Patient Information Leaflet

Aciclovir Dorom 400 mg tablets, 800 mg tablets, 400 mg/5 ml oral suspension

Generic medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including any not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Aciclovir Dorom is and what it is used for
What you need to know before taking Aciclovir Dorom
How to take Aciclovir Dorom
Possible side effects
How to store Aciclovir Dorom
Contents of the pack and other information

1. What Aciclovir Dorom is and what it is used for

Aciclovir Dorom contains aciclovir, a substance with antiviral properties, effective against infections caused by certain viruses ( Herpes ).
Aciclovir Dorom is used:

to treat skin and mucous membrane infections caused by the Herpes Simplex virus, including genital herpes (Herpes genitalis), except in children with severe herpes infections who have weakened immune systems (immunocompromised) and in newborns;
to treat recurrent Herpes simplex infections in people with normal immune defenses;
to prevent Herpes simplex infections in people with weakened immune systems (immunocompromised);
for the treatment of chickenpox and Herpes zoster.

Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Aciclovir Dorom

Do not use Aciclovir Dorom:

if you are allergic to the active substance, to valaciclovir, or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding, unless your doctor considers it strictly necessary.

Warnings and precautions
Talk to your doctor or pharmacist before using Aciclovir Dorom.
Pay special attention and consult your doctor before taking Aciclovir Dorom if:

you are taking medicines that may impair kidney function, as this may increase the risk of developing kidney problems. Your doctor will advise you whether any of the medicines you are taking fall into this category;
your kidney function is impaired or if you are elderly, as a dose reduction may be required. Furthermore, if you belong to either of these patient groups, your doctor will closely monitor your health status, since there is an increased risk of developing nervous system side effects such as: headache, dizziness, agitation, confusion, tremor, lack of coordination of voluntary muscle movements (ataxia), speech disorder (dysarthria), hallucinations, psychotic symptoms, seizures, drowsiness, brain abnormalities (encephalopathy), coma. These symptoms usually resolve upon discontinuation of treatment;
your immune defenses are severely compromised, as prolonged or repeated use of this medicine may lead to the development of resistant viruses, resulting in loss of aciclovir efficacy.

Taking high doses of aciclovir may cause excessive loss of body fluids;
therefore, if you are receiving high-dose aciclovir therapy, you should drink plenty of water to maintain adequate hydration.
Other medicines and Aciclovir Dorom
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking any of the following medicines:

probenecid, used mainly for the treatment of gout;
cimetidine, used to treat lesions in the stomach lining (gastric ulcer);
mycophenolate mofetil, used in transplant patients to prevent organ rejection;
theophylline, used for the treatment of asthma.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are pregnant, use this medicine only if strictly necessary and always under direct medical supervision, as its use is generally contraindicated during pregnancy.
Breastfeeding
Use aciclovir during breastfeeding only if strictly necessary and under direct medical supervision, as its use is generally contraindicated during breastfeeding.
Driving and using machines
Aciclovir Dorom may affect your ability to drive or operate machinery.
Your doctor will advise you whether you can drive or operate machinery after evaluating your clinical condition and any potential adverse effects that may occur during treatment.
Aciclovir Dorom tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Aciclovir Dorom oral suspension contains:

sorbitol: this medicine contains 3.24 g of sorbitol per 10 mL dose. 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, speak with your doctor before you (or the child) take this medicine. If you take a dose exceeding 22 mL, this medicine may cause gastrointestinal disturbances and have a mild laxative effect. The caloric value of sorbitol is 2.6 kcal/g;
methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate: may cause allergic reactions (including delayed reactions);
sodium: this medicine contains less than 1 mmol (23 mg) of sodium per 10 mL dose, i.e. it is essentially “sodium-free”.

