VALINGER 25 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached diagnostic tool!
2. Leaflet attached to the packaging: patient information
3. Valinger, 25 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Valinger and what is it used for
5. Important information before taking Valinger
   1. When not to take Valinger:
   2. Warnings and precautions
   3. Children and adolescents
   4. Valinger and other medicines
   5. Valinger with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Excipients
6. How to take Valinger
   1. Taking a higher dose of Valinger than recommended
7. Possible side effects
   1. If the patient experiences any of the following serious side effects, they should stop taking Valinger and seek immediate medical attention.
   2. Other side effects:
   3. Reporting side effects
8. How to store Valinger
9. Package contents and other information
   1. What Valinger contains
   2. What Valinger looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Before taking the medicine, use the attached diagnostic tool!

Leaflet attached to the packaging: patient information

Valinger, 25 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Valinger and what is it used for
• 2. Important information before taking Valinger
• 3. How to take Valinger
• 4. Possible side effects
• 5. How to store Valinger
• 6. Package contents and other information

1. What is Valinger and what is it used for

Valinger contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Valinger helps achieve an erection only if there is sexual stimulation.

2. Important information before taking Valinger

When not to take Valinger:

• If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking nitrates, as their concurrent use may cause a dangerous decrease in blood pressure. If the patient is taking any of these medicines, they should inform their doctor; these medicines are often used to relieve symptoms of angina pectoris (chest pain).
• If the patient is taking medicines that release nitric oxide (e.g., amyl nitrite, so-called poppers), as their concurrent use may cause a dangerous decrease in blood pressure.
• If the patient is taking riociguat. This medicine is 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 Valinger, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.
• If the patient has severe heart or liver problems.
• If the patient has recently had a stroke or heart attack or has low blood pressure.
• If the patient has certain rare hereditary eye diseases (such as retinitis pigmentosa).
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Valinger, the patient should discuss this with their doctor or pharmacist:

• If the patient has sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• If the patient has a penile deformity or Peyronie's disease.
• If the patient has heart problems. The doctor should carefully check if the patient's heart condition allows for the extra strain associated with sexual activity.
• If the patient has a stomach ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden hearing loss, they should stop taking Valinger and immediately contact their doctor.

Valinger should not be used by patients who have not been diagnosed with erectile dysfunction.

Valinger should not be used concurrently with other oral or topical treatments for erectile dysfunction.

Valinger is not intended for women.

Valinger should not be used concurrently with medicines used to treat pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. Patients with kidney or liver function disorders should not take a dose of sildenafil greater than 25 mg.

Children and adolescents

Valinger should not be used in individuals under 18 years of age.

Valinger and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Valinger in tablet form may interact with certain medicines, especially those used to treat chest pain. In the event of an emergency requiring immediate medical attention, the patient should inform their doctor or pharmacist that they have taken Valinger and when they did so. Valinger should not be taken with other medicines without the doctor's consent.

Valinger should not be used if the patient is taking nitrate medicines, as their concurrent use may cause a dangerous decrease in blood pressure. The patient should always inform their doctor or pharmacist if they are taking medicines that are usually used to treat angina pectoris (chest pain).

Valinger should not be used if the patient is taking medicines that release nitric oxide (e.g., amyl nitrite), as their concurrent use may cause a dangerous decrease in blood pressure.

The patient should inform their doctor or pharmacist if they are already taking riociguat.

If the patient is taking protease inhibitors used to treat HIV infections, they should inform their doctor; in such cases, it is recommended to start treatment with the lowest dose (25 mg) of sildenafil.

In some patients taking alpha-adrenergic blocking agents for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which can be symptoms of orthostatic hypotension, a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blocking agents concurrently. The occurrence of these symptoms is most likely within 4 hours of taking Valinger. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocking agent before starting to take Valinger. The doctor may decide to use a lower initial dose (25 mg) of sildenafil. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint) occur, the patient should first lie down or sit and wait for the symptoms to pass; drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly.

If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Valinger with food, drink, and alcohol

Valinger can be taken with or without food. However, taking Valinger during a large meal may prolong the time to the start of the medicine's action.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the potential of Valinger, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Valinger is not indicated for use in women.

