ACICLOVIR 8% Oral suspension

Зміст інструкції

1. Aciclovir GIT 800 mg tablets, 8 % oral suspension
   1. What is Aciclovir GIT and what is it used for
   2. What you need to know before taking Aciclovir GIT
   3. How to take Aciclovir GIT
   4. Possible side effects
   5. How to store Aciclovir GIT
   6. Contents of the pack and other information
2. Aciclovir GIT 5% cream
   1. What is Aciclovir GIT and what is it used for
   2. What you need to know before using Aciclovir GIT
3. Aciclovir GIT should not be applied in the mouth, eyes and vagina because it may
   1. How to use Aciclovir GIT
   2. Possible side effects
   3. How to store Aciclovir GIT
   4. Contents of the pack and other information

Aciclovir GIT 800 mg tablets, 8 % 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 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:

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

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

Aciclovir GIT contains an active ingredient called aciclovir, which belongs to a group of
medicines called antivirals.
Aciclovir GIT is indicated for:

• treating Herpes simplexinfections 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);
• suppressing Herpes simplexinfections that continue to recur in immunocompetent patients (with an immune system that functions normally)
• to prevent Herpes simplexinfections in immunocompromised patients (with an immune system that does not function normally)
• treating chickenpox and Herpes zoster(shingles).

2. What you need to know before taking Aciclovir GIT

Do not take Aciclovir GIT

• if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6).
• during breastfeeding (see “Pregnancy and breastfeeding”).

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

• you have kidney problems
• you are over 65 years of age
• if you have a severely weakened immune system

Talk to your doctor if you think any of these situations apply to you.The doctor may
reduce the dose of Aciclovir GIT.
Make sure you drink plenty of fluids such as waterwhile you are taking Aciclovir GIT.

Other medicines and Aciclovir GITTell your doctor or pharmacist if you are taking or 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 to treat 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 may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice.
Pregnancy
You should not take Aciclovir GIT without first consulting your doctor, who will assess
the benefit to you and the risk to your baby of taking Aciclovir GIT while you are
pregnant.
Breastfeeding

Aciclovir can pass into breast milk. If you are breastfeeding or plan to
do so, talk to your doctor before taking Aciclovir GIT. Driving and operating machinery
No studies have been conducted to assess the effects of Aciclovir GIT on the ability to drive and
operate machinery. Assess the possible occurrence of side effects that may alter the
level of attention.

Aciclovir GIT 800 mg tablets containssodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

Aciclovir GIT 8% oral suspension contains sorbitol.
This medicine contains 787.5 mg of sorbitol per 200 mg dose and 3,150 mg of sorbitol per
800 mg dose. 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 cannot transform fructose, talk to your doctor before
you (or your child) take this medicine. It may cause gastrointestinal problems and have a
mild laxative effect.

Aciclovir GIT 8% oral suspension contains Methyl parahydroxybenzoate and Propyl para-
hydroxybenzoate.
They may cause allergic reactions (including delayed reactions).

3. How to take Aciclovir GIT

Always take this medicine exactly as your doctoror pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
Aciclovir GIT should be taken as soon as possible after the appearance of the infection (at the first symptoms or when the
first lesions appear).
The dose you need to take will depend on the reason why Aciclovir GIT has been prescribed to you. The
doctor will discuss this with you.

Treatment of infections caused byHerpes simplexincluding genital herpes

• Adults and children aged 2 years or older:the recommended dose is 200 mg (or 2.5 ml of oral suspension) 5 times a day at intervals of approximately 4 hours.
• 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 nighttime dose.
Take Aciclovir GIT 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 (or 5 ml of oral suspension) or consider administration of
aciclovir by intravenous route.

Suppression of recurrences (infections that continue to recur) caused byHerpes simplexin
immunocompetent patients (with a normally functioning immune system)
The recommended dose in adultsis 200 mg (or 2.5 ml of oral suspension) 4 times a day.
Take the dose at intervals of 6 hours. The doctor may change the dose and also the interval between the various
administrations. You should always take Aciclovir GIT according to your doctor's instructions.
Take Aciclovir GIT until your doctor tells you to stop.
No specific data are available regarding the suppression of Herpes simplexinfections in children
with a normally functioning immune system.

Prophylaxis ofHerpes simplexinfections in immunocompromised patients (with an immune system
that does not function normally)

• Adults and children over 2 years of age:the recommended dose is 200 mg (or 2.5 ml of oral suspension) 4 times a day.
• Children under 2 years of age:the recommended dose is half the adult dose.

Take the dose at intervals of 6 hours.
Take Aciclovir GIT 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 (or 5 ml of oral suspension) or consider aciclovir for
intravenous administration.

Treatment of chickenpoxand Herpes zoster(shingles)
Adults

• 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 nighttime dose.
• Take Aciclovir GIT 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 administration of
aciclovir by intravenous route.

Use in children –
Treatment of chickenpox

• Children aged 6 years or older:the recommended dose is 800 mg (or 10 ml of oral suspension) 4 times a day.
• Children aged 2 years and under 6:the recommended dose is 400 mg (or 5 ml of oral suspension) 4 times a day.
• Children under 2 years of age:Treatment should be continued 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 Herpeszosterin children with a normally functioning immune
system.
For the treatment of Herpes zosterinfections in children with impaired immune function, the
doctor will consider administering aciclovir by intravenous route.

