Aciclovir Alfasigma

Package leaflet: Information for the patient

ACICLOVIR ALFASIGMA 400 mg tablets, 800 mg tablets

Aciclovir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking 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 ACICLOVIR ALFASIGMA is and what it is used for
ACICLOVIR ALFASIGMA tablets contain the active substance aciclovir and belong to a group of medicines called systemic antivirals. Aciclovir acts against herpesviruses.
The term "herpes" refers to a group of infections caused by viruses 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), genitals (genital herpes), or more extensive areas of the body such as the back and arms (herpes zoster or shingles).
ACICLOVIR ALFASIGMA tablets are indicated:
for the treatment of herpes simplex infections, the most common virus among the Herpesviridae, responsible for painful, roundish lesions, blisters, and redness affecting the skin and mucous membranes, including initial infections or recurrences (recurrent infections) of the genital area;
for the treatment of recurrent herpes simplex infections in patients with a normally functioning 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 Herpesviridae family).

2. What you should know before taking ACICLOVIR ALFASIGMA

Do not take ACICLOVIR ALFASIGMA

• if you are allergic to the active substance 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 dose of aciclovir to reduce the risk of undesirable effects affecting 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 ACICLOVIR ALFASIGMA may promote resistance of certain viruses, resulting in reduced response to treatment.
Consult your doctor if you think any of these situations apply to you. Your doctor may reduce the dose of ACICLOVIR ALFASIGMA.
If your doctor has prescribed a high dose of ACICLOVIR ALFASIGMA, take care to maintain adequate hydration by consuming 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 should pay particular attention when taking ACICLOVIR ALFASIGMA together with the following medicines:
medicines affecting the kidneys, such as probenecid, used to treat gout, and cimetidine, used to treat certain stomach disorders;
medicines containing mycophenolate mofetil, used to prevent rejection of transplanted kidney, heart, or liver;
theophylline, used for respiratory problems.
Inform your doctor if you are taking any of these medicines, as concomitant use with ACICLOVIR ALFASIGMA may reduce the kidneys' ability to remove aciclovir from the blood.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Limited clinical data recommend using ACICLOVIR ALFASIGMA during pregnancy only when strictly necessary and under medical supervision. Your doctor will assess whether the potential benefits of treatment for you outweigh the potential risks to the unborn child.
Breastfeeding
ACICLOVIR ALFASIGMA may be excreted in breast milk; therefore, your doctor will carefully evaluate whether you should take ACICLOVIR ALFASIGMA while breastfeeding.
Driving and using machines
ACICLOVIR ALFASIGMA may cause side effects that could affect your ability to drive or operate machinery, such as dizziness, drowsiness, and confusion. Therefore, exercise caution when driving or operating 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablet by mouth as instructed by your doctor.
It is very important to drink 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 five times a day, approximately every 4 hours, omitting the dose taken during the night.
Treatment should last for 5 days. In cases of severe, first-episode herpes infections, your doctor may advise you to extend the treatment.
If you have a severely weakened immune system (e.g. after a bone marrow transplant) or intestinal absorption problems, your doctor may prescribe a higher dose of 400 mg or alternatively consider administering aciclovir by intravenous infusion.
ACICLOVIR ALFASIGMA is most effective when treatment is started promptly and, in recurrent infections, at the first signs of herpes (burning, swelling, or itching) or at the first sign of a lesion.

Treatment of recurrent herpes simplex infections in patients with a non-compromised immune system
The recommended dose is 400 mg twice daily, approximately every 12 hours. In some patients, recurrent infections may require a daily dose of 800 mg of ACICLOVIR ALFASIGMA.
Stop treatment, always following your doctor's advice, every 6 or 12 months. This allows your doctor to monitor 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 weakened immune system (e.g. after a bone marrow transplant) or intestinal absorption problems, your doctor will prescribe a dose of 400 mg per tablet or alternatively consider administering aciclovir intravenously.
Your doctor will determine the duration of treatment based on the period of risk you are exposed to.

Treatment of herpes zoster (shingles) and varicella (chickenpox)
The recommended dose is 800 mg of ACICLOVIR ALFASIGMA tablets five times a day, every 4 hours (e.g. at breakfast, late morning, early afternoon, late afternoon, and evening), omitting the dose during the night.
Treatment should last for 7 consecutive days.
If you have a severely weakened immune system (e.g. after a bone marrow transplant) or intestinal absorption problems, your doctor will consider administering aciclovir intravenously.
ACICLOVIR ALFASIGMA is most effective when treatment is started promptly, at the first sign of a lesion.

