ACICLOVIR 400 mg Coated Tablet

Зміст інструкції

1. ACICLOVIR ALFASIGMA 400 mg tablets, 800 mg tablets
   1. What you need to know before taking ACICLOVIR ALFASIGMA
   2. How to take ACICLOVIR ALFASIGMA
   3. Possible side effects
   4. How to store ACICLOVIR ALFASIGMA
   5. Package Contents and Other Information
2. ACICLOVIR ALFASIGMA 800 mg tablets: each tablet contains 800 mg of aciclovir
3. ACICLOVIR ALFASIGMA 8% oral suspension
   1. What is ACICLOVIR ALFASIGMA and what is it used for
   2. What you need to know before taking ACICLOVIR ALFASIGMA
   3. How to take ACICLOVIR ALFASIGMA
   4. Possible side effects
   5. How to store ACICLOVIR ALFASIGMA
   6. Package contents and other information

ACICLOVIR ALFASIGMA 400 mg tablets, 800 mg tablets

Aciclovir

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

1. What is ACICLOVIR ALFASIGMA and what it is used for
ACICLOVIR ALFASIGMA tablets contains the active ingredient aciclovir and is a medicine
belonging to the family of systemic antiviral drugs. Aciclovir acts against herpes viruses.
The term herpes identifies a category of infections caused by the virus of the genus Herpesviridae. The
most common symptom of herpes is the appearance of small blisters on the skin, usually located
on the lips (herpes labialis), on the genitals (herpes genitalis) or on more extensive areas of the body, such as
back and arms (herpes zoster or shingles).
ACICLOVIR ALFASIGMA tablets is indicated:
in the treatment of herpes simplex infections, the most common virus among the Herpesviridae,
responsible for the appearance of painful and reddened rounded lesions and blisters that
affect the skin and mucous membranes, including infections that occur for the first time or following
relapses (recurrent infections) of the genitals;
in the treatment of recurrent herpes simplex infections in patients with a non-compromised
immune system;
for the prevention of herpes simplex infections in patients with a compromised immune system;
for the treatment of chickenpox and shingles, highly contagious infectious diseases
caused by the varicella zoster virus (also belonging to the Herpesviridaefamily).

2. What you need to know before taking ACICLOVIR ALFASIGMA

Do not take ACICLOVIR ALFASIGMA

• if you are allergic to the active ingredient aciclovir or 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 ALFASIGMA if:
you are elderly or have kidney problems. In these cases, your doctor may reduce the dosage of aciclovir to
reduce the risk of side effects that may affect the
nervous system. These effects generally resolve once treatment is stopped (see
section “Possible side effects”);
you have a severely compromised immune system, as prolonged or repeated use of
ACICLOVIR ALFASIGMA may promote resistance of some viruses, leading to a reduced
response to treatment.

Talk to your doctor if you think any of these situations apply to you.The doctor may
reduce the dose of ACICLOVIR ALFASIGMA.
If your doctor has prescribed a high dose of ACICLOVIR ALFASIGMA, pay attention to
maintaining a good state of hydration, introducing an appropriate
amount of fluids through your diet (see section “How to take ACICLOVIR ALFASIGMA”).

Other medicines and ACICLOVIR ALFASIGMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You must be particularly careful when taking ACICLOVIR ALFASIGMA together with the following
medicines:
medicines with effects on the kidneys, such as probenecid, used for the treatment of gout and
cimetidine, used to treat some stomach disorders;
medicines based on mycophenolate mofetil, used to prevent rejection by your
body of a transplanted kidney, heart or liver;
theophylline used for breathing problems.
Tell your doctor if you are taking these medicines, as concomitant use with ACICLOVIR
ALFASIGMA may reduce the effectiveness with which the kidneys remove aciclovir from the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Limited clinical data recommend the use of ACICLOVIR ALFASIGMA during pregnancy only in
cases of actual necessity and under the control of the doctor. The doctor will assess whether the possible benefits of
treatment for you outweigh the potential risks to the baby.

Breastfeeding
ACICLOVIR ALFASIGMA may be excreted in breast milk, therefore the doctor will carefully assess the possibility of
giving you ACICLOVIR ALFASIGMA during breastfeeding.

Driving and using machines
ACICLOVIR ALFASIGMA can cause side effects that may affect your ability to
drive and operate machinery, such as dizziness, drowsiness and confusion. Therefore, be careful
when driving and using machinery.

