SPEDRA 200 mg tablets

Introduction

Package Leaflet: Information for the Patient

Spedra 200 mg Tablets

avanafil

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Spedra and what is it used for
2. What you need to know before taking Spedra
3. How to take Spedra

1. Possible side effects
2. Storage of Spedra

1. Contents of the pack and further information

1. What is Spedra and what is it used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). Spedra is a treatment for adult men who suffer from erectile dysfunction (also known as impotence). This occurs when a man cannot achieve or maintain a firm erection for sexual intercourse.

Spedra works by helping the blood vessels in your penis to relax. This increases blood flow to the penis, helping it to stay 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 should engage in foreplay before sex, just as you would if you were not taking a medication to help you.

Spedra will not help you if you do not suffer from erectile dysfunction. Spedra is not indicated for use in 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 medication (listed in section 6).
• if you are taking medicines with "nitrites" for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can enhance the effects of these medicines and significantly 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 a severe heart problem.

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

• if you have low blood pressure or uncontrolled high blood pressure with medication.

• if you have chest pain (angina) or if you experience chest pain during sex.
• if you have a severe liver or heart problem.
• if you have lost vision in one eye due to a lack of blood supply 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 arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high 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 can pose a risk to you.

• if you suffer from priapism, i.e., a persistent erection that lasts 4 hours or more. This can occur in men with diseases such as sickle cell anemia, multiple myeloma, or leukemia.
• if you have a physical problem that affects the shape of your penis (such as angulation, 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.

Vision or hearing problems

Some men who take medicines like Spedra have experienced vision and hearing problems; see "Serious side effects" in section 4 for detailed information. It is not known whether these problems are directly related to Spedra, other conditions you may have, or a combination of factors.

If you experience sudden loss of vision or 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 of age.

Using Spedra with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Spedra may affect the activity of some medicines. Additionally, other medicines may affect the activity of Spedra.

In particular, inform your doctor and do not take Spedra if you are taking medicines with "nitrites" for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. It has been shown that Spedra enhances the effects of these medicines and significantly lowers 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 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 (see the beginning of section 2, "Do not take Spedra").

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

• medicines called "alpha-blockers" for prostate problems or to lower 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 breakdown of Spedra in the body ("moderate CYP3A4 inhibitors"), such as amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, or 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.

Using Spedra with drinks and alcohol

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

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

Fertility

No effects on sperm movement or structure have been observed after single oral doses of 200 mg of avanafil in healthy volunteers.

Repeated oral administration of avanafil 100 mg for a period of 26 weeks in healthy volunteers and in adult men with mild erectile dysfunction was not associated with any 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 machines.

3. How to take Spedra

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

In case of doubt, consult your doctor or pharmacist.

The recommended dose is one 100 mg tablet as needed. You should 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, it may be necessary to adjust the dose if Spedra is used with certain medicines. If you are taking a medicine 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.

You should take Spedra approximately 15 to 30 minutes before sexual intercourse. 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

If you take too much Spedra, inform your doctor immediately. You may experience more side effects than usual, and they may be worse.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

Stop taking Spedra and consult a doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment:

• a persistent erection that does not disappear ("priapism"). If the erection lasts more than 4 hours, it should be treated immediately, as it can cause permanent damage to the penis (e.g., the inability to achieve erections).
• blurred vision.

• sudden loss of vision in one or both eyes.

• sudden 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 serious side effects.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache

• flushing (redness of the skin)
• nasal congestion

Uncommon (may affect up to 1 in 100 people)

• dizziness

• feeling of drowsiness or intense fatigue
• sinus congestion
• lower back pain (lumbalgia)
• hot flashes
• shortness of breath during exercise

• changes in heartbeat that can be seen on an electrocardiogram (ECG)
• increased heart rate
• feeling of heartbeat in the chest (palpitations)
• indigestion, feeling of nausea
• blurred vision

• increased levels of liver enzymes

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

• flu

• flu-like illness

• nasal congestion or discharge

• allergic rhinitis (hay fever)
• congestion in the nose, sinuses, or upper airways that carry air to the lungs

• gout

• sleep disorders (insomnia)
• premature ejaculation
• feeling of strangeness

• feeling of nervousness
• chest pain
• severe chest pain
• rapid heartbeat (tachycardia)
• high blood pressure

• dry mouth

• stomach pain or acid reflux

• pain or discomfort in the lower abdomen
• diarrhea
• rash

• lower back pain or pain in the lower side of the chest
• muscle pain
• muscle spasms

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

• abnormal blood test results for bilirubin, a chemical compound produced from the normal breakdown of red blood cells
• abnormal blood test results 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Spedra

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

Do not use this medication after the expiration date stated on the blister and carton after "EXP": 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 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 Additional Information

Composition of Spedra

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

Appearance of Spedra and Package Contents

Spedra is a light yellow oval tablet with "100" engraved on one side. The tablets are presented in single-dose precut blisters containing 2x1, 4x1, 8x1, or 12x1 tablets.

Only some package 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 medication by contacting the local representative of the marketing authorization holder.

Date of the Last Revision of this Leaflet

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.