Acyclovir Alter

Package leaflet: Information for the patient

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

Aciclovir
Generic medicine
Please read 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 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

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

ACICLOVIR ALTER contains the active substance aciclovir, which belongs 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 simplex virus, including genital herpes (primary or recurrent), except for infections in newborns and severe infections in children with weakened immune systems (immunocompromised);
• to treat symptoms of recurrent Herpes simplex in people with normal immune defenses;
• to prevent Herpes simplex infections in people with weakened immune systems;
• 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 or during breastfeeding (see section "Pregnancy and breastfeeding");

Warnings and precautions
Talk to your doctor or pharmacist before taking ACICLOVIR ALTER.
Take this medicine with caution if you have kidney problems or if you are elderly, as a dose reduction may be necessary.
Drink plenty of water to maintain adequate hydration, especially when taking high oral doses of aciclovir.
Avoid using this medicine for prolonged periods or for repeated treatments, especially in individuals with weakened immune systems, as resistant viruses to aciclovir may develop.

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

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, use this medicine only if clearly needed and under direct medical supervision.
If you are breastfeeding, caution is recommended when taking this medicine.

Driving and using machines
There are no available data on the effect of this medicine on the ability to drive or use machinery.

ACICLOVIR ALTER oral suspension contains sorbitol, parahydroxybenzoates, and glycerol
This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).

3. How to take ACICLOVIR ALTER

Take this medicine exactly as directed by 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 well before use.
Treatment of Herpes simplex infections: The recommended dose is 200 mg (2.5 ml of oral suspension), 5 times daily at approximately 4-hour intervals, excluding the night.
Treatment should continue for 5 days, but may need to be prolonged in cases of severe primary infections.
In patients with very low immune defenses (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg (half a tablet or 5 ml of oral suspension).
Treatment should be started as soon as the first symptoms appear, such as itching or burning sensation, or as soon as the first lesions are observed.
Treatment of recurrent Herpes simplex symptoms in patients with normal immune defenses: The recommended dose is 200 mg (2.5 ml of oral suspension) 4 times daily at 6-hour intervals.
In some cases, 400 mg (5 ml of oral suspension) twice daily at 12-hour intervals, or 200 mg (2.5 ml of oral suspension) 3 times daily at 8-hour intervals or twice daily at 12-hour intervals, may also be effective.
In some patients taking 800 mg daily, recurrence of infection may occur.
Treatment should be periodically interrupted every 6 or 12 months to monitor for any changes in the disease.
Prevention of Herpes simplex infections in patients with low immune defenses: The recommended dose is 200 mg (2.5 ml of oral suspension) 4 times daily at 6-hour intervals.
In patients with very low immune defenses (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg (5 ml of oral suspension or half a tablet).
Treatment of Herpes zoster and chickenpox: The recommended dose is 800 mg as tablets or 10 ml of suspension 5 times daily at approximately 4-hour intervals, excluding the night.
Treatment should continue for 7 days.
Treatment should be started as soon as the first symptoms appear, such as itching or burning sensation, or as soon as the first lesions are observed.

Use in children
Treatment and prevention of Herpes simplex infections:

• Children over 2 years of age: dosage is the same as in adults.
• Children under 2 years of age: the recommended dose is half the adult dose. (Severe Herpes simplex infections in children with low immune defenses are an exception, for which ACICLOVIR ALTER is not indicated.)

Treatment of chickenpox:

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

Use in elderly patients
Your doctor will adjust the dose according to your kidney function.
It is advisable to drink plenty of fluids to maintain adequate hydration.
Use in patients with kidney problems
For the treatment of Herpes simplex infections in patients with severe kidney problems, the recommended dose is 200 mg (2.5 ml of oral suspension) twice daily at approximately 12-hour intervals.
For the treatment of chickenpox and Herpes zoster, the recommended dose is 800 mg of aciclovir as tablets or 10 ml of suspension, twice daily at approximately 12-hour intervals or three times daily at approximately 8-hour intervals, depending on the severity of kidney impairment.
It is advisable to drink plenty of fluids to maintain adequate hydration.
If you take more ACICLOVIR ALTER than you should
In case of accidental and prolonged overdose, symptoms such as nausea, vomiting, headache, and confusion may occur.
If you accidentally ingest or take an excessive dose of ACICLOVIR ALTER, contact your doctor immediately or go to the nearest hospital emergency department.
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):

• breathing problems (dyspnoea);
• liver problems with increased bilirubin and some liver enzymes;
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in 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;
• restlessness, confusion, tremor;
• problems with coordination of muscles involved in movement (ataxia);
• difficulty speaking (dysarthria);
• hallucinations, psychotic symptoms, seizures;
• drowsiness;
• brain damage (encephalopathy) and coma;
• liver problems (hepatitis and jaundice);
• severe kidney problems (kidney failure) and kidney pain.

Reporting of side effects
If you experience any side effects, 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 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 stated 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 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 ALTER contains
ACICLOVIR ALTER 800 mg tablets

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

ACICLOVIR ALTER 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, glycerol, dispersible cellulose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, cherry flavour, purified water.

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

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

Manufacturer
Tablets:
Fine Foods & Pharmaceuticals N.T.M. S.p.A. – Via Grignano, 43 – 24041 Brembate (BG)
Oral suspension:
ICE S.p.A. – Canton Moretti 29 – Località San Bernardo – 10090 Ivrea (TO)
January 2026