SILDENAFIL 20 мг Фильм-coated таблетки

Содержание инструкции

1. Sildenafil Dr. Reddy’s 20 mg film-coated tablets
   1. What is Sildenafil Dr. Reddy’s and what is it used for
   2. What you need to know before taking Sildenafil Dr. Reddy’s
   3. How to take Sildenafil Dr. Reddy’s
   4. Possible side effects
   5. How to store Sildenafil Dr. Reddy’s
   6. Contents of the pack and other information

Sildenafil Dr. Reddy’s 20 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start to take this medicine because it contains important
information for you.

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

Contents of this leaflet

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

1. What is Sildenafil Dr. Reddy’s and what is it used for

Sildenafil Dr. Reddy’s contains the active ingredient sildenafil which belongs to the class of medicines
called phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil Dr. Reddy’s reduces blood pressure in the blood vessels of the lungs by
dilating the pulmonary blood vessels.
Sildenafil Dr. Reddy’s is used for the treatment of adults and children and adolescents from 1 to 17 years
with high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension).

2. What you need to know before taking Sildenafil Dr. Reddy’s

Do not take Sildenafil Dr. Reddy’s:

• if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines containing nitrates or if you are taking substances that release nitric oxide, such as amyl nitrite (“poppers”). These medicines are often used to relieve chest pain attacks (or “angina pectoris”). Sildenafil Dr. Reddy’s may cause a considerable increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If you have any doubts, consult your doctor or pharmacist.
• 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 Dr. Reddy’s, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.
• if you have recently had a stroke, a heart attack or if you have a severe liver disease or very low blood pressure (< 90/50 mmHg).
• if you are taking a medicine to treat fungal infections, such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
• if you have previously experienced a loss of vision caused by a problem with blood flow to the optic nerve called non-arteritic anterior ischemic optic neuropathy (NAION)

Warnings and precautions
Talk to your doctor before taking Sildenafil Dr. Reddy’s if:

• the disease is due to obstruction or narrowing of a pulmonary vein rather than an artery.
• you have a serious heart problem.
• you have problems with the heart ventricles.
• you have high blood pressure in the blood vessels of the lungs.
• you have low blood pressure while at rest.
• you are losing large amounts of body fluids (dehydration), which can occur when you sweat a lot or when you do not drink enough fluids. This can happen if you are sick with fever, vomiting or diarrhea.
• you have a rare hereditary eye disease (retinitis pigmentosa).
• you have an abnormality of the red blood cells (sickle cell anemia), a cancer of the blood cells (leukemia), a cancer of the bone marrow (multiple myeloma) or any disease or deformity of the penis.
• you currently have a stomach ulcer, a bleeding disorder (such as hemophilia) or nosebleeds.
• you are taking medicines for erectile dysfunction.

When it has been used for the treatment of erectile dysfunction (ED), with PDE5 inhibitors, including sildenafil, the following adverse effects to the eyes have been reported, with frequency not known: partial, sudden, temporary or permanent reduction or loss of vision in one or both eyes.
If you experience a sudden decrease or loss of vision, stop taking Sildenafil Dr. Reddy’s and contact your doctor immediately(see also section 4)
Prolonged and sometimes painful erections have been reported in men after taking sildenafil. If you have an erection that lasts continuously for more than 4 hours, stop taking Sildenafil Dr. Reddy’sand contact your doctor immediately(see also section 4).

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you should tell your doctor because a dose adjustment may be necessary.

Children
Sildenafil Dr. Reddy’s should not be given to children under 1 year of age.

Other medicines and Sildenafil Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrite (“poppers”). These medicines are often used to relieve angina pectoris or “chest pain” (see section 2. What you need to know before taking Sildenafil Dr. Reddy’s).
• Tell your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary arterial hypertension (e.g. bosentan, iloprost
• Medicines containing St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (also used for epilepsy).
• Medicines that inhibit blood clotting (e.g. warfarin), although no adverse effects have been reported.
• Medicines containing erythromycin, clarithromycin, telithromycin (are antibiotics used to treat some bacterial infections), saquinavir (for HIV) or nefazodone (for depression), because a dose adjustment may be necessary.
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms that

lead to a lowering of blood pressure (e.g. dizziness, lightheadedness).

Sildenafil Dr. Reddy’s with food and drink
Do not drink grapefruit juice while being treated with Sildenafil Dr. Reddy’s.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. Sildenafil Dr. Reddy’s should not be taken during pregnancy unless absolutely necessary.
Sildenafil Dr. Reddy’s should not be given to women of childbearing potential unless they are using adequate contraceptive methods.
Stop breastfeeding when you start treatment with Sildenafil Dr. Reddy’s. Sildenafil Dr. Reddy’s should not be given to women during breastfeeding because it is not known whether the medicine passes into breast milk.