Use in children
Treatment of herpes simplex infections, including genital herpes

• Children aged 2 years and older: the recommended dose is 200 mg five times a day.
• Children under 2 years of age: the recommended dose is half the adult dose. For treatment of neonatal herpes virus infections, intravenous administration of aciclovir is recommended.

ACICLOVIR ALFASIGMA is not indicated in children with a weakened immune system who have severe herpes simplex infections.
Treatment of recurrent herpes simplex infections in children with a non-compromised immune system
There are no available clinical data on 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, an oral suspension formulation is available. The recommended dosage is 0.25 ml (corresponding to 20 mg) per kg of body weight, administered four times daily, without exceeding 10 ml per single dose (equivalent to 800 mg).
The treatment should last for 5 days.
There are no available data on the treatment of Herpes zoster in children with non-compromised immune systems.

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

Use in the elderly
Maintain adequate hydration by consuming sufficient fluids through your diet, especially when taking high doses of ACICLOVIR ALFASIGMA.
The physician may consider reducing the dosage of ACICLOVIR ALFASIGMA in elderly patients with age-related kidney problems.

Patients with kidney problems
For the treatment of herpes simplex infections in patients with severe kidney problems (severe renal impairment - creatinine clearance below 10 ml/min), the recommended dose is 200 mg taken twice daily, approximately every 12 hours.
For the treatment of varicella and herpes zoster in patients with severe renal impairment (creatinine clearance below 10 ml/min), the recommended dose is 800 mg taken twice daily, approximately every 12 hours.
In cases of moderate renal impairment (creatinine clearance between 10 and 25 ml/min), the recommended dose is 800 mg taken three times daily, approximately every 8 hours.
The physician will determine the duration of treatment.

If you take more ACICLOVIR ALFASIGMA than you should
Contact your doctor immediately if you take an excessive dose of ACICLOVIR ALFASIGMA.
If you accidentally take oral doses of ACICLOVIR ALFASIGMA higher than recommended for prolonged periods, you may experience adverse effects affecting the stomach or intestines, such as nausea and vomiting, and effects on the central nervous system, such as headache and confusion.
Exceeding the recommended intravenous doses may lead to increased levels of creatinine and nitrogen in the blood, potentially resulting in renal failure.
In cases of overdose, central nervous system effects have been reported, including confusion, hallucinations, agitation, seizures, and coma.

Management in case of ACICLOVIR ALFASIGMA overdose
Patients should be closely monitored to promptly detect any signs or symptoms of toxicity. Supportive measures for symptomatic overdose include hemodialysis (a blood purification therapy), which significantly contributes to removing aciclovir from the bloodstream.

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

If you stop taking ACICLOVIR ALFASIGMA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The frequency of side effects may vary depending on the condition being treated.
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 (dyspnoea);
• 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 articulation disorder (dysarthria), hallucinations, psychotic symptoms, seizures, drowsiness, altered brain function (encephalopathies), coma.
These nervous system side effects usually occur in people with kidney problems or other predisposing factors (see section “Warnings and precautions”). These effects usually improve when the dose of ACICLOVIR ALFASIGMA is reduced or treatment is discontinued.

Other side effects are listed below by frequency:

Common (may affect up to 1 in 10 people)
Headache, dizziness;
nausea, vomiting, diarrhoea, 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 (dyspnoea);
• swelling of the lips, face, neck, and throat (angioedema); reversible increase in blood levels of 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)

• feeling confused and agitated
• tremors
• unsteadiness when walking and lack of coordination (ataxia)
• slow and defective speech (dysarthria)
• seeing or hearing things that are not real (hallucinations)
• thought and perception disturbances 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 (anaemia), white blood cells (leucopenia), and platelets in the blood, the cells responsible for blood clotting (thrombocytopenia); inflammation of the liver (hepatitis), yellowish discoloration of the eyes and skin (jaundice); severe kidney failure, pain at the lower back (renal pain) which may be associated with kidney failure.

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 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 "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 ALFASIGMA contains

• The active substance 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 components are: microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate.

Description of the appearance of ACICLOVIR ALFASIGMA and contents of the pack

• ACICLOVIR ALFASIGMA 400 mg tablets contains 25 white, round 400 mg tablets, packed in PVC/aluminum blisters.
• ACICLOVIR ALFASIGMA 800 mg tablets contains 35 white, round 800 mg tablets, packed in PVC/aluminum 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

Patient Information Leaflet

ACICLOVIR ALFASIGMA 8% oral suspension

Aciclovir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 ACICLOVIR ALFASIGMA is and what it is used for

ACICLOVIR ALFASIGMA 8% oral suspension contains the active substance aciclovir and is a medicine belonging to the family of systemic antivirals. Aciclovir acts against herpesviruses.
The term herpes refers to a group of infections caused by viruses 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), genitals (herpes genitalis), or more extensive areas of the body such as the back and arms (herpes zoster or shingles).
ACICLOVIR ALFASIGMA 8% oral suspension is indicated:
for the treatment of herpes simplex infections, the most common virus among the Herpesviridae family, responsible for painful, roundish lesions and blisters accompanied by redness affecting the skin and mucous membranes, including infections occurring for the first time or recurrent episodes (recurrent infections) in the genital area;
for 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 Herpesviridae family).

