Viridal 10 EasyDuo Continuation Pack

Viridal 10 EasyDuo Pack

Viridal 10 EasyDuo


What Viridal is for


Viridal belongs to a group of medicines called prostaglandins.
Viridal contains the active ingredient alprostadil.
Alprostadil is similar to prostaglandin E1 (PGE1) that occurs naturally in the body.  The medicine works by widening blood vessels and increasing blood flow to your penis.

Viridal is used:


To help you get and maintain an erection when you have insufficient PGE1
By your doctor to test whether you suffer from impotence.
Viridal comes in a glass cartridge with two chambers.
One chamber contains alprostadil, the other contains sodium chloride solution.  These are mixed together to make a solution that is injected into the penis.
2. 

Before you use Viridal


Do not use Viridal if:
You are allergic to alprostadil
You are allergic to any of the other ingredients of Viridal (listed in section 6)
You have a deformity or disease of your penis
You have sickle-cell disease (abnormal red blood cells)
You have leukaemia (cancer of blood cells)
You have multiple myeloma (tumour of the bone marrow)
You have an implant in your penis
You have been told not to have sex for health reasons such as heart problems or a recent stroke
You have Peyronie's disease or any scarring or deformity of the penis or foreskin.
If any of the above applies to you talk to your doctor or pharmacist.

Check with your doctor before taking Viridal if:


You have or have ever had any heart problems
You have or have ever experienced fainting and blackouts
You have had short-term changes to your speech, hearing or vision
You suffer from lung problems
You suffer from blood clotting disease
You may need to have further tests before your doctor can give you this treatment
Viridal will not protect you or your partner from sexually transmitted diseases like chlamydia, gonorrhoea, herpes simplex virus, viral hepatitis, HIV, genital warts or syphilis.
As you may get a small amount of bleeding at the injection site, it is especially important that you use a condom to avoid sexually transmitted diseases.
Viridal does not interfere with ejaculation and fertility.
Tell your doctor if you are taking any of the following medicines:
Drugs to treat depression known as MAOIs such as phenelzine.  When taken with Viridal these can cause very high blood pressure
Other drugs injected into the penis for the treatment of erection difficulties such as papaverine or phentolamine.  Taking Viridal as well could cause a dangerously prolonged erection
Any other medicines used to treat erection difficulties including sildenafil.  When used in combination with Viridal, they could induce prolonged erection
Medicines to thin your blood such as warfarin.  These can cause bleeding at the site of injection of Viridal
Drugs to lower your blood pressure and change the diameter of your blood vessels.  Viridal may increase their effects and cause very low blood pressure.
Any other medicine, including medicines obtained without a prescription.
Medicines to treat blood clotting as you may need special attention.

Pregnancy and breast-feeding and Viridal


You should wear a condom if your partner is, may be or could become pregnant.  This is to avoid causing irritation of her vagina or possibly damaging the unborn baby.
If you have any questions on this or if your partner is breast-feeding, please ask your doctor or pharmacist for advice.

Driving and using machines and Viridal


If you feel dizzy or faint after using Viridal you should not drive or use machinery or tools.
3. 

How to use Viridal


Important:
Before you use Viridal at home, you must be taught how to prepare and inject it by your doctor.  You should never start treatment without talking to your doctor first.
Remember: If you find it difficult to use your hands properly or if you cannot see very well your partner can be taught how to give you the injection.
Discuss this with your doctor if necessary.

How much Viridal to use


To test for impotence and to find out the dose of Viridal you need:
For erectile dysfunction of primary neurological origin
Your doctor will give you a starting dose of 2.5 or 5 micrograms.  However, if your impotence is due to neurological problems, your doctor will give you a starting dose of 1.25 micrograms.
Your doctor will then increase your dose by 2.5 or 5 micrograms at a time
Your correct dose is the one which produces an erection which lasts for no longer than 1 hour.
For an erection:
Most men need between 10 and 20 micrograms for each injection
Do not use more than 40 micrograms in one injection.
Do not use more than 2 or 3 times a week with at least 24 hours between the injections.

