Spedra

Patient Information Leaflet

Spedra 50 mg tablets

avanafil
Read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Spedra is and what it is used for

The active substance in Spedra is called avanafil and belongs to a group of medicines
known as phosphodiesterase type 5 (PDE5) inhibitors.
Spedra is used in the treatment of adult men with erectile dysfunction (also known as
impotence), which is defined as the inability to achieve or maintain an erection suitable for sexual
activity.
Spedra works by helping the blood vessels in the penis to widen; the increased blood flow into the penis
helps it to become firm and erect during sexual stimulation. Spedra does not cure your erectile dysfunction.
It is important to note that Spedra works only if you are sexually stimulated. You and your partner
will still need to engage in foreplay to prepare for sexual intercourse, just as you would if you
were not taking any medication.
Spedra will not be of benefit to you 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 to 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 can 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 within the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure despite medication;
• if you have chest pain (angina) or experience chest pain during sexual intercourse;
• if you have severe liver or kidney problems;
• if you have lost vision in one eye due to a disease (non-arteritic ischemic optic neuropathy [NAION]) that reduces blood flow to the eye;
• if other members of 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 apply 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 "priapism", i.e. a persistent erection lasting 4 hours or more (this may occur in men with conditions 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 cavernosal fibrosis);
• if you have a bleeding disorder or an active peptic ulcer.

If any of the above conditions apply to you, consult your doctor or pharmacist before taking Spedra. If you have any doubts, consult your doctor or pharmacist.

Vision or hearing problems

Some men taking medicines like Spedra have experienced vision or hearing problems (for further details see "Serious side effects" in section 4). It is not known whether these problems are directly caused by Spedra, by other concomitant diseases, or by a combination of factors.

If you experience sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Spedra, stop taking Spedra immediately and contact your doctor without delay.

Children and adolescents

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

Other medicines and Spedra

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Spedra may affect the action of some of them. Some other medicines may in turn affect the action of Spedra.

In particular, inform 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 can seriously lower your blood pressure. 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").

Inform 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 may 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 apply to you, consult your doctor or pharmacist before taking Spedra. If you have any doubts, consult your doctor or pharmacist.

Spedra with food and alcohol

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

Fertility

Spedra did not affect sperm motility or morphology after single oral doses of 200 mg in healthy volunteers.

Repeated oral administration of avanafil 100 mg for 26 weeks in healthy volunteers and in adult males with mild erectile dysfunction was not associated with adverse effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra may cause dizziness or affect your vision. If this occurs, do not drive, ride a bicycle, or use tools or machinery.

3. How to take Spedra

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult 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 one 200 mg tablet if they decide that the 100 mg dose is too weak for you, or one 50 mg tablet if they decide that the 100 mg tablet is too strong for you. Dose adjustments may also be necessary when Spedra is taken together with other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, or 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 help you achieve an erection only if you are sexually stimulated.
Spedra can be taken with or without food; however, 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, inform your doctor immediately. You may experience more side effects than usual, and they may be more severe.
If you have any questions about the use of Spedra, consult 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 experience 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 lasting more than 4 hours, prompt treatment is necessary, otherwise you may suffer long-term damage to your penis (including inability to achieve erections);
• blurred vision;
• sudden decrease or loss of vision in one or both eyes;
• sudden decrease or loss of hearing (sometimes accompanied by dizziness or ringing in the ears).

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

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;
• drowsiness or fatigue;
• nasal sinus congestion;
• back pain;
• hot flushes;
• shortness of breath during physical activity;
• changes in heart rhythm on electrocardiogram (ECG);
• increased heart rate;
• rapid heartbeat (palpitations);
• indigestion, stomach discomfort;
• blurred vision;
• increased liver enzymes.

Rare (may affect up to 1 in 1000 people)

• influenza;
• flu-like illness;
• blocked or runny nose;
• allergic rhinitis;
• nasal, paranasal sinus, or upper airway congestion leading to the lungs;
• gout;
• sleep disorders (insomnia);
• premature ejaculation;
• feeling of discomfort;
• inability to remain still;
• chest pain;
• severe chest pain;
• rapid heartbeat;
• high blood pressure;
• low blood pressure;
• dry mouth;
• stomach ache 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;
• penile disorders;
• spontaneous erection without sexual stimulation;
• genital itching;
• persistent feeling of weakness and fatigue;
• swelling of the feet or ankles;
• increased blood pressure;
• pink or red-coloured urine, blood in the urine;
• abnormal additional heart sounds;
• abnormal results in the prostate test known as 'PSA';
• abnormal results in tests for bilirubin, a chemical produced by the normal breakdown of red blood cells;
• abnormal results in tests for creatinine, a chemical excreted in urine, useful for assessing kidney function;
• weight gain;
• fever;
• nosebleeds.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to 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 stated on the blister and on 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 medicines via wastewater 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 substance 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 a pale yellow oval tablet, marked "50" on one side. The tablets are supplied in unit dose divisible blisters containing 4x1, 8x1 or 12x1 tablets.
Not all pack sizes may be marketed in your country.

