Leaflet: information for the user

Vardenafilo STADA 5 mg film-coated tablets

Vardenafilo STADA 10 mg film-coated tablets

Vardenafilo STADA 20 mg film-coated tablets

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

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

1.What Vardenafilo Stada is and what it is used for

2.What you need to know before you start taking Vardenafilo Stada

3.How to take Vardenafilo Stada

4.Possible side effects

5.Storage of Vardenafilo Stada

6.Contents of the pack and additional information

Vardenafilo Stada contains vardenafilo, an active ingredient from the group of medications known as phosphodiesterase type 5 inhibitors, which are used to treat erectile dysfunction in adult men, a condition that consists of difficulty in achieving or maintaining an erection.

At least one in every ten men has, at some point, problems achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel alterations result in insufficient blood in the penis to achieve and maintain an erection.

Vardenafilo will only act when sexually stimulated. This medication reduces the action of a natural substance in the body that prevents an erection. Vardenafilo allows for the achievement of an erection with a sufficient duration to maintain a satisfactory sexual relationship.

Do not take Vardenafilo Stada

• If you are allergic to vardenafilo or any of the other components of this medication (listed in section 6). Signs of allergic reaction include skin rash, itching, swelling in the face or lips, and difficulty breathing.
• If you are taking medications that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafilo may severely affect your blood pressure.
• If you are taking ritonavir or indinavir, medications for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and taking ketoconazol or itraconazol, antifungal medications.
• If you have a severe heart or liver problem.
• If you are undergoing renal dialysis.
• If you have recently experienced a cerebral ischemic accident or a heart attack.
• If you have low blood pressure, or if you had it in the past.
• If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever suffered vision loss due to a lack of blood supply to the optic nerve, known as nonarteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat. This medication is used to treat pulmonary arterial hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as vardenafilo, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vardenafilo Stada.

Be especially careful with Vardenafilo Stada

• If you have heart problems, as having sex may pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or any hereditary heart disease that alters your electrocardiogram.
• If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernous fibrosis.
• If you have a disease that may cause erections that do not subside (priapism). For example, sickle cell anemia, multiple myeloma, and leukemia.
• If you have a stomach ulcer (also known as a gastric or peptic ulcer).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erectile dysfunction, including vardenafilo tablets coated with a film (see the section: “Use of Vardenafilo Stada with other medications”).
• If you have ever experienced sudden, temporary, or permanent loss of vision in one eye, do not take vardenafilo and consult your doctor immediately.

Children and adolescents

Vardenafilo should not be used in children or adolescents under 18 years old.

Other medications and Vardenafilo Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may cause problems, especially the following:

• Nitrates, medications for angina or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafilo may severely affect your blood pressure.
• Medications for the treatment of cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medications for HIV infections.
• Ketoconazol or itraconazol, antifungal medications.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a group of medications used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafilo tablets coated with a film in combination with another medication for erectile dysfunction, including vardenafilo buccal dispersible tablets.

Taking Vardenafilo Stada with food, drinks, and alcohol

• You can take vardenafilo with or without food, but it is recommended not to do so after a large meal or with a high-fat content, as the effect may be delayed.
• Do not drink grapefruit juice when taking vardenafilo, as it may interfere with the normal effect of the medication.
• Drinking alcoholic beverages may worsen erectile dysfunction problems.

Pregnancy and breastfeeding

Vardenafilo should not be used in women.

Driving and operating machinery

In some people, vardenafilo may cause dizziness or affect vision. Do not drive or operate tools or machinery if you feel dizzy or have vision problems after taking vardenafilo.

This medication contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafilo tablet25 to 60 minutes, approximately, before sexual activity. With sexual stimulation, you will be able to obtain an erection from 25 minutes and up to four or five hours after taking vardenafilo.

Swallow the tablet with a glass of water.

Do not take vardenafilofilm-coated tabletswith any other formulation of vardenafilo.

Do not take vardenafilomore than once a day.

If you estimate that the action of vardenafilois too strong or weak, inform your doctor. They may suggest changing to another formulation of vardenafilowith a different dose based on the effect it has on you.