ACICLOVIR ALFASIGMA 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 ALFASIGMA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Take the tablet by mouth following your doctor's instructions.
It is very important to take an adequate amount of fluids while taking high doses of
ACICLOVIR ALFASIGMA.

Use in adults

Treatment of herpes simplex infections including genital herpes
The recommended dose is 200 mg 5 times a day, approximately every 4 hours, omitting the intake of the
tablet during the night.
Treatment should last for 5 days. In cases of severe herpetic infections, developed for the
first time, your doctor may advise you to prolong the therapy.
If you have a severely compromised immune system (for example if you have undergone a bone marrow
transplant) or if you have difficulty absorbing at the intestinal level, your doctor may
prescribe a higher dosage, 400 mg or alternatively evaluate the need to administer
aciclovir via infusion directly into a vein (intravenously).
The maximum effectiveness of ACICLOVIR ALFASIGMA is achieved when treatment is started
promptly and, in the case of recurrent infections, at the first signs of herpes (burning, swelling or
itching) or at the first manifestations of a lesion.

Treatment of recurrent herpes simplex infections in patients with a non-compromised immune system

The recommended dose is 400 mg, 2 times a day, approximately every 12 hours. In some patients, recurrent
infections may occur with a daily dose of 800 mg of ACICLOVIR ALFASIGMA.
Stop the therapy, always following the doctor's judgment, every 6 or 12 months. This allows the
doctor to observe any changes in the course of the disease.

Preventive treatment (prophylaxis) of herpes simplex infections in patients with a compromised immune system

If you have a severely compromised immune system (for example if you have undergone a bone marrow
transplant) or if you have difficulty absorbing at the intestinal level, your doctor will prescribe you to
take a 400 mg tablet or, alternatively, evaluate the need to administer aciclovir
intravenously.
The doctor will determine the duration of therapy depending on the period of risk to which you are exposed.

Treatment of herpes zoster (shingles) and chickenpox
The recommended dose is 800 mg of ACICLOVIR ALFASIGMA in tablets 5 times a day,
every 4 hours (for example: at breakfast, in late morning, in the early afternoon, in the
late afternoon and in the evening), omitting the intake of the tablet during the night.
Treatment should last for 7 consecutive days.
If you have a severely compromised immune system (for example if you have undergone a bone marrow
transplant) or if you have difficulty absorbing at the intestinal level, your doctor will evaluate the
need to administer aciclovir intravenously.
The maximum effectiveness of ACICLOVIR ALFASIGMA is achieved when treatment is started
promptly, at the first manifestations of a lesion.

Use in children

Treatment of herpes simplex infections including genital herpes

• Children aged 2 years or older: the recommended dose is 200 mg 5 times a day.
• Children under 2 years of age: the recommended dose is half the adult dose. For the treatment of neonatal herpes virus infections, administration of Aciclovir intravenously is recommended.

In children with a weakened immune system with severe Herpes simplex infections
ACICLOVIR ALFASIGMA is not indicated.

Treatment of recurrent herpes simplex infections in children with a non-compromised immune system

No clinical data are available regarding the treatment of herpes simplex or herpes
zoster infections in children with a non-compromised immune system.

Prophylaxis and treatment of herpes simplex infections in children with a compromised immune system

Treatment of chickenpox and Herpes Zoster
For a more correct administration of ACICLOVIR ALFASIGMA in children, the
formulation in oral suspension is available, for which a dosage of 0.25 ml
(corresponding to 20 mg) per kg of body weight must be considered, to be administered 4 times a day, not exceeding
10 ml per single dose (corresponding to 800 mg).
Treatment should last for 5 days.
No data are available for the treatment of Herpes zoster in children with a non-compromised
immune system.

Treatment of herpes zoster infections in children with a compromised immune system
The doctor will evaluate the need to administer aciclovir intravenously.

Use in the elderly
Maintain good hydration, taking an adequate amount of fluids with your diet if
you are taking high doses of ACICLOVIR ALFASIGMA.
The doctor will evaluate the possibility of reducing the dosage of ACICLOVIR ALFASIGMA in elderly patients
with kidney problems related to advancing age.

