ACICLOVIR 800 mg Coated Tablet

Зміст інструкції

1. ACICLOVIR ALMUS in oral suspension form contains g 31.5 of sorbitol. When
2. ACICLOVIR ALMUS 5% - Cream

ACICLOVIR ALMUS 800 mg tablets
ACICLOVIR ALMUS 400 mg/ 5 ml oral suspension
Generic medicine
PHARMACOTHERAPEUTIC CATEGORY
Systemic antiviral

THERAPEUTIC INDICATIONS
ACICLOVIR ALMUS is indicated

• for the treatment of Herpes simplex infections of the skin and mucous membranes, including primary and recurrent genital Herpes (excluding neonatal Herpes Simplex infections and severe Herpes Simplex infections in immunocompromised children).
• for the suppression of Herpes simplex recurrences in patients with normal immune function.
• for the prophylaxis of Herpes simplex infections in patients with compromised immune function.
• for the treatment of chickenpox and Herpes zoster.

CONTRAINDICATIONS
Aciclovir tablets and oral suspension is contraindicated in patients with known hypersensitivity
to aciclovir, to valaciclovir or to any of the excipients.
Generally contraindicated in pregnancy and breastfeeding (see paragraph
“Special warnings”).

PRECAUTIONS FOR USE

Hydration status:Adequate hydration must be maintained in patients who
receive aciclovir intravenously or high doses of aciclovir orally.
The risk of renal damage is increased by the use of other nephrotoxic drugs.

Use in elderly patients and patients with renal impairment
Aciclovir is eliminated by means of renal clearance, therefore the dose must be reduced
in patients with renal impairment (see paragraph "Dosage, method and duration of administration").
Elderly patients are likely to have reduced renal function and therefore in this
group of patients the need for a dose reduction should be considered. Both elderly
patients and patients with renal impairment are at increased risk of developing neurological
side effects and must be carefully monitored for the appearance
of these effects. In reported cases, these reactions have generally
been reversible once treatment is stopped (see paragraph “Undesirable effects”).
Prolonged and repeated treatment cycles with aciclovir in severely
immunocompromised individuals can lead to the selection of strains of virus with reduced sensitivity
that may not respond to continued treatment with aciclovir.

Children, Elderly, Patients with specific clinical conditions
See "Dosage, method and duration of administration".

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines,
including those available without a prescription.
Aciclovir is mainly eliminated unchanged in the urine through active tubular secretion.
Any medicine administered simultaneously that is capable of
competing with this mechanism can increase plasma concentrations of
aciclovir. Probenecid and cimetidine through this mechanism determine an
increase in the area under the curve of plasma concentrations of aciclovir and therefore decrease its renal clearance. Similarly, concomitant administration of
aciclovir and mycophenolate mofetil, an immunosuppressant used in patients
undergoing transplantation, determines an increase in the area under the curve of plasma concentrations
of both aciclovir and the inactive metabolite of mycophenolate mofetil. This
however, no dosage adjustment is necessary given the wide
therapeutic index of aciclovir.
An experimental study on five male subjects indicates that concomitant therapy with
aciclovir increases the AUC of total theophylline administered by approximately 50%. It is recommended to
measure plasma concentrations during concomitant therapy with aciclovir.
Other drugs that interfere with renal function may alter some indices
of Aciclovir in the blood.

SPECIAL WARNINGS
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
The use of Aciclovir Almus should be considered only when the potential benefits outweigh the
possibility of unknown risks. A registry relating to the use of aciclovir in pregnancy has
provided data on pregnancy outcomes in women exposed to various formulations of
aciclovir after marketing. These observations have not shown an increase in the
number of birth defects among subjects exposed to aciclovir compared to
the general population and all birth defects found did not show any
peculiarity or common characteristics to suggest a single cause.

Breastfeeding
Following oral administration of 200 mg of Aciclovir, 5 times/day, the presence of Aciclovir has been observed in breast milk, at concentrations equal to 0.6-4.1 times the
corresponding plasma levels. These levels could potentially expose infants to doses of
Aciclovir up to 0.3 mg/kg/day. Therefore, caution is advised when using Aciclovir during
breastfeeding.

Effects on ability to drive and operate machinery
No adverse effects of Aciclovir on the ability to drive and operate machinery are known.

Important information about some excipients
ACICLOVIR ALMUS in the oral suspension form contains:

Glycerol: Glycerol is dangerous in high doses, can cause headache, stomach upset and
diarrhea;

ACICLOVIR ALMUS in oral suspension form contains g 31.5 of sorbitol. When

taken according to the recommended dosage, each 5 ml dose provides up to g 1.575 of

sorbitol. The product is not suitable in cases of fructose intolerance and may cause stomach upset and diarrhea

DOSE, METHOD AND TIME OF ADMINISTRATION
Shake the suspension before use.
The Aciclovir suspension pack is accompanied by a dosing syringe with level markings corresponding to capacities of 5 and 10 ml.

Adults
Treatment of Herpes simplex infections
200 mg 5 times a day at intervals of approximately 4 hours, omitting the nighttime dose. Treatment should be continued for 5 days but an extension may be necessary in cases of severe primary infections.
In patients with severely compromised immune function (e.g. after a bone marrow transplant) or in patients with decreased intestinal absorption, the dosage may be doubled to 400 mg in tablets or 5 ml of the suspension or, alternatively, the possibility of administering the drug by intravenous route may be evaluated.
Therapy should be started as soon as possible and, in the case of recurrent infections, preferably at the first symptoms or at the appearance of the first lesions.

Suppressive therapy for recurrent Herpes simplex infections in patients with normal immune function
200 mg 4 times a day at intervals of 6 hours.
Many patients can be successfully treated with the administration of 400 mg in tablets or 5 ml of the suspension 2 times a day at intervals of 12 hours.
Dosages of 200 mg 3 times a day at intervals of 8 hours or 2 times a day at intervals of 12 hours may also be effective.
In some patients, recurrences of the infection may occur with a total daily dose of 800 mg of Aciclovir
Therapy should be interrupted periodically at intervals of 6 or 12 months, in order to observe any changes in the natural history of the disease.

Prophylaxis of Herpes simplex infections in patients with compromised immune function
200 mg 4 times a day at intervals of 6 hours. In patients with severely compromised immune function (e.g. after a bone marrow transplant) or in patients with decreased intestinal absorption, the dosage may be doubled to 400 mg in tablets or 5 ml of the suspension or, alternatively, the possibility of administering the drug by intravenous route may be evaluated.
The duration of prophylaxis should be considered in relation to that of the period of risk.

Treatment of Herpes zoster and varicella
Tablet intake schedule throughout the day
800 mg in tablets or 10 ml of suspension 5 times a day at intervals of approximately 4 hours, omitting the nighttime dose. Treatment should be continued for 7 days.
In patients with severely compromised immune function (e.g. after a bone marrow transplant) or in patients with decreased intestinal absorption, the possibility of administering the drug by intravenous route may be evaluated.
Therapy should be started immediately after the onset of the infection, in fact treatment obtains better results if started at the appearance of the first lesions.

Children
For the treatment of Herpes simplex infections and for the prophylaxis of the same in those with compromised immune function, in children over 2 years of age the dosage is similar to that of adults. Under two years of age the dosage is halved.
Severe HSV infections in immunocompromised patients are an exception, for which Aciclovir Almus is not indicated (see paragraph “Therapeutic indications”).
For the treatment of varicella, in children over 6 years of age the dosage is 800 mg in tablets or 10 ml of suspension 4 times a day; in those between 2 and 6 years of age the dosage is 400 mg in tablets or 5 ml of suspension 4 times a day. The product should not be administered to children under 2 years of age, as the efficacy and safety of use in this age group have not been established. 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.
No specific data are available regarding the suppression of Herpes simplex infections or the treatment of Herpes zoster in children with normal immune function.
For the treatment of Herpes zoster in children with compromised immune function, administration of the drug by intravenous route should be considered.

Elderly
In the elderly, total Aciclovir elimination decreases with decreasing indices of renal function associated with advancing age. In elderly patients, the possibility of renal impairment must be taken into consideration and the dosage must be adjusted accordingly (see below “Renal impairment”). Elderly patients taking high doses of Aciclovir orally should maintain adequate fluid intake.
Particular attention must be paid to evaluating the possibility of reducing the dosage in elderly patients with impaired renal function.

Renal impairment
Caution is recommended when administering Aciclovir to patients with impaired renal function.
Adequate hydration must be maintained.
In the treatment of Herpes simplex infections, in patients with impaired renal function, the recommended oral dosage should not cause an accumulation of Aciclovir above levels that have been shown to be tolerated, following intravenous administration of the drug. In patients with severe renal impairment (creatinine clearance less than 10 ml/min), it is recommended to adjust the dose to 200 mg, administered 2 times a day at intervals of approximately 12 hours.
In the treatment of varicella and Herpes zoster, it is recommended to modify the dosage to 800 mg in tablets or 10 ml of suspension, administered 2 times a day at intervals

of approximately 12 hours, in patients with severe renal impairment (creatinine clearance less than 10 ml/min) and to 800 mg in tablets or 10 ml of suspension 3 times a day, administered at intervals of approximately 8 hours, in patients with moderate renal impairment (creatinine clearance between 10 and 25 ml/min).