Driving and using machines
Sildenafil Dr. Reddy’s can cause dizziness and can alter vision. Before driving and using machines you should be aware of how you react to this medicine.

Sildenafil Dr. Reddy’s contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Sildenafil Dr. Reddy’s

consult your doctor or pharmacist.
For adults, the recommended dose is 20 mg three times a day (to be taken at intervals of 6-8 hours)
with or without food.

Use in children and adolescents
For children and adolescents from 1 to 17 years of age, the recommended dose is 10 mg three times a day
for children and adolescents ≤ 20 kg or 20 mg three times a day for children and
adolescents > 20 kg, to be taken with or without food. Higher doses should not be used in children.
This medicine should only be used in case of administration of 20 mg three times a day.
Other pharmaceutical forms may be more appropriate for administration to patients weighing
≤ 20 kg and to other younger patients who are unable to swallow the tablets.

If you take more Sildenafil Dr. Reddy’s than you should
Do not take a quantity of medicine greater than that prescribed by
your doctor.
If you take a quantity of medicine greater than that prescribed, contact your doctor
immediately. Taking more Sildenafil Dr. Reddy’s than you should may increase the risk of
known side effects.

If you forget to take Sildenafil Dr. Reddy’s
If you forget to take Sildenafil Dr. Reddy’s, take the dose as soon as you remember and then
continue to take the medicine at the usual time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Sildenafil Dr. Reddy’s
Sudden discontinuation of treatment with Sildenafil Dr. Reddy’s may lead to
worsening of symptoms. Do not stop treatment with Sildenafil Dr. Reddy’s unless
your doctor decides to do so. Your doctor may tell you to reduce the dose over a few days before
completely stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Dr. Reddy’s can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should stop taking
Sildenafil Dr. Reddy’s and contact your doctor immediately (see also section 2):

• if you experience sudden vision impairment or loss of vision (frequency not known)
• if you experience an erection that lasts continuously for more than 4 hours. After taking sildenafil, prolonged and sometimes painful erections have been reported (frequency not known).

Adults
Very common side effects (may affect more than 1 in 10 people) have been
headache, flushing, indigestion, diarrhoea and pain in the arms or legs.
Common side effects (may affect up to 1 in 10 people) include:
skin infections, flu-like symptoms, inflammation of the sinuses, reduced number of
red blood cells (anaemia), fluid retention, sleep disorders, anxiety, migraine, tremor, sensation
of pins and needles, burning sensation, reduced sense of touch, bleeding in the back of the
eye, effects on the eyes, blurred vision and sensitivity to light, effects
on colour perception, eye irritation, eye inflammation/redness, dizziness,
bronchitis, nosebleed, increased nasal secretions, cough, stuffy nose, inflammation
of the stomach, gastroenteritis, heartburn, haemorrhoids, abdominal distension, dry
mouth, hair loss, skin redness, night sweats, muscle pain, back pain and
increased body temperature.
Uncommon side effects (may affect up to 1 in 100 people) reported include:
reduced visual acuity, double vision, abnormal sensation in the eye, bleeding of the penis,
blood in semen and/or urine, and excessive development of male breast tissue.
Skin rash, a sudden decrease or loss of hearing and
decreased blood pressure have also been reported, with frequency not known (frequency cannot be estimated
based on available data).
Children and adolescents
The following serious adverse events have been reported commonly (may affect up to 1 in
10 people): pneumonia, heart failure, right-sided heart failure, heart-related shock,
high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis,
viral infection of the stomach and intestines, urinary tract infection and tooth decay.
The following serious adverse events have been considered related to treatment and have been reported uncommonly (may affect up to 1 in 100 people): allergic reactions (such as skin rash,
swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsions,
irregular heartbeat, hearing loss, shortness of breath, inflammation of the digestive tract,
wheezing due to breathing problems.
Very common side effects (may affect more than 1 in 10 people) have been
headache, vomiting, sore throat, fever, diarrhoea, influenza and nosebleed.
Common side effects (may affect up to 1 in 10 people) have been:
nausea, increased erections, pneumonia and runny nose.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting
system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Sildenafil Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Dr. Reddy’s contains

• The active ingredient is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
• The other excipients are: Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K29-32, sodium croscarmellose, magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), macrogol 6000.

Description of the appearance of Sildenafil Dr. Reddy’s and contents of the pack
The film-coated tablets of Sildenafil Dr. Reddy’s are white and have a round and
biconvex shape. The tablets have “SL20” imprinted on one side.
The tablets are available in blisters in packs containing 90 (1x90) and 300 (3x100)
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DR. REDDY’S S.r.l.
Piazza S. Maria Beltrade, 1
20123 Milan, Italy

Manufacturer
Actavis Ltd
BLB 016 Bulebel Industrial Estate – Zejtun ZTN 3000 – Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: