ALFU-KAL XL

Alfu-Kal XL

Prolonged release Tablets:

The medicine is dispensed with a doctor’s prescription only.

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

Each prolonged release tablet contains:

10 mg Alfuzosin Hydrochloride.

Inactive ingredients: see section 6 in the leaflet.

Read this leaflet carefully in its entirety before using the

medicine.

Keep this leaflet, you may need to read it again. 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 your treatment. Do not

pass it on to others. It may harm them, even if it seems to you that

their medical condition is similar. The medicine is intended for

men. This medicine is not intended for treatment of children and

adolescents under the age of 16 years. If one of the side effects

worsens or if you experience a side effect not mentioned in this

leaflet, please refer to the doctor or pharmacist.

Always use according to the doctor’s instructions. Check with the

doctor or pharmacist if you are unsure.

The tablet should be swallowed whole with plenty of water after

dinner. It is forbidden to chew, crush or halve the tablet because it

may impact the absorption of the medicine in the body.

The dosage and treatment will be determined only by the doctor.

1.

WHAT IS THE MEDICINE INTENDED FOR?

Alfu-Kal XL is used for the treatment of symptoms associated with

benign prostatic hypertrophy and as an adjuvant treatment to

catheter withdrawal in urinary retention resulting from benign

prostatic hypertrophy.

Therapeutic group:

Alfu-Kal XL belongs to a group of

preparations called as alpha blockers and is a selective blocker of

the α1 (alpha one) receptor.

Special warnings regarding use of the medicine

Before treatment with the medicine, tell the doctor if:

you are being treated with medicines for treatment of

hypertension or with nitrate derivatives.

you are suffering from disturbed blood flow to the brain.

you are suffering from a heart disease.

you experienced a significant drop in blood pressure after taking

another medicine from the α (alpha) blockers group.

When taking the medicine, some patients may experience a

sudden drop in blood pressure when they sit down or stand up

quickly. This effect may occur within a few hours of taking the

medicine and may be accompanied by dizziness, sweating, a

feeling of tiredness, and even fainting. The patient must lie down

until the symptoms pass and refer to the doctor. It is therefore also

recommended to take the first dose before going to sleep.

The risk of developing low blood pressure and related side effects

may be higher in elderly patients and patients taking other

medicines for treatment of hypertension or nitrate derivatives

(medicines used for treatment of angina pectoris). Taking

dapoxetine in combination with Alfu-Kal XL may cause dizziness

and fainting.

If you suffer or have suffered from prolonged QT intervals on the

ECG or if you are taking medicines that cause prolonged QT

intervals on the ECG, you must be monitored before and while

taking the medicine.

Children and adolescents:

This medicine is not intended for treatment of children and

adolescents under the age of 16 years.

Reporting side effects:

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?

formType=AdversEffectMedic@moh.gov.il

In addition, you can report to Perrigo via the following address:

www.perrigo-pharma.co.il

Avoid poisoning! This medicine and all other medicines must be

kept in a closed place, out of the reach and sight 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 use the medicine after the expiry date (exp. date) that

appears on the carton and blister packages. The expiry date

refers to the last day of that month.

Store below 25°C.

Do not discard medicines via wastewater or household waste.

Ask the pharmacist how to discard medicines you no longer

require. These measures will help to protect the environment.

In addition to the active ingredient, the medicine also contains

the following inactive ingredients:

Hypromellose, Calcium hydrogen phosphate dehydrate,

Hydrogenated vegetable oil, Povidone K30, Colloidal anhydrous

silica, Magnesium stearate, Propylene glycol, Titanium dioxide

(E-171).

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

A white, round, biconvex tablet. The package contains 30 tablets.

10 tablets in each blister.

Registration holder and address: Perrigo Israel Agencies Ltd.,

1 Rakefet st., Shoham.

Manufacturer’s name and address: Rivopharm S.A., Manno,

Switzerland.

This leaflet was checked and approved by the Ministry of Health

in July 2015 and updated in accordance with the provisions of

the Ministry of Health in August 2018.

Registration number of the medicine in the National Drug

Registry of the Ministry of Health: 14123.31829

If you are taking, or have recently taken, other medicines,

including non-prescription medicines and food supplements

including herbal medicines, tell the doctor or pharmacis

t.

Do not take Alfu-Kal XL if you are taking other α (alpha) blockers.

Do not take Alfu-Kal XL in combination with certain medicines for

treatment of high blood pressure (medicines for reducing blood

pressure such as doxazosin, prazosin or urapidil).

Check with the doctor or pharmacist if you are taking medicines

for treatment of impotence (such as sildenafil), medicines for

treatment of hypertension, medicines for treatment of angina

pectoris (nitrates).

Taking nitrates for the treatment of symptoms of chest pain in

combination with Alfu-Kal XL may cause a drop in blood pressure.

Do not take Alfu-Kal XL if you are taking medicines for treatment

of HIV (such as protease inhibitors in combination with ritonavir or

cobicistat or nelfinavir) or medicines for treatment of hepatitis C

(such as telaprevir or boceprevir) or medicines for treatment of

fungal infections (such as ketoconazole, itraconazole,

posaconazole, voriconazole), or medicines for treatment of

bacterial infections (such as clarithromycin, erythromycin,

telithromycin). See section 2 “Do not use the medicine if”.

Substances for general anesthetics may cause a severe drop in

blood pressure.

Surgery and tests while taking Alfu-Kal XL

During treatment with Alfu-Kal XL, blood pressure must be

monitored, especially at the beginning of treatment.

If you are about to undergo surgery under general anesthesia, tell

the anesthesiologist that you are taking or have recently taken

Alfu-Kal XL. The doctor may decide to stop Alfu-Kal XL treatment

24 hours before the surgery.

If you are about to undergo cataract eye surgery, tell the surgeon if

you are taking or have taken Alfu-Kal XL, in order to prevent

complications during surgery.

Use of Alfu-Kal XL with food

Alfu-Kal XL should be taken immediately after dinner.

Use of Alfu-Kal XL and alcohol consumption

You may feel dizzy or weak when taking Alfu-Kal XL; if these

effects occur, do not consume alcohol.

Driving and use of machinery

Use of this medicine may cause dizziness, exhaustion and

disturbed vision. If these effects occur, do not drive or operate

machinery or dangerous tools.

Important information about some of the ingredients of the

medicine

Each tablet contains 0.560 mg propylene glycol.

The usual dosage is:

For benign prostatic hypertrophy - one tablet, once a day.

For adjuvant treatment to catheter withdrawal in urinary retention,

resulting from benign prostatic hypertrophy - one tablet, once a

day. Treatment is initiated on the day the catheter is inserted and

stopped the day after removal of the catheter (a total of 3-4 days).

Do not exceed the recommended dose.

If you accidentally took a higher dosage of Alfu-Kal XL

or if

someone has accidentally swallowed the medicine, refer

immediately to a hospital emergency room and bring the package

of the medicine with you. Remain in a lying position as much as

possible, to stop the side effects. Do not drive to the hospital by

yourself.

If you forgot to take Alfu-Kal XL

at the required time, do not take

a double dose to compensate for the forgotten dose. Skip this

dose and take the next dose at the regular time.

Adhere to the treatment as recommended by the doctor.

If you stop taking Alfu-Kal XL:

Continue taking Alfu-Kal XL even if there has been an

improvement in your health. Stop the treatment only if instructed

to do so by the doctor.

Chest pain (angina)-

usually occurs if you have suffered from

angina in the past.

If you suffer from chest pain stop treatment

with Alfu-Kal XL and refer to the doctor or hospital immediately.

This effect occurs in less than 1 in 10,000 users.

Allergic reaction

- you can notice signs of angioedema, such as

redness or skin rash, swelling (of the eyes, face, lips, mouth and

tongue), difficulty in breathing and swallowing. These are signs of

an allergic reaction. If these effects occur,

stop treatment with

Alfu-Kal XL and refer to the doctor or hospital immediately.

This effect occurs in less than 1 in 10,000 users.

Other side effects

As with any medicine, use of Alfu-Kal XL may cause side effects in

some users. These symptoms are likely to appear at the beginning

of treatment. Do not be alarmed when reading the list of side

effects. You may not suffer from any of them.

Do not take medicines in the dark! Check the label and the

dose each time you take medicine.

Wear glasses if you need them.

If you have further questions regarding use of the medicine,

consult the doctor or pharmacist.

2. BEFORE USING THE MEDICINE

3. HOW SHOULD YOU USE THE MEDICINE?

4. SIDE EFFECTS

5. HOW SHOULD THE MEDICINE BE STORED?

6. FURTHER INFORMATION

Drug interaction:

Do not use the medicine if:

you are

sensitive

(allergic) to the active ingredient

alfuzosin or to any of the other ingredients contained in the

medicine (see section 6 “Further Information”). Signs of

an allergic reaction include: rash, swallowing or

breathing problems, swelling of the lips, pharynx or tongue.

You suffer from a sudden drop in blood pressure when

you get up. It may be accompanied by dizziness or

fainting (Orthostatic hypotension).

you suffer from a liver function problem.

you suffer from severe kidney failure

(creatinine clearance below 30 ml/min)

you are being treated with other α (alpha) blockers

(such as: prazosin, trimazosin, urapidil).

you are taking medicines for treatment of HIV

(such as: protease inhibitors together with ritonavir or

cobicistat or nelfinavir) or medicines for treatment of

hepatitis C (such as telaprevir or boceprevir) or

medicines for treatment of fungal infections (such as:

ketoconazole, itraconazole, posaconazole, voriconazole)

or medicines for treatment of bacterial infections (such

as: clarithromycin, erythromycin, telithromycin). These

medicines may increase the Alfu-Kal XL blood

concentrations and cause side effects. See warnings in

the next section.

Common side effects

(occurs in less than 1 in 10 users):

Dizziness, weakness, fainting, headaches, nausea, abdominal

pain, feeling ill, a drop in blood pressure when changing position

from a lying to a standing or sitting position (orthostatic hypotension).

Uncommon side effects

(occurs in less than 1 in 100 users):

Vertigo, drowsiness, fainting (syncope), rapid heart rate (tachycardia),

palpitations, allergic rhinitis, diarrhea, dryness in the mouth, skin

rash, itchiness, edema, chest pain, flushing.