3. How to use Aciclovir Dorom

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take Aciclovir Dorom as directed by your doctor, as soon as you notice the first typical symptoms of Herpes (itching, burning sensation or pain) or the first lesions.
Recommended doses in adults

Treatment of Herpes simplex infections
Adults	200 mg (equivalent to 2.5 ml of oral suspension) - 5 times a day every 4 hours, excluding during the night.
Adults with impaired immune defenses or reduced intestinal absorption	The physician may decide to double the dose to 400 mg (equivalent to 1 tablet of 400 mg or 5 ml of oral suspension) - 5 times a day every 4 hours, excluding during the night.
Patients with impaired renal function *	200 mg (equivalent to 2.5 ml of oral suspension) - twice daily every 12 hours.

* Adequate hydration is recommended (drink plenty of fluids).
Duration of treatment:
Aciclovir therapy should last for at least 5 days, but treatment may need to be prolonged in cases of severe primary infections.

Treatment of recurrent Herpes simplex symptoms
Adults (one of the following three dosage regimens to be agreed with the physician)	200 mg (equivalent to 2.5 ml of oral suspension) - 4 times daily every 6 hours.
	400 mg (equivalent to 1 tablet of 400 mg or 5 ml of oral suspension) - 2 times daily every 12 hours.
	200 mg (equivalent to 2.5 ml of oral suspension) - 3 times daily every 8 hours or 2 times daily every 12 hours.

If recurrences should occur despite treatment with Aciclovir Dorom, consult your
physician.
Duration of treatment:
Your physician will indicate the treatment duration most suitable for your case.
Therapy should be periodically interrupted at intervals of 6 or 12 months to assess any changes in the course of the disease.

Prevention of Herpes simplex infections
Adults with low immune defenses	200 mg (equivalent to 2.5 ml of oral suspension) - 4 times a day every 6 hours.
Adults with very low immune defenses or reduced intestinal absorption	The physician may decide to double the dose to 400 mg (equivalent to 1 tablet of 400 mg or 5 ml of oral suspension) - 4 times a day every 6 hours.
Patients with impaired renal function *	200 mg (equivalent to 2.5 ml of oral suspension) - 2 times a day every 12 hours.

* Adequate hydration is recommended (drink plenty of fluids).
Duration of treatment:
Your doctor will determine the most appropriate duration of therapy for your individual case.

Treatment of Herpes zoster and varicella
Adults	800 mg (equivalent to 2 tablets of 400 mg or 10 ml of oral suspension) - 5 times daily every 4 hours, excluding nighttime.
Adults with very low immune defenses or reduced intestinal absorption	The physician will evaluate the acyclovir-based therapy most appropriate for your case.
Patients with moderately impaired renal function *	800 mg (equivalent to 2 tablets of 400 mg or 10 ml of oral suspension) - 3 times daily every 8 hours.
Patients with severely impaired renal function *	800 mg (equivalent to 2 tablets of 400 mg or 10 ml of oral suspension) - 2 times daily every 12 hours.

* It is recommended to maintain adequate hydration (drink plenty of fluids).
Duration of treatment:
The treatment should last 7 days.
Elderly patients
If you are an elderly patient taking high doses of Aciclovir Dorom, it is recommended to maintain adequate hydration (drink plenty of fluids). Your doctor may adjust the dosage of Aciclovir if you have kidney problems (see dosing for "Patients with impaired renal function").
Recommended doses in children
Always follow your doctor's instructions

Treatment and prevention of Herpes simplex or Herpes zoster infections
Children with normal immune defenses	Dosage recommendations for these patients are not available; therefore, always follow the doctor's instructions.
Children with weakened immune systems	Children aged 2 years and older: follow the adult dosage (always follow the doctor's instructions). Children under 2 years of age: the dose is half that of adults.*
Children with weakened immune systems and severe Herpes simplex infections	Aciclovir Dorom is contraindicated in these patients

* for the treatment of neonatal HSV infections, administration of aciclovir solution for infusion is recommended (suitable formulations are commercially available for these cases).
Duration of treatment:
Your doctor will advise you on the duration of therapy most appropriate for your case.

Treatment of chickenpox
Children over 6 years of age	800 mg (equivalent to 1 tablet of 800 mg, 2 tablets of 400 mg or 10 ml of oral suspension) - 4 times a day.
Children between 2 and 6 years of age	400 mg (equivalent to 1 tablet of 400 mg or 5 ml of oral suspension) - 4 times a day
Children under 2 years of age	20 mg/kg (not exceeding 800 mg per day) 4 times a day. The most commonly prescribed dose is 200 mg (equivalent to 2.5 ml of oral suspension) - 4 times a day.

Duration of treatment:
The treatment should last 5 days.
Instructions for use of the oral suspension
Shake the oral suspension well before use.
If you take more Aciclovir Dorom than you should
In case of accidental ingestion/overdose of this medicine,
contact your doctor immediately or go to the nearest hospital.
Accidental ingestion of aciclovir may cause the occurrence of adverse effects at the gastrointestinal level, such as nausea and vomiting, and effects on the nervous system, such as headache and confusion.
If you forget to take Aciclovir Dorom
Do not take a double dose to make up for the forgotten dose.
If you stop taking Aciclovir Dorom
Consult your doctor if you intend to discontinue the treatment.
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.
You must stop treatment and contact your doctor immediately if you experience
skin rashes, itching, hives, difficulty breathing (bronchospasm) or swallowing,
swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema),
as these could be symptoms of allergic reactions, even severe ones, which occur rarely.

Other possible side effects include:

Common (may affect up to 1 in 10 people)

headache;
dizziness;
nausea;
vomiting;
diarrhoea;
abdominal pain;
itching;
skin rashes;
immune system reaction to sunlight causing a rash accompanied by itching (photosensitivity reaction);
fatigue;
fever.

Uncommon (may affect up to 1 in 100 people)

urticaria;
sudden and widespread hair loss (alopecia).

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

difficulty breathing (dyspnoea);
reversible increase in bilirubin and related liver enzymes;
increased blood levels of nitrogen and creatinine;
anaphylactic reaction;
angioedema.

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

excessive decrease in red blood cells (anaemia);
reduction in white blood cells in the blood (leucopenia);
reduction in the number of blood cells called platelets (thrombocytopenia);
agitation;
confusion;
tremor;
lack of coordination of voluntary muscle movements due to nervous system damage (ataxia);
speech disorder due to nervous system damage (dysarthria);
hallucinations;
psychotic symptoms;
seizures;
somnolence;
brain disorders (encephalopathy);
inflammation of the liver (hepatitis);
yellowing of the skin and whites of the eyes (jaundice);
impairment of kidney function (acute traumatic kidney injury);
kidney pain, sometimes associated with kidney failure;
coma.

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:
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 Aciclovir Dorom

Keep this medicine out of the sight and reach of children.
Aciclovir Dorom tablets
This medicine does not require any special storage conditions.
Aciclovir Dorom oral suspension
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
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 Dorom contains
Aciclovir Dorom 400 mg tablets

The active substance is aciclovir. One tablet contains 400 mg of aciclovir.
The other components are: monohydrate lactose, maize starch, crospovidone, magnesium stearate.

Aciclovir Dorom 800 mg tablets

The active substance is aciclovir. One tablet contains 800 mg of aciclovir.
The other components are: monohydrate lactose, maize starch, crospovidone, magnesium stearate.

Aciclovir Dorom 400 mg/5 ml oral suspension

The active substance is aciclovir. 100 ml of oral suspension contain 8 g of aciclovir.
The other components are: non-crystallizable liquid sorbitol, glycerol, dispersible cellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, orange flavor, purified water.

Description of the appearance of Aciclovir Dorom and package contents
Aciclovir Dorom 400 mg tablets are supplied in a box containing 25 tablets in blister packs.
Aciclovir Dorom 800 mg tablets are supplied in a box containing 35 tablets in blister packs.
Aciclovir Dorom 400 mg/5 ml oral suspension is supplied in a box containing a 100 ml glass bottle with a dosing cup.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno 48 - Quinto de’ Stampi - Rozzano (MI)

Patient Information Leaflet

Aciclovir Dorom 5% cream

Generic medicine
Please read this leaflet carefully before using this medicine as 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.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4–5 days.

