Aciclovir Aurobindo Italia: detailed information

Patient Information Leaflet

Aciclovir Aurobindo Italia 800 mg tablets, 400 mg/5 ml oral suspension

Generic medicine
Please read all of 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 they have the same symptoms as you, because it could be harmful.
If you experience any adverse effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Aciclovir Aurobindo Italia is and what it is used for
What you need to know before taking Aciclovir Aurobindo Italia
How to take Aciclovir Aurobindo Italia
Possible side effects
How to store Aciclovir Aurobindo Italia
Contents of the pack and other information

1. What Aciclovir Aurobindo Italia is and what it is used for

Aciclovir Aurobindo Italia contains the active substance aciclovir, which belongs to a group of medicines used against viral infections known as antivirals.
Aciclovir Aurobindo Italia is indicated:

for the treatment of skin and mucous membrane infections caused by the Herpes simplex virus, including first episodes (primary genital herpes) as well as recurring episodes (recurrent genital herpes); however, Herpes simplex infections in newborns and Herpes simplex infections in immunocompromised children (with a weakened immune system, meaning their body is less able to fight infections) are excluded;
for the suppression of recurrent Herpes simplex infections in immunocompetent patients (with a normally functioning immune system);
for the prevention of Herpes simplex infections in immunocompromised patients (with a weakened immune system);
for the treatment of chickenpox and Herpes zoster (shingles).

2. What you should know before taking Aciclovir Aurobindo Italia

Do not take Aciclovir Aurobindo Italia

if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding, unless after careful evaluation by your doctor (see section “Pregnancy and breastfeeding”).

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

you have kidney problems;
you are over 65 years of age;
you have a severely weakened immune system. Talk to your doctor if you think any of these conditions apply to you. Your doctor may reduce the dose of Aciclovir Aurobindo Italia.

Make sure you drink plenty of fluids such as water while taking Aciclovir Aurobindo Italia.
Other medicines and Aciclovir Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
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 certain stomach disorders;
mycophenolate mofetil, used to prevent rejection of transplanted organs;
theophylline, used for respiratory problems.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
You must not take Aciclovir Aurobindo Italia without first consulting your doctor, who will evaluate the
benefits for you and the potential risks for your unborn child associated with taking Aciclovir Aurobindo
Italia during pregnancy.
Aciclovir may pass into breast milk. If you are breastfeeding or planning to breastfeed:
talk to your doctor before taking Aciclovir Aurobindo Italia.
Driving and using machines
No studies have been conducted to assess the effects of Aciclovir Aurobindo Italia on the ability to drive or
use machinery. Consider the possible occurrence of adverse effects that could affect your level of attention.
Aciclovir Aurobindo Italia 400 mg/5 ml oral suspension contains sorbitol
This medicine contains 1.575 g of sorbitol per 5 ml dose, equivalent to 315 mg/ml.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before you (or your child) take this medicine.
It may cause gastrointestinal disturbances and has a mild laxative effect.
Aciclovir Aurobindo Italia 400 mg/5 ml oral suspension contains parahydroxybenzoates
May cause allergic reactions (including delayed reactions).
Aciclovir Aurobindo Italia 800 mg tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Aciclovir Aurobindo Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
How to take Aciclovir Aurobindo Italia
Oral suspension: always shake well before use.
Take Aciclovir Aurobindo Italia as soon as possible after the onset of infection (at the first symptoms or
when the first lesions appear).
The dose you should take depends on the reason why Aciclovir Aurobindo Italia has been prescribed for you.
Your doctor will discuss this with you.
Treatment of Herpes simplex infections, including genital herpes

Adults and children over 2 years of age: the recommended dose is 200 mg (2.5 ml of oral suspension) 5 times daily.
Children under 2 years of age: the recommended dose is half the adult dose. For the treatment of neonatal herpes virus infections, intravenous aciclovir-containing medicines are recommended.

