Sildenafil Sandoz

Leaflet attached to the packaging: patient information

Sildenafil Sandoz, 100 mg, tablets

Sildenafil

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you and should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Sildenafil Sandoz contains the active substance sildenafil, which belongs to a group of so-called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by supporting the relaxation of blood vessels in the penis, which allows for increased blood flow to the penis during sexual arousal. Sildenafil Sandoz helps achieve an erection only if there is prior sexual stimulation. Sildenafil Sandoz is used to treat erectile dysfunction in adult men, i.e., impotence defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil Sandoz

When not to take Sildenafil Sandoz

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 concurrent use may cause potentially dangerous lowering of blood pressure. The patient should inform their doctor about taking any of these medicines, which are often used to alleviate symptoms of angina pectoris (chest pain). In case of doubt, consult a doctor or pharmacist. if the patient is taking any medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their concurrent use may also cause dangerous lowering of blood pressure; if the patient is taking riociguat - 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). It has been shown that PDE5 inhibitors, such as Sildenafil Sandoz, 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 if they have low blood pressure; if the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa; if the patient has ever had vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting treatment with Sildenafil Sandoz, the patient should discuss it with their doctor, pharmacist, or nurse if they have: sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer); penile deformation or Peyronie's disease; heart rhythm disorders. The doctor should assess whether the patient's heart condition allows for additional exertion associated with sexual activity. stomach ulcers or bleeding disorders (such as hemophilia). If sudden vision loss or sudden vision deterioration occurs, the patient should stop taking Sildenafil Sandoz and immediately consult their doctor. Sildenafil Sandoz should not be taken concurrently with other oral or topical erectile dysfunction therapies. Sildenafil Sandoz should not be taken with medicines used to treat pulmonary hypertension that contain sildenafil or other PDE5 inhibitors. Sildenafil Sandoz should not be used in the absence of erectile dysfunction. Sildenafil Sandoz is not intended for women. Special considerations for use in patients with renal or hepatic impairment Patients with renal or hepatic impairment should inform their doctor, who may decide to use a lower dose of Sildenafil Sandoz.

Children and adolescents

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

Sildenafil Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those they plan to take. Sildenafil Sandoz tablets may interact with some medicines, especially those used to treat chest pain. In case of a medical emergency, the patient should inform their doctor, pharmacist, or nurse about taking Sildenafil Sandoz and specify the time of its administration. Sildenafil Sandoz should not be taken concurrently with other medicines without the doctor's consent. The patient should not take Sildenafil Sandoz if they are taking nitrate medicines, as this combination may cause a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse about taking these medicines, which are often used to alleviate symptoms of angina pectoris (or "chest pain"). The patient should not take Sildenafil Sandoz if they are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as this combination may cause a dangerous decrease in blood pressure. If the patient is already taking riociguat, they should inform their doctor or pharmacist. In patients taking protease inhibitors used to treat HIV infections, the doctor may decide to use the lowest initial dose of Sildenafil Sandoz (25 mg). In some individuals taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur due to decreased blood pressure when standing up quickly. Such symptoms occurred in some individuals taking Sildenafil Sandoz and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Sildenafil Sandoz. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting treatment with Sildenafil Sandoz. The doctor may decide to use an initial dose of 25 mg of Sildenafil Sandoz. The patient should tell their doctor or pharmacist about all other medicines they are currently taking, have recently taken, or may take, including those containing sacubitril/valsartan, used to treat heart failure.

Using Sildenafil Sandoz with food, drink, and alcohol

Sildenafil Sandoz can be taken with or without food, but taking the medicine with a large meal may prolong the time to the start of its action. Alcohol may temporarily impair the ability to achieve an erection. To maximize the therapeutic benefits of Sildenafil Sandoz, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil Sandoz is not intended for use in women.

Driving and using machines

Sildenafil Sandoz may cause dizziness and visual disturbances. Before driving vehicles or operating machinery, the patient should determine how Sildenafil Sandoz affects them.

Sildenafil Sandoz contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially "sodium-free".

