Acyclovir Mylan Generics

Package leaflet: Information for the patient

Aciclovir Mylan Generics 400 mg tablets, 800 mg tablets, 400 mg/5 ml oral suspension

Generic medicine
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 they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Aciclovir Mylan Generics is and what it is used for
2. What you need to know before taking Aciclovir Mylan Generics
3. How to take Aciclovir Mylan Generics
4. Possible side effects
5. How to store Aciclovir Mylan Generics
6. Contents of the pack and other information

1. What Aciclovir Mylan Generics is and what it is used for

Aciclovir Mylan Generics contains the active substance aciclovir, which belongs to a group of medicines used to treat viral infections (antivirals).
Aciclovir Mylan Generics is used:

• to treat 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;
• to treat chickenpox and Herpes zoster.

2. What you should know before taking Aciclovir Mylan Generics

Do not take Aciclovir Mylan Generics

• 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 taking Aciclovir Mylan Generics.
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 if you are taking high oral doses of aciclovir.
Avoid using this medicine for long periods or for repeated treatments, especially if you have a weakened immune system, as resistant viruses may develop.
If you have a weakened immune system, you may develop a rare disease characterized by low platelet and red blood cell counts, neurological symptoms, and kidney abnormalities (thrombotic thrombocytopenic purpura and hemolytic-uremic syndrome), which may even lead to death.

Other medicines and Aciclovir Mylan Generics
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 using the following medicines:

• probenecid, 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 to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if clearly needed and under direct medical supervision.

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

Aciclovir Mylan Generics 400 mg/5 ml oral suspension contains sorbitol and parahydroxybenzoates
This medicine contains approximately 1.575 mg of sorbitol per 5 ml dose.
Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine.
It may cause gastrointestinal disturbances and has a mild laxative effect.
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).

Aciclovir Mylan Generics 400 mg and 800 mg tablets:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Aciclovir Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Instructions for use of Aciclovir Mylan Generics oral suspension
Shake the suspension well before use.
The package includes a dosing syringe with markings corresponding to levels of 2.5 ml, 5 ml, 7.5 ml and 10 ml.
To open the bottle, remove the dosing syringe, press down and turn simultaneously. To close, screw the cap tightly.
Treatment of Herpes simplex infections: The recommended dose is 200 mg five times daily at approximately 4-hour intervals, excluding nighttime.
Treatment should continue for 5 days, but may need to be prolonged in cases of severe primary infections.
In patients with very low immune defences (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg in tablets or 5 ml of oral suspension, or alternatively, intravenous administration of aciclovir may be considered.
Treatment should be started as soon as the first symptoms appear, such as itching or burning sensations, or as soon as the first lesions are observed.
Treatment of recurrent Herpes simplex infection symptoms in patients with normal immune defences: The recommended dose is 200 mg four times daily at 6-hour intervals.
In some cases, 400 mg in tablets or 5 ml of oral 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, recurrence of the infection may occur.
Treatment should be periodically interrupted at intervals of 6 or 12 months to monitor for any changes in the disease.
Prevention of Herpes simplex infections in patients with weakened immune defences: The recommended dose is 200 mg four times daily at 6-hour intervals.
In patients with very low immune defences (e.g. after bone marrow transplantation) or in patients with reduced intestinal absorption, the dose may be doubled to 400 mg in tablets or 5 ml of oral suspension, or alternatively, intravenous administration of aciclovir may be considered.
Treatment of Herpes zoster and chickenpox: The recommended dose is 800 mg in tablets or 10 ml of oral suspension five times daily at approximately 4-hour intervals, excluding nighttime.
Take the medicine throughout the day according to the following dosing schedule:

Treatment should be continued for 7 days.
In individuals with very low immune defenses (e.g., after bone marrow transplantation) or in individuals with reduced intestinal absorption, intravenous administration of aciclovir may be considered.
Treatment should be started as soon as the first symptoms appear, such as itching and skin irritation, 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 low immune defenses:

• Children aged 2 years and older: the dosage is similar to that for adults.
• Children under 2 years of age: the recommended dose is half that of the adult dose. Exceptions include severe Herpes simplex infections in immunocompromised children, for which Aciclovir Mylan Generics is not indicated.

Treatment of chickenpox (varicella):

• Children aged 6 years and older: the recommended dose is 800 mg as tablets (or 10 ml of suspension) 4 times daily.
• Children aged 2 years and under 6 years: the recommended dose is 400 mg as tablets (or 5 ml of suspension) 4 times daily.
• Children under 2 years of age: the recommended dose is 200 mg of aciclovir (or 2.5 ml of suspension) 4 times daily. Administration of 20 mg/kg body weight (without exceeding 800 mg) 4 times daily allows for a more precise dose adjustment. Treatment should be continued for 5 days.

Treatment of Herpes zoster in children with low immune defenses: in such cases, intravenous (i.v.) administration of aciclovir may be necessary.

Use in elderly patients
The physician will adjust the dosage based on kidney function.
It is advisable to drink abundant fluids to maintain adequate hydration.

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 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, either 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 fluids to maintain adequate hydration.

