VALINGER 50 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 Forte, 50 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 Forte and what is it used for
5. Important information before taking Valinger Forte
   1. When not to take Valinger Forte:
   2. Warnings and precautions
   3. Children and adolescents
   4. Valinger Forte and other medicines
   5. Valinger Forte with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Excipients
6. How to take Valinger Forte
   1. Taking a higher dose of Valinger Forte than recommended
7. Possible side effects
   1. If the patient experiences any of the following serious side effects, they should stop taking Valinger Forte and seek immediate medical attention.
   2. Other side effects:
   3. Reporting side effects
8. How to store Valinger Forte
9. Contents of the pack and other information
   1. What Valinger Forte contains
   2. What Valinger Forte 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 Forte, 50 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 your 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 tell their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or if they feel worse after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

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

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

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

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, as their concurrent use may cause dangerous lowering of blood pressure. If the patient is taking any of these medicines, they should tell 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 dangerous lowering of 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 Forte, 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 inherited eye diseases (such as retinitis pigmentosa).
• If the patient has ever experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Valinger Forte, 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 loss of vision, they should stop taking Valinger Forte and immediately consult a doctor.

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

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

Valinger Forte is not intended for 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 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 Forte should not be used in persons under 18 years of age.

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

The patient should not take Valinger Forte if they are taking nitrate medicines, as their concurrent use may cause dangerous lowering of 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).

The patient should not take Valinger Forte if they are taking medicines that release nitric oxide (e.g., amyl nitrite), as their concurrent use may cause dangerous lowering of blood pressure.

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

If the patient is taking protease inhibitors used to treat HIV infection, 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 who are taking alpha-adrenergic blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of orthostatic hypotension, characterized by a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. The occurrence of these symptoms is most likely within 4 hours of taking Valinger Forte. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Valinger Forte. The doctor may decide to use a lower dose (25 mg) of sildenafil initially. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting) occur, the patient should first lie down or sit and wait for the symptoms to pass; drinking water, taking 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 Forte with food, drink, and alcohol

Valinger Forte can be taken with or without food.

However, taking Valinger Forte during a heavy 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 Forte, the patient should not consume large amounts of alcohol 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

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means 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 the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

If the patient has previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, sildenafil in a dose of 50 mg should only be used if the patient did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., they did not achieve an erection sufficient for intercourse). If taking a lower dose of sildenafil (25 mg) allowed the patient to achieve an erection enabling them to have sexual intercourse, they should not take a dose of 50 mg.

Valinger Forte should not be taken more than once a day.

The patient should not take Valinger Forte concurrently 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 the patient feels that the effect of Valinger Forte is too strong or too weak, they should consult their doctor or pharmacist.

Valinger Forte helps achieve an erection only if there is sexual stimulation. The time after which the effect of Valinger Forte occurs varies from person to person 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 the patient does not achieve an erection or the duration of the erection is not sufficient for intercourse after taking Valinger Forte, they should inform their doctor.

Taking a higher dose of Valinger Forte 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.

The patient should not take more tablets than indicated in the patient leaflet.

The patient should contact their doctor in case of taking 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 Forte can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of Valinger Forte are usually mild to moderate and are short-term.

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

• An 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:
• The patient should sit half-up and try to relax.
• The patient should not take nitratesto 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, the patient should seek immediate medical attention.
• Sudden vision loss or vision loss - occurs rarely.
• Severe skin reactions - occur rarely. 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 occur in more than 1 in 10 people): headache.

Common(may occur in 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 with a colored aura, sensitivity to light, blurred vision, or decreased sharpness of vision), stuffy nose, dizziness.

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

Rare(may occur in 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 visual acuity, abnormal sensations in the eye, swelling of the eyes or eyelids, increased intraocular pressure (glaucoma), myopia, eye strain, small particles or dots in the visual field, seeing halos around light sources, pupil dilation, discoloration of the white of the eye, bleeding from the penis, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss or 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, circulatory disorders existed 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to store Valinger Forte

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

There are no special precautions for storage.

The patient should 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 stated.

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

6. Contents of the pack and other information

What Valinger Forte contains

• The active substance of the medicine is sildenafil. Each tablet contains 50 mg of sildenafil in the form of sildenafil citrate.
• Other ingredients are:
• 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, lacquer (E 132).

What Valinger Forte looks like and contents of the pack

Valinger Forte film-coated tablets are blue, elongated, and lens-shaped, with the marking "50" on one side. The tablet dimensions are 13 x 8 mm. The tablets are placed in blisters of 2 tablets and in perforated blisters of 4 x 1 tablet.

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:11.10.2023