3. How to take Sildenafil Sandoz

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The recommended initial dose is 50 mg. Sildenafil Sandoz should not be taken more than once a day.The patient should not take Sildenafil Sandoz tablets with medicines containing sildenafil that dissolve in the mouth. The patient should take a Sildenafil Sandoz tablet about an hour before planned sexual activity. The tablet should be swallowed without chewing or crushing, with a glass of water. The tablet can be divided into four equal doses. Dividing tablets The patient should place the tablet on a hard, flat surface with the break line facing up. Press the thumb in the middle of the tablet, and it will break into four equal doses. If the patient feels that the effect of Sildenafil Sandoz is too strong or too weak, they should consult their doctor or pharmacist. Sildenafil Sandoz allows for an erection only if there is prior sexual stimulation. The time it takes for Sildenafil Sandoz to start working varies from person to person but usually ranges from half an hour to one hour. The effect may occur later if the medicine is taken with a large meal. If the patient does not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking Sildenafil Sandoz, they should inform their doctor.

Taking a higher dose of Sildenafil Sandoz than recommended

It is possible to increase the frequency and severity of side effects. Taking a dose higher than 100 mg does not increase the efficacy of the medicine. The patient should not take more tablets than prescribed by their doctor.If the patient has taken more tablets than prescribed, they should contact their doctor. In case of further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Sildenafil Sandoz can cause side effects, although not everybody gets them. Side effects associated with Sildenafil Sandoz are usually mild to moderate and short-lived.

In case of any of the following serious side effects, the patient should stop taking Sildenafil Sandoz and seek immediate medical attention.

Allergic reaction - occurs uncommonly(may occur less frequently than in 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 up and try to relax, they should not take nitratesto alleviate chest pain under any circumstances.

• the patient should sit up and try to relax,
• they should not take nitratesto alleviate chest pain under any circumstances.

Prolonged and sometimes painful erection - occurs rarely(may occur less frequently than in 1 in 1000 people). If the erection lasts for more than 4 hours, the patient should seek immediate medical attention. Sudden vision loss or deterioration - occurs rarelySevere skin reactions - occur rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, genitals, and around the eyes, fever. Seizures or convulsions - occur rarely.

Other side effects

Very common(may occur more frequently than in 1 in 10 people) headache. Common(may occur less frequently than in 1 in 10 people) nausea, sudden flushing, hot flushes (a sudden feeling of heat in the upper body), indigestion, seeing a blue tint on objects, blurred vision, visual disturbances, feeling of a blocked nose, dizziness. Uncommon(may occur less frequently than in 1 in 100 people) vomiting, skin rash, eye irritation, eye discoloration, eye pain, seeing flashes of light, sensitivity to light, tearing, palpitations, rapid heartbeat, high or low blood pressure, muscle pain, drowsiness, decreased sense of touch, balance disorders, ringing in the ears, dry mouth, feeling of "stuffy" sinuses, nasal congestion (with symptoms such as runny nose, sneezing, and "stuffy" nose), abdominal pain, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of heat, feeling of fatigue. Rare(may occur less frequently than in 1 in 1000 people) fainting, stroke, heart attack, irregular heartbeat, temporary reduction of blood flow to parts of the brain, feeling of pressure in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye swelling or eyelid swelling, seeing dots or spots, seeing halos around light sources, dilated pupils, discoloration of the whites of the eyes, penile bleeding, blood in semen, dry nose, nasal congestion, irritation, sudden hearing loss or loss of hearing.

Reporting side effects

If the patient experiences any side effects, including any side effects 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 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. 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 medicine.

5. How to store Sildenafil Sandoz

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. Sildenafil Sandoz should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Sandoz contains

The active substance of Sildenafil Sandoz is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate). The other ingredients of the medicine are: calcium phosphate anhydrous, microcrystalline cellulose, copovidone, croscarmellose sodium, magnesium stearate, sodium saccharin, indigo carmine (E132), aluminum lake.

What Sildenafil Sandoz looks like and contents of the pack

Sildenafil Sandoz 100 mg is a blue, round, slightly speckled tablet with a cross-breaking line on both sides and the symbol "100" embossed on one side. The medicine is available in blisters of 1, 2, 4, 8, or 12 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder: Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer: Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Lek Pharmaceuticals d.d. Trimlini 2D 9220 Lendava, Slovenia Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany S.C. Sandoz, S.R.L. 7A Livezeni Street 540472 Targu Mures, Jud. Mures, Romania Lek S.A. ul. Domaniewska 50 C 02-672 Warsaw

To obtain more detailed information about the medicine and its names in other EU member states, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 48 22 209 70 00

Date of last revision of the leaflet: 08/2022

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