ACICLOVIR AUROVITAS 50 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Aciclovir Aurovitas 50 mg/g Cream EFG

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Aciclovir Aurovitas cream is and what it is used for.
2. What you need to know before using Aciclovir Aurovitas cream.
3. How to use Aciclovir Aurovitas cream.
4. Possible side effects.
5. Storage of Aciclovir Aurovitas cream.
6. Package Contents and Additional Information.

1. What Aciclovir Aurovitas Cream is and What it is Used for

Aciclovir Aurovitas contains aciclovir, an active ingredient belonging to the group of antiviral medicines.

It is indicated for the treatment of skin infections caused by the herpes simplex virus, including initial genital herpes and its recurrences, and cold sores.

2. What You Need to Know Before Using Aciclovir Aurovitas Cream

Do Not Use Aciclovir Aurovitas:

If you are allergic to the active ingredient or any of the other components of this medicine (listed in section 6).

• If you think this applies to you, do not use aciclovir cream until you have consulted your doctor.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medicine.

Before using aciclovir cream, your doctor will need to know:

• If recurrences are frequent, if you have a condition where your immune system functions worse or your body is less able to fight infections (e.g., if you have HIV or AIDS or have received a bone marrow transplant).
• Consult your doctor if you think this applies to you, so that they can decide whether you should switch to an oral formulation.

You should avoid contact between the cream and your eyes, and if it occurs, wash thoroughly with water and consult an ophthalmologist if necessary. Do not apply the product inside the mouth, nose, or vagina, as it may cause local irritation.

Genital herpes can be transmitted through sexual contact, even if the partner does not show symptoms. You should avoid sexual contact if a partner has signs or symptoms of genital herpes. Aciclovir does not prevent the transmission of herpes.

Do not exceed the recommended frequency of applications or duration of treatment.

To avoid contagion:

• Wash your hands after applying the product.
• Do not bring the lip lesion into contact with other areas of the body or with other people's skin, especially infants and children. While the lesion persists, try not to rub your face against your bedclothes if you sleep with someone else, do not share towels, and use paper towels and tissues to avoid reinfecting yourself.

If the lesion worsens or has not healed within 10 days, discontinue treatment and consult your doctor.

This medicine does not prevent subsequent outbreaks or reappearance of symptoms.

Children and Adolescents

For instructions on administering the medicine, see section 3.

Administration in children should always be done under medical supervision.

Other Medicines and Aciclovir Aurovitas Cream

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess the benefits and risks of using aciclovir cream during pregnancy.

Breastfeeding

Your doctor will assess the benefits and risks of using aciclovir cream during breastfeeding.

Driving and Using Machines

Aciclovir has no significant influence on driving or using machines.

Aciclovir Aurovitas Cream Contains Cetostearyl Alcohol and Propylene Glycol

As it contains propylene glycol, it may cause skin irritation.

As it contains cetostearyl alcohol, it may cause local skin reactions (such as contact dermatitis).

Aciclovir Aurovitas Cream Contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per application; it is essentially "sodium-free".

3. How to Use Aciclovir Aurovitas Cream

Topical use.

Follow the instructions for administration of Aciclovir Aurovitas indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Remember to use your medicine.

It should be applied to the lesions or impending lesions as soon as possible after the onset of infection. It is essential to start treatment during the period when the lesions have not yet appeared or when they first appear.

Your doctor will indicate the duration of treatment. Do not discontinue treatment before it is completed, as the infection may recur.

Adults and Children

• Apply a thin layer of cream to the affected area five times a day.
• Aciclovir cream applications should be spaced four hours apart, omitting the nighttime application. The suggested times are: 7 am, 11 am, 3 pm, 7 pm, and 11 pm.
• Treatment should be continued for 5 days. If healing has not occurred within 5 days, treatment may be extended for another 5 days, up to a total of 10 days.
• If symptoms worsen or do not improve within 10 days of treatment, discontinue use of the cream and consult your doctor.

Application of Aciclovir Aurovitas Cream

• Aciclovir cream should only be applied to the skin.
• Aciclovir cream is not for oral, ophthalmic, or vaginal use.
• Do not mix aciclovir cream with anything, including water or other medicines.

After applying aciclovir cream, wash your hands to avoid spreading it to other areas of the body or to other people.

If you think the effect of Aciclovir Aurovitas is too strong or too weak, tell your doctor or pharmacist.

Your doctor will indicate the duration of treatment with Aciclovir Aurovitas. Do not discontinue treatment before it is completed, as the healing may not be complete.

If You Use More Aciclovir Aurovitas Than You Should

If you use more aciclovir cream than you should, carefully remove the excess. Overdose is unlikely with this medicine.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested .

If You Forget to Use Aciclovir Aurovitas

In case of forgetting a dose, take it as soon as possible; however, if it is close to the time of your next application, omit the missed application and wait for the next one.

Do not take a double dose to make up for missed doses; simply continue with your usual treatment as soon as possible.

Do not exceed the recommended frequency of applications or duration of treatment.

If You Interrupt Treatment with Aciclovir Aurovitas Cream

Do Not Interrupt Treatment with Aciclovir Aurovitas Cream Without Consulting Your Doctor.

It is essential to use aciclovir cream for the indicated time to completely eliminate the infection.

4. Possible Side Effects

Like all medicines, Aciclovir Aurovitas can have side effects, although not everyone gets them.

Uncommon Side Effects (May Affect Up to 1 in 100 People):

• Transient burning or itching after application.
• Mild dryness or flaking of the skin.
• Itching sensation.

Rare Side Effects (May Affect Up to 1 in 1,000 People):

• Redness of the skin.
• Rash.

Very Rare Side Effects (May Affect Up to 1 in 10,000 People):

• Immediate hypersensitivity reactions (allergic reactions).

The signs of hypersensitivity may include:

• swelling of the face, lips, tongue, or other parts of the body (angioedema),
• rash, itching, or hives on the skin,
• shortness of breath, difficulty breathing, or wheezing,
• unexplained fever and feeling of fainting, especially when standing.

Contact a Doctor Immediately if You Have Any of These Symptoms. Stop Using Aciclovir Cream.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Aurovitas Cream

Keep Aciclovir Aurovitas out of the sight and reach of children.

Do not use Aciclovir Aurovitas after the expiration date stated on the carton. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Collection Point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aciclovir Aurovitas 50 mg/g Cream:

• The active ingredient is aciclovir.

Each gram of cream contains 50 mg of aciclovir.

• The other ingredients (excipients) are: a mixture of glycerol monostearate and polyoxyethylene-30 stearate (Arlatone 983 S), dimethicone, cetyl alcohol, liquid paraffin, white petrolatum, propylene glycol (each gram of cream contains 15 mg of propylene glycol), sodium hydroxide, and purified water.

Appearance of the Product and Package Contents

Aciclovir Aurovitas 50 mg/g cream is available in 2 g and 15 g tubes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Manufacturer:

Farmalabor, Productos Farmaceuticos S.A.

Zona Industrial de Condeixa-a-Nova

Condeixa-a-Nova, 3150-194,

Portugal

Date of Last Revision of this Package Leaflet:October 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es