Aciclovir PensA

Package leaflet: information for the patient

ACICLOVIR PENSA 800 mg tablets

Aciclovir
Generic medicine
Please read all of this leaflet carefully before you take 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 pass it on to other people, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ACICLOVIR PENSA contains the active substance aciclovir, which belongs to a group of medicines used against viral infections (antivirals).
ACICLOVIR PENSA 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 need to know before taking ACICLOVIR PENSA

Do not take ACICLOVIR PENSA

• 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 taking ACICLOVIR PENSA:
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, especially when taking high oral doses of
aciclovir.
Avoid using this medicine for long periods or for repeated treatments, especially in people with low
immune defenses, as aciclovir-resistant viruses may develop.
Other medicines and ACICLOVIR PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
In particular, inform your doctor and use this medicine with caution if you are taking the following medicines:

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice 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 PENSA tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take ACICLOVIR PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Treatment of Herpes simplex infections: The recommended dose is 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 defences (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg tablets or, alternatively, intravenous administration of the medicine may be considered.

Treatment should be started as soon as the first symptoms appear, such as itching and burning sensations, or as soon as the first lesions are noticed.

Treatment of recurrent Herpes simplex infection symptoms in patients with normal immune defences: The recommended dose is 200 mg, taken 4 times daily at 6-hour intervals.

In some cases, 400 mg tablets taken twice daily at 12-hour intervals, or 200 mg taken 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 low immune defences: The recommended dose is 200 mg, taken 4 times daily at 6-hour intervals.

In patients with very low immune defences (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg tablets or, alternatively, intravenous administration of the medicine may be considered.

Treatment of Herpes zoster and chickenpox: The recommended dose is 800 mg tablets, taken 5 times daily at approximately 4-hour intervals, excluding the night.

Take the medicine throughout the day according to the following schedule: 7:00, 11:00, 15:00, 19:00, and 23:00. Treatment must continue for 7 days.

In patients with very low immune defences (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 and burning sensations, or as soon as the first lesions are noticed.

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 of adults. (Severe Herpes simplex infections in children with low immune defences are an exception, for which ACICLOVIR PENSA is not indicated.)

Treatment of chickenpox:

• Children over 6 years of age: the recommended dose is 800 mg tablets, taken 4 times daily.
• Children aged between 2 and 6 years: the recommended dose is 400 mg tablets, taken 4 times daily.
• Children under 2 years of age: the medicine MUST NOT be administered.

Administration of 20 mg/kg body weight (without exceeding 800 mg) 4 times daily allows for more precise dose adjustment. Treatment should continue for 5 days.

Treatment of Herpes zoster in children with low immune defences: In such cases, intravenous aciclovir injection may be necessary.

Use in elderly patients

Your doctor will adjust the dose based on your kidney function.

It is advisable to drink plenty of water 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, taken twice daily at approximately 12-hour intervals.

In the treatment of chickenpox and Herpes zoster, the recommended dose is 800 mg aciclovir tablets, taken twice daily at approximately 12-hour intervals in patients with severe kidney problems (severe renal impairment, creatinine clearance less than 10 ml/min), or 3 times daily at approximately 8-hour intervals in patients with moderate kidney problems (moderate renal impairment, creatinine clearance between 10 and 25 ml/min).

It is advisable to drink plenty of water to maintain adequate hydration.

If you take more ACICLOVIR PENSA than you should

In case of accidental and prolonged overdose, symptoms such as nausea, vomiting, headache, and confusion may occur.

If you accidentally ingest or take an excessive oral dose of ACICLOVIR PENSA, contact your doctor immediately or go to the nearest hospital.

If you forget to take ACICLOVIR PENSA

Do not take 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, this medicine can cause side effects, although not everyone experiences 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;
• light sensitivity;
• fatigue;
• fever;

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

• urticaria;
• widespread, rapid hair loss;

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

• anaphylaxis;
• breathing difficulties (dyspnoea);
• liver problems with increased bilirubin and certain 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 (acute 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 PENSA

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 “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 PENSA contains
The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
The other ingredients are: microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate.
Description of the appearance of ACICLOVIR PENSA and contents of the pack
Pack of 35 tablets of 800 mg.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy
Manufacturer
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo, 1
03012, Anagni (FR)

Package leaflet: information for the user

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

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

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

Do not use ACICLOVIR PENSA

• 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 PENSA.
ACICLOVIR PENSA 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 necessary.
Avoid prolonged treatment with ACICLOVIR PENSA, as this could lead to an allergic reaction (sensitization). If this
occurs, stop treatment immediately and consult your doctor.
Other medicines and ACICLOVIR PENSA
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, suspect you may be pregnant, planning a pregnancy, or are 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 PENSA contains methyl paraben
This medicine contains methyl paraben, which may cause allergic reactions (including delayed reactions).

3. How to use ACICLOVIR PENSA

Use this medicine exactly as directed 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 PENSA cream to the affected lesions and areas as soon as you notice the first
symptoms of infection, such as itching, burning sensation, and pain. It is particularly important
to start treatment with ACICLOVIR PENSA as soon as the first symptoms appear or at the first sign of lesions.
Wash your hands thoroughly before and after applying the cream, and avoid rubbing or touching the lesions unnecessarily in order to prevent worsening or spreading of the infection.
Treatment should continue for at least 5 days and up to a maximum of 10 days.
If lesions are still present after 10 days, consult your doctor.
If you use more ACICLOVIR PENSA than you should
In case of accidental ingestion/intake of ACICLOVIR PENSA, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

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

• transient burning or pain;
• dryness and scaling 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)

• 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 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 PENSA

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 “Expiry”.
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 PENSA 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 paraben, purified water.

Description of the appearance of ACICLOVIR PENSA and contents of the pack
Pack containing one tube of 10 g cream.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6 – 20154 Milan
Italy
Manufacturer
Special Product’s Line S.p.A - Strada Paduni, 240 - 03012, Anagni (FR) - Italy
Mipharm S.p.A. - Via Quaranta, 12 - 20141 Milan – Italy