Valinger med

Package leaflet: Information for the patient

Valinger Med, 100 mg, film-coated tablets
Sildenafilum
Read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Valinger Med is and what it is used for
2. What you need to know 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 Valinger Med is and what it is used for

Valinger Med contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Valinger Med works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Valinger Med helps achieve an erection only if sexual stimulation is present.
Valinger Med is used to treat adult men with erectile dysfunction, sometimes known as impotence. This is defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Valinger Med

When not to use Valinger Med:

• 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 concomitant use may cause dangerous lowering of 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"), as their concomitant use may cause dangerous lowering of 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 Med, 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 severe 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 ischaemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Valinger Med, discuss the following with your doctor or pharmacist:

• If the patient has sickle cell anaemia (a disorder affecting red blood cells), leukaemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• If the patient has a penile anatomical deformation or Peyronie's disease.
• If the patient has heart problems. The doctor should carefully assess whether the heart condition allows for the additional strain associated with sexual activity.
• If the patient has a stomach ulcer or bleeding disorders (such as haemophilia).
• If the patient experiences sudden worsening of vision or sudden vision loss, they should stop taking Valinger Med and contact their doctor immediately.

Valinger Med should not be used in patients who have not been diagnosed with erectile dysfunction.
Valinger Med should not be used concomitantly with other oral or topical therapies for erectile dysfunction.
Valinger Med is not intended for use in women.
Valinger Med should not be used concomitantly 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. The doctor may decide to prescribe a lower dose of sildenafil.

Children and adolescents
Valinger Med should not be used in individuals under 18 years of age.

Valinger Med and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Valinger Med 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 the patient has taken Valinger Med and when it was taken. Do not take Valinger Med with other medicines without the doctor's approval.
Do not take Valinger Med if the patient is using nitrates, as their concomitant use may cause dangerous lowering of blood pressure. Always inform the doctor or pharmacist if the patient is taking medicines commonly used to treat angina (chest pain).
Do not take Valinger Med if the patient is using medicines that release nitric oxide (e.g. amyl nitrite), as their concomitant use may cause dangerous lowering of blood pressure.
Inform the doctor or pharmacist if the patient is already taking riociguat.
If the patient is taking protease inhibitors used in the treatment of HIV infection, they should inform their 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—low blood pressure upon standing up or sitting down quickly. These symptoms have been observed in some patients taking sildenafil concomitantly with alpha-blockers. Such symptoms are most likely to occur within 4 hours after taking Valinger Med. To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Valinger Med. The doctor may decide to initiate treatment with a low dose (25 mg) of sildenafil.
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform the 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 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 Med, significant amounts of alcohol should be avoided 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. Patients should understand how they react to Valinger Med before driving or operating machinery.

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

3. How to use Valinger Med

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist. The usual starting dose is 50 mg.
Valinger Med must not be taken more than once a day.
Valinger Med should be taken approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Valinger Med is too strong or too weak, consult your doctor or pharmacist.
Valinger Med helps achieve an erection only if sexual stimulation occurs. The time it takes for Valinger Med to work varies between individuals, but usually ranges from half an hour to one hour. The effect of Valinger Med may occur later if taken with a heavy meal.
If an erection does not occur after taking Valinger Med, or if the duration of the erection is insufficient for sexual intercourse, inform your doctor.
Taking a higher than recommended dose of Valinger Med
Adverse effects may occur more frequently and may be more severe.
Taking more than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient information 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported with the use of Valinger Med have usually been mild to moderate in intensity and transient.
If any of the following serious adverse reactions occur in a patient,
discontinue use of Valinger Med and seek immediate medical help.

• Allergic reaction – occurs not very often (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 not very often) : If it occurs during or after sexual intercourse:
• Adopt a semi-sitting position and try to relax.
• Do not use 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 longer 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, formation of blisters in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions – occur rarely.

Other adverse reactions:
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 of the face, hot flushes (symptoms include sudden feeling of warmth in the upper body), indigestion, visual disturbances (vision with colored halos, light sensitivity, blurred vision or reduced visual acuity), stuffy nose, dizziness.
Not very often (may occur in up to 1 in 100 people): vomiting, skin rash, eye irritation, eye hyperemia, eye pain, seeing flashes of light, bright vision, light sensitivity, eye tearing, 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 stuffy 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.
Rarely (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 throat tightness, lip numbness, bleeding into the back of the eye, eye irritation, retinal disease caused by atherosclerosis, iris disorders, double vision, decreased visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, increased intraocular pressure (glaucoma), myopia, eye strain, small particles or spots in the visual field, seeing halos around light sources (halo effect), pupil dilation, discoloration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden hearing loss or hearing impairment.
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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 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 responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Valinger Med

Keep this medicine out of sight and reach of children.
No special storage conditions apply to this medicine.
Do not use Valinger Med after the expiry date stated on the carton and blister pack following
"Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
• 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, lacquer (E 132).

What Valinger Med tablets look like and contents of the pack
Valinger Med coated tablets are blue, film-coated, elongated biconvex tablets with the imprint "100" on one side. The tablet dimensions are 17 x 9 mm.
Tablets are packed in blisters containing 1 or 2 tablets.

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