VARDENAFIL CHANELLE 10 MG ORODISPERSIBLE TABLETS - patient leaflet, side effects, dosage

Package Leaflet: Information for the user

Vardenafil

Read all of this leaflet carefully before you start using 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 Vardenafil Chanelle 10 mg Orodispersible Tablets is and what it is used for

• 2. What you need to know before you take Vardenafil Chanelle 10 mg Orodispersible Tablets

• 3. How to take Vardenafil Chanelle 10 mg Orodispersible Tablets

• 4. Possible side effects

• 5. How to store Vardenafil Chanelle 10 mg Orodispersible Tablets

• 6. Contents of the pack and other information

1. what vardenafil chanelle 10 mg orodispersible tablets is and what it is used for

Vardenafil Chanelle 10 mg Orodispersible Tablets contains Vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.

At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.

Vardenafil Chanelle 10 mg Orodispersible Tablets will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Vardenafil Chanelle 10 mg Orodispersible Tablets allows an erection to last long enough for you to satisfactorily complete sexual activity.

2. what you need to know before you take vardenafil chanelle 10 mg orodispersible tablets

Do not take Vardenafil Chanelle 10 mg Orodispersible Tablets:

• 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 a rash, itching, swollen face or lips and shortness of breath.
• If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil Chanelle 10 mg Orodispersible Tablets could seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
• If you have a severe heart or liver problem.
• If you are having kidney dialysis.
• If you have recently had a stroke or heart attack.
• If you have or have had low blood pressure.
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
• If you are taking riociguat. This drug is used to treat arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Vardenafil Chanelle 10 mg Orodispersible Tablets have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vardenafil Chanelle 10 mg Orodispersible Tablets.

• If you have heart trouble. It may be risky for you to have sex.
• If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
• If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
• If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
• If you have stomach ulcers (also called gastric or peptic ulcers).
• If you have a bleeding disorder (such as haemophilia).
• If you are using any other treatments for erection difficulties, including vardenafil film-coated tablets (see section: Other medicines and Vardenafil Chanelle 10 mg Orodispersible Tablets).
• If you experience sudden decrease or loss of vision, stop taking Vardenafil Chanelle 10 mg Orodispersible Tablets and contact your doctor immediately.

Children and adolescents

Vardenafil Chanelle 10 mg Orodispersible Tablets is not intended for use by children or adolescents under 18.

Other medicines and Vardenafil Chanelle 10 mg Orodispersible Tablets

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

Some medicines may cause problems, especially these:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil Chanelle 10 mg Orodispersible Tablets could seriously affect your blood pressure. Talk to a doctor before taking Vardenafil Chanelle 10 mg Orodispersible Tablets.
• Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV. Talk to a doctor before taking Vardenafil Chanelle 10 mg Orodispersible Tablets.
• Ketoconazole or itraconazole, anti-fungal medicines.
• Erythromycin, or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
• Riociguat.

Do not use Vardenafil Chanelle 10 mg Orodispersible Tablets combined with any other treatment for erectile dysfunction, including vardenafil film-coated tablets.

Vardenafil Chanelle 10 mg Orodispersible Tablets with food, drink and alcohol

• You can take Vardenafil Chanelle 10 mg Orodispersible Tablets with or without food, but do not take this medicine with any liquid.
• Don’t drink grapefruit juice when you use Vardenafil Chanelle 10 mg Orodispersible Tablets. It can interfere with the usual effect of the medicine.
• Alcoholic drink can make erection difficulties worse.

Pregnancy, breast-feeding and fertility

Vardenafil Chanelle 10 mg Orodispersible Tablets is not for use by women.

Driving and using machines

Vardenafil Chanelle 10 mg Orodispersible Tablets might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Vardenafil Chanelle 10 mg Orodispersible Tablets don’t drive or operate any tools or machines.

