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ACICLOVIR 50 MG / G CREAM - patient leaflet, side effects, dosage

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Patient leaflet - ACICLOVIR 50 MG / G CREAM

Aciclovir 50 mg/g Cream

Active substance: aciclovir

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactely as described in this leaflet or as your doctor or pharmacist has told you.

! Keep this leaflet. You may need to read it again.

! Ask your doctor or pharmacist if you need more information or advice.

! If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

! You must talk to a doctor if you do not feel better or if you feel worse after 10 days.

What is in this leaflet :

  • 1. What Aciclovir 50 mg/g Cream is and what it is used for

  • 2. What you need to know before you use Aciclovir 50 mg/g Cream

  • 3. How to use Aciclovir 50 mg/g Cream

  • 4. Possible side effects

  • 5. How to store Aciclovir 50 mg/g Cream

  • 6. Contents of the pack and other information

1. what aciclovir 50 mg/g cream is and what it is used for

Aciclovir 50 mg/g Cream is an antiviral cream. It contains the active substance aciclovir which is used to treat certain viral infections. It slows down virus growth.

Aciclovir 50 mg/g Cream is used to:

  • treat infections of the lips and face caused by herpes simplex virus.

You should apply Aciclovir 50 mg/g Cream to the skin within 24 hours of the onset of early signs of infection or recurrence. This typically begins with reddening of the skin and formation of blisters (lip herpes) or tingling and itching.

Do not use Aciclovir 50 mg/g Cream in the eyes.

2. what you need to know before you use aciclovir 50 mg/g cream do not use aciclovir 50 mg/g cream

  • if you are allergic (hypersensitive) to aciclovir, valaciclovir, propylene glycol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Aciclovir 50 mg/g Cream is only recommended for use on cold sores on the lips and face.

Please tell your doctor if you have or in the past have had any medical conditions or illnesses, especially

  • severe deficiency of the immune system, e.g.

! AIDS patients

! people who have received a bone marrow transplant.

In this case, your doctor may decide to prescribe you tablets instead.

You must NOT apply Aciclovir 50 mg/g Cream to the eyes or mucous membranes (e.g. in the mouth or vagina). This may lead to irritation.

Other medicines and Aciclovir 50 mg/g Cream

Tell your doctor or pharmacist if you are taking or have recently taken or might take other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

Aciclovir 50 mg/g Cream is not known to interact with other medicines.

  • When the active substance of Aciclovir 50 mg/g Cream (aciclovir) has been taken for example in tablet or injection form, the effect may be influenced by: probenecid (medicine used to treat gout), any medicine which affects the kidney function.

However, these medicines are unlikely to affect the way Aciclovir 50 mg/g Cream works.

Pregnancy and breast-feeding

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

Please ask your doctor about the use of Aciclovir 50 mg/g Cream during breastfeeding.

Driving and using machines

Aciclovir 50 mg/g Cream has no effect on the ability to drive or use machines.

Aciclovir 50 mg/g Cream contains cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis) and propylene glycol, which may cause skin irritation.

3. how to use aciclovir 50 mg/g cream

Always use Aciclovir 50 mg/g Cream exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Use Aciclovir 50 mg/g Cream as soon as possible after the start of the infection ideally, when the first signs or lesions appear.

You must NOT apply Aciclovir 50 mg/g Cream to the eyes or mucous membranes (e.g. in the mouth or vagina). This may lead to irritation.

Method of administration

To avoid worsening the infection or infecting other areas of the body:

  • Always wash your hands before and after applying the cream.
  • Avoid unnecessary rubbing of the lesions or touching them with a towel.

The usual dose is…

Apply a thin film of cream to the infected and surrounding skin areas 5 times daily every 4 hours. Use Aciclovir 50 mg/g Cream for 5 days. If healing has not occurred within this period, continue the treatment for further 5 days (i.e. for a total of 10 days).

You must contact a doctor if your symptoms worsen or do not improve after 10 days.

If you use more Aciclovir 50 mg/g Cream than you should

Do not use more Aciclovir 50 mg/g cream or apply more frequently than instructed. If you or anyone else swallows the cream accidentally, please contact your doctor for advice.

If you forget to use Aciclovir 50 mg/g Cream

Do not worry. Simply leave out that dose completely and then use your next dose at the right time. Do not apply a double amount to make up for a forgotten dose.

If you stop using Aciclovir 50 mg/g Cream

You should not stop using Aciclovir 50 mg/g Cream before the recommended course of treatment (5 days). In some cases, you may need to continue treatment for up to 10 days. If you want to stop using the cream, please check with your doctor first.

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

4. possible side effects

Like all medicines, Aciclovir 50 mg/g Cream can cause side effects, although not everybody gets them.

The following side effects have been reported:

Allergic reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop using Aciclovir cream and see a doctor straight away.

The signs may include:

  • rash, itching or hives on your skin
  • swelling of your face, lips, tongue or other parts of your body
  • shortness of breath, wheezing or having trouble breathing
  • unexplained fever and feeling faint, especially when standing up.

Other side effects include:

Uncommon (affects less than 1 in 100 people)

  • a burning or stinging feeling after applying the cream that goes away
  • mild drying or flaking of your skin
  • itching.

Rare (affects less than 1 in 1,000 people)

  • redness of your skin
  • skin rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store aciclovir 50 mg/g cream

Keep out of the reach and sight of children.

Do not store above 25#C. Do not refrigerate.

Do not use Aciclovir 50 mg/g Cream after the expiry date which is stated on the card box after EXP. The expiry date refers to the last day of that month.

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.

6. contents of the pack and further informationwhat aciclovir 50 mg/g cream containsthe active substance is aciclovir.

1 gram of Aciclovir cream contains 50 mg aciclovir

The other ingredients are:

  • potassium sorbate
  • citric acid
  • monohydrate sodium hydroxide
  • stearoyl macrogolglycerides
  • dimeticone
  • cetyl alcohol
  • liquid paraffin
  • white soft paraffin
  • propylene glycol
  • purified water

What Aciclovir 50 mg/g Cream looks like and contents of the pack

Aciclovir 50 mg/g Cream is available in pump dispensers of 2 g and in tubes of 2 g.

The pump dispenser consists mainly of polyethylene and polypropylene, and ispacked into a card box together with the package leaflet.

The tube consisting of aluminium and is closed with a polyethylene cap, and is packed into a card box together with the package leaflet.

Marketing Authorisation Holder and Manufacturer

STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany

Distributed by

Genus Pharmaceuticals, Park View House, 65 London Road, RG 14 1JN Newbury Berkshire

This leaflet was last revised in November 2019.

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