АКИКЛИН 400 мг Coated tablet

Содержание инструкции

1. Aciclin 400 mg tablets, 800 mg tablets
   1. What is Aciclin and what is it used for
   2. What you need to know before taking Aciclin
   3. How to take Aciclin
   4. Possible side effects
   5. How to store Aciclin
   6. Contents of the pack and other information
2. Aciclin 400 mg/5 ml oral suspension
   1. What is Aciclin and what is it used for
   2. What you need to know before taking Aciclin
   3. How to take Aciclin
   4. Possible side effects
   5. How to store Aciclin
   6. Contents of the pack and other information
3. Aciclin 50 mg/g cream
   1. What is Aciclin and what is it used for
   2. What you need to know before using Aciclin
   3. How to take Aciclin
   4. Possible side effects
   5. How to store Aciclin
   6. Contents of the pack and other information

Aciclin 400 mg tablets, 800 mg tablets

aciclovir
Generic medicine

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

1. What is Aciclin and what is it used for

Aciclin tablets contain the active ingredient aciclovir which belongs to a group of medicines
called systemic antivirals.
Aciclin tablets is indicated:
for the treatment of infections caused by Herpes simplex, responsible for the appearance of lesions and round blisters
that are painful and reddened and affect the skin and mucous membranes, including infections of the
genitals that occur for the first time or following recurrences (recurring infections);
to suppress Herpes simplexinfections that continue to recur in immunocompetent patients
(with an immune system that functions normally);
for the prevention of Herpes simplexinfections 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.

2. What you need to know before taking Aciclin

Do not take Aciclin 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);

Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclin if:
you are elderly or have kidney problems. In these cases, your doctor may reduce the dose of aciclovir to
reduce the risk of side effects that may affect the nervous system.
These effects usually resolve once treatment is stopped (see section “Possible
side effects”);
you have a severely weakened immune system, as prolonged or repeated use of Aciclin
may promote resistance of some viruses, causing a reduced response to treatment.
If your doctor has prescribed Aciclin in high doses, make sure you drink plenty of fluids such as waterwhile
taking Aciclin (see section “How to take Aciclin”).

Children and adolescents
Clinical data are not available regarding the treatment of infections caused by Herpes simplexor Herpes zosterin
children with a non-compromised immune system.

Other medicines and Aciclin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines: probenecid, used to treat gout;
cimetidine, used to treat some stomach problems;
medicines containing mycophenolate mofetil, used to prevent organ rejection after transplantation.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Limited clinical data recommend the use of Aciclin during pregnancy only when absolutely necessary and
under the supervision of a doctor. The doctor will assess whether the possible benefits of treatment outweigh the possibility
that unknown risks may occur.

Breastfeeding
Aciclin may be excreted in breast milk, therefore it should not be taken during breastfeeding.

Fertility
No data are available regarding fertility in women. Aciclovir tablets have not shown effects
on the number, morphology and motility of spermatozoa in men.

Driving and operating machinery
No studies have been conducted to investigate the effects of Aciclin on the ability to drive and operate
machinery. Assess the possible occurrence of side effects that may alter the level of
attention.

Aciclin 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 Aciclin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take the tablet by mouth following your doctor's instructions.
To help you take the correct dosage, which varies depending on the disease for which treatment is indicated,
other formulations and dosages of aciclovir are available.

Use in adults

Treatment of Herpes simplex infections
The recommended dose is 200 mg of aciclovir 5 times a day, approximately every 4 hours, omitting the dose
during the night. To obtain this recommended dose, other formulations and dosages of aciclovir are available.
Treatment should be continued 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, 400 mg of aciclovir, or alternatively consider administering aciclovir intravenously.
The maximum efficacy of Aciclin 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 200 mg of aciclovir 4 times a day, every 6 hours. To obtain this dose
recommended, other formulations of aciclovir are available.
Many patients can be successfully treated with dosages of 400 mg of aciclovir 2 times a day,
every 12 hours.
Dosages of 200 mg of aciclovir 3 times a day, every 8 hours, or 2 times a day at 12-hour intervals, can also be effective.
To obtain this recommended dose, other formulations and dosages of aciclovir are available.
In some patients, recurrent infections may occur with a total daily dose of 800 mg of
aciclovir.
Stop 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

The recommended dose is 200 mg of aciclovir 4 times a day, every 6 hours. To obtain this dosage,
other formulations and dosages of aciclovir are available.
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, 400 mg of aciclovir, or alternatively consider administering aciclovir intravenously.
The doctor will determine the duration of treatment based on the period of risk to which you are exposed.

