Download vector plus vector plus vector plus 80/12.5 160/12.5 160/25

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only.
VECTOR PLUS VECTOR PLUS VECTOR PLUS
80/12.5
Film-coated tablets
160/12.5
Film-coated tablets
160/25
Film-coated tablets
Composition:
Composition:
Composition:
Each tablet contains:
Each tablet contains:
Each tablet contains:
Valsartan 80 mg
Valsartan 160 mg
Valsartan 160 mg
Hydrochlorothiazide 12.5 mg Hydrochlorothiazide 12.5 mg Hydrochlorothiazide 25 mg
Inactive ingredients: see section 6: “Further information”.
Read this leaflet carefully in its entirety before using the medicine. This leaflet
contains concise information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment. Do not pass it on to
others. It may harm them, even if it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of hypertension in patients for whom combined therapy is needed.
Angiotensin II is a natural substance found in the body that causes constriction of
blood vessels, thus causing a rise in blood pressure. The active ingredient valsartan
in Vector Plus blocks the effect of angiotensin II. As a result, blood vessels relax and
blood pressure drops.
Diuretics reduce the amount of salts and water in the body by increasing the output
of urine.
Prolonged use helps to reduce and balance blood pressure.
Hypertension increases the workload of the heart and arteries. If this continues for a
long time, it can damage the blood vessels of the brain, heart and kidneys, which may
result in a stroke, heart failure, or kidney failure. Hypertension increases the risk of heart
attacks. Lowering the blood pressure to a normal level reduces the risk of developing
these disorders.
If you have questions about how Vector Plus works or why this medicine was prescribed
for you, ask the doctor.
Therapeutic group: A combination of an angiotensin II receptor antagonist with a
diuretic
2. BEFORE USING THE MEDICINE
If you are sensitive to any food or medicine, inform the doctor before taking the medicine.
This medicine is not intended for children and infants.
Do not use the preparation if:
∙ You are in the fourth or later month of pregnancy, namely, in the second or third
trimester of pregnancy (it is also preferable to avoid taking Vector Plus in the early
stages of pregnancy, see section 2 “Pregnancy and breastfeeding”).
∙ You are sensitive (allergic) to the active ingredients, sulfonamides or to any of the
additional ingredients contained in the medicine, detailed in section 6. If you think
you are allergic, refer to the doctor for advice.
If you are not sure which medicines to avoid, refer to the doctor or pharmacist.
∙ You have a severe kidney disease with inability to produce urine.
∙ You have a severe liver disease with destruction of the small bile ducts within the
liver (biliary cirrhosis) leading to the build up of bile in the liver (cholestasis).
∙ You have a high level of sugar in the blood and you have diabetes or impaired kidney
function and you are concomitantly taking an antihypertensive which contains
aliskiren (such as Rasilez).
∙ You are undergoing dialysis.
If any of these situations apply to you, inform the doctor without taking Vector Plus.
Special warnings regarding use of the medicine:
Do not use the medicine without consulting the doctor before starting
treatment:
If you have kidney disorders; if you have ever had swelling, particularly of the face and
throat, when taking other medicines (including an ACE inhibitor). If these symptoms
apply to you, stop taking Vector Plus and contact the doctor immediately. Never
take Vector Plus again; if you have diabetes (high blood sugar level); if you have fever,
rash and joint pain, which may be signs of lupus erythematosus, or if you have had this
disease in the past; if the doctor has told you that you have low blood potassium levels
(with or without symptoms such as muscle weakness, muscle spasms, abnormal heart
rhythm); if the doctor told you that you have low blood sodium levels (with or without
symptoms such as tiredness, confusion, muscle spasms, contractions); if the doctor
has told you that you have high blood calcium levels (with or without symptoms such
as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle
weakness and muscle spasms); if the doctor has told you that you have high blood uric
acid levels; if you have an allergy or asthma; if the doctor has told you that you have high
blood cholesterol or triglycerides levels; if you suffer from vomiting or diarrhea, or if you
are taking a high dosage of diuretics; if you are breastfeeding; if you are suffering from
heart failure or if you had a heart attack. Strictly follow the doctor’s orders regarding the
starting dosage. The doctor may also check your kidney function.
If you are taking an ACE inhibitor or aliskiren.
If one or more of these conditions apply to you, inform the doctor before taking Vector
Plus.
If you develop any of these symptoms, inform the doctor immediately.
