Spedra 50 mg tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Spedra 50 mg tablets

avanafil

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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. Package contents and other information

1. What Spedra is and what it is used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men with erectile dysfunction (also known as impotence). This occurs when a man is unable to achieve or maintain a firm erection sufficient for sexual intercourse.

Spedra works by helping the blood vessels in your penis to relax. This increases blood flow into the penis, helping it to become firm and erect following sexual stimulation. Spedra does not cure your condition.

It is important to know that Spedra only works if you receive sexual stimulation. You and your partner should engage in foreplay, as you normally would, to prepare for sexual activity, just as you would without taking a medicine to assist you.

Spedra will not help you if you do not have erectile dysfunction. Spedra is not intended for use in 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 medications containing "nitrates" for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can enhance the effects of these medications and significantly lower 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 serious heart condition.

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

• if you have hypotension or uncontrolled hypertension with medication.

• if you have chest pain (angina) or experience chest pain during sexual intercourse, or if you have severe liver or heart problems.

• 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 disorders (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 due to blood clots). PDE5 inhibitors have shown an increased hypotensive effect when used with 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

Talk to your doctor or pharmacist before starting Spedra:

• if you have heart problems. Sexual activity may pose a risk to you.

• if you have priapism, that is, 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 a physical condition affecting 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 Spedra. If in doubt, consult your doctor or pharmacist.

Vision or hearing problems

Some men taking medications like Spedra have experienced vision and hearing problems. See "Serious adverse reactions" in section 4 for detailed information. It is not known whether these problems are directly related to Spedra, to other medical conditions you may have, or to a combination of factors.

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed 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.

Use of Spedra with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as Spedra may affect the activity of some medicines. In addition, other medicines may affect the activity of Spedra.

Specifically, inform your doctor and do not take Spedra if you are taking medications containing "nitrates" for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra has been shown to enhance the effects of these medications and significantly lower 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 medicines:

• medications known as "alpha-blockers," used 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, used for epilepsy.
• carbamazepine, used for epilepsy, mood stabilization, or 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 together 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. If in doubt, consult your doctor or pharmacist.

Use of 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 heart rate and lower blood pressure. You may feel dizzy (especially when standing), have headaches, or feel your heartbeat in your chest (palpitations). Alcohol consumption may reduce your ability to achieve an erection.

Fertility

No effects on sperm motility or structure were observed after single oral doses of 200 mg avanafil in healthy volunteers.

Repeated oral administration of avanafil 100 mg over a 26-week period in healthy volunteers and 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 operate tools or machinery.

3. How to take Spedra

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

If in doubt, consult your doctor or pharmacist.

The recommended dose is one 100 mg tablet as needed. You must 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, dose adjustment may be necessary when Spedra is used together 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 at least a 2-day interval between doses.

You should 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 take effect.

If you take more Spedra than you should

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

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

4. Possible adverse effects

Like all medicines, this one may produce adverse effects, although not everyone experiences them.

Serious adverse effects

Stop taking Spedra and consult a doctor immediately if you experience any of the following serious adverse effects, as you may require urgent medical treatment:

• an erection that does not go away (“priapism”). If an erection lasts longer than 4 hours, immediate treatment is required, as permanent damage to the penis may occur (for example, the 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 serious adverse effects.

Other adverse 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 severe fatigue

• sinus congestion

• lower back pain (lumbago)

• hot flushes

• shortness of breath during exercise

• changes in heart rhythm observed on an electrocardiogram (ECG)

• increased heart rate

• sensation 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 leading to the lungs

• gout

• difficulty sleeping (insomnia)

• premature ejaculation

• unusual sensation

• feeling of nervousness

• chest pain

• severe chest pain

• tachycardia

• hypertension

• dry mouth

• stomach pain or heartburn

• pain or discomfort in the lower abdomen

• diarrhea

• rash

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

• muscle pain

• muscle spasms

• frequent urination (frequent need to urinate)

• penile disorders

• spontaneous erection without sexual stimulation

• genital itching

• persistent weakness or fatigue

• swelling in the feet or ankles

• hypertension

• pink or red urine, blood in the urine

• abnormal heart murmur

• abnormal blood test result for prostate-specific antigen (PSA)

• abnormal blood test result for bilirubin, a chemical compound produced during the normal breakdown of red blood cells

• abnormal blood test result for creatinine, a chemical compound excreted in urine, used as a measure of kidney function

• weight gain

• fever

• nosebleeds

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 pack and the carton after “EXP”: The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Spedra

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

Appearance of Spedra and contents of the pack

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

Some pack sizes may not 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

For further information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet

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