Patients with kidney problems
For the treatment of herpes simplex infections in patients suffering from severe kidney problems
(severe renal failure - creatinine clearance less than 10 ml/min) the recommended dose is
200 mg to be taken 2 times a day, approximately every 12 hours.
For the treatment of chickenpox and herpes zoster in patients with severe renal failure
(creatinine clearance less than 10 ml/min) the recommended dose is 800 mg to be taken 2
times a day, approximately every 12 hours.

In case of moderate renal failure (creatinine clearance between 10 and 25 ml/min), the
recommended dose is 800 mg to be taken 3 times a day, approximately every 8 hours.
The doctor will determine the duration of treatment.

If you take more ACICLOVIR ALFASIGMA than you should
Contact your doctor if you take an excessive dose of ACICLOVIR ALFASIGMA.
If you accidentally take doses of ACICLOVIR ALFASIGMA higher than those recommended and for
long periods, orally, you may experience adverse effects on the stomach or
intestines, such as nausea and vomiting, and on the central nervous system, such as headache and confused state.
Taking doses higher than those recommended intravenously may lead to an increase
in creatinine and nitrogen levels in the blood and consequent renal failure.

Treatment method in case of taking an excessive dose of ACICLOVIR ALFASIGMA
Patients must be carefully observed, in order to promptly identify signs or symptoms of
toxicity. Rescue procedures in case of symptomatic overdose, involve resorting to
hemodialysis (blood purification therapy) which significantly contributes to eliminating
aciclovir from the blood.

If you forget to take ACICLOVIR ALFASIGMA
Do not take a double dose to make up for the missed dose.

If you stop taking ACICLOVIR ALFASIGMA
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 incidence of side effects may vary depending on the condition for which treatment is indicated.
Stop treatment with ACICLOVIR ALFASIGMA and contact your doctor immediately if you
experience any of the following side effects:

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

• severe allergic reaction (anaphylaxis);
• difficulty breathing (dyspnea);
• swelling of the skin (angioedema).

Very rare side effects (may affect up to 1 in 10,000 people)
agitation, confusion, tremor, loss of muscle coordination (ataxia), slurred speech (dysarthria),
hallucinations, psychotic symptoms, seizures,
drowsiness, altered brain function (encephalopathies), coma.
These nervous system side effects generally occur in people with kidney problems or other
predisposing factors (see section “Warnings and precautions”). These effects normally improve
when the dosage of ACICLOVIR ALFASIGMA is reduced or treatment is stopped.
Other side effects are listed by frequency:

Common (may affect up to 1 in 10 people)
headache, dizziness;
nausea, vomiting, diarrhea, abdominal pain;
itching, rash, skin reaction after exposure to sunlight (photosensitivity);
fatigue, fever.

Uncommon (may affect up to 1 in 100 people)
allergic skin reaction (urticaria)
rapid and widespread hair loss.

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

• severe allergic reaction (anaphylaxis)
• shortness of breath (dyspnea)
• swelling of the lips, face, neck and throat (angioedema) reversible increase in bilirubin in the
  blood and liver enzymes; increased levels of nitrogen (azotemia) and creatinine in the blood.

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

• feeling of confusion and agitation
• tremors
• instability when walking and lack of coordination (ataxia)
• words spoken slowly and defectively (dysarthria)
• seeing or hearing things that do not exist (hallucinations)
• disturbances of 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) reduction in the number of red blood cells
  (anemia), white blood cells (leukopenia) and platelets in the blood, cells that are needed for
  coagulation (thrombocytopenia); inflammation of the liver (hepatitis), yellowish discoloration of
  the eyes and skin (jaundice); severe kidney failure, pain in the lower back (renal pain) that may
  be associated with kidney failure.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting
system at http://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 ALFASIGMA

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 “Scad”. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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. Package Contents and Other Information

What ACICLOVIR ALFASIGMA contains

• The active ingredient is aciclovir. ACICLOVIR ALFASIGMA 400 mg tablets: each tablet contains 400 mg of aciclovir.

