Package leaflet: Information for the patient

Valinger Forte, 50 mg, film-coated tablets
Sildenafilum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after taking the medicine, or if you feel worse, contact your doctor.

Table of contents

What Valinger Forte is and what it is used for
Important information before taking Valinger Forte
How to take Valinger Forte
Possible side effects
How to store Valinger Forte
Contents of the pack and other information

1. What Valinger Forte is and what it is used for

Valinger Forte 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 blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. Valinger Forte helps achieve an erection only when sexual stimulation is present.

Valinger Forte is used in the treatment of adult men with erectile dysfunction, sometimes referred to as impotence. This is defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before taking Valinger Forte

When not to take Valinger Forte:

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, because their concomitant use may cause a dangerous drop 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 (chest pain). If in doubt, consult a doctor or pharmacist.
If the patient is taking medicines that release nitric oxide (e.g. amyl nitrite, so-called "poppers"), because their simultaneous use may cause a dangerous drop in blood pressure.
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 Valinger Forte, 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.
If the patient has serious heart or liver problems.
If the patient has recently had a stroke or heart attack, or if they have low blood pressure.
If the patient has certain rare inherited 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 Valinger Forte, discuss this with your 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 been diagnosed with anatomical penile deformity or Peyronie's disease.
If the patient has heart problems. The doctor should carefully assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
If the patient has a stomach ulcer or bleeding disorders (such as hemophilia).
If the patient experiences sudden worsening of vision or sudden vision loss, they should stop taking Valinger Forte and contact their doctor immediately.

Valinger Forte should not be used by patients in whom erectile dysfunction has not been diagnosed.
Valinger Forte should not be used simultaneously with other oral or topical treatments for erectile dysfunction.
Valinger Forte is not intended for use in women.
Valinger Forte should not be used concurrently with medicines used to treat pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.

Special considerations in patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. Patients with impaired kidney or liver function should not take a dose of sildenafil higher than 25 mg.

Children and adolescents
Valinger Forte must not be used in individuals under 18 years of age.

Valinger Forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Valinger Forte tablets may interact with certain medicines, especially those used to treat chest pain. In case of a medical emergency, inform the doctor or pharmacist that you have taken Valinger Forte and when. Do not take Valinger Forte with other medicines without medical advice.
Do not take Valinger Forte if you are taking nitrates, because their concomitant use may cause a dangerous drop in blood pressure. Always inform your doctor or pharmacist if you are taking medicines commonly used to treat angina (chest pain).
Do not take Valinger Forte if you are taking medicines that release nitric oxide (e.g. amyl nitrite), because their simultaneous use may cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors used to treat HIV infection, inform your doctor; in such cases, treatment should be initiated with the lowest dose (25 mg) of sildenafil.
In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of orthostatic hypotension—a drop in blood pressure upon rapid standing or sitting up. Such symptoms have occurred in some patients taking sildenafil together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking Valinger Forte. To reduce the risk of such symptoms, patients should be on a stable dose of their alpha-blocker before starting Valinger Forte. The doctor may decide to initiate treatment with a low dose (25 mg) of sildenafil. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit, wait for symptoms to subside, and may also drink water, get fresh air, tense abdominal muscles, or cross their legs. Rapid standing or sitting should be avoided.
If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Valinger Forte with food, drink, and alcohol
Valinger Forte may be taken with or without food. However, taking Valinger Forte with a heavy meal may delay the onset of the medicine's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the effectiveness of Valinger Forte, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Valinger Forte is not indicated for use in women.

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

Excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Valinger Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, sildenafil at a dose of 50 mg should only be used if the patient did not achieve the desired effect (i.e. an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg. If the lower dose of sildenafil (25 mg) enabled an erection sufficient for sexual intercourse, the 50 mg dose should not be used.
Valinger Forte must not be taken more than once a day.
Do not take Valinger Forte together with other medicines containing sildenafil.
Valinger Forte should be taken approximately one hour before planned sexual activity.
The tablet should be swallowed whole with a glass of water.
If you feel that the effect of Valinger Forte is too strong or too weak, consult your doctor or pharmacist.
Valinger Forte helps achieve an erection only if sexual stimulation occurs. The time it takes for Valinger Forte to work varies between individuals, but usually ranges from half an hour to one hour. The effect of Valinger Forte may occur later if taken with a heavy meal.
If an erection does not occur after taking Valinger Forte, or if the duration of erection is insufficient for sexual intercourse, inform your doctor.
Taking more than the recommended dose of Valinger Forte
Adverse effects may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with the use of Valinger Forte have usually been mild to moderate in intensity and short-lived.
If any of the following serious adverse reactions occur in a patient,
discontinue use of Valinger Forte immediately and seek medical help at once.

Allergic reaction – occurs uncommonly (may occur in up to 1 in 100 people). 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:
- Adopt a semi-sitting position and try to relax.
- Do not take nitrates to relieve chest pain.
Prolonged and sometimes painful erections – occur rarely (may occur in up to 1 in 1000 people). If an erection lasts more than 4 hours, contact a doctor immediately.
Sudden worsening or loss of vision – occurs rarely.
Serious skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals, and around the eyes, fever.
Seizures or convulsions – occur rarely.

Other adverse reactions:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, sudden flushing of the face, hot flushes (symptoms include sudden feeling of warmth in the upper body), indigestion, visual disturbances (seeing colored halos, light sensitivity, blurred vision or reduced visual acuity), stuffy nose, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal mucositis (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, feeling of warmth, and feeling of fatigue.
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, sensation of throat tightness, lip numbness, retinal hemorrhage, eye irritation, retinopathy due to atherosclerosis, iris disorders, double vision, reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, increased intraocular pressure (glaucoma), myopia, eye fatigue, small specks or spots in the visual field, seeing halos around light sources (halo effect), pupil dilation, discoloration of the white of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden hearing loss.

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 adverse reactions, cardiovascular disorders were present prior to taking this medicine. It is not possible to determine whether these adverse reactions were directly related to the use of sildenafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Valinger Forte

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Valinger Forte contains

The active substance is sildenafil. Each tablet contains 50 mg of sildenafil in the form of sildenafil citrate.
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 Forte tablets look like and contents of the pack
Valinger Forte coated tablets are blue, elongated biconvex-shaped tablets marked with "50" on one side. The dimensions of the tablet are 13 x 8 mm. The tablets are packed in blisters containing 2 tablets, and in perforated blisters containing 4 x 1 tablet.

Marketing Authorisation 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

For more detailed information, please contact the representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]