Vardenafil Chanelle 10 mg Orodispersible Tablets contains Aspartame and Sodium

Aspartame: Aspartame This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet. Aspartameis a source of phenylalanine. It and may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 10 mg orodispersible tablet that is to say essentially ‘sodium-free’.

3. how to take vardenafil chanelle 10 mg orodispersible tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 10 mg.

Take a tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Vardenafil Chanelle 10 mg Orodispersible Tablets.

• Do not remove the orodispersible tablet from the blister until you are going to take it. With dry hands, pull the blister edge from the blister holder and press gently on top to release the tablet on your hand. Do not crush the tablet.
• Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva. The orodispersible tablet must be taken without any liquid.

Do not take Vardenafil Chanelle 10 mg Orodispersible Tablets with any other forms of vardenafil.

Do not take Vardenafil Chanelle 10 mg Orodispersible Tablets

Tell your doctor if you think Vardenafil Chanelle 10 mg Orodispersible Tablets is too strong or too weak. He or she may suggest a switch to an alternative Vardenafil Chanelle 10 mg Orodispersible Tablets formulation with a different dose, depending on how well it works for you.

If you take more Vardenafil Chanelle 10 mg Orodispersible Tablets than you should

Men who take too much Vardenafil Chanelle 10 mg Orodispersible Tablets may experience more side effects or may get severe back pain. If you take more Vardenafil Chanelle 10 mg Orodispersible Tablets than you should, tell your doctor.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.

Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients. If any of this happens, stop taking Vardenafil Chanelle 10 mg Orodispersible Tablets and contact your doctor immediately.

Sudden decrease or loss of hearing has been reported.

Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased 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 directly related to vardenafil.

The chance of having a side effect is described by the following categories:

Very common (may affect more than 1 in 10 users):

• Headache

Common (may affect up to 1 in 10 users):

• Dizziness
• Flushing
• Blocked or runny nose
• Indigestion

Uncommon (may affect up to 1 in 100 users):

• Swelling of skin and mucous tissue including swollen face, lips or throat
• Sleep disorder
• Numbness and impaired perception of touch
• Sleepiness
• Effects on vision; redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity
• Ringing in the ears; vertigo
• Fast heart beat or pounding heart
• Breathlessness
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry mouth
• Raised levels of liver enzymes in your blood
• Rash, reddened skin
• Back or muscle pain; increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness
• Prolonged erections
• Malaise

Rare (may affect up to 1 in 1,000 users):

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Seizure
• Increased pressure in the eye (glaucoma), lacrimation increased
• Effects on the heart (such as heart attack, altered heart beat or angina)
• High or low blood pressure
• Nose bleed
• Effect on results of blood tests to check liver function.
• Sensitivity of the skin to sun light
• Painful erections
• Chest pain
• Temporarily decreased blood flow to parts of brain

Very rare (may affect less than 1 in 10,000 users) or not known (frequency cannot be estimated from the available data):

• Blood in the urine (haematuria)
• Penile bleeding (penile haemorrhage)
• Presence of blood in the semen (haematospermia)
• Sudden death
• Bleeding in the brain

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 via the Yellow Card Scheme () or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store vardenafil chanelle 10 mg orodispersible tablets

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

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 the active substance is vardenafil. each orodispersible tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate).

• The other ingredients of the tablets are:
• Cellulose microcrystalline, sodium starch glycolate, silica colloidal anyhydrous, magnesium stearate, aspartame (E951), peppermint flavour and sodium stearyl fumarate.

What Vardenafil Chanelle 10 mg Orodispersible Tablets looks like and contents of the pack

Vardenafil Chanelle 10 mg Orodispersible Tablets are white to off white plain round tablets.

The tablets are available in blister packs of 1,2, 4 or 8 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer is Chanelle Medical, Dublin Road, Loughrea, Co. Galway, Ireland.

Manufacturer:

Aristo Pharma GmbH

Wallenroder StraBe 8–10

13435 Berlin

Germany

This leaflet was last revised in 04/2020.

Page 7 of 7