Treatment of Herpes zoster (shingles) and varicella
The recommended dose is 800 mg of aciclovir 5 times a day, approximately 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 be continued 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 consider administering
aciclovir intravenously.
The maximum efficacy of Aciclin is achieved when treatment is started promptly, at the first
manifestations of a lesion.

Use in children
There are no clinical data regarding the treatment of Herpes simplexor Herpes zosterinfections in
children with a non-compromised immune system.

Treatment of Herpes simplex infections and prophylaxis of the same in children with a compromised immune system

AgeRecommended dose
under 2 years half the adult dose.
over 2 years The dosage is similar to that of adults
To obtain this recommended dose, other formulations and dosages of aciclovir are available.

Treatment of varicella

AgeRecommended dose
under 2 years 200 mg of aciclovir 4 times a day.
To obtain this recommended dose, other
formulations and dosages of aciclovir are available.
between 2 and 6 years 400 mg of aciclovir 4 times a day
over 6 years 800 mg of aciclovir 4 times a day
Administering 20 mg/kg of body weight (not exceeding 800 mg) 4 times a day allows
a more precise dose adjustment.
Treatment should be continued for 5 days.

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
If your doctor has prescribed high doses of Aciclin, maintain good hydration by taking with
diet an adequate amount of fluids.
The doctor will assess the possibility of reducing the dosage of Aciclin in elderly patients with impaired renal
function.

Patients with kidney problems
For the treatment of Herpes simplexinfections in patients suffering from severe kidney problems
(severe renal insufficiency - creatinine clearance less than 10 ml/min) the recommended dose is 200
mg of aciclovir to be taken 2 times a day, approximately every 12 hours.
To obtain this recommended dose, other formulations and dosages of aciclovir are available.
For the treatment of varicella and Herpes zoster, the dosage must be modified as follows:

Creatinine clearanceRecommended dose

• 10 - 25 ml/min (moderate renal insufficiency)800 mg of aciclovir 3 times a day, approximately every 8 hours

less than 10 ml/min

(severe renal insufficiency)
800 mg of aciclovir 2 times a day, approximately every 12 hours
The doctor will determine the duration of treatment.

If you take more Aciclin than you should
In case of accidental ingestion/intake of an excessive dose of Aciclin, immediately warn
your doctor or go to the nearest hospital.
If you accidentally take doses of Aciclin 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 confusion.
Aciclovir overdose by intravenous route has resulted in increased serum creatinine,
azotemia and consequent renal failure. Neurological effects including confusion,
hallucinations, agitation, convulsions and coma have been described in association with overdose.

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

If you stop taking Aciclin
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 the treatment is indicated.
Stop treatment with Aciclin and contact your doctor immediately if you experience any of the following serious side effects:

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

• severe allergic reaction (anaphylaxis);
• difficulty breathing (dyspnea);
• swelling of the lips, face, neck and throat (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, 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 Aciclin is reduced or treatment is stopped.
The following side effects may also occur, listed by frequency:

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

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

Rare (may affect up to 1 in 1,000 people)
reversible increase in bilirubin and liver enzymes;
increased levels of nitrogen (azotemia) and creatinine in the blood.

Very rare (may affect up to 1 in 10,000 people)
reduction in the number of red blood cells (anemia), white blood cells (leukopenia) and platelets (thrombocytopenia); liver inflammation (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 possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 Aciclin

Keep this medicine out of the sight and reach of children.
Aciclin 800 mg tablets: Store in the original package, to protect the medicine from humidity.
Do not use this medicine after the expiry date that is reported on the package after “Scad”.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the medicine in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aciclin contains

• The active ingredient is aciclovir. Each Aciclin 400 mg tablet contains 400 mg of aciclovir. Each Aciclin 800 mg tablet contains 800 mg of aciclovir;
• The other ingredients are: microcrystalline cellulose, sodium starch glycolate, polyvinylpyrrolidone, magnesium stearate.