Rare side effects

(occurs in less than 1 in 10,000 users):

Allergic skin reaction, angioedema.

Other side effects that may possibly occur

(of unknown frequency):

Cerebral events in patients with disturbed blood flow to the brain, atrial

fibrillation, eye problems in patients who are undergoing cataract

surgery (see section 2 “Surgeries and tests while taking Alfu-Kal XL”),

vomiting, liver injury, cholestatic liver inflammation, prolonged erection,

a decrease in the number of white blood cells and platelets.

If a side effect has occurred, if any of the side effects worsen, or when

you suffer from a side effect not mentioned in the leaflet, consult with

the doctor.

؟ءﺍﻭﺩﻟﺍ ﻡﺩﺧﺗﺳﺗ ﻑﻳﻛ (۳ ﺐﻴﺒﻄﻟﺍ ﻊﻣ ﺺﺤﻔﺗ ﻥﺃ ﻚﻴﻠﻋ .ﺐﻴﺒﻄﻟﺍ ﺕﺎﻤﻴﻠﻌﺗ ﺐﺴﺤﺑ ﻡﺍﺪﺨﺘﺳﻻﺍ ﺎ

ﻤﺋﺍﺩ ﺐﺠﻳ .ﺪﻛﺄﺘﻣ ﺮﻴﻏ ﺖﻨﻛ ﺍﺫﺇ ﻲﻟﺪﻴﺼﻟﺍ ﻭﺃ ،ﻎﻀﻣ ﺮﻈﺤﻳ .ءﺎﺸﻌﻟﺍ ﺔﺒﺟﻭ ﺪﻌﺑ ءﺎﻤﻟﺍ ﻦﻣ ﺮﻴﺜﻜﻟﺍ ﻊﻣ ﻪﻠﻣﺎﻜﺑ ﺹﺮﻘﻟﺍ ﻊﻠﺑ ﺐﺠﻳ ﺹﺎﺼﺘﻣﺍ ﻰﻠﻋ ﺮﻴﺛﺎﺗ ﻙﺎﻨﻫ ﻥﻮﻜﻳ ﻥﺍ ﻦﻜﻤﻳ ﻪﻧﺍ ﺚﻴﺣ ﺹﺮﻘﻟﺍ ﻢﻴﺴﻘﺗ ﻭﺍ ﻖﺤﺳ .ﻢﺴﺠﻟﺍ ﻲﻓ ءﺍﻭﺪﻟﺍ .ﻂﻘﻓ ﺐﻴﺒﻄﻟﺍ ﻞﺒﻗ ﻦﻣ ﺎﻤﻫﺪﻳﺪﺤﺗ ﻢﺘﻳ ﺝﻼﻌﻟﺍ ﺔﻘﻳﺮﻃﻭ ﺔﻋﺮﺠﻟﺍ :ﻲﻫ ﺓﺩﺎﻋ ﺔﻟﻮﺒﻘﻤﻟﺍ ﺔﻋﺮﺠﻟﺍ .ﻡﻮﻴﻟﺍ ﻲﻓ ﺪﺣﺍﻭ ﺹﺮﻗ - ﺪﻴﻤﺣ ﺎﺗﺎﺘﺳﻭﺮﺑ ﻢﺨﻀﺗ ﻢﺨﻀﺘﻟ ﺔﺠﻴﺘﻧ ،ﻝﻮﺒﻟﺍ ﺱﺎﺒﺤﻧﺍ ﺪﻨﻋ (ﺮﺘﻴﺗﺎﻛ)ﺓﺮﻄﺜﻘﻟﺍ ﻦﻣ ﺺﻠﺨﺘﻠﻟ ﻞﻤﻜﻣ ﺝﻼﻌﻟ ﻝﺎﺧﺩﺍ ﻡﻮﻳ ﻲﻓ ﺝﻼﻌﻟﺍ ﺔﻳﺍﺪﺑ .ﻡﻮﻴﻟﺍ ﻲﻓ ﺪﺣﺍﻭ ﺹﺮﻗ ﺎﺗﺎﺘﺳﻭﺮﺒﻟﺍ ﻲﻓ ﺪﻴﻤﺣ .(ﺎﻣﻮﻳ ٤

٣ ﻪﻋﻮﻤﺠﻣ ﺎﻤﺑ) ﺓﺮﻄﺜﻘﻟﺍ ﺝﺍﺮﺧﺍ ﺪﻌﺑ ﺎﻣﻮﻳ ﺝﻼﻌﻟﺍ ﻑﺎﻘﻳﺍﻭ ﺓﺮﻄﺜﻘﻟﺍ

.ﺎﻬﺑ ﻰﺻﻭﻣﻟﺍ ﺔﻋﺭﺟﻟﺍ ﺯﻭﺎﺟﺗ ﺏﺟﻳ ﻻ ﻢﻫﺪﺣﺃ ﻊﻠﺑ ﺍﺫﺇ ﻭﺍ XL ﻝﺎﻛ-ﻭﻔﻟﺍ ﻥﻣ ﻰﻠﻋﺍ ﺔﻋﺭﺟ ﺄﻁﺧﻟﺍ ﻖﻳﺭﻁ ﻥﻋ ﺕﻟﻭﺎﻧﺗ ﺍﺫﺇ ﻲﻓ ﺉﺭﺍﻮﻄﻟﺍ ﺔﻓﺮﻏ ﻰﻟﺍﺍ ﺭﻮﻔﻟﺍ ﻰﻠﻋ ﻪ

