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

Active substance: LOSARTAN POTASSIUM

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TEVA UK Ref:

231-30-86263-W LEA LOSARTAN POTASSIUM AND HCTZ A/S TAB TUK

Version:

2

11 March 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

IN THIS LEAFLET:

Pharma code 1710

(Main)

1. What Losartan potassium and Hydrochlorothiazide
tablets are and what they are used for
2. Before you take Losartan potassium and
Hydrochlorothiazide tablets
3. How to take Losartan potassium and
Hydrochlorothiazide tablets
4. Possible side effects
5. How to store Losartan potassium and
Hydrochlorothiazide tablets
6. Further information

1

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 (hydrochlorothiazide).
Losartan and Hydrochlorothiazide is indicated for the
treatment of essential hypertension (high blood
pressure).

2

BEFORE YOU TAKE LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLETS

Do NOT take Losartan potassium and
Hydrochlorothiazide tablets:
• if you are allergic (hypersensitive) to losartan,
hydrochlorothiazide or to any of the other
ingredients of this medicine
• 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)
• if you are, think you may be or are planning to
become pregnant (see also “Pregnancy and
breast-feeding”)
• 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
pregnancy section).
Take special care with 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 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 potassium and
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).
Taking 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.
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;
(oral agents for diabetes or insulins).
Please also inform your doctor when it is planned to
apply iodine contrast media about taking Losartan
potassium and Hydrochlorothiazide.
Taking Losartan potassium and Hydrochlorothiazide
tablets with food and drink
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 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 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 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.
Breast-feeding
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 to
breast-feed.
Use in children and adolescents
There is no experience with the use of Losartan
potassium and Hydrochlorothiazide in children.
Therefore, Losartan potassium and
Hydrochlorothiazide should not be given to children.
Use in elderly patients
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 patients.
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
of Losartan potassium and Hydrochlorothiazide Tablets
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 medicinal product.

Top of page cut-off to middle of registration mark: 44 mm.

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:

Version:

231-30-86263-W LEA LOSARTAN POTASSIUM AND HCTZ A/S TAB TUK

2

PAGE 2: REAR FACE (OUTSIDE OF REEL)

3

HOW TO TAKE LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLETS

Always take Losartan potassium and
Hydrochlorothiazide tablets exactly as your doctor
has told you. Your doctor will decide on the
appropriate dose of Losartan potassium and
Hydrochlorothiazide depending on your condition
and 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 control of
your blood pressure.
High blood pressure
The usual dose of Losartan potassium and
Hydrochlorothiazide for most patients with high
blood pressure is 1 tablet of Losartan potassium and
Hydrochlorothiazide 50 mg/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/Hydrochlorothiazide 50 mg/12.5 mg
Film-coated Tablets or changed to 1 tablet daily of
Losartan/Hydrochlorothiazide 100 mg/25 mg
Film-coated Tablets (a stronger strength) per day. The
maximum daily dose is 2 tablets per day of
Losartan/Hydrochlorothiazide 50 mg/12.5 mg
Film-coated Tablets or 1 tablet daily of
Losartan/Hydrochlorothiazide 100 mg/25 mg
Film-coated Tablets.
If you take more Losartan potassium and
Hydrochlorothiazide tablets than you should
In case of an overdose, contact your doctor
immediately so that medical attention may be given
promptly. Overdosage can cause a drop in blood
pressure, palpitations, slow pulse, changes in blood
composition, and dehydration.
If you forget to take Losartan potassium and
Hydrochlorothiazide tablets
Try to take Losartan/Hydrochlorothiazide tablets daily
as prescribed. However, if you miss a dose, do not
take an extra dose. Just resume your usual schedule.

• 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 (more than 1 out of 10,000 patients and less
than 1 out of 1,000 patients):
• Hepatitis (inflammation of the liver), abnormal
liver function tests.
Not known (cannot be estimated, more than 1 out of
10,000 patients):
• Abnormal muscle breakdown which can lead to
kidney problems.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.

5

HOW TO STORE LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLETS

Keep out of the reach and sight of children.
Do not use Losartan potassium and
Hydrochlorothiazide tablets after the expiry date that
is stated on the carton after EXP The expiry date
.
refers to the last day of the month.
Do not store above 25°C.
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.

