Aciclovir Teva 200 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Aciclovir Teva 200 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could 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.

Package leaflet contents

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

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

Aciclovir Teva 200 mg contains an active substance called aciclovir. It belongs to a group of medicines known as antivirals. It is used to treat infections caused by viruses.

Aciclovir Teva is indicated for:

• Treatment of chickenpox and shingles (herpes zoster).
• Treatment of cold sores, genital herpes, and other infections caused by herpes simplex virus.
• Prevention of recurrent infections.
• Prevention of these infections in immunocompromised patients, i.e. patients with impaired immune system function.

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

Do not take aciclovirteva:

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

Do not take Aciclovir Teva if this applies to you. If you are unsure, speak with your doctor or pharmacist before taking Aciclovir Teva.

Warnings and Precautions for Teva

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

• if you have impaired kidney function,
• if you are an elderly person.

Consult your doctor or pharmacist if you have any doubts regarding the use of Aciclovir Teva.

It is important to drink an adequate amount of fluid while taking Aciclovir Teva.

Other medicines and aciclovir teva

Inform your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicines, including those obtained without a prescription or herbal medicines.

In particular, inform your doctor if you are taking any of the following medicines:

• probenecid, used to treat gout,
• cimetidine, used to treat peptic ulcers,
• mycophenolate mofetil, a medicine used in transplant patients.

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Some adverse effects such as drowsiness or sleepiness may affect your ability to concentrate and react. Do not drive or operate machinery if you feel your ability is impaired.

Aciclovir Teva contains sodium

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

3. How to take Aciclovir Teva

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

Taking this medicine:

• Take this medicine orally.
• Swallow the tablet whole with a little water.
• You may take this medicine with or without food.
• Begin taking Aciclovir Teva as soon as possible.

Your doctor will determine the duration and dosage of your treatment with this medicine. Another 800 mg tablet strength is also available on the market.

Treatment of chickenpox and shingles (herpes zoster)

• The usual dose is 800 mg, 5 times a day.
• You should leave an interval of 4 hours between doses (omitting the nighttime dose).

For example: 7, 11, 15, 19 and 23 hours.

• You should take Aciclovir Teva for 7 days.

Treatment of cold sores and genital herpes

• The usual dose is 200 mg, 5 times a day.
• You should leave an interval of 4 hours between doses (omitting the nighttime dose).

For example: 7, 11, 15, 19 and 23 hours.

• You should take Aciclovir Teva for 5 days, or longer if your doctor instructs you to do so.

For prevention of recurrent infections

• The usual dose is 200 mg, 4 times a day.
• You should leave an interval of 6 hours between doses.
  • You should take Aciclovir Teva for as long as your doctor directs.

For prevention of these conditions in immunocompromised patients, patients with impaired immune system function.

• The usual dose is 200 mg, 4 times a day.
• You should leave an interval of 6 hours between doses.
  • You should take Aciclovir Teva for as long as your doctor directs.

Your doctor may adjust the dose of Aciclovir Teva if:

• you are a child,
• you are elderly,
• you have kidney problems. If you have kidney problems, it is important to drink plenty of water while being treated with Aciclovir.

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

If you take more aciclovir tevadel than you should

In case of overdose or accidental ingestion, consult 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.

Symptoms of an overdose include effects on the stomach and intestines, such as nausea or vomiting, and effects on the central nervous system, such as confusion.

If you forget to take aciclovir teva

If you forget to take Aciclovir Teva, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for the missed doses. Take the next dose at your usual time.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

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

If you experience an allergic reaction, stop taking Aciclovir Teva and consult your doctor immediately.

Symptoms may include:

• rash, itching, or hives on the skin,
• swelling of the face, lips, tongue, or other parts of the body,
• difficulty breathing, wheezing, or shortness of breath,
• collapse.

Other side effects include:

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

• headache,
• dizziness,
• feeling sick or nausea,
• diarrhea,
• stomach pain,
• rash,
• skin rashes caused by sunlight (photosensitivity),
• pruritus,
• feeling tired,
• unexplained fever (high temperature) and feeling faint, especially when standing.

Uncommon (may affect up to 1 in 100 people):

• itchy skin rash,
• hair loss.

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

• changes in blood and urine test results,
• increased levels of liver enzymes.

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

• reduction in the number of red blood cells in the blood (anaemia),
• reduction in the number of white blood cells in the blood (leucopenia),
• reduction in the number of platelets in the blood (cells that help blood to clot) (thrombocytopenia),
• feeling weak,
• feeling agitated or confused,
• agitation or tremors,
• hallucinations (seeing or hearing things that are not there),
• seizures,
• unusual drowsiness or somnolence,
• unsteadiness when walking and lack of coordination,
• difficulty speaking,
• inability to think or judge clearly,
• unconsciousness (coma),
• paralysis of part or all of the body,
• disturbances in behaviour, speech, and eye movements,
• neck stiffness and sensitivity to light,
• inflammation of the liver (hepatitis),
• yellowing of the skin and eyes (jaundice),
• kidney problems resulting in little or no urine output,
• pain in the lower back, the kidney area of the back, or just above the hip (renal pain).

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if
it is a possible adverse reaction not listed in this leaflet. You may also
report them directly through the Spanish Pharmacovigilance System for
Human Medicines: https://www.notificaRAM.es. By reporting
adverse reactions, you can help provide more information on the safety of
this medicine.

5. Storage of Aciclovir Teva

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging and on the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of aciclovir teva

• The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.
• The other components are: povidone K 30 (E1202), sodium carboxymethyl starch (type A) (from potato starch) (E468), microcrystalline cellulose (E460) and magnesium stearate (E470b).

Appearance of the product and contents of the container

Aciclovir Teva is presented as white, round, biconvex tablets, marked on one side with "200".

They are supplied in packages of 25 or 30 tablets, packed in aluminum/PVC blisters.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

The Netherlands

Manufacturer

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Date of latest review of this leaflet: February 2023

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82577/P_82577.html