ﺟﻮﺗ ،ﺄﻄﺨﻟﺍ ﻖﻳﺮﻃ ﻦﻋ ءﺍﻭﺪﻟﺍ ﻒﻗﻮﻟ ﻥﺎﻜﻣﻻﺍ ﺭﺪﻗ ءﺎﻘﻠﺘﺳﻻﺍ ﺐﺠﻳ .ءﺍﻭﺪﻟﺍ ﺔﺒﻠﻋ ﻚﻌﻣ ﺮﻀﺣﺃﻭ ﻰﻔﺸﺘﺴﻤﻟﺍ .ﻚﺴﻔﻨﺑ ﻰﻔﺸﺘﺴﻤﻟﺍ ﻰﻟﺍ ﺓﺭﺎﻴﺴﻟﺍ ﺪﻘﺗ ﻻ .ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻻﺍ ﺔﺒﺟﻭ ﻝﻭﺎﻨﺗ ﻲﻐﺒﻨﻳ ﻻ ،ﺏﻮﻠﻄﻤﻟﺍ ﺖﻗﻮﻟﺍ ﻲﻓ XL ﻝﺎﻛ-ﻭﻔﻟﺍ ﻝﻭﺎﻧﺗ ﺕﻳﺳﻧ ﺍﺫﺇ ﺔﺒﺟﻮﻟﺍ ﻝﻭﺎﻨﺗﻭ ﺔﺒﺟﻮﻟﺍ ﻩﺬﻫ ﺯﻭﺎﺠﺗ .ﺔﻴﺴﻨﻤﻟﺍ ﺔﺒﺟﻮﻟﺍ ﻦﻋ ﺾﻳﻮﻌﺘﻠﻟ ﺔﻔﻋﺎﻀﻣ .ﺩﺎﺘﻌﻤﻟﺍ ﺖﻗﻮﻟﺍ ﻲﻓ ﺔﻴﻟﺎﺘﻟﺍ .ﺐﻴﺒﻄﻟﺍ ﺕﺎﻤﻴﻠﻌﺗ ﺐﺴﺣ ﺝﻼﻌﻟﺍ ﻰﻠﻋ ﺓﺮﺑﺎﺜﻤﻟﺍ ﺐﺠﻳ :XL ﻝﺎﻛ-ﻭﻔﻟﺍ ﻝﻭﺎﻧﺗ ﻥﻋ ﻑﻗﻭﺗﺗ ﺍﺫﺇ .ﻚﺘﺤﺻ ﺔﻟﺎﺣ ﻰﻠﻋ ﻦﺴﺤﺗ ﺃﺮﻃ ﺍﺫﺇ ﺎﻀﻳﺍ XL ﻝﺎﻛ-ﻮﻔﻟﺍ ﻝﻭﺎﻨﺗ ﺔﻠﺻﺍﻮﻣ ﺐﺠﻳ .ﻚﻟﺬﺑ ﺐﻴﺒﻄﻟﺍ ﻙﺮﻣﺍ ﺍﺫﺇ ﻂﻘﻓ ﺝﻼﻌﻟﺍ ﻒﻗﻭﺍ ﺓﺭﻣ ﻝﻛ ﻲﻓ ﺔﻋﺭﺟﻟﺍﻭ ﺔﻘﺻﻼﻟﺍ ﺹﺣﻓﺍ !ﻡﻼﻅﻟﺍ ﻲﻓ ءﺍﻭﺩﻟﺍ ﻝﻭﺎﻧﺗ ﺏﺟﻳ ﻻ

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ءﺍﻭﺩ ﺎﻬﻳﻓ ﻝﻭﺎﻧﺗﺗ .ﺎﻬﻳﻟﺍ ﺔﺟﺎﺣﺑ ﺕﻧﻛ ﺍﺫﺇ ﺔﻳﺑﻁ ﺕﺍﺭﺎﻅﻧ ﻊﺿﻭ ﺏﺟﻳ ﻭﺃ ﺏﻳﺑﻁﻟﺍ ﺭﺷﺗﺳﺍ ،ءﺍﻭﺩﻟﺍ ﻡﺍﺩﺧﺗﺳﺍ ﻝﻭﺣ ﺔﻳﻓﺎﺿﺇ ﺔﻠﺋﺳﺍ ﻙﻳﺩﻟ ﺕﻧﺎﻛ ﺍﺫﺇ