ACICLOVIR ALFASIGMA 800 mg tablets: 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 ALFASIGMA and package contents

• ACICLOVIR ALFASIGMA 400 mg tablets contains 25 round white tablets of 400 mg, packaged in PVC/aluminium blisters;
• ACICLOVIR ALFASIGMA 800 mg tablets contains 35 round white tablets of 800 mg, packaged in PVC/aluminium blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SOFAR S.p.A.,
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy

ACICLOVIR ALFASIGMA 8% oral suspension

Aciclovir

Read this leaflet carefully before you start taking 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 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 ALFASIGMA is and what it is used for
• 2. What you need to know before you take ACICLOVIR ALFASIGMA
• 3. How to take ACICLOVIR ALFASIGMA
• 4. Possible side effects
• 5. How to store ACICLOVIR ALFASIGMA
• 6. Contents of the pack and other information

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

ACICLOVIR ALFASIGMA 8% oral suspension contains the active ingredient aciclovir and is a
medicinal product belonging to the family of systemic antiviral drugs. Aciclovir acts against
herpes viruses.
The term herpes identifies a category of infections caused by viruses of the Herpesviridaegenus. The
most common symptom of herpes is the appearance of small blisters on the skin, usually located
on the lips (herpes labialis), on the genitals (herpes genitalis) or on more extensive areas of the body, such as
back and arms (herpes zoster or shingles).
ACICLOVIR ALFASIGMA 8% oral suspension is indicated:
in the treatment of herpes simplex infections, the most common virus among the Herpesviridae,
responsible for the appearance of lesions and roundish, painful blisters and redness that
affect the skin and mucous membranes, including infections that occur for the first time or
following recurrences (recurrent infections) of the genitals;
in the treatment of recurrent herpes simplex infections in patients with a non-compromised
immune system;
for the prevention of herpes simplex infections in patients with a compromised immune system;
for the treatment of chickenpox and herpes zoster, highly contagious infectious diseases
caused by the varicella zoster virus (also belonging to the Herpesviridaefamily).

2. What you need to know before taking ACICLOVIR ALFASIGMA

Do not take ACICLOVIR ALFASIGMA if

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

If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor or pharmacist before taking ACICLOVIR ALFASIGMA if:
you are elderly or have kidney problems. In these cases, your doctor may reduce the dose of aciclovir to
decrease the risk of developing undesirable effects that may affect the
nervous system. These effects generally resolve once treatment is stopped (see
section “Possible side effects”);
you have a severely compromised immune system, as prolonged or repeated use of
ACICLOVIR ALFASIGMA may promote resistance of some viruses, leading to a lower
response to treatment.

Talk to your doctor if you think any of these situations apply to you.The doctor may
reduce the dose of ACICLOVIR ALFASIGMA.
If your doctor has prescribed a high dose of ACICLOVIR ALFASIGMA, be careful to
maintain a good state of hydration, by introducing an appropriate
amount of fluids through your diet (see section “How to take ACICLOVIR ALFASIGMA”).

Children and adolescents
ACICLOVIR ALFASIGMA should not be given to children under 2 years of age who
have contracted chickenpox (see section “How to take ACICLOVIR ALFASIGMA”).

Other medicines and ACICLOVIR ALFASIGMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
You must be particularly careful when taking ACICLOVIR ALFASIGMA together with the following
medicines:
medicines with effects on the kidneys, such as probenecid, used to treat gout and
cimetidine, used to treat some stomach disorders;
medicines based on mycophenolate mofetil, used to prevent rejection by your
body of a transplanted kidney, heart or liver;
theophylline used for breathing problems.
Tell your doctor if you are taking these medicines, as concomitant use with ACICLOVIR
ALFASIGMA may reduce the effectiveness with which the kidneys remove aciclovir from the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Limited clinical data recommend the use of ACICLOVIR ALFASIGMA during pregnancy only in
cases of actual necessity and under the control of the doctor. The doctor will assess whether the possible benefits of
treatment for you outweigh the potential risks to the baby.

Breastfeeding
ACICLOVIR ALFASIGMA may be excreted in breast milk, therefore the doctor will carefully assess the possibility of
giving you ACICLOVIR ALFASIGMA during breastfeeding.

Driving and using machines
ACICLOVIR ALFASIGMA may cause side effects that may affect your ability to
drive and use machines, such as dizziness, drowsiness and confusion. Therefore, be cautious
when driving and using machines.
ACICLOVIR ALFASIGMA 8% oral suspension contains:

methyl parahydroxybenzoateand propyl parahydroxybenzoate: may cause allergic
reactions (including delayed reactions);

sorbitol:if your doctor has diagnosed you with intolerance to certain sugars, contact them before
taking this medicine.

3. How to take ACICLOVIR ALFASIGMA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Shake the suspension before use.
The ACICLOVIR ALFASIGMA 8% oral suspension package contains a dosing
measuring device with markings indicating levels corresponding to 5 and 10 ml.