OVERDOSE

Symptoms and signs:
Aciclovir is only partially absorbed at the intestinal level.
Patients who have occasionally ingested an overdose of up to 20 g of aciclovir in a single dose have generally not manifested toxic effects. Accidental and repeated overdoses of aciclovir orally, prolonged for several days, have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion). Overdoses of aciclovir by intravenous route have determined increases in serum creatinine levels, azotemia with consequent renal failure. Neurological effects including confusion, hallucinations, agitation, convulsions and coma have been described, associated with overdose by intravenous route.
Treatment
Patients must be carefully observed for any signs of toxicity.
Aciclovir is dialyzable. Hemodialysis contributes significantly to the elimination of aciclovir from the blood and may, therefore, be considered an option to be adopted in case of symptomatic overdose.
In case of accidental ingestion/intake of an excessive dose of Aciclovir Almus, immediately notify the doctor or go to the nearest hospital.
If you have any doubts about the use of Aciclovir Almus, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Aciclovir Almus can cause side effects, although not everyone will experience them.
The frequency categories associated with the adverse events reported below are estimates. Adequate data for assessing the incidence are not available for most events. In addition, the incidence of adverse events may vary depending on the indication.
The following convention has been used for the classification of undesirable effects in terms of frequency: very common ≥ 1/10; common ≥1/100, <1/10; uncommon ≥1/1000, <1/100; rare ≥1/10.000, <1/1000; very rare <1/10.000.

Hematopoietic system disorders
Very rare: anemia, leucopenia, thrombocytopenia
Immune system disorders
Rare: anaphylaxis

Psychiatric and nervous system disorders
Common: headache, dizziness
Very rare: agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, drowsiness, encephalopathy, coma.
The events reported above are usually reversible and generally occur in patients with severe renal impairment or with other predisposing factors.

Respiratory, thoracic and mediastinal disorders
Rare: dyspnea

Gastrointestinal disorders
Common: nausea, vomiting, diarrhea, abdominal pain

Hepatobiliary disorders
Rare: reversible increases in bilirubin and liver enzymes
Very rare: hepatitis, jaundice

Skin and subcutaneous tissue disorders
Common: itching, skin rashes (including photosensitivity)
Uncommon: urticaria. Rapid and widespread hair loss
In some patients, after oral administration of aciclovir, skin rashes have occurred, promptly disappearing with discontinuation of therapy.
Rapid and widespread hair loss has been associated with a wide range of diseases and the use of drugs, therefore the relationship of this event with therapy with aciclovir is uncertain.
Rare: angioedema

Renal and urinary disorders
Rare: increased urea and creatinine
Very rare: acute renal failure, renal pain
Renal pain may be associated with renal failure.

Systemic disorders and conditions related to the site of administration
Common: fatigue, fever
undesirable.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting of side effects helps to provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date reported on the packaging.
Warning: do not use the medicine after the expiry date indicated on the packaging.
Storage
800 mg tablets: store in a dry place.
Medicines should not be thrown into the drain or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.

COMPOSITION
ACICLOVIR ALMUS 800 mg TABLETS
One tablet contains:
Active ingredient: Aciclovir mg 800
Excipients: Microcrystalline cellulose, Sodium starch glycolate, Polyvinylpyrrolidone, Magnesium stearate

ACICLOVIR ALMUS 400 mg/ 5 ml ORAL SUSPENSION
5 ml of oral suspension contain:
Active ingredient: Aciclovir mg 400
Excipients: - Sorbitol (70% non-crystallizable), Glycerol, Dispersible cellulose, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Cherry aroma, Purified water.

PHARMACEUTICAL FORM AND CONTENT

• 800 mg tablets; pack of 35 tablets of 800 mg
• 400 mg/ 5 ml oral suspension; 100 ml bottle

MARKETING AUTHORISATION HOLDER
ALMUS S.r.l.
Via Cesarea 11/10

• 16121 - Genoa (GE)

MANUFACTURER AND FINAL CONTROLLER
Special Product’s Line S.p.A.
Via Campobello, n. 15

• 00040 - Pomezia (RM)

ACICLOVIR ALMUS 5% - Cream

Equivalent medicinal product

COMPOSITION
One gram of cream contains:
Aciclovir 50 mg
Excipients: Tefose 1500; Glycerin; Stearic acid; Liquid paraffin; Methylparaben; Purified water .

