LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE 100MG /25MG TABLETS

Active substance: LOSARTAN POTASSIUM

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1448

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE
50mg/12.5mg, 100mg/25mg TABLETS
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed
on this leaflet, please tell your doctor or pharmacist

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In this leaflet:
1. What Losartan potassium I Hydrochlorothiazide Tablets are and what they are
used for.
2. 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. Further information.
1. HAT LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE TABLETS ARE
W
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 vessels making it
harder for the blood to pass through them and causing your blood pressure to
increase.
Losartan potassium / Hydrochlorothiazide tablets block this effect of 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.
2. BEFORE YOU TAKE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE
TABLETS
Do not take losartan / hydrochlorothiazide tablets:
• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of
the other ingredients in this medicine.
• if you are allergic (hypersensitive) to other sulphonamide-derived medicines
(e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, 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 think any of these apply to you, do not take the tablets. Talk to your doctor
first and follow the advice given.
Take special care with Losartan / Hydrochlorothiazide tablets
• if you have previously suffered from swelling of the face, lips, throat or tongue
• if you take diuretics (water tablets)

TEMPLE Packaging Pvt. Ltd.
28476001 Email:-temple@bom4.vsnl.net.in
Customer: Lupin Pharma
Location: Goa
Product Code & Name: 230677 Losartan Potassium/Hctz 50,12.5,100,25mg Tabs (Insert-Front)
SAP Code: 30100004610
Customer Artwork No.:
Version No.: 2
File No.: 29058
Date: 22.08.2012
Open Size: 350 x 220 mm
Font: 9pt. Helvetica Condensed
Folding Size: 59 x 56 mm
Substrate: 40 gsm Bible Paper
Barcode value:
Colours: 1(Black)
Pharmacode value: 1448
Artwork Sr. No.: 188/8/12
Preforation: No
Artwork Status: Final
Gluing: No
Note -
This approval will be considered for final printing.

Please recheck for corrections indicated earlier, in this proof also.
Prepared by :
Q.C. Checked
Checked by:
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Customer Approval

Checked by:
Approved by:
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Production
Regulatory Affairs Quality Assurance

• 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).
Taking Losartan Potassium and Hydrochlorothiazide with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines including medicines obtained without a prescription.
You should also tell your doctor if you are taking any of the following:
• Potassium supplements, potassium sparing agents, or potassium-containing
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).
Taking 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 / hydrochlorothiazide tablets is not recommended for mothers who are
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.
Use in 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.
Important information about some of the ingredients:
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 your tablets exactly as your doctor has told you. You should 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 a dose 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, losartan / hydrochlorothiazide tablets 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 side effects of medicines are classified as follows:
Very common: happening in more than 1 in 10 patients
common:
happening in 1 in 100 to 1 in 10 patients
uncommon: happening in 1 in 1,000 to 1 in 100 patients
rare:
happening in 1 in 10,000 to 1 in 1,000 patients
very rare:
happening in less than 1 in 10,000 patients
not known:
(cannot be estimated from the available data)
The following side effects have been reported with losartan / hydrochlorothiazide
tablets:
Common:
• 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:
• 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
• Hepatitis (inflammation of the liver), abnormal liver function tests
Not Known
• Abnormal muscle breakdown which can lead to kidney problems
(rhabdomyolysis)
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE
TABLETS
Keep out of the reach and sight 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
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

TEMPLE Packaging Pvt. Ltd.
28476001 Email:-temple@bom4.vsnl.net.in
Customer: Lupin Pharma
Location: Goa
Product Code & Name: 230677 Losartan Potassium/Hctz 50,12.5,100,25mg Tabs (Insert-Back)
SAP Code: 30100004610
Customer Artwork No.:
Version No.: 2
File No.: 29058
Date: 22.08.2012
Open Size: 350 x 220 mm
Font: 9pt. Helvetica Condensed
Folding Size: 59 x 56 mm
Substrate: 40 gsm Bible Paper
Barcode value:
Colours: 1(Black)
Pharmacode value: 1448
Artwork Sr. No.: 188/8/12
Preforation: No
Artwork Status: Final
Gluing: No
Note -
This approval will be considered for final printing.

Please recheck for corrections indicated earlier, in this proof also.
Prepared by :
Q.C. Checked
Checked by:
Approved by:
George
Customer Approval

Checked by:
Approved by:
Packaging Dvmpt.
Production
Regulatory Affairs Quality Assurance

6. FURTHER 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 August 2012
CODE NO. GO/DRUGS/654

ID#: 230677

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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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