2. What you need to know before taking ACICLOVIR ALFASIGMA

Do not take ACICLOVIR ALFASIGMA if

• you are allergic to the active substance 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 undesirable effects affecting 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 ACICLOVIR ALFASIGMA may promote resistance in certain viruses, leading to reduced response to treatment.
Talk to your doctor if you think any of these situations apply to you. Your doctor may reduce the dose of ACICLOVIR ALFASIGMA.
If your doctor has prescribed a high dose of ACICLOVIR ALFASIGMA, take care to maintain adequate hydration by consuming an appropriate amount of fluids through your diet (see section "How to take ACICLOVIR ALFASIGMA").
Children and adolescents
ACICLOVIR ALFASIGMA must not be administered 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 medicines.
You should pay particular attention when taking ACICLOVIR ALFASIGMA together with the following medicines:
medicines affecting the kidneys, such as probenecid, used to treat gout, and cimetidine, used to treat certain stomach disorders;
medicines containing mycophenolate mofetil, used to prevent rejection of transplanted kidney, heart, or liver by your body;
theophylline, used for respiratory problems.
Inform your doctor if you are taking any of these medicines, as concomitant use with ACICLOVIR ALFASIGMA may reduce the kidneys' ability to remove aciclovir from the blood.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Limited clinical data recommend using ACICLOVIR ALFASIGMA during pregnancy only if clearly needed and under medical supervision. Your doctor will assess whether the potential benefits of treatment for you outweigh the potential risks to the unborn child.
Breastfeeding
ACICLOVIR ALFASIGMA may be excreted in breast milk; therefore, your doctor will carefully evaluate whether you should take ACICLOVIR ALFASIGMA while breastfeeding.
Driving and using machines
ACICLOVIR ALFASIGMA may cause side effects that can affect your ability to drive or operate machinery, such as dizziness, somnolence, and confusion. Therefore, exercise caution when driving or operating machinery.
ACICLOVIR ALFASIGMA 8% oral suspension contains:
methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate: may cause allergic reactions (including delayed reactions);
sorbitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ACICLOVIR ALFASIGMA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Shake the suspension well before use.
The package of ACICLOVIR ALFASIGMA 8% oral suspension includes a dosing spoon with markings indicating levels of 5 and 10 ml.

Use in adults
Treatment of herpes simplex infections
The recommended dose is 2.5 ml of oral suspension five times a day, approximately every 4 hours, omitting the nighttime dose.
Treatment should last for 5 days. In cases of severe, first-episode herpes infections, your doctor may advise you to extend the treatment.
If you have a severely weakened immune system (e.g. following bone marrow transplantation) or intestinal absorption problems, your doctor may prescribe a higher dose—5 ml of oral suspension—or alternatively consider administering aciclovir by intravenous infusion.
ACICLOVIR ALFASIGMA achieves maximum effectiveness when treatment is started promptly, and in recurrent infections, at the first signs of herpes (burning, swelling, or itching) or at the first appearance of a lesion.

Preventive treatment (prophylaxis) of recurrent herpes simplex infections in patients with non-compromised immune systems
The recommended dose is 5 ml twice daily, every 12 hours. In some patients taking this dosage, recurrent infections may still occur.
Interrupt treatment periodically, always following your doctor’s advice, every 6 or 12 months. This allows your doctor to monitor any changes in the course of the disease.

Preventive treatment (prophylaxis) of herpes simplex infections in patients with compromised immune systems
If you have a severely weakened immune system (e.g. following bone marrow transplantation) or intestinal absorption problems, your doctor will prescribe 5 ml of oral suspension, or alternatively consider administering aciclovir intravenously.
Your doctor will determine the duration of treatment based on the period of risk you are exposed to.

Treatment of herpes zoster (shingles) and varicella (chickenpox)
The recommended dose is 10 ml of suspension five times daily, every 4 hours (e.g. at breakfast, late morning, early afternoon, late afternoon, and evening), omitting the nighttime dose.
Treatment should last for 7 consecutive days.
If you have a severely weakened immune system (e.g. following bone marrow transplantation) or intestinal absorption problems, your doctor will consider administering aciclovir intravenously.
ACICLOVIR ALFASIGMA achieves maximum effectiveness when treatment is started promptly, at the first signs of a lesion.

