(50/12.5) mg - Pharmathen

PATIENT INFORMATION LEAFLET
FAXIVEN (50/12.5) mg & (100/25) mg
Losartan potassium & hydrochlorothiazide
1. DETERMINATION OF THE PHARMACEUTICAL
PRODUCT
1.1 FAXIVEN (50/12.5) mg and (100/25) mg
1.2 Composition:
Active substance: Losartan potassium
hydrochlorothiazide
Excipients:
Tablet core:
Microcrystalline Cellulose, Mannitol, Starch Pregelatinised,
Povidone, Sodium Starch Glycollate Type A, Magnesium
Stearate.
Coating:
Opadry 20J22730 (yellow) consisting of Hypromellose
5CP (E464), Titanium Dioxide (E171), Hyprolose (E463),
Propylene Glycol, Sorbitane Monooleate (E494), Sorbic
Acid (E200), Vanillin, Quinoline yellow, Aluminium Lake
(E104 CI 47005).
1.3 Pharmaceutical technical form:
Film-coated tablet
1.4 Contents in drastic substance:
FAXIVEN (50/12.5) mg, contains 50 mg losartan potassium
and 12,5 mg hydrochlorothiazide.
FAXIVEN (100/25) mg, contains 100 mg losartan
potassium and 25 mg hydrochlorothiazide.
1.5 Description-Package
Boxes of 10, 20 and 28 tablets
1.6 Pharmaceutical therapeutic class:
antihypertensive
Combination of one antagonist of the receptors of
angiostatine II and one diuretic (hydrochlorothiazide).
1.7 Marketing Authorisation Holder
Pharmathen S.A
6, Dervenakion Str.
15351,
Pallini, Athens,
Greece
1.8 Manufacturer
Pharmathen S.A
6, Dervenakion Str.
15351,
Pallini, Athens,
Greece
2. WHAT SHOULD YOU KNOW ABOUT THE DRUG
PRESCRIBED BY YOUR DOCTOR
2.1 General information
The component losartan of FAXIVEN decreases the
arterial pressure by the special inhibition of a substance
called angiotensin II. Angiotensin II contracts the vessels.
The component hydrochlorothiazide of FAXIVEN causes
the passage from your kidneys of more water and salt.
Losartan and Hydrochlorothiazide together decrease the
increased arterial pressure.
2.2 Indications
It is indicated for the treatment of hypertension for the
patients to monotherapy (single-agent therapy) does not
suffice.
2.3 Counter indications
Do not take the FAXIVEN if:
• you are allergic to any of its components
• you are allergic to any derivative of sulfonamide (ask
your doctor if you are not certain about what drugs are
sulfonamide derivatives)
• you have a serious renal disease
• you are pregnant, or breast feeding (see also 2.4.4. Use
in pregnancy and breast feeding)
• resisting to therapy
• hypokalemia, hyponatraemia, hypercalcemia,
symptomatic hyperuricemia.
2.4 Special caution during use
2.4.1 General
Tell to your doctor or your pharmacist any problem you
have or had and any allergies. Tell your doctor if yon
recently had excessive vomitus or diarrhea. It is very important
to tell your doctor if you have hepatic or renal disease,
stricture of the renal artery, kidney transplantation,
hypokalemia, hyponatremia, hypercalcemia, uric arthritis,
diabetes, systematic lupus erythematosus, congestive
cardiac failure, ischemic cardiac disease, cerebrovascular
disease. primary hyperaidosteronism, high levels of
cholesterine in blood or if you are on. other diuretics.
In such, cases, your doctor will probably need to adapt the
dosage of die drugs you are on.
Before any procedure of anesthesia (even by the dentist)
tell your doctor that you are on FAXIVEN because there is
a risk to have suddenly a decrease of the pressure due to
the anesthesia.
Although FAXIVEN contains a very small quantity of potassium,
it cannot substitute the supplements of potassium. If
your doctor lias prescribed supplements of potassium, you
must follow the therapy he will prescribe. During therapy
you must supervise the values of potassium, the electrolytes
and the se creatinine.
2.4.2 Use in children
There is no experience for the use of FAXIVEN in children,
therefore it should not be prescribed to children.
2.4.3 Use in elderly patients
Generally speaking FAXIVEN is effective and it is tolerated
as well as in younger patients in most elderly people.
2.4.4 Use in pregnancy and breast feeding
The use of FAXIVEN during pregnancy or breast feeding
is not indicated. If you are pregnant or if you become
pregnant when on FAXIVEN you must interrupt it and seek
advice from your doctor as soon as possible. Due to the
possibility of counter action in the breast feeding baby, it
must be decided if the breast feeding or the drug must be
interrupted,, taking into consideration the necessity of this
drug for the mother.
2.4.5 Driving and operating machines
Almost all patients can drive and operate machines but
you must not do jobs needing a special attention, (tor
instance, during a car or operating dangerous machines)
until you are certain about your tolerance of this drug.
2.4.6 Special caution for the excipients
See 2.3.
