Aciclovir ABC

Package leaflet: Information for the patient

ACICLOVIR ABC 5% cream

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ACICLOVIR ABC is and what it is used for

ACICLOVIR ABC contains an active substance called aciclovir, which belongs to a group of
medicines known as antivirals.
ACICLOVIR ABC is indicated for the treatment of cutaneous infections caused by the Herpes Simplex virus,
such as cold sores and primary (occurring for the first time) or
recurrent (recurring repeatedly) genital herpes.

2. What you need to know before using ACICLOVIR ABC

Do not use ACICLOVIR ABC

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

Warnings and precautions
Talk to your doctor or pharmacist before using ACICLOVIR ABC if:

• you are severely immunocompromised, meaning you have a condition in which your immune system does not function properly and your body is less able to fight infections (for example, if you have HIV or AIDS, or if you have had a bone marrow transplant).

Talk to your doctor or pharmacist if you think any of these situations apply to you before using Aciclovir ABC. In such cases, your doctor may decide to prescribe tablets instead.
Aciclovir ABC cream must not be applied inside the mouth, eyes, or vagina, as it may cause irritation.
Particular care should be taken to avoid accidental application to the eyes. If you use Aciclovir ABC for a prolonged period, sensitization reactions may occur; if this happens, treatment must be discontinued and you should consult your doctor.
If in doubt, consult your doctor or pharmacist before using Aciclovir ABC.

Other medicines and ACICLOVIR ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No clinically significant interactions have been identified.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist.
Do not use Aciclovir ABC without first consulting your doctor, who will evaluate the benefit of treatment with Aciclovir ABC for you and the potential risk to your unborn baby during pregnancy.

Breastfeeding
If you are breastfeeding or planning to breastfeed, talk to your doctor before using Aciclovir ABC.

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

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

3. How to use ACICLOVIR ABC

Use this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Apply 5 times a day at intervals of approximately 4 hours.

• ACICLOVIR ABC cream should be applied to the lesions or to the areas where they are developing as early as possible, preferably during the earliest stages (tingling, itching, burning, pain, and redness). Treatment may also be started during later stages (papules or blisters).
• Treatment should continue for at least 4 days for cold sores and for 5 days for genital herpes. If healing has not occurred, treatment may continue for up to a maximum of 10 days.

If you use more ACICLOVIR ABC than you should
If you have used more than the recommended dose, contact your doctor or pharmacist for advice. Aciclovir ABC cream is for external use only. In case of accidental ingestion, contact your doctor or pharmacist.
If you forget to use ACICLOVIR ABC

• If you forget to apply Aciclovir ABC, apply it as soon as possible when you remember. However, if it is almost time for the next application, skip the missed dose.
• Do not apply a double dose to make up for the missed application.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction, stop using Aciclovir ABC and contact your doctor immediately.

Uncommon side effects: (may affect up to 1 in 100 patients)

• temporary stinging or burning sensation after applying the cream
• moderate dryness and peeling of the skin
• itching

Rare side effects: (may affect up to 1 in 1,000 patients)

• skin irritation and redness (erythema)
• inflammation of the skin following application due to contact with the cream (contact dermatitis)

Very rare side effects: (may affect up to 1 in 10,000 patients)

• allergic reactions (hypersensitivity) including swelling of the lips, face, neck, and throat causing breathing difficulties (angioedema), and skin reactions (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 ACICLOVIR ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expires on".
The expiry date refers to the last day of that month.
Do not store above 25°C.
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.

6. Package contents and other information

What ACICLOVIR ABC contains

• The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: tefose 1500, glycerin, stearic acid, liquid paraffin, methyl p-hydroxybenzoate, purified water.

Description of the appearance of ACICLOVIR ABC and package contents
Pack containing one tube of 10 g of cream.
Marketing Authorization Holder
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72 Torino
Manufacturer
Lab.Italiano Biochimico Farmaceutico LISAPHARMA S.P.A.
Via Licinio, 11 – 22036 Erba (CO)

Patient information leaflet

ACICLOVIR ABC 800 mg tablets, 400 mg/5 ml oral suspension

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ACICLOVIR ABC is and what it is used for
2. What you need to know before taking ACICLOVIR ABC
3. How to take ACICLOVIR ABC
4. Possible side effects
5. How to store ACICLOVIR ABC
6. Contents of the pack and other information

1. What ACICLOVIR ABC is and what it is used for

ACICLOVIR ABC tablets and oral suspension contain an active substance called aciclovir, belonging to a group of medicines known as antivirals.
ACICLOVIR ABC is indicated for:

• treating Herpes simplex infections of the skin and mucous membranes, including first episodes (primary genital herpes) or recurrent episodes (recurrent genital herpes); however, Herpes simplex infections in newborns and Herpes simplex infections in immunocompromised children (with a weakened immune system, meaning their body is less able to fight infections) are excluded
• suppressing recurrent Herpes simplex infections in immunocompetent patients (with a normally functioning immune system)
• preventing Herpes simplex infections in immunocompromised patients (with a weakened immune system)
• treating chickenpox and Herpes zoster (shingles).

2. What you need to know before taking ACICLOVIR ABC

Do not take ACICLOVIR ABC

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

If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding")
Warnings and precautions
Talk to your doctor or pharmacist before taking ACICLOVIR ABC if:

• you have kidney problems
• you are over 65 years of age
• if you have a severely weakened immune system Talk to your doctor if you think any of these situations apply to you. Your doctor may reduce the dose of Aciclovir ABC. Make sure you drink plenty of fluids such as water while taking Aciclovir ABC.

Other medicines and ACICLOVIR ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• probenecid, used to treat gout;
• cimetidine, used to treat certain stomach disorders;
• mycophenolate mofetil, used to prevent rejection of transplanted organs;
• theophylline, used for respiratory problems.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist.
You must not take Aciclovir ABC without first consulting your doctor, who will assess the benefit to you and the potential risk to your baby of taking Aciclovir ABC during pregnancy.
Aciclovir may pass into breast milk. If you are breastfeeding or planning to breastfeed: talk to your
doctor before taking Aciclovir ABC.
Driving and using machines
No studies have been conducted to evaluate the effects of Aciclovir ABC on the ability to drive or use machinery. Consider the possibility of adverse effects that may affect your level of attention.
Important information about certain excipients
Aciclovir ABC 800 mg tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Aciclovir ABC 400 mg / 5 ml oral suspension contains parahydroxybenzoates
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Aciclovir ABC 400 mg / 5 ml oral suspension contains sorbitol
This medicine contains 3.15 g of sorbitol per 800 mg aciclovir dose (corresponding to 10 ml).
Sorbitol is a source of fructose. If your doctor has informed you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine.
It may cause gastrointestinal disturbances and has a mild laxative effect.

3. How to take ACICLOVIR ABC

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to take Aciclovir ABC
Oral suspension: always shake well before use.
Take Aciclovir ABC as soon as possible after the onset of infection (at the first symptoms or when the first lesions appear).
The dose you should take depends on why Aciclovir ABC has been prescribed for you. Your doctor will discuss this with you.

Treatment of Herpes simplex infections, including genital herpes

• Adults and children aged 2 years and older: the recommended dose is 200 mg five times daily.
• Children under 2 years of age: the recommended dose is half the adult dose.

Take the doses at approximately 4-hour intervals, skipping the nighttime dose.
Take Aciclovir ABC for 5 days, or longer if your doctor recommends it.
In adult patients with a severely weakened immune system (e.g. after bone marrow transplantation) or with impaired intestinal absorption, your doctor may decide to double the dose to 400 mg (half a tablet or 5 ml of oral suspension), or consider administering Aciclovir ABC intravenously.
Aciclovir ABC is not indicated for severe Herpes simplex infections in children with weakened immune systems.

Suppression of recurrences (infections that keep recurring) of Herpes simplex in immunocompetent patients (with normally functioning immune system)
The recommended dose in adults is 200 mg four times daily.
Take the doses at approximately 6-hour intervals. Your doctor may adjust the dose and the interval between doses. You must always take Aciclovir ABC exactly as directed by your doctor.
Continue taking Aciclovir ABC for as long as your doctor tells you to.
There are no available data on the suppression of Herpes simplex infections in children with normally functioning immune systems.

Prophylaxis of Herpes simplex infections in immunocompromised patients (with weakened immune system)

• Adults and children aged 2 years and older: the recommended dose is 200 mg four times daily.
• Children under 2 years of age: the recommended dose is half the adult dose.

Take the doses at approximately 6-hour intervals.
Take Aciclovir ABC for as long as your doctor tells you to.
In adult patients with a severely weakened immune system (e.g. after bone marrow transplantation) or with impaired intestinal absorption, your doctor may decide to double the dose to 400 mg (half a tablet or 5 ml of oral suspension), or consider administering Aciclovir ABC intravenously.

