Patient Information Leaflet: Information for the Patient

Spedra 50 mg Tablets

avanafil

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

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. How to take Spedra
2. Possible side effects

1. Storage of Spedra
2. Contents of the pack and additional information

Spedra contains the active ingredient avanafilo. It belongs to a group of medicines called type 5 phosphodiesterase inhibitors (PDE5). Spedra is a treatment for adult males who suffer from erectile dysfunction (also known as impotence). This occurs when a male is unable to achieve or maintain a firm erection to engage in sexual intercourse.

Spedra works by helping the blood vessels in your penis to relax. This increases blood flow to the penis, helping it to remain hard and erect after sexual stimulation. Spedra does not cure your condition.

It is essential that you know Spedra only works if you receive sexual stimulation. You and your partner must perform prior sexual stimulation to prepare for sex, just as you would without taking a medication to help you.

Spedra will not help you if you do not suffer from erectile dysfunction. Spedra is not indicated for women.

Do not take Spedra:

• if you are allergic to avanafilo or any of the other components of this medication (listed in section 6).
• if you are taking medications with “nitrates” for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra may potentiate the effects of these medications and significantly decrease your blood pressure.

• if you are taking medications for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir, or atazanavir
• if you are taking medications for fungal infections, such as ketoconazole, itraconazole, or voriconazole, or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
• if you have a severe heart problem

• if you have had a stroke or heart attack in the last 6 months

• if you have uncontrolled hypertension or hypotension

• if you have chest pain (angina) or if you experience chest pain during sexual intercourse if you have a severe liver or heart problem
• if you have lost vision in one eye due to insufficient blood flow to the eye (non-arteritic anterior ischemic optic neuropathy [NAION])
• if you have a family history of certain eye problems (such as retinitis pigmentosa).
• If you are taking riociguat. This medication is used to treat pulmonary hypertension (elevated blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (elevated blood pressure secondary to blood clots). PDE5 inhibitors have shown an increase in the hypotensive effects of this medication. Consult your doctor if you are taking riociguat or are unsure.

Do not take Spedra if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before taking Spedra.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Spedra:

• if you have heart problems. Having sex may pose a risk to you

• if you have priapism, that is, a persistent erection that lasts 4 hours or more. This can occur in men with conditions such as sickle cell anemia, multiple myeloma, or leukemia
• if you have a physical problem that affects the shape of your penis (such as curvature, Peyronie's disease, or cavernosal fibrosis)
• if you have a bleeding disorder or active peptic ulceration.

If you are in any of the above situations, consult your doctor or pharmacist before starting to take Spedra. In case of doubt, consult your doctor or pharmacist.

Visual or auditory problems

Some men who take medications like Spedra have experienced visual and auditory problems, see “Serious adverse reactions”, in section 4 for detailed information. It is not known if these problems are directly related to Spedra, other conditions you may have, or a combination of factors.

If you experience sudden vision loss or decreased vision, or if your vision is distorted or blurred while taking Spedra, stop taking Spedra and contact your doctor immediately.

Children and adolescents

Spedra is not indicated for use in children or adolescents under 18 years old.

Use of Spedra with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, as Spedra may affect the activity of some medications. Additionally, other medications may affect the activity of Spedra.

Specifically, inform your doctor and do not take Spedra if you are taking medications with “nitrates” for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. It has been shown that Spedra potentiates the effects of these medications and significantly decreases your blood pressure. Do not take Spedra if you are taking medications for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir, or atazanavir, or if you are taking medications 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 medications:

• medications called “alpha-blockers”, for prostate problems or to lower blood pressure
• medications 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, for mood stabilization, or for certain types of pain
• other medications that may reduce the breakdown of Spedra in the body (“moderate CYP3A4 inhibitors”), such as amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.
• riociguat

Do not use Spedra with other treatments for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil.

If you are in any of the above situations, consult your doctor or pharmacist before taking Spedra. In case of doubt, consult your doctor or pharmacist.