If you take more Aciclovir Mylan Generics than you should
In case of accidental and prolonged overdose, symptoms such as nausea, vomiting, headache, and confusion may occur.
If you take an excessive dose of Aciclovir Mylan Generics, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to take Aciclovir Mylan Generics
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 everyone experiences them.
The following side effects may occur:

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

• headache, dizziness;
• nausea, vomiting;
• diarrhoea, abdominal pain;
• itching, 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):

• sudden potentially life-threatening allergic reaction (anaphylaxis);
• breathing difficulties (dyspnoea);
• liver problems with increased bilirubin and certain 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;

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;
• loss of muscle coordination (ataxia), speech disorder (dysarthria);
• hallucinations, psychosis, seizures;
• somnolence;
• brain disease (encephalopathy), coma;
• liver problems (hepatitis and jaundice);
• severe kidney problems (renal failure), kidney pain.

Not known (frequency cannot be estimated from the available data):

• swelling of hands, ankles or feet (peripheral oedema);
• swelling of glands in the neck, armpits or groin (lymphadenopathy);
• severe confusion (delirium);
• severe skin condition that may affect the mouth and other body parts;
• rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome);
• severe skin reaction starting with painful red areas, followed by large blisters and ending with peeling of skin layers, accompanied by fever and chills, muscle pain and general malaise (toxic epidermal necrolysis);
• presence of blood in the urine (haematuria).

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

5. How to store Aciclovir Mylan Generics

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.
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 Mylan Generics contains
Aciclovir Mylan Generics 400 mg tablets

• The active substance is aciclovir. Each tablet contains 400 mg of aciclovir.
• The other components are: microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate.

Aciclovir Mylan Generics 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.

Aciclovir Mylan Generics 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 70%, glycerol, dispersible cellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, cherry flavour, purified water.

Description of the appearance of Aciclovir Mylan Generics and contents of the pack
Aciclovir Mylan Generics 400 mg tablets: Pack containing 25 tablets of 400 mg in blister packs.
Aciclovir Mylan Generics 800 mg tablets: Pack containing 35 800 mg scored tablets in blister packs.
Aciclovir Mylan Generics 400 mg/5 ml oral suspension: Pack containing one 100 ml glass bottle of oral suspension and a dosing spoon with markings corresponding to 5 ml and 10 ml volumes.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, 10015 S. Bernardo d'Ivrea (TO)

Package leaflet: Information for the user

Aciclovir Mylan Generics 5% cream

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What Aciclovir Mylan Generics is and what it is used for
2. What you need to know before using Aciclovir Mylan Generics
3. How to use Aciclovir Mylan Generics
4. Possible side effects
5. How to store Aciclovir Mylan Generics
6. Package contents and other information

1. What Aciclovir Mylan Generics is and what it is used for

Aciclovir Mylan Generics is a cream for application to the skin that contains the active substance aciclovir, which belongs to a group of medicines used to treat viral infections (antivirals).
Aciclovir Mylan Generics is used to treat infections caused by the Herpes Simplex virus, 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 a few days.

2. What you need to know before using Aciclovir Mylan Generics

Do not use Aciclovir Mylan Generics

• 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 Mylan Generics.
Aciclovir Mylan Generics must not be applied to the eyes or to the internal mucous membranes of the mouth or vagina,
as it may cause irritation.
Consult 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
such cases, oral administration of aciclovir may be necessary.
Avoid prolonged treatment, as it may cause an allergic reaction (sensitization). If this occurs, stop treatment
immediately and consult your doctor.
Other medicines and Aciclovir Mylan Generics
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if clearly needed and under the direct supervision of your doctor.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or operate machinery.
Aciclovir Mylan Generics contains methyl parahydroxybenzoate
Methyl parahydroxybenzoate may cause allergic reactions (including delayed reactions).

3. How to use Aciclovir Mylan Generics

Use this medicine exactly as stated in this leaflet or as directed 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 Aciclovir Mylan Generics cream to the lesions or to areas where lesions are developing, as soon as you notice the first symptoms of infection, such as itching and skin irritation.
Treatment may also be started in later stages (papules or blisters).
Treatment should continue for at least 4 days for herpes labialis and for 5 days for genital herpes. If healing has not occurred, treatment may be continued for up to a maximum of 10 days.
If you use more Aciclovir Mylan Generics than you should
In case of accidental ingestion or overdose of Aciclovir Mylan Generics, contact your doctor immediately or go to the nearest hospital emergency department.
Cases of overdose have not been reported. Even if the entire contents of the cream tube are ingested, adverse effects are not expected to occur.
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:
Uncommon (may affect up to 1 in 100 people):

• burning, transient pain;
• moderate dryness and peeling of the skin;
• itching.

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

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

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

• allergic reactions such as angioedema (characterized by swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing and breathing), urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 Mylan Generics

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.
Do not store above 25°C.
Do not dispose of medicines 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 Mylan Generics contains

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

Description of the appearance of Aciclovir Mylan Generics and contents of the pack
Pack containing one tube of 3 g of cream.
Or
Pack containing one tube of 10 g of cream.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)