Use in adults

Treatment of herpes simplex infections
The recommended dose is 2.5 ml of oral suspension 5 times a day, approximately every 4 hours,
omitting the dose during the night.
Treatment should last for 5 days. In cases of severe herpetic infections, developed for
the first time, your doctor may advise you to prolong the therapy.
If you have a severely compromised immune system (e.g. if you have undergone a bone marrow
transplant) or if you have difficulty absorbing at the intestinal level, your doctor may
prescribe a higher dosage, 5 ml of oral suspension or alternatively consider the need to
administer aciclovir via infusion directly into a vein (intravenously).
The maximum effectiveness of ACICLOVIR ALFASIGMA is achieved when treatment is started
promptly and, in the case of recurrent infections, at the first signs of herpes (burning, swelling or
itching) or at the first manifestations of a lesion.

Treatment of recurrent herpes simplex infections in patients with a non-compromised immune system

The recommended dose is 5 ml, 2 times a day every 12 hours. In some patients taking this
dosage, recurrent infections may occur.
Discontinue therapy, always following the doctor's judgment, every 6 or 12 months. This allows the
doctor to observe any changes in the course of the disease.

Preventive (prophylactic) treatment of herpes simplex infections in patients with a compromised immune system

If you have a severely compromised immune system (e.g. if you have undergone a bone marrow
transplant) or if you have difficulty absorbing at the intestinal level, your doctor will prescribe you to
take 5 ml of oral suspension or, alternatively, consider the need to administer aciclovir
intravenously.
The doctor will determine the duration of therapy depending on the period of risk to which you are exposed.

Treatment of herpes zoster (shingles) and chickenpox
The recommended dose is 10 ml of suspension 5 times a day, every 4 hours (e.g.: at breakfast time,
late morning, early afternoon, late afternoon and in the evening), omitting
the dose during the night.
Treatment should last for 7 consecutive days.
If you have a severely compromised immune system (e.g. if you have undergone a bone marrow
transplant) or if you have difficulty absorbing at the intestinal level, the doctor will assess the
need to administer aciclovir intravenously.
The maximum effectiveness of ACICLOVIR ALFASIGMA is achieved when treatment is started
promptly, at the first manifestations of a lesion.

Use in children

Treatment of herpes simplex infections including genital herpes

• Children aged 2 years or older: the recommended dose is 200 mg 5 times a day.
• Children under 2 years of age: the recommended dose is half the adult dose. For the treatment of neonatal herpes virus infections, the administration of Aciclovir via intravenous is recommended. In children with a weakened immune system with severe Herpes simplex infections ACICLOVIR ALFASIGMA is not indicated.

Treatment of recurrent herpes simplex infections in children with a non-compromised immune system

No clinical data are available regarding the treatment of herpes simplex or herpes
zoster infections in children with a non-compromised immune system.

Prophylaxis and treatment of herpes simplex infections in children with a compromised immune system

Treatment of chickenpox and Herpes Zoster
For more accurate administration of ACICLOVIR ALFASIGMA in children, a dosage of 0.25 ml (corresponding to 20 mg) per kg of body weight should be considered,
to be administered 4 times a day, not exceeding 10 ml per single dose (corresponding to 800 mg).
Treatment should last for 5 days.
No data are available for the treatment of Herpes zoster in children with a non-compromised
immune system.

Treatment of herpes zoster infections in children with a compromised immune system
The doctor will assess the need to administer aciclovir intravenously.

Use in the elderly
Maintain good hydration, consuming an adequate amount of fluids with your diet if
you are taking high doses of ACICLOVIR ALFASIGMA.

The doctor will assess the possibility of reducing the dosage of ACICLOVIR ALFASIGMA in elderly patients
with kidney problems related to advancing age.

Patients with kidney problems
For the treatment of herpes simplex infections in patients suffering from severe kidney problems
(severe renal insufficiency - creatinine clearance less than 10 ml/min) the recommended dose is
2.5 ml of oral suspension to be taken 2 times a day, approximately every 12 hours.
For the treatment of chickenpox and herpes zoster in patients with severe renal insufficiency
(creatinine clearance less than 10 ml/min) the recommended dose is 10 ml of oral suspension
to be taken 2 times a day, approximately every 12 hours.
In case of moderate renal insufficiency (creatinine clearance between 10 and 25 ml/min), the
recommended dose is 10 ml of oral suspension to be taken 3 times a day, approximately every 8 hours.
The doctor will determine the duration of treatment.

