tablet of Losartan potassium and Hydrochlorothiazide
Reporting of side effects
50 mg/12.5 mg per day to control blood pressure over the 24-hour
If you get any side effects, talk to your doctor, pharmacist or
period. This can be increased to 2 tablets once daily of
nurse. This includes any possible side effects not listed in this
Losartan/Hydrochlorothiazide 50 mg/12.5 mg Film-coated tablets
leaflet. You can also report side effects directly via the Yellow Card
or changed to 1 tablet daily of Losartan/Hydrochlorothiazide
Scheme at: www.mhra.gov.uk/yellowcard.
100 mg/25 mg Film-coated tablets (a stronger strength) per day.
By reporting side effects you can help provide more information
The maximum daily dose is 2 tablets per day of Losartan/
on the safety of this medicine.
Hydrochlorothiazide 50 mg/12.5 mg Film-coated tablets or 1 tablet
daily of Losartan/Hydrochlorothiazide 100 mg/25 mg Film-coated
How to store Losartan potassium and
If you take more Losartan potassium and Hydrochlorothiazide
tablets than you should
Keep this medicine out of the sight and reach of children.
In case of an overdose, contact your doctor immediately so that
Do not use this medicine after the expiry date which is stated on
medical attention may be given promptly. Overdosage can cause a
the carton after EXP. The expiry date refers to the last day of the
drop in blood pressure, palpitations, slow pulse, changes in blood
composition, and dehydration.
Do not store above 25° C.
If you forget to take Losartan potassium and Hydrochlorothiazide
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away of medicines you
Try to take Losartan/Hydrochlorothiazide tablets daily as
no longer use. These measures will help protect the environment.
prescribed. Do not take a double dose to make up for a forgotten
dose. Just resume your usual schedule.
Contents of the pack and other information
If you stop taking Losartan potassium and Hydrochlorothiazide
What Losartan potassium and Hydrochlorothiazide tablets
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
• The active substance are losartan potassium and
hydrochlorothiazide. Each tablet contains either 50 mg of
Possible side effects
losartan potassium and 12.5 mg of hydrochlorothiazide or
100 mg of losartan potassium and 25 mg of hydrochlorothiazide.
Like all medicines, this medicinecan cause side effects, although
other ingredients are
not everybody gets them.
Tablet core: lactose monohydrate, cellulose microcrystalline
If you experience the following, stop taking Losartan potassium
(E460a), pregelatinised starch (maize), magnesium stearate
and Hydrochlorothiazide tablets and tell your doctor immediately
or go to the casualty department of your nearest hospital:
poly(vinyl alcohol), titanium dioxide (E171), macrogol
• A severe allergic reaction (rash, itching, swelling of the face,
3350, talc (E553b), yellow iron oxide (E172).
lips, mouth or throat that may cause difficulty in swallowing or
What Losartan potassium and Hydrochlorothiazide tablets looks
This is a serious but rare side effect, which affects more than 1 out like and contents of the pack
of 10,000 patients but fewer than 1 out of 1,000 patients. You may • Losartan potassium and Hydrochlorothiazide 50/12.5 mg
Film-Coated Tablets are yellow, oval, bi-convex tablets, marked
need urgent medical attention or hospitalisation.
with “5” and “0” on one side and a score line on both sides
The following side effects have been reported:
tablet can be divided into equal doses.
Common: may affect up to 1 in 10 people
• Cough, upper airway infection, congestion in the nose, sinusitis, • Losartan potassium and Hydrochlorothiazide 100/25 mg
Film-Coated Tablets are yellow, oval, bi-convex tablets,
debossed "1" and "00" on one side and breakline on both sides.
• Diarrhoea, abdominal pain, nausea, indigestion
• Muscle pain or cramps, leg pain, back pain
The tablet can be divided into equal doses.
• Insomnia, headache, dizziness
• The 50/12.5 mg tablets are available in pack sizes of 1, 14, 20, 28,
• Weakness, tiredness, chest pain
30, 56, 60, 84, 90, 98 and 100 tablets, calendar packs of 28 tablets
• Increased potassium levels (which can cause an abnormal heart
and hospital packs of 50x1 and 280 (10x28) tablets
rhythm), decreased haemoglobin levels
HDPE bottles with tamper-evident screw cap: 100 and 250 tablets.
Uncommon: may affect up to 1 in 100 people
• The 100/25 mg tablets are available in pack sizes of 1, 7, 14, 20,
• Anaemia, red or brownish spots on the skin (sometimes
28, 30, 56, 60, 84, 90, 98 and 100 tablets, calendar packs of 7 and
especially on the feet, legs, arms and buttocks, with joint pain,
28 tablets and hospital packs of 50x1 and 280 (10x28) tablets.
swelling of the hands and feet and stomach pain), bruising,
HDPE bottles with tamper-evident screw cap: 30 and 100 tablets.
reduction in white blood cells, clotting problems and bruising
Not all pack sizes may be marketed.
• Loss of appetite, increased uric acid levels or frank gout,
increased blood sugar levels, abnormal blood electrolyte levels Marketing Authorisation Holder and Manufacturer
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East
• Anxiety, nervousness, panic disorder (recurring panic attacks),
Sussex, BN22 9AG, UK
confusion, depression, abnormal dreams, sleep disorders,
sleepiness, memory impairment
This leaflet was last revised in September 2015
• Pins and needles or similar sensations, pain in the extremities,
trembling, migraine, fainting
Losartan potassium and Hydrochlorothiazide Tablets contains
Losartan potassium and 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
• Blurred vision, burning or stinging in the eyes, conjunctivitis,
worsening eyesight, seeing things in yellow
• Ringing, buzzing, roaring or clicking in the ears
• 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
323 x 200
Page 2 of 3
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.