ACICLOVIR SANDOZ CARE 50 mg/g CREAM

Introduction

Leaflet: information for the user

ACICLOVIR SANDOZ CARE 50 mg/g cream

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

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 10 days

Contents of the leaflet

1. What is Aciclovir Sandoz Care and what is it used for
2. What you need to know before starting to use Aciclovir Sandoz Care
3. How to use Aciclovir Sandoz Care
4. Possible side effects
5. Storage of Aciclovir Sandoz Care
6. Package contents and additional information

1. What is Aciclovir Sandoz Care and what is it used for

This medication belongs to the group of medications called antivirals, for topical use.

It is indicated for the local relief of symptoms caused by cold sores (fever blisters), such as: itching, stinging or tingling.

You should consult a doctor if it worsens or does not improve within 10 days.

2. What you need to know before starting to use Aciclovir Sandoz Care

Do not use Aciclovir Sandoz Care:

• if you are allergic to aciclovir or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aciclovir Sandoz Care.

• Do not apply to the mucous membranes of the mouth, eye, or vagina, as it may cause irritation. Special care should be taken to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.
• Do not exceed the recommended application frequency or treatment duration.
• Before starting treatment with this medication, immunodeficient patients (e.g., patients with HIV (AIDS), those who have received a transplant, or who are undergoing radiotherapy or chemotherapy) should consult their doctor.
• Since cold sores are a recurrence of an infection inside the mouth that is usually contracted at an early age, a medical diagnosis is necessary, especially in the case of children, in whom the symptoms of this first infection may go unnoticed or be confused with teething disorders or other oral conditions.
• In case of severe disease or frequent recurrences, your doctor should consider systemic treatment.

Children and adolescents

Application in children under 12 years of age should always be done under medical supervision.

Administration in children over 12 years of age is the same as for adults, see below.

Other medications and Aciclovir Sandoz Care

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

No interactions with aciclovir associated with this route of administration (topical) have been described.

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 medication.

Pregnancy

There is not enough information on the effects of administering the cream during pregnancy. Systemic administration of aciclovir to rats and rabbits has not produced teratogenic or embryotoxic effects.

Human experience is limited, so the cutaneous use of aciclovir should only be considered when the potential benefits outweigh the unknown risks.

Breastfeeding

No information is available on aciclovir levels in breast milk after topical administration.

Driving and using machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

Aciclovir Sandoz Care contains cetyl alcohol, propylene glycol, and sodium

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

This medication contains 0.15 g of propylene glycol per gram of cream. Propylene glycol may cause skin irritation. This medication contains propylene glycol; do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

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

3. How to use Aciclovir Sandoz Care

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is for cutaneous use only on the lip.

The medication will be administered as soon as possible after the appearance of signs or symptoms of the process.

Remember to use your medication. Do not stop treatment before it is finished, as the infection caused by the virus may recur.

Adults and children over 12 years of age

Apply five times a day, approximately every four hours, except during sleep hours.

Apply a sufficient amount of product to cover the affected area with a thin layer.

Continue treatment for 5 days. If complete healing has not occurred after 5 days, treatment may be extended for another 5 days, up to a total of 10 days.

You should consult a doctor if it worsens or does not improve after 10 days.

After applying this medication, wash your hands to avoid spreading the lesion to other areas of the body or infecting others.

If you think the effect of aciclovir is too strong or too weak, inform your doctor or pharmacist.

If you use more Aciclovir Sandoz Care than you should

It is unlikely that poisoning will occur due to external use; however, consult your doctor or pharmacist immediately.

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 medication and the amount ingested.

If you forget to use Aciclovir Sandoz Care

Do not use a double dose to make up for forgotten doses; continue with the usual treatment as soon as possible.

Do not exceed the recommended application frequency or treatment duration.

If you interrupt treatment with Aciclovir Sandoz Care

Do not interrupt treatment before your doctor advises you to do so, as your healing may not be complete and your disease may recur.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Rare side effects(may affect up to 1 in 100 people):

• burning or itching sensation after applying aciclovir,
• mild dryness or flaking of the skin,
• pruritus sensation.

Very rare side effects(may affect up to 1 in 1,000 people):

• redness of the skin,
• contact dermatitis (a type of local allergy) after applying the medication. When sensitivity tests have been performed, it has been shown that the substances that cause it are more frequently components of the cream rather than aciclovir.

Very rare side effects(may affect up to 1 in 10,000 people):

• immediate hypersensitivity reactions, including angioedema (an inflammatory process of the deep skin that manifests with throat inflammation or difficulty swallowing or breathing). If this effect is very intense, you should go to a medical center as it requires emergency measures.

Prolonged use of the medication in cream may lead to sensitivity phenomena; if they appear, treatment should be discontinued and a doctor consulted.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aciclovir Sandoz Care

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

This medication does not require special storage conditions. Keep in the original packaging.

Do not use this medication after the expiration date shown on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Aciclovir Sandoz Care 50 mg/g cream

• The active ingredient is aciclovir. Each gram contains 50 mg of aciclovir.
• The other components are: arlatone 983 S, dimethicone, cetyl alcohol, liquid paraffin, white petrolatum, propylene glycol, sodium hydroxide (E 524), and purified water.

Appearance of the product and package contents

White or almost white cream, presented in aluminum tubes of 2 or 15 g, packaged in cardboard boxes.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Liconsa S.A.

Avda. Miralcampo, Nº 7

Pol. Ind. Miralcampo (Azuqueca de Henares)

19200 – Spain

or

Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí

Barcelona, Spain

Date of the last revision of this leaflet:July 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/