If you take more ACICLOVIR ALFASIGMA than you should
Contact your doctor if you take an excessive dose of ACICLOVIR ALFASIGMA.
If you accidentally take doses of ACICLOVIR ALFASIGMA higher than those recommended and for
long periods, orally, you may experience undesirable effects on the stomach or
intestines, such as nausea and vomiting, and on the central nervous system, such as headache and confusion.
Taking doses higher than those recommended intravenously, may lead to an increase
in creatinine and nitrogen levels in the blood and consequent renal failure.
Effects on the central nervous system, such as confusion, hallucinations, agitation, convulsions and coma, have been described in relation to overdose.

Treatment method in case of taking an excessive dose of ACICLOVIR ALFASIGMA
Patients must be carefully observed, in order to promptly identify signs or symptoms of
toxicity. Rescue procedures in case of symptomatic overdose, involve resorting to
hemodialysis (blood purification therapy) which significantly contributes to eliminating
aciclovir from the blood.

If you forget to take ACICLOVIR ALFASIGMA
Do not take a double dose to make up for the missed dose.

If you stop taking ACICLOVIR ALFASIGMA
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 incidence of side effects may vary depending on the condition for which treatment is indicated.
Stop treatment with ACICLOVIR ALFASIGMA and contact your doctor immediately if you
experience any of the following side effects:

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

• severe allergic reaction (anaphylaxis);
• difficulty breathing (dyspnea);
• swelling of the skin (angioedema).

Very rare side effects (may affect up to 1 in 10,000 people)
agitation, confusion, tremor, loss of muscle coordination (ataxia), speech disorder
(dysarthria), hallucinations, psychotic symptoms, convulsions,
drowsiness, altered brain function (encephalopathies), coma.
These nervous system side effects generally occur in people with kidney problems or other
predisposing factors (see section “Warnings and precautions”). These effects
usually improve when the dosage of ACICLOVIR ALFASIGMA is reduced or the
treatment is stopped.
Other side effects are listed by frequency:

Common (may affect up to 1 in 10 people)
headache, dizziness;
nausea, vomiting, diarrhea, abdominal pain;
itching, rash, skin reaction after exposure to sunlight (photosensitivity);
fatigue, fever.

Uncommon (may affect up to 1 in 100 people)
allergic skin reaction (urticaria)
rapid and widespread hair loss.

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

• severe allergic reaction (anaphylaxis)
• shortness of breath (dyspnea)
• swelling of the lips, face, neck and throat (angioedema) reversible increase in bilirubin in the blood and liver enzymes; increased levels of nitrogen (azotemia) and creatinine in the blood.

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

• feeling of confusion and agitation
• tremors
• instability when walking and lack of coordination (ataxia)
• words pronounced slowly and defectively (dysarthria)
• seeing or hearing things that do not exist (hallucinations)
• disturbances of thought and perception related to a psychiatric disorder (psychotic symptoms)
• convulsions
• drowsiness
• brain damage (encephalopathy)
• loss of consciousness (coma)
• yellowing of the whites of the eyes or skin (jaundice) reduction in the number of red blood cells (anemia), white blood cells (leukopenia) and platelets in the blood, cells that are needed for coagulation (thrombocytopenia); inflammation of the liver (hepatitis), yellowish discoloration of the eyes and skin (jaundice); severe kidney failure, pain in the lower back (renal pain) which may be associated with kidney failure

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the
national reporting system at http://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 ALFASIGMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging box after
“Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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. Package contents and other information

What ACICLOVIR ALFASIGMA contains
The active ingredient is aciclovir.
5 ml of oral suspension contains 400 mg of aciclovir
The other ingredients are: sorbitol 70%, glycerol, dispersible cellulose, methyl
parahydroxybenzoate, propyl parahydroxybenzoate, cherry aroma, purified water.

Description of the appearance of ACICLOVIR ALFASIGMA and package contents
ACICLOVIR ALFASIGMA 8% oral suspension is available in a 120 ml PVC bottle,
containing 100 ml of milky 80 mg/ml suspension, sealed with a screw aluminum cap and
equipped with a dosing measuring cup.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SOFAR S.p.A.,
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy