Spedra (Avanafil) 100mg Tablets 8 UK

• Spedra is rapidly absorbed with a quick onset of action making it suitable for on-demand usage (Can work in 15 minutes)
• Spedra is an option for men who have failed with other similar products
• Spedra is effective for up to 6 hours and can be taken with or without food
• Spedra is well tolerated

Package leaflet: Information for the patient
Spedra 50 mg tablets
Spedra 100 mg tablets
Spedra 200 mg tablets
Avanafil
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-
Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in 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 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 suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect
penis suitable for sexual activity. Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your
condition.
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 get ready for sex - just as you would if you were not taking a medicine to help you.
Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women.
2. What you need to know before you take Spedra
Do not take Spedra:
• If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
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•If you are taking "nitrate" medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can increase the effects of
these medicines and severely 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 infecti
ons such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
•If you have a serious cardiac problem
•If you have had a stroke or heart attack in the last 6 months
•If you have an irregular heartbeat ("arrhythmia") or heart problems that run in your family, as shown on a heart tracing (ECG)
• If you have low blood pressure or high blood pressure not controlled by medicines
•If you have chest pain (angina) or you get chest pain during sexual intercourse
•If you have a serious liver or kidney problem
•If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteriticischemic optic neuropathy [NAION])
•If certain serious eye problems run in your family (such as retinitis pigmentosa).
Do not take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.
Warnings and precautions
Talk to your doctor or pharmacist before taking Spedra:
•If you have heart trouble. It may be risky for you to have sexual intercourse
•If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.
•If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie's disease or cavernosal fibrosis)
•If you have any bleeding disorder or active peptic ulceration.
If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.
Problems with your sight or hearing
Some men taking medicines like Spedra have had problems with their sight and hearing - see "Serious side effects" in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.
Children and adolescents
Spedra should 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. This is because Spedra can affect the way some other medicines work. Also some other medicines can affect the way Spedra works.
In particular, tell your doctor and do not take Spedra if you are taking
"nitrate" medicines for chest pain (angina) such as amyl nitrite or glyceryl trin
itrate. Spedra has been shown to increase the effects of these medicines and severely 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 if you are taking medicines for fungal infections such as
ketoconazole, itraconazole or voriconazole or
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certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘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 your high blood pressure
•medicines for an 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 stabilise your mood or for certain types of pain
•other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4 inhibitors') including amprenavir, aprepitant
, diltiazem, fluconazole, fosamprenavir, and verapamil.
Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.
If any of the above apply to you talk to your doct or or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.
Fertility
There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.
Currently, no data on sperm development in healthy adult males and adult males with mild erectile dysfunction are available.
Spedra with drink and alcohol
Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.
Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.
Driving and using machines
Spedra can make you feel dizzy or affect your vision. If this happens, do not drive, cycle, use tools or machines.
3. How to take Spedra
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is a 100 mg tablet, as needed.
You should not take Spedra more than once a day. Tell your doctor if you think Spedra is too strong or too weak. He/she may suggest you switch to a different dose of this medicine. Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhi
bitors') the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.
You should take Spedra about 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated.
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Spedra can be taken with or without food; if taken with food, it may take longer to work.
If you take more Spedra than you should
If you take too much Spedra, you should tell your doctor straight away. You may get more side effects than usual and they may be worse.
If you have any further questions on 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 see a doctor straight away 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 get an erection that lasts more than 4 hours, this must be treated as soon as possible or lasting damage can happen to your penis (including not being able to get erections).
•blurred vision.
•sudden decrease or loss of vision in one or both eyes.
•sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).
Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects 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)
•feeling dizzy
•feeling sleepy or very tired
•sinus congestion
•back pain
•hot flush
•feeling out of breath when you exert yourself
•heartbeat changes seen on a heart tracing (ECG)
•increased heart beat
•feeling your heartbeat in your chest (palpitations)
•indigestion, feeling or being sick to your stomach
•blurry vision
•raised liver enzymes
Rare (may affect up to 1 in 1,000 people)
•influenza
•influenza-like illness
•stuffy or runny nose
•hayfever
•congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
•gout
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•trouble sleeping (insomnia)
•premature ejaculation
•feeling strange
•feeling unable to keep still
•chest pain
•serious chest pain
•fast heart beat
•high blood pressure
•dry mouth
•stomach ache or heartburn
•pain or discomfort in the lower abdomen
•diarrhoea
•rash
•pain in the lower back or side of lower chest
•muscle aches or pains
•muscle spasms
•frequent urination
•penile disorder
•spontaneous erection without sexual stimulation
•itching in the genital area
•feeling weak or tired all the time
•swelling in the feet or ankles
•increased blood pressure
•pink or red urine, blood in the urine
•abnormal extra sound from the heart
•an abnormal blood test result for a prostate test called ‘PSA'
•an abnormal blood test result for bilirubin, a chemical produced from
the normal breakdown of red blood cells
•an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
•weight gain
•fever
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(see details below). By reporting side
effects you can help provide more information on the safety of this medicine.
United Kingdom Yellow Card Scheme Website
:www.mhra.gov.uk/yellowcard
Ireland
Reports may be made by following the links to the online reporting option accessible from the IMB homepage, or by completing the downloadable report form also accessible from the IMB website, which may be completed manually and submitted to the IMB via freepost, to the following address:
FREEPOST, Pharmacovigilance Section, Irish Medicines Board, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website:www.imb.ie
e-mail:imbpharmacovigilance@imb.ie
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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 carton after "EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage condition.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These
measures 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, 100 mg or 200 mg of avanafil.
•The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, low substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).
What Spedra looks like and contents of the pack
Spedra is a pale yellow oval tablet, marked "50", "100" or "200" on one side.
50 mg tablets: The tablets are provided in blister packs containing 4, 8, or 12 tablets.
100 mg tablets: The tablets are provided in blister packs containing 2, 4, 8, or 12 tablets.
200 mg tablets: The tablets are provided in blister packs containing 4, 8, or 12 tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
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.
For any information about this medicinal product, please 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
ТП"Берлин-Хеми АГ"
тел
.: +359 2 96 55 365
Luxembourg/Luxemburg
Menarini Benelux NV/SA
Tél/Tel: + 32 (0)2 721 4545
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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
Berlin-Chemie/A.Menarini Danmark ApS
Tlf: +4548 217 110
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
Menarini International Operations Luxembourg
S.A.
Tlf: +352 264976
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: +40 211 232 34 32
Ireland
A. Menarini Pharmaceuticals Ltd
Tel: +353 1 284 6744
Slovenija
Berlin-Chemie AG, Podružnica Ljubljana
Tel: +386 01 300 2160
Ísland
Menarini International Operations Luxembourg
S.A.
Sími: +352 264976
Slovenská republika
Berlin-Chemie AG - obchodné zastúpenie v SR
Tel: +421 2 544 30 730
Italia
A. Menarini Industrie Farmaceutiche Riunite
s.r.l.
Tel: +39-055 56801
Suomi/Finland
Berlin-Chemie/A.Menarini Suomi OY
Puh/Tel: +358 403 000 760
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Κύπρος
MENARINI HELLAS AE
Τηλ
: +30 210 8316111-13
Sverige
Menarini International Operations Luxembourg
S.A.
Tel: +352 264976
Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210
United Kingdom
A. Menarini Farmaceutica Internazionale S.R.L.
Tel: +44 (0)1628 856400
This leaflet was last revised in December 2013.
Detailed information on this medicine is availa
ble on the European Medicines Agency web site:
http://www.ema.europa.eu.