Vardenafil holsten

Package leaflet: Information for the user

Vardenafil Holsten, 5 mg, tablets
Vardenafil Holsten, 10 mg, tablets
Vardenafil Holsten, 20 mg, tablets
Vardenafilum
Please read all of this leaflet carefully before taking 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

Vardenafil Holsten contains vardenafil, an active substance belonging to a group of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition in which men have difficulty achieving or maintaining an erection.
At least one in ten men experiences problems achieving or maintaining an erection. The cause may be physical factors, psychological factors, or a combination of both.
However, regardless of the cause, the result is the same: due to changes in the muscles and blood vessels, insufficient blood flows into the penis to achieve and maintain adequate rigidity.
Vardenafil Holsten works only when a man is sexually stimulated. The medicine reduces the activity of a chemical substance in the body that causes the end of an erection. Vardenafil Holsten helps achieve an erection that is sufficiently sustained to allow full satisfaction during 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). Symptoms of an allergic reaction include: rash, itching, swelling of the face or lips, difficulty in breathing.
• if the patient is taking medicines containing nitrates (e.g. glyceryl trinitrate used for angina pectoris) or medicines that release nitric oxide (e.g. amyl nitrite). Taking these medicines together with Vardenafil Holsten may seriously affect blood pressure.
• if the patient is taking ritonavir or indinavir, medicines used in the treatment of human immunodeficiency virus (HIV) infection.
• if the patient is over 75 years of age 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 suffered a stroke or heart attack.
• if the patient currently or previously has low blood pressure.
• if the patient’s family has a history of degenerative eye diseases (e.g. retinitis pigmentosa).
• if the patient has ever experienced sudden vision loss due to damage of the optic nerve caused by insufficient blood flow, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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). PDE5 inhibitors such as Vardenafil Holsten have been shown to 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 exercise special caution when taking Vardenafil Holsten

• if the patient has heart problems. In such cases, sexual activity may be dangerous.
• if the patient has an irregular heartbeat (arrhythmia) or any congenital heart disease affecting the ECG pattern.
• if the patient has conditions affecting the shape of the penis (penile curvature, Peyronie’s disease, cavernosal fibrosis).
• if the patient has conditions that may cause prolonged erection (priapism), such as sickle cell anemia, multiple myeloma, leukemia.
• if the patient has a stomach ulcer (also known as peptic ulcer).
• if the patient has blood clotting disorders (such as hemophilia).
• if the patient has previously used any other treatment for erectile dysfunction, including vardenafil in the form of orally disintegrating tablets (see section Other medicines and Vardenafil Holsten).
• if the patient experiences sudden worsening of vision or sudden vision loss, they should stop taking Vardenafil Holsten and contact a 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, particularly:

• medicines used to treat angina pectoris: nitrates or nitric oxide-releasing agents (such as amyl nitrite). Taking these medicines together with Vardenafil Holsten may severely affect blood pressure. Consult your 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 your doctor before taking Vardenafil Holsten.
• ketoconazole or itraconazole, antifungal medicines.
• erythromycin or clarithromycin, macrolide antibiotics.
• alpha-adrenergic receptor blockers used to treat hypertension and enlarged prostate (benign prostatic hyperplasia).
• riociguat.

Do not take Vardenafil Holsten tablets together with any other medicines used to treat erectile dysfunction.
Vardenafil Holsten with food, drink, and alcohol

• Vardenafil Holsten may be taken with or without food, but when taken with food, it is advisable to avoid heavy, fatty meals, as they may delay the effect of the medicine.
• While taking Vardenafil Holsten, do not drink grapefruit juice, as it may adversely affect the medicine’s action.
• Alcoholic beverages may worsen difficulties in achieving an erection.

Pregnancy and breastfeeding
Vardenafil Holsten is not a medicine for women.
Driving and operating machinery
In some people, taking Vardenafil Holsten may cause dizziness or visual disturbances. If dizziness or visual disturbances occur after taking Vardenafil Holsten, do not drive or operate tools and 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 individuals with phenylketonuria.

