Aciclovir Doc Generici

Package leaflet: Information for the patient

ACICLOVIR DOC Generici 400 mg tablets, 800 mg tablets, 400 mg/5 ml oral suspension

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

1. What ACICLOVIR DOC Generici is and what it is used for

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

• to treat 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 recurrent Herpes simplex in people with normal immune defenses;
• to prevent Herpes simplex infections in people with weakened immune systems;
• to treat chickenpox and Herpes zoster.

2. What you need to know before taking ACICLOVIR DOC Generici

Do not take ACICLOVIR DOC Generici

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

Warnings and precautions
Talk to your doctor or pharmacist before taking ACICLOVIR DOC Generici.
Take this medicine with caution if you have kidney problems or if you are elderly, as a lower dose may be required.
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 in people with weakened immune systems, as this may lead to the development of aciclovir-resistant viruses.
Other medicines and ACICLOVIR DOC Generici
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 might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, use 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 DOC Generici 400 mg/5 ml oral suspension contains

• sorbitol This medicine contains 1400 mg of sorbitol in 5 ml of solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your 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 your child) take this medicine. It may cause gastrointestinal disturbances and has a mild laxative effect.
• methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate May cause allergic reactions (including delayed reactions).

ACICLOVIR DOC Generici tablets contain lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ACICLOVIR DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Instructions for use of ACICLOVIR DOC Generici oral suspension
Shake the suspension well before use.
The package includes a dosing syringe with markings corresponding to 5 ml and 10 ml levels.
Use in adults
Treatment of Herpes simplex infections: the recommended dose is 200 mg, taken 5 times daily at intervals of approximately 4 hours, 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 sensation, or as soon as the first lesions are observed.
Treatment of recurrent Herpes simplex infection symptoms in patients with normal immune defenses: the recommended dose is 200 mg 4 times daily at 6-hour intervals.
In some cases, 400 mg in tablets or 5 ml of suspension twice daily at 12-hour intervals; or 200 mg 3 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 natural course of the disease.
Prevention of Herpes simplex infections in patients with weakened immune systems: the recommended dose is 200 mg 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 suspension, taken 5 times daily at intervals of approximately 4 hours, excluding the night.
Take the medicine throughout the day according to the following schedule: at breakfast, late morning, early afternoon, late afternoon, and evening.
Treatment should continue 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 medicine may be considered.
Treatment should be started as soon as the first symptoms appear, such as itching or burning sensation, or as soon as the first lesions are observed.
Use in children
Treatment and prevention of Herpes simplex infections:

• Children over 2 years of age: dosage is similar to that in adults;
• Children under 2 years of age: the recommended dose is half that for adults.

Severe Herpes simplex infections in immunocompromised children are an exception, for which ACICLOVIR DOC Generici is not indicated (see section 1).
Treatment of chickenpox:

• Children over 6 years of age: the recommended dose is 800 mg in tablets (or 10 ml of suspension) 4 times daily;
• Children between 2 and 6 years of age: the recommended dose is 400 mg in tablets (or 5 ml of suspension) 4 times daily;
• Children under 2 years of age: the medicine should not be administered. Administration of 20 mg/kg body weight (not exceeding 800 mg) 4 times daily allows for more precise dose adjustment. Treatment should continue for 5 days.

Treatment of Herpes zoster in immunocompromised children: in such cases, intravenous aciclovir administration may be necessary.
Use in elderly patients
Your doctor will adjust the dose based on kidney function.
It is advisable to drink plenty of fluids to maintain adequate hydration.
Use in patients with kidney problems
In the treatment of Herpes simplex infections in patients with severe kidney problems, the recommended dose is 200 mg twice daily at approximately 12-hour intervals.
In the treatment of chickenpox and Herpes zoster, the recommended dose is 800 mg of aciclovir in tablets or 10 ml of suspension twice daily at approximately 12-hour intervals, or 3 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 DOC Generici than you should
In case of accidental and prolonged overdose, nausea, vomiting, headache, and confusion may occur.
If you accidentally take an excessive dose of ACICLOVIR DOC Generici, contact your doctor immediately or go to the nearest hospital.
If you forget to take ACICLOVIR DOC Generici
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 everybody 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 (including photosensitivity);
• 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)

• breathing problems (dyspnoea);
• liver problems with increased bilirubin and certain liver enzymes;
• severe allergic reactions (anaphylaxis);
• swelling due to fluid accumulation (angioedema);
• increased blood levels of nitrogen and creatinine.

