Aciclovir EG

Package leaflet: Information for the patient

ACICLOVIR EG 200 mg tablets, 400 mg tablets, 800 mg tablets, 400 mg/5 ml oral suspension

Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ACICLOVIR EG contains the active substance aciclovir, which belongs to a group of medicines used against viral infections (antivirals).
ACICLOVIR EG is used:

• for the treatment of skin and mucous membrane infections caused by the Herpes simplex virus, including genital herpes (primary or recurrent), except for infections in newborns and severe infections in immunocompromised children;
• to treat symptoms of Herpes simplex recurrence in people with normal immune defenses;
• to prevent Herpes simplex infections in people with weakened immune systems;
• for the treatment of chickenpox and Herpes zoster.

2. What you should know before taking ACICLOVIR EG

Do not take ACICLOVIR EG

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

Warnings and precautions
Talk to your doctor or pharmacist before taking ACICLOVIR EG:
Take this medicine with caution if you have kidney problems or if you are elderly, as a dose reduction may be necessary.
Drink plenty of water to maintain adequate hydration if you are taking high oral doses of aciclovir.
Avoid using this medicine for long periods or for repeated treatments, especially if you have a weakened immune system.

Other medicines and ACICLOVIR EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor and take this medicine with caution if you are using the following medicines:

• probenecid, used for gout;
• cimetidine, used to treat stomach ulcers;
• mycophenolate mofetil, used in transplant patients;
• theophylline, used for asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if clearly needed and under direct medical supervision.

Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery.

ACICLOVIR EG 200 mg tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

ACICLOVIR EG 200 mg, 400 mg, 800 mg tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

ACICLOVIR EG 400 mg/5 ml oral suspension contains sodium, sorbitol and parahydroxybenzoates
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of suspension, i.e. essentially 'sodium-free'.
This medicine contains sorbitol. Sorbitol is a source of fructose. If your doctor has told 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, speak with your doctor before you (or the child) take this medicine.
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).

3. How to take ACICLOVIR EG

Always take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.
Instructions for use of ACICLOVIR EG oral suspension: shake the suspension well before use.
The package includes a dosing dispenser with markings corresponding to levels of 5 ml and 10 ml.
To open the bottle, remove the dosing dispenser, press down and turn at the same time. To close, screw tightly.
Treatment of Herpes simplex infections: the recommended dose is 1 tablet of 200 mg, taken 5
times daily at approximately 4-hour intervals, excluding the night.
Treatment should continue for 5 days, but may need to be prolonged in cases of severe primary
infections.
In patients with very low immune defenses (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg in tablets or 5 ml of oral suspension, or alternatively, intravenous administration of the medicine may be considered.
Treatment should be started as soon as the first symptoms appear, such as itching or burning sensations, or as soon as the first lesions are observed.
Treatment of recurrent Herpes simplex infections in patients with normal immune defenses: the recommended dose is 1 tablet of 200 mg taken 4 times daily at 6-hour intervals.
In some cases, 400 mg in tablets or 5 ml of oral suspension twice daily at 12-hour intervals, or 200 mg three times daily at 8-hour intervals or twice daily at 12-hour intervals, may also be effective.
In some patients, recurrence of the infection may occur.
Treatment should be periodically interrupted at intervals of 6 or 12 months to monitor any changes in the disease.
Prevention of Herpes simplex infections in patients with low immune defenses: the recommended dose is 1 tablet of 200 mg taken 4 times daily at 6-hour intervals.
In patients with very low immune defenses (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg in tablets or 5 ml of oral suspension, or alternatively, intravenous administration of the medicine may be considered.
Treatment of Herpes zoster and chickenpox: the recommended dose is 800 mg in tablets or
10 ml of oral suspension, taken 5 times daily at approximately 4-hour intervals, excluding the night.
Take the medicine throughout the day according to the following dosing schedule:

Treatment should be continued for 7 days.
In patients with very low immune defenses (e.g., after bone marrow transplantation) or in patients with reduced intestinal absorption, intravenous administration of the medication may be considered.
Treatment should be started as soon as the first symptoms appear, such as itching and burning sensation, or as soon as the first lesions are observed.

