SPEDRA 50 mg Film-Coated Tablets

Зміст інструкції

1. Spedra 50 mg tablets
   1. What is Spedra and what is it used for
   2. What you need to know before taking Spedra
   3. How to take Spedra
   4. Possible side effects
   5. How to store Spedra
   6. Contents of the pack and other information
2. Spedra 100 mg tablets
   1. What is Spedra and what is it used for
   2. What you need to know before taking Spedra
   3. How to take Spedra
   4. Possible side effects
   5. How to store Spedra
   6. Package contents and other information
3. Spedra 200 mg tablets
   1. What is Spedra and what is it used for
   2. What you need to know before taking Spedra
   3. How to take Spedra
   4. Possible side effects
   5. How to store Spedra
   6. Package contents and other information

Spedra 50 mg tablets

avanafil

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Spedra is and what it is used for
• 2. What you need to know before you take Spedra
• 3. How to take Spedra
• 4. Possible side effects
• 5. How to store Spedra
• 6. Contents of the pack and other information

1. What is Spedra and what is it used for

The active substance contained in Spedra is called avanafil and belongs to a group of medicines
called phosphodiesterase type 5 (PDE5) inhibitors.
Spedra is used in the treatment of adult men who suffer from erectile dysfunction (also known as
impotence), represented by the inability to achieve or maintain an erection suitable for sexual
activity.
Spedra works by helping the blood vessels in the penis to dilate; the increased blood flow to the penis
helps it to remain rigid and erect during sexual excitement. Spedra does not cure your dysfunction.
It is important to note that Spedra only works if you are sexually stimulated. You and your partner
will still need to use foreplay to prepare for sexual intercourse, as you would if you
were not taking any medicine.
Spedra will not be helpful if you do not have erectile dysfunction. Spedra is not a medicine for women.

2. What you need to know before taking Spedra

Do not take Spedra:

• if you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines containing nitrates for chest pain (angina), such as amyl nitrite or nitroglycerin. Spedra may enhance the effects of these medicines and seriously lower your blood pressure;
• if you are taking medicines for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir;
• if you are taking medicines for fungal infections, such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin;
• if you have serious heart problems;
• if you have had a stroke or heart attack in the last 6 months;
• if you have low or uncontrolled high blood pressure;
• if you have chest pain (angina) or the chest pain comes on during sexual activity
• if you have a serious problem with your liver or kidneys;
• if you have lost vision in one eye due to an illness (non-arteritic anterior ischemic optic neuropathy [NAION]) that reduces the amount of blood to the eyes;
• if other people in your family suffer from serious eye problems (such as retinitis pigmentosa);
• if you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or have any doubts, consult your doctor.

Do not take Spedra if any of the above situations applies to you. If you have any doubts, consult your
doctor or pharmacist before taking Spedra.

Warnings and precautions
Talk to your doctor or pharmacist before taking Spedra:

• if you have heart problems. It may be risky for you to have sexual intercourse;
• if you have been affected by “priapism”, that is a persistent erection lasting 4 hours or more (this can happen in men affected by diseases such as sickle cell anemia, multiple myeloma or leukemia);
• if you have an abnormality in the shape of your penis (such as curvature, Peyronie's disease or cavernous fibrosis);
• if you have a bleeding disorder or an active peptic ulcer.

If any of the above situations applies to you, talk to your doctor or
pharmacist before taking Spedra. If you have any doubts consult your doctor or pharmacist.
Problems with vision or hearing
Some men taking medicines like Spedra have experienced problems with vision or hearing (for
more details see "Serious side effects" in section 4). It is not known whether these problems
are due directly to Spedra, to other concomitant diseases or to a combination of factors.
If you experience sudden decrease or loss of vision or if your vision is distorted or blurred
while taking Spedra, stop taking Spedra and contact your doctor immediately.

Children and adolescents
Spedra must not be taken by children and adolescents under 18 years of age.

