Vardenafil Holsten

Package Leaflet: Information for the User

Vardenafil Holsten, 5 mg, tablets

Vardenafil Holsten, 10 mg, tablets

Vardenafil Holsten, 20 mg, tablets

Vardenafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Vardenafil Holsten and what is it used for
• 2. Important information before taking Vardenafil Holsten
• 3. How to take Vardenafil Holsten
• 4. Possible side effects
• 5. How to store Vardenafil Holsten
• 6. Contents of the pack and other information

1. What is Vardenafil Holsten and what is it used for

Vardenafil Holsten contains vardenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition which means that a man cannot achieve or maintain a penile erection sufficient for satisfactory sexual performance.

At least one in ten men has problems getting or keeping an erection. The reasons for this can be physical or psychological, or a combination of both. However, the cause is always the same: due to changes in the muscles and blood vessels, not enough blood flows into the penis to make it stiff.

Vardenafil Holsten works only if a man is sexually stimulated. The medicine reduces the activity of a chemical in the body, which causes the erection to disappear. Vardenafil Holsten allows an erection to last long enough to have satisfactory sexual intercourse.

2. Important information before taking Vardenafil Holsten

When not to take Vardenafil Holsten

• if you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, itching, swelling of the face or lips, difficulty breathing.
• if you are taking medicines containing nitrates (e.g. trinitroglycerin used for angina pectoris) or medicines that release nitric oxide (e.g. amyl nitrite). Taking these medicines with Vardenafil Holsten can seriously affect your blood pressure.
• if you are taking ritonavir or indinavir, medicines used to treat HIV infection.
• if you are over 75 years old and are taking the antifungal medicines ketoconazole or itraconazole.
• if you have severe heart or liver disease.
• if you are having dialysis.
• if you have had a stroke or heart attack recently.
• if you have low blood pressure.
• if you or a family member have a rare inherited eye disease (e.g. retinitis pigmentosa).
• if you have ever had a condition that resulted in loss of vision due to damage to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy.
• if you are taking riociguat, a medicine used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as Vardenafil Holsten, enhance the blood pressure lowering effect of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions

Before taking Vardenafil Holsten, tell your doctor or pharmacist.

When to be particularly careful with Vardenafil Holsten

• if you have heart problems. In this case, sex can be dangerous.
• if you have irregular heartbeats (arrhythmias) or any congenital heart disease that affects the ECG tracing.
• if you have conditions that affect the shape of the penis (e.g. Peyronie's disease, penile angulation, cavernosal fibrosis).
• if you have conditions that may cause prolonged erections (e.g. sickle cell anemia, multiple myeloma, leukemia).
• if you have stomach ulcers (also known as peptic ulcers).
• if you have bleeding disorders (e.g. hemophilia).
• if you have been treated with any other erectile dysfunction treatment, including vardenafil in the form of orodispersible tablets (see section "Other medicines and Vardenafil Holsten").
• if you experience sudden loss of vision or sudden hearing loss, stop taking Vardenafil Holsten and contact your doctor immediately.

Children and adolescents

Vardenafil Holsten is not intended for use in children and adolescents under 18 years of age.

Other medicines and Vardenafil Holsten

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription.

• medicines used to treat angina pectoris: nitrates or nitric oxide donors (e.g. amyl nitrite). Taking these medicines with Vardenafil Holsten can seriously affect your blood pressure. Consult your doctor before taking Vardenafil Holsten.
• medicines used to treat irregular heartbeats, such as quinidine, procainamide, amiodarone, or sotalol.
• medicines used to treat HIV infection, such as ritonavir or indinavir. Consult your doctor before taking Vardenafil Holsten.

Consult your doctor before taking Vardenafil Holsten.

• ketoconazole or itraconazole, antifungal medicines.
• erythromycin or clarithromycin, macrolide antibiotics.
• alpha-blockers used to treat high blood pressure and enlarged prostate (benign prostatic hyperplasia).
• riociguat.

Do not take Vardenafil Holsten tablets with any other erectile dysfunction treatments.

Vardenafil Holsten with food, drink, and alcohol

• Vardenafil Holsten can be taken with or without food, but it is recommended to avoid heavy and fatty meals, as they may delay the effect of the medicine.
• Do not drink grapefruit juice while taking Vardenafil Holsten, as it may affect the medicine's action.
• Alcoholic drinks can make erectile dysfunction worse.