.ﻲﻟﺩﻳﺻﻟﺍ ﺔﻳﺑﻧﺎﺟ ﺽﺍﺭﻋﺃ (٤ ﺽﺍﺮﻋﺃ ﻰﻟﺍ ﻱﺩﺆﻳ ﺪﻗ

ﻝﺎﻛ-ﻮﻔﻟﺍ ﻡﺍﺪﺨﺘﺳﺍ ،ءﺍﻭﺩ ﻞﻛ ﻲﻓ ﻝﺎﺤﻟﺍ ﻮﻫ ﺎﻤﻛ ﻲﻓ ﺽﺍﺮﻋﻻﺍ ﻚﻠﺗ ﺮﻬﻈﺗ ﻥﺍ ﻝﻮﻘﻌﻤﻟﺍ ﻦﻣ .ﻦﻴﻣﺪﺨﺘﺴﻤﻟﺍ ﺾﻌﺑ ﻯﺪﻟ ﺔﻴﺒﻧﺎﺟ .ﺎﻬﻨﻣ ﻱﺃ ﻦﻣ ﻲﻧﺎﻌﺗ ﻻ ﺪﻗ ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﺔﻤﺋﺎﻗ ﺓءﺍﺮﻗ ﺪﻨﻋ ﻒﺨﺗ ﻻ .ﺝﻼﻌﻟﺍ ﺔﻳﺍﺪﺑ ﺍﺫﺇ ﻖﺑﺎﺴﻟﺍ ﻲﻓ ﺎﻨﻴﺠﻧﺍ ﻦﻣ ﺖﻴﻧﺎﻋ ﺍﺫﺇ ﺓﺩﺎﻋ ﺙﺪﺤﺗ - (ﺎﻧﻳﺟﻧﺃ) ﺭﺩﺻﻟﺍ ﻲﻓ ﻡﻟﺍ ﻰﻟﺍ ﺍﺭﻭﻓ ﻪﺟﻭﺗﻭ XL ﻝﺎﻛ-ﻭﻔﻟﺎﺑ ﺝﻼﻌﻟﺍ ﻑﻗﻭﺍ ﺭﺩﺻﻟﺍ ﻲﻓ ﻡﻟﺍ ﻥﻣ ﻲﻧﺎﻌﺗ ﻦﻴﺑ ﻦﻣ ﻞﻤﻌﺘﺴﻣ ١ ﻦﻣ ﻞﻗﺍ ﺪﻨﻋ ﺓﺮﻫﺎﻈﻟﺍ ﻩﺬﻫ ﺙﺪﺤﺗ .ﻰﻔﺷﺗﺳﻣﻟﺍ ﻭﺃ ﺏﻳﺑﻁﻟﺍ .١٠,٠٠٠ ﻭﺍ ﺭﺍﺮﻤﺣﻻﺍ ﻞﺜﻣ ﺍﺪﻴﻣﻮﻴﺠﻧﺍ ﺕﺎﻣﻼﻋ ﺰﻴﻤﺗ ﻥﺍ ﻊﻴﻄﺘﺴﺗ - ﻲﺳﺳﺣﺗ ﻝﻌﻓ ﺩﺭ ﻲﻓﻭ ،ﻢﻔﻟﺍ ﻲﻓ ،ﻦﻴﺘﻔﺸﻟﺍ ﻲﻓ ،ﻪﺟﻮﻟﺍ ﻲﻓ ،ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ) ﺥﺎﻔﺘﻧﺍ ،ﺪﻠﺠﻟﺍ ﻲﻓ ﺢﻔﻄﻟﺍ ﺍﺫﺇ .ﻲﺴﺴﺤﺗ ﻞﻌﻓ ﺩﺭ ﺕﺎﻣﻼﻋ ﻩﺬﻫ .ﻊﻠﺒﻟﺍ ﻲﻓﻭ ﺲﻔﻨﺘﻟﺍ ﻲﻓ ﺕﺎﺑﻮﻌﺻ (ﻥﺎﺴﻠﻟﺍ ﻭﺍ ﺏﻳﺑﻁﻟﺍ ﻰﻟﺍ ﺍﺭﻭﻓ ﻪﺟﻭﺗﻭ XL ﻝﺎﻛ-ﻭﻔﻟﺎﺑ ﺝﻼﻌﻟﺍ ﻑﻗﻭﺍ ﺮﻫﺍﻮﻈﻟﺍ ﻚﻠﺗ ﺙﺪﺤﺗ .١٠,٠٠٠ ﻦﻴﺑ ﻦﻣ ﻞﻤﻌﺘﺴﻣ ١ ﻦﻣ ﻞﻗﺍ ﺪﻨﻋ ﺓﺮﻫﺎﻈﻟﺍ ﻩﺬﻫ ﺙﺪﺤﺗ .ﻰﻔﺷﺗﺳﻣﻟﺍ ﻰﻟﺍ ﺔﻳﻓﺎﺿﺇ ﺔﻳﺑﻧﺎﺟ ﺽﺍﺭﻋﺃ :(١٠ ﻦﻴﺑ ﻦﻣ ﻞﻤﻌﺘﺴﻣ ١ ﻦﻣ ﻞﻗﺍ ﻯﺪﻟ ﺮﻬﻈﺗ) ﺔﻌﺋﺎﺷﻟﺍ ﺔﻳﺑﻧﺎﺟﻟﺍ ﺽﺍﺭﻋﻷﺍ ،ﺽﺮﻤﻟﺎﺑ ﺭﻮﻌﺸﻟﺍ ،ﻦﻄﺑ ﻡﻻﺍ ،ﻥﺎﻴﺜﻏ ،ﺱﺍﺭ ﻡﻻﺍ ،ءﺎﻤﻏﺍ ،ﻒﻌﺿ ،ﺔﺧﻭﺩ ﻭﺍ ﻑﻮﻗﻮﻟﺍ ﺔﻴﻌﺿﻭ ﻰﻟﺍ ءﺎﻘﻠﺘﺳﻻﺍ ﺔﻴﻌﺿﻭ ﻦﻣ ﻝﺎﻘﺘﻧﻻﺍ ﻦﻴﺣ ﻡﺪﻟﺍ ﻂﻐﺿ ﻁﻮﺒﻫ

