Tadalafil Goibela 5 mg Filmdragerad tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

22-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
tadalafil
Tillgänglig från:
Laboratorios Cinfa S.A.
ATC-kod:
G04BE08
INN (International namn):
tadalafil
Dos:
5 mg
Läkemedelsform:
Filmdragerad tablett
Sammansättning:
natriumlaurilsulfat Hjälpämne; tadalafil 5 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
55118
Tillstånd datum:
2017-09-01

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Package leaflet: information for the user

Tadalafil Goibela 5 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Tadalafil Goibela is and what it is used for

2. What you need to know before you take Tadalafil Goibela

3. How to take Tadalafil Goibela

4. Possible side effects

5. How to store Tadalafil Goibela

6. Contents of the pack and other information

1. What Tadalafil Goibela is and what it is used for

This medicine contains the active substance tadalafil which belongs to a group of medicines called

phosphodiesterase type 5 inhibitors.

Tadalafil Goibela 5 mg is used to treat adult men with:

erectile dysfunction

. This is when a man cannot get, or keep a hard, erect penis suitable for

sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a

hard erect penis suitable for sexual activity.

Following sexual stimulation tadalafil works by helping the blood vessels in your penis to

relax, allowing the flow of blood into your penis. The result of this is improved erectile

function. Tadalafil will not help you if you do not have erectile dysfunction. It is important

to note that tadalafil

for the treatment of erectile dysfunction does not work if there is no

sexual stimulation. You and your partner will need to engage in foreplay, just as you would if

you were not taking a medicine for erectile dysfunction.

Urinary symptoms associated with a common condition called

benign prostatic hyperplasia

This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting

to pass water, a feeling of not completely emptying the bladder and a more frequent need to

pass water even at night. Tadalafil improves blood flow to, and relaxes the muscles of, the

prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Tadalafil

has been shown to improve these urinary symptoms as early as 1-2 weeks after starting

treatment.

2. What you need to know before you take

Tadalafil Goibela

Do not take

Tadalafil Goibela if you:

are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a

group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”).

Tadalafil has been shown to increase the effects of these medicines. If you are taking any

form of nitrate or are unsure tell your doctor.

have serious heart disease or recently had a heart attack within the last 90 days.

recently had a stroke within the last 6 months.

have low blood pressure or uncontrolled high blood pressure.

ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy

(NAION), a condition described as “stroke of the eye”.

are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high

blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e.,

high blood

pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as

tadalafil, have been shown to increase the hypotensive effects of this medicine. If you are

taking riociguat or are

unsure tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tadalafil Goibela.

Be aware that sexual activity carries a possible risk to patients with heart disease because it

puts an extra strain on your heart. If you have a heart problem you should tell your doctor.

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor

will check you for prostate cancer before starting treatment with Tadalafil Goibela for benign

prostatic hyperplasia.

Tadalafil does not treat prostate cancer.

Before taking the tablets, tell your doctor if you have:

sickle cell anaemia (an abnormality of red blood cells).

multiple myeloma (cancer of the bone marrow).

leukaemia (cancer of the blood cells).

any deformation of your penis.

a serious liver problem.

a severe kidney problem.

It is not known if tadalafil is effective in patients who have had:

pelvic surgery.

removal of all or part of the prostate gland in which nerves of the prostate are cut (radical

non- nerve-sparing prostatectomy).

If you experience sudden decrease or loss of vision, stop taking Tadalafil Goibela and contact

your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil.

Although it is not known if the event is directly related to tadalafil, if you experience

decreased or sudden hearing loss, stop taking

Tadalafil Goibela

and contact your doctor

immediately.

Tadalafil is not intended for use by women.

Children and adolescents

Tadalafil is not intended for use by children and adolescents under the age of 18.

Other medicines and Tadalafil Goibela

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Do not take Tadalafil Goibela if you are already taking nitrates.

Some medicines may be affected by tadalafil or they may affect how well tadalafil will work. Tell

your doctor or pharmacist if you are already taking:

an alpha blocker (used to treat high blood pressure or urinary symptoms associated with

benign prostatic hyperplasia).

other medicines to treat high blood pressure.

riociguat.

a 5- alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors

for treatment of AIDS or HIV infection.

phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).

rifampicin, erythromycin, clarithromycin or itraconazole.

other treatments for erectile dysfunction.