Other medicines and Spedra
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, as Spedra can affect the effect of some of them. Some other
medicines can also affect the effect of Spedra.
In particular, tell your doctor and do not take Spedra if you are taking medicines containing nitrates for
chest pain (angina), such as amyl nitrite or nitroglycerin. Spedra enhances the effects of
these medicines and lowers your blood pressure seriously. Also do not take Spedra if you are
taking medicines for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir or
atazanavir or medicines for fungal infections, such as ketoconazole, itraconazole or voriconazole or
certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see the beginning of
section 2 “Do not take Spedra”).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• so-called alpha-blockers, for prostate problems or for lowering high blood pressure;
• medicines for irregular heartbeat (“arrhythmia”) such as quinidine, procainamide, amiodarone or sotalol;
• antibiotics for infections such as erythromycin;
• phenobarbital or primidone for epilepsy;
• carbamazepine, for epilepsy, to stabilize mood or for certain types of pain;
• other medicines that can reduce the metabolism of Spedra in the body (“moderate CYP3A4 inhibitors”), including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil;
• riociguat.

Do not use Spedra together with other treatments for erectile dysfunction, such as sildenafil, tadalafil or
vardenafil.
If any of the above situations applies to you, talk to your doctor or
pharmacist before taking Spedra. If you have any doubts consult your doctor or pharmacist.

Spedra with drinks and alcohol
Grapefruit juice can increase exposure to the medicine and should be avoided within 24
hours before taking Spedra. Drinking alcohol together with taking Spedra can increase your
heart rate and lower your blood pressure. You may feel dizzy (especially
when standing up) and have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol can
also reduce your ability to have an erection.

Fertility
Spedra has not affected sperm motility or morphology after single oral doses of 200 mg
in healthy volunteers.
Repeated oral administration of avanafil 100 mg for a period of 26 weeks to healthy volunteers
and to adult males with mild erectile dysfunction has not been associated with side effects on
sperm concentration, number, motility or morphology.

Driving and using machines
Spedra can cause dizziness or alter vision. If this happens, do not drive, ride a bicycle or use
tools or machinery.

3. How to take Spedra

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one 100 mg tablet, as needed. Do not take Spedra more than once
a day. Your doctor may prescribe a dose of one 200 mg tablet if they have decided that the 100 mg dose is
too weak for you, or a dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet is
too strong for you. Dose adjustments may also be necessary when Spedra is used together with other
medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil
(“moderate CYP3A inhibitors”), the recommended dose of Spedra is one 100 mg tablet, with
an interval of at least 2 days between doses.
Take Spedra approximately 30 minutes before sexual activity. Remember that Spedra will only help you
achieve an erection if you are sexually stimulated.
Spedra can be taken with or without food; if taken with food, it may take longer
to take effect.

If you take more Spedra than you should
If you take too much Spedra, you should inform your doctor immediately. You may experience more
side effects than usual and they may be more severe.
If you have any doubts about the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Stop taking Spedra and contact your doctor immediately if you notice any of the
following serious side effects (you may need urgent medical treatment):

• an erection that will not go away (“priapism”). If you have an erection that lasts longer than 4 hours, it needs to be treated promptly or your penis could be damaged permanently (including the inability to have erections);
• blurred vision;
• sudden decrease or loss of vision in one or both eyes;
• sudden decrease or loss of hearing (you may also experience dizziness or ringing in your ears).

Stop taking Spedra and contact your doctor immediately if you notice any of the
serious side effects mentioned above.

Other side effects include:
Common (may affect up to 1 in 10 people)

• headache;
• hot flushes;
• nasal congestion. Uncommon (may affect up to 1 in 100 people)
• dizziness;
• sleepiness or fatigue;
• sinus congestion;
• back pain;
• hot flashes;
• shortness of breath during exercise;
• changes in heartbeats on an electrocardiogram (ECG);
• increased heart rate;
• fast heartbeat (palpitations);
• indigestion, stomach pain;
• blurred vision;
• increased liver enzymes.

Rare (may affect up to 1 in 1000 people)

• influenza;
• flu-like illness;
• stuffy or runny nose;
• allergic rhinitis;
• congestion of the nose, sinuses, or upper airways leading air to the lungs;
• gout;
• sleep disorders (insomnia);
• premature ejaculation;
• feeling unwell;
• inability to sit still;
• chest pain;
• severe chest pain;
• fast heartbeat;
• high blood pressure;
• dry mouth;
• stomach pain or heartburn;
• pain or discomfort in the lower abdomen;
• diarrhea;
• skin rash;
• pain in the lower back or lower side of the chest;
• muscle aches;
• muscle contractions;
• frequent need to urinate;
• penis disorders;
• spontaneous erection without sexual stimulation;
• itching in the genital area;
• persistent feeling of weakness and fatigue;
• swelling of the feet or ankles;
• increased blood pressure;
• pink or red urine, blood in urine;
• abnormal extra heart sound;
• abnormal results in a test for the prostate called ‘PSA’;
• abnormal results in tests for bilirubin, a chemical produced by the normal breakdown of red blood cells;
• abnormal results in a test for creatinine, a chemical excreted in urine, useful for assessing kidney function;
• weight gain;
• fever.
• nosebleed.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 Spedra

