تريتايس كومب ٢٫٥ ملغم/١٢٫٥ ملغ

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor's instructions. Consult the doctor

or pharmacist if you are uncertain. The dosage and treatment regimen

will be determined by the doctor only.

Take the tablet at the same time every day, usually in the

morning.

Swallow the medicine whole, with liquid.

Do not chew or crush the tablet.

The Tritace Comp 2.5 mg/12.5 mg and Tritace Comp 5 mg/25 mg

tablets can be halved on the score line to two equal halves.

How much to take

Treatment of hypertension

Your doctor may change the dosage until control of your blood

pressure is attained.

Elderly patients

Your doctor may lower the starting dosage and increase it slowly

during the treatment.

If you accidentally took a higher dosage or if a child accidentally

swallows the medicine:

Refer to a doctor or to the closest emergency room. Do not drive

by yourself; ask someone else to drive you or order an ambulance.

Bring the package of this medicine with you, so that the doctor will

know what you took.

If you forgot to take the medicine:

If you forgot to take this medicine at the regular time, take a dose at the

next regular dosing time. Never take two doses together to compensate

for a missed dose!

If you have further questions regarding use of the medicine, consult

a doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Tritace Comp may cause side effects in

some users. Do not be alarmed when reading the list of side effects.

You may not experience any of them.

Discontinue treatment with Tritace Comp and refer to a doctor

immediately if you experience any of the following severe side

effects – you may need emergency medical attention.

swelling of the face, lips or throat, which causes swallowing or

breathing difficulties, as well as tingling and rash – these can be

signs of a severe allergic reaction to Tritace Comp.

a severe skin reaction including rash, mouth ulcers, worsening of

a pre-existing skin disease, reddening, blistering or detachment of

skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis

or erythema multiforme).

Report to the doctor immediately if you experience any of the

following side effects:

- increased heart rate, strong and irregular heartbeat (palpitations),

chest pain, tightness in the chest or a more serious problem such as

heart attack or stroke

- shortness of breath, coughing or fever lasting 2-3 days and reduced

appetite; these could be signs of a lung problem, including

inflammation of the lungs

- bruising more easily, bleeding for longer than usual, any sign of

bleeding (e.g., bleeding from the gums), purple spots, marks on the

skin or getting infections more easily than usual, sore throat and

fever, feeling tired, faint, dizzy or having pale skin - these can be

signs of blood or bone marrow problems

- severe abdominal pain which can radiate to the back - could be a

sign of pancreatitis

- fever, chills, tiredness, loss of appetite, abdominal pain, nausea,

yellowing of the skin or eyes (jaundice) - can be signs of liver

problems such as inflammation of the liver or liver damage

Other side effects include:

Please tell your doctor if any of the following effects worsens or lasts

longer than a few days.

Common effects (occurring in up to 1 in 10 people)

- headache, feeling tired or weak

- feeling dizzy – likely to happen at the beginning of Tritace Comp

treatment or when the dosage of Tritace Comp is raised

- dry cough or bronchitis

- blood tests showing higher blood sugar levels than usual. If you

have diabetes, this may exacerbate your disease

- blood tests showing higher uric acid or lipid levels than usual

- pain, redness and swelling of the joints

Uncommon effects (occurring in up to 1 in 100 people)

- skin rash with or without raised areas

- flushing, fainting, low blood pressure, particularly when standing

up or sitting up quickly

- balance problems

- itching or unusual skin sensitivity such as stinging, numbness or

tingling feeling

- loss of or change in the sense of taste

- sleep problems

- feeling depressed, anxious, more nervous than usual or restless

- blocked nose, sinusitis or difficulty breathing

- inflammation of the gums, swollen mouth

- in the eyes - redness, tingling, swelling or tearing

- ringing in the ears

- blurred vision

- hair loss

- chest pain

- muscle pain

- constipation, abdominal pain

- indigestion or feeling sick

- urinating more than usual

- sweating more than usual or feeling thirsty

- reduction or loss of appetite

- increase or change in the heart rate

- swelling of the arms and legs - can be a sign of the body retaining

more fluids than usual

- fever

- impotence in men

- blood test results showing a reduction in the number of red

blood cells, white blood cells or platelets or in the amount of

hemoglobin

- blood test results indicating changes in function of the liver, pancreas

or kidneys

- blood test results showing a lower blood potassium level than

usual

Very rare effects (occurring in up to 1 in 10,000 people)

- vomiting, diarrhea or heartburn

- redness or swelling of the tongue or dry mouth

- blood test results showing a higher blood potassium level than

usual

Other reported side effects:

Please tell your doctor if any of the following effects worsens or lasts

longer than a few days.

