Aciclovir Zentiva

Italy
Brand name Aciclovir Zentiva
Form tablets
Active substance / Dosage
ACICLOVIR
Prescription type Prescription only
ATC code
J05AB01
Registration number 046277
Manufacturer ZENTIVA ITALIA S.R.L.

Table of Contents

Package leaflet: Information for the patient

Aciclovir Zentiva 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, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to 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 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

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

Aciclovir Zentiva 800 mg tablets contain an active substance called aciclovir. This belongs to
a group of medicines known as antivirals. It works by killing or inhibiting the growth of viruses.
Aciclovir Zentiva tablets are indicated for:

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

2. What you need to know before taking Aciclovir Zentiva

Do not take Aciclovir Zentiva:

  • 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 Zentiva if the above applies to you. If you are unsure, consult 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 unsure whether the above applies to you, consult 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This warning includes medicines without a prescription, including herbal products.
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
  • theophylline, used in patients with chronic obstructive pulmonary disease or asthma

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or 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’.

3. How to take Aciclovir Zentiva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The score line is intended 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.
  • Tablets may 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 for you. Your
doctor will discuss this with you.
Treatment of chickenpox and herpes zoster (shingles)

  • The recommended dose is 800 mg five times daily.
  • Take each dose at approximately 4-hour intervals. Recommended times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
  • Take Aciclovir Zentiva for 7 days.

Your doctor may adjust the dose of Aciclovir Zentiva:

  • if it is for a child. The recommended dose for children over 6 years of age is 800 mg four times daily
  • 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.

Inform your doctor before taking Aciclovir Zentiva if any of the above apply to you.
If you take more Aciclovir Zentiva than you should
Aciclovir Zentiva is usually not harmful unless taken in excessive amounts for several days. Contact
your doctor or pharmacist if you take too much Aciclovir Zentiva. Take the medicine pack with you.
If you forget to take Aciclovir Zentiva

  • If you forget to take Aciclovir Zentiva, 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 forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 taking Aciclovir Zentiva and contact your doctor immediately.
Symptoms 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 or vomiting
  • diarrhoea
  • stomach 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 skin rash (urticaria)
  • hair loss

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

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

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 (cells that help blood to clot) in the blood (thrombocytopenia)
  • feeling confused and agitated
  • tremors
  • hallucinations (seeing or hearing things that are not real)
  • seizures
  • drowsiness
  • unsteadiness when walking and lack of coordination
  • slow or slurred speech
  • 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
  • inflammation of the liver (hepatitis)
  • yellowing of the whites of the eyes or skin (jaundice)
  • kidney problems resulting in little or no urine passed
  • pain in the lower back, in the area corresponding to the kidneys or just above the hip area (kidney pain)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the reporting system at the following website: 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 above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after (Exp ).
The expiry date refers to the last day of that month.
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 Zentiva contains

  • The active substance 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 package contents
Aciclovir Zentiva 800 mg tablets are white, elongated, biconvex tablets, engraved on one side (length approx. 19 mm, width approx. 10 mm).
The tablets are available in packs containing PVC/aluminum 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 EEA Member States under the following names:
CZ - Aciclovir Zentiva
IT - Aciclovir Zentiva

Patient Information Leaflet

Aciclovir Zentiva 400 mg tablets, 200 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, as 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 Zentiva is and what it is 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

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

Aciclovir Zentiva contains an active substance called aciclovir, which belongs to a group of
medicines known as antivirals. It works by killing or inhibiting the growth of viruses.
Aciclovir Zentiva tablets are indicated for:

  • treating chickenpox and Herpes zoster (shingles)
  • treating cold sores, genital herpes, and other herpes simplex infections
  • preventing the recurrence of these infections once they have been treated
  • treating these infections in patients with a weakened immune system, meaning 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 unsure, consult 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 unsure whether any of these situations apply to you, consult your doctor or pharmacist before
taking Aciclovir Zentiva. Make sure you drink plenty of fluids while taking Aciclovir Zentiva.
Other medicines and Aciclovir Zentiva
Inform 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, 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
  • theophylline, used in patients with chronic obstructive pulmonary disease or asthma

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist.
Driving and using machines
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 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Aciclovir Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
Take this medicine

  • Take this medicine by mouth.
  • The tablet should be swallowed whole with a glass of water.
  • The tablet can be taken with or without food.
  • Start taking Aciclovir Zentiva as soon as possible. The dose you need depends on why this medicine has been prescribed for you. Your doctor will discuss this with you. The 800 mg tablet is also available.

Treatment of chickenpox and herpes zoster (shingles)

  • The recommended dose is 800 mg five times a day.
  • Take the doses at approximately 4-hour intervals. 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 and genital herpes infections

  • The recommended dose is 200 mg five times a day.
  • Take the doses at approximately 4-hour intervals. The recommended times are: 7:00, 11:00, 15:00, 19:00 and 23:00.
  • Take Aciclovir Zentiva for 5 days, or longer if your doctor tells you to do so.

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

  • The recommended dose is 200 mg four times a day.
  • Take the doses at approximately 6-hour intervals.
  • Continue taking Aciclovir Zentiva until your doctor tells you to stop.

Your doctor may adjust 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. Inform your doctor before taking Aciclovir Zentiva if any of 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. If you take more than you should, speak to your doctor or pharmacist. Take the medicine pack with you.
If you forget to take Aciclovir Zentiva

  • If you forget to take Aciclovir Zentiva, 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with this medicine:
Allergic reactions (may affect up to 1 in 1,000 patients)
If you have an allergic reaction, stop taking Aciclovir Zentiva and contact your doctor immediately.
Symptoms may include:

  • rash, itching or hives on the skin
  • swelling of the face, lips, tongue or other body parts
  • 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):

  • itching, itchy skin rash (urticaria)
  • hair loss

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

  • changes in certain blood and urine tests
  • increased levels of liver enzymes
  • shortness of breath (dyspnoea)
  • swelling of the lips, face, neck and throat causing breathing difficulties (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 (blood cells that help blood to clot) (thrombocytopenia)
  • feeling confused and agitated
  • tremor or trembling
  • 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
  • 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 Zentiva

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after (Exp ).
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Aciclovir Zentiva contains

  • The active substance is aciclovir. Each tablet contains 400 mg of aciclovir.
  • The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.
  • The other components 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 marked with "200" on one side and with 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/aluminum blisters of 25 or 30 tablets.
Aciclovir Zentiva 400 mg tablets are available in packs containing PVC/aluminum 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 Milan
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 under the following names:
CZ - Aciclovir Zentiva
IT - Aciclovir Zentiva