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

Manufacturer:
Menarini - Von Heyden GmbH
Leipziger Straße 7-13
01097 Dresden
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien Lietuva
Menarini Benelux NV/SA UAB “BERLIN-CHEMIE MENARINI
Tél/Tel: + 32 (0)2 721 4545 BALTIC”
Tel: +370 52 691 947

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” Menarini Benelux NV/SA
ЕООД Tél/Tel: + 32 (0)2 721 4545
тел.: +359 2 454 0950

Česká republika Magyarország
Berlin-Chemie/A.Menarini Ceska republika Berlin-Chemie/A. Menarini Kft.
s.r.o. Tel.: +36 23501301
Tel: +420 267 199 333

Danmark Malta
Pharmaprim AB Menarini International Operations Luxembourg
Tlf: +46 8355933 S.A.
Tel: +352 264976

Deutschland Nederland
Berlin-Chemie AG Menarini Benelux NV/SA
Tel: +49 (0) 30 67070 Tel: +32 (0)2 721 4545

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti Pharmaprim AB
Tel: +372 667 5001 Tlf: +46 8355933

Ελλάδα Österreich
MENARINI HELLAS AE A. Menarini Pharma GmbH
Τηλ: +30 210 8316111-13 Tel: +43 1 879 95 85-0

España Polska
Laboratorios Menarini S.A. Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +34-93 462 88 00 Tel.: +48 22 566 21 00

France Portugal
MENARINI France A. Menarini Portugal – Farmacêutica, S.A.
Tél: +33 (0)1 45 60 77 20 Tel: +351 210 935 500

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. Berlin-Chemie A. Menarini S.R.L.
Tel: + 385 1 4821 361 Tel: +40 21 232 34 32

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

Ísland Slovenská republika
Pharmaprim AB Berlin-Chemie / A. Menarini Distribution
Sími: +46 8355933 Slovakia s.r.o.
Tel: +421 2 544 30 730

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

Κύπρος Sverige
MENARINI HELLAS AE Pharmaprim AB
Τηλ: +30 210 8316111-13 Tel: +46 8355933

Latvija United Kingdom (Northern Ireland)
SIA Berlin-Chemie/Menarini Baltic A. Menarini Farmaceutica Internazionale S.R.L.
Tel: +371 67103210 Tel: +44 (0)1628 856400

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

Patient information leaflet

Spedra 100 mg tablets

avanafil
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Spedra is and what it is used for

The active substance in Spedra is called avanafil and belongs to a group of medicines known as phosphodiesterase type 5 (PDE5) inhibitors.
Spedra is used in the treatment of adult men with erectile dysfunction (also known as impotence), which is defined as the inability to achieve or maintain an erection suitable for sexual activity.
Spedra works by helping the blood vessels in the penis to widen; the increased blood flow into the penis helps it to become firm and erect during sexual stimulation. 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 engage in foreplay to prepare for sexual intercourse, just 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 to 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 can 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 within the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure despite medication;
• if you have chest pain (angina) or experience chest pain during sexual activity;
• if you have severe liver or kidney problems;
• if you have lost vision in one eye due to a disease (non-arteritic anterior ischemic optic neuropathy [NAION]) that reduces blood flow to the eye;
• if other members of 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 apply 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 suffer from "priapism", i.e. a persistent erection lasting 4 hours or more (this may occur in men with conditions such as sickle cell anemia, multiple myeloma, or leukemia);
• if you have an abnormal shape of the penis (such as curvature, Peyronie's disease, or cavernosal fibrosis);
• if you have a bleeding disorder or active peptic ulcer.

If any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Spedra. If you have any doubts, consult your doctor or pharmacist.

Vision or hearing problems

Some men taking medicines like Spedra have experienced vision or hearing problems (for further details, see "Serious side effects" in section 4). It is not known whether these problems are directly caused by Spedra, by other concurrent medical conditions, or by a combination of factors.

If you experience sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Spedra, stop taking Spedra immediately and contact your doctor without delay.

Children and adolescents

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

Other medicines and Spedra

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Spedra may affect the action of some of them. Some other medicines may in turn affect the action of Spedra.

In particular, inform 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 can seriously lower your blood pressure. 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").

