SILDENAFIL 100 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Sildenafil Ranbaxy, 100 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Sildenafil Ranbaxy and what is it used for
4. Important information before taking Sildenafil Ranbaxy
   1. When not to take Sildenafil Ranbaxy
   2. Warnings and precautions
   3. Children and adolescents
   4. Sildenafil Ranbaxy and other medicines
   5. Sildenafil Ranbaxy with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Sildenafil Ranbaxy contains
5. How to take Sildenafil Ranbaxy
   1. Taking a higher dose of Sildenafil Ranbaxy than recommended
6. Possible side effects
   1. Serious side effects
   2. If you experience any of the following side effects, stop taking Sildenafil Ranbaxy and contact your doctor immediately:
   3. Other side effects:
   4. Reporting side effects
7. How to store Sildenafil Ranbaxy
8. Contents of the packaging and other information
   1. What Sildenafil Ranbaxy contains
   2. What Sildenafil Ranbaxy looks like and what the pack contains
   3. Marketing authorization holder and manufacturer:

Leaflet attached to the packaging: patient information

Sildenafil Ranbaxy, 100 mg, film-coated 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, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not mentioned in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Sildenafil Ranbaxy contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Ranbaxy helps achieve an erection only under the influence of sexual stimulation. Sildenafil Ranbaxy 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 Ranbaxy

When not to take Sildenafil Ranbaxy

• if you are allergic (hypersensitive) to sildenafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines called nitrates, as their simultaneous use may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any medicines from this group. These medicines are often used to relieve symptoms of angina pectoris (chest pain). In case of doubt, consult your doctor or pharmacist;
• if you are taking medicines that release nitric oxide, such as amyl nitrite (inhaled for recreational purposes), 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 secondary to blood clots). It has been shown that PDE5 inhibitors, such as Sildenafil Ranbaxy, enhance the hypotensive effect of this medicine. If you are taking riociguat or are unsure, tell your doctor;
• if you have severe heart or liver disease;
• if you have recently had a stroke, heart attack, or have low blood pressure;
• if you have a rare inherited eye disease (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 starting to take Sildenafil Ranbaxy, discuss it with your doctor, pharmacist, or nurse if you have:

• sickle-cell anemia (a red blood cell disorder), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer);
• penile deformity or Peyronie's disease;
• heart problems; in this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity;
• stomach ulcers or bleeding disorders (such as hemophilia);
• sudden vision loss or sudden loss of vision; stop taking Sildenafil Ranbaxy and contact your doctor immediately.

Sildenafil Ranbaxy should not be taken with other oral or topical medicines used to treat erectile dysfunction. Sildenafil Ranbaxy should not be taken with medicines for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors. The medicine should not be used in patients who have not been diagnosed with erectile dysfunction. Sildenafil Ranbaxy is not intended for use in women. Use in patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor. The doctor may decide to reduce the dose.

Children and adolescents

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

Sildenafil Ranbaxy and other medicines

Tell your doctor or pharmacist about all medicines you have taken recently or plan to take. Sildenafil Ranbaxy may interact with some medicines, especially those used to treat angina pectoris (chest pain). In a situation requiring emergency medical intervention, inform your doctor, pharmacist, or nurse about taking Sildenafil Ranbaxy and when it was taken. Do not take Sildenafil Ranbaxy with other medicines without your doctor's advice. Do not take Sildenafil Ranbaxy if you are taking medicines called nitrates, as their simultaneous use may cause a dangerous drop in blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any medicines from this group; they are often used to relieve symptoms of angina pectoris. Do not take Sildenafil Ranbaxy if you are taking products that release nitric oxide, such as amyl nitrite (inhaled for recreational purposes), as their simultaneous use may cause a dangerous drop in blood pressure. If you are already taking riociguat, tell your doctor or pharmacist. In patients taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with the lowest dose (25 mg) of a sildenafil-containing preparation. In patients taking medicines such as ketoconazole and itraconazole (used to treat fungal infections), erythromycin (an antibiotic), and cimetidine (used to treat stomach ulcers), your doctor may recommend starting with the lowest dose (25 mg) of a sildenafil-containing preparation. Sildenafil may interact with medicines used to lower high blood pressure in the blood vessels of the lungs (pulmonary hypertension), such as bosentan, and with medicines used to treat bacterial infections, such as rifampicin. In some patients who take alpha-adrenergic blocking agents for high blood pressure or enlarged prostate, dizziness or fainting may occur, which may be symptoms of low blood pressure. Such symptoms have occurred in some patients taking Sildenafil Ranbaxy and alpha-adrenergic blocking agents. It is most likely to happen within 4 hours of taking Sildenafil Ranbaxy. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocking agent before taking Sildenafil Ranbaxy. Your doctor may recommend taking a lower initial dose (25 mg) of a sildenafil-containing preparation. Inform your doctor or pharmacist if you are taking any medicines containing sacubitril/valsartan, which are used to treat heart failure.

Sildenafil Ranbaxy with food, drink, and alcohol

Sildenafil Ranbaxy can be taken with or without food. However, taking Sildenafil Ranbaxy during a heavy meal may delay the onset of the medicine's action. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the effect of the medicine, do not consume large amounts of alcohol before taking Sildenafil Ranbaxy.

Pregnancy, breastfeeding, and fertility

Sildenafil Ranbaxy is not indicated in women.

Driving and using machines

Sildenafil Ranbaxy may cause dizziness and vision disturbances. Before driving or operating machinery, patients should check how they react to the medicine.

Sildenafil Ranbaxy contains

Sildenafil Ranbaxy contains the dye cochineal red (E124), lac, which may cause allergic reactions.

3. How to take Sildenafil Ranbaxy

This medicine should always be taken exactly as advised by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended initial dose is 50 mg. Other medicines containing sildenafil in a dose of 50 mg are available on the market. Sildenafil Ranbaxy should not be taken more than once a day. Sildenafil Ranbaxy should be taken about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water. If you feel that the effect of Sildenafil Ranbaxy is too strong or too weak, consult your doctor or pharmacist. Sildenafil Ranbaxy allows for an erection only under the condition of sexual stimulation. The time after which the effect of the medicine occurs varies from patient to patient, but usually, it is between half an hour and one hour. The effect of Sildenafil Ranbaxy may occur later if taken during a heavy meal. Contact your doctor if, after taking Sildenafil Ranbaxy, you do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil Ranbaxy than recommended

The patient may experience more frequent side effects, and they 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 prescribed. In case of doubts about the use of the medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Sildenafil Ranbaxy can cause side effects, although not everybody gets them. Side effects reported in connection with the use of Sildenafil Ranbaxy are usually mild, moderate, and short-term.

Serious side effects

If you experience any of the following side effects, stop taking Sildenafil Ranbaxy and contact your doctor immediately:

• allergic reaction - occurs uncommonly(may occur in 1 in 100 people) symptoms: sudden wheezing, difficulty breathing, dizziness, swelling of the eyelids, face, lips, or throat;
• chest pain - occurs uncommonlyIf these symptoms occur during or after sexual intercourse, you should:
• take a half-sitting position and try to relax,
• not take nitrates to relieve chest pain;
• prolonged and sometimes painful erection - occurs rarely(may occur in 1 in 1000 people). If the erection lasts for more than 4 hours, contact your doctor immediately;
• sudden vision loss or loss of vision - occurs rarely;
• severe skin reactions - occur rarelysymptoms: intense peeling and swelling of the skin, blisters in the mouth, on the genitals, or around the eyes, fever;
• seizures or epileptic fits - occur rarely.

Other side effects:

Very common(occur in more than 1 in 10 people): headache.
Common(occur in less than 1 in 10 people): nausea, facial flushing, hot flushes (symptoms include a feeling of heat in the upper part of the body), indigestion, seeing a blue tinge on objects, blurred vision, disturbances in vision, stuffy nose, and dizziness.
Uncommon(occur in less than 1 in 100 people): vomiting, rash, conjunctival hyperemia and/or eye redness, eye pain, seeing flashes of light, increased sensitivity to light, excessive tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, decreased sensation of touch, dizziness, ringing in the ears, dry mouth, stuffy or congested sinuses, sinusitis (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot, and feeling tired.
Rare(occur in less than 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to a part of the brain, feeling of compression in the throat, numbness of the lips, bleeding in the back of the eye, eye irritation, myopia, eye pain, increased intraocular pressure, disturbances of the iris, eye disorders, 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, dilation of the pupil, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, sudden weakness or loss of hearing.

Reporting side effects

If you experience any side effects, including any not mentioned in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Ranbaxy

Keep the medicine out of the sight and reach of children. The medicinal product does not require special storage conditions. Do not use this medicine after the expiry date 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. This will help protect the environment.

6. Contents of the packaging and other information

What Sildenafil Ranbaxy contains

• The active substance of the medicine is sildenafil.

Each film-coated tablet of Sildenafil Ranbaxy contains 100 mg of sildenafil, in the form of sildenafil citrate.

• The other ingredients of the medicine are: the core of the tablet: microcrystalline cellulose, anhydrous calcium phosphate, sodium croscarmellose, magnesium stearate, the coating of the tablet: hypromellose, cochineal red (E124), lac, macrogol 400, titanium dioxide (E171), iron oxide red (E172), indigo carmine (E132), lac.

What Sildenafil Ranbaxy looks like and what the pack contains

Sildenafil Ranbaxy 100 mg film-coated tablets are red, triangular, and have a rounded shape, with the inscription "S23" on one side and a smooth surface on the other. The tablets are available in blister packs containing 4, 8, and 24 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder: Ranbaxy (Poland) Sp. z o.o. ul. Idzikowskiego 16 00-710 Warsaw tel. 22 642 07 75 Manufacturer: Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132JH Hoofddorp, Netherlands Terapia S.A. Str. Fabricii Nr 124 Cluj-Napoca 400 632 Romania Date of last revision of the leaflet:21.01.2025