Revastad - Sildenafil uses, dose and side effects

Sildenafil is used to treat adults and children and adolescents from 1 to 17 years of age with high blood pressure in the blood vessels of the lungs ( pulmonary arterial hypertension ).

Sildenafil contained in Revastad may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Revastad

Do not use Revastad

if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6)
if you are taking medicines that contain nitrates or nitric oxide donors such as amyl nitrite. These medications are often given to relieve angina (or angina pectoris ). Revastad may cause a serious increase in the effect of these drugs. Tell your doctor if you are taking any of these medicines. If you are not sure, ask your doctor or pharmacist
if you take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor
if you have recently had a stroke, heart attack, severe liver disease, or very low blood pressure (<90/50 mmHg)
if you are taking medicines containing ketoconazole or itraconazole to treat fungal infections or medicines containing ritonavir (for HIV )
if you have ever before lost your sight due to a problem with the blood flow to the nerve in the eye called non-arteritic anterior ischemic optic infarction/neuropathy (NAION).

Warnings and cautions

Talk to a doctor before taking Revastad if you:

have a disease due to a blocked or narrowed vein in the lung, rather than a blocked or narrowed artery
have severe heart problems
have problems with the chambers of the heart
have high blood pressure in the blood vessels of the lungs
have low blood pressure at rest
loses a large number of body fluids ( dehydration ) which can occur if you sweat a lot or do not drink enough fluid. This can happen if you are sick with fever, vomiting, or diarrhea
have a rare inherited eye disease ( retinitis pigmentosa )
have abnormal red blood cells (sickle cell anemia), blood cell cancer ( leukemia ), bone marrow cancer (multiple myeloma )
any disease of the penis or deformed penis
right now have stomach ulcers or a bleeding disorder (such as hemophilia ) or problems with nosebleeds
uses drugs for erectile dysfunction.

When used to treat male erectile dysfunction (ED), the following side effects on vision have been reported with PDE5 inhibitors, including sildenafil, at an unknown frequency: partial, sudden, temporary, or permanent visual impairment or loss of vision in one or both eyes.

If you experience sudden visual impairment or loss of vision, stop taking Revastad and contact your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been reported in men after using sildenafil. If you get an erection that lasts longer than 4 hours, stop taking Revastad and contact your doctor immediately (see also section 4).

Especially to take into account patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Children and young people

Revastad should not be given to children under 1 year of age.

Other medicines and Revastad

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

drugs containing nitrates, or nitric oxide donors such as amyl nitrite. These medicines are often given to relieve angina pectoris or angina (see section 2. What you need to know before you take Revastad)
tell your doctor or pharmacist if you are already taking riociguat
treatment for pulmonary hypertension (eg bosentan, iloprost)
medicines containing St. John’s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy )
blood-thinning drugs (eg warfarin ) even if they did not show any side effects
medicines containing erythromycin, clarithromycin, telithromycin ( antibiotics for the treatment of specific bacterial infections ), saquinavir (for the treatment of HIV ), or nefazodone (for depression), as your dose may need to be adjusted
alpha-receptor blockers (eg doxazosin ) for the treatment of high blood pressure or prostate problems, as the combination of the two drugs, can cause symptoms that lead to a decrease in your blood pressure (eg dizziness and dizziness).

Revastad with food, drink, and alcohol

You should not drink grapefruit juice while you are being treated with Revastad.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Revastad should be used during pregnancy only when needed.

Revastad should not be used in women of childbearing potential unless appropriate contraception is used.

Stop breastfeeding when you start treatment with Revastad. Revastad should not be given to breastfeeding women, as it is not known if the medicine passes into breast milk.

Driving and using machines

Revastad may cause dizziness and affect vision. You should be aware of how you react to the medicine before driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Revastad contains lactose and sodium

Revastad contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Revastad contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘ sodium-free. is next to “sodium-free”.

How to use Revastad

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

For adults :

The recommended dose is 20 mg (1 tablet) three times daily.