Description of the appearance of Aciclin and contents of the pack
Aciclin 400 mg tablets contain 25 white, round 400 mg tablets packaged in blisters of
ALU/PVC/PVDC.
Aciclin 800 mg tablets contain 35 white, oval 800 mg tablets packaged in blisters of
ALU/PVC/PVDC.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Aciclin 400 mg/5 ml oral suspension

Aciclovir
Generic medicine

Read this leaflet carefully before you start to take 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What Aciclin is and what it is used for
• 8. What you need to know before you take Aciclin
• 9. How to take Aciclin
• 10. Possible side effects
• 11. How to store Aciclin
• 12. Contents of the pack and other information

1. What is Aciclin and what is it used for

Aciclin oral suspension contains the active ingredient aciclovir which belongs to a group of medicines
called systemic antivirals.
Aciclin oral suspension is indicated:
for the treatment of herpes simplex infections, responsible for the appearance of lesions and roundish
painful blisters and redness affecting the skin and mucous membranes, including infections of the
genitals that occur for the first time or following recurrences (recurring infections);
to suppress Herpes simplexinfections that continue to recur in immunocompetent patients
(with an immune system that functions normally)
for the prevention of Herpes simplexinfections 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.

2. What you need to know before taking Aciclin

Do not take Aciclin 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);

Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclin if:
you are elderly or have kidney problems. In these cases, your doctor may reduce the dose of aciclovir to
reduce the risk of side effects that may affect the nervous system.
These effects usually resolve once treatment is stopped (see section “Possible
side effects”);
you have a severely weakened immune system, as prolonged or repeated use of Aciclin
may promote resistance of some viruses, causing a reduced response to treatment.
If your doctor has prescribed Aciclin in high doses, make sure you drink plenty of fluids such as waterwhile
taking Aciclin (see section “How to take Aciclin”).

Children and adolescents
Clinical data are not available regarding the treatment of herpes simplex or herpes zoster infections in
children with a non-compromised immune system.

Other medicines and Aciclin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines: probenecid, used to treat gout;
cimetidine, used to treat some stomach disorders;
medicines containing mycophenolate mofetil, used to prevent rejection of transplanted organs.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Limited clinical data recommend the use of Aciclin 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 outweigh the possibility
that risks may occur.

Breastfeeding
Aciclin may be excreted in breast milk, therefore it should not be taken during breastfeeding.

Fertility
No data are available regarding fertility in women. Aciclovir tablets have not shown effects
on the number, morphology and motility of spermatozoa in men.

Driving and using machines
Studies have not been conducted to verify the effects of Aciclin on the ability to drive and use
machinery. Assess the possible occurrence of side effects that may alter the level of
attention.

Aciclin oral suspension contains:

• sorbitol:this medicine contains 2.3 g of sorbitol in 5 ml of suspension. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or the child) take this medicine. It may cause gastrointestinal problems and have a mild laxative effect.
• methyl parahydroxybenzoateand propyl parahydroxybenzoate: may cause allergic reactions (including delayed ones).

4. How to take Aciclin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The package contains a dosing cup, on which there are level markings corresponding to 5
ml and 10 ml.
Shake the suspension before use.

To open the bottle, press the cap down and
simultaneously rotate it counterclockwise (fig.1).
To close the bottle, screw the cap on tightly by rotating it in the
opposite direction.
fig. 1
To make it easier to take the correct dosage, which varies depending on the disease for which the
treatment is indicated, other formulations and other dosages of aciclovir are available.

Use in adults

Treatment of Herpes simplex infections
The recommended dose is 200 mg of aciclovir 5 times a day, approximately every 4 hours, omitting
the dose during the night.
Treatment should be continued 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, 400 mg of aciclovir (corresponding to 5 ml of oral suspension) or alternatively consider the
administration of aciclovir intravenously.
The maximum efficacy of Aciclin 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

compromised immune system
The recommended dose is 200 mg of aciclovir 4 times a day, every 6 hours.
Many patients can be successfully treated with dosages of 400 mg of aciclovir (corresponding to 5 ml
of oral suspension) 2 times a day, every 12 hours. Dosages of
200 mg of aciclovir 3 times a day, every 8 hours, or 2 times a day at 12-hour intervals can also be effective.
In some patients, recurrent infections may occur with a total daily dosage of 800 mg of aciclovir.
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

compromised immune system
The recommended dose is 200 mg of aciclovir 4 times a day, every 6 hours.
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, 400 mg of aciclovir (corresponding to 5 ml of oral suspension), or alternatively consider the
administration of aciclovir intravenously.
The doctor will determine the duration of treatment based 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 (corresponding to 10 ml of oral suspension) 5 times a day,
approximately every 4 hours (e.g.: at breakfast, in late morning, in the early afternoon,
in the late afternoon and in the evening), omitting the dose during the night.
Treatment should be continued 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 evaluate the administration of
aciclovir intravenously.
The maximum efficacy of Aciclin is achieved when treatment is started promptly, at the first
manifestations of a lesion.

Use in children
There is no clinical data regarding the treatment of herpes simplex or herpes zoster infections in
children with a non-compromised immune system.

Treatment of herpes simplex infections and prophylaxis of the same in children with a compromised immune system

compromised immune system

AgeRecommended dose
under 2 years Half the adult dose. To obtain this dose
recommended, other formulations and
other dosages of aciclovir are available.
over 2 years The dosage is similar to that of adults

Treatment of chickenpox

AgeRecommended dose
under 2 years 200 mg of aciclovir 4 times a day
between 2 and 6 years 400 mg of aciclovir (5 ml of oral suspension) 4 times a day
over 6 years 800 mg of aciclovir (10 ml of oral suspension) 4 times a day
Administering 20 mg/kg of body weight (not exceeding 800 mg) 4 times a day allows
a more precise dose adjustment.
Treatment should be continued for 5 days.

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
If your doctor has prescribed high doses of Aciclin, maintain good hydration by consuming an
adequate amount of fluids with your diet.
The doctor will assess the possibility of reducing the dosage of Aciclin in elderly patients with impaired renal
function.

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 200
mg of aciclovir to be taken 2 times a day, approximately every 12 hours.
For the treatment of chickenpox and herpes zoster, the dosage must be modified as follows:

Creatinine clearanceRecommended dose

• 10 - 25 ml/min (moderate renal insufficiency)800 mg of aciclovir (corresponding to 10 ml of oral suspension) 3 times a day, approximately every 8 hours

less than 10 ml/min

(severe renal insufficiency)
800 mg of aciclovir (corresponding to 10 ml of
oral suspension) 2 times a day, approximately every 12 hours
The doctor will determine the duration of treatment.

If you take more Aciclin than you should
In case of accidental ingestion/intake of an excessive dose of Aciclin, immediately inform
your doctor or go to the nearest hospital.
If you accidentally take doses of Aciclin 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 confusion.
Overdose of aciclovir intravenously has resulted in increased serum creatinine,
azotemia and subsequent renal failure. Neurological effects including confusion,
hallucinations, agitation, convulsions and coma have been described in association with overdose

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

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

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

• severe allergic reaction (anaphylaxis);
• difficulty breathing (dyspnea);
• swelling of the lips, face, neck and throat (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 normally
improve when the dosage of Aciclin is reduced or treatment is stopped.
The following side effects listed by frequency may also occur:

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

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

Rare (may affect up to 1 in 1,000 people)
reversible increase in bilirubin and liver enzymes;
increased levels of nitrogen (azotemia) and creatinine in the blood.

Very rare (may affect up to 1 in 10,000 people)
reduction in the number of red blood cells (anemia), white blood cells (leukopenia) and platelets (thrombocytopenia);
liver inflammation (hepatitis), yellowing 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 experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 Aciclin

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 “Exp”.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the medicine in intact packaging, correctly stored.
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.

7. Contents of the pack and other information

What Aciclin contains
The active ingredient is aciclovir.
5 ml of oral suspension contains 400 mg of aciclovir.
The other ingredients are: non-crystallizing sorbitol, glycerol, powdered cellulose, methyl
parahydroxybenzoate, propyl parahydroxybenzoate, cherry aroma, purified water.

