LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE 100MG /25MG TABLETS

Active substance: LOSARTAN POTASSIUM

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Package Leaflet: Information for the user
Losartan Potassium/ Hydrochlorothiazide
50mg/12.5mg, 100mg/25mg Tablets
Losartan Potassium and Hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine
beacuse 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 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. See section 4.
What is in this leaflet:
1. What Losartan potassium I Hydrochlorothiazide Tablets are and what they
are used for.
2. What you need to know before you take Losartan potassium I
Hydrochlorothiazide Tablets.
3. How to take Losartan potassium I Hydrochlorothiazide Tablets.
4. Possible side effects.
5. How to store Losartan potassium I Hydrochlorothiazide Tablets.
6. Contents of the pack and other information.
1. WHAT LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE TABLETS
ARE AND WHAT THEY ARE USED FOR
Losartan potassium / Hydrochlorothiazide tablet contains two active
ingredients.
These are Losartan potassium and Hydrochlorothiazide. Losartan belongs
to a group of medicines known as angiotensin-ll receptor antagonists.
Angiotensin II is a chemical occurring in the body, which tightens your blood
LOSARTAN POTASSIUM /
vessels making it harder for the blood to pass through them and causing
HYDROCHLOROTHIAZIDE
your blood pressure to increase.
50mg/12.5mg, 100mg/25mg TABLETS
Losartan potassium / Hydrochlorothiazide tablets block this effect of
237174
angiotensin II, causing the blood vessels to relax. Hydrochlorothiazide works
by making your kidneys pass more water and salt. Together, losartan and
hydrochlorothiazide lower high blood pressure.

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K

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN POTASSIUM
/ HYDROCHLOROTHIAZIDE TABLETS
Do not take losartan / hydrochlorothiazide tablets:
• if you are allergic to losartan, hydrochlorothiazide or to any of the other
ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to other sulphonamide-derived
medicines (e.g. other thiazides, some antibacterial drugs such as cotrimoxazole, ask your doctor if you are not sure)
• if you are more than 3 months pregnant. (It is also better to avoid Losartan
/ Hydrochlorothiazide tablets in early pregnancy - see pregnancy section.)
• 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 have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren.
If you think any of these apply to you, do not take the tablets. Talk to your
doctor first and follow the advice given.

Warnings and Precautions
Talk to your doctor or pharmacist before taking Losartan/Hydrochlorothiazide
tablets
• if you have previously suffered from swelling of the face, lips, throat or
tongue
• if you take diuretics (water tablets)
• 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 a “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 erythematosus).
• 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 aldesterone by the adrenal gland,
caused by an abnormality within the gland).
• You must tell your doctor if you think you are (or might become) pregnant.
Losartan / Hydrochlorothiazide tablets 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 at that stage (see
pregnancy section).
• If you are taking any of the following medicines used to treat high blood
pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular
if you have diabetes-related kidney problems.
- 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 Tablets’.
Other medicines and Losartan potassium / Hydrochlorothiazide tablets
Tell your doctor or pharmacist if you are taking have recently taken or might
take any other medicines.
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 tablets”
and “Warnings and precautions”).
You should also tell your doctor if you are taking any of the following:
• Potassium supplements, potassium sparing agents, or potassiumcontaining salt substitutes
• Rifampicin, a drug used in the treatment of tuberculosis (TB)
• Fluconazole, a drug used for treating fungal infections such as thrush
• NSAlDs (non-steroidal anti-inflammatory drugs) such as indomethacin,
used to treat patients with arthritis and for treating certain types of pain
• Tricyclic antidepressants, drugs used to treat depression and anxiety
• Antipsychotics, medicines used to treat conditions such as schizophrenia

• Antispasmotics such as baclofen or medicines which relax your muscles
(tubocurarine)
• Anticholinergic agents such as atropine used to treat muscular spasm and
asthma
• Medicines used to treat cancer such as amifostine or methotrexate
• Alcohol (this may affect your blood pressure)
• Barbiturates, sedative drugs which may be used in the treatment of
sleeplessness or epilepsy
• Narcotics, morphine like drugs used for severe pain
• Antidiabetic drugs (medicines for the treatment of diabetes), including oral
agents to lower blood sugar and insulin (metformin)
• Other drugs used to reduce blood pressure such as methyldopa
• Other diuretics (water tablets)
• Resins which are used to reduce high cholesterol levels (colestyramine /
colestipol)
• ACTH (corticotrophin), used to test whether your adrenal glands are
working properly
• Corticosteroids, used to treat various conditions including rheumatism,
arthritis, allergic conditions, certain skin diseases, asthma or certain blood
disorders
• Pressor amines, such as adrenaline used for the treatment of hypotension,
shock, cardiac failure, asthma or allergies
• Lithium, a drug used to treat certain mental disorders.
• Medicines used to treat gout (probenecid)
• Medicines used to treat epilepsy (such as carbamazepine)
• Digitalis glycosides such as digoxin which is used to treat certain heart
conditions
• Medicines used to treat abnormal heart rhythm such as quinidine and
amiodarone
• Medicines used to suppress the immune function such as ciclosporin
• Antifungal agents such as amphotericin, corticosteroids, laxatives such as
senna (may increase the amount of potassium excreted) or glycyrrhizin
(found in liquorice).
Losartan Potassium I Hydrochlorothiazide Tablets with food and drink
Losartan potassium I Hydrochlorothiazide Tablets does not usually interact
with food therefore it can be administered with or without food. You are
advised not to drink alcohol whilst taking these tablets; alcohol and losartan /
hydrochlorothiazide tablets may increase each other’s effects.
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 /
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 / hydrochlorothiazide tablets.
Losartan/hydrochlorothiazide tablets is 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Losartan/hydrochlorothiazidetabletsisnotrecommendedformotherswhoare
breast-feeding, and your doctor may choose another treatment for you if you
wish to breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine.
Children and adolescents:
There is no experience with the use of losartan/hydrochlorothiazide tablets in
children. Therefore, these tablets should not be given to children.