Contents of this leaflet:

What Aciclovir Dorom is and what it is used for
What you need to know before using Aciclovir Dorom
How to use Aciclovir Dorom
Possible side effects
How to store Aciclovir Dorom
Package contents and other information

1. What Aciclovir Dorom is and what it is used for

Aciclovir Dorom contains aciclovir, a substance with antiviral properties, effective against infections caused by certain viruses ( Herpes ).
Aciclovir Dorom is used to treat skin infections caused by the Herpes Simplex virus at the following sites:

lips (Herpes labialis);
genitals (Herpes genitalis).

Consult your doctor if you do not feel better or feel worse after 4–5 days.

2. What you need to know before using Aciclovir Dorom

Do not use Aciclovir Dorom if you are allergic to the active substance, to valaciclovir, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Aciclovir Dorom.
DO NOT apply Aciclovir Dorom cream inside the mouth, in the eyes (be careful not to touch your eyes after applying the cream), or in the vagina, as it may cause irritation.
It is possible that, especially with prolonged use, sensitization reactions may occur, i.e. allergic reactions to the medicine or to other structurally similar medicines. You must stop treatment and immediately inform your doctor if you develop skin rashes, itching, breathing difficulties (bronchospasm) or swallowing difficulties, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema), as these could be symptoms of potentially severe allergic reactions.
Take particular care and consult your doctor before taking Aciclovir Dorom if you suffer from diseases that have weakened your immune system (for example, if you have AIDS or have undergone a bone marrow transplant), because in such cases you are more susceptible to infections and your doctor may prefer to prescribe oral aciclovir.
Other medicines and Aciclovir Dorom
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Aciclovir Dorom 5% cream does not affect or affects only negligibly the ability to drive or use machinery.
Aciclovir Dorom contains methyl parahydroxybenzoate, sodium methyl parahydroxybenzoate, propyl parahydroxybenzoate: these may cause allergic reactions (including delayed reactions).

3. How to use Aciclovir Dorom

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.
The recommended dose is 5 applications per day at intervals of approximately 4 hours.
Treatment with aciclovir should last at least 4 days for labial herpes and at least 5 days for genital herpes. If the infection has not healed, your doctor may advise continuing treatment for another 5 days, without exceeding a total of 10 days of therapy.
Apply Aciclovir Dorom cream to the lesions, to areas where they are developing, or as soon as you notice the first typical symptoms of herpes (itching, burning sensation, or pain).

If you use more Aciclovir Dorom than you should
Accidental ingestion of the contents of this medicine is unlikely to cause serious adverse effects, but it may cause irritation of the mucous membranes in the mouth.
If accidental ingestion occurs, contact your doctor or pharmacist.

If you forget to use Aciclovir Dorom
Resume applying the cream as soon as you remember, following exactly the instructions provided in this leaflet or those given by your doctor or pharmacist.

If you stop using Aciclovir Dorom
Consult your doctor if you intend to discontinue treatment.

If you have any questions 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.
You must stop treatment and contact your doctor immediately if you develop
skin rashes, itching, hives, difficulty breathing (bronchospasm) or swallowing,
swelling of the face, hands and feet, eyes, lips and/or tongue
(angioedema), as these could be symptoms of allergic reactions, including severe ones, which occur very rarely.

Other possible side effects include:

Uncommon (may affect up to 1 in 100 people)

transient burning or pain;
dry skin or peeling of the skin (skin exfoliation);
itching.

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

skin irritation (erythema);
contact dermatitis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly through 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 Aciclovir Dorom

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 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. Contents of the pack and other information

What Aciclovir Dorom contains

The active substance is aciclovir. 100 g of cream contain 5 g of aciclovir.
The other components are: Tefose 1500, glycerol, liquid paraffin, stearic acid, methyl 4-hydroxybenzoate, sodium methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, purified water.

