АКИКЛОВІР ПЕНСА 5% Крем

Зміст інструкції

1. ACICLOVIR PENSA 800 mg tablets
   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
2. ACICLOVIR PENSA 5% cream
   1. What is ACICLOVIR PENSA and what is it used for
   2. What you need to know before you use 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

ACICLOVIR PENSA 800 mg tablets

Aciclovir

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 ingredient 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 simplexvirus, including genital herpes (primary or recurrent), except for infections in newborns and for severe infections in children with low immune defenses (immunocompromised);
• to treat the symptoms of the recurrence of Herpes simplexin people with normal immune defenses;
• to prevent Herpes simplexinfections in people with low immune defenses;
• 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, because a
reduction in the dose may be necessary.
Drink plenty of water to maintain adequate hydration if you are taking high doses of
aciclovir orally.
Avoid using this medicine for long periods or for repeated treatments, especially in people with low
immune defenses, because resistant viruses may develop to aciclovir.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary and under the direct
supervision of your doctor.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive and operate
machinery.

ACICLOVIR PENSA tablets contains 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 following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Treatment ofHerpes simplexinfections:the recommended dose is 200 mg, 5 times a day at
intervals of approximately 4 hours, excluding at night.
Treatment should be continued for 5 days, but an extension may be necessary in cases of severe primary
infections.
In people with very low immune defenses (e.g. after a bone marrow transplant) or in
people with reduced intestinal absorption, the dosage may be doubled to 400 mg in
tablets or, alternatively, the possibility of administering the medicine by
intravenous route may be considered.
Therapy should be started as soon as you notice the appearance of the first symptoms, such as itching and a burning sensation, or as soon as you notice the first lesions.

Treatment of symptoms of recurrentHerpes simplexinfection in patients with normal immune
defenses:the recommended dose is 200 mg 4 times a day at intervals of 6 hours.
In some cases, 400 mg tablets, 2 times a day at intervals of 12 hours or 200
mg 3 times a day at intervals of 8 hours or 2 times a day at intervals of 12 hours are also effective.
In some patients, a recurrence of the infection may occur.
Therapy should be interrupted periodically at intervals of 6 or 12 months, in order to observe
any changes in the natural history of the disease.

Prevention ofHerpes simplexinfections in patients with low immune defenses:the dose
recommended is 200 mg 4 times a day at intervals of 6 hours.
In people with very low immune defenses (e.g. after a bone marrow transplant) or in
people with reduced intestinal absorption, the dosage may be doubled to 400 mg in
tablets or, alternatively, the possibility of administering the medicine by
intravenous route may be considered.

Treatment ofHerpes zosterand chickenpox: the recommended dose is 800 mg in tablets 5 times a
day at intervals of approximately 4 hours, excluding at night.
Take the medicine throughout the day according to the following intake schedule: 7:00 AM, 11:00 AM,
3:00 PM, 7:00 PM, 11:00 PM. Treatment should be continued for 7 days.
In people with very low immune defenses (e.g. after a bone marrow transplant) or in
people with reduced intestinal absorption, the possibility of administering
the medicine by intravenous route may be considered.
Therapy should be started as soon as you notice the appearance of the first symptoms, such as itching and a burning sensation, or as soon as you notice the first lesions.

Use in children
Treatment and prevention ofHerpes simplexinfections:

• Children over 2 years of age: the dosage is similar to that of adults,
• Children under 2 years of age: the recommended dose is half that for adults. (An exception is made for severe Herpes simplexinfections in children with low immune defenses, for which ACICLOVIR PENSA is not indicated). Treatment of chickenpox:
• Children over 6 years of age: the recommended dose is 800 mg in tablets 4 times a day;
• Children between 2 and 6 years of age: the recommended dose is 400 mg in tablets 4 times a day;
• Children under 2 years of age: the medicine should NOT be administered. Administration of 20 mg/kg of body weight (not exceeding 800 mg) 4 times a day allows for a more precise dosage adjustment. Treatment should be continued for 5 days.

