HERPEX 50 mg/g cream Aciclovir

• Short description
• How to use

• • HERPEX cream is indicated in the treatment of labial herpes lesions
  • resulting from infection by Herpes simplex virus type 1.

• CONTENT
  What HERPEX cream looks like and contents of the pack Herpex cream is a white, smooth cream without agglomerates or foreign particles. Each pack contains one aluminum tube with 10 g of cream, together with a leaflet for the patient.

  Method of use

  It is important to start treatment as soon as the first symptoms of cold sores appear. Many patients with cold sores can recognize when they are about to have cold sores, that is, they feel a stinging, itching or tingling sensation. It is recommended to apply the HERPEX cream as early as possible, for example, in the tingling phase. However, you can start to treat cold sores in the phase of the vesicles. Carefully follow the instructions below: Adults and children aged 12 years of age or older: Wash your hands before and after applying HERPEX cream to avoid the worsening of the lesions or the transmission of the infection to someone else or to other parts of your body. Apply the cream, with your finger, covering completely the infected area. Apply the cream to the affected area 5 times a day, every four hours. It is not necessary to apply during the night. Continue the treatment for 4 days. If your cold sore has not healed after that period, you can maintain the treatment for further 6 days. If complete healing has not occurred after 10 days or if your cold sore gets worse, consult your doctor. Do not exceed the recommended dose!

• General information
• Ingredients

• Package leaflet: Information for the patient

  HERPEX 50 mg/g cream

  Aciclovir

  Read the leaflet carefully before you start taking this medicine because it contains important information for you.

  Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.  

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

  - Ask your pharmacist if you need more information or advice.  

  - If you get any 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 HERPEX is and what it is used for  

  2. What you need to know before you use HERPEX  

  3. How to use HERPEX

  4. Possible side effects  

  5. How to store HERPEX

  6. Contents of the pack and other information

  1. What HERPEX is and what it is used for

  HERPEX cream is a medicinal product for cutaneous application. Aciclovir, the active substance of HERPEX cream, belongs to a group of medicines known as antivirals.  

  HERPEX cream is indicated in the treatment of labial herpes lesions resulting from infection by Herpes simplex virus type 1.  

  HERPEX cream is used to treat early signs and symptoms (eg numbness, itching or redness) of cold sore in the lips and face to reduce the risk of cold sore progression to blisters.

  Even if the cold sore develops to blisters, aciclovir (the active ingredient of HERPEX cream) will shorten the treatment process by approximately half to one day compared to an aciclovir-free cream.

  If after 10 days you do not feel better or your condition gets worse, you should seek medical attention.

  2. What you need to know before you use HERPEX

  Do not use HERPEX if:

  - you are allergic to active substance aciclovir or any of the other ingredients of this medicine (listed in section 6);

  Warnings and precautions

  Talk to your doctor or pharmacist before  using HERPEX cream.

   Use only in lip or face lesions caused by Herpes simplex. Do not apply the cream in the mucous membranes, namely inside the mouth, eyes or in the genital area as it may be irritant. If you are not sure if you have cold sores, talk to you doctor.  

  Please, remember that cold sore is contagious. You should take precautions to prevent the possible transmission of the virus, especially in the presence of active lesions.  

  You should wash your hands before and after cream application. You should also avoid touching or scratching the lesions with your hands or even with a towel so as to avoid aggravating or transmitting the infection to someone else or to other parts of your body.

  Children and adolescents

  HERPEX cream should not be used in children below the age of 12 years.

  Other medicines and HERPEX cream

  Please, tell your doctor or pharmacist if you are using or have recently use any other medicines, including medicines obtained without a prescription.

  No interactions with other medicines are known.

  HERPEX cream with foods, drinks and alcohol

  Do not apply the cream just before eating because you can swallow it.

  Pregnancy, breast-feeding and fertility

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

   Driving and using machines

  HERPEX cream does not affect the ability to drive or use machines.

  HERPEX cream contains:

  - cetostearyl alcohol. May cause local skin reactions (eg contact dermatitis);

  - propylene glycol (E1520). May cause skin irritation;

  - sodium laurylsulfate (E 487). This medicine contains 7.5 mg of sodium lauryl sulfate in 1 g of cream. It can cause local skin reactions (a sensation of pinching and burning) or may increase skin reactions caused by other products when applied to the same site.

  3. How to use HERPEX cream

  Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist told you. Check with your doctor or pharmacist if you are not sure.

  It is important to start treatment as soon as the first symptoms of cold sores appear.

  Many patients with cold sores can recognize when they are about to have cold sores, that is, they feel a stinging, itching or tingling sensation. It is recommended to apply the HERPEX cream as early as possible, for example, in the tingling phase. However, you can start to treat cold sores in the phase of the vesicles.  

  Carefully follow the instructions below:

  Adults and children aged 12 years of age or older:

  Wash your hands before and after applying HERPEX cream to avoid the worsening of the lesions or the transmission of the infection to someone else or to other parts of your body.  

  Apply the cream, with your finger, covering completely the infected area.  

  Apply the cream to the affected area 5 times a day, every four hours. It is not necessary to apply during the night.

  Continue the treatment for 4 days. If your cold sore has not healed after that period, you can maintain the treatment for further 6 days. If complete healing has not occurred after 10 days or if your cold sore gets worse, consult your doctor.  

  Do not exceed the recommended dose!

  Do not mix HERPEX cream with other skin creams or lotions.

  Use in children and adolescents

  HERPEX cream do not use in children under 12 years of age.

  If you use more HERPEX cream than you should

  Adverse effects are unlikely if you accidentally use too much or swallow the cream. However, if you or someone else in your environment, especially a child, has swallowed a large amount of cream by mistake, tell your doctor immediately.

  If you forget to use HERPEX cream

  Do not use a double dose to make up for a forgotten.  

  Apply the cream as soon as possible and then return to the usual interval.

  If you stop using HERPEX cream

  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.

  The adverse events are presented according to MedDRA system organ classification within each frequency area and after decreasing degree of severity: Very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

  Skin and subcutaneous tissue disorders:

  Uncommon - transient burning or stinging immediately after application of the cream; slight drying or scaling of the skin; itching;

  Rare - redness of the skin; changing the color of the skin; allergic skin reaction (contact dermatitis).

  Immune system disorders:

  Very rare - rapid hypersensitivity reactions, including angioedema and urticaria.

  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 Bulgarian Drug Agency, Address: 8, Damyan Gruev Str. 1303 Sofia; Country Bulgaria; Phone: +359 2 890 34 17, уебсайт: www.bda.bg; Email: bda@bda.bg. By reporting side effects you can help provide more information on the safety of this medicine.

  5. How to store HERPEX cream

  Do not store above 25 ºC.  

  Keep this medicine out of the sight and reach of children.

  Do not use this medicine after the expiry date which is stated on the carton box after “EXP:” and on the tube. The expiry date refers to the last day of that month.

  Shelf life after first opening of the tube: 12 months.

  Do not use this medicine if you notice of the visible signs of deterioration.

  Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  6. Contents of the pack and other information

  What HERPEX cream contains

  - The active substance is aciclovir. 1 g of the cream contains 50 mg aciclovir (5% aciclovir, w/w).

  - The other excipient are: cetostearyl alcohol, liquid paraffin, propylene glycol (E 1520), sodium laurylsulfate (E 487), poloxamer 407, white soft paraffin and purified water.

  What HERPEX cream looks like and contents of the pack

  Herpex cream is a white, smooth cream without agglomerates or foreign particles.

  Each pack contains one aluminum tube with 10 g of cream, together with a leaflet for the patient.

  Marketing Authorisation Holder  

  Fortex Nutraceuticals Ltd.

  10, Prohladen kat Street,  

  1362 Sofia, Bulgaria

  Manufacturer

  MEDINFAR MANUFACTURING, S.A.

  Parque Industrial Armando Martins Tavares

  Rua Outeiro da Armada, 5

  Condeixa-a-Nova

  3150-194 Sebal

  Portugal

  This leaflet was last revised in November 2023.

   

   

• What HERPEX cream contains

  - The active substance is aciclovir. 1 g of the cream contains 50 mg aciclovir (5% aciclovir, w/w).

  - The other excipient are: cetostearyl alcohol, liquid paraffin, propylene glycol (E 1520), sodium laurylsulfate (E 487), poloxamer 407, white soft paraffin and purified water.

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