- difficulty concentrating, feeling restless or confused

- change of color in the fingers and toes when you are cold and then

stinging or pain when you warm up (Raynaud's phenomenon)

- breast enlargement in men

- blood clots

- hearing disturbances

- conjunctival dryness

- objects appearing yellow

- dehydration

- swelling, pain or redness of the cheeks (inflammation of the salivary

glands)

- swelling in the gut (intestinal angioedema), manifested by abdominal

pain, vomiting or diarrhea

- increased sensitivity to sunlight

- severe peeling of the skin, stinging, lumpy rash or other skin

problems such as reddish rash of the face or forehead

- skin rash or bruises

- blotches on the skin and sensation of cold in the extremities

- nail problems (for instance, loosening or detachment of the nail

from its bed)

- muscle stiffness or inability to move the joints

- muscle weakness or cramps

- reduced sexual desire in men or women

- blood in the urine - this may be a sign of a kidney problem

- higher than usual level of sugar in the urine

- increase in certain white blood cells (eosinophilia) - that was

observed in blood tests

- blood test results showing a deficiency of blood cells in your blood

(pancytopenia)

- blood test results showing a change in the level of salts, e.g., sodium,

calcium, magnesium and chloride in your blood

concentrated urine (dark in color), nausea or vomiting, muscle

cramps, confusion and fits which may be as a result of a disturbance in

secretion of the hormone which regulates secretion of urine (ADH). If

you experience these effects, refer to the doctor as soon as possible

- slowed or changed reactions

- change in the way things smell

- difficulty breathing or worsening of asthma

- strong eye pain, blurred vision, or seeing a halo around lights,

headache, tearing, nausea or vomiting, that may be symptoms of

a disease called glaucoma.

If a side effect occurs, if a side effect worsens or if you suffer from a

side effect not mentioned in this leaflet, consult the doctor.

Side effects can be reported to the Ministry of Health by clicking on

the link “Report Side Effects of Drug Treatment” found on the Ministry

of Health homepage (www.health.gov.il) that directs you to the online

form for reporting side effects, or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formT

ype=AdversEffectMedic@moh.gov.il

5. HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine and any other medicine must be

kept in a safe place out of the reach of children and/or infants to

avoid poisoning.

Do not induce vomiting without explicit instruction from the doctor.

Do not use the medicine after the expiry date (exp. date) that appears

on the package/tray (blister). The expiry date refers to the last day of

that month.

Storage: below 25°C.

6. FURTHER INFORMATION

In addition to the active ingredients, Tritace Comp 2.5 mg/12.5 mg and

Tritace Comp 5 mg/25 mg also contain:

Pregelatinized

starch,

Microcr ystalline

cellulose,

Hydroxypropylmethylcellulose, Sodium stearyl fumarate.

What the medicine looks like and the contents of the pack:

The tablets are packed in trays (blisters).

The Tritace Comp 2.5 mg/12.5 mg tablets are oblong, white or almost

white, with a score line. HNV and the company logo are imprinted

on each side.

The Tritace Comp 5 mg/25 mg tablets are oblong, white or almost

white, with a score line. HNW and the company logo are imprinted

on each side.

All the strengths are packaged in PVC/Aluminum trays (blisters) of

14 or 28.

Not all the package sizes are marketed.

This leaflet does not contain all the information about your

medicine. If you have any question or are not sure about anything,

please ask your doctor.

License holder name and address: sanofi-aventis Israel ltd., 10 Beni

Gaon Street, Netanya.

Manufacturer name and address: Sanofi S.P.A., Italy.

This leaflet was checked and approved by the Ministry of Health in

March 2017.

Registration number of the medicine in the National Drug Registry

of the Ministry of Health:

Tritace Comp 2.5 mg/12.5 mg

122 27 30187

Tritace Comp 5 mg/25 mg

122 28 30188