Aciclovir Aurobindo Pharma

Patient Information Leaflet

Aciclovir Aurobindo Pharma 200 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Aciclovir Aurobindo Pharma contains an active substance called aciclovir, which belongs to a group of
medicines known as 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 they have been treated;
• preventing the recurrence of these infections in people with weakened immune systems who are less able to fight infections.

2. What you should know before taking Aciclovir Aurobindo Pharma

Do not take Aciclovir Aurobindo Pharma:

• if you are allergic to aciclovir, valaciclovir, or to any of the other ingredients of this medicine (listed in section 6). Do not take Aciclovir Aurobindo Pharma if this applies to you. If you are unsure, consult 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 unsure whether the above applies to you, consult 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription and herbal preparations.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• probenecid, used for the treatment of gout;
• cimetidine, used to treat stomach ulcers;
• mycophenolate mofetil, used to prevent rejection of transplanted organs.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Some side effects such as tiredness or drowsiness may impair your concentration and reaction ability.
Make sure you are not affected in this way 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 exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
How to take this medicine:

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

The dose you should take depends on why Aciclovir Aurobindo Pharma has been prescribed to you. Your 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 doses 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 doses 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 longer if your doctor instructs you to do so.

To prevent recurrence of these infections once they have healed

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

To prevent recurrence of these infections in people with weakened immune systems
who are less able to fight infections

• The usual dose is one 200 mg tablet four times a day.
• Take the doses at intervals of approximately 6 hours.
• Continue taking 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 old;
• you have kidney problems. If you have kidney problems, it is important to drink plenty of water while taking Aciclovir Aurobindo Pharma.

Inform your doctor before taking Aciclovir Aurobindo Pharma if any of the above applies to you.
If you take more Aciclovir Aurobindo Pharma than you should
Aciclovir Aurobindo Pharma is usually not harmful unless taken in excessive amounts for several days.
Speak to your doctor or pharmacist if you take too much Aciclovir Aurobindo Pharma. Bring the medicine
packaging 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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

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

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

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

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

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 certain blood and urine tests;
• increased levels of liver enzymes.

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

• reduced number of red blood cells in the blood (anaemia);
• reduced number of white blood cells in the blood (leucopenia);
• reduced number of platelets in the blood (cells that help blood to clot) (thrombocytopenia);
• feeling weak;
• feeling agitated or confused;
• tremors;
• hallucinations (seeing or hearing things that are not real);
• seizures;
• feeling unusually tired or drowsy;
• 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;
• disturbances in behaviour, speech and eye movements;
• neck pain and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the whites of the eyes or skin (jaundice);
• kidney problems resulting in little or no urine production;
• 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 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 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 on the carton 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 medicines 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 Aurobindo Pharma contains
The active substance is aciclovir. Each 200 mg tablet contains 200 mg of aciclovir.
The other components are:
microcrystalline cellulose (type 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.
White to almost white, round, uncoated tablets (diameter: 9.5 mm), biconvex, marked with 'AR 200' on one side and smooth on the other.
Aciclovir Aurobindo Pharma is available in blister packs.
Pack sizes:
25, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Italy: Aciclovir Aurobindo Pharma
Portugal: Aciclovir Aurovitas
Spain: Aciclovir Aurovitas 200 mg comprimidos EFG

Package leaflet: information for the patient

Aciclovir Aurobindo Pharma 400 mg tablets

Generic medicine
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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

7. What Aciclovir Aurobindo Pharma is and what it is used for
8. What you need to know before taking 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 Aciclovir Aurobindo Pharma is and what it is used for

Aciclovir Aurobindo Pharma contains an active substance called aciclovir, which belongs to a group of
medicines known as 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 they have been treated;
• preventing the recurrence of these infections in people with weakened immune systems 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 to any of the other ingredients of this medicine (listed in section 6). Do not take Aciclovir Aurobindo Pharma if any of the above applies to you. If you are unsure, consult 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 unsure whether the above applies to you, consult 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal preparations.
In particular, inform 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Some side effects such as tiredness or drowsiness 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 exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How to take this medicine:

• Take this medicine by mouth.
• Swallow the tablet whole with some water.
• Start taking Aciclovir Aurobindo Pharma as soon as possible.

The dose you should take depends on why Aciclovir Aurobindo Pharma has been prescribed for you. Your 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 doses at intervals of about 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 doses at intervals of about 4 hours.
• Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Aurobindo Pharma for five days, or longer if your doctor tells you to.

To prevent recurrence of these infections once they have been treated

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

To prevent recurrence of these infections in people with weakened immune systems
who are less able to fight infections.

