ACICLOVIR 200 mg Coated Tablets

Зміст інструкції

1. Aciclovir Aurobindo Pharma 200 mg tablets
   1. What is Aciclovir Aurobindo Pharma and what it is used for
   2. What you need to know before taking Aciclovir Aurobindo Pharma
   3. How to take Aciclovir Aurobindo Pharma
   4. Possible side effects
   5. How to store Aciclovir Aurobindo Pharma
   6. Package Contents and Other Information
2. Aciclovir Aurobindo Pharma 400 mg tablets
   1. What is Aciclovir Aurobindo Pharma and what it is used for
   2. What you need to know before taking Aciclovir Aurobindo Pharma
   3. How to take Aciclovir Aurobindo Pharma
   4. Possible side effects
   5. How to store Aciclovir Aurobindo Pharma
   6. Package Contents and Other Information
3. Aciclovir Aurobindo Pharma 800 mg tablets
   1. What is Aciclovir Aurobindo Pharma and what it is used for
   2. What you need to know before you take Aciclovir Aurobindo Pharma
   3. How to take Aciclovir Aurobindo Pharma
   4. Possible side effects
   5. How to store Aciclovir Aurobindo Pharma
   6. Package contents and other information

Aciclovir Aurobindo Pharma 200 mg tablets

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

1. What is Aciclovir Aurobindo Pharma and what it is used for

Aciclovir Aurobindo Pharma contains an active ingredient called aciclovir, which belongs to a group of
medicines called antivirals. It works by killing or stopping the growth of viruses.

Aciclovir Aurobindo Pharma is indicated for:

• treating chickenpox and shingles;
• treating cold sores, genital herpes and other herpes simplex infections;
• preventing the recurrence of these infections once treated;
• preventing the recurrence of these infections in people whose immune system works less well and who are less able to fight infections.

2. What you need to know before taking Aciclovir Aurobindo Pharma

Do not take Aciclovir Aurobindo Pharma:

• if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6). Do not take Aciclovir Aurobindo Pharma if the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Aciclovir Aurobindo Pharma.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclovir Aurobindo Pharma if:

• you have kidney problems;
• you are over 65 years of age.

If you are not sure if the above applies to you, ask your doctor or pharmacist before taking Aciclovir
Aurobindo Pharma. It is important that you drink plenty of water while taking Aciclovir Aurobindo
Pharma.

Other medicines and Aciclovir Aurobindo Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription and herbal remedies.
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 stomach ulcers;
• mycophenolate mofetil, used to prevent rejection of transplanted organs.

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

Driving and operating machinery
Some undesirable effects such as feeling tired or drowsy may impair your ability to concentrate and react.
Make sure you are not affected before driving or operating machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Aciclovir Aurobindo Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Taking this medicine:

• Take this medicine by mouth.
• The tablet must be swallowed whole with a little water.
• Start taking Aciclovir Aurobindo Pharma as soon as possible.

The dose to be taken will depend on the reason why you have been given Aciclovir Aurobindo Pharma. The doctor
will discuss this with you. An 800 mg tablet is also available.

Treatment of chickenpox and shingles

• The usual dose is one 800 mg tablet five times a day.
• Take the dose at intervals of approximately 4 hours.
• Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Aurobindo Pharma for seven days.

Treatment of cold sores and genital herpes

• The usual dose is one 200 mg tablet five times a day.
• Take the dose at intervals of approximately 4 hours.
• Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Aurobindo Pharma for five days, or for a longer time if your doctor tells you to do so.

To avoid the recurrence of these infections once cured

• The usual dose is one 200 mg tablet four times a day.
• Take the dose at intervals of approximately 6 hours.
• Take Aciclovir Aurobindo Pharma until your doctor tells you to stop.

To prevent the recurrence of these infections in people whose immune system works less
well and who are less able to fight infections

• The usual dose is one 200 mg tablet four times a day.
• Take the dose at intervals of approximately 6 hours.
• Take Aciclovir Aurobindo Pharma until your doctor tells you to stop.

Your doctor may need to adjust the dose of Aciclovir Aurobindo Pharma if:

• it is for a child;
• you are over 65 years of age;
• you have kidney problems. If you have kidney problems, it is important that you drink plenty of water while taking Aciclovir Aurobindo Pharma.

Tell your doctor before taking Aciclovir Aurobindo Pharma if the above applies to you.

If you take more Aciclovir Aurobindo Pharma than you should
Aciclovir Aurobindo Pharma is usually not harmful, unless you take too much for several days.
Talk to your doctor or pharmacist if you take too much Aciclovir Aurobindo Pharma. Bring the package
of the medicine with you.

If you forget to take Aciclovir Aurobindo Pharma

• If you forget to take Aciclovir Aurobindo Pharma, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Allergic reactions(may affect up to 1 in 1,000 people)
If you get an allergic reaction, stop taking Aciclovir Aurobindo Pharma and see your doctor
immediately.
Signs of an allergic reaction can include:

• skin rash, itching or hives;
• swelling of the face, lips, tongue or other parts of the body;
• shortness of breath, wheezing or difficulty breathing;
• collapse.

Other side effects include:
Common(may affect up to 1 in 10 people):

• headache;
• dizziness;
• nausea;
• vomiting;
• diarrhoea;
• abdominal pain;
• skin rash;
• skin reaction after exposure to sunlight (photosensitivity);
• itching;
• fatigue;
• unexplained fever (high temperature) and feeling faint, especially when standing up.

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

• itching, itchy rash;
• hair loss.

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

• effects on some blood and urine tests;
• increased liver enzymes.

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

• reduced number of red blood cells (anaemia);
• reduced number of white blood cells (leucopenia);
• reduced number of platelets (cells that help blood to clot) (thrombocytopenia);
• feeling weak;
• feeling agitated or confused;
• tremors;
• hallucinations (seeing or hearing things that do not exist);
• convulsions;
• feeling unusually tired or sleepy;
• unsteadiness when walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• loss of consciousness (coma);
• paralysis of part or all of the body;
• behaviour, speech and eye movement disorders;
• neck pain and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the whites of the eyes or skin (jaundice);
• kidney problems where little or no urine is produced;
• pain in the lower back, in the area corresponding to the kidneys or just above the hip (renal pain).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Aciclovir Aurobindo Pharma

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 label and the package 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 Aurobindo Pharma contains
The active ingredient is aciclovir. Each 200 mg tablet contains 200 mg of aciclovir.
The other ingredients are:
microcrystalline cellulose (grade 101), sodium starch glycolate (type A), povidone (K-30), colloidal silicon dioxide
anhydrous, magnesium stearate.

Description of the appearance of Aciclovir Aurobindo Pharma and package contents
Tablets.
Uncoated tablets from white to off-white, round (diameter: 9.5 mm), biconvex, with ‘AR
200’ imprinted on one side and smooth on the other.
Aciclovir Aurobindo Pharma is available in blister packs.
Packs of:
25, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Aciclovir Aurobindo Pharma
Portugal: Aciclovir Aurovitas
Spain: Aciclovir Aurovitas 200 mg comprimidos EFG

Aciclovir Aurobindo Pharma 400 mg tablets

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

7. What is Aciclovir Aurobindo Pharma and what it is used for

Aciclovir Aurobindo Pharma contains an active substance called aciclovir, which belongs to a group of
medicines called antivirals. It works by killing or stopping the growth of viruses.

Aciclovir Aurobindo Pharma is indicated for:

• treating chickenpox and shingles;
• treating cold sores, genital herpes and other herpes simplex infections;
• preventing the recurrence of these infections once treated;
• preventing the recurrence of these infections in people whose immune system works less well and who are less able to fight infections.

8. What you need to know before taking Aciclovir Aurobindo Pharma

Do not take Aciclovir Aurobindo Pharma:

• if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6). Do not take Aciclovir Aurobindo Pharma if the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Aciclovir Aurobindo Pharma.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclovir Aurobindo Pharma if:

• you have kidney problems;
• you are over 65 years of age.

If you are not sure if the above applies to you, ask your doctor or pharmacist before taking Aciclovir
Aurobindo Pharma. It is important that you drink plenty of water while taking Aciclovir Aurobindo
Pharma.

Other medicines and Aciclovir Aurobindo Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription and herbal remedies.
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 stomach ulcers;
• mycophenolate mofetil, used to prevent rejection of transplanted organs.

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

Driving and operating machinery
Some undesirable effects such as feeling tired or drowsy may impair your ability to concentrate and react.
Make sure you are not affected before driving or operating machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially ‘sodium-free’.

9. How to take Aciclovir Aurobindo Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

Taking this medicine:

• Take this medicine by mouth.
• The tablet must be swallowed whole with a little water.
• Start taking Aciclovir Aurobindo Pharma as soon as possible.

The dose to be taken will depend on the reason why you have been given Aciclovir Aurobindo Pharma. The doctor
will discuss this with you. A 200 mg tablet is also available.

Treatment of chickenpox and shingles

• The usual dose is two 400 mg tablets five times a day.
• Take the dose at intervals of approximately 4 hours.
• Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Aurobindo Pharma for seven days.