Inform the doctor immediately if you experience a decrease in vision or eye pain. These
could be symptoms of an increase of intraocular pressure which can occur within
hours to weeks of taking Vector Plus. If not treated, this can lead to permanent vision
impairment.
This preparation may change glucose tolerance.
If you are taking other medicines, including non-prescription medicines and nutritional
supplements, tell the doctor or pharmacist. In particular, inform the doctor or pharmacist
if you are taking medicines from the following groups:
Other antihypertensives, especially ACE inhibitors, such as enalapril, lisinopril, ramipril,
especially if you are suffering from impaired kidney function resulting from diabetes
or aliskiren; potassium-sparing medicines, potassium supplements, salt substitutes
containing potassium or other medicines that may change potassium levels in the
blood such as heparin. The doctor may perform periodic tests of your blood potassium
levels; certain antibiotics (from the rifamycin group), a medicine used to protect against
transplant rejection (ciclosporin) or an anti-retroviral used to treat HIV/AIDS infection
(ritonavir) may increase the effect of Vector Plus; lithium, antidepressants, antipsychotics
(medicines used to treat certain psychological conditions); vitamin D and calcium salts;
cortisone-like medicines, steroids, carbenoxolone (a medicine used to treat ulceration
and inflammation), antibiotics such as penicillin G, amphotericin, antiarrhythmics;
digoxin or other digitalis glycosides (medicines used to treat heart problems); insulin
or oral antidiabetics (medicines used to treat high blood sugar levels); cholestyramine,
colestipol or other resins (medicines used mainly to treat high lipid levels in the blood);
medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory
drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors). The
doctor may also check your kidney function; muscle relaxants (medicines used during
surgery); ciclosporin (a medicine used during transplantations and for autoimmune
disorders); allopurinol (a medicine used to treat gout); amantadine (a medicine used
to treat Parkinson’s disease and also used to treat or prevent certain illnesses caused
by viruses); diazoxide (a medicine used to treat high blood pressure or hypoglycemia);
certain medicines for treating cancer; methyldopa; anticholinergic medicines (medicines
used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder
spasm, asthma, motion sickness, muscle spasms, Parkinson’s disease and as an aid
to anesthesia); barbiturates, narcotics (medicines with sleep-inducing properties) and
alcohol; antiepileptics, such as carbamazepine (medicines used to treat convulsions);
pressor-amines, such as noradrenaline (substances that raise blood pressure).
Use of Vector Plus and food:
The medicine may be taken with or without food.
Pregnancy and breastfeeding:
Tell the doctor if you are pregnant, think that you are pregnant (or might become pregnant).
The doctor will normally advise you to stop taking the medicine before you become
pregnant or immediately after you know you are pregnant, and to take another medicine
instead of Vector Plus. The medicine is not recommended in early stages of pregnancy,
and is forbidden for use from the fourth month of pregnancy and onwards, as it may
cause severe harm to your baby.
Breastfeeding newborns in the first few weeks after delivery (especially premature babies)
is not recommended when taking the medicine.
If the baby is older, the doctor will tell you about the benefits and risks of taking Vector
Plus while breastfeeding in comparison to alternative treatment options.
Important information regarding some of the ingredients of the medicine: The
tablets contain lactose. If you have been told in the past by a doctor that you have an
intolerance to certain sugars, consult with the doctor commencing treatment with this
medicine.
Driving and drinking alcohol:
Like many other antihypertensives, Vector Plus may cause dizziness in certain patients.
Therefore, before driving a vehicle, operating machinery or carrying out any activity that
requires concentration, make sure you know how you react to the effects of Vector Plus.
Avoid drinking alcohol during the course of treatment, as it may cause an additional drop
in blood pressure and/or increase the likeliness of dizziness or fainting.
Sun exposure:
This medicine may cause particular sensitivity to sun exposure; therefore, avoid sun
exposure and be sure to have proper protection (long clothes, hat, sunscreens, etc.).
3. HOW SHOULD YOU USE THE MEDICINE?
Always use according to the doctor’s instructions.
Check with the doctor or pharmacist if you are uncertain.
The recommended dosage is one Vector Plus 80/12.5 or Vector Plus 160/12.5 or
Vector Plus 160/25 tablet, once a day.
The doctor may prescribe a higher or lower dosage of the medicine, depending on your
reaction to treatment.
Do not exceed the recommended dose.
Patients with high blood pressure usually do not notice the signs of this problem. Many
feel well. Therefore, it is very important to take the preparation exactly as instructed by
the doctor and to be sure to visit the doctor even if you feel well.