Tadalafil Goibela with drink and alcohol

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well

Tadalafil Goibela will work and should be taken with caution. Talk to your doctor for further

information.

Fertility

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm

was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines

Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how

you react to the tablets before driving or using machines.

Tadalafil Goibela contains lactose:

If you have been told by your doctor that you have an intolerance to some sugars, contact your

doctor before taking this medicinal product.

3. How to take Tadalafil Goibela

Always take this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

Tadalafil Goibela tablets are for oral use in men only. Swallow the tablet whole with some water.

The tablets can be taken with or without food.

The score line is only there to help you break the tablet if you have difficulty swallowing it

whole and not to divide into equal doses.

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to

take Tadalafil Goibela, avoid excessive drinking (blood alcohol level of 0.08% or greater), since

this may increase

the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended dose

is one 5 mg tablet taken once a day at approximately the same time of

the day. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This

will be given as a 2.5mg tablet.

Do not take Tadalafil Goibela more than once a day.

When taken once a day Tadalafil Goibela allows you to obtain an erection, when sexually

stimulated, at any time point during the 24 hours of the day. Once a day dosing of Tadalafil

Goibela may be useful to men who

anticipate having sexual activity two or more times per

week.

It is important to note that tadalafil does not work if there is no sexual stimulation. You and your

partner will need to engage in foreplay, just as you would if you were not taking a medicine for

erectile dysfunction.

Drinking alcohol may affect your ability to get an erection.

For the treatment benign prostatic hyperplasia

dose

is one 5 mg tablet taken once a day at approximately the same time of the day.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg

tablet taken once a day.

Do not take Tadalafil Goibela more than once a day.

If you take more Tadalafil Goibela than you should

Contact your doctor. You may experience side effects described in section 4.

If you forget to take

Tadalafil Goibela

Take your dose as soon as you remember but do not take a double dose to make up for a forgotten

tablet. You should not take tadalafil more than once a day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical

help immediately:

allergic reactions including rashes (frequency uncommon).

chest pain - do not use nitrates but seek immediate medical assistance (frequency

uncommon).

priapism, a prolonged and possibly painful erection after taking tadalafil (frequency rare). If

you have such an erection, which lasts continuously for more than 4 hours you should

contact a doctor immediately.

sudden loss of vision (frequency rare).

Other side effects have been reported:

Common

(seen in 1 to 10 in every 100 patients)

headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion

and indigestion.

Uncommon

(seen in 1 to 10 in every 1,000 patients)

dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain,

difficulty in breathing,

presence of blood in urine, prolonged erection, pounding heartbeat

sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in

the ears, swelling of the hands, feet or ankles and feeling tired.

Rare

(seen in 1 to 10 in every 10,000 patients)

fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden

decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile

bleeding, presence of blood in semen and increased sweating.

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men

had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely

reported.

Some additional rare side effects

have been reported in men taking tadalafil that were not seen

in clinical trials. These include:

migraine, swelling of the face, serious allergic reaction which causes swelling of the face or

throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular

heartbeats, angina and sudden cardiac death.

The side effect dizziness has been reported more frequently in men over 75 years of age taking

tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking

tadalafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on

the safety of this medicine.

5. How to store Tadalafil Goibela

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after

‘EXP’. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Goibela contains

The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.

The other ingredients are: lactose monohydrate, hydroxypropylcellulose, croscarmellose

sodium, sodium laurilsulfate, microcrystalline cellulose, magnesium stearate, iron oxide yellow

E172, hypromellose, titanium dioxide E171, macrogol.

What Tadalafil Goibela looks like and contents of the pack

Tadalafil Goibela 5 mg is a light yellow film-coated tablet, 6 mm cylindrical shaped, biconvex,

debossed with “TD5” on one side and scored on the other.

Tadalafil Goibela 5 mg is available in blister packs containing 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

LABORATORIOS CINFA, S.A.

C/Olaz-Chipi, 10-Polígono Industrial Areta,

31620 Huarte-Pamplona (Navarra)

Spain

This leaflet was last revised in: 2017-07-13

Detailed information on this medicine is available on the website of {name of the MS Agency}

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