5 mg & 10 mg & 20 mg film-coated tablets
vardenafil
What Vardenafil STADA is and what it is used for
Vardenafil Stada 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 Stada only works when you are sexually stimulated. Vardenafil Stada reduces the effect of the natural substances in your body, causing the erection to disappear. Vardenafil Stada allows an erection to last long enough for you to have satisfactory completion of sexual activity.
Vardenafil contained in Vardenafil Stada 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 using Vardenafil STADA
Do not use Vardenafil STADA
- 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 Stada
- if you are taking ritonavir or indinavir, medicines used to treat infection with the human immunodeficiency virus ( HIV )
- if you are over 75 years of age and are taking ketoconazole or itraconazole, antifungal medicines
- if you have serious heart or liver problems
- if you are receiving 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 Stada, 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 Stada.
Take special care with Vardenafil Stada
- 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 disease, 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 clot (such as hemophilia )
- if you are using any other treatments for erectile dysfunction, including vardenafil orodispersible tablets (see section: Other medicines and Vardenafil Stada)
- if you experience sudden deterioration or loss of vision, stop taking Vardenafil Stada and contact your doctor immediately.
Children and young people
Vardenafil Stada is not intended for use in children or adolescents under 18 years of age.
Other medicines and Vardenafil STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 Stada.
- Medicines that affect heart rhythms, such as quinidine, procainamide, amiodarone, or sotalol.
- Ritonavir or indinavir, medicines against HIV .
- Ketoconazole or itraconazole , antifungal drugs.
- 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 Stada film-coated tablets in combination with any other treatment for erectile dysfunction, including Vardenafil orodispersible tablets.
Vardenafil STADA with food, drink, and alcohol
- You can take Vardenafil Stada with or without food – but preferably not after a heavy or high-fat meal as this can delay the effect.
- Do not drink grapefruit juice while taking Vardenafil Stada. It can affect the effectiveness of the medicine.
- Consuming alcohol can make erectile dysfunction worse.
Pregnancy, breastfeeding, and fertility
Vardenafil Stada should not be used on women.
Driving ability and use of machinery
Vardenafil Stada can 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 Vardenafil Stada.
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.
Vardenafil STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to use Vardenafil STADA
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 Vardenafil Stada tablet 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 Stada.
Swallow one tablet with a glass of water.
Do not take Vardenafil Stada film-coated tablets with any other form of vardenafil.
Do not use Vardenafil Stada more than once a day.
Tell your doctor if you think Vardenafil Stada is too strong or too weak. He or she may prescribe switching to a different formulation of Vardenafil Stada with a different dose, depending on how well it works for you.
If you have used too much Vardenafil STADA
Men who take too much Vardenafil Stada may experience more side effects or have severe back pain. If you take more Vardenafil Stada than you should tell your doctor.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask 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 Vardenafil Stada 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.
Common (may affect up to 1 in 10 users):
- dizziness
- bleeding
- nasal congestion or runny nose
- stomach upset.
Uncommon (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 decreased 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 er
- malaise.
Rare (may affect up to 1 in 1,000 users):
- inflammation of the eye ( conjunctivitis )
- allergic reaction
- anxiety
- fainting
- memory loss
- convulsions
- increased pressure in the eye ( glaucoma ), increased tear flow
- effects on the heart (such as heart attack, altered heart rhythm, or angina pectoris)
- 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 has been reported (may affect up to 1 in 10,000 users or may affect an unknown number of users):
- blood in the urine ( hematuria )
- penile bleeding
- blood in the semen (hematospermia)
- sudden death
- cerebral hemorrhage.
How Vardenafil STADA should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 °C.
Use before the expiry date stated on the blister or carton after EXP. The expiration date is the last day of the specified month.
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. Each tablet contains 5 mg, 10 mg, or 20 mg of vardenafil (as vardenafil hydrochloride trihydrate).
Other ingredients are:
Tablet core: microcrystalline cellulose (E460), crospovidone type A (E1202), anhydrous colloidal silicon dioxide (E551), magnesium stearate (E470b).
Film cover:
poly(vinyl alcohol) (E1203), titanium dioxide (E171), talc (E553b), macrogol (E1521), methacrylic acid – ethyl acrylate copolymer, yellow iron oxide (E172), sodium bicarbonate (E500 (ii)), red iron oxide (E172)
Appearance and package sizes of the medicine
Vardenafil Stada 5 mg film-coated tablets are light yellow, diameter 6 mm, marked with ‘A719’ on one side.
Vardenafil Stada 10 mg film-coated tablets are light yellow, diameter 7 mm, marked with ‘A721’ on one side.
Vardenafil Stada 20 mg film-coated tablets are light yellow, diameter 8.5 mm, marked with ‘A723’ on one side.
PVC/Aclar-Al blister.
5 mg: 4, 12 and 20 film-coated tablets.
10 mg and 20 mg: 2, 4, 8, 12 and 20 film-coated tablets.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark
Actavis Ltd.
BLB016 Bulebel Industrial Estate
TN3000 Olive
Malta
Local Representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark