Revatio 10 mg. / Ml. 90 ml.

What is Revatio is and what it is used
Revatio contains the active ingredient sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5).
Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs. Revatio is used to treat high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension) in adults and children and adolescents aged 1 to 17 years.

2. What you need to know before you take Revatio
Do not take Revatio:
if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
if you are taking medicines containing nitrates or nitric oxide donors such as amyl nitrate ("club drugs"). These medicines are often given for relief of chest pain (or angina). Revatio can cause a serious increase in the effects of these medicines. Tell your doctor if you are taking any of these medicines. If in doubt, ask your doctor or pharmacist;
if you have recently had a stroke, a heart attack or have severe liver disease or very low blood pressure (<90/50 mmHg);
If taking a medicine for the treatment of fungal infections, such as ketoconazole or itraconazole or containing ritonavir (for HIV);
if you have ever had loss of vision because of the blood supply to the optic nerve, called non-arteritic anterior ischemic optic neuropathy (NAION).
Warnings and Precautions
Talk to your doctor before taking Revatio, if you:
have the disease due to a blocked or narrow vein in the lungs, and a blocked or narrowed artery;
have a severe heart problem;
have impaired pumping function of the chambers of the heart;
have high blood pressure in the blood vessels of the lungs;
have low blood pressure at rest;
lose large amounts of body fluids (dehydration) which can occur when you sweat a lot or do not drink enough fluids. This can happen if you are sick with fever, vomiting or diarrhea;
have a rare inherited eye disease (retinitis pigmentosa);
have abnormality of erythrocytes (sickle cell anemia), cancer of the blood cells (leukemia), cancer of the bone (multiple myeloma), or any disease or deformity of the penis;
currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds;
taking medicines for erectile dysfunction.
In use, PDE5 inhibitors, including sildenafil, for treating erectile dysfunction in males (SE) are reported with an unknown frequency following visual side effects; Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes.
If you experience sudden decrease or loss of vision, stop taking Revatio and contact your doctor immediately (see. Also point 4).
There have been reports of prolonged and sometimes painful erections in men after taking sildenafil. If you have an erection that lasts more than four hours, stop taking Revatio and immediately contact your doctor (see also section 4).

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems, as may be necessary to adjust the dose.

children
Revatio should not be used in children under the age of one year.

Other medicines and Revatio
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
Medicines containing nitrates or nitric oxide donors such as amyl nitrate ("club drugs"). These medicines are often given for relief of angina or chest pain (see section 2. What you need to know before you take Revatio);
Another treatment of pulmonary hypertension (eg. Bosentan, iloprost);
Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy);
Medication to thin the blood (eg. Warfarin), although they do not lead to side effects;
Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as may be necessary to adjust your dose;
Treatment with alpha-blocker (eg., Doxazosin) for high blood pressure or prostate problems, as the combination of the two drugs may cause symptoms, leading to a lowering of blood pressure (eg. Dizziness, vertigo).
Revatio with food and drink
You should not drink grapefruit juice during treatment with Revatio.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Revatio should not be used during pregnancy unless strictly necessary.
Revatio should not be administered to women of childbearing potential unless using appropriate contraceptive methods.
Stop breast feeding when you start treatment with Revatio. Revatio should not be administered to nursing women because it is not known if the medicine passes into breast milk.

Driving and using machines
Revatio can cause dizziness and can affect vision. You need to know how you react to the medicine before you drive or operate machinery.

Revatio contains sorbitol
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Revatio
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
In adults, the recommended dose is 20 mg three times daily (6 to 8 hours apart) taken with or without food.

Use in children and adolescents
The recommended dose for children and adolescents aged 1 to 17 years or 10 mg (1 ml oral suspension) three times a day for children and adolescents weighing 20 kg or less, or 20 mg (2 ml oral suspension) three times a day for children and adolescents weighing over 20 kg, taken with or without food. Children should not be administered at higher doses.
The oral suspension must be shaken well for a minimum of 10 seconds before use.

Instructions for preparation of oral suspension
It is recommended that your pharmacist to prepare the oral suspension before you are granted.
If prepared oral suspension is in a liquid form. If the powder is dissolved, you need to prepare the oral suspension by following the instructions below.

Note: To reconstitute the contents of the bottle should be used a total volume of 90 ml (3 x 30 ml) of water irrespective of the dose you will receive.
1. Gently shake the bottle to aerate the powder.
2. Remove the cap.
3. Measure with the measuring cup (included in carton) 30 ml of water to the marked marking and pour water into the bottle. Measure cup with 30 ml of water and add them to the bottle.
4. Place the lid back on the bottle and shake vigorously for at least 30 seconds.
5. Remove the cap.
6. Measure the cup with 30 ml of water and add them to the bottle. You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking.
7. Reattach the bottle and shake vigorously for at least 30 seconds.
8. Remove the cap.
9. Press the adapter into the neck of the bottle. The adapter is provided in order to fill the oral syringe with medicine from the bottle. Reattach the bottle.
10. Write down the date of the expiry date of the reconstituted oral suspension on the bottle label (the shelf life of reconstituted oral suspension is 30 days from the date of preparation). After this date, the unused oral suspension should be discarded or returned to your pharmacist.

