Sildenafil Medreg

Package Leaflet: Information for the Patient

Sildenafil Medreg, 100 mg, Film-Coated Tablets

Sildenafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet:

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

1. What is Sildenafil Medreg and what is it used for

Sildenafil Medreg contains the active substance sildenafil, which belongs to a group of phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Medreg helps to achieve an erection, only if you are sexually aroused.

Sildenafil Medreg is used to treat erectile dysfunction in adult men, also known as impotence. This occurs when a man cannot get or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil Medreg

When not to take Sildenafil Medreg:

• 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 their simultaneous use may lead to a dangerous drop in blood pressure. Tell your doctor if you are taking any of these medicines, as they are often used to relieve angina pectoris (chest pain). If in doubt, consult your doctor or pharmacist.
• If you are taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their simultaneous use may also cause a dangerous drop in blood pressure.
• If you are taking riociguat. This medicine is used to treat pulmonary arterial 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 blocking the pulmonary artery and/or its branches). It has been shown that PDE5 inhibitors, such as Sildenafil Medreg, enhance the hypotensive effect of this medicine. If you are taking riociguat or are unsure if you are taking it, tell your doctor.

PDE5 inhibitors, such as Sildenafil Medreg, may increase the hypotensive effect of riociguat. If you are taking riociguat or are unsure if you are taking it, tell your doctor.

• If you have severe heart or liver disease.
• If you have recently had a stroke or heart attack, and in cases of low blood pressure.
• If you have hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before taking Sildenafil Medreg, discuss it with your doctor or pharmacist:

• if you have sickle cell anemia (a condition that affects red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow);
• if you have a physical deformity of the penis or Peyronie's disease;
• if you have heart problems. In this case, your doctor should assess whether your heart is healthy enough for extra strain, such as sexual activity;
• if you have stomach ulcers or bleeding disorders (such as hemophilia);
• if you experience sudden vision loss or sudden hearing loss, stop taking the medicine and contact your doctor immediately.

Do not take Sildenafil Medreg with other oral or topical treatments for erectile dysfunction.

Do not take Sildenafil Medreg with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or other PDE5 inhibitors.

Sildenafil Medreg should not be used by patients who have not been diagnosed with erectile dysfunction.

Sildenafil Medreg is not intended for use by women.

Use of Sildenafil Medreg in patients with kidney or liver problems

Patients with kidney or liver problems should inform their doctor. The doctor may decide to prescribe a lower dose of the medicine.

Children and adolescents

Sildenafil Medreg should not be used in persons under 18 years of age.

Sildenafil Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Sildenafil Medreg may interact with some medicines, especially those used to treat chest pain. If your condition gets worse, tell your doctor or pharmacist that you are taking Sildenafil Medreg. Do not take Sildenafil Medreg with other medicines without your doctor's advice.

Do not take Sildenafil Medreg if you are taking nitrates, as their simultaneous use may lead to a dangerous drop in blood pressure.

Always tell your doctor, pharmacist, or nurse if you are taking nitrates, which are used to treat angina pectoris (chest pain).

Do not take Sildenafil Medreg if you are taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their simultaneous use may also lead to a dangerous drop in blood pressure.

If you are already taking riociguat, tell your doctor or pharmacist.

When taking protease inhibitors for the treatment of HIV infection, it is recommended to start with the lowest dose (25 mg).

In some patients taking alpha-blockers for high blood pressure or prostate enlargement, dizziness or fainting may occur, which can be symptoms of orthostatic hypotension, a drop in blood pressure when standing up or sitting quickly. Such symptoms have occurred in some patients taking Sildenafil Medreg and alpha-blockers. This is most likely to happen within 4 hours of taking Sildenafil Medreg. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-blocker before starting treatment with Sildenafil Medreg. The doctor may decide to use a lower starting dose (25 mg).

Tell your doctor or pharmacist about taking medicines containing sacubitril with valsartan, used to treat heart failure.

Sildenafil Medreg with food, drink, and alcohol

Sildenafil Medreg can be taken with or without food.

Although taking Sildenafil Medreg 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 therapeutic effects of the medicine, do not consume large amounts of alcohol before taking Sildenafil Medreg.

