ACICLOVIR ALTER 800 mg Tabletka powlekana

Treść ulotki

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

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

Aciclovir

Generic medicine

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

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

ACICLOVIR ALTER contains the active ingredient aciclovir belonging to a group of medicines
used against viral infections (antivirals).
ACICLOVIR ALTER is used:

• for the treatment of skin and mucous membrane infections caused by the Herpes simplexvirus, including genital herpes (primary or recurrent), except for infections in newborns and for severe infections in children with low immune defenses (immunocompromised);
• to treat the symptoms of the recurrence of Herpes simplexin people with normal immune defenses;
• to prevent Herpes simplexinfections in people with low immune defenses;
• for the treatment of chickenpox and Herpes zoster.

2. What you need to know before taking ACICLOVIR ALTER

Do not take ACICLOVIR ALTER

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

Warnings and precautions
Consult your doctor or pharmacist before taking ACICLOVIR ALTER.
Take this medicine with caution if you have kidney problems or if you are elderly, because a
dose reduction may be necessary.
Drink plenty of water to maintain adequate hydration if you are taking high
doses of aciclovir orally.
Avoid using this medicine for long periods or for repeated treatments, especially in
people with low immune defenses, because resistant viruses may develop to aciclovir.

Other medicines and ACICLOVIR ALTER
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor and take this medicine with caution if you are taking:

• probenecid, a medicine used for gout;
• cimetidine, used to treat stomach ulcers;
• mofetil mycophenolate, used in patients undergoing transplantation;
• theophylline, used for asthma.

Pregnancy and breastfeeding
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 before taking this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under the
direct supervision of your doctor.
If you are breastfeeding, caution is recommended when taking this medicine.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive and
operate machinery.

ACICLOVIR ALTER oral suspension contains sorbitol, para-hydroxybenzoates and glycerol
This medicine contains sorbitol, if your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.
This medicine contains para-hydroxybenzoates, which may cause allergic reactions (even
delayed).

3. How to take ACICLOVIR ALTER

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

Instructions for use of ACICLOVIR ALTER oral suspension:Shake the suspension before use.

Treatment ofHerpes simplexinfections:the recommended dose is 200 mg (2.5 ml of
oral suspension), 5 times a day at intervals of approximately 4 hours, excluding at night.
Treatment should be continued for 5 days but an extension may be necessary in cases of
severe primary infections.
In people with very low immune defenses (e.g. after a bone marrow
transplant) or in people with decreased intestinal absorption, the dosage may be
doubled to 400 mg (half a tablet or 5 ml of oral suspension).
Therapy should be started as soon as you notice the appearance of the first symptoms, such as itching and
burning sensation, or as soon as you notice the first lesions.

Treatment of symptoms of recurrentHerpes simplexinfection in patients with
normal immune defenses:The recommended dose is 200 mg (2.5 ml of oral suspension) 4
times a day at intervals of 6 hours.
In some cases, 400 mg (5 ml of oral suspension), 2 times a day at intervals of
12 hours or 200 mg (2.5 ml of oral suspension), 3 times a day at intervals of 8 hours or 2
times a day at intervals of 12 hours are also effective.
In some patients taking 800 mg per day, a recurrence of
infection may occur.
Therapy should be interrupted periodically at intervals of 6 or 12 months, in order to
observe any changes in the disease.

Prevention ofHerpes simplexinfections in patients with low immune defenses:The dose
recommended is 200 mg (2.5 ml of oral suspension) 4 times a day at intervals of 6 hours.
In people with very low immune defenses (e.g. after a bone marrow
transplant) or in people with decreased intestinal absorption, the dosage may be
doubled to 400 mg (5 ml of oral suspension or half a tablet).

Treatment ofHerpes zosterand chickenpox: The recommended dose is 800 mg in tablets
or 10 ml of suspension 5 times a day at intervals of approximately 4 hours, excluding at night.
Treatment should be continued for 7 days.
Therapy should be started as soon as you notice the appearance of the first symptoms, such as itching and
burning sensation, or as soon as you notice the first lesions.

Use in children
Treatment and prevention ofHerpes simplexinfections:

• Children over 2 years of age: the dosage is similar to that of adults.
• Children under 2 years of age: the recommended dose is half that for adults. (An exception is made for severe Herpes simplexinfections in children with low immune defenses, for which ACICLOVIR ALTER is not indicated).

