Sildenafil ranbaxy

Patient Information Leaflet

Sildenafil Ranbaxy, 100 mg, film-coated tablets
Sildenafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet Contents

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

1. What Sildenafil Ranbaxy is and what it is 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 blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Ranbaxy helps achieve an erection only in the presence of sexual stimulation.
Sildenafil Ranbaxy is used to treat erectile dysfunction in adult men, that is, impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Sildenafil Ranbaxy

When not to use Sildenafil Ranbaxy

• if the patient is allergic (hypersensitive) to sildenafil or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking medicines called nitrates, because their concomitant use may cause dangerous lowering of blood pressure. The doctor should be informed if the patient is taking any medicines from this group. These medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist;
• if the patient is taking nitric oxide-releasing medicines, e.g. amyl nitrite (inhaled for recreational purposes), because their concomitant 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 secondary to blood clots). PDE5 inhibitors such as Sildenafil Ranbaxy have been shown to potentiate the hypotensive 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, heart attack, or has low blood pressure;
• if the patient has a rare inherited eye disease (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 Ranbaxy, discuss this with a doctor, pharmacist, or nurse 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);
• anatomical deformation of the penis or Peyronie's disease;
• heart problems; in this case, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity;
• peptic ulcer disease or bleeding disorders (such as hemophilia);
• sudden decrease in vision or sudden vision loss; treatment with Sildenafil Ranbaxy should be stopped immediately and the patient should contact a doctor without delay.

Sildenafil Ranbaxy must not be used concomitantly with other oral or topical medicines used to treat erectile dysfunction.
Sildenafil Ranbaxy must not be used concomitantly with medicines for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
Sildenafil Ranbaxy should not be used in patients in whom erectile dysfunction has not been diagnosed.
Sildenafil Ranbaxy is not intended for use in women.

Use in patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to reduce the dose.

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

Sildenafil Ranbaxy and other medicines
Tell your doctor or pharmacist about all medicines the patient has recently taken, as well as any medicines the patient plans to take.
Sildenafil Ranbaxy may interact with certain medicines, especially those used to treat angina (chest pain). In an emergency requiring immediate medical intervention, inform the doctor, pharmacist, or nurse that Sildenafil Ranbaxy has been taken and when it was taken. Do not take Sildenafil Ranbaxy together with other medicines without a doctor's recommendation.
Do not take Sildenafil Ranbaxy if the patient is using medicines called nitrates, because their concomitant use may cause dangerous lowering of blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking any medicines from this group; they are often used to relieve symptoms of angina.
Do not take Sildenafil Ranbaxy if the patient is using nitric oxide-releasing products, e.g. amyl nitrite (inhaled for recreational purposes), because their concomitant use may cause 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) of sildenafil-containing preparations.
In patients taking medicines such as ketoconazole and itraconazole (used to treat fungal infections), erythromycin (an antibiotic), or cimetidine (used to treat peptic ulcers), the doctor may recommend starting with the lowest dose (25 mg) of sildenafil-containing preparations.
Sildenafil may interact with medicines used to lower high blood pressure in the pulmonary blood vessels (pulmonary hypertension), e.g. bosentan, and with medicines used to treat bacterial infections, e.g. rifampicin.
In some patients who are taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or feeling faint—symptoms that may indicate a drop in blood pressure—may occur when quickly sitting or standing up. Such symptoms have occurred in some patients taking Sildenafil Ranbaxy together with alpha-blockers. This is most likely within 4 hours after taking Sildenafil Ranbaxy. To reduce the risk of these symptoms, the patient should be on a stable dose regimen of alpha-blockers before using Sildenafil Ranbaxy. The doctor may recommend starting with a lower initial dose (25 mg) of sildenafil-containing preparations.
Inform the doctor or pharmacist if the patient is taking any medicines containing sacubitril/valsartan, which are used in the treatment of heart failure.

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

Pregnancy, breastfeeding, and fertility
Sildenafil Ranbaxy is not indicated for use in women.