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 blister and the carton after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Spedra contains

• The active ingredient is avanafil. Each tablet contains 50 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, low substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate and yellow iron oxide (E172). Description of the appearance of Spedra and contents of the pack

Spedra is an oval, pale yellow tablet, with “50” imprinted on one side. The tablets
are supplied in divisible blister packs containing 4x1, 8x1 or 12x1 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder:
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-
1611 Luxembourg, Luxembourg.

Manufacturer:
Menarini - Von Heyden GmbH
Leipziger Straβe 7-13
01097 Dresden
Germany
or
Sanofi Winthrop Industrie
1, rue de la Vierge
Ambares et Lagrave
33565 Carbon-Blanc-Cedex
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Lietuva
UAB “BERLIN-CHEMIE MENARINI
BALTIC”
Tel: +370 52 691 947

България
“Берлин-Хеми/А. Менарини България”
ЕООД
тел.: +359 2 454 0950

Luxembourg/Luxemburg
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Česká republika
Berlin-Chemie/A.Menarini Ceska republika
s.r.o.
Tel: +420 267 199 333

Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301

Danmark
Pharmaprim AB
Tlf: +46 8355933

Malta
Menarini International Operations Luxembourg
S.A.
Tel: +352 264976

Deutschland
Berlin-Chemie AG
Tel: +49 (0) 30 67070

Nederland
Menarini Benelux NV/SA
Tel: +32 (0)2 721 4545

Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001

Norge
Pharmaprim AB
Tlf: +46 8355933

Ελλάδα
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Österreich

• A. Menarini Pharma GmbH Tel: +43 1 879 95 85-0

España
Laboratorios Menarini S.A.
Tel: +34-93 462 88 00

Polska
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00

France
MENARINI France
Tél: +33 (0)1 45 60 77 20

Portugal

• A. Menarini Portugal – Farmacêutica, S.A. Tel: +351 210 935 500

Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: + 385 1 4821 361

România
Berlin-Chemie A. Menarini S.R.L.
Tel: +40 21 232 34 32

Ireland

• A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744 SlovenijaBerlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160 ÍslandPharmaprim AB Sími: +46 8355933 Slovenská republikaBerlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730

Italia

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56801 Suomi/FinlandBerlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760

Κύπρος
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Sverige
Pharmaprim AB
Tel: +46 8355933

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210

United Kingdom (Northern Ireland)

• A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

Spedra 100 mg tablets

avanafil

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Spedra is and what it is used for
• 2. What you need to know before you take Spedra
• 3. How to take Spedra
• 4. Possible side effects
• 5. How to store Spedra
• 6. Contents of the pack and other information

1. What is Spedra and what is it used for

The active substance contained in Spedra is called avanafil and belongs to a group of medicines
called phosphodiesterase type 5 (PDE5) inhibitors.
Spedra is used in the treatment of adult men who suffer from erectile dysfunction (also known as
impotence), represented by the inability to achieve or maintain an erection suitable for sexual
activity.
Spedra works by helping the blood vessels in the penis to dilate; the increased blood flow to the penis
helps it to remain rigid and erect during sexual excitement. Spedra does not cure your erectile dysfunction.
It is important to note that Spedra only works if you are sexually stimulated. You and your partner
will still need to use foreplay to prepare for sexual intercourse, as you would if you
were not taking any medication.
Spedra will not be helpful if you do not have erectile dysfunction. Spedra is not a medicine for women.