orthostatic hypotension

) ﺱﻮﻠﺠﻟﺍ :(١٠٠ ﻦﻴﺑ ﻦﻣ ﻞﻤﻌﺘﺴﻣ ١ ﻦﻣ ﻞﻗﺍ ﻯﺪﻟ ﺮﻬﻈﺗ) ﺔﻌﺋﺎﺷ ﺕﺳﻳﻟ ﺔﻳﺑﻧﺎﺟ ﺽﺍﺭﻋﺍ ،(ﺎﻳﺩﺭﺎﻜﻴﻛﺎﺗ) ﻊﻳﺮﺳ ﺐﻠﻗ ﻝﺪﻌﻣ

(syncope)

ءﺎﻤﻏﺍ ،ﺱﺎﻌﻧ ،(ﻮﺠﻴﺗﺮﻓ) ﺭﺍﻭﺩ ﻲﻓ ﺢﻔﻃ ،ﻢﻔﻟﺍ ﻲﻓ ﻑﺎﻔﺟ ،ﻝﺎﻬﺳﺍ ،ﻲﺴﺴﺤﺘﻟﺍ ﻒﻧﻷﺍ ﻥﻼﻴﺳ ،ﺐﻠﻗ ﺕﺎﻀﺒﻧ

.ﺩ

ﺭﻮﺗ ،ﺭﺪﺼﻟﺍ ﻲﻓ ﻢﻟﺍ ،ﺔﻣﺫﻭ ،ﺔﻜﺣ ،ﺪﻠﺠﻟﺍ :(١٠,٠٠٠ ﻦﻴﺑ ﻦﻣ ﻞﻤﻌﺘﺴﻣ ١ ﻦﻣ ﻞﻗﺍ ﻯﺪﻟ ﺮﻬﻈﺗ) ﺓﺭﺩﺎﻧ ﺔﻳﺑﻧﺎﺟ ﺽﺍﺭﻋﺍ .ﺍﺪﻴﻣﻮﻴﺠﻧﺍ ،ﻱﺪﻠﺟ ﻲﺴﺴﺤﺗ ﻞﻌﻓ ﺩﺭ :(ﻑﻭﺮﻌﻣ ﺮﻴﻏ ﺎﻬﻋﻮﻴﺷ) ﺙﺩﺣﺗ ﺩﻗ ﻲﺗﻟﺍ ﻯﺭﺧﺍ ﺔﻳﺑﻧﺎﺟ ﺽﺍﺭﻋﺍ ﻰﻟﺍ ﻡﺪﻟﺍ ﻖﻓﺪﺗ ﻲﻓ ﺕﺎﺑﺍﺮﻄﺿﺍ ﻦﻣ ﻥﻮﻧﺎﻌﻳ ﻰﺿﺮﻣ ﺪﻨﻋ ﺔﻴﻏﺎﻣﺩ ﺙﺍﺪﺣﺍ ﻥﻮﻌﻀﺨﻳ ﻦﻳﺬﻟﺍ ﻰﺿﺮﻤﻟﺍ ﺪﻨﻋ ﻦﻴﻨﻴﻌﻟﺍ ﻲﻓ ﻞﻛﺎﺸﻣ ،ﻲﻨﻳﺫﻷﺍ ﻥﺎﻔﺟﺮﻟﺍ ،ﻍﺎﻣﺪﻟﺍ ﻲﻓ ﺕﺎﺻﻮﺤﻓﻭ ﺔﻴﺣﺍﺮﺟ ﺕﺎﻴﻠﻤﻋ" ٢ ﺪﻨﺒﻟﺍ ﺮﻈﻧﺍ) ﺖﻛﺭﺎﺘﻜﻠﻟ ﺔﻴﺣﺍﺮﺟ ﺔﻴﻠﻤﻌﻟ ،ﻱﻭﺍﺮﻔﺼﻟﺍ ﺪﺒﻛ ﺏﺎﻬﺘﻟﺍ ،ﺔﻳﺪﺒﻛ ﺔﺑﺎﺻﺍ ،ﺆﻴﻘﺗ ،("XL ﻝﺎﻛ-ﻮﻔﻟﺍ ﻝﻭﺎﻨﺗ ﺖﻗﻭ .ﺔﻳﻮﻣﺪﻟﺍ ﺢﺋﺎﻔﺼﻟﺎﺑﻭ ءﺎﻀﻴﺒﻟﺍ ﻡﺪﻟﺍ ﺎﻳﻼﺧ ﺩﺪﻋ ﻲﻓ ﻁﻮﺒﻫ ،ﻞﺻﺍﻮﺘﻣ ﺏﺎﺼﺘﻧﺍ ﺎﻣﺪﻨﻋ ﻭﺃ ،ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻯﺪﺣﺇ ﺖﻤﻗﺎﻔﺗ ﺍﺫﺇ ،ﻲﺒﻧﺎﺟ ﺽﺭﺎﻋ ﺮﻬﻇ ﺍﺫﺇ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺍ ﻚﻴﻠﻋ ،ﺓﺮﺸﻨﻟﺍ ﻲﻓ ﺎﻫﺮﻛﺫ ﻢﺘﻳ ﻢﻟ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺃ ﻦﻣ ﻲﻧﺎﻌﺗ :ﺔﻳﺑﻧﺎﺟﻟﺍ ﺽﺍﺭﻋﻷﺍ ﻥﻋ ﻍﻼﺑﻹﺍ ﻂﻐﻀﻟﺍ ﻝﻼﺧ ﻦﻣ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻰﻟﺍ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺍ ﻦﻋ ﻍﻼﺑﻻﺍ ﻥﺎﻜﻣﻻﺎﺑ ﻲﻓ ﺩﻮﺟﻮﻤﻟﺍ "ﻲﺋﺍﻭﺩ ﺝﻼﻋ ﺮﺛﺇ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺍ ﻦﻋ ﻍﻼﺑﻹﺍ" ﻂﺑﺍﺭ ﻰﻠﻋ ﻪﺟﻮﻳ ﻱﺬﻟﺍ