Use in children
Treatment of herpes simplex infections, including genital herpes

• Children aged 2 years and older: the recommended dose is 200 mg five times daily.
• Children under 2 years of age: the recommended dose is half the adult dose. For treatment of neonatal herpes virus infections, intravenous aciclovir is recommended. ACICLOVIR ALFASIGMA is not indicated for severe herpes simplex infections in children with weakened immune systems.

Preventive and treatment of recurrent herpes simplex infections in children with non-compromised immune systems
There are no clinical data available on the treatment of herpes simplex or herpes zoster infections in children with non-compromised immune systems.

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

Treatment of varicella and Herpes Zoster

For a 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, administered 4 times a day, without exceeding 10 ml per single dose (corresponding to 800 mg).
Treatment should last for 5 days.
There are no available data on the treatment of Herpes zoster in children with non-compromised immune systems.

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

Use in elderly patients
Maintain adequate hydration by consuming sufficient fluids through your diet if you are taking high doses of ACICLOVIR ALFASIGMA.
The physician will assess the possibility of reducing the dosage of ACICLOVIR ALFASIGMA in elderly patients with age-related kidney problems.

Patients with kidney problems
For the treatment of herpes simplex infections in patients with severe kidney problems (severe renal impairment - creatinine clearance less than 10 ml/min), the recommended dose is 2.5 ml of oral suspension taken twice daily, approximately every 12 hours.
For the treatment of varicella and herpes zoster in patients with severe renal impairment (creatinine clearance less than 10 ml/min), the recommended dose is 10 ml of oral suspension taken twice daily, approximately every 12 hours.
In cases of moderate renal impairment (creatinine clearance between 10 and 25 ml/min), the recommended dose is 10 ml of oral suspension taken 3 times a day, approximately every 8 hours.
The physician will determine the duration of treatment.

If you take more ACICLOVIR ALFASIGMA than you should
Contact your doctor in case of accidental overdose of ACICLOVIR ALFASIGMA.
If you accidentally take oral doses of ACICLOVIR ALFASIGMA higher than recommended and for prolonged periods, you may experience adverse effects affecting the stomach or intestines, such as nausea and vomiting, and effects on the central nervous system, such as headache and confusion.
Taking higher-than-recommended doses intravenously may lead to increased levels of creatinine and nitrogen in the blood and subsequent renal failure.
In cases of overdose, central nervous system effects have been reported, including confusion, hallucinations, agitation, seizures, and coma.

Management in case of accidental overdose of ACICLOVIR ALFASIGMA
Patients should be closely monitored to promptly identify any signs or symptoms of toxicity. Management procedures in symptomatic overdose include hemodialysis (blood purification therapy), which significantly contributes to removing 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 using 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 being treated.
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 (dyspnoea);
• 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 articulation disorder (dysarthria), hallucinations, psychotic symptoms, seizures, drowsiness, altered brain function (encephalopathy), coma.
These nervous system side effects usually occur in people with kidney problems or other predisposing factors (see section “Warnings and precautions”). These effects generally improve when the dose of ACICLOVIR ALFASIGMA is reduced or treatment is discontinued.

Other side effects are listed below by frequency:

Common (may affect up to 1 in 10 people)
Headache (cephalalgia), dizziness;
nausea, vomiting, diarrhoea, 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 (dyspnoea)
• swelling of the lips, face, neck and throat (angioedema)
  reversible increase in blood bilirubin levels and liver enzymes; increase in blood nitrogen (azotaemia) and creatinine levels.

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

• feeling confused and agitated
• tremors
• unsteadiness when walking and lack of coordination (ataxia)
• slow and defective speech (dysarthria)
• seeing or hearing things that are not real (hallucinations)
• thought and perception disorders 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 (anaemia), white blood cells (leucopenia), and platelet count (blood cells responsible for clotting) (thrombocytopenia);
  inflammation of the liver (hepatitis), yellowish discoloration of 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 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 the following website: 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 stated on the outer packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 ALFASIGMA contains
The active substance is aciclovir.
5 ml of oral suspension contain 400 mg of aciclovir.
The other components are: sorbitol 70%, glycerol, dispersible cellulose, methyl
parahydroxybenzoate, propyl parahydroxybenzoate, cherry flavour, purified water.

Description of the appearance of ACICLOVIR ALFASIGMA and contents of the pack
ACICLOVIR ALFASIGMA 8% oral suspension comes in a 120 ml PVC bottle containing 100 ml of milky suspension at 80 mg/ml, sealed with a screw-off aluminium cap and supplied with a dosing spoon.

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