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/hydrochlorothiazide tablets contains lactose:
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The usual dose is 50 mg losartan potassium and 12.5 mg hydrochlorothiazide
daily. If your blood pressure is not controlled with this, your doctor will
normally prescribe one tablet of Losartan potassium and hydrochlorothiazide
daily (100 mg losartan potassium and 25 mg hydrochlorothiazide).
Losartan potassium I hydrochlorothiazide tablets should be swallowed with
a glass of water.
You must keep taking Losartan potassium I hydrochlorothiazide tablets every
day and exactly as your doctor has told you. It is important that you take
Losartan potassiumIhydrochlorothiazide tablets for as long as your doctor
prescribes, in order to keep your blood pressure controlled.
If you are aged over 75 years you should check with your doctor before
taking your tablets.
You can take Losartan potassium / hydrochlorothiazide tablets with or
without food. It is recommended that you take your tablet at the same time
each day.
If you take more Losartan potassium / Hydrochlorothiazide tablets than
you should
If you take an overdose by mistake, contact your doctor immediately or attend
the nearest hospital casualty department. Overdosage can cause a drop in
blood pressure, palpitations, slow pulse, changes in blood composition and
dehydration.
If you forget to take Losartan potassium / Hydrochlorothiazide tablets or
take too many
Try to take Losartan potassium and Hydrochlorothiazide daily as prescribed.
However, if you miss a dose, just carry on with the next dose as normal. Do
not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, 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 your 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 with losartan /
hydrochlorothiazide tablets:
Common may affect up to 1 in 10 people:
• cough, upper airway infection, congestion in the nose, sinusitis, sinus
disorder
• dizziness, headache, insomnia
• diarrhoea, abdominal pain, nausea, indigestion

• muscle pain or cramps, leg pain, back pain
• weakness, tiredness, chest pain
• increased potassium levels (which can cause an abnormal heart rhythm),
decreased haemoglobin levels.
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 and bruising.
• 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.
• 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, 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 infection, sugar in the urine
• Decreased sexual appetite, impotence
• Swelling of the face, fever
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
• Abnormal muscle breakdown which can lead to kidney problems
(rhabdomyolysis)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine the safety of this medicine.
5. HOW TO STORE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE
TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in original package, in order to protect from
moisture.
Do not use the tablets after the expiry date, which is stated on the carton
after ‘EXP’.
The expiry date refers to the last day of that month.

Disposal
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Losartan Potassium I Hydrochlorothiazide Tablets contain
Active ingredients:
The active substances are losartan potassium 50 mg equivalent to
45.8 mg of Losartan and 12.5 mg hydrochlorothiazide for losartan potassium/
hydrochlorothiazide 50mg / 12.5mg tablets.
The active substances are losartan potassium 100 mg equivalent to
91.6 mg of Losartan and 25 mg hydrochlorothiazide for losartan potassium /
hydrochlorothiazide 100 mg/25mg tablets.
Other ingredients: Lactose anhydrous, Cellulose microcrystalline, Starch
Pregelatinised, Silica Colloidal anhydrous, Magnesium Stearate.
The coating of Losartan potassium / hydrochlorothiazide tablets contains
hypromellose, hydroxypropylcellulose, titanium dioxide, iron oxide yellow.
What Losartan Potassium I Hydrochlorothiazide Tablets look like and the
contents of the pack
Losartan potassium/Hydrochlorothiazide 50mg / 12.5 mg Tablet is available
as Yellow, capsule shaped, biconvex, film-coated tablets, debossed with ‘50’
on one side and plain on the other side.
Losartan potassium/Hydrochlorothiazide 100mg / 25 mg Tablet is available
as yellow, tear drop shaped, biconvex, film-coated tablets, debossed with
‘100’ on one side and plain on the other side.
Losartan potassium / Hydrochlorothiazide Tablets 50mg / 12.5mg as well as
100mg / 25mg are supplied in blister packs of 28 tablets
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited,
Victoria Court,
Bexton Road,
Knutsford,
Cheshire WA16 OPF
United Kingdom
This leaflet was last revised in September 2014
CODE NO. GO/DRUGS/654

ID#: 237174

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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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