(www.health.gov.il

) ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻊﻗﻮﻤﻟ ﺔﻴﺴﻴﺋﺮﻟﺍ ﺔﺤﻔﺼﻟﺍ ﻰﻟﺍ ﻝﻮﺧﺪﻟﺍ ﻖﻳﺮﻃ ﻦﻋ ﻭﺍ ،ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮﻋﺍ ﻦﻋ ﻍﻼﺑﻼﻟ ﺖﻧﺮﺘﻧﺍ ﺓﺭﺎﻤﺘﺳﺍ ﻰﻟﺍ :ﻂﺑﺍﺮﻟﺍ

https//forms gov il/globaldata/getsequence/getsequence

aspx?formType=AdversEffectMedic@moh.gov.il

: ﻲﻟﺎﺘﻟﺍ ﻥﺍﻮﻨﻌﻟﺍ ﻰﻠﻋ ﻮﻐﻳﺮﻓ ﺔﻛﺮﺷ ﻰﻟﺍ ﻎﻴﻠﺒﺘﻟﺍ ﻥﺎﻜﻣﻻﺎﺑ ﺔﻓﺎﺿﻻﺎﺑ

www.perrigo-pharma.co.il

؟ءﺍﻭﺩﻟﺍ ﻥ

ّ

ﺯﺧ

ُ

ﻳ ﻑﻳﻛ (٥

ﺪﻴﻌﺑ ﻖﻠﻐﻣ ﻥﺎﻜﻣ ﻲﻓ ﺮﺧﺃ ءﺍﻭﺩ ﻞﻛﻭ ءﺍﻭﺪﻟﺍ ﺍﺬﻫ ﻆﻔﺣ ﺐﺠﻳ !ﻢ

ﻤﺴﺘﻟﺍ ﺐ

ﻨﺠﺗ .ﻢﻤﺴﺘﻟﺍ ﻯﺩﺎﻔﺘﺗ ﻚﻟﺬﺑﻭ ﻊﺿﺮﻟﺍ ﻭﺃ/ﻭ ﻝﺎﻔﻃﻷﺍ ﺔﻳﺅﺭ ﻯﺪﻣﻭ ﻱﺪﻳﺃ ﻝﻭﺎﻨﺘﻣ ﻦﻋ .ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﺔﺤﺿﺍﻭ ﺕﺎﻤﻴﻠﻌﺗ ﻥﻭﺩ ﻦﻣ ﺆﻴﻘﺘﻟﺍ ﺐ

ﺒﺴﺗ ﻻ ﺮﻫﺎﻈﻟﺍ

(exp. date)