2. What you need to know before taking Spedra

Do not take Spedra:

• if you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines containing nitrates for chest pain (angina), such as amyl nitrite or nitroglycerin. Spedra may enhance the effects of these medicines and seriously lower your blood pressure;
• if you are taking medicines for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir;
• if you are taking medicines for fungal infections, such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin;
• if you have severe heart problems;
• if you have had a stroke or heart attack in the last 6 months;
• if you have low or uncontrolled high blood pressure;
• if you have chest pain (angina) or the chest pain comes on during sexual activity
• if you have a severe liver or kidney problem;
• if you have lost vision in one eye due to a disease (non-arteritic anterior ischemic optic neuropathy [NAION]) that reduces the amount of blood to the eyes;
• if other people in your family suffer from serious eye problems (such as retinitis pigmentosa);
• if you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or have any doubts, consult your doctor.

Do not take Spedra if any of the above situations applies to you. If you have doubts, consult your
doctor or pharmacist before taking Spedra.

Warnings and precautions
Talk to your doctor or pharmacist before taking Spedra:

• if you have heart problems. It may be risky for you to have sexual intercourse;
• if you have been affected by “priapism”, i.e. a persistent erection lasting 4 hours or more (this can happen in men affected by diseases such as sickle cell anemia, multiple myeloma or leukemia);
• if you have an abnormality in the shape of your penis (such as curvature, Peyronie's disease or cavernous fibrosis);
• if you have a bleeding disorder or an active peptic ulcer.

If any of the above situations applies to you, talk to your doctor or
pharmacist before taking Spedra. If you have doubts consult your doctor or pharmacist.
Problems with vision or hearing
Some men taking medicines like Spedra have experienced problems with vision or hearing (for
more details see "Serious adverse reactions" in section 4). It is not known whether these problems
are directly due to Spedra, to other concomitant diseases or to a combination of factors.
If you experience sudden decrease or loss of vision or if your vision is distorted or blurred
while taking Spedra, stop taking Spedra and contact your doctor immediately.

Children and adolescents
Spedra should not be taken by children and adolescents under the age of 18 years.

Other medicines and Spedra
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, as Spedra can influence the effect of some of them. Some other
medicines can also influence the effect of Spedra.
In particular, tell your doctor and do not take Spedra if you are taking medicines containing nitrates for
chest pain (angina), such as amyl nitrite or nitroglycerin. Spedra enhances the effects of
these medicines and lowers your blood pressure seriously. Also do not take Spedra if you are
taking medicines for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir or
atazanavir or medicines for fungal infections, such as ketoconazole, itraconazole or voriconazole or
certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see the beginning
of section 2 “Do not take Spedra”).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• so-called alpha-blockers, for prostate problems or for lowering high blood pressure;
• medicines for irregular heartbeat (“arrhythmia”) such as quinidine, procainamide, amiodarone or sotalol;
• antibiotics for infections such as erythromycin;
• phenobarbital or primidone for epilepsy;
• carbamazepine, for epilepsy, to stabilize mood or for certain types of pain;
• other medicines that can reduce the metabolism of Spedra in the body (“moderate CYP3A4 inhibitors”), including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil;
• riociguat.

Do not use Spedra together with other treatments for erectile dysfunction, such as sildenafil, tadalafil or
vardenafil.
If any of the above situations applies to you, talk to your doctor or
pharmacist before taking Spedra. If you have doubts consult your doctor or pharmacist.

Spedra with drinks and alcohol
Grapefruit juice can increase exposure to the medicine and should be avoided within 24
hours before taking Spedra. Drinking alcohol together with taking Spedra can increase your
heart rate and lower your blood pressure. You may feel dizzy (especially
when standing up) and have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol can
also reduce your ability to get an erection.

Fertility
Spedra has not affected sperm motility or morphology after single oral doses of 200 mg
in healthy volunteers.
Repeated oral administration of avanafil 100 mg for a period of 26 weeks to healthy volunteers
and to adult males with mild erectile dysfunction has not been associated with adverse effects on
sperm concentration, number, motility or morphology.

Driving and operating machinery
Spedra can cause dizziness or alter vision. If this happens, do not drive, cycle or use
tools or machinery.

3. How to take Spedra

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one 100 mg tablet, as needed. Do not take Spedra more than once
a day. Your doctor may prescribe a dose of one 200 mg tablet if they have decided that the 100 mg dose is
too weak for you, or a dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet is
too strong for you. Dose adjustments may also be necessary when Spedra is used together with other
medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil
(“moderate CYP3A inhibitors”), the recommended dose of Spedra is one 100 mg tablet, with
an interval of at least 2 days between doses.
Take Spedra approximately 15 to 30 minutes before sexual activity. Remember that Spedra will
only help you achieve an erection if you are sexually stimulated.
Spedra can be taken with or without food; if taken with food, it may take longer
to take effect.

