Sildenafil medreg

Package leaflet: Information for the patient

Sildenafil Medreg, 100 mg, film-coated tablets
Sildenafilum
Please read this leaflet carefully before taking the 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 doubts, please consult your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents:

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

Sildenafil Medreg contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Sildenafil Medreg works by helping to relax blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Medreg helps to achieve an erection only if there is prior sexual stimulation.
Sildenafil Medreg is used to treat erectile dysfunction in adult men, also known as impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil Medreg

When not to use Sildenafil Medreg:

• 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 lead to a dangerous drop in blood pressure. The patient should inform the doctor if they are taking any medicines from this group; these drugs are often used to relieve symptoms of angina (chest pain). In case of doubt, consult a doctor or pharmacist.

• If the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called poppers), because their simultaneous use may also cause dangerous lowering of blood pressure.

• If the patient is 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). Inhibitors of PDE5, such as Sildenafil Medreg, have been shown to intensify the hypotensive effect of riociguat. If the patient is taking riociguat or is unsure whether they are taking it, 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 hereditary degenerative retinal disorders, such as 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 Medreg, discuss the following with your doctor or pharmacist:

• 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 anatomical deformity of the penis or Peyronie's disease;
• if the patient has heart problems. In such cases, 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 bleeding disorders (such as hemophilia);
• if sudden worsening of vision or sudden vision loss occurs, the patient should stop taking the medicine immediately and contact a doctor without delay.

Sildenafil Medreg must not be used together with other oral or topical treatments for erectile dysfunction.
Sildenafil Medreg must not be used together with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Sildenafil Medreg should not be used in patients in whom erectile dysfunction has not been diagnosed.
Sildenafil Medreg is not intended for use in women.

Use of Sildenafil Medreg 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.

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

Sildenafil Medreg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Sildenafil Medreg may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates, inform the doctor or pharmacist about taking Sildenafil Medreg. Do not take Sildenafil Medreg together with other medicines without medical advice.
Do not use Sildenafil Medreg if the patient is taking nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates used to treat angina (chest pain).
Do not use Sildenafil Medreg if the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called poppers), as their concomitant use may also lead to dangerous lowering of blood pressure.
If the patient is already taking riociguat, they should inform their doctor or pharmacist.
In patients taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with the lowest dose (25 mg).
In some patients taking alpha-adrenergic blocking agents for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of orthostatic hypotension—low blood pressure upon rapid standing or sitting up. Such symptoms have been reported in some patients taking Sildenafil Medreg together with alpha-adrenergic blocking agents. This is most likely within 4 hours after taking Sildenafil Medreg. To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-adrenergic blocking agent before starting treatment with Sildenafil Medreg. The doctor may decide to use a lower starting dose (25 mg).
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Sildenafil Medreg with food, drink, and alcohol
Sildenafil Medreg can be taken with or without food. However, taking Sildenafil Medreg with a heavy meal may delay the onset of the drug's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic benefit of the medicine, significant amounts of alcohol should not be consumed before taking Sildenafil Medreg.

Pregnancy, breastfeeding, and fertility
Sildenafil Medreg is not intended for use in women.

Driving and operating machinery
Sildenafil Medreg may cause dizziness and visual disturbances. Patients should be aware of how they react to the medicine before driving or operating machinery.

Sodium content of Sildenafil Medreg
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free."

3. How to take Sildenafil Medreg

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended starting dose is 50 mg.
Sildenafil Medreg should not be taken more than once a day.
Do not take Sildenafil Medreg tablets in combination with another sildenafil product in the form of orally disintegrating 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, consult your doctor or pharmacist.
Sildenafil Medreg enables an erection only in the presence of sexual stimulation.
The time to onset of effect 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 Medreg, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
The tablet may be divided in half to obtain a 50 mg dose. To take a 25 mg dose, a different medicine should be used.
Taking a higher than recommended dose of Sildenafil Medreg
Unwanted 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 will experience them.
Adverse effects reported with Sildenafil Medreg are usually mild or moderate in intensity and transient.
If any of the following adverse effects occur, stop taking Sildenafil Medreg and seek immediate medical help:

• Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms: sudden wheezing, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly. If it occurs during or after sexual intercourse:
  • adopt a semi-sitting position and try to relax,
  • do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erection – occurs rarely (may affect up to 1 in 1,000 people). If erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely.

Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, genital organs and around the eyes, fever.

• Seizures or convulsions – occur rarely.

Other adverse effects:
Very common (may affect more than 1 in 10 patients):

• Headache.

Common (may affect up to 1 in 10 patients):

• Nausea, sudden flushing of the face, hot flushes (symptoms include sudden feeling of warmth in the upper part of the body), indigestion, seeing coloured halos, blurred vision), visual disturbances, stuffy nose, dizziness.

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

• Vomiting, skin rash, eye irritation, eye hyperaemia, eye pain, seeing flashes of light, transient sensations of bright light, 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, dryness of the mouth, sensation of blockage or blocked sinuses, nasal mucosal inflammation (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastroesophageal reflux (symptoms include heartburn), presence of blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling of fatigue.

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

• Fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to certain parts of the brain, sensation of tightness in the throat, numbness of the lips, bleeding behind the eye, double vision, reduced visual acuity, sensory disturbances in the eye, swelling of the eye or eyelid, small particles or spots in the visual field, seeing halos around lights, pupil dilation, discoloration of the white part of the eye, penile bleeding, presence of blood in semen, dry nose, swelling inside the nose, irritability, and sudden decrease in hearing or hearing loss.

Since market introduction, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that in most, but not all, men who experienced these adverse effects, cardiac disorders were present before taking this medicine. It is not possible to determine whether these adverse effects were related to the use of Sildenafil Medreg.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sildenafil Medreg

Keep this medicine out of sight and reach of children.
No special precautions for storage of the medicinal product.
Do not use this medicine after the expiry date stated on the packaging. 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 what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• Tablet coating: Opadry II Blue 85F505164 (polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, indigo carmine, shellac (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, embossed with “126” on one side and “J” on the other.
Pack sizes:
1, 2, 4, 8, 10, 12, 20, 24, 28 or 90 film-coated tablets in PVC/Aluminum or PVC/PVDC/Aluminum blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Sildenafil Medreg
Czech Republic: Sildenafil Medreg
Romania: Sildenafil Gemax Pharma 100 mg comprimate filmate
Slovakia: Sildenafil Medreg 100 mg filmom obalené tablety
Italy: Sildenafil Medreg