The doctor may also change the dose of Aciclovir GIT 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 GIT. Talk to your doctor before taking Aciclovir GIT if the above applies to you.

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

• experience nausea, headache or vomiting
• feel confused or agitated. Tell your doctor or pharmacist if you have taken too much Aciclovir GIT and show them the medicine packaging.

If you forget to take Aciclovir GIT

• If you forget to take Aciclovir GIT, 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.

Stop taking Aciclovir GITand contact your doctor
immediately.Common side effects(may affect up to 1in 10people):

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

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

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

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

• severe allergic reaction (anaphylaxis)
• shortness of breath (dyspnoea)
• swelling of the lips, face, neck and throat (angioedema)

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

• feeling confused and agitated
• tremors
• instability when walking and lack of coordination (ataxia)
• slow and slurred speech (dysarthria)
• seeing or hearing things that are not there (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)
• inflammation of the liver (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 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 GIT

Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is reported on the packaging after EXP. The
expiry date refers to the last day of that month.
800 mg tablets: store in a dry place.
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 GIT 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. 5 ml of oral suspension contains 400 mg of aciclovir.
• The other ingredients are sorbitol (70% non-crystallizing), glycerol, dispersible cellulose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, cherry aroma, purified water.

Description of the appearance of Aciclovir GIT and contents of the pack
Aciclovir GIT 800 mg tablets: packs of 35 tablets in blisters
Aciclovir GIT 8% Oral suspension: pack containing a 100 ml bottle of suspension
oral and a measuring device

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SF GROUP S.r.l.
Via Tiburtina 1143
00156 Rome

Manufacturer
Tablets
FINE FOODS & FARMACEUTICALS N.T.M. S.P.A.
via R. Follereau, 25
24027 NEMBRO (BG)
Oral suspension
MONTEFARMACO S.p.A.

• V. G. Galilei, 7 20016 Pero (MI)

Aciclovir GIT 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 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:

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

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

Aciclovir GIT contains an active ingredient called aciclovir, which belongs to a group of
medicines called antivirals.
Aciclovir GIT is indicated for treating skin infections caused by the Herpes simplex
virus, 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 GIT

Do not use Aciclovir GIT

• If you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6).
• Generally contraindicated in pregnancy and breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using Aciclovir GIT if:

• you are severely immunocompromised, meaning your immune defenses are low and your body is less able to fight infections (for example if you have AIDS or 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 GIT. In this case, your doctor may decide to prescribe you the
tablets.

Aciclovir GIT should not be applied in the mouth, eyes and vagina because it may

cause irritation.
Take particular care to avoid accidental application in the eyes
If you use Aciclovir GIT for a long period of time, sensitization phenomena may occur; if this happens, you should stop treatment and consult your doctor.
If you have any doubts, ask your doctor or pharmacist before using Aciclovir GIT.

Other medicines and Aciclovir GIT
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
No interactions with other medicines 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 GIT without first consulting your doctor, who will assess the benefit
for you and the risk to your baby of treatment with Aciclovir
GIT while you are pregnant.

Breastfeeding
If you are breastfeeding or plan to breastfeed, talk to your doctor before using
Aciclovir GIT.

Driving and operating machinery
No effects on the ability to drive vehicles and operate machinery are known.

Aciclovir GIT contains methyl parahydroxybenzoate
This medicine contains methyl-parahydroxybenzoate, which may cause allergic reactions (including
delayed reactions)

3. How to use Aciclovir GIT

Use this medicine following the doctor's instructions exactly. If you have any doubts,
consult your doctor or pharmacist.

• Apply 5 times a day at intervals of approximately 4 hours. Aciclovir GIT cream should be applied to the lesions, or to the areas where they are developing as soon as possible, as soon as you notice the appearance of tingling, itching, burning, pain and redness.
• Treatment should continue for at least 5 days up to a maximum of 10 if no healing has occurred.

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

If you forget to use Aciclovir GIT

• If you forget to use Aciclovir GIT, 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 GIT and contact your doctor
immediately.

Uncommon side effects(may affect up to1 in 100people)

• temporary sensation of pain or burning after application of the cream.
• moderate dryness and flaking of the skin
• itching

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

• 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 1in 10,000people

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

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 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 GIT

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is reported on the packaging after
(EXP.). The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
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 GIT contains
The active ingredient is aciclovir. One gram of cream contains 50 mg of aciclovir
The other ingredients are: tefose 1500; glycerin; stearic acid; liquid paraffin; methyl
parahydroxybenzoate, purified water.

Description of the appearance of Aciclovir GIT and contents of the pack
5% aciclovir cream in a 10 g tube pack.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
SF GROUP S.r.l. – Via Tiburtina 1143, 00156 Rome

Manufacturer
SPECIAL PRODUCT’S LINE S.P.A.
VIA FRATTA ROTONDA VADO LARGO, 1
03012, Anagni (FR) – Italy