If you take more Spedra than you should
If you take too much Spedra, you should inform your doctor immediately. You may experience more
side effects than usual and they may be more severe.
If you have any doubts about the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects
Stop taking Spedra and contact a doctor immediately if you notice any of the
following serious side effects (you may need urgent medical treatment):

• an erection that will not go away (“priapism”). If you have an erection that lasts longer than 4 hours, it needs to be treated straight away, or your penis may be damaged permanently (including loss of ability to have erections);
• blurred vision;
• sudden loss of vision in one or both eyes;
• sudden loss of hearing (you may also experience dizziness or ringing in your ears).

Stop taking Spedra and contact a doctor immediately if you notice any of the
serious side effects mentioned above.

Other side effects include:
Common (may affect up to 1 in 10 people)

• headache;
• hot flushes;
• nasal congestion. Uncommon (may affect up to 1 in 100 people)
• dizziness;
• sleepiness or fatigue;
• sinus congestion;
• back pain;
• hot flushes;
• shortness of breath during exercise;
• changes in heartbeats on an electrocardiogram (ECG);
• increased heart rate;
• fast heartbeat (palpitations);
• indigestion, stomach pain;
• blurred vision;
• increased liver enzymes.

Rare (may affect up to 1 in 1000 people)

• flu;
• flu-like illness;
• stuffy or runny nose;
• allergic rhinitis;
• congestion of the nose, sinuses or upper airways leading to the lungs;
• gout;
• sleep disorders (insomnia);
• premature ejaculation;
• feeling unwell;
• inability to sit still;
• chest pain;
• severe chest pain;
• fast heartbeat;
• high blood pressure;
• dry mouth;
• stomach pain or heartburn;
• pain or discomfort in the lower abdomen;
• diarrhoea;
• skin rash;
• pain in the lower back or lower side of the chest;
• muscle pain;
• muscle contractions;
• frequent need to urinate;
• penis disorders;
• spontaneous erection without sexual stimulation;
• itching in the genital area;
• persistent feeling of weakness and fatigue;
• swelling of the feet or ankles;
• increased blood pressure;
• pink or red urine, blood in urine;
• abnormal extra heart sound;
• abnormal results in a test for the prostate called ‘PSA’;
• abnormal results in tests for bilirubin, a chemical produced by the normal breakdown of red blood cells;
• abnormal results in a test for creatinine, a chemical excreted in urine, used to assess kidney function;
• weight gain;
• fever;
• nosebleed.

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 through the national reporting system
listed in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Spedra

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 blister and the box after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Spedra contains

• The active ingredient is avanafil. Each tablet contains 100 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate and yellow iron oxide (E172).

Description of Spedra and package contents
Spedra is an oval, pale yellow tablet, with “100” imprinted on one side. The tablets
are supplied in divisible blister packs for unit dose containing 2x1, 4x1, 8x1 or 12x1 tablets.
Not all pack sizes may be marketed in your country.

Marketing authorisation holder:
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-
1611 Luxembourg, Luxembourg.

Manufacturer:
Menarini - Von Heyden GmbH
Leipziger Straβe 7-13
01097 Dresden
Germany
or
Sanofi Winthrop Industrie
1, rue de la Vierge
Ambares et Lagrave
33565 Carbon-Blanc-Cedex
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Lietuva
UAB “BERLIN-CHEMIE MENARINI
BALTIC”
Tel: +370 52 691 947

България
“Берлин-Хеми/А. Менарини България”
ЕООД
тел.: +359 2 454 0950

Luxembourg/Luxemburg
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Česká republika
Berlin-Chemie/A.Menarini Ceska republika
s.r.o.
Tel: +420 267 199 333

Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301

Danmark
Pharmaprim AB
Tlf: +46 8355933

Malta
Menarini International Operations Luxembourg
S.A.
Tel: +352 264976

Deutschland
Berlin-Chemie AG
Tel: +49 (0) 30 67070

Nederland
Menarini Benelux NV/SA
Tel: +32 (0)2 721 4545

Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001

Norge
Pharmaprim AB
Tlf: + 46 8355933

Ελλάδα
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Österreich

• A. Menarini Pharma GmbH Tel: +43 1 879 95 85-0

España
Laboratorios Menarini S.A.
Tel: +34-93 462 88 00

Polska
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00

France
MENARINI France
Tél: +33 (0)1 45 60 77 20

Portugal

• A. Menarini Portugal – Farmacêutica, S.A. Tel: +351 210 935 500

Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: + 385 1 4821 361

România
Berlin-Chemie A. Menarini S.R.L.
Tel: +40 21 232 34 32

Ireland

• A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744 SlovenijaBerlin-Chemie / A. Menarini Distribution Ljubljana d.o.o Tel: +386 01 300 2160

Ísland
Pharmaprim AB
Sími: + 46 8355933

Slovenská republika
Berlin-Chemie / A. Menarini Distribution
Slovakia s.r.o
Tel: +421 2 544 30 730

Italia

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56801 Suomi/FinlandBerlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760

Κύπρος
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Sverige
Pharmaprim AB
Tel: + 46 8355933

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210

United Kingdom (Northern Ireland)

• A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

Spedra 200 mg tablets

avanafil

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Spedra is and what it is used for
• 2. What you need to know before you take Spedra
• 3. How to take Spedra
• 4. Possible side effects
• 5. How to store Spedra
• 6. Contents of the pack and other information

1. What is Spedra and what is it used for

The active substance contained in Spedra is called avanafil and belongs to a group of medicines
called phosphodiesterase type 5 (PDE5) inhibitors.
Spedra is used in the treatment of adult men who suffer from erectile dysfunction (also known as
impotence), represented by the inability to achieve or maintain an erection suitable for sexual
activity.
Spedra works by helping the blood vessels in the penis to dilate; the increased blood flow to the penis
helps it to remain rigid and erect during sexual excitement. Spedra does not cure your erectile dysfunction.
It is important to note that Spedra only works if you are sexually stimulated. You and your partner
will still need to use foreplay to prepare for sexual intercourse, as you would if you
were not taking any medicine.
Spedra will not be helpful if you do not have erectile dysfunction. Spedra is not a medicine for women.

2. What you need to know before taking Spedra

Do not take Spedra:

• if you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines containing nitrates for chest pain (angina), such as amyl nitrite or nitroglycerin. Spedra may enhance the effects of these medicines and seriously lower your blood pressure
• if you are taking medicines for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
• if you are taking medicines for fungal infections, such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
• if you have serious heart problems
• if you have had a stroke or heart attack in the last 6 months
• if you have low or uncontrolled high blood pressure with medicines
• if you have chest pain (angina) or the chest pain comes on during sexual activity
• if you have a severe problem with your liver or kidneys
• if you have lost vision in one eye due to an illness (non-arteritic anterior ischemic optic neuropathy [NAION]) that reduces the amount of blood to the eyes
• if other people in your family suffer from serious eye problems (such as retinitis pigmentosa)
• if you are taking riociguat. This medicine 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 due to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or have any doubts, consult your doctor.

Do not take Spedra if any of the above situations applies to you. If you have any doubts, consult your
doctor or pharmacist before taking Spedra.

Warnings and precautions
Talk to your doctor or pharmacist before taking Spedra:

• if you have heart problems. It may be risky for you to have sexual activity;
• if you have suffered from “priapism”, i.e. a persistent erection lasting 4 hours or more (this can happen in men suffering from diseases such as sickle cell anemia, multiple myeloma or leukemia);
• if you have an abnormality in the shape of your penis (such as curvature, Peyronie's disease or cavernous fibrosis);
• if you have a bleeding disorder or an active peptic ulcer.

If any of the above situations applies to you, talk to your doctor or
pharmacist before taking Spedra. If you have any doubts consult your doctor or pharmacist.
Problems with vision or hearing
Some men taking medicines like Spedra have experienced problems with vision or hearing (for
more details see "Serious side effects" in section 4). It is not known whether these problems
are directly due to Spedra, to other concomitant diseases or to a combination of factors.
If you experience sudden decrease or loss of vision or if your vision is distorted or blurred
while taking Spedra, stop taking Spedra and contact your doctor immediately.

Children and adolescents
Spedra should not be taken by children and adolescents under the age of 18 years.