3. How to take Vardenafil Holsten

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. The recommended dose is 10 mg.
A Vardenafil Holsten tablet should be taken approximately 25 to 60 minutes before anticipated sexual activity. Following sexual stimulation, the patient may achieve an erection at any time between 25 minutes and 4–5 hours after taking the tablet.
The tablet should be swallowed 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, inform your doctor. Your doctor may decide to switch you to an alternative strength of Vardenafil Holsten, depending on your response to the medicine.
Taking more than the recommended dose of Vardenafil Holsten
In men who take too high a dose of Vardenafil Holsten, more adverse reactions may occur, and severe back pain may develop. If you take more Vardenafil Holsten than prescribed, contact your doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone. Most of these effects are mild or moderate. In some patients, partial, sudden, transient or permanent loss of vision in one or both eyes has been reported. Treatment with Vardenafil Holsten should be discontinued and medical advice sought immediately. Cases of sudden worsening or loss of hearing have been reported. In men taking vardenafil, cases of sudden death, rapid or irregular heartbeat, myocardial infarction, chest pain, and cerebral circulation disorders (including transient ischaemic attack and cerebral haemorrhage) have been observed. In most men who experienced these adverse effects, pre-existing heart problems were present before taking this medicine. It cannot be determined whether these events were directly related to the use of vardenafil.

The likelihood of occurrence of adverse effects is described by the following categories:

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

• headache

Common (may occur in less than 1 in 10 people):

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

Uncommon (may occur in less than 1 in 100 people):

• swelling of the skin and mucous membranes, tissues, including facial, lip or throat swelling
• sleep disorders
• numbness and disturbances in touch sensation
• drowsiness
• visual disturbances, eye redness, colour vision disturbances, eye pain and eye discomfort, light sensitivity
• tinnitus, dizziness with balance disturbances
• rapid heartbeat or palpitations
• shortness of breath
• stuffy nose
• acid regurgitation, gastritis, abdominal pain, diarrhoea, vomiting, nausea, dry mouth
• increased liver enzyme activity in blood
• rash, skin redness
• back or muscle pain, increased blood levels of an enzyme found in muscles (creatine kinase), muscle stiffness
• prolonged erections
• malaise

Rare (may occur in less than 1 in 1,000 people):

• eye inflammation (conjunctivitis)
• allergic reaction
• anxiety
• fainting
• memory loss (amnesia)
• seizure
• increased intraocular pressure (glaucoma), excessive tearing
• cardiac effects (e.g. myocardial infarction, altered heartbeat or angina)
• increased or decreased blood pressure
• nosebleeds
• abnormal liver function test results
• photosensitivity
• painful erections
• chest pain
• transient ischaemic attack

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

• blood in urine (haematuria)
• penile bleeding
• presence of blood in semen (haemospermia)
• sudden death
• cerebral haemorrhage

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Vardenafil Holsten

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after
"Expiry date (EXP)". The expiry date refers to the last day of the specified
month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures 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 (E172), iron oxide yellow (E172), magnesium stearate.

What Vardenafil Holsten looks like and contents of the pack
Vardenafil Holsten 5 mg are orange, round, biconvex tablets (diameter: 6 mm) with the number "5" embossed on one side.
Vardenafil Holsten 10 mg are orange, round, biconvex tablets (diameter: 7 mm) with the number "10" embossed on one side.
Vardenafil Holsten 20 mg are orange, round, biconvex tablets (diameter: 9 mm) with the number "20" embossed on one side.
Tablets are available in blister packs containing 2, 4, 8, 12 or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Vardenafil Holsten
Romania: Vardenafil Holsten
Poland: Vardenafil Holsten

For further information, please contact the local representative of the Marketing Authorisation Holder:
UAB SanoSwiss
Lvovo 25-701, LT-09320 Vilnius
Lithuania