Driving and operating machinery
Sildenafil Ranbaxy may cause dizziness and visual disturbances. Patients should assess how they react to the medicine before driving or operating machinery.

Sildenafil Ranbaxy contains cochineal carmine (E124), lac
Sildenafil Ranbaxy contains the colouring agent cochineal carmine (E124), lac, which may cause allergic reactions.

3. How to use Sildenafil Ranbaxy

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg. Other medicines containing sildenafil in a 50 mg dose are available on the market.
Sildenafil Ranbaxy must not be taken more than once a day.
Sildenafil Ranbaxy should be taken approximately one hour before planned sexual activity. Swallow the tablet 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 enables an erection to be achieved only in the presence of sexual stimulation.
The time it takes for the medicine to work varies between individuals, but usually ranges from half an hour to one hour. The effect of Sildenafil Ranbaxy may occur later if taken with a heavy meal.
Contact your doctor if, after taking Sildenafil Ranbaxy, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil Ranbaxy
Adverse 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 doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects reported with the use of Sildenafil Ranbaxy are usually
mild, moderate and transient.
Serious adverse effects
If any of the following adverse effects occur, stop taking Sildenafil Ranbaxy and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (may occur in 1 out of 100 people); symptoms: sudden wheezing, difficulty breathing, dizziness, swelling of the eyelids, face, lips or throat;
• Chest pain – occurs uncommonly. If these symptoms occur during or after sexual intercourse, you should:
• Sit half-upright and try to relax,
• Do not take nitrates to relieve chest pain;
• Prolonged and sometimes painful erection – occurs rarely (may occur in 1 out of 1000 people). If erection lasts more than 4 hours, contact your doctor immediately;
• Sudden decrease or loss of vision – occurs rarely;
• Severe skin reactions – occur rarely; symptoms: severe peeling and swelling of the skin, appearance of blisters in the mouth, on the genitals or around the eyes, fever;
• Seizures or epileptic fits – occur rarely.

Other adverse effects:
Very common (occur in more than 1 out of 10 people): headache.
Common (occur in less than 1 out of 10 people): nausea, facial flushing, hot flushes (these symptoms include a feeling of warmth in the upper part of the body), dyspepsia, coloured vision, blurred vision, visual disturbances, stuffy nose, and dizziness.
Uncommon (occur in less than 1 out of 100 people): vomiting, rash, conjunctival congestion and/or redness, eye pain, seeing flashes of light, bright vision, light sensitivity, excessive tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus, dry mouth, stuffy or blocked sinuses, nasal mucositis (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, feeling of warmth, and feeling of fatigue.
Rare (occur in less than 1 out of 1000 people): fainting, stroke, myocardial infarction, irregular heartbeat, transient reduction in blood flow to part of the brain, sensation of tightness in the throat, lip numbness, bleeding into the back of the eye, eye irritation, myopia, eye pain, increased intraocular pressure, iris disorders, eye disorders, double vision, decreased visual acuity, abnormal sensations inside 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 sclera, penile bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, sudden hearing loss or deafness.
Since the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. Importantly, in most, but not all, men who experienced these adverse effects, cardiac disorders had already occurred before taking Sildenafil Ranbaxy. It is not possible to determine whether these adverse effects were directly related to the use of Sildenafil Ranbaxy.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
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 Ranbaxy

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this 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 how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Ranbaxy contains

• The active substance is sildenafil.

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

• Other ingredients are:
  For the tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
  For the tablet coating: hypromellose, carmine red (E124), lacquer, polyethylene glycol 400, titanium dioxide (E171), iron oxide red (E172), indigo carmine (E132), lacquer.

What Sildenafil Ranbaxy looks like and contents of the pack
Sildenafil Ranbaxy 100 mg coated tablets are red, round triangular-shaped tablets, embossed with the code "S23" on one side and smooth on the other side.
The tablets are available in blister packs containing 4, 8, or 24 tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Tel. 22 642 07 75

Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp,
The Netherlands
Terapia S.A.
Fabricii Street No. 124
Cluj-Napoca 400 632
Romania