Other medicines and Spedra
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, as Spedra can affect the effect of some of them. Some other
medicines can also affect the effect of Spedra.
In particular, tell your doctor and do not take Spedra if you are taking medicines containing nitrates for
chest pain (angina), such as amyl nitrite or nitroglycerin. Spedra enhances the effects of
these medicines and lowers your blood pressure seriously. Also, do not take Spedra if you are
taking medicines for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir or
atazanavir or medicines for fungal infections, such as ketoconazole, itraconazole or voriconazole or
certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see the beginning of
section 2 “Do not take Spedra”).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• so-called alpha-blockers, for prostate problems or for lowering high blood pressure;
• medicines for irregular heartbeat (“arrhythmia”) such as quinidine, procainamide, amiodarone or sotalol;
• antibiotics for infections such as erythromycin;
• phenobarbital or primidone for epilepsy;
• carbamazepine, for epilepsy, to stabilize mood or for certain types of pain;
• other medicines that can reduce the metabolism of Spedra in the body (“moderate CYP3A4 inhibitors”), including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil;
• riociguat.

Do not use Spedra together with other treatments for erectile dysfunction, such as sildenafil, tadalafil or
vardenafil.
If any of the above situations applies to you, talk to your doctor or
pharmacist before taking Spedra. If you have any doubts consult your doctor or pharmacist.

Spedra with drinks and alcohol
Grapefruit juice can increase exposure to the medicine and should be avoided within 24
hours before taking Spedra.
Drinking alcohol together with taking Spedra can increase your heart rate and lower your
blood pressure. You may feel dizzy (especially when standing up) and have a headache or
feel your heart beating in your chest (palpitations). Drinking alcohol can also reduce your ability to
have an erection.

Fertility
Spedra has not affected the motility or shape of sperm after single oral doses of 200 mg
in healthy volunteers.
Repeated oral administration of avanafil 100 mg for a period of 26 weeks to healthy volunteers
and to men with mild erectile dysfunction has not been associated with side effects on
sperm concentration, number, motility or morphology.

Driving and using machines
Spedra can cause dizziness or alter vision. If this happens, do not drive, ride a bicycle or use
tools or machines.

3. How to take Spedra

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one 100 mg tablet, as needed. Do not take Spedra more than once
a day. Your doctor may prescribe a dose of one 200 mg tablet if they have decided that the 100 mg dose is
too weak for you, or a dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet is
too strong for you. Dose adjustments may also be necessary when Spedra is used together with other
medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil
(“moderate CYP3A inhibitors”), the recommended dose of Spedra is one 100 mg tablet, with
an interval of at least 2 days between doses.
Take Spedra approximately 15 to 30 minutes before sexual activity. Remember that Spedra will
only help you achieve an erection if you are sexually stimulated.
Spedra can be taken with or without food; if taken with food, it may take longer
to take effect.

If you take more Spedra than you should
If you take too much Spedra, you should inform your doctor immediately. You may experience more
side effects than usual and they may be more serious.
If you have any doubts about the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Stop taking Spedra and contact a doctor immediately if you notice any of the following serious side effects (you may need urgent medical treatment):

• an erection that will not go away (“priapism”). If you have an erection that lasts longer than 4 hours, it needs to be treated as soon as possible or your penis could be damaged permanently (including the inability to have erections);
• blurred vision;
• sudden decrease or loss of vision in one or both eyes;
• sudden decrease or loss of hearing (you may also experience dizziness or ringing in your ears).

Stop taking Spedra and contact a doctor immediately if you notice any of the serious side effects mentioned above.

Other side effects include:
Common (may affect up to 1 in 10 people)

• headache;
• flushing;
• nasal congestion. Uncommon (may affect up to 1 in 100 people)
• dizziness;
• sleepiness or fatigue;
• sinus congestion;
• back pain;
• hot flushes;
• shortness of breath during exercise;
• changes in heartbeats on an electrocardiogram (ECG);
• increased heart rate;
• fast heartbeat (palpitations);
• indigestion, stomach pain;
• blurred vision;
• increased liver enzymes.

