5 mg, 10 mg, and 20 mg film-coated tablets
vardenafil
What Vardenafil Accord is and what it is used for
Vardenafil Accord contains vardenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. They are used to treat erectile dysfunction in adult men, a condition that involves difficulty in getting and maintaining an erection.
At least 1 in 10 men have problems getting or maintaining an erection at some point. There may be physical causes or psychological causes, or a mixture of both. Whatever the reason, changes in muscles and blood vessels mean that not enough blood stays in the penis to make it hard and keep it hard.
Vardenafil Accord only works when you are sexually stimulated. Vardenafil Accord reduces the effect of the natural substances in your body, which causes the erection to disappear. Vardenafil Accord allows an erection to last long enough for you to have satisfactory completion of sexual activity.
Vardenafil contained in Vardenafil Accord may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Vardenafil Accord
Do not take Vardenafil Accord
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include skin rash, itching, swollen face or lips, and shortness of breath.
- If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or nitric oxide donors such as amyl nitrite. Your blood pressure can be seriously affected by taking these medicines at the same time as Vardenafil Accord.
- If you are taking ritonavir or indinavir, medicines used to treat infection with the human immunodeficiency virus ( HIV ).
- If you are over 75 and are taking ketoconazole or itraconazole, antifungal medicines.
- If you have serious heart or liver problems.
- If you receive kidney dialysis.
- If you have recently had a stroke or heart attack.
- If you have or have had low blood pressure.
- If there are hereditary eye diseases in your family (such as retinitis).
- If you have ever had a condition where you lost your sight through damage to the optic nerve, which can be caused by insufficient blood supply, called non-arteritic anterior ischemic optic infarct/neuropathy (NAION).
- If you take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs as a result of blood clots). PDE5 inhibitors, such as Vardenafil Accord, have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil Accord.
Take special care with Vardenafil Accord
- If you have heart problems. It can be risky for you to have sex.
- If you have an irregular heart rhythm ( cardiac arrhythmia ) or congenital heart disease that affects your electrocardiogram ( ECG ).
- If you have any physical condition that affects the shape of the penis. This includes conditions called angulation, Peyronie’s disease, and connective tissue disease of the corpus callosum.
- If you have a disease that can give you an erection that does not go away (priapism). This includes sickle cell anemia, multiple myeloma, and leukemia.
- If you have a stomach ulcer (also called gastric or peptic ulcer ).
- If you have disorders of the blood’s ability to coagulate (such as hemophilia).
- If you are using any other treatments for erectile dysfunction, including vardenafil orodispersible tablets (see section: Other medicines and Vardenafil Accord).
- If you experience sudden deterioration or loss of vision, stop taking Vardenafil Accord and contact your doctor immediately.
Children and young people
Vardenafil Accord is not intended for use in children or adolescents under 18 years of age.
Other medicines and Vardenafil Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Some medicines can cause problems, especially these:
- Nitrates, anti-anginal drugs, or nitric oxide donors, such as amyl nitrite. Your blood pressure can be seriously affected by taking these medicines at the same time as Vardenafil Accord.
- Medicines that affect heart rhythms, such as quinidine, procainamide, amiodarone, or sotalol.
- Ritonavir or indinavir, drugs against HIV .
- Ketoconazole or itraconazole, antifungal medicine.
- Erythromycin or clarithromycin, macrolide antibiotics.
- Alpha-receptor blockers are a type of medicine used in the treatment of high blood pressure and benign prostatic hyperplasia.
- Riociguat.
Do not use Vardenafil Accord film-coated tablets in combination with any other treatment for erectile dysfunction, including Vardenafil orodispersible tablets.
Vardenafil Accord with food, drink, and alcohol
- You can take Vardenafil Accord with or without food – but preferably not after a heavy or high-fat meal as this may delay the effect.
- Do not drink grapefruit juice while using this medicine. It can affect the effectiveness of the medicine.
- Consuming alcohol can make erectile dysfunction worse.
Pregnancy and breastfeeding
This medicine should not be used in women.
Driving ability and use of machinery
Vardenafil Accord may make some people feel dizzy or affect their vision. Do not drive or use tools or machines if you feel dizzy, or if your vision is affected after taking this medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to take Vardenafil Accord
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. The recommended dose is 10 mg.
Take one tablet of Vardenafil Accord approximately 25 to 60 minutes before sexual activity.
