ACICLOVIR 5 % Krem

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

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

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

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

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

• for the treatment of skin and mucous membrane infections caused by the Herpes simplexvirus, including genital herpes that occurs for the first time (primary genital herpes) or that continues to recur (recurrent genital herpes); infections from Herpes simplexin 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 recur in immunocompetent patients (with a normally functioning immune system);
• to prevent Herpes simplexinfections in immunocompromised patients (with a less effective immune system);
• for the treatment of chickenpox and Herpes zoster(shingles).

2. What you need to 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.The doctor may reduce the dose of Aciclovir Aurobindo Italia.

Make sure you drink plenty of fluids such as waterwhile taking Aciclovir Aurobindo Italia.

Other medicines and Aciclovir Aurobindo Italia
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 to treat gout;
• cimetidine, used to treat some stomach disorders;
• mycophenolate mofetil, used to prevent rejection of transplanted organs;
• theophylline, used for breathing problems.

Pregnancy and breastfeeding
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.
You should not take Aciclovir Aurobindo Italia without first consulting your doctor, who will assess the benefit for you and the risk to your baby of taking Aciclovir Aurobindo Italia while pregnant.
Aciclovir can pass into breast milk. If you are breastfeeding, or planning to breastfeed:

talk to your doctorbefore 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 and use machines. Assess the possible occurrence of side effects that may alter the 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) 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.

Aciclovir Aurobindo Italia 400 mg/5 ml oral suspension contains para-hydroxybenzoates
May cause allergic reactions (including delayed reactions).

Aciclovir Aurobindo Italia 800 mg tablets contains 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

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

How to take Aciclovir Aurobindo Italia
Oral suspension: always shake before use.
Take Aciclovir Aurobindo Italia 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 Aurobindo Italia has been prescribed to you.
Your doctor will discuss this with you.

Treatment ofHerpes simplexinfections 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 a day.
• Children under 2 years of age: the recommended dose is half the adult dose. For the treatment of neonatal herpes virus infections, the administration of other medicines based on aciclovir by intravenous route is recommended.

Take the dose at intervals of approximately 4 hours, skipping the night dose.
Take Aciclovir Aurobindo Italia for 5 days or for longer if prescribed by your doctor.
In 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 another medicine based on aciclovir by intravenous route.
In children with a weakened immune system with severe Herpes simplexinfections, Aciclovir Aurobindo Italia is not indicated.

Suppression of recurrences (infections that continue to reappear) ofHerpes simplexin immunocompetent patients (with a normally functioning immune system)
The recommended dose is 200 mg (2.5 ml of oral suspension) 4 times a day.
Take the dose at intervals of approximately 6 hours. The doctor may change the dose and also the interval between administrations. You should always take Aciclovir Aurobindo Italia according to your doctor's instructions.
Take Aciclovir Aurobindo Italia until your doctor tells you to stop.
There is no data available for the suppression of Herpes simplexinfections in children with a normally functioning immune system.

Prophylaxis ofHerpes simplexinfections in immunocompromised patients (with a less well-functioning immune system)

• Adults and children over 2 years of age: the recommended dose is 200 mg (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 approximately 6 hours.
Take Aciclovir Aurobindo Italia 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 another medicine based on aciclovir by intravenous route.

Treatment of chickenpox andHerpes zoster(shingles)
Adults

• The recommended dose is 800 mg (one tablet or 10 ml of suspension) 5 times a day.
• Take the dose at intervals of approximately 4 hours, skipping the night dose.
• Take Aciclovir Aurobindo Italia 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 another medicine based on aciclovir by intravenous route.

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 a day.
• Children between 2 and 6 years of age: the recommended dose is 400 mg (half a tablet or 5 ml of suspension), 4 times a day.
• Children under 2 years of age: the medicine should not be administered.
• Take Aciclovir Aurobindo Italia for 5 days.

Administering 20 mg/kg of body weight (not exceeding 800 mg) 4 times a day allows for a more precise dose adjustment.
There is no data 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 other medicines based on aciclovir by intravenous route.

The doctor may also change 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 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 convulsions;
• lose consciousness (coma). Tell 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 the next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on 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.

• If you have an allergic reaction, stop taking Aciclovir Aurobindo Italia and contact your doctorimmediately.

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, raised skin (urticaria);
• rapid 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 azotaemia, creatinine, bilirubin and enzymes produced by the liver.

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

• feeling of confusion and agitation;
• tremor;
• instability when walking and lack of coordination (ataxia);
• words spoken slowly and defectively (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);
• 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. You can also report side effects directly through 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 package to protect the medicine from moisture.
Oral suspension: this medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Scad”.
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 Aurobindo Italia contains
Aciclovir Aurobindo Italia 800 mg tablets

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

Aciclovir Aurobindo Italia 400 mg/5 ml 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 Aurobindo Italia and contents of the pack
800 mg tablets:
Blister pack containing 35 tablets.
Oral suspension:
Pack containing a 100 ml bottle of oral suspension.
Not all pack sizes may be marketed.

Marketing Authorisation 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)

Aciclovir Aurobindo Italia 5% cream

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 may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aciclovir Aurobindo Italia is a cream for application to the skin that contains the active substance aciclovir
belonging to a group of medicines used against viral infections called antivirals.
Aciclovir Aurobindo Italia is used for the treatment of infections caused by the Herpes Simplexvirus
such as lip herpes and primary (which appears for the first time) or recurrent genital herpes (which
continues to reappear).

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 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 Aurobindo Italia cream. In this case, your doctor may decide to prescribe you tablets.

Aciclovir Aurobindo Italia 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 Aurobindo Italia for a long period of time, sensitization may occur.
If this happens, stop treatment immediately and see your doctor.
If you have any doubts, talk to your doctor or pharmacist before using Aciclovir Aurobindo Italia.

Other medicines and Aciclovir Aurobindo Italia
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
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
You should not use Aciclovir Aurobindo Italia without first consulting your doctor, who will assess the
benefit to you and the risk to your baby of treatment with Aciclovir Aurobindo Italia while you are
pregnant.
Breastfeeding
If you are breastfeeding or plan to do so, talk to your doctor before using Aciclovir Aurobindo
Italia.

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

Aciclovir Aurobindo Italia contains methyl parahydroxybenzoate
It may cause allergic reactions (including delayed reactions).

3. How to use Aciclovir Aurobindo Italia

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

• Apply 5 times a day at intervals of approximately 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 the later stages (papules or vesicles).
• Therapy should 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 Aurobindo Italia than you should
If you have used a higher dose than recommended, 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 the use of this medicine, ask 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 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 Aurobindo Italia and contact your doctorimmediately.

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

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

Rare side effects(may affect up to 1 in 1,000 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 10,000 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 effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help to 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.
Do not store at a temperature above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
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 Aurobindo Italia 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 parahydroxybenzoate, purified water.

Description of the appearance of Aciclovir Aurobindo Italia and contents of the pack
Pack containing a tube of 10 g of cream.

Marketing Authorisation 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)