Take the doses at approximately 4-hour intervals, omitting the nighttime dose.
Take Aciclovir Aurobindo Italia for 5 days, or longer if prescribed by your doctor.
In patients with severely weakened immune systems (e.g. after bone marrow transplantation) or with reduced intestinal absorption, your doctor may decide to double the dose to 400 mg (half a tablet or 5 ml of oral suspension) or consider administering another aciclovir-containing medicine intravenously.
Aciclovir Aurobindo Italia is not indicated for children with weakened immune systems who have severe Herpes simplex infections.
Suppression of recurrences (infections that keep reappearing) of Herpes simplex in immunocompetent
patients (with normally functioning immune system)
The recommended dose is 200 mg (2.5 ml of oral suspension) 4 times daily.
Take the doses at approximately 6-hour intervals. Your doctor may adjust the dose and the interval between doses.
You must always take Aciclovir Aurobindo Italia exactly as directed by your doctor.
Continue taking Aciclovir Aurobindo Italia for as long as your doctor tells you to.
There are no data available on the suppression of Herpes simplex infections in children with normally functioning immune systems.
Prophylaxis of Herpes simplex infections in immunocompromised patients (with weakened immune
system)

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

Take the doses at approximately 6-hour intervals.
Continue taking Aciclovir Aurobindo Italia for as long as your doctor tells you to.
In adult patients with severely weakened immune systems (e.g. after bone marrow transplantation) or with reduced intestinal absorption, your doctor may decide to double the dose to 400 mg (half a tablet or 5 ml of oral suspension) or consider administering another aciclovir-containing medicine intravenously.
Treatment of chickenpox and Herpes zoster (shingles)
Adults

The recommended dose is 800 mg (one tablet or 10 ml of suspension) 5 times daily.
Take the doses at approximately 4-hour intervals, omitting the nighttime dose.
Take Aciclovir Aurobindo Italia for 7 days. In patients with severely weakened immune systems (e.g. after bone marrow transplantation) or with reduced intestinal absorption, your doctor may consider administering another aciclovir-containing medicine intravenously.

Children – Treatment of chickenpox

Children over 6 years of age: the recommended dose is 800 mg (one tablet or 10 ml of suspension), 4 times daily.
Children aged 2 years and under 6 years: the recommended dose is 400 mg (half a tablet or 5 ml of suspension), 4 times daily.
Children under 2 years of age: this medicine must not be administered.
Take Aciclovir Aurobindo Italia for 5 days.

Administration of 20 mg/kg body weight (not exceeding 800 mg) 4 times daily allows for more precise dose adjustment.
There are no data available on the treatment of Herpes zoster in children with normally functioning immune systems.
For the treatment of Herpes zoster infections in children with weakened immune systems, your doctor will consider administering other aciclovir-containing medicines intravenously.
Your doctor may also adjust the dose of Aciclovir Aurobindo Italia 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 Aurobindo Italia. Talk to your doctor before taking Aciclovir Aurobindo Italia if any of the above applies to you.

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

experience nausea, headache or vomiting;
feel confused or agitated;
see or hear things that are not there (hallucinations);
have seizures;
lose consciousness (coma). Inform your doctor or pharmacist if you have taken too much Aciclovir Aurobindo Italia and show them the medicine packaging.

If you forget to take Aciclovir Aurobindo Italia

If you forget to take Aciclovir Aurobindo Italia, 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.

4. Possible side effects

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

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

headache (cephalalgia);
dizziness;
nausea;
vomiting;
diarrhoea;
abdominal pain;
itching (pruritus);
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);
sudden and widespread hair loss.

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

severe allergic reaction (anaphylaxis);
shortness of breath (dyspnoea);
swelling of the face, lips, neck and throat (angioedema);
changes in some laboratory tests: increased blood urea nitrogen, creatinine, bilirubin and liver enzymes.

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

confusion and agitation;
tremor;
unsteadiness when walking and lack of coordination (ataxia);
slow or slurred speech (dysarthria);
seeing or hearing things that are not real (hallucinations);
disturbances in thought and perception related to a psychiatric disorder (psychotic symptoms);
seizures;
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 in kidney function (acute renal failure);
pain in the lower back, in the area corresponding to the kidneys (renal pain);
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 (thrombocytopenia).

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 national reporting system at 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 Italia

Keep this medicine out of the sight and reach of children.
Tablets: store in the original packaging to protect the medicine from moisture.
Oral suspension: this medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging 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 Aurobindo Italia Contains
Aciclovir Aurobindo Italia 800 mg tablets

The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
The other components are: microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate.

