ACICLOVIR 200 mg Coated Tablets

Зміст інструкції

1. Aciclovir Zentiva 800 mg tablets
   1. What is Aciclovir Zentiva and what is it used for
   2. What you need to know before you take Aciclovir Zentiva
   3. How to take Aciclovir Zentiva
   4. Possible side effects
   5. How to store Aciclovir Zentiva
   6. Contents of the pack and other information
2. Aciclovir Zentiva 400 mg tablets
   1. What is Aciclovir Zentiva and what is it used for
   2. What you need to know before taking Aciclovir Zentiva
   3. How to take Aciclovir Zentiva
   4. Possible side effects
   5. How to store Aciclovir Zentiva
   6. Contents of the pack and other information

Aciclovir Zentiva 800 mg tablets

aciclovir

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Aciclovir Zentiva and what is it used for

Aciclovir Zentiva 800 mg tablets contains an active ingredient called aciclovir. This belongs to
a group of medicines called antivirals. It works by killing or blocking the growth of viruses.
Aciclovir Zentiva tablets is indicated for:

• treating chickenpox and Herpes zoster (shingles) in adults and children over 6 years of age.

2. What you need to know before you take Aciclovir Zentiva

Do not take Aciclovir Zentiva:

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

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclovir Zentiva:

• if you have kidney problems
• if 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 Zentiva. It is important that you drink plenty of water while taking Aciclovir Zentiva.

Other medicines and Aciclovir Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This warning includes medicines you buy without a prescription, including
herbal products.
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
• mofetil mycophenolate used to prevent organ rejection after transplantation.
• theophylline used in patients with chronic obstructive pulmonary disease or asthma

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

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

3. How to take Aciclovir Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The score line is only to facilitate breaking the tablet in case you have difficulty
swallowing it whole.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablet with a little water.
• The tablets can be taken with or without food
• Start taking Aciclovir Zentiva as soon as possible.

The dose you need to take will depend on the reason why this medicine has been prescribed to you. The
doctor will discuss this with you.
Treatment of chickenpox and shingles (herpes zoster)

• The recommended dose is 800 mg 5 times a day.
• Take the dose at intervals of approximately 4 hours. The recommended times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Zentiva for 7 days.

The doctor may modify the dose of Aciclovir Zentiva:

• if it is for a child. The recommended dose for children over 6 years of age is 800 mg 4 times a day
• if you are over 65 years of age
• if you have kidney problems, if you have kidney problems it is important that you drink plenty of water while taking Aciclovir Zentiva.

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

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

If you forget to take Aciclovir Zentiva

• If you forget to take Aciclovir Zentiva, 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 questions about 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.
The following side effects may occur with this medicine:

Allergic reactions(may affect up to 1 in 1,000 people)
If you have an allergic reaction, stop takingAciclovir Zentiva and contact your doctor
immediately.
Symptoms may 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 or vomiting
• diarrhoea
• abdominal pain
• skin rashes
• 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):

• itchy, raised skin patches (urticaria)
• hair loss Rare (may affect up to 1 in 1,000 people)
• changes in some blood and urine tests
• increased liver enzymes.
• shortness of breath (dyspnoea).
• swelling of the lips, face, neck and throat causing difficulty breathing (angioedema).
• severe allergic reaction (anaphylaxis) 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 with blood clotting) in the blood (thrombocytopenia)
• feeling confused and agitated
• tremors
• hallucinations (seeing or hearing things that do not exist)
• convulsions
• drowsiness
• unsteadiness when walking and lack of coordination
• speech that is slow and slurred
• inability to think or judge clearly
• loss of consciousness (coma)
• paralysis of part or all of the body
• behavioural disturbances, speech disturbances and eye movement disturbances
• inflammation of the liver (hepatitis)
• yellowing of the whites of the eyes or skin (jaundice)
• kidney problems where little or no urine is passed
• pain in the lower back, in the area corresponding to the kidneys or just above the area of the flanks (renal 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.

5. How to store Aciclovir Zentiva

Do not store at a temperature above 30°C.
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 box and blister after (Expiry Date).
The expiry date refers to the last day of that month.
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 Aciclovir Zentiva contains

• The active ingredient is aciclovir. Each tablet contains 800 mg of aciclovir
• The other ingredients are: povidone K30, sodium starch glycolate type A, microcrystalline cellulose and magnesium stearate.

Description of the appearance of Aciclovir Zentiva and contents of the pack
Aciclovir Zentiva 800 mg tablets are white, elongated, biconvex tablets with an incision on one side
(length approx. 19 mm, width approx. 10 mm).
The tablets are available in packs containing PVC/aluminium blisters of 25 or 35 tablets.
Not all pack sizes will be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ZENTIVA ITALIA S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy

Manufacturer:
Pharmaceutical Works Polpharma S.A.
19 Pelplińska Str.
83-200 Starogard Gdański
Poland

This medicinal product is authorised in the Member States of the EEA with the following names:
CZ - Aciclovir Zentiva
IT - Aciclovir Zentiva

Aciclovir Zentiva 400 mg tablets

Aciclovir Zentiva 200 mg tablets
aciclovir

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if 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 Zentiva is and what it is used for
• 2. What you need to know before you take Aciclovir Zentiva
• 3. How to take Aciclovir Zentiva
• 4. Possible side effects
• 5. How to store Aciclovir Zentiva
• 6. Contents of the pack and other information

1. What is Aciclovir Zentiva and what is it used for

Aciclovir Zentiva contains an active ingredient called aciclovir, which belongs to a group of
medicines called antivirals. It works by killing or blocking the growth of viruses.
Aciclovir Zentiva tablets is indicated for:

• treating chickenpox and shingles (herpes zoster)
• treating cold sores, genital herpes and other herpes simplex infections
• blocking the recurrence of these infections once treated
• Treating these infections in patients with an immune system that is not functioning as well, which means that their body is less able to fight infections.

2. What you need to know before taking Aciclovir Zentiva

Do not take Aciclovir Zentiva:

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

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Aciclovir Zentiva:

• if you have kidney problems
• if you are over 65 years of age

If you are not sure if any of these situations apply to you, ask your doctor or pharmacist before taking Aciclovir Zentiva. Make sure you drink plenty of fluids while taking Aciclovir Zentiva.

Other medicines and Aciclovir Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal products.
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
• mofetil mycophenolate used to prevent rejection of transplanted organs.
• theophylline used in patients with chronic obstructive pulmonary disease or asthma

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.

Driving and operating machinery
Some side effects such as 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 1mmol of sodium (23 mg) per tablet, that is to say it is
essentially ‘sodium-free’.

3. How to take Aciclovir Zentiva

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

Take this medicine

• Take this medicine by mouth.
• The tablet must be swallowed whole with a little water.
• The tablet can be taken with or without food
• Start taking Aciclovir Zentiva as soon as possible. The dose you need to take will depend on the reason why this medicine has been prescribed to you. The doctor will discuss this with you. An 800 mg tablet is also available.

Treatment of chickenpox and shingles (herpes zoster)

• The recommended dose is 800 mg 5 times a day.
• Take the dose at intervals of approximately 4 hours. The recommended times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Zentiva for 7 days.

Treatment of herpes labialis (cold sores) and genital herpes

• The recommended dose is 200 mg 5 times a day
• Take the dose at intervals of approximately 4 hours. The recommended times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Take Aciclovir Zentiva for 5 days, or for longer if your doctor tells you to. To prevent the recurrence of these infections in patients whose immune system works less well and whose bodies are less able to fight infections
• The recommended dose is 200 mg 4 times a day
• Take the dose at intervals of approximately 6 hours
• Take Aciclovir Zentiva until your doctor tells you to stop.

The doctor may modify the dose of Aciclovir Zentiva:

• if it is for a child
• if you are over 65 years of age
• if you have kidney problems; if you have kidney problems it is important that you drink plenty of water while taking Aciclovir Zentiva. Tell your doctor before taking Aciclovir Zentiva if the above applies to you.

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

If you forget to take Aciclovir Zentiva

• If you forget to take Aciclovir Zentiva, 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 questions about 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.
The following side effects may occur with this medicine:

Allergic Reactions(may affect up to 1 in 1000 people)
If you have an allergic reaction stop takingAciclovir Zentiva and contact your doctor
immediately. Symptoms may 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 or vomiting
• diarrhoea
• abdominal pain
• skin rashes
• skin reaction after exposure to sunlight (photosensitivity)
• itching
• fatigue
• unexplained fever (high temperature) and feeling faint, especially when getting up. Uncommon (may affect up to 1 in 100 people):
• itching, itchy skin rash (urticaria)
• hair loss

Rare (may affect up to 1 in 1000 people)

• changes in some blood and urine tests
• increased liver enzymes.
• shortness of breath (dyspnoea).
• swelling of the lips, face, neck and throat, causing difficulty breathing (angioedema).
• severe allergic reaction (anaphylaxis)

Very rare (may affect up to 1 in 10000 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 confused and agitated
• tremor or shaking
• 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
• behavioural, speech and eye movement disorders
• inflammation of the liver (hepatitis)
• yellowing of the whites of the eyes or skin (jaundice)
• kidney problems where no or reduced 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.
You can also report side effects directly through 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 Zentiva

Do not store at a temperature above 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and on the blister after (Expiry).
The expiry date refers to the last day of that month.
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 Aciclovir Zentiva contains

• The active ingredient is aciclovir. Each tablet contains 400 mg of aciclovir
• The active ingredient is aciclovir. Each tablet contains 200 mg of aciclovir
• The other ingredients are: povidone K30, sodium starch glycolate type A, microcrystalline cellulose and magnesium stearate.

Description of the appearance of Aciclovir Zentiva and contents of the pack
Aciclovir Zentiva 200 mg tablets are white, round, biconvex tablets with "200" imprinted on
one side and a diameter of approx. 9 mm.
Aciclovir Zentiva 400 mg tablets are white, round, biconvex tablets with a diameter of approx.
11 mm.
Aciclovir Zentiva 200 mg tablets are available in packs containing PVC/aluminium blisters of
25 or 30 tablets.
Aciclovir Zentiva 400 mg tablets are available in packs containing PVC/aluminium blisters of
25 or 70 tablets.
Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ZENTIVA ITALIA S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy

Manufacturer:
Pharmaceutical Works Polpharma S.A.
19 Pelplińska Str.
83-200 Starogard Gdański
Poland

This medicinal product is authorised in the EEA member states with the following names:
CZ - Aciclovir Zentiva
IT - Aciclovir Zentiva