ACKLAB 5 % Krem

Treść ulotki

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

ACKLAB 5% cream

Aciclovir

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 10 days.

Contents of this leaflet

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

1. What ACKLAB is and what it is used for

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

2. What you need to know before you use 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
Consult your doctor before using ACKLAB

• if you are not sure you have herpes labialis,
• if you have a particularly severe form of herpes labialis,
• if your immune system is compromised (for example if you have undergone a bone marrow transplant or if you have AIDS). In this case, consult your doctor for the treatment of any infection. Use with caution with ACKLAB
• ACKLAB is for external use only and should only be used to treat lesions on the lips caused by herpes simplex. Therefore, do not apply ACKLAB to the mucous membranes of the mouth, nose, eyes, and do not use it to treat genital herpes.
• Do not rub the lesions unnecessarily and do not touch them with the towel to avoid worsening or transmitting the infection. Always wash your hands before and after applying the cream or after touching the lesions. Do not touch your eyes in particular 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 long period of time, sensitization phenomena (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, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, ACKLAB should only be used after consulting your doctor,
who will assess the possible risks and benefits for the mother and for the baby.

Driving and operating machinery
No adverse effects on the ability to drive and operate machinery are known.

ACKLAB contains methyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate, which can cause allergic reactions (even
delayed)

3. How to use ACKLAB

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
ACKLAB is for external use only.
Start treatment as soon as the first symptoms of the infection appear (e.g. itching and/or burning and/or pain). If you have not started treatment as soon as you had the first symptoms
of the infection, you can also start it when blisters appear. ACKLAB can be used both
in the early stages of the infection (itching and/or burning and/or pain), and in the blister stage.
Wash your hands before and after applying the cream and avoid rubbing the lesions unnecessarily or
touching them with a towel to prevent worsening or transmission of the infection.

How much
Caution: do not exceed the recommended dose.

Adults and adolescents over the age of 12 years
The recommended dose is one application 5 times a day at intervals of approximately 4 hours, skipping
the night application. Apply the amount of cream needed to cover the entire infected area,
including the outer edges of any blisters.

Children under the age of 12 years
ACKLAB should not be used in children under 12 years of age (see paragraph Do not use

ACLAB).

For how long
Continue treatment for at least 4 days. If you are not healed after 4 days, you can continue the
treatment for up to a maximum of 10 days
If the lesions are still present after 10 days, consult your doctor.
Also consult your doctor if the disorder recurs or if you notice any
recent change in its characteristics

If you use more ACKLAB than you should
Even if the cream is applied in excessive amounts or is ingested, no adverse effects are expected.
However, if you have used a dose higher than recommended or have accidentally ingested
ACKLAB, inform your doctor immediately or go to the nearest hospital.

If you forget to use ACKLAB
If you have forgotten to apply the cream, do not worry. Apply the cream as soon as you remember and then
continue treatment as before. Do not use a double dose to compensate for forgetting the
dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• temporary burning or pain after application of ACKLAB
• moderate dryness and scaling of the skin
• itching. Rare side effects (may affect up to 1 in 1,000):
• 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):
• immediate allergic reactions (hypersensitivity) including swelling of the lips, face, neck and throat (angioedema) and skin reaction (urticaria). If you experience an allergic reaction with symptoms such as facial swelling, stop using the product and seek immediate medical attention. These side effects are generally transient. Adherence to the instructions contained in the

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 at a temperature above 25 °C. Do not refrigerate.
Do not use this medicine after the expiry date which is stated on the packaging after Expiry. The
expiry date refers to the last day of the month. The expiry date refers to the product
in intact packaging, correctly stored.
After the first opening of the tube, the medicine must be used within 3 months; after this
period, any remaining medicine must be disposed of.
Do not dispose of any medicine in 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 have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What ACKLAB contains:

• the active ingredient 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 packACKLAB is presented in the form of a white and homogeneous cream. The pack contains 1 tube of 2 g of cream. MARKETING AUTHORISATION HOLDERSF Group S.r.l. - Via Tiburtina 1143 - 00156 Rome

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