Package leaflet: Information for the patient

ACKLAB 5% cream

Aciclovir
Please read this leaflet carefully before using this medicine because it contains
important information for you.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 10 days.

Contents of this leaflet

What ACKLAB is and what it is used for
What you need to know before using ACKLAB
How to use ACKLAB
Possible side effects
How to store ACKLAB
Contents of the pack and other information

1. What ACKLAB is and what it is used for

ACKLAB contains the active substance aciclovir, which is used for the treatment of infections caused by herpes viruses, including the herpes simplex virus.
ACKLAB is used in adults and adolescents over 12 years of age for the treatment of lip infections (recurrent herpes labialis) caused by the herpes simplex virus.
Consult your doctor if lip lesions are still present after 10 days.

2. What you need to know before using ACKLAB

Do not use ACKLAB

if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6),
in children under 12 years of age.

Warnings and precautions
Talk to your doctor before using ACKLAB

if you are unsure whether you have cold sores,
if you have a particularly severe form of cold sores,
if your immune system is weakened (for example, if you have undergone a bone marrow transplant or have AIDS). In such cases, consult your doctor for treatment of any infection.

Be careful with ACKLAB:

ACKLAB is for external use only and should only be used to treat lesions on the lips caused by herpes simplex. Do not apply ACKLAB to the mucous membranes of the mouth, nose, or eyes, and do not use it to treat genital herpes.
Do not rub the lesions unnecessarily and avoid touching them with a towel to prevent worsening or spreading the infection. Always wash your hands before and after applying the cream or after touching the lesions. In particular, avoid touching your eyes after touching the lesions or applying the cream. If the cream accidentally comes into contact with your eyes, rinse them thoroughly with lukewarm water. If you use ACKLAB for a prolonged period, sensitization reactions (allergic reactions) may occur. If this happens, stop treatment and consult your doctor.

Other medicines and ACKLAB
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is unlikely that ACKLAB will interact significantly with other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, ACKLAB should only be used after consulting your doctor, who will evaluate the potential risks and benefits for both mother and child.

Driving and using machines
No adverse effects on the ability to drive or use machinery are known.

ACKLAB contains methyl 4-hydroxybenzoate
This medicine contains methyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use ACKLAB

Use this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions.
If in doubt, consult your doctor or pharmacist.
ACKLAB is for external use only.
Start treatment as soon as the first symptoms of infection appear (e.g. itching and/or burning and/or pain).
If you did not start treatment immediately upon experiencing the first symptoms of infection, you may begin
treatment even when blisters appear. ACKLAB can be used both in the early stage of infection (itching and/or
burning and/or pain), and during the blister stage.
Wash your hands before and after applying the cream, and avoid unnecessarily rubbing the lesions or touching
them with a towel, to prevent worsening or spreading of the infection.

Dosage
Warning: Do not exceed the recommended dose.

Adults and adolescents aged over 12 years
The recommended dose is one application five times daily at intervals of approximately 4 hours, skipping the
night-time application. Apply enough cream to cover the entire affected area, including the outer edges of any blisters.

Children under 12 years of age
ACKLAB must not be used in children under 12 years of age (see section Do not use ACKLAB).

Duration of treatment
Continue treatment for at least 4 days. If you have not healed after 4 days, you may continue treatment for up to a maximum of 10 days.
If lesions are still present after 10 days, consult your doctor.
Also consult your doctor if the condition recurs repeatedly or if you notice any recent changes in its characteristics.

If you use more ACKLAB than you should
Even if excessive amounts of the cream are applied or if it is accidentally ingested, adverse effects are not expected.
However, if you have used more than the recommended dose or have accidentally ingested ACKLAB, inform your doctor immediately or go to the nearest hospital.

If you forget to use ACKLAB
If you forget to apply the cream, do not worry. Apply it as soon as you remember, then continue treatment as before.
Do not apply a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ACKLAB can cause side effects, although not everyone experiences them.
The side effects reported for ACKLAB are:
Uncommon side effects (may affect up to 1 in 100 people):

burning or temporary pain after application of ACKLAB
moderate dryness and peeling of the skin
itching. Rare side effects (may affect up to 1 in 1,000 people):
redness of the skin (erythema)
skin inflammation following application due to contact with the cream (contact dermatitis). Very rare side effects (may affect up to 1 in 10,000 people):
immediate allergic reactions (hypersensitivity) including swelling of the lips, face, neck and throat (angioedema) and skin reaction (urticaria). If an allergic reaction occurs with symptoms such as facial swelling, stop using the product and contact your doctor immediately. These side effects are generally temporary. Following the instructions in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ACKLAB

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Do not refrigerate.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of the month. The expiry date applies to the product in its original, unopened packaging, correctly stored.
After first opening the tube, the medicine should be used within 3 months; after this period, any remaining medicine must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the information about the medicine available; therefore, retain both the carton and the package leaflet.

6. Contents of the pack and other information

What ACKLAB contains:

the active substance is aciclovir; one gram of cream contains 50 mg of aciclovir
the other ingredients are Tefose 1500; Glycerin; Stearic acid; Liquid paraffin; Methyl parahydroxybenzoate; Purified water.

Description of the appearance of ACKLAB and contents of the pack
ACKLAB is a white, homogeneous cream. The pack contains one tube with 2 g of cream.

Marketing Authorisation Holder
SF Group S.r.l. - Via Tiburtina 1143 - 00156 Rome, Italy

Manufacturer
SPECIAL PRODUCT’S LINE S.P.A.
VIA FRATTA ROTONDA VADO LARGO, 1
03012, Anagni (FR) – Italy