Pregnancy, breastfeeding, and fertility

Sildenafil Medreg is not intended for use by women.

Driving and using machines

Sildenafil Medreg may cause dizziness and impaired vision. Before driving or operating machinery, patients should be aware of how they react to the medicine.

Sildenafil Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means it is essentially 'sodium-free'.

3. How to take Sildenafil Medreg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended starting dose is 50 mg.

Do not take Sildenafil Medreg more than once a day.

Do not take Sildenafil Medreg in the form of film-coated tablets in combination with another sildenafil in the form of orodispersible tablets.

Sildenafil Medreg 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 Medreg is too strong or too weak, talk to your doctor or pharmacist.

Sildenafil Medreg will only help you to achieve an erection if you are sexually stimulated.

The time it takes for Sildenafil Medreg to start working varies from person to person, but it usually takes between half an hour to one hour. The effect may occur later if you take the medicine after a large meal.

Consult your doctor if, after taking Sildenafil Medreg, you do not get an erection or if the erection is not sufficient for sexual intercourse.

The tablet can be split into two to obtain a 50 mg dose. To take a 25 mg dose, use a different medicine.

Taking a higher dose of Sildenafil Medreg than recommended

In this case, the patient may experience more frequent side effects, and they may be more intense. Taking a dose higher than 100 mg does not increase the efficacy of the medicine.

Do not take more tablets than your doctor prescribes.

Consult your doctor if you have taken more tablets than prescribed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Medreg can cause side effects, although not everybody gets them.

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

If you experience any of the following side effects, stop taking Sildenafil Medreg and seek medical help immediately:

• An allergic reaction occurs uncommonly(may affect up to 1 in 100 people) Symptoms: 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:
• take a semi-sitting position and try to relax,
• do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1,000 people) If an erection lasts for more than 4 hours, seek medical help immediately.
• Sudden loss of vision - 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 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 sudden feeling of heat in the upper body), indigestion, color tinge to vision, blurred vision, stuffy nose, dizziness.

Uncommon(may affect up to 1 in 100 people):

• Vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing light flashes, temporary disturbance in color vision, increased sensitivity to light, lacrimation, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, somnolence, decreased tactile sensitivity, dizziness, ringing in the ears, dry mouth, feeling of 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 of warmth, and feeling of tiredness.

Rare(may affect up to 1 in 1,000 people):

• Fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, double vision, reduced sharpness of vision, disturbance in vision, swelling of the eye or eyelid, small particles or spots in the field of vision, seeing halos around lights, dilation of the pupil, discoloration of the white of the eye, bleeding from the penis, blood in semen, dry nose, swelling of the inside of the nose, irritability, and sudden decrease in hearing or loss of hearing.

After the medicine has been on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is worth noting that in most, but not all men who experienced these side effects, heart disease was present before taking this medicine. It is not possible to determine whether these side effects were related to the use of Sildenafil Medreg.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

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 Sildenafil Medreg

Keep this medicine out of the sight and reach of children.

No special precautions for storage are necessary.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that 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 will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Medreg contains

The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

The other ingredients are:

• Tablet core: microcrystalline cellulose, calcium phosphate anhydrous, sodium croscarmellose, magnesium stearate.
• Tablet coating: Opadry II Blue 85F505164 (polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, indigo carmine, lake (E 132)) and Opadry Clear 02K19253 (hypromellose 5 cp, triacetin).

What Sildenafil Medreg looks like and contents of the pack

Blue, round, biconvex film-coated tablets with a dividing line, with "126" embossed on one side and "J" on the other side.

Pack sizes:

1, 2, 4, 8, 10, 12, 20, 24, 28, or 90 film-coated tablets in PVC/Aluminum or PVC/PVDC/Aluminum blisters, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Medreg s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

tel.: (+420) 516 770 199

Manufacturer:

Medis International a.s.

Průmyslová 961/16

747 23 Bolatice

Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:

Sildenafil Medreg

Czech Republic:

Sildenafil Medreg

Romania:

Sildenafil Gemax Pharma 100 mg film-coated tablets

Slovakia:

Sildenafil Medreg 100 mg film-coated tablets

Date of last revision of the leaflet: