Consumer medicine information

Noumed Valaciclovir


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I taking Noumed Valaciclovir?

Noumed Valaciclovir contains the active ingredient valaciclovir hydrochloride hydrate. Noumed Valaciclovir is used to treat herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash, ophthalmic zoster, recurrent herpes labialis (cold sores), clinical episodes of genital herpes simplex infections and the prevention of recurrent genital herpes. It also used to prevent cytomegalovirus (CMV) infection and disease following solid organ transplantation. CMV is another type of herpes virus that can cause symptoms similar to glandular fever (high temperature, sore throat and swollen glands). For more information, see Section 1. Why am I using Noumed Valaciclovir? in the full CMI.

2. What should I know before I take Noumed Valaciclovir?

Do not take if you have ever had an allergic reaction to valaciclovir hydrochloride hydrate or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Noumed Valaciclovir? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Noumed Valaciclovir and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Noumed Valaciclovir?

  • Your doctor will tell you how many tablets to take each day.
  • Swallow the tablets whole with a glass of water and take Noumed Valaciclovir at about the same time each day.

More instructions can be found in Section 4. How do I take Noumed Valaciclovir? in the full CMI.

5. What should I know while taking Noumed Valaciclovir?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking Noumed Valaciclovir.
  • If you become pregnant, or are trying to become pregnant, or intend to breastfeed while taking this medicine, tell your doctor immediately.
  • Drink plenty of water while you are taking Noumed Valaciclovir
  • If you are going to have surgery, tell your surgeon or anaesthetist that you are taking this medicine.
  • Tell your doctor if you are about to have any blood tests as it may interfere with the results of some tests.
Things you should not do
  • Do not stop using this medicine suddenly, or change the dose, without first checking with your doctor.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful driving or operating machinery until you know how Noumed Valaciclovir affects you
Looking after your medicine
  • Keep Noumed Valaciclovir tablets in a cool dry place where the temperature stays below 25°C
  • Keep your tablets in the packaging until it is time to take them

For more information, see Section 5. What should I know while using Noumed Valaciclovir? in the full CMI.

6. Are there any side effects?

Common side effects: headache, gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain, indigestion), dry mouth, fever, difficulty sleeping, chills, back pain, nervousness, skin rash which may be itchy or weakness. Serious side effects: symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin, unusual bruising or bleeding, agitation or tremor, psychotic episode, convulsions or seizures or coma, uncoordinated eye and muscle movements and speech or difficulty speaking.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Noumed Valaciclovir

Active ingredient(s): [valaciclovir hydrochloride hydrate]


Consumer Medicine Information (CMI)

This leaflet provides important information about using Noumed Valaciclovir. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Noumed Valaciclovir.

Where to find information in this leaflet:

1. Why am I taking Noumed Valaciclovir?
2. What should I know before I take Noumed Valaciclovir?
3. What if I am taking other medicines?
4. How do I take Noumed Valaciclovir?
5. What should I know while taking Noumed Valaciclovir?
6. Are there any side effects?
7. Product details

1. Why am I taking Noumed Valaciclovir?

Noumed Valaciclovir contains the active ingredient valaciclovir hydrochloride hydrate. Noumed Valaciclovir belongs to a group of medicines called antivirals. Valaciclovir hydrochloride hydrate works by stopping the multiplication of the viruses which causes herpes, shingles and cold sores. It can reduce the length and severity of an outbreak of shingles and cold sores and the duration of pain, and shorten the healing time of crusts, associated with shingles and cold sores. It does not eliminate the herpes virus (Herpes Simplex Virus or HSV) from the body.

Noumed Valaciclovir is used for the treatment of genital herpes, shingles (herpes zoster), ophthalmic zoster (shingles affecting the eye region) and cold sores (herpes labialis). It also used to prevent cytomegalovirus (CMV) infection and disease following solid organ transplantation. CMV is another type of herpes virus that can cause symptoms similar to glandular fever (high temperature, sore throat and swollen glands).

2. What should I know before I take Noumed Valaciclovir?

Warnings

Do not take Noumed Valaciclovir if:

  • you are allergic to valaciclovir hydrochloride hydrate, acyclovir, or any of the ingredients listed at the end of this leaflet.
  • you are pregnant, trying to become pregnant, or breastfeeding.
  • you have severe kidney disease.

Check with your doctor if you:

  • have allergies to any other medicines, foods, preservatives, or dyes.
  • you have a kidney or liver condition.
  • you are anaemic (reduced red blood cells or iron stores). Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, such as the elderly.
  • previous skin reactions with valaciclovir which may include a rash, fever, facial swelling or blistering/ peeling skin.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Use in children

Noumed Valaciclovir should not be given to children.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor if you are taking or plan to take any of the following:

  • Mycophenolate mofetil
  • Ciclosporin
  • Tacrolimus
  • Aminoglycosides
  • Organoplatinum compounds
  • Iodinated contrast media
  • Methotrexate
  • Pentamidine
  • Foscarnet

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Noumed Valaciclovir.

4. How do I take Noumed Valaciclovir?

How much to take / use:

Prevention of CMV infection and disease

  • The usual dose for adults and children over 12 years of age is four 500 mg tablets four times a day for 90 days.
  • If you have a kidney disease, your doctor may reduce the dose.

Shingles

  • It is important the treatment for shingles is started within the first three days of the shingles attack.
  • The normal dose to take is two tablets with water three times a day.
  • If you think you have been advised to take a different dose, talk to your doctor or pharmacist.

Cold sores

  • The normal dose to take for the one day regimen is four tablets with water twice a day, with the second dose taken about 12 hours after the first dose.

Treatment of acute (short term) genital herpes

  • If you have had a herpes infection before, you should start to take Noumed Valaciclovir tablets as early as possible if you think you are about to have another recurrence (attack). Dosing should ideally start just before, or straight after the first signs of HSV infection appear. For the treatment of HSV infection, the usual dose to take is one tablet with water twice daily.

Suppressive (long term) treatment of genital herpes

  • To prevent the herpes infection appearing again, the usual dose to take is 500 mg once daily. Your doctor may recommend that you take this as a divided dose (i.e. 250 mg twice daily).
  • If you think you have been advised to take a different dose, talk to your doctor or pharmacist.

When to take / use Noumed Valaciclovir

  • Noumed Valaciclovir can be taken before or after food.
  • Take your medicine at about the same time each day.
  • Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
  • For the prevention of CMV infection and disease, the tablets should be taken four times a day (i.e. morning, noon, afternoon or evening).
  • For the treatment of shingles the usual times to take the tablets are in the morning, afternoon and evening.
  • For the treatment of cold sores the tablets should be taken at the earliest symptom of a cold sore (e.g tingling, itching, or burning). Treatment for cold sores should not exceed 1 day (2 doses) and the doses should be taken 12 hours apart.
  • For the treatment of herpes simplex infections (genital herpes), the usual times to take the tablets are in the morning and evening.

How long to take Noumed Valaciclovir

  • For the prevention of CMV infection and disease, the usual course of treatment is 90 days.
  • For shingles the usual course of treatment is seven days.
    Do not stop taking your medicine before the course of treatment is finished just because you feel better. The shingles may not be completely over.
  • For cold sores the course of treatment should not exceed 1 day (2 doses) and the doses should be taken 12 hours apart.
  • For the treatment of herpes simplex (genital herpes), the usual course of treatment is 5 days. However, in some instances your doctor may want you to take your tablets for 10 days.
  • For the prevention of herpes infections, you should continue to take this medicine every day as prescribed by your doctor.
  • Do not stop taking Noumed Valaciclovir tablets just because you feel better. The herpes outbreak may not be completely over.

If you forget to take Noumed Valaciclovir

For prevention of CMV infection and disease, the treatment of shingles or the treatment of herpes simplex (genital herpes), if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking it as you would normally.

For the treatment of cold sores, take the second dose as soon as possible once the 12 hours have passed.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you take too much Noumed Valaciclovir

If you think that you have taken too much Noumed Valaciclovir, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while taking Noumed Valaciclovir?

Things you should do

  • Tell any other doctors, dentists, and pharmacists who treat you that you are taking Noumed Valaciclovir.
  • Tell your doctor immediately if you become pregnant, are trying to become pregnant or intend to breastfeed while taking Noumed Valaciclovir.
  • Drink plenty of water while you are taking Noumed Valaciclovir.
  • If you are going to have surgery, tell your surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
  • Tell your doctor if your symptoms are not improving or are worsening while you are taking Noumed Valaciclovir.
  • Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
  • It is recommended that patients using Noumed Valaciclovir continuously to prevent or reduce recurrent outbreaks, or to reduce the risk of transmitting the virus that causes genital herpes, also avoid contact when symptoms are present and always use condoms.
  • Noumed Valaciclovir does not cure genital herpes or completely eliminate the risk of transmission. Because genital herpes is a sexually transmitted disease, you should minimise having intercourse when you have an outbreak of herpes or show any symptoms. This will avoid the risk of spreading the herpes to your partner.

Things you should not do

  • Do not give Noumed Valaciclovir tablets to anyone else, even if they have the same condition as you.
  • Do not take Noumed Valaciclovir to treat any other complaints unless your doctor tells you to.
  • Do not stop taking Noumed Valaciclovir, or change the dose, without first checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Noumed Valaciclovir affects you.

Looking after your medicine

  • Keep Noumed Valaciclovir tablets in a cool dry place where the temperature stays below 25°C.
  • Keep your tablets in the packaging until it is time to take them.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do
  • headache
  • gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain, indigestion)
  • dry mouth
  • fever
  • difficulty sleeping
  • chills
  • back pain
  • nervousness
  • skin rash which may be itchy
  • weakness
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
  • sensitivity to UV light, such as development of a rash like sunburn even after short exposure to UV or sunlight
  • dizziness, confusion, imagining sights or sounds (hallucinations), difficulty in thinking
  • drowsiness or decreased consciousness
  • tiredness, dizziness, or being short of breath when exercising (signs of anaemia)
  • high blood pressure
  • damage to the kidneys, which gets better when Noumed Valaciclovir is stopped
  • unusual bruising or bleeding, Tell your doctor immediately if you notice any bruising or bleeding as it may indicate that the number of platelets (a type of blood cell responsible for blood clotting) in the blood are reduced.
  • skin reactions which may include a rash, fever, facial swelling or blistering or peeling skin
  • damage to the liver, which gets better when Noumed Valaciclovir treatment is stopped
  • agitation or tremor
  • psychotic episode
  • convulsions or seizures or coma
  • brain injury
  • uncoordinated eye and muscle movements and speech or difficulty speaking
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Allergy-related symptoms

  • cough, shortness of breath, wheezing or difficulty breathing;
  • swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin.
Stop taking Noumed Valaciclovir and call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Noumed Valaciclovir contains

Active ingredient
(main ingredient)
Each tablet contains Valaciclovir Hydrochloride Hydrate
Other ingredients
(inactive ingredients)
  • microcrystalline cellulose
  • crospovidone
  • povidone
  • magnesium stearate
  • Opadry White 13B58802.

Do not take this medicine if you are allergic to any of these ingredients.

What Noumed Valaciclovir looks like

Noumed Valaciclovir is distributed in Australia by: Noumed Valaciclovir 500 mg capsule shaped film coated tablets – White to off-white capsule shaped film coated tablets with ‘500’ debossed on one side and plain on other side. Pack size: 10, 20*, 30, 42 and 100* film-coated tablets. (AUST R 298203)

Noumed Valaciclovir 1000 mg capsule shaped film coated tablets* – White to off-white, capsule shaped film coated tablets with “1000” debossed on one side and plain on other side. Pack size: 21 and 50 film-coated tablets

*Not currently marketed in Australia

Who distributes Noumed Valaciclovir

Noumed Valaciclovir is distributed in Australia by:

Avallon Pharmaceuticals Pty Ltd.
Level 5, 7 Eden Park Drive
Macquarie Park, NSW, 2113
Phone: 1800 930 999 (Australia)

This leaflet was prepared in May 2022.

Published by MIMS September 2022