Use in children
Treatment of Herpes simplex infections and prevention of Herpes simplex infections in children with
weakened immune systems :

• Children older than 2 years: the dosage is the same as for adults.
• Children younger than 2 years: the recommended dose is half that of adults (except for severe Herpes simplex infections in immunocompromised children, for which ACICLOVIR EG is not indicated).

Treatment of chickenpox (varicella) :

• Children older than 6 years: the recommended dose is 800 mg as tablets (or 10 ml of suspension) 4 times daily.
• Children between 2 and 6 years of age: the recommended dose is 400 mg as tablets (or 5 ml of suspension) 4 times daily.
• Children younger than 2 years: the recommended dose is 200 mg (2.5 ml of suspension) 4 times daily. Administration of 20 mg/kg body weight (without exceeding 800 mg) 4 times daily allows for a more precise dose adjustment. Treatment should be continued for 5 days.

Treatment of Herpes zoster in children with weakened immune systems: in such cases, intravenous aciclovir administration may be necessary.

Use in elderly patients
The doctor will adjust the dosage according to kidney function.
It is advisable to drink plenty of fluids to maintain adequate hydration.

Use in patients with kidney problems
Aciclovir should be used with caution in patients with kidney problems.
For the treatment of Herpes simplex infections in patients with severe kidney problems, the recommended dose is 200 mg twice daily, approximately 12 hours apart.
For the treatment of chickenpox and Herpes zoster, the recommended dose is 800 mg of aciclovir as tablets or 10 ml of suspension, twice daily at approximately 12-hour intervals, or three times daily at approximately 8-hour intervals, depending on the severity of kidney problems.
It is advisable to drink plenty of fluids to maintain adequate hydration.

If you take more ACICLOVIR EG than you should
In case of accidental and prolonged overdose, symptoms such as nausea, vomiting, headache, and confusion may occur.
If you take an excessive dose of ACICLOVIR EG, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to take ACICLOVIR EG
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Common: (may affect up to 1 in 10 people)

• headache, dizziness;
• nausea, vomiting;
• diarrhoea and abdominal pain;
• itching and skin rash;
• sensitivity to light;
• fatigue;
• fever.

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

• urticaria;
• rapid and widespread hair loss*.

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

• sudden, potentially life-threatening allergic reaction (anaphylaxis);
• breathing problems (dyspnoea);
• liver problems with increased bilirubin and some liver enzymes;
• swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing and breathing (angioedema);
• increased levels of nitrogen and creatinine in the blood.

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

• reduction in the number of red blood cells (anaemia), white blood cells (leucopenia) and platelets (thrombocytopenia) in the blood;
• agitation, confusion, tremor;
• problems with muscles involved in movement (ataxia) and speech (dysarthria);
• hallucinations, psychotic symptoms, seizures;
• somnolence;
• brain damage (encephalopathy) and coma;
• liver problems (hepatitis and jaundice);
• severe kidney problems (renal failure) and kidney pain.

* Rapid and widespread hair loss has been associated with a wide range of medical conditions and with the use of medicines; therefore, the relationship of this event to aciclovir therapy is uncertain.
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 ACICLOVIR EG

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 "Exp".
The expiry date refers to the last day of that month.
800 mg tablets: store in a dry place.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACICLOVIR EG contains
ACICLOVIR EG 200 mg tablets

• The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.
• The other components are: lactose, microcrystalline cellulose, sodium starch glycolate, polyvinylpyrrolidone, magnesium stearate.

ACICLOVIR EG 400 mg tablets

• The active substance is aciclovir. Each tablet contains 400 mg of aciclovir.
• The other components are: microcrystalline cellulose, sodium starch glycolate, polyvinylpyrrolidone, red iron oxide (E 172), magnesium stearate.

ACICLOVIR EG 800 mg 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.

ACICLOVIR EG 400 mg/5 ml oral suspension

• The active substance is aciclovir. 5 ml of oral suspension contain 400 mg of aciclovir.
• The other components are: sorbitol (70% non-crystallizable), glycerol, microcrystalline cellulose and sodium carboxymethylcellulose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, orange flavour, purified water.

Description of the appearance of ACICLOVIR EG and contents of the pack
Aciclovir EG 200 mg tablets: pack containing 25 tablets of 200 mg in blister.
Aciclovir EG 400 mg tablets: pack containing 25 tablets of 400 mg in blister.
Aciclovir EG 800 mg tablets: pack containing 35 tablets of 800 mg in blister.
Aciclovir EG 400 mg/5 ml oral suspension: pack containing one glass bottle with 100 ml of oral suspension and an oral dosing syringe with markings corresponding to 5 ml and 10 ml volumes.

Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milano
Manufacturer
Tablets:
Doppel Rozzano S.r.l.- Via Volturno, 48 – Rozzano
Vamfarma S.r.l. - Via Kennedy, 5 - 26833 Comazzo (LO)
Oral suspension:
Cosmo SpA Via C. Colombo, 1 20020 Lainate (MI)
Package leaflet: information for the user

ACICLOVIR EG 5% cream

Generic medicine
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 further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

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

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

ACICLOVIR EG is a topical cream containing the active substance aciclovir,
which belongs to a group of medicines used to treat viral infections (antivirals).
ACICLOVIR EG is used to treat infections caused by the Herpes simplex virus,
both on the lips (cold sores) and on the genitals (primary or recurrent genital herpes).
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before using ACICLOVIR EG

Do not use ACICLOVIR EG

• if you are allergic to aciclovir, valaciclovir, propylene glycol, 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 EG.
ACICLOVIR EG must not be applied to the eyes or to the mucous membranes inside the mouth or vagina, as it may cause irritation.
Consult your doctor and use this medicine with caution if you have a weakened immune system, as you are more susceptible to infections (for example, if you have AIDS or have undergone a bone marrow transplant). In such cases, oral administration of aciclovir may be necessary.
Avoid prolonged treatment, as it may cause an allergic reaction (sensitization). If this occurs, stop treatment immediately and consult your doctor.
Other medicines and ACICLOVIR EG
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if clearly needed and under the direct supervision of your doctor.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery.
ACICLOVIR EG contains cetostearyl alcohol, sodium lauryl sulfate, and propylene glycol
This medicine contains cetostearyl alcohol, which may cause localised skin reactions (e.g. contact dermatitis).
This medicine contains 7.5 mg of sodium lauryl sulfate per g of cream. Sodium lauryl sulfate may cause skin irritation (sensation of itching or burning) or intensify skin reactions caused by other medicines when applied to the same area.
This medicine contains 200 mg of propylene glycol per g of cream.

3. How to use ACICLOVIR EG

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment consists of 5 applications per day at approximately 4-hour intervals.
Apply ACICLOVIR EG cream to the lesions or to areas where lesions are developing as soon as you notice the first symptoms of infection, such as itching, burning sensation, and pain (prodromal symptoms or erythema). Treatment may also be started at later stages, when small skin elevations (papules) or blisters appear.
Treatment should continue for at least 4 days for cold sores (labial herpes) 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 EG than you should
In case of accidental ingestion of a large amount of ACICLOVIR EG, contact your doctor immediately or go to the nearest hospital emergency department.
Cases of overdose have not been reported. Even if the entire contents of the tube of cream were ingested, adverse effects are not expected.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people):

• transient burning or pain;
• moderate dryness and shedding of the outer layer (desquamation) of the skin;
• itching.

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

• redness of the skin (erythema);
• inflammatory skin reaction (contact dermatitis), mainly due to components of the base cream.

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

• allergic reactions manifesting as swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema), hives.

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 EG

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
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. Contents of the pack and other information

What ACICLOVIR EG contains

• The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: poloxamer 407, cetostearyl alcohol, sodium lauryl sulfate, white soft paraffin, liquid paraffin, sucrose monopalmitate, propylene glycol (E1520), purified water.

Description of the appearance of ACICLOVIR EG and contents of the pack
Pack containing one tube of 3 g of cream.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 – 20136 Milan – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – Cortemaggiore (PC)
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)
Patient Information Leaflet

ACICLOVIR EG 5% cream

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 others, even if their symptoms are the same as yours, as it may 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 EG is and what it is used for
2. What you need to know before using ACICLOVIR EG
3. How to use ACICLOVIR EG
4. Possible side effects
5. How to store ACICLOVIR EG
6. Contents of the pack and other information

2. What ACICLOVIR EG is and what it is used for

ACICLOVIR EG is a cream for application to the skin that contains the active substance aciclovir,
which belongs to a group of medicines used to treat viral infections (antivirals).
ACICLOVIR EG is used to treat infections caused by the Herpes simplex virus, both on the
lips (cold sores) and in the genital area (primary or recurrent genital herpes).

2. What you need to know before using ACICLOVIR EG

Do not use ACICLOVIR EG

• if you are allergic to aciclovir, valaciclovir, propylene glycol, 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 EG.
ACICLOVIR EG must not be applied to the eyes or to the internal mucous membranes of the mouth or vagina, as it may cause irritation.
Consult your doctor and use this medicine with caution if you have a weakened immune system, as you are more susceptible to infections (for example, if you have AIDS or have undergone a bone marrow transplant). In such cases, oral administration of aciclovir may be necessary.
Avoid prolonged treatment, as it may lead to an allergic reaction (sensitization). If this occurs, stop treatment immediately and consult your doctor.
Other medicines and ACICLOVIR EG
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under the direct supervision of your doctor.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery.
ACICLOVIR EG contains cetearyl alcohol, sodium lauryl sulfate, and propylene glycol
This medicine contains cetearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis).
This medicine contains 7.5 mg of sodium lauryl sulfate per gram of cream. Sodium lauryl sulfate may cause skin irritation (sensation of itching or burning) or intensify skin reactions caused by other medicines when applied to the same area.
This medicine contains 200 mg of propylene glycol per gram of cream.

3. How to use ACICLOVIR EG

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment consists of 5 applications per day at intervals of approximately 4 hours.
Apply ACICLOVIR EG cream to the lesions or to the areas where they are developing as
soon as you notice the first symptoms of infection, such as itching, burning sensation, and
pain (prodromal symptoms or erythema). Treatment may also be started during later stages
characterized by the appearance of small skin elevations (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 EG than you should
In case of accidental ingestion of an excessive amount of ACICLOVIR EG, contact
your doctor immediately or go to the nearest hospital emergency department.
Cases of overdose have not been reported. Even if the entire contents of the cream tube are
ingested, adverse effects are not expected to occur.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people):

• transient burning or pain;
• moderate dryness and loss of the outer layer (desquamation) of the skin;
• itching.

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

• redness of the skin (erythema);
• inflammatory skin reaction (contact dermatitis), mainly due to components of the base cream.

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

• allergic reactions manifesting as swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema), hives.

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 EG

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 "Exp".
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 EG contains

• The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: poloxamer 407, cetostearyl alcohol, sodium lauryl sulfate, white soft paraffin, liquid paraffin, sucrose monopalmitate, propylene glycol (E1520), purified water.

Description of the appearance of ACICLOVIR EG and the contents of the pack
Pack containing one 10 g tube of cream.
Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 – 20136 Milan – Italy.
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – Cortemaggiore (PC).
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino, S.S. 16 Zona Industriale - 73010 Zollino (LE)