If you take more Vardenafilo Stada than you should

Taking too many vardenafilo tabletsmay cause more side effects and produce intense back pain. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most of these side effects are mild or moderate.

Some patients have experienced a decrease in vision or partial loss of vision, sudden, temporary, or permanent, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

There have also been reported cases of sudden hearing loss or hearing loss.

There have been reported cases of sudden death, rapid or irregular heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary reduction of blood flow to parts of the brain and cerebral hemorrhage), in men taking vardenafil. Most men who have experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine if these events were directly related to vardenafil.

The possibility of presenting a side effect is described using the following categories:

Very common side effects (can affect more than 1 in 10 people):

• Headache

Common side effects (can affect up to 1 in 10 people):

• Dizziness
• Facial flushing
• Nasal congestion or discharge
• Indigestion

Uncommon side effects (can affect up to 1 in 100 people):

• Swelling of the skin and mucous membranes, including facial, lip, or throat swelling
• Sleep disturbances
• Numbness and altered sensation of touch
• Drowsiness
• Effects on vision; eye bleeding, effects on color vision, eye pain, and photosensitivity
• Tinnitus; vertigo
• Palpitations or rapid heartbeat
• Difficulty breathing
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth(oral dryness)
• Elevation of liver enzymes in blood
• Skin rashes
• Back pain or muscle pain; elevated muscle creatine phosphokinase in blood; muscle stiffness
• Prolonged erection
• General feeling of discomfort

Rare side effects (can affect up to 1 in 1,000 people):

• Eye inflammation (conjunctivitis)(conjunctivitis)
• Allergic reaction
• Anxiety.
• Fainting.
• Amnesia (memory loss)
• Seizures
• Glaucoma (increased intraocular pressure), watery eyes
• Effects on the heart (such as myocardial infarction, tachycardia, or angina)
• High or low blood pressure
• Nasal bleeding
• Alterations in liver function test results in blood
• Sensitivity to sunlight
• Painful erection.
• Chest pain
• Temporary reduction of blood flow to parts of the brain

Very rare or unknown frequency side effects (can affect fewer than 1 in 10,000 people or the frequency cannot be estimated from available data):

• Blood in urine (hematuria)
• Bleeding in the penis (penile hemorrhage)
• Blood in semen (hematospermia)
• Sudden death
• Cerebral hemorrhage

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Vardenafilo Stada

-The active ingredient is vardenafilo.

Vardenafilo Stada 5 mg: each tablet contains 5 mg of vardenafilo (as trihydrate hydrochloride).

Vardenafilo Stada 10 mg: each tablet contains 10 mg of vardenafilo (as trihydrate hydrochloride).

Vardenafilo Stada 20 mg: each tablet contains 20 mg of vardenafilo (as trihydrate hydrochloride).

-The other components are:

Tablet core: microcrystalline cellulose (E460); crospovidone type A (E1202); anhydrous colloidal silica (E551); magnesium stearate (E470b).

Coating:polyvinyl alcohol (E1203); titanium dioxide (E171); talc (E553b); macrogol (E1521); acid methacrylic copolymer; yellow iron oxide (E172); sodium hydrogen carbonate (E500 (ii)); red iron oxide (E172).

Appearance of the product and contents of the package

Vardenafilo Stada 5 mg are round tablets, coated with a yellowish clear film of 6 mm and engraved with “A719” on one side.

Vardenafilo Stada 10 mg are round tablets, coated with a yellowish clear film of 7 mm and engraved with “A721” on one side.

Vardenafilo Stada 20 mg are round tablets, coated with a yellowish clear film of 8.5 mm and engraved with “A723” on one side.

It is presented in PVC/Aclar-Al blisters containing:

Vardenafilo Stada 5 mg: 4, 12 or 20 tablets.

Vardenafilo Stada 10 mg and Vardenafilo Stada 20 mg: 2, 4, 8, 12 or 20 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastasse 2-18

61118 Bad Vilbel

Germany

or

Actavis Ltd.

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 Vienna

Austria

Last review date of this leaflet:November 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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