Treatment of chickenpox:

• Children over 6 years of age: the recommended dose is 800 mg in tablets (or 10 ml of suspension) 4 times a day.
• Children between 2 and 6 years of age: the recommended dose is 400 mg (in tablets or 5 ml of suspension) 4 times a day.
• Children under 2 years of age: 200 mg (2.5 ml of suspension) 4 times a day. Administration of 20 mg/kg of body weight (not exceeding 800 mg) 4 times a day allows for a more precise dosage adjustment. Treatment should be continued for 5 days.

Use in the elderly
The doctor will adjust the dosage based on your kidney function
It is advisable to drink plenty of water to maintain adequate hydration.

Use in people with kidney problems
In the treatment of Herpes simplexinfections in people with severe kidney problems, the dose
recommended is 200 mg (2.5 ml of oral suspension), 2 times a day at intervals of approximately
12 hours.
In the treatment of chickenpox and Herpes zoster, the recommended dose is 800 mg of aciclovir
in tablets or 10 ml of suspension, 2 times a day at intervals of approximately 12 hours or 3 times a
day, at intervals of approximately 8 hours, depending on the severity of the kidney problems.
It is advisable to drink plenty of water to maintain adequate hydration.

If you take more ACICLOVIR ALTER than you should
In case of accidental and prolonged overdose, nausea, vomiting, headache,
confusion may occur.
If you accidentally ingest/take an excessive dose of ACICLOVIR ALTER, immediately warn
your doctor or go to the Emergency Room of the nearest hospital.

If you forget to take ACICLOVIR ALTER
Do not take a double dose to make up for the missed dose.
If you have any doubts 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 gets them.
The following side effects may occur:

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

• headache, dizziness;
• nausea, vomiting;
• diarrhoea and abdominal pain;
• itching and skin rash;
• sensitivity to light;
• fatigue;
• fever.

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

• urticaria;
• rapid and widespread hair loss.

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

• difficulty breathing (dyspnea);
• liver problems with increased bilirubin and some liver enzymes;
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (angioedema);
• increased levels of nitrogen and creatinine in the blood;
• severe allergic reaction (anaphylaxis)

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

• reduction in the number of red blood cells (anaemia), white blood cells (leucopenia) and platelets (thrombocytopenia) in the blood;
• agitation, confusion, tremor;
• problems with the coordination of the muscles responsible for movement (ataxia)
• difficulty speaking (dysarthria);
• hallucinations, psychotic symptoms, convulsions;
• drowsiness;
• brain damage (encephalopathy) and coma;
• liver problems (hepatitis and jaundice);
• severe kidney problems (renal failure) and kidney pain.

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 national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store ACICLOVIR ALTER

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 “Scad”.
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 ALTER contains
ACICLOVIR ALTER 800 mg 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.

ACICLOVIR ALTER 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, glycerol, dispersible cellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cherry aroma, purified water.

Description of the appearance of ACICLOVIR ALTER and contents of the pack
Pack of 35 tablets of 800 mg.
Pack containing a 100 ml bottle of oral suspension.

Marketing Authorisation Holder and Manufacturer
Laboratori Alter S.r.l., via Egadi, 7 – 20144 Milano

Manufacturer
Tablets:
FINE FOODS & PHARMACEUTICALS NTM SPA – Via R. Follerau, 25 – 24027 Nembro (BG).
Oral suspension:
ABC Farmaceutici S.p.A. – Canton Moretti 29 – Località San Bernardo – 10090 Ivrea (TO)

ACICLOVIR ALTER 5% cream

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 4-5 days.

Contents of this leaflet:

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

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

ACICLOVIR ALTER is a cream for topical application that contains the active ingredient aciclovir, belonging to
a group of medicines used against viral infections (antivirals).
ACICLOVIR ALTER is used for the treatment of skin infections caused by the Herpes simplexvirus,
both on the lips (cold sores) and on the genitals (primary or recurrent genital herpes).
Consult your doctor if you do not feel better or if you feel worse after 4-5 days.

2. What you need to know before using ACICLOVIR ALTER

Do not use ACICLOVIR ALTER

• 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 ALTER.
ACICLOVIR ALTER should not be applied to the eyes, or to the internal mucous membranes of the mouth or vagina, because
it may cause irritation.
Talk to your doctor and use this medicine with caution if you have a weakened immune system, as you are more
susceptible to infections (for example if you have AIDS or have undergone a bone marrow transplant). In
this case, oral administration of aciclovir may be necessary.
Avoid long-term treatment, as it may cause an allergic reaction (sensitization). If this
happens, stop treatment immediately and see your doctor.