Driving and using machines

Valinger may cause dizziness and visual disturbances. Patients should be aware of how they react to Valinger before driving or operating machinery.

Excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially "sodium-free".

3. How to take Valinger

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

The recommended dose of the medicine is 25 mg (1 tablet). The doctor may, after consultation, recommend a different dosing regimen.

Valinger should not be taken more than once a day.

Valinger should not be taken with other medicines containing sildenafil.

Valinger should be taken approximately 1 hour before planned sexual activity. The tablet should be swallowed whole with a glass of water.

If the patient feels that the effect of Valinger is too strong or too weak, they should consult their doctor or pharmacist.

Valinger helps achieve an erection only if there is sexual stimulation. The time it takes for Valinger to start working varies from person to person but is usually between half an hour and one hour. The effect of Valinger may occur later if taken with a large meal.

If, after taking Valinger, an erection does not occur or the duration of the erection is not sufficient for sexual intercourse, the patient should inform their doctor.

Taking a higher dose of Valinger than recommended

The patient may experience more frequent side effects, and they may be more severe.

Taking a dose greater than 100 mg does not increase the efficacy of the medicine.

Do not take more tablets than indicated in the patient leaflet.

The patient should contact their doctor if they have taken more tablets than recommended.

If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Valinger can cause side effects, although not everybody gets them.

Side effects reported in association with Valinger are usually mild to moderate and are short-lived.

If the patient experiences any of the following serious side effects, they should stop taking Valinger and seek immediate medical attention.

Allergic reaction - occurs uncommonly(may affect up to 1 in 100 people). Its symptoms include sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.

Chest pain (occurs uncommonly):

• If it occurs during or after sexual intercourse:
• Take a semi-sitting position and try to relax.
• Do not take nitratesto relieve chest pain. Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1000 people).

If the erection lasts for more than 4 hours, the patient should immediately contact their doctor.

Sudden vision loss or hearing loss - occurs rarely.

Severe skin reactions - occur rarely.

Their symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.

Seizures or convulsions - occur rarely.

Other side effects:

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

Common(may affect up to 1 in 10 people): nausea, sudden flushing, hot flushes (symptoms include a sudden feeling of heat in the upper body), indigestion, visual disturbances (seeing a colored glow, sensitivity to light, blurred vision, or decreased sharpness of vision), stuffy nose, dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, dazzled vision, sensitivity to light, eye watering, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sense of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal inflammation (symptoms include a runny nose, sneezing, and a stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling hot, and feeling tired.

Rare(may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, eye irritation, retinal disease caused by atherosclerosis, disorders of the iris, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, increased intraocular pressure (glaucoma), myopia, eye fatigue, small particles or dots in the field of vision, seeing halos around light sources, pupil dilation, discoloration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden loss of hearing.

After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. In most, but not all, patients who experienced these side effects, cardiovascular disorders were present before taking the medicine. It is impossible to determine whether these side effects were directly related to the use of sildenafil.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

Al. Jerozolimskie 181C, 02-222 Warsaw, Poland. 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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Valinger

The medicine should be stored out of sight and reach of children.

There are no special precautions for storing the medicine.

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 month.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Valinger contains

The active substance of the medicine is sildenafil. Each tablet contains 25 mg of sildenafil in the form of sildenafil citrate.

The other ingredients are:

• Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium croscarmellose.
• Coating: hypromellose (2910; 6 mPa∙s), titanium dioxide (E 171), macrogol 6000, talc, indigo carmine, lake (E 132).

What Valinger looks like and contents of the pack

Valinger film-coated tablets are blue, elongated, and biconvex, with the marking "25" on one side. The tablet dimensions are 10 x 5 mm. The tablets are packaged in blisters of 2 tablets and in perforated blisters of 4 x 1 tablet.

Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland.

Manufacturer

Orion Corporation Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland. Laboratorios Normon, S.A., Ronda de Valdecarrizo, 6, 28760 Tres Cantos, Madrid, Spain. Orion Corporation Orion Pharma, Joensuunkatu 7, FI-24100 Salo, Finland.

To obtain more detailed information, the patient should contact the representative of the marketing authorization holder: Orion Pharma Poland Sp. z o.o., [email protected].

Date of last revision of the leaflet:22.07.2022