Use of Spedra with beverages and alcohol

Orange juice may increase exposure to the medication and should be avoided within 24 hours of taking Spedra.

Consuming alcohol at the same time as Spedra may increase heart rate and lower blood pressure. You may feel dizzy (especially when standing), experience headaches, or feel heart palpitations. Alcohol consumption may also decrease your ability to achieve an erection.

Fertility

No effects on sperm movement or structure were observed after a single oral dose of 200 mg of avanafilo in healthy volunteers.

Repeated oral administration of avanafilo 100 mg for a period of 26 weeks in healthy volunteers and in men with mild erectile dysfunction did not associate with any adverse effects on sperm concentration, count, motility, or morphology.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor.

Consult your doctor or pharmacist if you are unsure.

The recommended dose is one 100 mg tablet as needed. Do not take Spedra more than once a day. Your doctor may prescribe a 200 mg tablet if they consider the 100 mg dose too weak for you, or a 50 mg tablet if they consider the 100 mg dose too strong. Additionally, the dose may need to be adjusted if Spedra is used with certain medications. If you are taking a medication, such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, or verapamil (“moderate CYP3A4 inhibitors”), the maximum 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 receive sexual stimulation.

Spedra can be taken with or without food. If taken with food, it may take longer to act.

If you take more Spedra than you should

Inform your doctor immediately if you take too much Spedra. You may experience more adverse reactions than usual, and they may be more severe.

Ask your doctor or pharmacist if you have any other questions about the use of this medication.

Like all medicines, it may cause side effects, although not everyone will experience them.

Severe side effects

Stop taking Spedra and consult a doctor immediately if you notice any of the following severe side effects, which may require urgent medical treatment:

• a persistent erection ("priapism"). If the erection lasts more than 4 hours, it should be treated immediately, as it may cause permanent damage to the penis (e.g., 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 consult a doctor immediately if you notice any of the above severe side effects.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• headache

• flushing (skin redness)
• nasal congestion

Less common (may affect up to 1 in 100 people):

• feeling of dizziness

• feeling of intense drowsiness or fatigue sinus congestion
• lower back pain
• angina
• shortness of breath with exercise

• changes in heart rhythm that are seen on an electrocardiogram (ECG)
• increased heart rate
• palpitations (heart palpitations)
• indigestion, nausea
• blurred vision

• elevation of liver enzyme levels

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

• influenza

• flu-like illness

• nasal congestion or discharge

• allergic rhinitis (hay fever)

• nasal congestion, nasal sinuses, or upper respiratory tract congestion
• gout
• insomnia (difficulty sleeping)
• premature ejaculation
• strange sensation

• anxiety
• chest pain
• severe chest pain
• tachycardia
• hypertension

• dry mouth

• stomach pain or acid reflux

• lower abdominal pain or discomfort
• diarrhea
• eruption

• lower back or side pain
• muscle pain
• muscle spasms

• frequent urination (frequent need to urinate)
• penile disorders
• spontaneous erection without sexual stimulation
• itching in the genital area
• persistent weakness or fatigue
• swelling in the feet or ankles
• hypertension
• urine of pink or red color, blood in the urine
• abnormal heart murmur
• an abnormal result of a blood test for the prostate called "PSA"

• an abnormal result of a blood test for bilirubin, a chemical compound produced from the normal breakdown of red blood cells
• an abnormal result of a blood test for creatinine, a chemical compound excreted in the urine, which serves as a measure of kidney function
• weight gain
• fever
• nasal bleeding

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box after “CAD”: The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Spedra

• The active ingredient 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).

Appearance of Spedra and contents of the pack

Spedra is an oval-shaped yellowish tablet with “100” engraved on one side. The tablets are presented in pre-cut single-dose blisters containing 2x1, 4x1, 8x1, or 12x1 tablets.

Only some 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.

or

Sanofi Winthrop Industrie

1, rue de la Vierge

Ambares et Lagrave

33565 Carbon-Blanc-Cedex

France

You can request more information about this medicine by contacting the local representative of themarketing authorization holder.

Last update of this leaflet

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