Other medicines and ACICLOVIR ALTER
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,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under the direct
supervision of your doctor.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive and operate
machinery.

ACICLOVIR ALTER contains methyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate which may cause allergic reactions (including
delayed reactions).

3. How to use ACICLOVIR ALTER

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The treatment involves 5 applications per day at intervals of approximately 4 hours.
Apply ACICLOVIR ALTER cream to the lesions, or to the areas where they are developing, as soon as you notice the appearance of itching and a burning or painful sensation (prodromes or erythema).
Therapy should continue for at least 4 days for lip herpes and for 5 days for genital herpes. If no improvement is seen, treatment may continue for a maximum of 10 days.

If you use more ACICLOVIR ALTER than you should
In case of accidental ingestion of an excessive amount of ACICLOVIR ALTER, contact your doctor immediately or go to the Emergency Room of the nearest hospital.
No cases of overdose have been reported. Even if the entire contents of the cream tube are ingested, no adverse effects should occur.
If you have any doubts about 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.
The following side effects may occur:

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

• transient burning or pain.

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

• dryness and flaking of the skin;
• itching;
• redness of the skin (erythema);
• inflammatory skin reaction (contact dermatitis) mainly due to the components of the cream base.

Very Rare(may affect up to 1 in 10,000 people):

• angioedema (swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing);
• 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store ACICLOVIR ALTER

Keep this medicine out of sight and reach of children.
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 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 ALTER 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 ALTER and contents of the pack
Pack containing a tube of 3 g of cream.

Marketing authorisation holder and manufacturer
Laboratori Alter S.r.l., Via Egadi 7 – 20144 Milano– Italy
LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA S.p.A. - Via Licinio,11 22036 Erba (CO)

ACICLOVIR ALTER 5% cream

Aciclovir

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 4-5 days

Contents of this leaflet

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

2. What you need to know before using ACICLOVIR ALTER

3. How to use ACICLOVIR ALTER

4. Possible side effects

5. How to store ACICLOVIR ALTER

6. Contents of the pack and other information

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

ACICLOVIR ALTER cream contains an active ingredient called aciclovir, which belongs to a group of
medicines called antivirals.
ACICLOVIR ALTER 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 (which
continues to reappear) genital herpes.
See a doctor if you do not feel better or if you feel worse after 4-5 days.

2. What you need to know before using ACICLOVIR ALTER

Do not use ACICLOVIR ALTER

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

Warnings and precautions
Talk to your doctor or pharmacist before using ACICLOVIR ALTER.
ACICLOVIR ALTER should not be applied to the eyes, or to the mucous membranes of the mouth or vagina as it may
cause irritation.
Talk to your doctor and use this medicine with caution if:

• you are severely immunocompromised, i.e. you are in a condition where your immune system works less well and your body is more susceptible to infections (for example if you have HIV or AIDS or if you have undergone a bone marrow transplant). In this case, oral administration of aciclovir may be necessary.

Avoid long-term treatment, as it may cause an allergic reaction (sensitization). If this
happens, stop treatment immediately and see your doctor.

Other medicines and ACICLOVIR ALTER
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 may be pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under direct
medical supervision.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive and operate
machinery.

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

3. How to use ACICLOVIR ALTER

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The treatment involves 5 applications a day at intervals of approximately 4 hours.
Apply ACICLOVIR ALTER cream to the lesions, or to the areas where they are developing, as soon as you notice the appearance of itching and a sensation of burning or pain (prodromes or erythema).
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 ALTER than you should
In case of accidental ingestion of an excessive amount of ACICLOVIR ALTER, contact your doctor immediately or go to the Emergency Room of the nearest hospital.
No cases of overdose have been reported. Even if the entire contents of the cream tube are ingested, no undesirable effects should occur.
If you have any doubts about 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.
The following side effects may occur:

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

• transient burning or pain.

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

• dryness and flaking of the skin;
• itching;
• redness of the skin (erythema);
• inflammatory skin reaction (contact dermatitis) mainly due to the components of the cream base.

Very Rare(may affect up to 1 in 10,000 people):

• angioedema (swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing);
• 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 national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store ACICLOVIR ALTER

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 “Exp.”.
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 ALTER 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 ALTER and contents of the pack
Cream - Pack containing a tube of 10 g of 5% cream.

Marketing Authorisation Holder and Manufacturer
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milano

Manufacturer
LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA S.p.A. - Via Licinio,11 22036 Erba (CO)