With sexual stimulation, you may get an erection anywhere between 25 minutes and up to 4 to 5 hours after taking Vardenafil Accord.
- Swallow one tablet with a glass of water.
Do not take Vardenafil Accord film-coated tablets with any other form of vardenafil.
Do not use Vardenafil Accord more than once a day.
Tell your doctor if you think Vardenafil Accord is too strong or too weak. He or she may prescribe switching to a different formulation of vardenafil with a different dose, depending on how well it works for you.
If you have used too much Vardenafil Accord
Men who take too much Vardenafil Accord may experience more side effects or have severe back pain.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are of mild to moderate severity.
Partial, sudden, temporary, or permanent visual impairment or loss of vision in one or both eyes has been experienced by patients. Stop taking this medicine and contact your doctor immediately. Sudden hearing loss or deafness has been reported.
Cases of sudden death, fast or changed heartbeats, heart attacks, chest pain, and problems with blood circulation in the brain (including temporarily reduced blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were due to vardenafil.
Possible side effects are reported in the following categories:
Very common:
may affect more than 1 in 10 users
- Headache
Usual:
may affect up to 1 in 10 users
- Dizziness
- Bleeding
- Nasal congestion or runny nose
- Stomach upset
Less common:
may affect up to 1 in 100 users
- Swelling of the skin and mucous membranes which includes swelling of the face, lips, and throat
- Sleep problems
- Numbness and reduced sensitivity to touch
- Somnolence
- Visual effects such as red eyes, effects on color vision, eye pain and discomfort, light sensitivity
- Ringing in the ears, vertigo
- Increased heart rate or palpitations
- Respiratory distress
- Nasal congestion
- Acid reflux, gastritis, stomach ache, diarrhea, vomiting, nausea, dry mouth
- Increased levels of liver enzymes in the blood
- Skin rash, skin redness
- Back or muscle pain, increase of a muscle enzyme in the blood (creatine phosphokinase), muscle stiffness
- Prolonged erection _
- Feeling of illness
Rare:
may affect up to 1 in 1,000 users
- Inflammation of the eye ( conjunctivitis )
- Allergic reaction
- Anxiety
- Fainting
- Memory loss
- Seizures
- Increased pressure in the eye ( glaucoma ), increased tear flow
- Effects on the heart (such as heart attack, altered heart rhythm, or angina)
- High or low blood pressure
- Nosebleed
- Influence on the results of blood tests to examine the liver function
- Hypersensitivity of the skin to sunlight
- Painful erection er
- Chest pain
- Temporarily reduced blood flow to parts of the brain
Very rare or frequency not known:
may affect less than 1 in 10,000 users or frequency cannot be estimated from available data
- Blood in the urine ( hematuria )
- Penile bleeding
- Blood in the semen (hematospermia)
- Sudden death; Cerebral hemorrhage
How to store Vardenafil Accord
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP.
The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used.
These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is vardenafil. Vardenafil Accord 5 mg film-coated tablets: Each tablet contains 5 mg vardenafil (as hydrochloride trihydrate).Vardenafil Accord 10 mg film-coated tablets: Each tablet contains 10 mg of vardenafil (as hydrochloride trihydrate).Vardenafil Accord 20 mg film-coated tablets: Each tablet contains 20 mg of vardenafil (as hydrochloride trihydrate).
- Other ingredients are tablet core: Crospovidone (type B), magnesium stearate, microcrystalline cellulose, anhydrous, colloidal silicon dioxide film coating: Macrogol 400, hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
Appearance and package sizes of the medicine
Vardenafil Accord 5 mg: Beige, round, biconvex film-coated tablets, approximately 5.5 mm in diameter and debossed with “FA1” on one side and plain on the other side.
Vardenafil Accord 10 mg: Beige, round, biconvex film-coated tablets, approximately 6.8 mm in diameter and debossed with “FA2” on one side and plain on the other side.
Vardenafil Accord 20 mg: Beige, round, biconvex film-coated tablets, approximately 8.9 mm in diameter and debossed with “FA3” on one side and plain on the other side.
The tablets are supplied in PVC/PVdC aluminum blisters containing 2, 4, 8, 12, and 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Laboratory Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona,
Spain
Paradox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z oo,
ul. Lutomirska 50,95-200 Pabianice, Poland