VIRIDAL DUO 40 MICROGRAM/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Active substance: ALPROSTADIL
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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 Like all medicinesViridal 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 A sensation of tension in the penis Pain at the site of injection Lumps at the site of injection or in your penis after long-term use. Spot-like bruising at the site of injection Uncontrollable muscle movement Erections might occur more often and longer in duration Bend or kink in the penis, especially after longterm use
The injection site must be within the area shown in figure 10. Fig 11:
Postcode Date of birth Signature Date My doctors name and address is: Surname Initials Address 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 to 10 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 515 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 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
Uncommon side effects (affect less than 1 in 100 people): Swollen or tight foreskin Reddening, itching, swelling, blistering, numbness, tenderness or a feeling of warmth at the site of injection Bleeding at the site of injection Headache 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 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. 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.
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 25C 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 In Ireland UCB (Pharma) Ireland Limited United Drug House Magna Drive Magna Business Park Citywest Road Dublin 24, Ireland Manufacturer Aesica Pharmaceuticals GmbH Alfred-Nobel-Strasse 10 D-40789 Monheim Germany This leaflet was last updated in October 2012. If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Limited 208 Bath Road Slough, Berkshire SL1 3WE, UK Or UCB (Pharma) Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24, Ireland
viridal duo 10/20/40 micrograms/ml powder and solvent for solution for injection
ALPROSTADIL
Postcode N.B.This informationwill be sent, even if you prefer not to fill in your doctors name and address. PLEASE RETURNTHIS SECTION OF LEAFLET ONLY
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Patient Information Leaflet Read all of this leaflet carefully before you start using this medicine. Keep this leaflet.You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet, Viridal Duo 10, 20 and 40 micrograms/ml powder and solvent for solution for injection will all be referred to as Viridal. In this leaflet: 1.What Viridal is for 2.Before you use Viridal 3.How to use Viridal 4.Possible side effects 5.How to store Viridal 6.Further information. 1. 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 are a woman or a child. 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 have Peyronies disease or any scarring or deformity of the penis or foreskin. 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. 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 Viagra 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. Pregnancy and breast-feeding 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 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: Your doctor will give you a starting dose of 2.5 or 5 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 Fig 1: C (1) (2)
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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. B Fig 4:
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. Fig 7:
Telephone Advice Line Further information is available by telephone from: Viridal duo Patient Helpline freephone 0800 7312698 (UK only) This is a fully automated, free service for ordering replacement injectors and needle cutters. Advice and replacement injectors can also be ordered by writing to: FREEPOST RLSG-HARX-BGGA UCB Pharma Limited 208 Bath Road Slough Berkshire SL1 3WE UK
A 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) Fig 2:
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 Fig 5: 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. Fig 9:
Screw the plunger onto the back thread of the injector body. Check that the seal on the injection needle is not broken. Tear off the seal.
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.
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

