Package Insert: Information for the User

Aciclovir Aurovitas 200 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Aciclovir Aurovitas contains the active ingredient called aciclovir.It belongs to a group of medicines called antivirals. It works by eliminating or preventing the growth of viruses.

Aciclovir can be used for:

• Treating chickenpox and shingles.
• Treating cold sores, genital herpes and other infections caused by the herpes simplex virus.
• Preventing these infections from coming back after they have occurred.
• Stopping these infections in patients whose immune system does not function properly, meaning their body has less ability to fight off infections.

Do not take Aciclovir Aurovitas:

• If you are allergic to aciclovir, valaciclovir or to any of the other components of this medication (including those listed in section 6).

Do not take aciclovir tablets if the above applies to you. If you are unsure, consult your doctor or pharmacist before taking aciclovir.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aciclovir Aurovitas:

• If you have kidney problems.
• If you are over 65 years old.

If you are unsure whether the above applies to you, consult your doctor or pharmacist before taking aciclovir. It is important that you drink plenty of water while taking aciclovir.

Taking Aciclovir Aurovitas and other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication, including over-the-counter medications such as herbal remedies.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Probenecid, used to treat gout.
• Cimetidine, used to treat stomach ulcers.
• Mycophenolate mofetil, used to prevent your body from rejecting transplanted organs.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Some side effects such as drowsiness or sleepiness may affect your ability to concentrate and react. Make sure your ability is not affected before driving or operating machinery.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration of this medication

• Take this medication orally.
• The tablet should be swallowed whole with a little water.
• Start taking aciclovir as soon as possible.

The dose you should take will depend on the use for which you have been prescribed it. Your doctor will discuss this with you. Tablets of 800 mg are also available.

Treatment of chickenpox and shingles

• The usual dose is one 800 mg tablet 5 times a day.
• Space each dose at intervals of 4 hours.
• Suggested hours are:7 am, 11 am, 3 pm, 7 pm, and 11 pm.
• You should take aciclovir for 7 days.

Treatment of cold sores and genital herpes

• The usual dose is one 200 mg tablet 5 times a day.
• Space each dose at intervals of 4 hours.
• Suggested hours are:7 am, 11 am, 3 pm, 7 pm, and 11 pm.
• You should take aciclovir for 5 or more days as indicated by your doctor.

Prevention of these infections from recurring after having had them

• The usual dose is one 200 mg tablet 4 times a day.
• Try to space each dose at intervals of 6 hours.
• You should take this medication until your doctor tells you to stop treatment.

Treatment to stop these infections in patients whose immune system does not function properly and whose bodies have less ability to fight infections

• The usual dose is one 200 mg tablet 4 times a day.
• Try to space each dose at intervals of 6 hours.
• You should take this medication until your doctor tells you to stop treatment.

Your doctor may adjust the aciclovir dose if:

• You are a child.
• You are over 65 years old.
• You have kidney problems. If you have any kidney disease, it is essential that you drink plenty of water while taking aciclovir.

In case any of the above situations occur, consult your doctor before taking this medication.

If you take more Aciclovir Aurovitas than you should

Aciclovir Aurovitas is usually not harmful, unless you take too many tablets over several days.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeAciclovir Aurovitas

• If you forget to take aciclovir, take the next dose as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for the missed doses.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Allergic reactions(may affect up to 1 in 1,000 people)

If you experience an allergic reaction,stop taking aciclovir and seek medical attention immediately.

The symptoms may include:

• Rash, itching, or hives on your skin.
• Inflammation of your face, lips, tongue, and other parts of your body.
• Shortness of breath, wheezing, or difficulty breathing.
• Loss of consciousness.

Other side effects include:

Frequent(may affect up to 1 in 10 people)

• Headache.
• Dizziness.
• Feeling unwell.
• Diarrhea.
• Stomach pain.
• Rash.
• Skin reaction after exposure to sunlight (photosensitivity).
• Itching.
• Feeling tired.
• Fever (high temperature) without apparent cause and feeling faint, especially when standing up.

Occasional(may affect up to 1 in 100 people)

• Itching, rash.
• Hair loss.

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

• Abnormal blood and urine test results.
• Increased liver enzymes.

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

• Decreased red blood cell count (anemia).
• Decreased white blood cell count (leucopenia).
• Decreased platelet count (thrombocytopenia).
• Weakness.
• Feeling agitated or confused.
• Restlessness or tremor.
• Hallucinations (seeing or hearing things that are not there).
• Seizures.
• Feeling unusually sleepy or drowsy.
• Difficulty walking or loss of coordination.
• Difficulty speaking.
• Inability to think or decide clearly.
• Loss of consciousness (coma).
• Paralysis in one part of your body or your entire body.
• Alterations in behavior, speech, or eye movement.
• Stiffness of the neck and sensitivity to light.
• Inflammation of the liver (hepatitis).
• Yellowing of your skin or the white of your eyes (jaundice).
• Problems with your kidneys, where you pass little or no urine.
• Back pain, kidney pain, or pain just above your hip (kidney pain).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAciclovir Aurovitas

• The active ingredient is aciclovir. Each tablet contains 200 mg of aciclovir.
• The other components are: microcrystalline cellulose (PH-101), sodium carboxymethyl starch (type A) (derived from potato starch), povidone K-30, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

Uncoated tablets, white to off-white in color, round (9.5 mm in diameter), biconvex, engraved with “AR 200” on one face and smooth on the other.

Aciclovir Aurovitas is packaged in blister packs.

Packaging sizes:25, 100, and 250 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Manufacturer responsible:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Aciclovir Aurovitas 200 mg tablets EFG

Italy:Aciclovir Aurobindo Pharma

Portugal:Aciclovir Aurovitas

Last revision date of this leaflet: February 2019

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).