This medicine should only be used when administering 20 mg three times daily. Other forms of medicine are available for the treatment of patients weighing less than 20 kg, as well as for younger patients who are unable to swallow tablets.

Method of administration

Leave 6 – 8 hours between doses. Can be taken with or without food.

Use for children and adolescents

For children and adolescents between 1 and 17 years of age who weigh:

MORE than 20 kg: the recommended dose is 20 mg (1 tablet) three times daily.

LESS THAN 20 kg: the recommended dose is 10 mg three times daily.

Higher doses should not be used in children.

If you use more Revastad than you should

Do not take more medicines than your doctor tells you to do. If you take more medicines than you have been told to take, contact your doctor immediately. Taking more Revastad than you should increase the risk of known side effects.

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor or hospital immediately for an assessment of the risk and advice.

If you forget to use Revastad

If you forget to take Revastad, take a dose as soon as you remember. Then continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Revastad

Sudden discontinuation of Revastad treatment may make your symptoms worse. Do not stop taking Revastad unless your doctor tells you to. Your doctor may ask you to reduce your dose for a few days before stopping completely.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most serious side effects:

If you experience any of the following side effects, stop taking Revastad and contact your doctor immediately (see also section 2):

if you experience a sudden deterioration or loss of vision (no known frequency)
if you have an erection that lasts longer than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (no known frequency).

Other side effects are

Adults

Very common (may affect more than 1 user in 10):

headache
flushing
digestive problems
diarrhea
pain in the arms and legs.

Common (may affect up to 1 in 10 people)

user):
infection under the skin
flu-like symptoms
sinusitis
decreased number of red blood cells ( anemia )
fluid accumulation in the body
difficulty sleeping
anxiety
migraine
shaking
numbness and tingling
burning sensation
impaired skin sensitivity
bleeding at the back of the eye
impact on vision
blurred vision and light shading
effect on color vision
eye irritation
bloodshot eyes / red eyes
dizziness
tracheal catarrh
nosebleeds
Runny nose
cough
nasal congestion
gastrointestinal inflammation
heartburn
hemorrhoids
stretched abdomen
dry mouth
hair loss
reddening of the skin
night sweats
muscle aches
back pain and increased body temperature.

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

decreased visual acuity
double vision
abnormal feeling in the eyes
bleeding in the penis
presence of blood in semen and/or urine
breast augmentation in men.

Has been reported (occurs in an unknown number of users):

rash
sudden decrease or loss of hearing
lowered blood pressure.

Additional side effects in children and adolescents

The following serious side effects have been reported commonly (may affect up to 1 in 10 people):

pneumonia
heart failure
right ventricular failure
heart-related shock
high blood pressure in the lungs
chest pain
fainting
respiratory tract infection
tracheal inflammation
viral infection of the stomach and intestines
urinary tract infection
caries.

The following serious adverse reactions were considered treatment-related and have been reported as uncommon (may affect up to 1 in 100 people):

allergic reactions (such as skin rash, swelling of the face, lips, and tongue, wheezing, difficulty breathing and swallowing)
cramps
irregular heartbeats
hearing loss
respiratory distress
inflammation of the stomach and intestines
wheezing due to obstructed airflow.

Very common (may affect more than 1 user in 10):

headache
vomiting
throat infection
fever
diarrhea
influenza
nosebleed.

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

nausea
increased erection
pneumonia
Runny nose.

How to store Revastad

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is sildenafil. 1 tablet contains 20 mg of sildenafil (as citrate).

Other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), hydroxypropylcellulose (E463), croscarmellose sodium (E468), colloidal anhydrous silica (E551), sodium stearyl fumarate (E485).

Film coating: Opadry II White (consisting of hypromellose 2910 (E464)), titanium dioxide (E171), FCC polydextrose (E1200), talc (E553b), maltodextrin, medium-chain triglycerides.

What the medicine looks like and the contents of the pack

Revastad is a round, biconvex, white film-coated tablet with a diameter of about 7.1 mm and a thickness of about 3.4 mm.

The tablets are supplied in PVC / PVdC / Al blisters containing

30, 90, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Alternative manufacturers

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Local representative