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 movement-coordinating muscles (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.

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 DOC Generici

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 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 package and other information

What ACICLOVIR DOC Generici contains
ACICLOVIR DOC Generici 400 mg tablets
The active substance is aciclovir. Each tablet contains 400 mg of aciclovir.
The other components are lactose, microcrystalline cellulose, maize starch, polyvinylpyrrolidone, magnesium stearate, red iron oxide.

ACICLOVIR DOC Generici 800 mg tablets
The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
The other components are: lactose, microcrystalline cellulose, maize starch, polyvinylpyrrolidone, magnesium stearate.

ACICLOVIR DOC Generici 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% solution, glycerol, dispersible cellulose (Avicel RC 159), methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, cherry flavor, purified water.

Description of the appearance of ACICLOVIR DOC Generici and contents of the pack
The 400 mg tablets are available in blisters of 25 tablets.
The 800 mg tablets are available in blisters of 35 tablets.
The oral suspension is available in a pack containing a 100 ml bottle and a dosing spoon.

Marketing Authorization Holder and Manufacturer
DOC Generici S.r.l. - Via Turati 40 – 20121 Milan - Italy.

Manufacturer
ACICLOVIR DOC Generici tablets
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri 71 - Sanremo (Imperia) - Italy.
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino – S.S. 16 Zona Industriale – 73010 Zollino (Lecce) - Italy.

ACICLOVIR DOC Generici 400 mg/5 ml oral suspension
ABC Farmaceutici S.p.A. – Canton Moretti 29 – Loc. San Bernardo – Ivrea (Turin) - Italy.

Package leaflet: information for the user

ACICLOVIR DOC Generici 5% cream

Generic medicine
Please read this leaflet carefully before using this medicine as 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, contact your pharmacist.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

1. What ACICLOVIR DOC Generici is and what it is used for
2. What you need to know before using ACICLOVIR DOC Generici
3. How to use ACICLOVIR DOC Generici
4. Possible side effects
5. How to store ACICLOVIR DOC Generici
6. Package contents and other information

1. What ACICLOVIR DOC Generici is and what it is used for

ACICLOVIR DOC Generici is a cream for application to the skin that contains the active substance aciclovir, belonging to a group of medicines used against viral infections (antivirals).
ACICLOVIR DOC Generici is used for the treatment of 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 DOC Generici

Do not use ACICLOVIR DOC Generici

• 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 DOC Generici.
ACICLOVIR DOC Generici 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 (in oral formulation) may be required.
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 DOC Generici
Inform your doctor or pharmacist if you are 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 vehicles or
operate machinery.
ACICLOVIR DOC Generici contains

• propylene glycol This medicine contains 100 mg of propylene glycol in 1 g of cream. It may cause skin irritation. Since this medicine contains propylene glycol, do not use it on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist.
• sodium lauryl sulfate This medicine contains 10 mg of sodium lauryl sulfate in 1 g of cream. It may cause skin irritation (stinging or burning sensation) or intensify skin reactions caused by other medicines when applied to the same area.

3. How to use ACICLOVIR DOC Generici

Use this medicine exactly as stated in this leaflet or according to the instructions provided by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The treatment consists of 5 applications per day at intervals of approximately 4 hours.
Apply ACICLOVIR DOC Generici cream to the lesions or to the areas where they are developing,
as soon as you notice the first symptoms of infection (itching, burning sensation, or pain).
Continue the treatment for at least 5 days and up to a maximum of 10 days.
If you use more ACICLOVIR DOC Generici than you should
In case of accidental ingestion of an excessive amount of ACICLOVIR DOC Generici, contact your
doctor immediately or go to the Emergency Room of the nearest hospital.

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;
• dryness and peeling 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 cream base.

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

• angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing), urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 DOC Generici

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 DOC Generici contains

• The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: propylene glycol, tefose, labrafil, vaseline oil, poloxamer 407, sodium lauryl sulfate, purified water.

Description of the appearance of ACICLOVIR DOC Generici and the contents of the pack
The cream is available in tubes of 3 g or 10 g.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milan - Italy.
Manufacturer
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino – S.S. 16 Zona Industriale – 73010 Zollino (Lecce) - Italy.