ACICLOVIR 400 mg /5 Ml Zawiesina Doustna

Treść ulotki

1. ACICLOVIR ABC 5% cream
   1. What is ACICLOVIR ABC and what is it used for
   2. What you need to know before using ACICLOVIR ABC
   3. How to use ACICLOVIR ABC
   4. Possible side effects
   5. How to store ACICLOVIR ABC
   6. Contents of the pack and other information
2. ACICLOVIR ABC 800 mg tablets, 400 mg/5 ml oral suspension
   1. What ACICLOVIR ABC is and what it is used for
   2. What you need to know before taking ACICLOVIR ABC
   3. How to take ACICLOVIR ABC
   4. Possible side effects
   5. How to store ACICLOVIR ABC
   6. Contents of the pack and other information

ACICLOVIR ABC 5% cream

Aciclovir

Generic medicine

Read this leaflet carefully before using 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 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:

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

1. What is ACICLOVIR ABC and what is it used for

ACICLOVIR ABC contains an active ingredient called aciclovir, which belongs to a group of
medicines called antiviral drugs.
ACICLOVIR ABC is indicated for treating skin infections caused by the Herpes Simplexvirus,
such as lip herpes and primary (which occurs for the first time) or
recurrent genital herpes (which continues to recur).

2. What you need to know before using ACICLOVIR ABC

Do not use ACICLOVIR ABC

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

Warnings and precautions
Talk to your doctor or pharmacist before using ACICLOVIR ABC if:

• you are severely immunocompromised, i.e. you are in a condition where your immune system works less well and your body is less able to fight infections (for example if you have HIV or AIDS or if you have undergone a bone marrow transplant).

Talk to your doctor or pharmacist if you think any of these situations apply to you before
using Aciclovir ABC. In this case, the doctor may decide to prescribe you the tablets.
Aciclovir ABC cream should not be applied to the mouth, eyes or vagina as it may
cause irritation.
Particular care should be taken to avoid accidental application to the eyes. If you use
Aciclovir ABC for a long period of time, sensitization may occur;
if this happens, stop treatment and consult your doctor.
If you have any doubts, talk to your doctor or pharmacist before using Aciclovir ABC.

Other medicines and ACICLOVIR ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
No clinically significant interactions have been identified.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice.
You should not use Aciclovir ABC without first consulting your doctor, who will assess
the benefit to you and the risk to your baby of treatment with Aciclovir ABC while you are
pregnant.

Breastfeeding
If you are breastfeeding or plan to do so, talk to your doctor before using Aciclovir
ABC.

Driving and using machines
No effects on the ability to drive and operate machinery are known.

ACICLOVIR ABC contains methyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions
(including delayed ones)

3. How to use ACICLOVIR ABC

Use this medicine following the instructions of your doctor exactly at all times. If you have any doubts,
consult your doctor or pharmacist.
Apply 5 times a day at intervals of approximately 4 hours.

• ACICLOVIR ABC cream must be applied to the lesions, or to the areas where they are developing, as soon as possible, preferably during the earliest stages (tingling, itching, burning, pain and redness). Treatment may also be started during the later stages (papules or blisters).
• Treatment must continue for at least 4 days for lip herpes and for 5 days for genital herpes. If no healing has occurred, treatment may continue for up to a maximum of 10 days.

If you use more ACICLOVIR ABC than you should
If you have used a higher dose than recommended, contact your doctor or pharmacist for
advice. Aciclovir ABC cream is for external use only; in case of accidental ingestion, contact your
doctor or pharmacist.

If you forget to use ACICLOVIR ABC

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction stop using Aciclovir ABC and contact your doctor immediately.

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

• temporary stinging or burning sensation after applying the cream
• moderate dryness and flaking of the skin;
• itching.

Rare side effects:(may affect up to 1 in 1000 people)

• irritation and redness of the skin (erythema);
• inflammation of the skin following application due to contact with the cream (contact dermatitis),

Very rare side effects:(may affect up to 1 in 10000 people)

• allergic reactions (hypersensitivity) including swelling of the lips, face, neck and throat causing difficulty in breathing (angioedema) and skin reaction (urticaria) Reporting of side effectsIf 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 ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expires
on”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
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. Contents of the pack and other information

What ACICLOVIR ABC contains

• The active ingredient is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other ingredients are: tefose 1500, glycerin, stearic acid, liquid paraffin, methyl paraben, purified water.

Description of the appearance of ACICLOVIR ABC and contents of the pack
Pack containing a tube of 10 g of cream.