Aciclovir Aurobindo Italia 400 mg/5 ml oral suspension

The active substance is aciclovir. 5 ml of oral suspension contain 400 mg of aciclovir.
The other components are: sorbitol (70% non-crystallizable), glycerol, dispersible cellulose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, cherry flavor, purified water.

Description of the Appearance of Aciclovir Aurobindo Italia and Contents of the Package
800 mg tablets:
Blister pack containing 35 tablets.
Oral suspension:
Pack containing one 100 ml bottle of oral suspension.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 - 21047 Saronno (VA)

Manufacturer
ABC Farmaceutici S.p.A. - Via Cantone Moretti, 29 (loc. San Bernardo) - 10090 Ivrea (Torino)

Package leaflet: information for the user

Aciclovir Aurobindo Italia 5% cream

Generic medicine
Please read this leaflet carefully before using 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Aciclovir Aurobindo Italia is and what it is used for
What you need to know before using Aciclovir Aurobindo Italia
How to use Aciclovir Aurobindo Italia
Possible side effects
How to store Aciclovir Aurobindo Italia
Contents of the pack and other information

1. What Aciclovir Aurobindo Italia is and what it is used for

Aciclovir Aurobindo Italia is a topical cream containing the active substance aciclovir, which belongs to a group of medicines used against viral infections known as antivirals.
Aciclovir Aurobindo Italia is used to treat infections caused by the Herpes Simplex virus, such as cold sores (labial herpes) and primary (first episode) or recurrent (recurring) genital herpes.

2. What you need to know before using Aciclovir Aurobindo Italia

Do not use Aciclovir Aurobindo Italia

if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding, unless after careful evaluation by your doctor (see section “Pregnancy and breastfeeding”).

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

you are severely immunocompromised, meaning you have a condition in which your immune system functions less effectively and your body is less able to fight infections (for example, if you have HIV or AIDS, or have undergone a bone marrow transplant). Consult your doctor or pharmacist if you think any of these situations apply to you before using Aciclovir Aurobindo Italia cream. In such cases, your doctor may decide to prescribe tablets instead.

Aciclovir Aurobindo Italia must not be applied inside the mouth, eyes, or vagina, as it may cause irritation.
Particular care should be taken to avoid accidental application into the eyes.
If you use Aciclovir Aurobindo Italia for a prolonged period, sensitization reactions may occur. If this happens, stop treatment immediately and consult your doctor.
If in doubt, consult your doctor or pharmacist before using Aciclovir Aurobindo Italia.

Other medicines and Aciclovir Aurobindo Italia
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
No clinically significant interactions have been identified.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
You must not use Aciclovir Aurobindo Italia without first consulting your doctor, who will assess the benefit of treatment for you and the potential risk to your unborn child during pregnancy.

Breastfeeding
If you are breastfeeding or are considering doing so, speak with your doctor before using Aciclovir Aurobindo Italia.

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

Aciclovir Aurobindo Italia contains methyl 4-hydroxybenzoate
It may cause allergic reactions (including delayed-type reactions).

3. How to use Aciclovir Aurobindo Italia

Use this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.

Apply 5 times a day at intervals of about 4 hours. Aciclovir Aurobindo Italia cream should 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 later stages (papules or blisters).
Treatment should continue for at least 4 days for cold sores and for 5 days for genital herpes. If healing has not occurred, treatment may continue for up to a maximum of 10 days.

If you use more Aciclovir Aurobindo Italia than you should
If you have applied more than the recommended dose, contact your doctor or pharmacist for advice.
Aciclovir Aurobindo Italia cream is for external use only; in case of accidental ingestion, contact your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to use Aciclovir Aurobindo Italia

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

4. Possible side effects

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

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

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

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

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

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

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

5. How to store Aciclovir Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging 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 you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Aciclovir Aurobindo Italia Contains

The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
The other components are: tefose 1500, glycerin, stearic acid, liquid paraffin, methyl parahydroxybenzoate, purified water.

Description of the Appearance of Aciclovir Aurobindo Italia and Package Contents
Pack containing one tube of 10 g of cream.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 - 21047 Saronno (VA)
Manufacturer
Special Product’s line S.p.A., strada Paduni 240 - 03012 Anagni (FR)