PHARMACEUTICAL FORM AND CONTENT
Tube of 5% Aciclovir cream in a pack containing a Tube of 10 g of cream for topical use 5%

PHARMACOTHERAPEUTIC CATEGORY
Topical antiviral chemotherapeutic agents

AUTHORISATION HOLDER
ALMUS S.r.l.
Via Cesarea n. 11/10

• 16121 - Genoa

PRODUCER AND FINAL CONTROLLER
Special Product’s Line S.p.A.
Via Campobello 15
00040 Pomezia (RM)

THERAPEUTIC INDICATIONS
Aciclovir cream is indicated in the treatment of cutaneous infections caused by Herpes simplex
such as:

• Primary or recurrent genital herpes.
• Lip herpes.

CONTRAINDICATIONS
Aciclovir cream is contraindicated in patients with a known hypersensitivity to aciclovir, to
valaciclovir or to any of the excipients.
Generally contraindicated in pregnancy and breastfeeding (see Special warnings and precautions for use).

PRECAUTIONS FOR USE
None particular

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those available without a prescription.
No particular clinically significant interactions have been identified.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product is not for ophthalmic use, nor is the application of the cream recommended on the
mucous membranes of the mouth, eyes and vagina as it may cause irritation.
Particular care should be taken to avoid accidental application to the eyes.
In severely immunocompromised patients (patients with AIDS or patients with bone marrow
transplant) the administration of aciclovir in oral formulations should be considered. Such patients should be advised to consult their doctor regarding the treatment of any infection.
Use, especially if prolonged, of the product may lead to sensitization phenomena. If this
occurs, treatment should be discontinued and the treating physician consulted.

Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
The use of Aciclovir Almus should be considered only when the potential benefits outweigh the
possibility of unknown risks, however systemic exposure to aciclovir after topical application
of aciclovir cream, is very low.
A registry relating to the use of aciclovir in pregnancy after marketing, has provided data on pregnancy outcomes in women exposed to various formulations of
aciclovir.
These observations have not shown an increase in the number of birth defects in subjects exposed to aciclovir compared to the general population and all birth defects detected
did not show any particularity or common characteristics, such as to suggest a single cause.

Breastfeeding
Limited data in humans indicate that the drug is found in breast milk after
systemic administration. However, the dose received by an infant following the use
of Aciclovir cream in the mother, should be insignificant.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Aciclovir cream should be applied 5 times a day at intervals of approximately 4 hours.
Aciclovir cream should be applied to the lesions, or to the areas where they are
developing, as soon as possible after the onset of infection.

It is particularly important to start treatment of recurrent episodes during the
prodromal phase (the first symptoms of infection namely itching and/or burning and/or pain) or
at the first appearance of the lesions.
Treatment should continue for at least 5 days and up to a maximum of 10 if no
healing has occurred.

OVERDOSE
In case of ingestion/accidental intake of an excessive dose of Aciclovir cream
immediately inform the doctor or go to the nearest hospital.
If you have any doubts about the use of Aciclovir cream, consult your doctor or pharmacist.
Even if the entire contents of a 10 g tube of Aciclovir cream containing 500 mg of aciclovir are ingested, no adverse effects should be expected.
Single intravenous doses up to 80 mg/kg have been administered accidentally without
adverse effects. Aciclovir can be removed by dialysis.

UNDESIRABLE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following convention has been used for the classification of undesirable effects in
terms of frequency: very common ≥1/10, common ≥1/100 and <1/10, uncommon ≥1/1000 and
<1/100, rare ≥1/10.000 and < 1/1000, very rare <1/10.000.

Skin and subcutaneous tissue disorders
Uncommon: transient burning or pain after application, moderate dryness,
skin flaking and itching.
Rare: erythema, contact dermatitis after application.
Where sensitivity tests have been conducted, it has been shown that reactivity phenomena
were related to the components of the cream rather than to aciclovir.

Immune system disorders
Very rare: immediate hypersensitivity reactions including angioedema and urticaria
If you experience any side effects, consult your doctor.
It is important to inform your doctor of the occurrence of adverse effects not described in the

SHELF LIFE AND STORAGE
Refer to the expiry date printed on the packaging.
Caution: do not use the medicine after the expiry date indicated on the packaging; this
date refers to the product in intact packaging, stored correctly.
Storage conditions
Store at a temperature not exceeding 25°C.
Keep out of the reach and sight of children.