Use this medicine at regular intervals, as determined by the attending doctor, preferably
in the morning hours. Taking the medicine at the same time every day will help you
remember when to take the medicine.
Do not chew! Swallow the medicine with a glass of water.
The tablet can be crushed or halved – for immediate use.
Tests and follow-up:
Vector Plus can only be taken after a medical examination. Vector Plus may not be
suitable for all patients.
It is important that the attending doctor will check your progress at periodic visits, to be
sure that the medicine is working properly.
Regular blood tests may be performed before and during treatment with Vector Plus.
These tests will monitor the amount of electrolytes (such as potassium, sodium, calcium
or magnesium) in the blood and can also monitor your kidney function, especially if you
are over the age of 65, if you have certain heart, liver or kidney diseases, or if you are
taking potassium supplements.
Signs of overdose are: severe dizziness and/or fainting, abnormal tiredness, muscle
weakness or cramps or irregular heart beat. If you took an overdose, or if a child has
accidentally swallowed the medicine, refer immediately to a doctor or proceed to a
hospital emergency room, and bring the package of the medicine with you.
If you forgot to take the medicine at the required time, do not take a double dose. Take a
dose as soon as you remember; if it is almost time for the next dose, skip the forgotten
dose; take the next dose at the regular time and consult the doctor. Adhere to the
treatment regimen recommended by the doctor. Do not change the dosage or stop the
treatment without consulting the doctor. Even if there is an improvement in your health,
do not stop treatment with the medicine without consulting the doctor.
If you have further questions regarding use of the medicine or regarding for how long
you should take Vector Plus, consult the doctor or pharmacist.
4. SIDE EFFECTS
As with any medicine, use of Vector Plus may cause side effects in some users. Do not
be alarmed by the list of side effects. You may not suffer from any of them.
Refer to the doctor immediately if you have one or more of the following symptoms:
breathlessness (possible symptoms of noncardiogenic pulmonary edema); sudden
loss of consciousness (possible symptoms of loss of consciousness due to temporary
deficiency in blood flow to the brain [syncope]); severe reduction in urine output (possible
symptoms of kidney disturbance or kidney failure); fever, throat pain or ulcers in the mouth
due to infections (possible symptoms of reduced blood neutrophil levels [neutropenia]);
muscle weakness, muscle spasms, abnormal heart rhythm (possible symptoms of low
blood potassium levels); tiredness, confusion, muscle trembling, convulsions (possible
symptoms of low blood sodium levels) (effects of unknown frequency).
Additional side effects:
Occurring infrequently (affect between 1 to 10 in every 1,000 patients): thirst, low urine
output, dark urine, dry flushed skin, agitation (possible symptoms of dehydration);
numbness or tingling (possible symptoms of paresthesia); vision disorders; tiredness;
cough; muscle pain; noises in the ears; dizziness (possible symptoms of hypotension).
Occurring very rarely (may affect less than 1 in every 10,000 patients): dizziness; diarrhea;
joint pain.
Reported side effects with unknown frequency: abnormal kidney function test results
(possible symptoms of increased levels of serum uric acid or creatinine or blood urea nitrogen);
abnormal liver function test results (possible symptoms of increased serum bilirubin).
The following side effects have been observed during clinical trials with Vector Plus:
abdominal pain; upper abdominal pain; anxiety; joint pain and stiffness (arthritis); weakness;
back pain; cough with phlegm together with chest pain and fever (bronchitis or acute
bronchitis); chest pain; fainting on standing up; stomach discomfort after a meal (dyspepsia);
breathlessness; dry mouth; nose bleed; inability to achieve or maintain an erection;
gastroenteritis; headache; excessive sweating; decreased skin sensitivity; flu; insomnia;
ligament sprain; muscle spasms; muscle strain; nasal congestion; nasopharyngitis; nausea;
neck pain; edema; swollen hands, ankles or feet (peripheral edema); otitis media; pain in the
extremities; palpitations; sore throat (pharyngolaryngeal pain); particularly high frequency
of passing urine; fever; feeling of pressure pain in the cheeks and forehead (sinusitis); sinus
congestion; drowsiness; fast heart beat; upper respiratory tract infection; urinary tract
infection; spinning sensation (vertigo); viral infections; vision disturbances.
The following side effects have been reported with other products containing valsartan
or hydrochlorothiazide alone.
Valsartan: abdominal pain; spinning sensation (vertigo); decreased level of hemoglobin
and decreased percentage of red blood cells in the blood (which can, in severe cases,
lead to anemia); unusual bleeding and bruising (a drop in the number of platelets); rash,
itching, together with some of the following signs or symptoms: fever, joint pain, muscle
pain, swollen lymph nodes and/or flu-like symptoms (other allergic/hypersensitivity
reactions including serum sickness); muscle spasms; abnormal heart rhythm (increase
of potassium levels); purplish-red spots, fever, itching (vasculitis); elevation of liver
function values; allergic reaction with symptoms such as rash, itching, dizziness, swelling
of the face or lips or tongue or throat, difficulty breathing or swallowing (angioedema);
blisters on the skin (sign of dermatitis bullous); rash, itching; severely decreased urine
output (kidney failure).
Hydrochlorothiazide: skin rash with or without difficulties in breathing (possible signs
of hypersensitivity reactions); facial rash, joint pain, muscle disorder, fever (possible
signs of lupus erythematosus); rash, red skin, blistering of the lips, eyes or mouth, skin
peeling, fever (possible signs of erythema multiforme); rash, purplish-red spots, fever,
itching (possible signs of necrotizing vasculitis); confusion, tiredness, muscle twitching
and spasm, rapid breathing (possible signs of hypochloremic alkalosis); gastrointestinal
disturbances, such as nausea, vomiting, constipation, abdominal pain, frequent urination,
thirst, muscle weakness and twitching (possible signs of hypercalcemia); severe upper
abdominal pain (possible signs of pancreatitis); severe or persistent vomiting or diarrhea,
irregular heart beat (possible signs of arrhythmia); purple skin patches (possible sign of
a drop in the number of platelets, purpura); fever, sore throat, more frequent infections
(possible signs of severe deficiency of granulocytes [a type of white blood cell]); fever,
sore throat or mouth ulcers due to infections (possible signs of a decrease in white blood
cell levels); weakness, bruising and frequent infections (possible signs of a decrease
in the number of red and white blood cells, including platelets); pale skin, tiredness,
breathlessness, dark urine (possible signs of hemolytic anemia); severely decreased
urine output (possible sign of kidney disorder or kidney failure); decrease in vision or
pain in the eyes due to high pressure (possible signs of acute angle-closure glaucoma);
high levels of lipids in the blood; low levels of magnesium in the blood; high levels of
uric acid in the blood; itchy rash or other forms of rash (urticaria); decreased appetite;
mild nausea and vomiting; dizziness, fainting on standing up (orthostatic hypotension);
inability to achieve or maintain an erection (impotence); high levels of sugar in the
blood or in the urine; increased sensitivity of the skin to the sun; abdominal discomfort,
constipation or diarrhea; yellowing of the eyes and skin; headache; dizziness; sleep
disorders; depression; tingling or numbness (paresthesia); vision disorders; muscle
spasms; fever; weakness.
If one or more of the side effects worsen, or if you suffer from a side effect not mentioned
in the leaflet, consult with the doctor.
5. HOW SHOULD THE MEDICINE BE STORED?
∙ Avoid poisoning! This medicine and any other medicine, should be kept in a safe place
out of the reach of children and/or infants in order to avoid poisoning. Do not induce
vomiting unless explicitly instructed to do so by the doctor.
∙ Do not take medicines in the dark! Check the label and the dose each time you take
medicine. Wear glasses if you need them.
∙ Do not use the medicine after the expiry date (exp. date) that appears on the package.
The expiry date refers to the last day of that month.
∙ Store in a dry place, below 25°C.
∙ Do not store different medications in the same package. Do not use if the package of
the preparation is damaged.
6. FURTHER INFORMATION
In addition to the active ingredients, the medicine also contains:
Lactose monohydrate, Microcrystalline cellulose, Crospovidone, Magnesium stearate,
Colloidal silicon dioxide, Opadry (orange, yellow).
What the medicine looks like and the contents of the package:
Vector Plus is packaged in trays (blisters) inserted in a carton box. Each package
contains 28 tablets.
Vector Plus are round, film-coated, biconvex, orange tablets with a score line on one
side.
Registration holder: Unipharm Ltd., P.O.B. 21429, Tel Aviv 6121301.
Manufacturer: Trima Ltd., Kibbutz Maabarot.
This leaflet was checked and approved by the Ministry of Health in March 2016.
Registration number of the medicine in the National Drug Registry of the Ministry of
Health:
Vector Plus 80/12.5:
145 46 33145 00
Vector Plus 160/12.5: 146 06 33406 00
Vector Plus 160/25:
145 47 33146 00
119858010
0616F