Inform 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, mood stabilization, or certain types of pain;
• other medicines that may 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 apply to you, consult your doctor or pharmacist before taking Spedra. If you have any doubts, consult your doctor or pharmacist.

Spedra with food and alcohol

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

Fertility

Spedra did not affect sperm motility or morphology after single oral doses of 200 mg in healthy volunteers.

Repeated oral administration of avanafil 100 mg over a period of 26 weeks in healthy volunteers and adult males with mild erectile dysfunction was not associated with adverse effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra may cause dizziness or affect your vision. If this occurs, do not drive, ride a bicycle, or use tools or machinery.

3. How to take Spedra

Take this medicine exactly as your doctor has told you. If you have any doubts, consult 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 one 200 mg tablet if he decides that the 100 mg dose is too weak for you, or one 50 mg tablet if he decides that the 100 mg tablet is too strong for you. Dose adjustments may also be necessary when Spedra is taken together with other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or 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 help you achieve an erection only if you are sexually stimulated.
Spedra can be taken with or without food; however, 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 must inform your doctor immediately. You may experience more side effects than usual, and they may be more severe.
If you have any questions about how to use Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Stop taking Spedra and contact a doctor immediately if you experience 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 lasting more than 4 hours, it must be treated as soon as possible, otherwise your penis may suffer long-term damage (including inability to achieve 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 the ears).

Stop taking Spedra and contact a doctor immediately if you experience any of the serious side effects listed 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 physical activity;
• changes in heart rhythm on electrocardiogram (ECG);
• increased heart rate;
• rapid heartbeat (palpitations);
• indigestion, stomach discomfort;
• blurred vision;
• increased liver enzymes.

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

• influenza;
• flu-like illness;
• stuffy or runny nose;
• allergic rhinitis;
• nasal, paranasal sinus, or upper airway congestion leading to the lungs;
• gout;
• sleep disorders (insomnia);
• premature ejaculation;
• feeling unwell;
• inability to stay still;
• chest pain;
• severe chest pain;
• rapid heartbeat;
• high blood pressure;
• low blood pressure;
• dry mouth;
• stomach ache 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;
• penile disorders;
• spontaneous erection without sexual stimulation;
• itching in the genital area;
• persistent feeling of weakness and fatigue;
• swelling of the feet or ankles;
• increase in blood pressure;
• pink or red-coloured urine, presence of blood in the urine;
• abnormal extra heart sound;
• abnormal results in the prostate test known as ‘PSA’;
• abnormal results in tests for bilirubin, a chemical produced by the normal breakdown of red blood cells;
• abnormal results in tests for creatinine, a chemical excreted in urine, useful for assessing kidney function;
• weight gain;
• fever;
• nosebleeds.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 stated on the blister and 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 medicines via 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 substance is avanafil. Each tablet contains 100 mg of avanafil.
• The other components are mannitol, fumaric acid, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate and yellow iron oxide (E172).

Description of the appearance of Spedra and the contents of the pack
Spedra is a pale yellow, oval tablet, with "100" engraved on one side. The tablets
are supplied in unit-dose blisters containing 2x1, 4x1, 8x1 or 12x1 tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorization Holder:
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-
1611 Luxembourg, Luxembourg.
Manufacturer:
Menarini - Von Heyden GmbH
Leipziger Straße 7-13
01097 Dresden
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.
België/Belgique/Belgien Lietuva
Menarini Benelux NV/SA UAB “BERLIN-CHEMIE MENARINI
Tél/Tel: + 32 (0)2 721 4545 BALTIC”
Tel: +370 52 691 947
България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” Menarini Benelux NV/SA
ЕООД Tél/Tel: + 32 (0)2 721 4545
tel.: +359 2 454 0950
Česká republika Magyarország
Berlin-Chemie/A.Menarini Ceska republika Berlin-Chemie/A. Menarini Kft.
s.r.o. Tel.: +36 23501301
Tel: +420 267 199 333
Danmark Malta
Pharmaprim AB Menarini International Operations Luxembourg
Tlf: +46 8355933 S.A.
Tel: +352 264976
Deutschland Nederland
Berlin-Chemie AG Menarini Benelux NV/SA
Tel: +49 (0) 30 67070 Tel: +32 (0)2 721 4545
Eesti Norge
OÜ Berlin-Chemie Menarini Eesti Pharmaprim AB
Tel: +372 667 5001 Tlf: + 46 8355933
Ελλάδα Österreich
MENARINI HELLAS AE A. Menarini Pharma GmbH
Τηλ: +30 210 8316111-13 Tel: +43 1 879 95 85-0
España Polska
Laboratorios Menarini S.A. Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +34-93 462 88 00 Tel.: +48 22 566 21 00
France Portugal
MENARINI France A. Menarini Portugal – Farmacêutica, S.A.
Tél: +33 (0)1 45 60 77 20 Tel: +351 210 935 500
Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. Berlin-Chemie A. Menarini S.R.L.
Tel: + 385 1 4821 361 Tel: +40 21 232 34 32
Ireland Slovenija
A. Menarini Pharmaceuticals Ireland Ltd Berlin-Chemie / A. Menarini Distribution
Tel: +353 1 284 6744 Ljubljana d.o.o
Tel: +386 01 300 2160
Ísland Slovenská republika
Pharmaprim AB Berlin-Chemie / A. Menarini Distribution
Sími: + 46 8355933 Slovakia s.r.o
Tel: +421 2 544 30 730
Italia Suomi/Finland
A. Menarini Industrie Farmaceutiche Riunite Berlin-Chemie/A.Menarini Suomi OY
s.r.l. Puh/Tel: +358 403 000 760
Tel: +39-055 56801
Κύπρος Sverige
MENARINI HELLAS AE Pharmaprim AB
Τηλ: +30 210 8316111-13 Tel: + 46 8355933
Latvija United Kingdom (Northern Ireland)
SIA Berlin-Chemie/Menarini Baltic A. Menarini Farmaceutica Internazionale S.R.L.
Tel: +371 67103210 Tel: +44 (0)1628 856400
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Patient Information Leaflet