• The usual dose is one 200 mg tablet four times a day.
• Take the doses at intervals of about 6 hours.
• Continue taking 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 old;
• you have kidney problems. If you have kidney problems, it is important to drink plenty of water while taking Aciclovir Aurobindo Pharma.

Inform your doctor before taking Aciclovir Aurobindo Pharma if any of 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.
Speak to your doctor or pharmacist if you take too much Aciclovir Aurobindo Pharma. Bring the medicine pack 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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

10. Possible side effects

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

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

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

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

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 certain blood and urine tests;
• increased levels of liver enzymes.

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

• reduced number of red blood cells in the blood (anaemia);
• reduced number of white blood cells in the blood (leucopenia);
• reduced number of platelets in the blood (cells that help the blood to clot) (thrombocytopenia);
• feeling weak;
• feeling agitated or confused;
• tremors;
• hallucinations (seeing or hearing things that are not there);
• seizures;
• feeling unusually tired or drowsy;
• 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;
• disturbances in behaviour, speech and eye movements;
• neck pain and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the whites of the eyes or the skin (jaundice);
• kidney problems resulting in little or no urine production;
• 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, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the 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 stated on the label and the carton 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.

12. Package contents and other information

What Aciclovir Aurobindo Pharma contains
The active substance is aciclovir. Each 400 mg tablet contains 400 mg of aciclovir.
The other components 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, white to off-white, round (diameter: 11.8 mm), biconvex, marked with 'AR' and '400' separated by a breakline 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 containing 25 tablets.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Italy: Aciclovir Aurobindo Pharma
Portugal: Aciclovir Aurovitas

Patient information leaflet

Aciclovir Aurobindo Pharma 800 mg tablets

Generic medicine
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, consult 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:

13. What Aciclovir Aurobindo Pharma is and what it is used for
14. What you need to know before taking 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 Aciclovir Aurobindo Pharma is and what it is used for

Aciclovir Aurobindo Pharma contains an active substance called aciclovir, which belongs to a group of
medicines known as 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 taking Aciclovir Aurobindo Pharma

Do not take Aciclovir Aurobindo Pharma:

• if you are allergic to aciclovir, valaciclovir, or to 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 unsure, consult 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 unsure whether the above applies to you, consult 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those not requiring a prescription and herbal preparations.
In particular, inform 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, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please seek advice from your doctor or pharmacist before taking this medicine.
Driving and using machines
Some side effects such as tiredness or drowsiness 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 exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How to take this medicine:

• Take this medicine by mouth.
• Swallow the tablet whole with a little water.
• Start taking Aciclovir Aurobindo Pharma as soon as possible.

The dose you should take depends on why you have been prescribed Aciclovir Aurobindo Pharma. Your 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 doses at intervals of about 4 hours.
• Suggested times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Aurobindo Pharma for seven days.

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

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

Inform your doctor before taking Aciclovir Aurobindo Pharma if any of 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 medicine
packaging 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 your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

16. Possible side effects

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

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

• rash, itching or hives on the skin;
• 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;
• stomach pain;
• skin rash;
• skin reaction after exposure to sunlight (photosensitivity);
• itching;
• fatigue;
• unexplained fever (high temperature) and feeling faint, especially when standing.

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 certain blood and urine tests;
• increased levels of liver enzymes.

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

• reduced number of red blood cells in the blood (anaemia);
• reduced number of white blood cells in the blood (leucopenia);
• reduced number of platelets in the blood (cells that help blood to clot) (thrombocytopenia);
• feeling weak;
• feeling agitated or confused;
• tremors;
• hallucinations (seeing or hearing things that are not real);
• seizures;
• feeling unusually tired or drowsy;
• 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;
• disturbances in behaviour, speech and eye movements;
• neck pain and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the whites of the eyes or skin (jaundice);
• kidney problems resulting in little or no urine production;
• 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, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the 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 stated on the label and the carton 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.

18. Package contents and other information

What Aciclovir Aurobindo Pharma contains
The active substance is aciclovir. Each 800 mg tablet contains 800 mg of aciclovir.
The other components 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, white to off-white, oblong, biconvex, marked with ‘AR’ and ‘800’ separated by a breakline on one side and smooth on the other. The tablet can be divided into two equal doses.
Size: 21 mm x 10 mm.
Aciclovir Aurobindo Pharma is available in blister packs.
Pack sizes:
35, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Italy: Aciclovir Aurobindo Pharma
Portugal: Aciclovir Aurovitas
Spain: Aciclovir Aurovitas 800 mg tablets EFG