Aciclovir Sandoz Care 50 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ACICLOVIR SANDOZ CARE 50 mg/g cream

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

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 10 days.

Contents of the leaflet

1. What Aciclovir Sandoz Care is and what it is used for
2. What you need to know before using Aciclovir Sandoz Care
3. How to use Aciclovir Sandoz Care
4. Possible side effects
5. How to store Aciclovir Sandoz Care
6. Contents of the pack and other information

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

This medicine belongs to a group of medicines called topical antiviral agents.

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

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

2. What you need to know before using Aciclovir Sandoz Care

Do not use Aciclovir Sandoz Care:

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

Warnings and precautions

Talk to your doctor or pharmacist before using Aciclovir Sandoz Care.

• Do not apply on mucous membranes of the mouth, eye, or vagina, as this may cause irritation. Take special care to avoid accidental entry into the eye. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
• Do not exceed the recommended frequency of application or the duration of treatment.
• Immunocompromised patients (e.g., patients with HIV infection (AIDS), organ transplant recipients, or those undergoing radiotherapy or chemotherapy) should consult their doctor before starting treatment with this medicine.
• Since cold sores are a recurrence of an infection acquired early in life, an initial medical diagnosis is necessary, especially in children, in whom symptoms of the primary infection may go unnoticed or be mistaken for teething problems or other oral conditions.
• In cases 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 carried out under medical supervision.

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

Other medicines and Aciclovir Sandoz Care

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

Pregnancy and breastfeeding

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

Pregnancy

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

Experience in humans is limited; therefore, cutaneous use of aciclovir should only be considered when the potential benefits outweigh the possible unknown risks.

Breastfeeding

There is no information available on aciclovir levels in breast milk following topical administration.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or none.

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

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

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

This medicine contains less than 1 mmol of sodium (23 mg) per gram of cream; essentially “sodium-free”.

3. How to use Aciclovir Sandoz Care

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is for cutaneous use only on the lip of the mouth.

The medicine should be applied as soon as possible after the appearance of signs or symptoms of the condition.

Remember to use your medicine. Do not stop treatment prematurely, as the viral infection may recur.

Adults and children over 12 years of age

Apply five times daily, approximately every four hours, except during sleeping 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 within 5 days, treatment may be extended for another 5 days, up to a maximum of 10 days total.

Consult a doctor if your condition worsens or does not improve after 10 days.

After applying this medicine, wash your hands to prevent spreading the lesion to other parts of the body or transmitting it to other people.

If you feel that 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

Cases of intoxication are unlikely due to its external use; however, consult your doctor or pharmacist immediately.

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

If you forget to use Aciclovir Sandoz Care

Do not use a double dose to make up for missed doses. Continue with your regular treatment as soon as possible.

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

If you stop treatment with Aciclovir Sandoz Care

Do not interrupt treatment earlier than advised by your doctor, as healing may not be complete and your condition may recur.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

• transient burning or itching after application of aciclovir,
• mild dryness or peeling 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) following application of the medicine. When sensitization tests have been performed, it has been shown that the substances causing it are more frequently components of the cream rather than aciclovir itself.

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

• immediate hypersensitivity reactions including angioedema (inflammatory condition affecting deep layers of the skin, manifesting as swelling of the throat or difficulty swallowing or breathing). If this effect is severe, seek medical attention immediately, as emergency measures may be required.

Prolonged use of the cream may lead to sensitization phenomena; if these occur, treatment should be discontinued and a doctor consulted.

Reporting of 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 leaflet. You may also report them directly via the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Sandoz Care

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the container after CAD/EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Sandoz Care 50 mg/g cream

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

Description of the product and contents of the container

White or almost white cream, supplied in aluminum tubes containing 2 g or 15 g, packed in cardboard boxes.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Liconsa S.A.

Avda. Miralcampo, No. 7

Miralcampo Industrial Estate (Azuqueca de Henares)

19200 – Spain

or

Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí

Barcelona, Spain

Date of the most recent review of this leaflet: July 2022

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