Aciclovir Aurovitas 800 mg tablets EFG

Package leaflet: Information for the user

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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

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

Aciclovir can be used to:

• Treat chickenpox and shingles.

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

Do not take Aciclovir Aurovitas:

• If you are allergic to aciclovir, valaciclovir, or to any of the other ingredients of this medicine (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

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

• If you have kidney problems.
• If you are over 65 years of age.

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 with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription such as herbal 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 stomach ulcers.
• Mycophenolate mofetil, used to prevent your body rejecting transplanted organs.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

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

3. How to take Aciclovir Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Taking this medicine

• Take this medicine by mouth.
• The tablet should be swallowed whole with some water.
• Start taking aciclovir as soon as possible.

The dose you should take depends on the condition being treated. Your doctor will discuss this with you.

Treatment of chickenpox and shingles

• The usual dose is one 800 mg tablet 5 times a day.
• Each dose should be spaced at intervals of 4 hours. 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 any kidney disease, it is important to drink plenty of water while taking aciclovir.

If any of the above situations apply, consult your doctor before taking this medicine.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 contact your doctor immediately.

Symptoms may include:

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

Other adverse 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 cause and feeling faint, 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)

• Abnormalities in blood and urine tests.
• Increased liver enzymes.

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

• Decrease in red blood cells (anaemia).
• Decrease in white blood cells (leucopenia).
• Decrease in platelets (cells that help blood to clot) (thrombocytopenia).
• Weakness.
• Feeling agitated or confused.
• Restlessness or tremor.
• Hallucinations (seeing or hearing things that do not exist).
• Seizures.
• Feeling unusually sleepy or drowsy.
• Unsteadiness when walking or lack of coordination.
• Difficulty speaking.
• Inability to think or decide clearly.
• Loss of consciousness (coma).
• Paralysis in part or all of the body.
• Changes in behaviour, speech, or eye movements.
• Neck stiffness and sensitivity to light.
• Inflammation of the liver (hepatitis).
• Yellowing of the skin or whites of the eyes (jaundice).
• Kidney problems, resulting in little or no urine passed.
• Pain in the lower back, kidney area of the back, or just above the hip (kidney pain).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are: microcrystalline cellulose (PH-101), sodium carboxymethylstarch (type A) (derived from potato starch), povidone K-30, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and contents of the pack

Uncoated tablets, white to off-white, elongated, biconvex, engraved with 'AR' and '800' separated by a score line on one side and plain 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.

Pack sizes: 35, 100 and 250 tablets.

Only some 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

Tel.: 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 medicinal product 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 most recent review of this leaflet: February 2019

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