6

FURTHER INFORMATION

What Losartan potassium and Hydrochlorothiazide
tablets contain:
• The active ingredients are losartan potassium and
Like all medicines, Losartan potassium and
hydrochlorothiazide. Each tablet contains either
Hydrochlorothiazide tablets can cause side effects,
50 mg of losartan potassium and 12.5 mg of
although not everybody gets them.
hydrochlorothiazide or 100 mg of losartan
potassium and 25 mg of hydrochlorothiazide.
If you experience the following, stop taking Losartan
potassium and Hydrochlorothiazide tablets and tell
• The other ingredients are:
your doctor immediately or go to the casualty
Tablet core: lactose monohydrate, cellulose
department of your nearest hospital:
microcrystalline (E460a), pregelatinised starch
• A severe allergic reaction (rash, itching, swelling of
(maize), magnesium stearate (E572).
the face, lips, mouth or throat that may cause
Film-coat: poly (vinyl alcohol), titanium dioxide (E171),
difficulty in swallowing or breathing).
macrogol 3350, talc (E553b), yellow iron oxide (E172).
This is a serious but rare side effect, which affects
What Losartan potassium and Hydrochlorothiazide
more than 1 out of 10,000 patients but fewer than 1
tablets look like and contents of the pack:
out of 1,000 patients. You may need urgent medical
• Losartan potassium and Hydrochlorothiazide
attention or hospitalisation.
50/12.5 mg Film-coated Tablets are yellow, oval,
bi-convex tablets, marked with “5” and “0” on one
The following side effects have been reported:
side and a score line on both sides.
Common (affecting fewer than one person in 10 but
more than one person in 100):
The score line is only to facilitate breaking for ease of
• Cough, upper airway infection, congestion in the
swallowing and not to divide into equal doses.
nose, sinusitis, sinus disorder
• Losartan potassium and Hydrochlorothiazide
• Diarrhoea, abdominal pain, nausea, indigestion
100/25 mg Film-coated Tablets are yellow, oval,
• Muscle pain or cramps, leg pain, back pain
bi-convex tablets, debossed "1" and "00" on one
• Insomnia, headache, dizziness
side and breakline on both sides.
• Weakness, tiredness, chest pain
The breakline is only to facilitate breaking for ease
• Increased potassium levels (which can cause an
of swallowing and not to divide into equal doses.
abnormal heart rhythm), decreased haemoglobin
levels.
• The 50/12.5 mg tablets are available in pack sizes
of 1, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
Uncommon (affecting fewer than one person in 100
calendar packs of 28 tablets and hospital packs of
but more than one person in 1,000):
50x1 and 280 (10x28) tablets.
• Anaemia, red or brownish spots on the skin
HDPE bottles with tamper-evident screw cap:
(sometimes especially on the feet, legs, arms and
100 tablets.
buttocks, with joint pain, swelling of the hands and
• The 100/25 mg tablets are available in pack sizes of
feet and stomach pain), bruising, reduction in
1, 7, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets,
white blood cells, clotting problems and bruising
calendar packs of 7 and 28 tablets and hospital
• Loss of appetite, increased uric acid levels or frank
packs of 50x1 and 280 (10x28) tablets.
gout, increased blood sugar levels, abnormal
HDPE bottles with tamper-evident screw cap:
blood electrolyte levels
30 and 100 tablets.
• Anxiety, nervousness, panic disorder (recurring
panic attacks), confusion, depression, abnormal
Not all pack sizes may be marketed.
dreams, sleep disorders, sleepiness, memory
Marketing Authorisation Holder and Manufacturer
impairment
TEVA UK Limited, Eastbourne, BN22 9AG
• Pins and needles or similar sensations, pain in the
This leaflet was last revised in March 2014
extremities, trembling, migraine, fainting
• Blurred vision, burning or stinging in the eyes,
PL 00289/0967-0968
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
86263-W
spasms, vomiting, dry mouth, inflammation of a
salivary gland, toothache
160 x 323

4

POSSIBLE SIDE EFFECTS

11 March 2014

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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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