Treatment of chickenpox and Herpes zoster (shingles):

• The recommended dose is 800 mg (or 10 ml of oral suspension) five times daily.
• Take the doses at approximately 4-hour intervals, skipping the nighttime dose.
• Take Aciclovir ABC for 7 days.

In patients with a severely weakened immune system (e.g. after bone marrow transplantation) or with impaired intestinal absorption, your doctor may consider administering Aciclovir ABC intravenously.

Children - Treatment of chickenpox:

• Children aged 6 years and older: the recommended dose is 800 mg (or 10 ml of oral suspension) four times daily.
• Children aged 2 years and under 6 years: the recommended dose is 400 mg (or 5 ml of oral suspension) four times daily.
• Children under 2 years of age: the recommended dose is 200 mg (or 2.5 ml of oral suspension) four times daily.
• Take Aciclovir ABC for 5 days.

Administration of 20 mg/kg body weight (not exceeding 800 mg) four times daily allows for more precise dose adjustment.
There are no available data on the treatment of Herpes zoster in children with normally functioning immune systems.
For the treatment of Herpes zoster infections in children with weakened immune systems, your doctor will consider administering Aciclovir ABC intravenously.

Your doctor may also adjust the dose of Aciclovir ABC if:

• you are over 65 years of age
• you have kidney problems. If you have kidney problems, it is important to drink plenty of fluids while taking Aciclovir ABC. Talk to your doctor before taking Aciclovir ABC if any of the above applies to you.

If you take more ACICLOVIR ABC than you should
If you accidentally take too much Aciclovir ABC, contact your doctor or pharmacist for advice.
If you take too much Aciclovir ABC, you may:

• experience nausea, headache, or vomiting
• feel confused or agitated
• see or hear things that are not there (hallucinations)
• have seizures
• lose consciousness (coma)

Inform your doctor or pharmacist if you have taken too much Aciclovir ABC, and show them the medicine package.

If you forget to take ACICLOVIR ABC

• If you forget to take Aciclovir ABC, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction, stop taking Aciclovir ABC and contact your doctor immediately.

Common side effects: (may affect up to 1 in 10 people)

• headache (cephalaea)
• dizziness
• nausea
• vomiting
• diarrhoea
• abdominal pain
• itching
• skin rash, including skin reaction after exposure to sunlight (photosensitivity)
• fatigue
• fever

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

• itchy skin rash (urticaria)
• sudden and widespread hair loss

Rare side effects: (may affect up to 1 in 1,000 people)

• severe allergic reaction (anaphylaxis)
• shortness of breath (dyspnoea)
• swelling of the lips, face, neck and throat (angioedema)
• changes in some laboratory tests: increased blood urea, creatinine, bilirubin and liver enzymes

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

• confusion and agitation
• tremors
• unsteadiness when walking (ataxia)
• slurred or defective speech (dysarthria)
• Seeing or hearing things that are not there (hallucinations)
• disturbances in thought and perception related to a psychiatric disorder (psychotic symptoms)
• seizures
• drowsiness
• brain damage (encephalopathy)
• loss of consciousness (coma)
• yellowing of the whites of the eyes or skin (jaundice)
• inflammation of the liver (hepatitis)
• rapid decline in kidney function (acute kidney failure)
• pain in the lower back, in the area corresponding to the kidneys (renal pain)
• reduced number of red blood cells in the blood (anaemia)
• reduced number of white blood cells in the blood (leucopenia)
• reduced number of platelets in the blood (thrombocytopenia)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 ACICLOVIR ABC

Keep this medicine out of the sight and reach of children.
Tablets: store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
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.

6. Package contents and other information

What ACICLOVIR ABC contains
Tablets

• The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other components are: microcrystalline cellulose, sodium starch glycolate, polyvinylpyrrolidone, magnesium stearate.

Oral suspension

• The active substance is aciclovir. Each 5 ml of oral suspension contains 400 mg of aciclovir.
• The other components are: sorbitol (70% non-crystallizable), glycerol, dispersible cellulose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, black cherry flavor, purified water.

Description of the appearance of ACICLOVIR ABC and package contents
Aciclovir ABC tablets are supplied in blister packs of 35 tablets.
Aciclovir ABC 400 mg/5 ml is supplied in a pack containing a 100 ml bottle of oral suspension, equipped with a dosing syringe.

Marketing Authorization Holder
Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – Turin
Manufacturer
ABC Farmaceutici S.p.A., - Canton Moretti, 29 - Loc. San Bernardo - 10015 Ivrea (TO)