Treatment of cold sores and genital herpes

• The usual dose is one 200 mg tablet five times a day.
• Take the dose at intervals of approximately 4 hours.
• Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Aurobindo Pharma for five days, or for longer if your doctor tells you to do so.

To avoid the recurrence of these infections once cured

• The usual dose is one 200 mg tablet four times a day.
• Take the dose at intervals of approximately 6 hours.
• Take Aciclovir Aurobindo Pharma until your doctor tells you to stop.

To prevent the recurrence of these infections in people whose immune system works less
well and who are less able to fight infections.

• The usual dose is one 200 mg tablet four times a day.
• Take the dose at intervals of approximately 6 hours.
• Take Aciclovir Aurobindo Pharma until your doctor tells you to stop.

Your doctor may need to adjust the dose of Aciclovir Aurobindo Pharma if:

• you are a child;
• you are over 65 years of age;
• you have kidney problems. If you have kidney problems, it is important that you drink plenty of water while taking Aciclovir Aurobindo Pharma.

Tell your doctor before taking Aciclovir Aurobindo Pharma if the above applies to you.

If you take more Aciclovir Aurobindo Pharma than you should
Aciclovir Aurobindo Pharma is usually not harmful, unless you take too much for several days.
Talk to your doctor or pharmacist if you take too much Aciclovir Aurobindo Pharma. Bring the package
of the medicine with you.

If you forget to take Aciclovir Aurobindo Pharma

• If you forget to take Aciclovir Aurobindo Pharma, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Allergic reactions(may affect up to 1 in 1,000 people)
If you have an allergic reaction, stop taking Aciclovir Aurobindo Pharma and see your doctor
immediately.
Signs of an allergic reaction can include:

• skin rash, itching or hives;
• swelling of the face, lips, tongue or other parts of the body;
• shortness of breath, wheezing or difficulty breathing;
• collapse.

Other side effects include:
Common(may affect up to 1 in 10 people):

• headache;
• dizziness;
• nausea;
• vomiting;
• diarrhoea;
• abdominal pain;
• skin rash;
• skin reaction after exposure to sunlight (photosensitivity);
• itching;
• fatigue;
• unexplained fever (high temperature) and feeling faint, especially when standing up.

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

• itching, itchy rash;
• hair loss.

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

• effects on some blood and urine tests;
• increased enzymes in the liver.

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

• reduced number of red blood cells (anaemia);
• reduced number of white blood cells (leucopenia);
• reduced number of platelets in the blood (cells that help to clot blood) (thrombocytopenia);
• feeling weak;
• feeling agitated or confused;
• tremors;
• hallucinations (seeing or hearing things that do not exist);
• convulsions;
• feeling unusually tired or sleepy;
• unsteadiness when walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• loss of consciousness (coma);
• paralysis of a part or all of the body;
• behavioural disturbances, speech disturbances and eye movement disturbances;
• neck pain and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the whites of the eyes or skin (jaundice);
• kidney problems where no or little urine is produced;
• pain in the lower back, in the area corresponding to the kidneys or just above the hip (renal pain).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects you can help provide more information on the safety of this medicine.

11. How to store Aciclovir Aurobindo Pharma

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 label and the packaging after EXP.
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.

12. Package Contents and Other Information

What Aciclovir Aurobindo Pharma contains
The active ingredient is aciclovir. Each 400 mg tablet contains 400 mg of aciclovir.
The other ingredients are:
microcrystalline cellulose (grade 101), sodium starch glycolate (type A), povidone (K-30), colloidal silicon dioxide
anhydrous, magnesium stearate.

Description of the appearance of Aciclovir Aurobindo Pharma and package contents
Tablets.
Uncoated tablets, from white to off-white, round (diameter: 11.8 mm), biconvex, with imprinted
‘AR’ and ‘400’ separated by a break line on one side and smooth on the other. The tablet can be divided into
two equal doses.
Aciclovir Aurobindo Pharma is available in blister packs of 25 tablets.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Aciclovir Aurobindo Pharma
Portugal: Aciclovir Aurovitas

Aciclovir Aurobindo Pharma 800 mg tablets

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:

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

13. What is Aciclovir Aurobindo Pharma and what it is used for

Aciclovir Aurobindo Pharma contains an active ingredient called aciclovir, which belongs to a group of
medicines called antivirals. It works by killing or stopping the growth of viruses.

Aciclovir Aurobindo Pharma is indicated for:

• treating chickenpox and shingles.

14. What you need to know before you take Aciclovir Aurobindo Pharma

Do not take Aciclovir Aurobindo Pharma:

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

Do not take Aciclovir Aurobindo Pharma if the above applies to you. If you are not sure, ask your doctor or
pharmacist before taking Aciclovir Aurobindo Pharma.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclovir Aurobindo Pharma if:

• you have kidney problems;
• you are over 65 years of age.