Marketing Authorisation Holder
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72 Torino

Manufacturer
Lab.Italiano Biochimico Farmaceutico LISAPHARMA S.P.A.
Via Licinio, 11 – 22036 Erba (CO)

ACICLOVIR ABC 800 mg tablets, 400 mg/5 ml oral suspension

Aciclovir

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

1. What ACICLOVIR ABC is and what it is used for

ACICLOVIR ABC tablets and oral suspension contains an active ingredient called aciclovir
belonging to a group of medicines called antivirals.
ACICLOVIR ABC is indicated for:

• to treat infections from Herpes simplex of the skin and mucous membranes, including genital herpes that occurs for the first time (primary genital herpes) or that continues to recur (recurrent genital herpes); infections from Herpes simplex in newborns and infections from Herpes simplexin immunocompromised children (with a less effective immune system, meaning their body is less able to fight infections) are excluded
• to suppress Herpes simplexinfections that continue to occur in immunocompetent patients (with a normally functioning immune system)
• to prevent Herpes simplexinfections in immunocompromised patients (with a less effective immune system)
• to treat chickenpox and Herpes zoster(shingles).

2. What you need to know before taking ACICLOVIR ABC

Do not take ACICLOVIR ABC

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

If you are pregnant or if you are breastfeeding (see “Pregnancy and breastfeeding”

Warnings and precautions
Talk to your doctor or pharmacist before taking ACICLOVIR ABC if:

• you have kidney problems
• you are over 65 years of age
• if you have a severely weakened immune system See your doctor if you think any of these situations apply to you.The doctor may reduce the dose of Aciclovir ABC. Make sure you drink plenty of fluids such as waterwhile taking Aciclovir ABC.

Other medicines and ACICLOVIR ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:

• probenecid, used for the treatment of gout;
• cimetidine, used to treat some stomach problems;
• mofetil mycophenolate, used to prevent rejection of transplanted organs
• theophylline used for breathing problems

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice.
You should not take Aciclovir ABC without first consulting your doctor, who will assess the benefit
for you and the risk to your baby of taking Aciclovir ABC while you are pregnant.
Aciclovir can pass into breast milk. If you are breastfeeding, or plan to: talk to your
doctorbefore taking Aciclovir ABC.

Driving and using machines
No studies have been conducted to assess the effects of Aciclovir ABC on the ability to drive and
use machines. Assess the possible occurrence of side effects that may alter the
level of attention.

Important information about some excipients
Aciclovir ABC 800 mg tablets contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

Aciclovir ABC 400 mg / 5 ml oral suspension contains parabens
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which
may cause allergic reactions (including delayed reactions).

Aciclovir ABC 400 mg / 5 ml oral suspension contains sorbitol
This medicine contains 3.15 g of sorbitol per dose of 800 mg of aciclovir (corresponding to 10
ml).
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant
to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic
disease in which patients are unable to break down fructose, talk to your doctor before you
(or your child) take this medicine.
It may cause gastrointestinal problems and have a mild laxative effect.

3. How to take ACICLOVIR ABC

Always take this medicine exactly as your doctor has told you. If you have doubts
consult your doctor or pharmacist.

How to take Aciclovir ABC
Oral suspension: always shake before use.
Take Aciclovir ABC as soon as possible after the onset of infection (at the first symptoms or
when the first lesions appear).
The dose you need to take will depend on the reason why Aciclovir ABC has been prescribed to you. The
doctor
will discuss this with you.

Treatment ofHerpes simplexinfections including genital herpes

• Adults and children aged 2 years or over:the recommended dose is 200 mg 5 times a day.
• Children under 2 years of age:the recommended dose is half the adult dose.

Take the dose at intervals of approximately 4 hours, skipping the night dose.
Take Aciclovir ABC for 5 days or for longer if your doctor recommends it.
In adult patients with a severely weakened immune system (e.g. after a bone marrow
transplant) or with decreased intestinal absorption, the doctor may decide to
double the dose to 400 mg (half a tablet or 5 ml of oral suspension), or consider
administering Aciclovir ABC intravenously.
In children with a weakened immune system with severe Herpes simplexinfections, Aciclovir
ABC is not indicated.

Suppression of recurrences (infections that keep coming back) ofHerpes simplexin
immunocompetent patients (with a normally functioning immune system)
The recommended dose in adults is 200 mg 4 times a day.
Take the dose at intervals of approximately 6 hours. The doctor may change the dose and also the interval between
the various administrations. You should always take Aciclovir ABC according to the instructions of
the doctor.
Take Aciclovir ABC until your doctor tells you to stop.
No data are available for the suppression of Herpes simplexinfections in children with a
normally functioning immune system.

Prophylaxis ofHerpes simplexinfections in immunocompromised patients (with a
immune system that works less well)

• Adults and children aged 2 years or over: the recommended dose is 200 mg 4 times a day.
• Children under 2 years of age: the recommended dose is half the adult dose.

Take the dose at intervals of approximately 6 hours.
Take Aciclovir ABC until your doctor tells you to stop.
In adult patients with a severely weakened immune system (e.g. after a bone marrow
transplant) or with decreased intestinal absorption, the doctor may decide to double
the dose to 400 mg (half a tablet or 5 ml of suspension), or consider administering
Aciclovir ABC intravenously.

Treatment of varicella andHerpes zoster (shingles):

• The recommended dose is 800 mg (or 10 ml of oral suspension) 5 times a day.
• Take the dose at intervals of approximately 4 hours, skipping the night dose.
• Take Aciclovir ABC for 7 days.

In patients with a severely weakened immune system (e.g. after a bone marrow
transplant) or with decreased intestinal absorption, the doctor may consider
administering Aciclovir ABC intravenously.

Children -
Treatment of varicella:

• Children aged 6 years or over:the recommended dose is 800 mg (or 10 ml of suspension) 4 times a day.
• Children aged 2 years and under 6 years:the recommended dose is 400 mg (or 5 ml of suspension) 4 times a day.
• Children under 2 years of age:the recommended dose is 200 mg (or 2.5 ml of suspension), 4 times a day.
• Take Aciclovir ABC for 5 days

Administration of 20 mg/kg of body weight (not exceeding 800 mg) 4 times a day,
allows for a more precise dose adjustment.
No data are available for the treatment of Herpes zosterin children with a normally functioning immune
system.
For the treatment of Herpes zosterinfections in children with a weakened immune
system,
the doctor will consider administering Aciclovir ABC intravenously.

The doctor may also change the dose of Aciclovir ABC if:

• you are over 65 years of age
• you have kidney problems. If you have kidney problems, it is important that you drink plenty of fluids while taking Aciclovir ABC. Talk to your doctor before taking Aciclovir ABC if the above applies to you.

If you take more ACICLOVIR ABC than you should
If you accidentally take too much Aciclovir ABC, contact your doctor or pharmacist for
advice.
If you take too much Aciclovir ABC you may:

• experience nausea, headache or vomiting
• feel confused or agitated
• see or hear things that are not there (hallucinations)
• have convulsions
• lose consciousness (coma) Tell your doctor or pharmacist if you have taken too much Aciclovir ABC and show them the packaging of the medicine.

If you forget to take ACICLOVIR ABC

• If you forget to take Aciclovir ABC 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction stop taking Aciclovir ABCand contact your doctor
immediately.

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

• headache
• dizziness
• nausea
• vomiting
• diarrhoea
• abdominal pain
• itching
• skin rash including skin reaction after exposure to sunlight (photosensitivity)
• fatigue
• fever.

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

• itchy skin rash (urticaria);
• rapid and widespread hair loss

Rare side effects:(may affect up to 1 in 1000 people)

• severe allergic reaction (anaphylaxis)
• shortness of breath (dyspnoea)
• swelling of the lips, face, neck and throat (angioedema)
• alteration of some laboratory tests: increase in azotemia, creatinine, bilirubin and enzymes produced by the liver

Very rare side effects:(may affect up to 1 in 10000 people)

• feeling of confusion and agitation
• tremors;
• instability when walking (ataxia)
• words spoken slowly and defectively (dysarthria);
• Seeing or hearing things that do not exist (hallucinations)
• thought and perception disorders related to a psychiatric disorder (psychotic symptoms)
• convulsions;
• drowsiness;
• brain damage (encephalopathy)
• loss of consciousness (coma)
• yellowing of the whites of the eyes or skin (jaundice)
• liver inflammation (hepatitis)
• rapid reduction of kidney function (acute renal failure)
• pain in the lower back, in the area corresponding to the kidneys (renal pain)
• reduction in the number of red blood cells in the blood (anaemia)
• reduction in the number of white blood cells in the blood (leucopenia)
• reduction in the number of platelets in the blood (thrombocytopenia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.

5. How to store ACICLOVIR ABC

Keep this medicine out of the sight and reach of children.
Tablets: store in the original package to protect the medicine from humidity.
Do not use this medicine after the expiry date which is reported on the packaging 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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACICLOVIR ABC contains
Tablets

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

Oral suspension

• The active ingredient is aciclovir. Each 5 ml of oral suspension contains 400 mg of aciclovir.
• The other ingredients are: sorbitol (70% non-crystallizing), glycerol, dispersible cellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cherry aroma, purified water.

Description of the appearance of ACICLOVIR ABC and contents of the pack
Aciclovir ABC tablets are supplied in blister packs of 35
Aciclovir ABC 400 mg/ 5 ml is supplied in a pack containing a 100 ml bottle of
oral suspension, equipped with a measuring cup

Marketing Authorisation Holder
Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – Turin

Manufacturer
ABC Farmaceutici S.p.A., - Canton Moretti, 29 - Loc. San Bernardo - 10015 Ivrea (TO)