Amodivyr

Package leaflet: information for the patient

AMODIVYR 800 mg tablets, 400 mg/5 ml oral suspension

Aciclovir
Generic medicine
Please read all of 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, because it could 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 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

1. What AMODIVYR is and what it is used for

AMODIVYR contains the active substance aciclovir, which belongs 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 first episodes (primary genital herpes) and recurrent episodes (recurrent genital herpes); infections caused by Herpes simplex in newborns and severe Herpes simplex infections in immunocompromised children (with a weakened 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 weakened immune system)
• • to treat varicella (chickenpox) and Herpes zoster (shingles).

2. What you should 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 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, the doctor may reduce the dose of Amodivyr.
• 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 medicines.

• In particular, inform your doctor or pharmacist if you are taking any of the following medicines:
• probenecid, used to treat gout
• cimetidine, used to treat certain stomach disorders
• mycophenolate mofetil, used to prevent rejection of transplanted organs
• theophylline, used for respiratory problems.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist.
You must not take AMODIVYR without first consulting your doctor, who will evaluate the benefit to you and the potential risk to your baby of taking AMODIVYR during pregnancy.
Aciclovir may pass into breast milk.
If you are breastfeeding or planning to breastfeed:
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 or use machinery. Consider the possible occurrence of adverse effects that may affect the level of alertness.
Important information about some excipients of Amodivyr
AMODIVYR 800 mg tablets contain less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
AMODIVYR 400 mg/5 ml oral suspension contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate which may cause allergic reactions (including delayed reactions).
AMODIVYR 400 mg/5 ml oral suspension 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) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.

3. How to take AMODIVYR

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Oral suspension: Shake the suspension well before use. Do not dilute the suspension.
The package includes a dosing cup with markings indicating levels of 5 ml and 10 ml.
To open the bottle, remove the dosing cup, press down and turn at the same time. To close, screw the cap tightly.

Treatment of Herpes simplex infections:
The recommended dose is 200 mg (2.5 ml of solution), taken 5 times daily at intervals of approximately 4 hours, excluding during 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 those with reduced intestinal absorption, the dose may be doubled to 400 mg (corresponding to 5 ml of oral suspension), or alternatively, intravenous administration of the medicine may be considered.
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 solution) 4 times daily at 6-hour intervals.
In some cases, 400 mg (corresponding to 5 ml of suspension) twice daily at 12-hour intervals, or 200 mg three times daily at 8-hour intervals, or twice daily at 12-hour intervals, may also be effective.
In some patients receiving a total daily dose of 800 mg, recurrence of infection may occur.
Treatment should be periodically interrupted every 6 or 12 months to monitor for any disease changes.

Prevention of Herpes simplex infections in patients with low immune defenses:
The recommended dose is 200 mg (2.5 ml of solution) 4 times daily at 6-hour intervals.
In patients with very low immune defenses (e.g. after bone marrow transplantation) or in those with reduced intestinal absorption, the dose may be doubled to 400 mg (corresponding to 5 ml of oral suspension), or alternatively, intravenous administration of the medicine may be considered.

Treatment of Herpes zoster and chickenpox:
The recommended dose is 800 mg as tablets or 10 ml of suspension, taken 5 times daily at intervals of approximately 4 hours, excluding during the 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 individuals with reduced intestinal absorption, intravenous administration of the medicine may be considered.
Treatment should be started as soon as the first symptoms appear, such as itching and burning sensation, or as soon as the first lesions are observed.

Use in children
Treatment of Herpes simplex infections and prevention of Herpes simplex infections in children with weakened immune defenses:

• Children over 2 years of age: the dosage is the same as for adults.
• Children under 2 years of age: the recommended dose is half that of adults. (Severe Herpes simplex infections in immunocompromised children are an exception, for which AMODIVYR 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, corresponding to 5 ml of suspension, 4 times daily.
• Children under 2 years of age: this medicine must not be administered.

Administration of 20 mg/kg body weight (without exceeding 800 mg) 4 times daily allows for more precise dose adjustment. Treatment should be continued for 5 days.

Treatment of Herpes zoster in immunocompromised children: in such cases, intravenous (endovenous) aciclovir administration may be required.

Treatment of Herpes zoster in children with normal immune defenses: no data are available.

