ACICLOVIR AUROVITAS 800 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Aurovitas 800 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Aciclovir Aurovitas contains the active substance called aciclovir. It belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.

Aciclovir can be used for:

• Treating chickenpox and shingles.

2. What you need to know before you take Aciclovir Aurovitas

Do not take Aciclovir Aurovitas:

• If you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6).

Do not take the aciclovir tablets if any of the above applies to you. If you are not sure, 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 not sure if any of 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, such as herbal medicines.

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 stomach ulcers.
• Myphenolate 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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 using machinery.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Aciclovir Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking this medicine

• Take this medicine by mouth.
• 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 it has been prescribed. Your doctor will discuss this with you.

Treatment of chickenpox and shingles

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

Your doctor may adjust the dose of aciclovir if:

• You are a child.
• You are over 65 years old.
• You have kidney problems. If you have kidney disease, it is important that you drink plenty of water while being treated with aciclovir.

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

If you take more Aciclovir Aurovitas than you should

Aciclovir Aurovitas is normally not harmful, unless you take too many tablets for several days.

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

If you forget to take Aciclovir 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 missed doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

If you experience an allergic reaction, stop taking aciclovir and see your doctor immediately.

Symptoms may include:

• Rash, itching, or hives on your skin.
• Swelling of the face, lips, tongue, and other parts of your body.
• Shortness of breath, wheezing, or difficulty breathing.
• Collapse.

Other side effects include:

Common(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 reason and feeling of fainting, especially when standing up.

Uncommon(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 tests.
• Increased liver enzymes.

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

• Decrease in the number of red blood cells (anemia).
• Decrease in the number of white blood cells (leukopenia).
• Decrease in the number of platelets (cells that help blood clot) (thrombocytopenia).
• Weakness.
• Feeling agitated or confused.
• Agitation or tremors.
• Hallucinations (seeing or hearing things that do not exist).
• Seizures.
• Feeling unusually sleepy or drowsy.
• Difficulty walking or lack of coordination.
• Difficulty speaking.
• Inability to think or decide clearly.
• Loss of consciousness (coma).
• Paralysis in a part of the body or in the whole body.
• Changes in behavior, speech, or eye movement.
• Stiff neck and sensitivity to light.
• Liver inflammation (hepatitis).
• Yellowing of your skin or the whites of your eyes (jaundice).
• Kidney problems, where you pass little or no urine.
• Pain in the lower back, the kidney area of your back, or just above the hip (kidney pain).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Aurovitas

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 carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Aurovitas

• The active substance is aciclovir. Each tablet contains 800 mg of aciclovir.
• The other ingredients are: microcrystalline cellulose (PH-101), sodium carboxymethyl starch (type A) (derived from potato starch), povidone K-30, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the pack

Tablets without coating, white to off-white, elongated, biconvex, engraved with 'AR' and '800' separated by a score line on one side and smooth on the other. The tablet can be divided into equal doses. The size is 21 mm x 10 mm.

Aciclovir Aurovitas is packaged in blister packs.

Package sizes:35, 100, and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

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 under the following names:

Spain: Aciclovir Aurovitas 800 mg tablets EFG

Italy: Aciclovir Aurobindo Pharma

Portugal: Aciclovir Aurovitas

Date of the last revision of this leaflet: February 2019

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