ﺔﻴﺣﻼﺼﻟﺍ ءﺎﻬﺘﻧﺍ ﺦﻳﺭﺎﺗ ﺪﻌﺑ ءﺍﻭﺪﻟﺍ ﻡﺍﺪﺨﺘﺳﺍ ﺐﺠﻳ ﻻ ﻰﻟﺍ ﺮﻴﺸﻳ ﺔﻴﺣﻼﺼﻟﺍ ءﺎﻬﺘﻧﺍ ﺦﻳﺭﺎﺗ .ﺮﺘﺴﻴﻟﺎﺒﻟﺍ ﺓﻮﺒﻋﻭ ﻥﻮﺗﺮﻜﻟﺍ ﺓﻮﺒﻋ ﻰﻠﻋ . ﺮﻬﺸﻟﺍ ﻚﻟﺫ ﻦﻣ ﺮﻴﺧﻷﺍ ﻡﻮﻴﻟﺍ .ﺔﻳﻮﺌﻣ ﺔﺟﺭﺩ ٢٥ ﻦﻣ ﻞﻗﺃ ﺓﺭﺍﺮﺣ ﺔﺟﺭﺪﺑ ﻦﻳﺰﺨﺘﻟﺍ ﺐﺠﻳ ﻝﺄﺳﺍ .ﺔﻴﺘﻴﺒﻟﺍ ﺕﺎﻳﺎﻔﻨﻟﺍ ﻰﻟﺍ ﻭﺍ ﻱﺭﺎﺠﻤﻟﺍ ﻩﺎﻴﻣ ﻲﻓ ﺔﻳﻭﺩﺍ ءﺎﻘﻟﺍ ﻲﻐﺒﻨﻳ ﻻ ﻚﻠﺗ ﻉﺎﺒﺗﺍ .ﺮﺜﻛﺍ ﺎﻬﺟﺎﺘﺤﺗ ﻻ ﺔﻳﻭﺩﺍ ﻦﻣ ﺺﻠﺨﺘﻟﺍ ﻦﻜﻤﻳ ﻒﻴﻛ ﻲﻟﺪﻴﺼﻟﺍ .ﺔﺌﻴﺒﻟﺍ ﻰﻠﻋ ﻅﺎﻔﺤﻟﺍ ﻲﻓ ﺪﻋﺎﺴﻳ ﻞﺋﺎﺳﻮﻟﺍ ﺔﻳﻓﺎﺿﺍ ﺕﺎﻣﻭﻠﻌﻣ (٦ ﺔﻟﺎ

ﻌﻓ ﺮﻴﻐﻟﺍ ﺩﺍﻮﻤﻟﺍ ﻰﻠﻋ ﺎﻀﻳﺃ ءﺍﻭﺪﻟﺍ ﻱﻮﺘﺤﻳ ،ﺔﻟﺎ

ﻌﻔﻟﺍ ﺓﺩﺎﻤﻟﺍ ﻰﻟﺍ ﺔﻓﺎﺿﻹﺎﺑ :ﺔﻴﻟﺎﺘﻟﺍ

Hypromellose, Calcium hydrogen phosphate dehydrate,

Hydrogenated vegetable oil, Povidone K30, Colloidal

anhydrous silica, Magnesium stearate, Propylene glycol,

Titanium dioxide (E-171).m

ﻦﻣ ﺔﺑ

ﺪﺤﻣﻭ ﺓﺭﻭﺪﻣ ،ﺾﻴﺑﺍ ﺹﺮﻗ :ﺔﺒﻠﻌﻟﺍ ﻯﻮﺘﺤﻣ ﻮﻫ ﺎﻣﻭ ءﺍﻭﺪﻟﺍ ﻭﺪﺒﻳ ﻒﻴﻛ .ﺹﺍﺮﻗﺍ ١٠ ( ﺔﺣﻮﻟ) ﺮﺘﺴﻴﻟﺎﺑ ﻞﻛ ﻲﻓ .ﺎﺻﺮﻗ ٣٠ ﺔﺒﻠﻌﻟﺍ ﻲﻓ .ﺎﻬﻴﺒﻧﺎﺟ ﻉﺭﺎﺷ ،ﺓﺩﻭﺪﺤﻤﻟﺍ ﺕﻮﻳﻮﻨﺧﻮﺳ ﻞﻴﺋﺍﺮﺳﺍﻮﻐﻳﺮﺑ :ﻪﻧﺍﻮﻨﻋﻭ ﻞﻴﺠﺴﺘﻟﺍ ﺐﺣﺎﺻ .ﻢﻫﻮﺷ ،١ ﺖﻔﻴﻛﺭ .ﺍﺮﺴﻳﻮﺳ ،ﻮﻧﺎﻣ ،ﺃ .ﺱ ﻡﺭﺎﻓﻮﺒﻳﺭ :ﻪﻧﺍﻮﻨﻋﻭ ﺞﺘﻨﻤﻟﺍ ﻢﺳﺍ ﻮﻴﻟﻮﻳ ﻲﻓ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻞﺒﻗ ﻦﻣ ﺎﻬﻴﻠﻋ ﺔﻗﺩﺎﺼﻤﻟﺍﻭ ﺓﺮﺸﻨﻟﺍ ﻩﺬﻫ ﺺﺤﻓ ﻢﺗ

٢٠١٨ ﺲﻄﺴﻏﺍ ﻲﻓ ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﺕﺎﻤﻴﻠﻌﺗ ﺐﺟﻮﻤﺑ ﺎﻬﻠﻳﺪﻌﺗ ﻢﺗﻭ ، ٢٠١٥

:ﺔﺤﺼﻟﺍ ﺓﺭﺍﺯﻭ ﻲﻓ ﻲﻣﻮﻜﺤﻟﺍ ﺔﻳﻭﺩﻷﺍ ﻞﺠﺳ ﻲﻓ ءﺍﻭﺪﻟﺍ ﻞﻴﺠﺴﺗ ﻢﻗﺭ ١٤١٢٣.٣١٨٢٩

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