Treatment of recurrent Herpes simplex infection symptoms in children: no data are available.

Use in elderly patients
The doctor may adjust 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 patients with kidney problems
Aciclovir should be used with caution 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 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 abundant amounts 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 medicine package.

If you take too much Amodivyr, you may:

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

If you forget to take Amodivyr

• If you forget to take Amodivyr, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for the forgotten 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 (cephalalgia)
• dizziness
• nausea
• vomiting
• diarrhoea
• abdominal pain
• itching (pruritus)
• 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)
• changes in certain laboratory tests: increased blood urea nitrogen, creatinine, bilirubin and liver enzymes

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

• feeling confused and agitated
• tremors
• unsteadiness when walking and lack of coordination (ataxia)
• slow and defective speech (dysarthria)
• seeing or hearing things that are not there (hallucinations)
• disturbances in thought and perception related to a psychiatric disorder (psychotic symptoms)
• seizures
• 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 in 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, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the pack 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 AMODIVYR contains
AMODIVYR 800 mg tablets

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

AMODIVYR 400 mg/5 ml oral suspension

• The active substance is aciclovir. Each 5 ml of oral suspension contains 400 mg of aciclovir.
• The other components are: sorbitol (70%), glycerol, dispersible cellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cherry flavour, 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 blister packs.
AMODIVYR 400 mg/5 ml oral suspension: Pack containing one 100 ml glass bottle of oral suspension and an oral dosing syringe with markings corresponding to 5 ml and 10 ml volumes.

Marketing Authorization 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)

Package leaflet: information for the user

AMODIVYR 50 mg/g cream

Aciclovir
Generic medicine
Please read this leaflet carefully before using 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using AMODIVYR
3. How to use AMODIVYR
4. Possible side effects
5. How to store AMODIVYR
6. Package contents and other information

1. What AMODIVYR is and what it is used for

AMODIVYR is a cream to be applied to the skin that contains the active substance aciclovir, which belongs to a group of medicines used against viral infections (antivirals).
AMODIVYR is indicated for the treatment of cutaneous infections caused by the Herpes simplex virus, such as cold sores and primary (occurring for the first time) or recurrent (continuing to reappear) genital herpes.

2. What you should know before using 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 must not be applied in the mouth, eyes, or vagina, as it may cause irritation. Take special care to avoid accidental application into the eyes.
Talk to your doctor or pharmacist before using AMODIVYR if you are severely immunocompromised, that is, if you have a condition in which the immune system functions less effectively 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).
In such cases, your doctor may decide to prescribe oral aciclovir instead.
If you use Amodivyr for a prolonged period, sensitization reactions may occur; if this happens, treatment should be discontinued and you should consult your doctor.

Other medicines and AMODIVYR
Inform your doctor or pharmacist if you are currently using, 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, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist.
You must not use Amodivyr without first consulting your doctor, who will evaluate the benefit of treatment for you and the potential risk to your baby during pregnancy.

Breastfeeding
If you are breastfeeding or planning to breastfeed, talk to your doctor before using Amodivyr.

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

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

3. How to use AMODIVYR

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Treatment consists of 5 applications per day at intervals of approximately 4 hours.
Apply AMODIVYR cream to the lesions or to areas where lesions are developing, as soon as you
notice itching, burning, or pain (prodromal symptoms or erythema).
Treatment should continue for at least 5 days. If healing has not occurred, treatment may be
continued for up to a maximum of 10 days.
If you use more AMODIVYR than you should
If you have used more than the recommended dose, 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 are ingested, adverse effects are not expected to 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 patients):

• temporary stinging or burning sensation after application of the cream
• moderate dryness and peeling of the skin
• itching

Rare side effects (may affect up to 1 in 1,000 patients):

• 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 patients):

• allergic reactions (hypersensitivity) including swelling of the lips, face, neck and throat causing breathing difficulties (angioedema), and skin reaction (urticaria)

Reporting of side effects
If you experience any side effect, 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 the following website:
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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not store above 25°C.
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 AMODIVYR contains

• The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
• The other components are: tefose 1500, glycerin, stearic acid, liquid paraffin, methyl parahydroxybenzoate, purified water.

Description of the appearance of AMODIVYR and package contents
Pack containing one tube of 10 g of cream.
Marketing Authorization 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)