Pregnancy and breastfeeding

Vardenafil Holsten is not intended for use in women.

Driving and using machines

Some people may experience dizziness or visual disturbances while taking Vardenafil Holsten. If you experience dizziness or visual disturbances after taking Vardenafil Holsten, do not drive or operate machinery.

Vardenafil Holsten contains aspartame (E951):

Each 5 mg tablet contains 2.5 mg of aspartame (E951). Each 10 mg tablet contains 5 mg of aspartame (E951). Each 20 mg tablet contains 10 mg of aspartame (E951). Aspartame is a source of phenylalanine and may be harmful to people with phenylketonuria.

3. How to take Vardenafil Holsten

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. The recommended dose is 10 mg. Take a Vardenafil Holsten tablet about 25 to 60 minutes before you plan to have sex. After sexual stimulation, you can achieve an erection between 25 minutes and 4-5 hours after taking the medicine. Swallow the tablet with a glass of water. Do not take Vardenafil Holsten more than once a day.If you feel that the effect of Vardenafil Holsten is too strong or too weak, tell your doctor. Your doctor may decide to change you to an alternative Vardenafil Holsten formulation with a different strength, depending on your response to the medicine.

Taking more than the recommended dose of Vardenafil Holsten

If you take more Vardenafil Holsten than you should, you may experience more side effects. In case of an overdose, contact your doctor.

4. Possible side effects

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

Some patients have experienced partial, sudden, transient, or permanent vision loss in one or both eyes. Stop taking Vardenafil Holsten and contact your doctor immediately. There have been reports of sudden hearing loss. Men taking vardenafil have reported cases of sudden death, accelerated or disturbed heart rhythm, heart attack, chest pain, and cerebrovascular problems (including transient ischaemic attack and stroke). In most cases, these men had pre-existing heart problems. It is not possible to determine whether these events were directly related to vardenafil.

The risk of a side effect is described as follows:

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

• headache

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

• dizziness
• flushing
• nasal congestion or stuffy nose
• indigestion

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

• skin and mucous membrane disorders, including face, lips, or throat swelling
• sleep disorders
• numbness or abnormal sensation
• sleepiness
• effects on vision, redness of the eyes, effects on color vision, eye pain, and eye discomfort, sensitivity to light
• ringing in the ears, dizziness with balance disorders
• rapid heartbeat or palpitations
• shortness of breath
• nasal congestion
• acid reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth
• increased liver enzyme activity in the blood
• rash, skin redness
• back pain or muscle pain, increased muscle enzyme activity in the blood (creatine phosphokinase), muscle stiffness
• prolonged erections
• feeling unwell

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

• inflammation of the eye (conjunctivitis)
• allergic reaction
• anxiety
• fainting
• memory loss (amnesia)
• seizures
• increased pressure in the eye (glaucoma), increased tearing
• effects on the heart (e.g. heart attack, irregular heartbeat, or angina)
• increased or decreased blood pressure
• nasal bleeding
• effects on liver function tests
• skin sensitivity to sunlight
• painful erections
• chest pain
• transient ischaemic attack

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

• blood in the urine (hematuria)
• penile bleeding
• blood in the semen (hematospermia)
• sudden death
• stroke

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vardenafil Holsten

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vardenafil Holsten contains

• The active substance is vardenafil. Each tablet contains 5 mg, 10 mg, or 20 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other ingredients are: microcrystalline cellulose, crospovidone, type A, colloidal anhydrous silica, aspartame (E951), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), magnesium stearate.

What Vardenafil Holsten looks like and contents of the pack

Vardenafil Holsten 5 mg is an orange, round, biconvex tablet (diameter: 6 mm) with "5" engraved on one side. Vardenafil Holsten 10 mg is an orange, round, biconvex tablet (diameter: 7 mm) with "10" engraved on one side. Vardenafil Holsten 20 mg is an orange, round, biconvex tablet (diameter: 9 mm) with "20" engraved on one side. The tablets are available in blister packs containing 2, 4, 8, 12, or 20 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holsten Pharma GmbH, Hahnstraße 31-35, 60528 Frankfurt am Main, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Vardenafil Holsten, Romania: Vardenafil Holsten, Poland: Vardenafil Holsten

For further information, please contact your local representative of the marketing authorization holder:

UAB SanoSwiss, Lvovo 25-701, LT-09320 Vilnius, Lithuania

Date of last revision of the package leaflet: 07/2022