SILDENAFIL 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Sildenafil Medical Valley, 100 mg, Film-Coated Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
3. What is Sildenafil Medical Valley and what is it used for
4. Important information before taking Sildenafil Medical Valley
   1. When not to take Sildenafil Medical Valley:
   2. Warnings and precautions
   3. Children and adolescents
   4. Sildenafil Medical Valley and other medications
   5. Sildenafil Medical Valley with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to take Sildenafil Medical Valley
   1. Taking a higher dose of Sildenafil Medical Valley than recommended
6. Possible side effects
   1. In case of any of the following side effects, the patient should stop taking Sildenafil Medical Valley and seek medical help immediately:
   2. Other side effects:
   3. Reporting side effects
7. How to store Sildenafil Medical Valley
8. Contents of the pack and other information
   1. What Sildenafil Medical Valley contains
   2. What Sildenafil Medical Valley looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Sildenafil Medical Valley, 100 mg, Film-Coated Tablets

Sildenafil

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept for future reference, in case it needs to be read again.
• In case of any further doubts, the patient should consult a doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

Sildenafil Medical Valley contains the active substance sildenafil, which belongs to a group of phosphodiesterase type 5 inhibitors. The medication works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Medical Valley helps achieve an erection only if there is sexual stimulation. Sildenafil Medical Valley is used to treat erectile dysfunction in adult men, also known as impotence. This is the inability to achieve or maintain an erection of the penis sufficient for sexual intercourse.

2. Important information before taking Sildenafil Medical Valley

When not to take Sildenafil Medical Valley:

• -If the patient is allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).
• If the patient is taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medications from this group; these medications are often used to relieve symptoms of angina pectoris (chest pain). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is taking medications that release nitric oxide, such as amyl nitrite (so-called poppers; nitrites used recreationally by inhalation), as their concurrent use may also cause a dangerous decrease in blood pressure.
• if the patient is taking riociguat. This medication 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 Sildenafil Medical Valley, enhance the blood pressure-lowering effect of this medication. If the patient is taking riociguat or is unsure, they should inform their doctor.

blood pressure. 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 hereditary eye disorders (retinitis pigmentosa).
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Sildenafil Medical Valley, the patient should discuss it with their doctor, pharmacist, or nurse.

• 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 physical deformity of the penis or Peyronie's disease.
• If the patient has heart problems. The doctor should assess whether the patient's heart condition allows for the extra strain associated with sexual activity.
• If the patient has stomach ulcers or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden hearing loss, they should stop taking Sildenafil Medical Valley and contact their doctor immediately.

Sildenafil Medical Valley should not be taken with other oral or topical treatments for erectile dysfunction. Sildenafil Medical Valley should not be taken with therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Sildenafil Medical Valley should not be taken if erectile dysfunction has not been diagnosed. Sildenafil Medical Valley should not be taken by women. Special precautions for patients with kidney or liver function disordersPatients with kidney or liver function disorders should inform their doctor, who may decide to administer a lower dose of the medication. The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Children and adolescents

Sildenafil Medical Valley should not be taken by persons under 18 years of age.

Sildenafil Medical Valley and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Sildenafil Medical Valley may interact with some medications, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Sildenafil Medical Valley and the time it was taken. The patient should not take Sildenafil Medical Valley with other medications without their doctor's advice. The patient should not take Sildenafil Medical Valley if they are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina pectoris (chest pain). The patient should not take Sildenafil Medical Valley if they are taking medications that release nitric oxide, such as amyl nitrite (so-called poppers), as their concurrent use may also cause a dangerous decrease in 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, their doctor may recommend starting with the lowest dose (25 mg) of Sildenafil Medical Valley. In some patients taking alpha-blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur when standing up or sitting down quickly, which may be symptoms of low blood pressure. Such symptoms have occurred in some patients taking sildenafil and alpha-blockers. Their occurrence is most likely within 4 hours of taking sildenafil. To reduce the likelihood of these symptoms, the patient should regularly take their fixed dose of alpha-blocker before starting Sildenafil Medical Valley. The doctor may decide to use a lower initial dose (25 mg) of Sildenafil Medical Valley. The patient should inform their doctor or pharmacist if they are taking medications containing sacubitril with valsartan, used to treat 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 during a large meal may prolong the time it takes for the medication to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Sildenafil Medical Valley, the patient should not consume significant amounts of alcohol before taking the medication.

Pregnancy, breastfeeding, and fertility

Sildenafil Medical Valley should not be taken by women.

Driving and using machines

Sildenafil Medical Valley may cause dizziness and vision disturbances. Before driving or operating machinery, the patient should be aware of how they react to Sildenafil Medical Valley.

3. How to take Sildenafil Medical Valley

This medication should always be taken exactly as advised by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. The usual starting dose is 50 mg. Sildenafil Medical Valley should 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 the patient feels that the effect of Sildenafil Medical Valley is too strong or too weak, they should consult their doctor or pharmacist. Sildenafil Medical Valley allows an erection only if there is sexual stimulation. The time it takes for Sildenafil Medical Valley to work varies from person to person, but it usually takes between half an hour to one hour. The effect may occur later if the medication is taken after a large meal. The patient should consult their doctor if, after taking Sildenafil Medical Valley, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil Medical Valley than recommended

Side effects may occur more frequently and may be more severe. Taking a dose higher than 100 mg does not increase the efficacy of the medication. The patient should not take more tablets than prescribed by their doctor.The patient should consult their doctor if they have taken more tablets than recommended. In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Sildenafil Medical Valley can cause side effects, although not everybody gets them. Side effects reported in association with sildenafil are usually mild or moderate and short-lived.

In case of any of the following side effects, the patient should stop taking Sildenafil Medical Valley and seek medical help immediately:

• 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 uncommonlyIf it occurs during or after sexual intercourse, the patient:
• Should sit half-up and try to relax;
• Should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in up to 1 in 1000 people) If an erection lasts more than 4 hours, the patient should seek medical help immediately.
• Sudden vision loss or hearing loss - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs 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 feeling of heat in the upper body), indigestion, seeing with a blue tint, blurred vision, visual disturbances, 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, eye discomfort, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensitivity to touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal congestion (symptoms include a cold, sneezing, and a 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) include: fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to part of the brain, feeling of tightness in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing. After the medication 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 side effects, heart function disorders existed before taking the medication. It is not possible to determine whether these side effects were related to the use of Sildenafil Medical Valley.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Sildenafil Medical Valley

This medication should be stored out of sight and reach of children. There are no special precautions for the storage of the medicinal product. Sildenafil Medical Valley should not be taken 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. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Medical Valley contains

• The active substance of the medication is sildenafil. Each film-coated tablet contains 100 mg of sildenafil (as sildenafil citrate).
• Other ingredients of the medication are:
• Core: microcrystalline cellulose, calcium phosphate anhydrous, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica.
• Coating: hypromellose (type 2910), titanium dioxide (E 171), macrogol 6000, talc, and indigo carmine aluminum 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, and marked with "100". Sildenafil Medical Valley 100 mg is supplied in blisters, in packs containing 4, 8, or 12 tablets.

Marketing authorization 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 authorized in the Member States of the European Economic Area 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 Date of last revision of the leaflet:21.05.2023