Dymavig 10 mg Filmdragerad tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

20-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-08-2018

Aktiva substanser:
tadalafil
Tillgänglig från:
Sigillata Ltd,
ATC-kod:
G04BE08
INN (International namn):
tadalafil
Dos:
10 mg
Läkemedelsform:
Filmdragerad tablett
Sammansättning:
tadalafil 10 mg Aktiv substans; laktosmonohydrat Hjälpämne; natriumlaurilsulfat Hjälpämne
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Blister, 4 tabletter
Bemyndigande status:
Avregistrerad
Godkännandenummer:
55214
Tillstånd datum:
2017-07-13

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04-07-2018

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04-07-2018

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

13-07-2017

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Package leaflet: Information for the user

Dymavig 10 mg film-coated tablets

tadalafil

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 Dymavig is and what it is used for

What you need to know before you take Dymavig

How to take Dymavig

Possible side effects

How to store Dymavig

Contents of the pack and other information

1.

What Dymavig is and what it is used for

Dymavig 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. Dymavig has been shown to significantly improve

the ability of obtaining a hard erect penis suitable for sexual activity.

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

phosphodiesterase type 5 inhibitors. Following sexual stimulation Dymavig 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. Dymavig will not help you if you do not have erectile dysfunction.

It is important to note that Dymavig 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 Dymavig

Do not take Dymavig:

if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section

if you 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”).

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

of nitrate or are unsure tell your doctor.

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

if you recently had a stroke within the last 6 months.

if you have low blood pressure or uncontrolled high blood pressure.

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

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

if you 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 Dymavig

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 Dymavig 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 Dymavig 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 Dymavig and contact your doctor immediately.

Dymavig is not intended for use by women.

Children and adolescents

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

Other medicines and Dymavig

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

medicines.

Do not take Dymavig if you are already taking nitrates.

Some medicines may be affected by Dymavig or they may affect how well Dymavig 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.

Dymavig with food, drink and alcohol

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

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 Dymavig in clinical studies have reported dizziness. Check carefully how you react

to the tablets before driving or using machines.

Dymavig contains lactose

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

before taking this medicine.

3.

How to take Dymavig

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

if you are not sure.

Dymavig 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 recommended starting dose

is one 10 mg tablet before sexual activity.

If the effect of this dose is too weak your doctor may increase the dose to 20 mg. Dymavig tablets are

for oral use.

You may take a Dymavig tablet at least 30 minutes before sexual activity. Dymavig may still be

effective up to 36 hours after taking the tablet.

Do not take Dymavig more than once a day. Dymavig 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 Dymavig 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 Dymavig, 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 Dymavig 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 Dymavig (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 (may affect up to 1 in 10 people)

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

indigestion.

Uncommon (may affect up to 1 in 100 people)

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 (may affect up to 1 in 1,000 people)

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 Dymavig. 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 Dymavig 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

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

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 Dymavig

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 ʻEXPʼ.

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

This medicine 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 Dymavig contains

The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.

The other ingredients are:

Tablet core:

lactose monohydrate, pregelatinised starch, colloidal anhydrous silica,

croscarmellose sodium, sodium laurilsulfate, magnesium stearate.

Film-coat:

hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b),

iron oxide yellow (E172), iron oxide red (E172).

What Dymavig looks like and contents of the pack

Dymavig 10 mg is a pale yellow, oval shaped, film-coated tablet (tablet), debossed with “10” on one

side and plain on the other side. The tablet is 11 mm x 6.6 mm in diameter and 3.9 – 4.5 mm in

thickness.

Pack sizes

Dymavig 10 mg is available in blister packs containing 4 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sigillata Limited

Fourth Floor 20 Margaret Street

W1W 8 RS London

Manufacturer

<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the following

names:

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised in 2018-07-04

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