Description of the appearance of Aciclovir Dorom and contents of the pack
Aciclovir Dorom is presented in a cardboard box containing one 3 g tube of cream.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC) Italy

Patient Information Leaflet

Aciclovir Dorom 5% cream

Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could 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:

What Aciclovir Dorom is and what it is used for
What you need to know before using Aciclovir Dorom
How to use Aciclovir Dorom
Possible side effects
How to store Aciclovir Dorom
Contents of the pack and other information

1. What Aciclovir Dorom is and what it is used for

lips (Herpes labialis);
genitals (Herpes genitalis).

Consult your doctor if you do not feel better or if you feel worse after 4 - 5 days.

2. What you need to know before using Aciclovir Dorom

Do not use Aciclovir Dorom if you are allergic to the active substance, to valaciclovir, or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Aciclovir Dorom.
DO NOT apply Aciclovir Dorom cream inside the mouth, in the eyes (take care not to touch your eyes after applying the cream), or in the vagina, as it may cause irritation.
Prolonged use, especially, may lead to sensitization reactions, i.e. allergic reactions to the drug or to other structurally similar medicines. You must stop treatment and contact your doctor immediately if you develop skin rashes, itching, breathing difficulties (bronchospasm), or difficulty swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema), as these may be symptoms of even severe allergic reactions.
Exercise particular caution and consult your doctor before taking Aciclovir Dorom if you suffer from diseases that have weakened your immune system (for example, if you have AIDS or have undergone a bone marrow transplant), because in such cases you are more susceptible to infections and your doctor may prefer to prescribe oral aciclovir.
Other medicines and Aciclovir Dorom
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Aciclovir Dorom 5% cream does not affect or affects negligibly the ability to drive or use machinery.
Aciclovir Dorom contains methyl parahydroxybenzoate, sodium methyl parahydroxybenzoate, propyl parahydroxybenzoate: these may cause allergic reactions (including delayed reactions).

3. How to use Aciclovir Dorom

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 5 applications per day at intervals of approximately 4 hours.
Treatment with aciclovir should last at least 4 days for oral herpes and at least 5 days for genital herpes. If the infection has not healed, your doctor may advise continuing treatment for another 5 days, without exceeding a total of 10 days of treatment.
Apply Aciclovir Dorom cream to the lesions, to areas where they are developing, or as soon as you notice the first typical symptoms of herpes (itching, burning sensation, or pain).

If you use more Aciclovir Dorom than you should
Accidental ingestion of the contents of this medicine is not expected to cause serious adverse effects, but it may cause irritation of the mucous membranes in the mouth.
In case of accidental ingestion, contact your doctor or pharmacist.

If you forget to use Aciclovir Dorom
Resume applying the cream as soon as you remember, following always the instructions provided in this leaflet, or those given by your doctor or pharmacist.

If you stop using Aciclovir Dorom
Consult your doctor if you intend to stop treatment.
If you have any questions 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.
You must stop treatment and contact your doctor immediately if you develop skin rash, itching, hives, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema), as these could be symptoms of allergic reactions, including severe ones, which occur very rarely.

Other possible side effects include:

Uncommon (may affect up to 1 in 100 people)

transient burning or pain;
dry skin or peeling of the skin (skin exfoliation);
itching.

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

skin irritation (erythema);
contact dermatitis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Aciclovir Dorom

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 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. Contents of the pack and other information

What Aciclovir Dorom contains

The active substance is aciclovir. 100 g of cream contain 5 g of aciclovir.
The other components are: Tefose 1500, glycerol, liquid paraffin, stearic acid, methyl parahydroxybenzoate, sodium methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description of the appearance of Aciclovir Dorom and pack contents
Aciclovir Dorom is presented in a cardboard box containing a 10 g tube of cream.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC) Italy