Spedra 200 mg tablets

avanafil
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Spedra is and what it is used for

The active substance contained in Spedra is called avanafil and belongs to a group of medicines known as phosphodiesterase type 5 (PDE5) inhibitors.
Spedra is used to treat adult men who suffer from erectile dysfunction (also known as impotence), which is defined as the inability to achieve or maintain an erection suitable for sexual activity.
Spedra works by helping the blood vessels in the penis to widen; the increased blood flow into the penis helps it to become firm and erect during sexual stimulation. Spedra does not cure your erectile dysfunction.
It is important to note that Spedra works only if you are sexually stimulated. You and your partner will still need to engage in foreplay to prepare for sexual intercourse, just as you would if you were not taking any medication.
Spedra will not be beneficial 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 to 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 can 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 within the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure despite medication;
• if you have chest pain (angina) or experience chest pain during sexual intercourse;
• if you have severe liver or kidney problems;
• if you have lost vision in one eye due to a disease (non-arteritic ischemic optic neuropathy [NAION]) that reduces blood flow to the eye;
• if other members of 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 apply 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 suffer from "priapism," i.e., a prolonged erection lasting 4 hours or more (this may occur in men with conditions 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 cavernosal fibrosis);
• if you have a bleeding disorder or an active peptic ulcer.

If any of the above situations apply to you, consult your doctor or pharmacist before taking Spedra. If you have any doubts, consult your doctor or pharmacist.

Vision or hearing problems

Some men taking medicines like Spedra have experienced vision or hearing problems (for further details, see "Serious side effects" in section 4). It is not known whether these problems are directly caused by Spedra, by other concomitant diseases, or by a combination of factors.

If you experience sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Spedra, stop taking Spedra immediately and contact your doctor without delay.

Children and adolescents

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

Other medicines and Spedra

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Spedra may affect the action of some of them. Some other medicines may also affect the action of Spedra.

In particular, inform your doctor and do not take Spedra if you are taking nitrates for chest pain (angina), such as amyl nitrite or nitroglycerin. Spedra enhances the effects of these medicines and can seriously lower your blood pressure. 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").

Inform your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers, used 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, mood stabilization, or certain types of pain;
• other medicines that may 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 apply to you, consult your doctor or pharmacist before taking Spedra. If you have any doubts, consult your doctor or pharmacist.

Spedra with food and alcohol

Grapefruit juice may increase exposure to the medicine and should be avoided within 24 hours before taking Spedra.

Drinking alcohol while taking Spedra may increase your heart rate and lower your blood pressure. You may experience dizziness (especially when standing), headache, or feel your heart beating in your chest (palpitations). Drinking alcohol may also reduce your ability to achieve an erection.

Fertility

Spedra did not affect sperm motility or morphology after single oral doses of 200 mg in healthy volunteers.

Repeated oral administration of avanafil 100 mg for 26 weeks in healthy volunteers and in adult males with mild erectile dysfunction was not associated with adverse effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra may cause dizziness or affect your vision. If this occurs, do not drive, ride a bicycle, or use tools or machinery.

