Tadalafil Goibela 20 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:
20 mg
Läkemedelsform:
Filmdragerad tablett
Sammansättning:
tadalafil 20 mg Aktiv substans; laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
55120
Tillstånd datum:
2017-09-01

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Package leaflet: Information for the user

Tadalafil Goibela 20 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

What Tadalafil Goibela is and what it is used for

What you need to know before you take Tadalafil Goibela

How to take Tadalafil Goibela

Possible side effects

How to store Tadalafil Goibela

Contents of the pack and other information

1.

What Tadalafil Goibela is and what it is used for

Tadalafil is a treatment for 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.

Tadalafil Goibela contains the active substance tadalafil which belongs to a group of

medicines called phosphodiesterase type 5 inhibitors. 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 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.

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 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.

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 or pharmacist 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 it into equal doses.

The recommended starting dose

is one 10 mg tablet before sexual activity. However, you

have been given the dose of one 20mg tablet as your doctor has decided that the

recommended dose of 10mg is too weak.

You may take a Tadalafil Goibela tablet at least 30 minutes before sexual activity. Tadalafil

Goibela may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil Goibela more than once a day. Tadalafil Goibela 10 mg and 20 mg is

intended for use prior to anticipated sexual activity and is not recommended for continuous

daily use.

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 and may temporarily lower your

blood pressure. If you have taken or are planning to take tadalafil, avoid excessive drinking

(blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when

standing up.

If you take more Tadalafil Goibela than you should

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

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 20 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 20 mg is a yellow film-coated tablet, 15x7 mm oblong shaped, biconvex,

debossed with “TD2” on one side and scored on the other.

Tadalafil Goibela 20 mg is available in blister packs containing 4, 8 or 12 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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