If you are not sure if the above applies to you, ask your doctor or pharmacist before taking Aciclovir
Aurobindo Pharma. It is important that you drink plenty of water while taking Aciclovir Aurobindo
Pharma.

Other medicines and Aciclovir Aurobindo Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription and herbal remedies.
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 stomach ulcers;
• mycophenolate mofetil, used to prevent organ rejection after transplantation.

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

Driving and using machines
Some side effects such as feeling tired or sleepy may impair your ability to concentrate and react.
Make sure you are not affected before driving or using machines.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially ‘sodium-free’.

15. How to take Aciclovir Aurobindo Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Taking this medicine:

• Take this medicine by mouth.
• The tablet must be swallowed whole with a little water.
• Start taking Aciclovir Aurobindo Pharma as soon as possible.

The dose to be taken will depend on the reason why you have been given Aciclovir Aurobindo Pharma. The doctor
will discuss this with you.

Treatment of chickenpox and shingles

• The usual dose is one 800 mg tablet five times a day.
• Take the dose at intervals of approximately 4 hours.
• Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Aurobindo Pharma for seven days.

The doctor may need to adjust the dose of Aciclovir Aurobindo Pharma if:

• it is for a child;
• you are over 65 years of age;
• you have kidney problems. If you have kidney problems, it is important that you drink plenty of water while taking Aciclovir Aurobindo Pharma.

Inform your doctor before taking Aciclovir Aurobindo Pharma if the above applies to you.

If you take more Aciclovir Aurobindo Pharma than you should
Aciclovir Aurobindo Pharma is usually not harmful, unless you take too much for several days.
Talk to your doctor or pharmacist if you take too much Aciclovir Aurobindo Pharma. Bring the packaging
of the medicine with you.

If you forget to take Aciclovir Aurobindo Pharma

• If you forget to take Aciclovir Aurobindo Pharma, take it as soon as possible when you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

16. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Allergic reactions(may affect up to 1 in 1,000 people)
If you have an allergic reaction, stop taking Aciclovir Aurobindo Pharma and see your doctor
immediately.
Signs of an allergic reaction can include:

• skin rash, itching or hives;
• swelling of the face, lips, tongue or other parts of the body;
• shortness of breath, wheezing or difficulty breathing;
• collapse.

Other side effects include:
Common(may affect up to 1 in 10 people):

• headache;
• dizziness;
• nausea;
• vomiting;
• diarrhoea;
• abdominal pain;
• skin rash;
• skin reaction after exposure to sunlight (photosensitivity);
• itching;
• fatigue;
• unexplained fever (high temperature) and feeling faint, especially when standing up.

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

• itching, itchy skin rash;
• hair loss.

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

• effects on some blood and urine tests;
• increased enzymes in the liver.

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

• reduced number of red blood cells (anaemia);
• reduced number of white blood cells (leucopenia);
• reduced number of platelets in the blood (cells that help to clot the blood) (thrombocytopenia);
• feeling weak;
• feeling agitated or confused;
• tremors;
• hallucinations (seeing or hearing things that do not exist);
• convulsions;
• feeling unusually tired or sleepy;
• instability when walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• loss of consciousness (coma);
• paralysis of part or all of the body;
• behaviour, speech and eye movement disorders;
• neck pain and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the whites of the eyes or skin (jaundice);
• kidney problems where no or little urine is produced;
• pain in the lower back, in the area corresponding to the kidneys or just above the hip (kidney pain).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By
reporting side effects you can help provide more information on the safety of this medicine.

17. How to store Aciclovir Aurobindo Pharma

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 label and 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.

18. Package contents and other information

What Aciclovir Aurobindo Pharma contains
The active ingredient is aciclovir. Each 800 mg tablet contains 800 mg of aciclovir.
The other ingredients are:
microcrystalline cellulose (grade 101), sodium starch glycolate (type A), povidone (K-30), colloidal anhydrous silica,
magnesium stearate.

Description of the appearance of Aciclovir Aurobindo Pharma and package contents
Tablets.
Uncoated tablets, from white to off-white, oblong, biconvex, imprinted with ‘AR’ and ‘800’ separated
by a break line on one side and smooth on the other. The tablet can be divided into two equal doses.
The size is 21 mm x 10 mm.
Aciclovir Aurobindo Pharma is available in blister packs.
Packs of:
35, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Aciclovir Aurobindo Pharma
Portugal: Aciclovir Aurovitas
Spain: Aciclovir Aurovitas 800 mg comprimidos EFG