2.5 Counteraction with other drugs and other forms
of counteraction
You must inform your doctor on all other drugs you are
on or you intend to take, including those not needing a
prescription. It is particularly important, for your doctor
to know if you are on supplements of potassium, drugs
containing potassium or substitutes of sails containing
potassium, other drugs to decrease your pressure, other
diuretics, resins decreasing the increased cholesterol
(cholestyramine, cholestipole) drugs tor diabetes including
insulin, muscle relaxants, amgiocontracture amines as the
corticosteroids, the tetrakiosctide drugs for the pain and
anhritis named steroid anti-inflammatory drugs,
vaclophene lithium (a drug used for the treatment of a
precise form of depression).
Suppressants, tranquillizers, narcotics, alcohol and
analgesics may increase the decrease of arterial pressure
achieved by the FAXIVEN and for this reason, you must
keep your doctor informed.

You must also inform, your doctor if you are on antidepressants,
neuroleptics, asiernisole, terphenadine, erythromycin,
intravenous, vepridib alophantrin, pentamidine,
soultopride, vincamine, antiarrhythmia drugs, digitalis,
amphotericin B, laxatives stimulating the bowel movement,
metamorphine, amantadine, cyclosporine salts of calcium
and iodine contrast media,
2.6 Dosage and way of administration
doctor. It is important to continue on FAXIVEN for the
period prescribed by your doctor so as to maintain the
smooth control of arterial pressure.
The usual dosage to start and maintain the FAXIVEN is
one tablet FAXIVEN
(50/12.5) once daily. For the patients that do not
(50/12.5) the dosage may be increased to two tablets
(50/12.5) once daily or one tablet FAXIVEN (100/25) once
daily.
The maximum dose is two tablets FAXIVEN (50/12.5) once
daily or one tablet FAXIVEN (100/25) once daily.
The maxima antihypertensive action is achieved within a
period of 3 weeks after the onset of therapy.
The (100/25) should not he used as initial therapy in
with high doeses of diuretics).
The FAXIVEN is contraindicated in patients with serious
renal failure (creatinine clearance < 3.0 ml/min).
The FAXIVEN is not recommended for patients with
hepatic failure.
The FAXIVEN 50/12.5 and FAXIVEN 100/25 are the proper
alternatives for patients who can be on therapy
simultaneously with losartan and hydrochlorothiazide.
The FAXIVEN may be administered together with other
antihypertensives.
The FAXIVEN may be administered independently of the
meals.
Use in elderly patients
Clinical studies did not show clinically important
differences in the effectiveness and safety of the FAXIVEN
in elderly patients aged > 65 years.
No adaptation of the dose is necessary for the 50/12.5 in
these patients.
But, in elderly people over >75 years the initial dose
recommended is 25 mg losartan, that is ½ tablet FAXIVEN
50/12.5 mg.
In elderly patients the renal function should be supervised
as well as the potassium levels in blood.
Use in children
Effectiveness and safety in children are not yet
documented.
2.7 Overdosage
In case of overdosage, you must advise your doctor so as
to have immediate medical assistance.
2.8 What to do when you miss a dose
Try to take FAXIVEN every day as prescribed.
If you miss a dose, do not take any additional dose, you
must simply continue your usual program.
2.9 Undesirable effects
Each drug may have undesirable effects
In most patients, the FAXIVEN is well tolerated.
The most frequent reported in the clinical studies
undesirable effect is the dizziness.
Gastrenteric: Hepatitis has been reported occasionally in
patients on Losartan, diarrhea.
Respiratory: Cough has been reported.
Skin: rash
Also, undesirable effects seen separately with each one
of the components and may appear with, the FAXIVEN is
diarrhea, gastric irritation, cramps, dizziness, weakness,
eruption, edema of the face and hyperglycemia, glycosuria,
hyperurikemia, changes of potassium, blood urea, se
creatinine and disturbances of the electrolytes balance.
You must contact; your doctor immediately for any
undesirable effect you have even those not reported above
or for any unusual symptom.
2.10 Expiry date
Do not use the drug after the month and year mentioned
numbers show the month and the two last show the year.
2.11 Special precautions for the storage of the drug
Keep the drug in a temperature of ≤25°C.
Keep the contained well closed. Do not open the package
with the aluminum but only if you are ready to take the
drug.
Keep all drugs in a safe place for from the reach of
children.
2.12 Date of last review of the instructions for use
15/04/2008
3. INFORMATION CONCERNING THE R1G1 IT I \SE
OF THE DRUGS
This drug was prescribed by your doctor only for your
precise medical problem. You must, not give it to other
persons or use it for another disease without previous
advice of your doctor.
If during the treatment, a problem appears with this
drug, you must inform your doctor immediately or your
pharmacist.
If you have questions concerning the information of this
drug or you need a better information for your medical
problem do not hesitate to ask this information from your
doctor or your pharmacist.
You must take the drug according to the information you
are given in order to have an effective and sale drug.
For your safety and your health it is necessary to read
carefully all information concerning the drug.
Do not keep the drags in the cupboards of the bathroom
because heat and humidity may change the drug and
render it harmful to your health.
Do not keep drugs you need no more or drugs that have
expired.
For a greater safety, keep all drugs in a safe place far from
the reach of children.
4. Provision of the drug
This drug is sold only by medical prescription.
of this drug in the market, are as follows:
Hypersensitivity: Anaphylaxis reactions, angioedema. If
you present an allergic reaction including edema to the
lace, the lips, the larynx and the lingual that may cause
an obstruction of the airways and/or the tongue that may
drug and advise immediately your doctor.,