Rare (may affect up to 1 in 1000 people)

• influenza;
• flu-like illness;
• stuffy or runny nose;
• allergic rhinitis;
• congestion of the nose, sinuses or upper airways leading air to the lungs;
• gout;
• sleep disorders (insomnia);
• premature ejaculation;
• feeling unwell;
• inability to sit still;
• chest pain;
• severe chest pain;
• fast heartbeat;
• high blood pressure;
• dry mouth;
• stomach pain or heartburn;
• pain or discomfort in the lower abdomen;
• diarrhoea;
• skin rash;
• pain in the lower back or lower side of the chest;
• muscle aches;
• muscle contractions;
• frequent need to urinate;
• penis disorders;
• spontaneous erection without sexual stimulation;
• itching in the genital area;
• persistent feeling of weakness and fatigue;
• swelling of the feet or ankles;
• increased blood pressure;
• pink or red urine, blood in the urine;
• abnormal extra heart sound;
• abnormal results in a test for the prostate called ‘PSA’;
• abnormal results in tests for bilirubin, a chemical produced by the normal breakdown of red blood cells;
• abnormal results in a test for creatinine, a chemical excreted in urine, useful for assessing kidney function;
• weight gain;
• fever.
• nosebleed

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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spedra

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 blister and the box after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Spedra contains

• The active substance is avanafil. Each tablet contains 200 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, low substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate and yellow iron oxide (E172).

Description of Spedra and package contents
Spedra is an oval, pale yellow tablet, with “200” imprinted on one side. The tablets
are supplied in blister packs with divisible unit doses containing 2x1, 4x1, 8x1 or 12x1 tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder:
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-
1611 Luxembourg, Luxembourg

Manufacturer:
Menarini - Von Heyden GmbH
Leipziger Straβe 7-13
01097 Dresden
Germany
or
Sanofi Winthrop Industrie
1, rue de la Vierge
Ambares et Lagrave
33565 Carbon-Blanc-Cedex
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Lietuva
UAB “BERLIN-CHEMIE MENARINI
BALTIC”
Tel: +370 52 691 947

България
“Берлин-Хеми/А. Менарини България”
ЕООД
тел.: +359 2 454 0950

Luxembourg/Luxemburg
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545

Česká republika
Berlin-Chemie/A.Menarini Ceska republika
s.r.o.
Tel: +420 267 199 333

Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301

Danmark
Pharmaprim AB
Tlf: + 46 8355933

Malta
Menarini International Operations Luxembourg
S.A.
Tel: +352 264976

Deutschland
Berlin-Chemie AG
Tel: +49 (0) 30 67070

Nederland
Menarini Benelux NV/SA
Tel: +32 (0)2 721 4545

Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001

Norge
Pharmaprim AB
Tlf: + 46 8355933

Ελλάδα
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Österreich

• A. Menarini Pharma GmbH Tel: +43 1 879 95 85-0

España
Laboratorios Menarini S.A.
Tel: +34-93 462 88 00

Polska
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00

France
MENARINI France
Tél: +33 (0)1 45 60 77 20

Portugal

• A. Menarini Portugal – Farmacêutica, S.A. Tel: +351 210 935 500

Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: + 385 1 4821 361

România
Berlin-Chemie A. Menarini S.R.L.
Tel: +40 21 232 34 32

Ireland

• A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744 SlovenijaBerlin-Chemie / A. Menarini Distribution Ljubljana d.o.o Tel: +386 01 300 2160 ÍslandPharmaprim AB Sími: + 46 8355933 Slovenská republikaBerlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730

Italia

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56801 Suomi/FinlandBerlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760

Κύπρος
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Sverige
Pharmaprim AB
Tel: +46 8355933

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210

United Kingdom (Northern Ireland)

• A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE MARKETING
AUTHORISATION(S)
Scientific conclusions
In light of the PRAC assessment of the PSUR(s) for avanafil, the PRAC’s scientific conclusions are as
follows:
In light of the available data on central serous chorioretinopathy from the literature and spontaneous
reports, including in one case a close temporal association, a positive dechallenge and in light of a
plausible mechanism of action, the PRAC considers that a causal relationship between avanafil and
central serous chorioretinopathy represents a reasonable possibility. The PRAC concluded that the
product information for medicinal products containing avanafil should be amended accordingly.
Following review of the PRAC recommendation, the CHMP agrees with the overall conclusions and with
the justification for the recommendation.

Justification for the variation of the marketing authorisation(s)
Based on the scientific conclusions on avanafil, the CHMP considers that the benefit/risk ratio of the
medicinal product(s) containing avanafil is unchanged subject to the proposed amendments to the
product information.
The CHMP recommends the variation of the marketing authorisation(s).