Vardenafil Holsten

Leaflet accompanying the packaging: information for the user

Vardenafil Holsten, 5 mg, tablets

Vardenafil Holsten, 10 mg, tablets

Vardenafil Holsten, 20 mg, tablets

Vardenafil

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the 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, a substance belonging to a group of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, i.e., a condition in which there are difficulties in achieving or maintaining an erection.
At least one in ten men has problems with achieving or maintaining an erection. Their cause may be physical or psychological factors, or a combination of both.
However, regardless of the cause, the effect is the same: due to changes in muscles and blood vessels, too little blood flows to the penis to ensure and maintain its proper stiffness.
Vardenafil Holsten only works when a man is sexually stimulated. The medicine reduces the activity of a chemical substance in the body that causes the erection to subside. Vardenafil Holsten allows for an erection that is long enough for the patient to achieve full satisfaction from sexual intercourse.

2. Important information before taking Vardenafil Holsten

When not to take Vardenafil Holsten

• if the patient is allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include: rash, itching, swelling of the face or lips, difficulty breathing.
• if the patient is taking medicines containing nitrates (e.g., trinitroglycerin used in angina pectoris) or medicines that release nitric oxide (e.g., amyl nitrite). Taking these medicines at the same time as Vardenafil Holsten can seriously affect blood pressure.
• if the patient is taking ritonavir or indinavir, medicines used to treat HIV infection.
• if the patient is over 75 years old and is taking antifungal medicines - ketoconazole or itraconazole.
• if the patient has severe heart or liver disease.
• if the patient is undergoing dialysis.
• if the patient has recently had a stroke or heart attack.
• if the patient has currently or has had low blood pressure.
• if there is a history of degenerative eye diseases in the patient's family (e.g., pigmentary retinal degeneration).
• if the patient has ever had a condition characterized by loss of vision due to damage to the optic nerve due to insufficient blood supply, called non-arteritic anterior ischemic optic neuropathy.
• if the patient is taking riociguat. This is 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 PDE5 inhibitors, such as Vardenafil Holsten, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions

Before starting to take Vardenafil Holsten, consult a doctor or pharmacist.

When to be particularly careful when taking Vardenafil Holsten

• if the patient has heart problems. In such a situation, sex can be dangerous.
• if the patient has an irregular heart rhythm (arrhythmia) or any congenital heart disease that affects the ECG recording.
• if the patient has conditions that affect the shape of the penis (penile curvature, Peyronie's disease, fibrosis of the cavernous bodies).
• if the patient has diseases that can cause persistent erections (priapism), such as: sickle cell anemia, multiple myeloma, leukemia.
• if the patient has a stomach ulcer (also called peptic ulcer).
• if the patient has blood clotting disorders (such as hemophilia).
• if the patient has used any other treatment for erectile dysfunction, including vardenafil in the form of tablets that dissolve in the mouth (see section Other medicines and Vardenafil Holsten).
• if the patient experiences sudden worsening of vision or sudden loss of vision, they should stop taking Vardenafil Holsten and contact their 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 medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Some medicines may cause problems, and in particular:

• medicines used to treat angina pectoris: nitrates or nitric oxide-releasing medicines (such as amyl nitrite). Taking these medicines at the same time as Vardenafil Holsten can have a very unfavorable effect on blood pressure. Consult a doctor before taking Vardenafil Holsten.
• medicines used to treat heart rhythm disorders, such as: quinidine, procainamide, amiodarone, or sotalol.
• medicines used to treat HIV infection, such as ritonavir or indinavir. Consult a doctor before taking Vardenafil Holsten.

Consult a doctor before taking Vardenafil Holsten.

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

Do not take Vardenafil Holsten tablets with any other medicines used to treat erectile dysfunction.

Vardenafil Holsten with food, drink, and alcohol

• Vardenafil Holsten can be taken with or without food, but when taken with food, it is better 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 have an unfavorable effect on the medicine.
• Alcoholic beverages may exacerbate erection problems.

Pregnancy and breastfeeding

Vardenafil Holsten is not a medicine for women.

Driving and using machines

In some people, taking Vardenafil Holsten may cause dizziness or vision disturbances. If dizziness or vision disturbances occur after taking Vardenafil Holsten, do not drive vehicles or operate tools and machines.

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

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist. The recommended dose is 10 mg.
Take a Vardenafil Holsten tablet about 25 minutes to 60 minutes before starting sexual activity. After sexual stimulation, the patient can achieve an erection at any time between 25 minutes and 4-5 hours after taking the medicine.
Swallow the tablet with a glass of water.
Do not take Vardenafil Holstenmore 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 switch to an alternative form of Vardenafil Holsten with a different strength, depending on your reaction to the medicine.

Taking a higher dose of Vardenafil Holsten than recommended

In men who have taken too much Vardenafil Holsten, more side effects may occur, and severe back pain may occur. If you have taken more Vardenafil Holsten than recommended, contact your doctor.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of these effects are mild or moderate.
In some patients, partial, sudden, transient, or permanent vision loss in one or both eyes has occurred. Stop taking Vardenafil Holsten and contact your doctor immediately. There have been reports of sudden hearing loss.
In men taking vardenafil, there have been reports of sudden death, accelerated or disturbed heart rhythm, heart attack, chest pain, and cerebral circulation problems (including transient cerebral ischemia and cerebral hemorrhage). In most men who experienced these side effects, heart problems existed before taking this medicine. It cannot be determined whether these events were directly related to taking vardenafil.
The risk of a side effect is described by the following categories:
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 feeling of a blocked nose
• indigestion

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

• swelling of the skin and mucous membranes, including face, lips, or throat
• sleep disorders
• numbness and tingling
• drowsiness
• 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 disturbances
• 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 activity in the blood of the enzyme found in muscles (creatine phosphokinase), muscle stiffness
• prolonged erections
• malaise

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

• inflammation in the eye (conjunctivitis)
• allergic reaction
• anxiety
• fainting
• memory loss (amnesia)
• seizures
• increased pressure in the eyeball (glaucoma), increased tearing
• effects on the heart (i.e., heart attack, changed heartbeat, or angina)
• increased or decreased blood pressure
• nasal bleeding
• effects on liver function test results
• skin sensitivity to sunlight
• painful erections
• chest pain
• transient cerebral ischemia

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

• blood in the urine (hematuria)
• bleeding from the penis
• presence of blood in the semen (hematospermia)
• sudden death
• cerebral hemorrhage

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor. 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:
Jerozolimskie Avenue 181 C, 02-222 Warsaw, phone: +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.
Reporting side effects will help gather 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 the month stated.
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), iron oxide red (E 172), iron oxide yellow (E 172), magnesium stearate.

What Vardenafil Holsten looks like and contents of the pack

Vardenafil Holsten 5 mg is orange, round, biconvex tablets (diameter: 6 mm) with the number "5" embossed on one side.
Vardenafil Holsten 10 mg is orange, round, biconvex tablets (diameter: 7 mm) with the number "10" embossed on one side.
Vardenafil Holsten 20 mg is orange, round, biconvex tablets (diameter: 9 mm) with the number "20" embossed 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 more information, contact your local representative of the marketing authorization holder:

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

Date of last revision of the leaflet: 07/2022