Description of the appearance of Aciclin and contents of the pack
Milky-colored suspension contained in a 100 ml glass bottle, closed with a screw cap. The
pack also includes a measuring device.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)

Manufacturer
ABC Farmaceutici S.p.A.
Canton Moretti, 29 - Loc. S. Bernardo d’Ivrea
10090 Ivrea (TO)

Aciclin 50 mg/g cream

aciclovir
Generic medicine

Read this leaflet carefully before 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 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:

• 13. What Aciclin is and what it is used for
• 14. What you need to know before you use Aciclin
• 15. How to use Aciclin
• 16. Possible side effects
• 17. How to store Aciclin
• 18. Contents of the pack and other information

1. What is Aciclin and what is it used for

Aciclin 50mg/g cream contains the active ingredient aciclovir, which belongs to a group of medicines
called antiviral drugs for topical use. Aciclovir works against herpes viruses.
Aciclin 50mg/g cream is indicated in the treatment of skin infections caused by the Herpes

simplexvirus such as lip herpes and primary (which occurs for the first time) or
recurrent genital herpes (which continues to reappear).

2. What you need to know before using Aciclin

Do not use Aciclin 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).

Warnings and precautions
Talk to your doctor or pharmacist before using Aciclin cream.
Do not apply Aciclin cream to the soft tissues (mucous membranes) of the mouth, eyes and vagina as
this may cause irritation.
Take particular care when using the cream, in order to avoid accidental application
in the eyes.
If you use Aciclin cream for a long period of time, sensitization may occur; if this happens, you should stop treatment and consult your doctor.
Tell your doctor before using this medicine if you have a severely compromised
immune system (immunocompromised), e.g. if you have AIDS (acquired immunodeficiency
syndrome) or if you have undergone bone marrow transplantation. In this case, your doctor will assess the possibility
of prescribing aciclovir orally (tablets, oral suspension or granules for oral suspension).

Other medicines and Aciclin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No clinically significant interactions with other medicines have been identified.

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

Pregnancy
Do not use Aciclin without first consulting your doctor. The doctor will assess whether the possible benefits of
treatment outweigh the possibility of unknown risks occurring.
Systemic exposure to aciclovir, following topical (local) application of Aciclin cream, is very low.

Breastfeeding
If you are breastfeeding or plan to do so, talk to your doctor before using Aciclin.
Limited data indicate that Aciclin may be excreted in breast milk following systemic administration.
However, the dose received by an infant following the use of Aciclin cream in the
mother should be negligible.

Driving and using machines
No studies have been conducted to evaluate the effects of aciclovir on the ability to drive vehicles and
operate machinery.

Aciclin 50 mg/g cream contains:

• methyl parahydroxybenzoate which may cause allergic reactions (including delayed reactions).

5. How to take Aciclin

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Apply Aciclin cream 5 times a day, approximately every 4 hours for at least 5 consecutive days.
Aciclin cream should be applied to the lesions or to the areas where they are developing as
soon as possible, preferably during the earliest stages (tingling, itching, burning, pain and
redness). Treatment may also be started during the later stages (papules or vesicles).
If healing does not occur within the first 5 days of treatment, the application of the cream may
be prolonged for another 5 days (up to a maximum of 10 days).

If you use more Aciclin than you should
In case of accidental ingestion/intake of an excessive dose of Aciclin, immediately inform your
doctor or go to the nearest hospital.

If you forget to use Aciclin
If you forgot to apply the cream, do so as soon as you remember; then continue the application
according to the usual schedule. Do not apply a double dose to compensate for the forgotten one.

If you stop the treatment with Aciclin
If you have any doubts about the use of Aciclin, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with Aciclin and contact your doctor immediately if you experience any of the
following serious side effects:

Very rare (may affect up to 1 in 10,000 people)
allergic reactions (immediate hypersensitivity reactions) including swelling of the lips, face,
neck and throat causing difficulty in breathing (angioedema) and skin reaction
(urticaria).
The following side effects may also occur, listed by frequency:

Uncommon (may affect up to 1 in 100 people)
burning or brief pain after applying the cream;
moderate dryness and scaling of the skin;
itching.

Rare (may affect up to 1 in 1,000 people)
skin irritation (erythema);
skin inflammation after application due to contact with the cream (contact dermatitis)

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
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 Aciclin

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.
The expiry date indicated refers to the medicine in intact packaging, correctly stored.
Store at a temperature below 25°C.
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.

8. Contents of the pack and other information

What Aciclin contains
The active ingredient is aciclovir. 1 g of cream contains 50 mg of aciclovir.
The other ingredients are: tefose 1500, stearic acid glycerol, liquid paraffin, methyl
parahydroxybenzoate, purified water.

Description of the appearance of Aciclin and contents of the pack
Aciclin is a white cream contained in an aluminium tube of 10 g.

Marketing authorisation holder and manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)