Leaflet: information for the user

ACICLOVIR SANDOZ CARE 50 mg/g cream

Read this leaflet carefully before you start to use this medicine because it contains important information for you.

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

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

1.What is Aciclovir Sandoz Care and what it is 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.Contents of the pack and additional information

This medicine belongs to a group of medicines called topical antivirals.

It is indicated for the local relief of symptoms caused by cold sores (herpes labial), such as: itching, burning or tingling.

Consult a doctor if it worsens or does not improve in 10 days.

Do not use Aciclovir Sandoz Care:

• if you are allergic to aciclovir or 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 on the mucous membrane of the mouth, eye, or vagina as it may cause irritation. Be especially careful 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 frequency of applications or duration of treatment.
• Before starting treatment with this medication, immunocompromised patients (e.g., patients with HIV infection (AIDS), individuals who have received a transplant, or those undergoing radiation or chemotherapy treatment), must consult their doctor.
• As herpes labial is a recurrence of an infection within the mouth that is usually contracted at an early age, a first medical diagnosis is necessary, especially in children, in whom the symptoms of this first infection may be overlooked or confused with dental problems or other oral processes.
• In case of severe illness or frequent recurrences, your doctor should consider systemic treatment.

Children and adolescents

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

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

Other medications and Aciclovir Sandoz Care

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

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

Pregnancy and breastfeeding

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

Pregnancy

There is insufficient 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.

The experience in humans is limited, so the topical use of aciclovir should only be considered when the potential benefits outweigh the unknown possible risks.

Breastfeeding

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

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Aciclovir Sandoz Care contains cetomacrogol, propylene glycol, and sodium

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

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 g of cream; it is essentially "sodium-free".

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

This medication is for exclusive use on the skin of the lip of the mouth.

The medication should 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 completed, as the infection caused by the virus may reappear.

Adults and children over 12 years old

Apply five times a day, approximately every four hours, excluding 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 in 5 days, treatment may be extended for an additional 5 days to a total of 10 days.

Consult a doctor if symptoms worsen or do not improve after 10 days.

After applying this medication, wash your hands to prevent the spread of the lesion to other areas of the body or the transmission of the infection to others.

If you estimate that the action 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 you will experience symptoms of intoxication due to its 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Aciclovir Sandoz Care

Do not use a double dose to compensate for the missed dose, continue with the usual treatment as soon as possible.

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

If you interrupt treatment with Aciclovir Sandoz Care

Do not interrupt treatment before the recommended time, as your healing may not be complete and your disease may reappear.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Less common adverse effects(may affect up to 1 in 100 people):

• Mild burning or itching sensations after applying aciclovir,
• Mild dryness or flaking of the skin,
• Sensation of pruritus.

Rare adverse 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, more frequently, the substances responsible are components of the cream rather than aciclovir.

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

• Immediate hypersensitivity reactions including angioedema (inflammatory process of the deep skin layer that manifests with inflammation of the throat or difficulty swallowing or breathing). If this effect is very intense, seek medical attention as it requires emergency measures.

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

Reporting Adverse Effects

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

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

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

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 vaseline, propylene glycol, sodium hydroxide (E 524) and purified water.

Appearance of the product and contents of the packaging

White or almost white cream presented in aluminium tubes of 2 or 15 g that are packaged in cardboard boxes.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: July 2022

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/