Sildenafil medical valley

Package leaflet: Information for the patient

Sildenafil Medical Valley, 100 mg, film-coated tablets
Sildenafilum
Please read the entire leaflet before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

1. What Sildenafil Medical Valley is and what it is used for

Sildenafil Medical Valley contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. The medicine works by helping to relax blood vessels in the penis, thereby increasing blood flow into the penis during sexual stimulation.
Sildenafil Medical Valley helps achieve an erection only if sexual stimulation is present.
Sildenafil Medical Valley is used in the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This is the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Sildenafil Medical Valley

When not to use Sildenafil Medical Valley:

• 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 medicines called nitrates, because taking them together may lead to a dangerous drop in blood pressure. The patient should inform their doctor if they are taking any medicines from this group; these medicines are often used to relieve angina (chest pain). If in doubt, consult a doctor or pharmacist.

• If the patient is taking drugs that release nitric oxide, e.g., amyl nitrite (so-called "poppers"; inhaled nitrites used recreationally), because taking them together may also 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 lung pressure caused by blood clots). PDE5 inhibitors such as Sildenafil Medical Valley 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 disease.

• If the patient has recently had a stroke or heart attack, or has low blood pressure.

• If the patient has certain rare inherited eye disorders (retinitis pigmentosa).

• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Sildenafil Medical Valley, discuss this with a doctor, pharmacist, or nurse.

• If the patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• If the patient has been diagnosed with penile anatomical deformity or Peyronie's disease.
• If the patient has heart problems. The doctor should assess whether the condition of the heart muscle allows for the additional strain associated with sexual activity.
• If the patient has peptic ulcer disease or blood clotting disorders (such as hemophilia).
• If the patient experiences sudden worsening of vision or sudden vision loss, treatment with Sildenafil Medical Valley should be stopped immediately and the patient should contact their doctor without delay.

Sildenafil Medical Valley must not be used together with other oral or topical treatments for erectile dysfunction.
Sildenafil Medical Valley must not be used together with arterial pulmonary hypertension (PAH) therapies involving sildenafil or other PDE5 inhibitors.
Sildenafil Medical Valley should not be taken if erectile dysfunction has not been diagnosed.
Sildenafil Medical Valley must not be used in women.

Special precautions for patients with kidney or liver impairment
Patients with impaired kidney or liver function should inform their doctor, who may decide to prescribe a lower dose.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free."

Children and adolescents
Sildenafil Medical Valley must not be used in individuals under 18 years of age.

Sildenafil Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Sildenafil Medical Valley may interact with certain medicines, particularly those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, inform the doctor, pharmacist, or nurse that Sildenafil Medical Valley was taken and when it was taken. Do not take Sildenafil Medical Valley together with other medicines without medical advice.
Do not take Sildenafil Medical Valley if the patient is using medicines called nitrates, because taking them together may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates, which are used to treat angina (chest pain).
Do not take Sildenafil Medical Valley if the patient is using drugs that release nitric oxide, e.g., amyl nitrite (so-called "poppers"), because taking them together may also cause a dangerous drop in blood pressure.
Inform the doctor or pharmacist if the patient is taking riociguat.
If the patient is taking protease inhibitors used in the treatment of HIV infection, the doctor may recommend starting treatment with the lowest dose (25 mg) of Sildenafil Medical Valley.
In some patients taking α-adrenergic blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur when standing up or sitting down quickly, which may be symptoms of low blood pressure. Such symptoms have been reported in some patients taking sildenafil together with α-adrenergic blockers. These symptoms are most likely to occur within 4 hours after taking sildenafil. To reduce the risk of such symptoms, the patient should be on a stable dose of their α-adrenergic blocker before starting treatment with Sildenafil Medical Valley. The doctor may decide to use a lower starting dose (25 mg) of Sildenafil Medical Valley.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Sildenafil Medical Valley with food, drink, and alcohol
Sildenafil Medical Valley can be taken with or without food. However, taking Sildenafil Medical Valley 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 therapeutic benefit of Sildenafil Medical Valley, significant alcohol intake should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
Sildenafil Medical Valley must not be used in women.

Driving and operating machinery
Sildenafil Medical Valley may cause dizziness and visual disturbances. Before driving or operating machinery, the patient should understand how they react to Sildenafil Medical Valley.

3. How to use Sildenafil Medical Valley

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. The usual starting dose is 50 mg.
Sildenafil Medical Valley must not be taken more than once a day.
Sildenafil Medical Valley 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 Sildenafil Medical Valley is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Medical Valley enables an erection only in the presence of sexual stimulation. The time to onset of effect of Sildenafil Medical Valley varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Sildenafil Medical Valley, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil Medical Valley
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 prescribed by your doctor.
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects reported with sildenafil use are usually mild or
moderate in intensity and temporary.
If any of the following adverse effects occur, stop taking Sildenafil Medical Valley and seek
immediate medical help:

• Allergic reaction – occurs not commonly (may occur in 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs not commonly. If chest pain occurs during or after sexual intercourse, the patient:
  • Should sit half-upright and try to relax;
  • Must not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occurs rarely (may occur in 1 in 1000 people). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occurs rarely
• Severe skin reactions – occurs rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, genital area and around the eyes, fever.
• Seizures or convulsions – occurs rarely

Other adverse effects:
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 a feeling of warmth in the upper body), indigestion, vision with a coloured hue, blurred vision, visual disturbances, stuffy nose, dizziness.
Not common (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, inflammation of the nasal mucosa (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 tightness in the throat, numbness of the lips, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small specks or dots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discoloration of the sclera, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss or deafness.
Since the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important to note that in most, but not all, men who experienced these adverse effects, cardiac disorders were present before taking Sildenafil Medical Valley. It is not possible to determine whether these adverse effects were related to the use of Sildenafil Medical Valley.

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

5. How to store Sildenafil Medical Valley

This medicinal product should be kept out of the sight and reach of children.
No special precautions for storage of the medicinal product are required.
Do not use Sildenafil Medical Valley after the expiry date stated on the cardboard packaging and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Medical Valley contains

• The active substance is sildenafil. Each coated tablet contains 100 mg of sildenafil (as sildenafil citrate).
• Other ingredients are:
• Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica.
• Coating: hypromellose (type 2910), titanium dioxide (E 171), macrogol 6000, talc, indigo carmine aluminium lake (E 132).

What Sildenafil Medical Valley looks like and contents of the pack
Sildenafil Medical Valley 100 mg film-coated tablets are blue, elongated in shape, marked with "100".
Sildenafil Medical Valley 100 mg is supplied in blisters, in packs containing 4, 8 or 12 tablets.
Marketing Authorisation Holder:
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid
Spain
LABORATORIOS LICONSA, S.A.
Avenida Miralcampo, 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain
This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Silchemo 25/50/100 mg, Filmtabletten
Denmark: Sildenafil Medical Valley
Netherlands: Afilon 25/50/100 mg, Filmomhulde tablet
Iceland: Sildenafil Medical Valley 50/100 mg filmuhúðuð tafla
Poland: Sildenafil Medical Valley