How to inject Viridal


For each injection you will need:
a) Easy-Duo® reusable.  If you have used Viridal before you should already have an injector.  You may also obtain one by calling the free phone number given at the end of the leaflet
b) One cartridge, which is made up of two chambers.
There will be 10, 20 or 40 micrograms of alprostadil (white powder) in the top chamber, and 1 ml of sterile saline (colourless liquid) in the bottom chamber
c) One injection needle with outer protective cap (1) and inner protective cap (2)
Check that the seal on the injection needle is not broken.  Tear off the seal.
Put the needle on the end of the injector by screwing it clockwise until it is tight.  Always screw on the injection needle before inserting the cartridge.
Unscrew the plunger from the injector.  Take the cartridge and clean the tip with alcohol swab.  Insert the cartridge into the transparent body of the injector.  Take care to advance the bulge into the groove of the injector
Screw the plunger onto the back thread of the injector body.
Hold the injector with the needle pointing up.  Push the plunger forward until the two grey stoppers of the cartridge meet.  You will see that the liquid passes into the front chamber and the powder dissolves within a few seconds.  Shake the injector gently until no bits can be seen.  At first the solution may appear slightly cloudy because of the bubbles, but this will clear after a short time.
Remove the outer and inner protective caps of the needle.  Warning: do not touch anything with the tip of the needle so that it stays clean and sterile (free from germs).
While you hold the injector with the needle pointing up, tap against the injector vigorously until all bubbles have moved upward.  Cautiously advance the plunger until one drop of the solution leaves the needle.  Make sure that all air was removed from the cartridge.
Set the dose your doctor prescribed you.  To do so, move the plunger of the injector slowly upward until the upper edge of the front grey stopper has reached the prescribed dose.
Make sure that your penis has been cleaned thoroughly.
Clean the injection site with an alcohol swab.  Draw the penis slightly away from your body until the intended injection site has dried.
Take the injector and make sure that the grey stopper is at the prescribed dose and that no air bubbles are in the cartridge.
The injection site must be within the area shown in figure 10.
Hold the injector in your fingers as shown.  Always hold it level with the penis and insert the needle almost completely straight, into the penis.
The place where you inject should be within the area shown on the picture.  Use a different side of the penis than you used the last time.
Pushing your thumb gently on the plunger, inject the solution slowly over a period of 5 to10 seconds.
After injection, remove the injector and needle from your penis and put it down.  If bleeding occurs, apply pressure to the injection site with a clean pad for 3 minutes to stop the bleeding.  If it continues to occur, carry on applying pressure until it stops.
It will take between 5-15 minutes for your erection to develop.  Your erection should last for about one hour.  If it lasts for between 2-4 hours, discuss this with your doctor.  If it lasts for longer than 4 hours, contact your doctor immediately.

Disposing of the used Viridal pack:


Cut the needle with a needle cutter (available from your doctor, pharmacist or the Marketing Authorisation holder)
Unscrew the needle base and put it into a container for needles (called a sharps bin) (also available from your doctor or pharmacist)
Remove the cartridge by unscrewing the plunger from the injector body and sliding out the cartridge.
Wash the Easy-Duo® injector with warm water and a mild detergent.  Once dry, store it in original carton for your next injection.
Do not throw the injector away.  Not all packs contain injectors so you will need to use this again for your next injection.  However, do not use a damaged injector.  Replacements are available from the company.
Place the cartridge in a plastic bag and tie it carefully.  This can be thrown away with normal household rubbish.
It is important to discard any unused medicine.  The mixture of Viridal Duo you have made is intended for single use only and any unused contents should be disposed of with the cartridge
Medical check-ups
After the first time you use this medicine and then again every 3 months or so, your doctor will ask you to have check-ups.  These are to make sure that your medicine is working properly and that the dose you are taking is right for you.
If you use more Viridal than you should
Immediately contact the nearest hospital casualty department or your doctor.  Using too much Viridal can cause your erection to last too long and may require treatment by a specialist doctor to reverse the effects.
4. 

