CIALIS 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TADALAFIL

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

G04BE08

Pharmaceutical form:

FILM COATED TABLETS

Composition:

TADALAFIL 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

LILLY S.A., SPAIN

Therapeutic group:

TADALAFIL

Therapeutic area:

TADALAFIL

Therapeutic indications:

For the treatment of erectile dysfunction in adult men.

Authorization date:

2023-05-31

Patient Information leaflet

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PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a physician’s prescription only_ _
Cialis 10 mg
Cialis 20 mg
Coated tablets
Coated tablets
Composition:
Composition:
Each tablet contains:
Each tablet contains:
Tadalafil 10 mg to be used_ “ON DEMAND”_
Tadalafil 20 mg to be used_ “On Demand”_
Cialis 2.5 mg
Cialis 5 mg
Coated tablets
Coated tablets
Composition:
Composition:
Each tablet contains:
Each tablet contains:
Tadalafil 2.5 mg for _“Once-a-Day”_ use
Tadalafil 5 mg for _“Once-a-Day”_ use
Inactive ingredients and allergens in the preparation: See Chapter 2
Section
“important information about some of the ingredients of this
medicine” and
Chapter 6 “Additional information”.
Read the entire leaflet carefully before using this medicine. This
leaflet
contains concise information about this medicine. If you have any
additional
questions, contact your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass
it on to others. It might harm them even if their illness seems to be
the same as
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Cialis 2.5, 10 and 20 mg is indicated for the treatment of erectile
dysfunction in
men.
Cialis 5 mg is indicated for:
The treatment of erectile dysfunction in men.
The treatment of symptoms of benign prostatic hyperplasia (BPH).
The treatment of men with erectile dysfunction and symptoms of benign
prostatic
hyperplasia (BPH).
Therapeutic group: Urologicals, drugs used in erectile dysfunction.
Cialis contains the active substance tadalafil which belongs to a
group of
medicines called phosphodiesterase type 5 inhibitors.
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Erectile dysfunction is when a man cannot get, or keep a hard, erect
penis
suitable for sexual activity. Cialis has been shown to significantly
improve the
ability of obtaining a hard erect penis suitable for sexual activity.
Following sexual stimulation, Cialis works by helping the

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
CIALIS 2.5 mg film-coated tablets
CIALIS 5 mg film-coated tablets
CIALIS 10 mg film-coated tablets
CIALIS 20 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each 2.5 mg tablet contains 2.5 mg tadalafil.
Each 5 mg tablet contains 5 mg tadalafil.
Each 10 mg tablet contains 10 mg tadalafil.
Each 20 mg tablet contains 20 mg tadalafil.
Excipient with known effect
Each 2.5 mg coated tablet contains 87 mg lactose (as monohydrate).
Each 5 mg coated tablet contains 121 mg lactose (as monohydrate).
Each 10 mg coated tablet contains 170 mg lactose (as monohydrate).
Each 20 mg coated tablet contains 233 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The 2.5 mg tablets are light orange-yellow and almond shaped, marked
"C 2 ½" on one side.
The 5 mg tablets are light yellow and almond shaped, marked "C 5" on
one side.
The 10 mg tablets are light yellow and almond shaped, marked “C
10” on one side.
The 20 mg tablets are yellow and almond shaped, marked “C 20” on
one side.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of erectile dysfunction in adult men.
In order for tadalafil to be effective
for the treatment of erectile dysfunction, sexual stimulation is
required.
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CIALIS 5 mg for once daily use is also indicated for the treatment of
the signs and symptoms of benign
prostatic hyperplasia (BPH).
CIALIS 5 mg for once daily use is also indicated for the treatment of
ED and the signs and symptoms of
BPH (ED/BPH).
CIALIS is not indicated for use by women.
4.2
Posology and method of administration
Posology
_Erectile dysfunction in adult men _
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or without
food.
In those patients in whom tadalafil 10 mg does not produce an adequate
effect, 20 mg might be tried. It
may be taken at least 30 minutes prior to sexual activity.
The max