VALINGER 100 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Valinger Med, 100 mg, film-coated tablets
   1. You should 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:
3. What is Valinger Med and what is it used for
4. Important information before taking Valinger Med
   1. When not to take Valinger Med:
   2. Warnings and precautions
   3. Children and adolescents
   4. Valinger Med and other medicines
   5. Valinger Med with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Excipients
5. How to take Valinger Med
   1. Taking a higher dose of Valinger Med than recommended
6. Possible side effects
   1. If you experience any of the following serious side effects, stop taking Valinger Med and seek medical help immediately.
   2. Other side effects:
   3. Reporting side effects
7. How to store Valinger Med
8. Contents of the pack and other information
   1. What Valinger Med contains
   2. What Valinger Med looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Valinger Med, 100 mg, film-coated tablets

Sildenafil

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Valinger Med 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 Med helps to achieve an erection only if there is sexual stimulation.

Valinger Med is used to treat adult men with erectile dysfunction, sometimes called impotence. This is when a man cannot get, or keep, a hard erection that is sufficient for satisfactory sexual activity.

2. Important information before taking Valinger Med

When not to take Valinger Med:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as this can cause a dangerous drop in blood pressure. If you are taking any of these medicines, you should tell your doctor; these medicines are often used to treat angina (chest pain).
• If you are taking medicines that release nitric oxide, such as amyl nitrite (sometimes called "poppers"), as this can cause a dangerous drop in blood pressure.
• If you are taking riociguat, a medicine used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as Valinger Med, can increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should tell your doctor.
• If you have severe heart or liver problems.
• If you have recently had a stroke or heart attack or have low blood pressure.
• If you have certain rare inherited eye diseases, such as retinal pigmentosa.
• If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".

Warnings and precautions

Before taking Valinger Med, you should discuss this with your doctor or pharmacist:

• If you have sickle cell anemia (a disease of the red blood cells), leukemia (a cancer of the blood), or multiple myeloma (a cancer of the bone marrow).
• If you have a deformity of your penis or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check whether your heart can cope with the extra strain of having sex.
• If you have stomach ulcers or bleeding problems (such as hemophilia).
• If you experience sudden severe loss of vision or loss of vision, you should stop taking Valinger Med and contact your doctor immediately.

Valinger Med should not be taken by patients who do not have erectile dysfunction.

Valinger Med should not be taken at the same time as other oral or topical treatments for erectile dysfunction.

Valinger Med is not intended for use by women.

Valinger Med should not be taken at the same time as medicines used to treat pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.

Special considerations for patients with kidney or liver problems

Patients with kidney or liver problems should inform their doctor. The doctor may decide to use a lower dose of sildenafil.

Children and adolescents

Valinger Med should not be taken by people under 18 years of age.

Valinger Med and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take.

Valinger Med, in tablet form, may interact with some medicines, especially those used to treat chest pain.

In the event of an emergency that requires immediate medical attention, you should inform your doctor or pharmacist that you have taken Valinger Med and when you took it.

You should not take Valinger Med with other medicines without consulting your doctor.

You should not take Valinger Med if you are taking nitrates, as this can cause a dangerous drop in blood pressure.

You should always inform your doctor or pharmacist if you are taking medicines that are usually used to treat angina (chest pain).

You should not take Valinger Med if you are taking medicines that release nitric oxide (such as amyl nitrite), as this can cause a dangerous drop in blood pressure.

You should inform your doctor or pharmacist if you are already taking riociguat.

If you are taking protease inhibitors, used to treat HIV infections, you should inform your doctor; in this case, it is recommended to start treatment with the lowest dose (25 mg) of sildenafil.

In some patients who take alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or fainting 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-blockers at the same time.

The occurrence of these symptoms is most likely within 4 hours of taking Valinger Med.

To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-blocker before starting to take Valinger Med.

The doctor may decide to use an initial lower dose (25 mg) of sildenafil.

If you are taking medicines containing sacubitril with valsartan, used to treat heart failure, you should tell your doctor or pharmacist.

Valinger Med with food, drink, and alcohol

Valinger Med can be taken with or without food.

However, taking Valinger Med with a large meal may prolong the time it takes for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol.

To maximize the potential of Valinger Med, you should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Valinger Med is not indicated for use in women.

Driving and using machines

Valinger Med may cause dizziness and visual disturbances.

Before driving or using machines, patients should be aware of how they react to Valinger Med.

Excipients

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

3. How to take Valinger Med

This medicine should always be taken exactly as your doctor has instructed.

In case of doubt, you should ask your doctor or pharmacist.

The usual starting dose is 50 mg.

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

Valinger Med 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 Med is too strong or too weak, you should talk to your doctor or pharmacist.

Valinger Med will only help you to achieve an erection if you are sexually stimulated.

The time it takes for Valinger Med to start working varies from person to person, but it normally takes between half an hour and one hour.

The effect of Valinger Med may be delayed if you take it with a large meal.

If, after taking Valinger Med, you do not get an erection or if your erection does not last long enough to have satisfactory sexual intercourse, you should talk to your doctor.

Taking a higher dose of Valinger Med than recommended

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

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

You should not take more tablets than the recommended dose.

You should contact your doctor if you have taken more tablets than recommended.

In case of any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

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

If you experience any of the following serious side effects, stop taking Valinger Med and seek medical help immediately.

• An allergic reaction - occurs uncommonly(may affect 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:
• Sit half-upright and try to relax.
• Do not use nitratesto alleviate chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1000 people). If an erection lasts for more than 4 hours, you should contact your doctor immediately.
• Sudden loss of vision - occurs rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe skin peeling and swelling, blistering of the skin, mouth, genitals, and around the eyes, fever.
• Seizures or fits - 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 blue tinge, sensitivity to light, blurred vision, or reduced 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, increased light sensitivity, blurred vision, reduced sharpness of vision, eye swelling, 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 nose, nasal congestion (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 affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, temporary 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, reduced sharpness of vision, abnormal sensations in the eye, eye or eyelid swelling, increased intraocular pressure (glaucoma), short-sightedness, eye strain, small particles or spots in the field of vision, seeing halos around lights, pupil dilation, discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, nasal congestion, 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.

Most, but not all, patients who experienced these side effects had pre-existing heart disease before taking this medicine.

It is impossible to determine whether these side effects were directly related to the use of sildenafil.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.

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

Al. Jerozolimskie 181C

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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valinger Med

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

There are no special precautions for storage.

Do not use Valinger Med after the expiry date stated on the carton and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste.

You should ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Contents of the pack and other information

What Valinger Med contains

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil in the form of sildenafil citrate.
• The 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, lake (E 132).

What Valinger Med looks like and contents of the pack

Valinger Med film-coated tablets are blue, film-coated, and have an elongated lens shape with the marking "100" on one side. The dimensions of the tablet are 17 x 9 mm.

The tablets are packaged in blisters of 1 or 2 tablets.

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, you 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