3. How to take Spedra

Take this medicine exactly as your doctor has told you. If you are unsure, consult 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 the 100 mg dose is found to be too weak for you, or one 50 mg tablet if the 100 mg tablet is found to be too strong for you. Dose adjustments may also be necessary when Spedra is taken together with other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, or 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; however, if taken with food, it may take longer to work.
If you take more Spedra than you should
If you take too much Spedra, inform your doctor immediately. You may experience more side effects than usual, and they may be more severe.
If you have any doubts about how to use Spedra, speak to 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 experience 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 lasting more than 4 hours, it must be treated as soon as possible, otherwise you may suffer long-term damage to your penis (including inability to achieve erections);
• blurred vision;
• sudden decrease or loss of vision in one or both eyes;
• sudden decrease or loss of hearing (sometimes you may also experience dizziness or ringing in the ears).

Stop taking Spedra and contact a doctor immediately if you notice any of the serious side effects listed 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;
• nasal sinus congestion;
• back pain;
• hot flushes;
• shortness of breath during physical activity;
• changes in heart rhythm on electrocardiogram (ECG);
• increased heart rate;
• rapid heartbeat (palpitations);
• indigestion, stomach discomfort;
• blurred vision;
• increased liver enzymes.

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

• influenza;
• flu-like illness;
• stuffy or runny nose;
• allergic rhinitis;
• nasal, paranasal sinus, or upper respiratory tract congestion (air passages leading to the lungs);
• gout;
• sleep disorders (insomnia);
• premature ejaculation;
• feeling unwell;
• inability to remain still;
• chest pain;
• severe chest pain;
• rapid heartbeat;
• high blood pressure;
• low blood pressure;
• dry mouth;
• stomach ache or heartburn;
• pain or discomfort in the lower abdomen;
• diarrhoea;
• rash;
• pain in the lower back or lower side of the chest;
• muscle pain;
• muscle contractions;
• frequent need to urinate;
• penile 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-coloured urine, presence of blood in the urine;
• abnormal extra heart sound;
• abnormal results in the prostate test known as 'PSA';
• abnormal results in tests for bilirubin, a chemical produced by the normal breakdown of red blood cells;
• abnormal results in tests for creatinine, a chemical excreted in urine, useful for assessing kidney function;
• weight gain;
• fever;
• nosebleeds.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed 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 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 the appearance of Spedra and pack contents
Spedra is a pale yellow, oval tablet, marked "200" on one side. The tablets
are supplied in unit-dose divisible blisters 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 Straße 7-13
01097 Dresden
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Menarini Benelux NV/SA UAB “BERLIN-CHEMIE MENARINI
Tél/Tel: + 32 (0)2 721 4545 BALTIC”
Tel: +370 52 691 947

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” Menarini Benelux NV/SA
ЕООД Tél/Tel: + 32 (0)2 721 4545
тел.: +359 2 454 0950

Česká republika Magyarország
Berlin-Chemie/A.Menarini Ceska republika Berlin-Chemie/A. Menarini Kft.
s.r.o. Tel.: +36 23501301
Tel: +420 267 199 333

Danmark Malta
Pharmaprim AB Menarini International Operations Luxembourg
Tlf: + 46 8355933 S.A.
Tel: +352 264976

Deutschland Nederland
Berlin-Chemie AG Menarini Benelux NV/SA
Tel: +49 (0) 30 67070 Tel: +32 (0)2 721 4545

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti Pharmaprim AB
Tel: +372 667 5001 Tlf: + 46 8355933

Ελλάδα Österreich
MENARINI HELLAS AE A. Menarini Pharma GmbH
Τηλ: +30 210 8316111-13 Tel: +43 1 879 95 85-0

España Polska
Laboratorios Menarini S.A. Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +34-93 462 88 00 Tel.: +48 22 566 21 00

France Portugal
MENARINI France A. Menarini Portugal – Farmacêutica, S.A.
Tél: +33 (0)1 45 60 77 20 Tel: +351 210 935 500

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. Berlin-Chemie A. Menarini S.R.L.
Tel: + 385 1 4821 361 Tel: +40 21 232 34 32

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

Ísland Slovenská republika
Pharmaprim AB Berlin-Chemie / A. Menarini Distribution
Sími: + 46 8355933 Slovakia s.r.o.
Tel: +421 2 544 30 730

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

Κύπρος Sverige
MENARINI HELLAS AE Pharmaprim AB
Τηλ: +30 210 8316111-13 Tel: +46 8355933

Latvija United Kingdom (Northern Ireland)
SIA Berlin-Chemie/Menarini Baltic A. Menarini Farmaceutica Internazionale S.R.L.
Tel: +371 67103210 Tel: +44 (0)1628 856400

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