Aciclovir Viatris 5% cream 2g tube for Cold Sores

Aciclovir Viatris 5% cream for the management of outbreaks of cold sores. It can be used on adults and children over 6 years old.  Aciclovir Viatris 5% cream blocks the multiplication of the virus responsible for this condition. Aciclovir Viatris 5% cream is characterized by an eruption at the level of the mouth which takes the form of a “bouquet” of vesicles containing a clear liquid. They will become opaque or form a bubble which will rupture to give way to a scab which will fall off after a few days without leaving a scar.

 Aciclovir Viatris 5% cream helps to get rid of cold sores.

• Aciclovir Viatris 5% cream is essential to treat a cold sore at the first signs for optimal efficiency
• Aciclovir Viatris 5% is an anti-viral for topical use in the form of a cream which will be applied locally to the cold sore
• Aciclovir Viatris 5% cream will help treat cold sores and limit their progression.
• Aciclovir Viatris 5% cream's application will also soothe feelings of irritation and limit the risk of contamination.

Keep away from children. From 6 years of age. Not for Pregnant women. Apply Aciclovir Viatris 5% cream to lesion up to 5 times per day, every 3 to 4 hours, not at nights.

Contra-Indications:  If you have any doubts about the nature of the lesions on your lips, consult your doctor or pharmacist, especially if the lesions appear elsewhere than in the usual place. This cream should not be applied to the oral or vaginal mucous membranes.

Some hygiene rules should accompany the treatment with aciclovir cream such as avoiding close contact, kissing a toddler, touching the lesions and then touching eyes, eyelids with your hands.

It is not recommended to use other creams with Aciclovir 5% Viatris cream.

The use of Aciclovir 5% Viatris cream during pregnancy and breastfeeding requires the advice of your doctor or pharmacist.

Aciclovir 5% should be applied to the lesions at the first symptoms in the lips and around the lesions, 5 times a day.

Hands should be washed thoroughly before applying this cream and after. Aciclovir cream is applied with the finger from the beginning of the appearance of the first symptoms (itching or burning) before the blisters appear.  The sooner the Aciclovir cream is applied, the more effective the treatment will be.

It is even recommended to apply Aciclovir cream widely around the lesion.

Applications of Aciclovir should be spread over the day, at an interval of 3 to 4 hours and without nocturnal application. The duration of treatment is limited to 10 days, if symptoms persist, stop treatment and consult your doctor or pharmacist.

If a dose is missed, do not double the application.

Packaging: 2 g tube

Please read the following full disclosure.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 18/03/2022

1. NAME OF THE MEDICINE

ACICLOVIR VIATRIS COUNCIL 5%, cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Aciclovir................................................................................................................................ 50 mg

Per 1 g of cream.

Excipients with known effect: propylene glycol, cetyl alcohol.

For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream.

4. CLINICAL DATA

4.1. Therapeutic indications

Treatment of outbreaks of localized oral herpes (also called "cold sores").

4.2. Dosage and method of administration

Reserved for adults and children over 6 years old.

Dosage

Apply the cream 5 times a day, exclusively on herpetic lesions located on the lips, each application being spaced at least 3 to 4 hours apart and without nocturnal application. It is recommended to apply the cream widely around the lesions.

The treatment is most effective if it is started at the first symptoms announcing an outbreak of oral herpes.

The duration of treatment should not exceed 5 days without medical advice.

Wash hands carefully before and after applying the cream to the lesion.

Instructions for using the pump:

It is recommended to perform at least 3 to 4 slow and complete presses, to properly prime the pumping device from the first use and to ensure optimal delivery of the product.

Method of administration

Topical use.

4.3. Contraindications

· Children under 6 years,

· Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to valaciclovir.

4.4. Special warnings and precautions for use

Intraoral, ocular or intravaginal application of the cream is not recommended as it can be irritating to the mucous membranes. Avoid accidental contact with the eyes.

In severely immunocompromised patients (for example, patients with AIDS or patients who have undergone bone marrow transplantation), oral treatment with aciclovir should be considered. Such patients should be advised to consult their doctor immediately for the treatment of any infection.

Excipients

This medicine contains 150 mg of propylene glycol per 1 g of cream.

This medicine contains cetyl alcohol and may cause local skin reactions (for example, contact dermatitis).

4.5. Interactions with other medicines and other forms of interactions

No clinically significant interaction has been identified.

4.6. Fertility, pregnancy and lactation

Pregnancy

The use of aciclovir should only be considered if the potential benefits of treatment outweigh possible unknown risks, however, systemic exposure to aciclovir after topical application of aciclovir cream is very low.

A post-marketing pregnancy surveillance registry has documented the outcomes of pregnancies in women exposed to any form of aciclovir. The results of the registry have not shown an increase in the number of congenital anomalies in subjects exposed to aciclovir compared to the general population, and the congenital anomalies did not present any particularities or elements suggesting a common cause.

Systemic administration of aciclovir has had no embryotoxic or teratogenic effect in internationally accepted standard tests in rabbits, rats, and mice.

In non-standard tests in rats, fetal malformations were observed but only at very high subcutaneous doses associated with maternal toxicity. The clinical relevance of these findings is uncertain.

Breastfeeding

Limited data in humans show that aciclovir passes into breast milk after systemic administration. However, the dose received by an infant following maternal use of aciclovir cream would be insignificant.

Breastfeeding is possible while taking this medication.

Do not apply the cream to the nipples to avoid ingestion by the infant.