Instructions for use:
Your pharmacist will advise you how to take an medicine using the oral syringe provided in the package. After reconstitution, the oral suspension should only be administered using the oral syringe, available in each package. Before using the oral suspension, please see the instructions below.
1. Vigorously shake the closed bottle of reconstituted oral suspension for at least 10 seconds before use. Remove the cap.
2. While the bottle is upright on a flat surface, insert the tip of the oral syringe into the adapter.
3. Turn the bottle upside down while holding the oral syringe. Slowly pull the plunger of the oral syringe to the graduation which marks your dose (1 ml download delivers a dose of 10 mg, 2 ml of downloading delivers a dose of 20 mg). To measure the dose accurately, the top edge of the plunger should be aligned with the mark of the oral syringe.
4. If you see large bubbles, slowly push the plunger back into the syringe. This will return the medicine back into the bottle. Repeat step 3 again.
5. Turn the bottle up as not remove the oral syringe. Remove the oral syringe from the bottle.
6. Place the tip of the oral syringe into the mouth. Aim the tip of the oral syringe towards the inside of the cheek. Slowly push the plunger of the oral syringe. Do not squirt the medicine quickly. If the drug should be administered to a child, make sure the child is sitting upright or stick before being given the drug.
7. Put the cap back on the bottle, leaving the adapter in place. Wash the oral syringe as instructed below.

Cleaning and storing the syringe:
1. The syringe should be washed after each dose. Pull the plunger of the syringe and wash both parts with water.
2. Dry the two parts. Push the plunger back into the syringe. Store the medication in a clean and safe place.

If you take more Revatio than
You should not take more medicine than you appointed your doctor. If you take more than the designated amount of the drug, contact your doctor immediately. Taking more than the prescribed dose of Revatio can increase the risk of known side effects.

If you forget to take Revatio
If you forget to take Revatio, 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 the missed dose.

If you stop taking Revatio
Abrupt discontinuation of treatment with Revatio may lead to your symptoms getting worse. Do not stop taking Revatio, unless your doctor has told you to do this. Your doctor may tell you to reduce the dose over a few days before stopping completely.

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

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

If you experience any of these side effects, you should stop taking Revatio and contact a doctor immediately (see also section 2):
If you experience sudden decrease or loss of vision (frequency not known);
if you get an erection that lasts more than 4 hours. Prolonged and sometimes painful erection has been reported in men after taking sildenafil (frequency not known).
adults
Very commonly reported (may affect more than 1 in 10 people) are the following side effects:
headache, facial flushing, indigestion, diarrhea and pain in the hands and feet.
Commonly reported side effects (may affect up to 1 in 10 people) include:
infection under the skin, flu-like symptoms, inflammation of the sinuses, reduced number of red blood cells (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, numbness or tingling in the limbs, burning sensation, reduced skin sensitivity to touch, bleeding in the back of the eye, effects on vision, blurred vision and light sensitivity, effects on color vision, eye irritation, bloodshot eyes / red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis , heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.
Side effects reported uncommonly (may affect up to 1 in 100 people) include:
decreased sharpness of vision, double vision, abnormal sensation in the eye, bleeding from the penis, blood in semen and / or urine and breast enlargement in men.
Reported is not known (from the available data can not be estimated) Skin rash and sudden decrease or loss of hearing, as well as lowering blood pressure.

Children and adolescents
The following serious adverse events have been reported commonly (may affect up to 1 in 10 people):
pneumonia, heart failure, right heart failure, shock, high pressure in the pulmonary artery, chest pain, seizures, respiratory tract infection, bronchitis, viral infection of the stomach and small intestine, urinary tract infections and dental caries.
The following serious adverse events were assessed as related to treatment and were reported uncommonly (may affect up to 1 in 100 people):
allergic reaction (eg. skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing and swallowing), seizures, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, breathing difficulty due to disturbed airflow.
Very commonly reported side effects (may affect more than 1 in 10 people) are:
headache, nausea, throat infection, fever, diarrhea, influenza and epistaxis.
Commonly reported side effects (may affect up to 1 in 10 people) are:
nausea, increased erections, pneumonia and fever.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet. You can also report side effects directly through a national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Revatio
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.

dust
Do not store above 30 ° C.
Store in the original package in order to protect from moisture.

Prepared oral suspension
Do not store above 30 ° C or refrigerated at 2 to 8 ° C. Do not freeze. Any amount of suspension left 30 days after preparation should be discarded.

Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Revatio:
The active substance is sildenafil (as sildenafil citrate).
After reconstitution, each ml oral suspension contains 10 mg of sildenafil (as citrate). One bottle of reconstituted oral suspension (112 ml) contains 1,12 g of sildenafil (as citrate).
The other ingredients are: sorbitol, citric acid anhydrous, sucralose, sodium citrate, xanthan gum, maltodextrin, concentrate grape juice, acacia, concentrate pineapple juice, citric acid, natural flavor, titanium dioxide (E171), sodium benzoate (E211), silica colloidal anhydrous.

What Revatio looks like and contents of the pack
Revatio is supplied as white to off-white powder for oral suspension, which when reconstituted with water becomes white oral suspension flavored grapes.
One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32,27 g powder for oral suspension.
After reconstitution, the bottle contains 112 ml of oral suspension, of which 90 ml is intended for use.

Type of packaging: 1 bottle.
Each pack also contains a polypropylene measuring cup (graduated dispense 30 ml), polypropylene oral syringe (3 ml) with HDPE plunger and a LDPE bottle adapter.