AMODIVYR 800 mg Tabletka Powlekana

Treść ulotki

1. AMODIVYR 800 mg tablets, 400 mg/5 ml oral suspension
   1. What AMODIVYR is and what it is used for
   2. What you need to know before taking AMODIVYR
   3. How to take AMODIVYR
   4. Possible side effects
   5. How to store AMODIVYR
   6. Contents of the pack and other information
2. AMODIVYR 50 mg/g cream
   1. What AMODIVYR is and what it is used for
   2. What you need to know before you use AMODIVYR
   3. How to use AMODIVYR
   4. Possible side effects
   5. How to store AMODIVYR
   6. Contents of the pack and other information

AMODIVYR 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 their symptoms are the same as yours, as it could 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 AMODIVYR is and what it is used for
• 2. What you need to know before you take AMODIVYR
• 3. How to take AMODIVYR
• 4. Possible side effects
• 5. How to store AMODIVYR
• 6. Contents of the pack and other information

1. What AMODIVYR is and what it is used for

AMODIVYR contains the active substance aciclovir, belonging to a group of medicines used
against viral infections (antivirals).
AMODIVYR is indicated:

• - to treat Herpes simplex infections of the skin and mucous membranes, including genital herpes that occurs for the first time (primary genital herpes) or that continues to recur (recurrent genital herpes); infections of Herpes simplex in newborns and severe infections of Herpes simplex in immunocompromised children (with a less effective immune system, meaning their body is less able to fight infections) are excluded
• - to suppress recurrent Herpes simplex infections in immunocompetent patients (with a normally functioning immune system)
• - to prevent Herpes simplex infections in immunocompromised patients (with a less effective immune system)
• - to treat chickenpox and Herpes zoster (shingles).

2. What you need to know before taking AMODIVYR

Do not take AMODIVYR

• if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in the section Contents of the pack and other information);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking AMODIVYR if:

• you have kidney problems,
• you are over 65 years of age. In these cases, your doctor may reduce the dose of Amodivyr.
• if you have a severely weakened immune system.

Make sure you drink plenty of fluids, such as water, while taking Amodyvir.

Other medicines and AMODIVYR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

• 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
• mofetil mycophenolate, used to prevent rejection of transplanted organs
• theophylline, used for breathing problems.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice.
You should not take AMODIVYR without first consulting your doctor, who will assess
the benefit to you and the risk to your baby of taking AMODIVYR while
pregnant.
Aciclovir can pass into breast milk.
If you are breastfeeding, or planning to do so:
talk to your doctor before taking AMODIVYR.

Driving and using machines
No studies have been conducted to assess the effects of AMODIVYR on the ability to drive and
use
machines. Assess the possible occurrence of side effects that may alter the level of
attention.

Important information about some of the excipients in Amodivyr
AMODIVYR 800 mg tablets contains less than 1 mmol (23 mg) of sodium per dose, which is
essentially ‘sodium-free’.
AMODIVYR 400 mg/5 ml oral suspension contains methyl parahydroxybenzoate and propyl para-
hydroxybenzoatewhich may cause allergic reactions (including delayed reactions).
AMODIVYR 400 mg/5 ml oral suspension also contains 1575 mg of sorbitol per dose
equivalent to 315 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or the
child) are intolerant to some sugars, or if you have a diagnosis of hereditary fructose
intolerance, a rare genetic disorder where patients cannot metabolize fructose,
talk to your doctor before you (or the child) take this medicine. Sorbitol may
cause gastrointestinal problems and have a mild laxative effect.

3. How to take AMODIVYR

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
How to take AMODIVYR

Oral suspension:Shake the suspension before use. Do not dilute the suspension.
The package includes a dosing syringe with markings corresponding to
a level of 5 ml and 10 ml.
To open the bottle, remove the syringe, press and turn simultaneously. To close
screw tightly.

Treatment of infections caused byHerpes simplex
the recommended dose is 200 mg (2.5 ml of solution), 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, corresponding to 5 ml of oral suspension, or alternatively, the
opportunity for administration of the medicine by intravenous route may be evaluated.
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 recurrence of infection fromHerpes simplexin patients with
normal immune defenses:
The recommended dose is 200 mg (2.5 ml of solution) 4 times a day at intervals of 6 hours.
In some cases, 400 mg, corresponding to 5 ml of suspension, 2 times a day at
intervals of 12 hours or 200 mg 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 treated with a total daily dose of 800 mg, a
recurrence of the infection may occur.
Therapy should be interrupted periodically at intervals of 6 or 12 months, to be able to
observe any changes in the disease.

Prevention of infections fromHerpes simplexin patients with low immune defenses:
The recommended dose is 200 mg (2.5 ml of solution) 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, corresponding to 5 ml of oral suspension, or alternatively, the
opportunity for administration of the medicine by intravenous route may be evaluated.

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.
Take the medicine throughout the day according to the following dosing schedule:
Treatment should be continued for 7 days.

In people with very low immune defenses (e.g. after a bone marrow
transplant) or in people with decreased intestinal absorption, the opportunity for
administration of the medicine by intravenous route may be evaluated.
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 of infections fromHerpes simplexand prevention of infections fromHerpes simplex
in children with low immune defenses:

• 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. (Exceptions are made for severe Herpes simplexinfections in children with low immune defenses, for which AMODIVYR 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 corresponding to 5 ml of suspension 4 times a day.
• Children under 2 years of age: this medicine should not be administered.

The 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.

Treatment ofHerpes zosterin children with low immune defenses:in this case, the
administration of acyclovir by injection into the vein (intravenous route) may be necessary.

Treatment ofHerpes zosterin children with normal immune defenses: no
data are available
Treatment of symptoms of recurrence of infection fromHerpes simplexin children: no
data are available
Use in the elderly
The doctor may modify the dose of Amodivyr 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 Amodivyr .

Use in people with kidney problems
Acyclovir must be used with caution in patients with kidney problems.
In the treatment of Herpes simplexinfections in people with severe kidney problems, the recommended dose is 200 mg (2.5 ml of 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 acyclovir
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 take plenty of water to maintain adequate hydration.

If you take more Amodivyr than you should
If you accidentally take too much Amodivyr, contact your doctor or pharmacist for advice and
show them the package of the medicine.
If you take too much Amodivyr you may:

• have nausea, headache or vomiting
• feel confused or agitated
• see or hear things that are not there (hallucinations)
• have convulsions
• lose consciousness (coma)

If you forget to take Amodivyr

• If you forget to take Amodivyr, take it as soon as possible when 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 the missed dose.

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 Amodivyr and contact your doctor immediately.
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 skin rash (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 lips, face, neck and throat (angioedema)
• alteration of some laboratory tests: increase in blood urea nitrogen, 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
• tremors
• instability when walking and lack of coordination (ataxia)
• words spoken slowly and defectively (dysarthria)
• seeing or hearing things that do not exist (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)
• inflammation of the liver (hepatitis)
• rapid reduction of kidney function (acute renal failure) which may be associated with pain in the lower back (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 https://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 AMODIVYR

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.
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 AMODIVYR contains
AMODIVYR 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.

AMODIVYR 400 mg/5 ml oral suspension

• The active ingredient is aciclovir. Each 5 ml of oral suspension contains 400 mg of aciclovir.
• The other ingredients are: sorbitol (70%), glycerol, dispersible cellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cherry aroma, purified water.

Description of the appearance of AMODIVYR and contents of the pack
AMODIVYR 800 mg tablets: Pack containing 35 tablets of 800 mg in blisters.
AMODIVYR 400 mg/5 ml oral suspension: Pack containing a 100 ml glass bottle
of oral suspension and a measuring cup with level markings corresponding to capacities of 5 and
10 ml.

Marketing Authorisation Holder
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)

Manufacturers
Fulton Medicinali S.p.A. – Via Marconi 28/9 – Arese (MI)
Special Product’s Line S.p.A. – Strada Paduni, 240 - 03012 Anagni (FR)

AMODIVYR 50 mg/g cream

Aciclovir
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 their symptoms are the same as yours, as it could 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 AMODIVYR is and what it is used for
• 2. What you need to know before you use AMODIVYR
• 3. How to use AMODIVYR
• 4. Possible side effects
• 5. How to store AMODIVYR
• 6. Contents of the pack and other information

1. What AMODIVYR is and what it is used for

AMODIVYR is a cream for topical application that contains the active ingredient aciclovir which
belongs to a group of medicines used against viral infections (antivirals).
AMODIVYR is indicated for the treatment of skin infections caused by the Herpes simplexvirus such
as labial herpes and primary (occurring for the first time) or recurrent genital herpes
(which continues to recur)

2. What you need to know before you use AMODIVYR

Do not use AMODIVYR

• 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 AMODIVYR.
Amodivyr cream 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.
Talk to your doctor or pharmacist before using AMODIVYR if you are severely
immunocompromised, i.e. you are in a condition where your immune system works
less well and your body is less able to fight infections (e.g. if you have
HIV or AIDS or if you have undergone a bone marrow transplant).
In this case, your doctor may decide to prescribe aciclovir orally.
If you use Amodivyr for a long period of time, sensitization may occur; if
this happens, stop treatment and consult your doctor.

Other medicines and AMODIVYR
Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines.
No interactions with other medicines have been identified

Pregnancy and breastfeeding
Pregnancy
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.
You should not use Amodivyr without first consulting your doctor, who will assess the
benefit to you and the risk to your baby of treatment with Amodivyr while you are
pregnant.

Breastfeeding
If you are breastfeeding or plan to do so, talk to your doctor before using Amodivyr.

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

AMODIVYR contains methyl parahydroxybenzoate
This medicine contains methyl parahydroxybenzoate, which can cause allergic reactions (including
delayed reactions).

3. How to use AMODIVYR

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The treatment involves 5 applications per day at intervals of approximately 4 hours.
Apply AMODIVYR 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 5 days. If no improvement is observed, treatment may
continue for a maximum of 10 days.

If you use more AMODIVYR than you should
If you have used a dose higher than recommended, contact your doctor or pharmacist for
advice. Amodyvir cream is for external use only; in case of accidental ingestion, contact your doctor
or pharmacist.
Even if the entire contents of the tube of cream are ingested, no undesirable effects should
occur.

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 Amodivyr and contact your doctor immediately.
Uncommon side effects (may affect up to 1 in 100 people):

• temporary stinging or burning sensation after applying the cream
• moderate dryness and flaking of the skin
• 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 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, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 AMODIVYR

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 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 AMODIVYR 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 AMODIVYR and contents of the pack
Pack containing a tube of 10 g of cream.

Marketing Authorisation Holder
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)

Manufacturers
Lachifarma S.r.l. – S.S: 16 Zona industriale – 73010 Zollino (LE)