Fertility

See the clinical studies in section 5.2.

4.7. Effects on ability to drive and use machines

There are no data concerning the effects on the ability to drive vehicles and use machines.

4.8. Undesirable effects

The following convention has been used for the classification of undesirable effects in terms of frequency: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1000, < 1/100); Rare (≥ 1/10,000, < 1/1000); Very rare (< 1/10,000).

Data from clinical studies have been used to assign a frequency category to the adverse effects observed during these clinical studies with aciclovir 3% ophthalmic ointment. Because of the nature of the observed adverse effects, it is not possible to unequivocally determine which effects are related to the administration of the drug and which effects are related to the disease.

Data from spontaneous reports have been used as a basis to determine the frequency of effects observed after the product was marketed.

Skin and subcutaneous tissue disorders

Uncommon: Transient tingling or burning sensations following application of the cream, slight skin dryness or flaking, itching.

Rare: Erythema, contact dermatitis following application.

In sensitivity tests carried out, the excipients in the cream provoked a stronger reactivity than aciclovir.

Immune system disorders

Very rare: Immediate hypersensitivity reaction, including angioedema and urticaria.

Declaration of suspected adverse reactions

The declaration of suspected adverse reactions after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk balance of the medicine. Health professionals report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

No adverse effect is to be expected in case of oral ingestion of the entire contents of a 10g tube of cream containing 500mg of aciclovir.

Doses of 800 mg 5 times per day have been administered orally for 7 days in the treatment of shingles without adverse effects.

Intravenous administration of a single dose of 80 mg/kg caused no adverse effects.

5. PHARMACOLOGICAL PROPERTIES

   5.1. Pharmacodynamic properties

   Pharmacotherapeutic class: topical antiviral, ATC code: D06BB03.

   Aciclovir itself is a pharmacodynamically inactive compound. After penetrating cells infected by the herpes simplex virus (HSV), aciclovir is converted into its active form, aciclovir triphosphate. This conversion is catalyzed by HSV's thymidine kinase, an enzyme essential for the replication of the virus. Thus, the HSV ensures the synthesis of its own antiviral agent. The affinity of aciclovir for viral DNA polymerase is 10-20 times higher than its affinity for cellular DNA polymerase.

   Aciclovir selectively inhibits the viral enzymatic activity. Viral DNA polymerase incorporates aciclovir into the virus's DNA.

   Aciclovir lacks a 3'-hydroxyl radical; as a result, no other nucleotide can be added by forming 3'-5' bonds, causing the end of the chain and therefore the effective reduction of viral replication.

   The two species of herpes simplex virus, type 1 and type 2 are highly sensitive to aciclovir.

   In deeply immunocompromised patients, prolonged or repeated treatment with aciclovir may result in the selection of viral strains with reduced sensitivity. Therefore, these patients will no longer respond to aciclovir treatment.

   5.2. Pharmacokinetic properties

   Aciclovir penetrates the skin. In a steady state, intradermal concentrations of aciclovir are higher than the minimum inhibitory tissue concentration. Aciclovir is not detectable in the blood after application to the skin. The results reported below concern oral or intravenous administration.

   The main metabolite is 9-(carboxymethoxymethyl) guanine. It represents 10 to 15% of the drug excreted by the renal route. Most of the quantity of aciclovir arriving in the plasma is eliminated unchanged by the kidneys (both by glomerular filtration and tubular excretion).

   The plasma half-life of aciclovir in patients with normal renal function is approximately 3 hours. The binding to plasma proteins is relatively low (9-33%).

   Interactions by displacement of protein binding sites are therefore unlikely. 

   5.3. Preclinical safety data

   A large number of in vitro tests have shown that chromosomal lesions are possible at very high doses. During in vivo studies, chromosomal lesions were not observed. Long-term studies in rats and mice did not reveal any carcinogenic effect of aciclovir. In standardized trials according to international standards, systemic administration of aciclovir to various animal species did not result in embryotoxic or teratogenic effects. In a non-standardized test in rats, effects on the fetus were observed only at very high doses that also caused maternal toxicity.

   6. PHARMACEUTICAL DATA

   6.1. List of excipients

   Propylene glycol, white petroleum jelly, liquid paraffin, macrogol stearic glycerides, cetyl alcohol, dimethicone, purified water.

   6.2. Incompatibilities

   Not applicable.

   6.3. Shelf life

   For the tube: 3 years.

   For the bottle with metered-dose pump: 30 months.

   6.4. Special storage precautions

   Store at a temperature not exceeding 25°C.

   6.5. Nature and contents of the outer packaging

   2 g in a tube (varnished aluminum).

   2 g in a metered-dose pump bottle (polypropylene) with a piston (LDPE).

   6.6. Special precautions for disposal and handling

   No special requirements.

   7. MARKETING AUTHORIZATION HOLDER

   VIATRIS HEALTH

   1, TURIN STREET

   69007 LYON

   8. MARKETING AUTHORIZATION NUMBER(S)

   · 34009 354 005 6 7: 2 g in tube (varnished aluminum).

   · 34009 376 860 6 8: 2 g in metered-dose pump bottle (polypropylene).

   9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

   [to be completed later by the holder]

   10. DATE OF UPDATE OF THE TEXT

   [to be completed later by the holder]

   11. DOSIMETRY

   Not applicable.

   12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

   Not applicable.

   CONDITIONS OF PRESCRIPTION AND DISPENSING

   Over-the-counter medication.