Treatment ofHerpes zosterin children with low immune defenses:in this case, administration of acyclovir by intravenous injection (intravenous route) may be
necessary.

Use in the elderly
The doctor will adjust the dosage based on your kidney function.
It is advisable to drink plenty of water to maintain adequate hydration.

Use in people with kidney problems
In the treatment of Herpes simplexinfections in people with severe kidney problems, the recommended dose is 200 mg, 2 times a day at intervals of approximately 12 hours.
In the treatment of chickenpox and Herpes zoster, the recommended dose is 800 mg of acyclovir in
tablets, 2 times a day at intervals of approximately 12 hours in patients with severe kidney problems
(severe renal impairment, creatinine clearance less than 10 ml/min) or 3 times a day, at
intervals of approximately 8 hours 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, nausea, vomiting, headache,
confusion may occur.
In case of accidental ingestion/intake of an excessive dose of ACICLOVIR PENSA orally
immediately inform your doctor 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 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;
• 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 1000 people)

• anaphylaxis
• breathing problems (dyspnoea);
• liver problems with increased bilirubin and certain liver enzymes;
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty 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 the muscles responsible for movement (ataxia) and speech (dysarthria);
• hallucinations, psychotic symptoms, convulsions;
• drowsiness;
• brain damage (encephalopathy) and coma;
• liver problems (hepatitis and jaundice);
• serious kidney problems (acute renal failure) and kidney pain;

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 ACICLOVIR PENSA

Keep this medicine out of the sight and reach of children.
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 that month.
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.

6. Contents of the pack and other information

What ACICLOVIR PENSA contains
The active ingredient 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 Authorisation 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)

ACICLOVIR PENSA 5% cream

Aciclovir

Generic medicine

Read this leaflet carefully before you start using this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, please 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 you use 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 is ACICLOVIR PENSA and what is it used for

ACICLOVIR PENSA contains the active ingredient aciclovir belonging to a group of medicines used
against viral infections (antivirals).
ACICLOVIR PENSA is used for the treatment of infections caused by the Herpes Simplexvirus, both on the
lips (cold sores) and on the genitals (primary or recurrent genital herpes).

2. What you need to know before you use 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 should not be applied to the eyes, or to the internal mucous membranes of the mouth or vagina,
as this may cause irritation.
Talk to 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
this case, oral administration of aciclovir (in oral formulation) may be necessary.
Avoid long-term treatment with ACICLOVIR PENSA, as this may cause
an allergic reaction (sensitization). If this happens, stop treatment immediately and
see your doctor.

Other medicines and ACICLOVIR PENSA
Tell 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, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely
necessary and under the direct supervision of your doctor.

Driving and using machines
No data are available to establish the effect of the medicine on the ability to drive and 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 following the instructions of your doctor or pharmacist exactly. If you have any doubts,
consult your doctor or pharmacist.
The treatment involves 5 applications per day at intervals of approximately 4 hours.
Apply ACICLOVIR PENSA cream to the lesions and areas to be treated as soon as you notice the appearance of 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 of infection or the
first appearance of the lesions occur.
Wash your hands thoroughly before and after applying the cream and avoid rubbing the
lesions unnecessarily or touching them in order to avoid worsening or transmission of the infection.
Therapy should continue for at least 5 days and up to a maximum of 10 days.
If the 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 everybody gets 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 1000 people)
• redness of the skin (erythema);
• inflammatory skin reaction (contact dermatitis), mainly due to the 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 that can cause difficulty swallowing and breathing), urticaria.

Reporting of side effects
If you get any side effects, even those 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 ACICLOVIR PENSA

Keep this medicine out of the sight and reach of children.
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 that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 PENSA contains

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other ingredients 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 a tube of 10 g of cream.

Marketing Authorisation 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