Possible side effects of Viridal


Like all medicines Viridal can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
An erection that lasts for more than 4 hours
Serious allergic reactions which causes difficulty in breathing or dizziness
Skin reactions such as rashes and blistering.
Very common side effects (affect more than 1 in 10 people):
Pain in the penis
Common side effects (affect less than 1 in 10 people):
Burning sensation during injection which quickly gets better
Pain at the site of injection
Lumps at the site of injection or in your penis after long-term use.
Spot-like bruising (blood spots under the skin) at the site of injection
Fluttering or vibrating feeling sensation due to uncontrollable muscle movement
Erections might occur more often and longer in duration
Bend or kink in the penis, especially after long-term use
Uncommon side effects (affect less than 1 in 100 people):
Reddening, itching, swelling, blistering, numbness, tenderness or a feeling of warmth at the site of injection
Bleeding at the site of injection
Headache
Priapism (prolonged erection of more than 4 hours)
Fungal infection
Common cold
Reduced sense of touch or sensation
Heightened sense of touch or sensation
Dilation of the pupils
Changes to heart rhythm or increased heart rate
Low blood pressure
Raised creatinine
Decreased or altered blood flow to the arms or legs
Feeling sick
Dry mouth
Skin rash
Excessive sweating
Pain when urinating, urinating more frequently or a sudden need to urinate
Bleeding in the urethra, which can cause there to be blood in your urine
A general increase in iron stores in the body
Problems attaining or maintaining an erection
Problems with ejaculation
Painful or swollen testicles
Lumps on the testicles
Pain in the pelvis
Pain, swelling or reddening of the scrotum
Pain, swelling or reddening at the tip of the penis
Rare side effects (affect less than 1 in 1000 people)
Serious allergic reactions which causes difficulty in breathing or dizziness
Skin reactions such as rashes and blistering
Drop in blood pressure, which may cause dizziness or fainting
Scarring of the inside of the penis after long-term use.
Rare nervous system disorders like vertigo (disorientation with spinning sensation), dizziness
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very rare side effects (affect less than 1 in 10,000 people)
Isolated cases of thrombocytopenia (abnormal drop in the number of platelets)
Not known (frequency cannot be estimated from the available data)
Loss of memory, stroke
Insufficient blood flow to the heart muscle via the coronary arteries, often resulting in chest pain (angina pectoris); heart attack

Reporting of side effects of Viridal


If you get any side effects, talk to your doctor, pharmacist or nurse.  This includes any possible side effects not listed in this leaflet.  You can also report side effects directly via:
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website:
E-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme
Website:
By reporting side effects, you can help provide more information on the safety of this medicine.
5.  How to store Viridal
Keep out of the reach and sight of children
Do not use Viridal after the expiry date on the label.  The expiry date refers to the last day of that month
Store below 25°C and in the original packaging in order to protect from light
Do not use Viridal if you notice some moisture in the powder
When you have mixed the powder with the liquid in the injector, use immediately.  This cannot be stored.
Return any medicine you no longer need to your pharmacist.
6.  Further information
What Viridal contains
There are three strengths of Viridal that contain the active substance alprostadil 10, 20 or 40 micrograms.
The other ingredients of the powder are lactose monohydrate and alfadex.
The liquid contains sodium chloride and water for injection.
What Viridal looks like and contents of the pack
Viridal is a powder and solvent for solution for injection.  Viridal comes in a glass cartridge with two chambers.  One chamber contains a white powder with the active ingredient alprostadil.  The other contains a clear, colourless solution of sodium chloride solution.  This is used to dissolve the powder.
There are various packs containing:
1 cartridge, 1 needle with and without injector
2 cartridges, 2 needles with and without injector
6 cartridges and 6 needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
In UK
UCB Pharma Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
United Kingdom
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel-Strasse 10
D-40789 Monheim
Germany

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