ACICLOVIR 800 mg Tablets

Contents of the Package Leaflet

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

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

Aciclovir Teva 800 mg contains the active ingredient 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 herpes zoster.

2. What you need to know before taking Aciclovir Teva

Do not take Aciclovir Teva

• or to any of the other ingredients of this medication (listed in section 6).

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

Warnings and Precautions

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

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

Consult your doctor or pharmacist if you have any doubts related to taking Aciclovir Teva.

It is essential to drink a sufficient amount of liquid while taking Aciclovir Teva.

Other Medicines and Aciclovir Teva

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

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

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

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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 medication.

Driving and Using Machines

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

Aciclovir Teva contains sodium

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

3. How to Take Aciclovir Teva

Follow the exact administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Taking this medication:

• Take this medication orally.
• Take the tablet whole with a little water.
• You can take this medication with or without food.
• Start taking Aciclovir Teva as soon as possible.

The score line is used to divide the tablet into equal doses.

Your doctor will indicate the duration and dosage of your treatment with this medication.

Treatment of chickenpox and herpes zoster

• The usual dose is 800 mg, 5 times a day.
• You should leave a 4-hour gap between doses (omitting the nighttime dose).

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

• You should take Aciclovir Teva for 7 days.

Your doctor may adjust the dose of Aciclovir Tevaif:

• if you are a child,
• if you are an elderly person,
• if you have kidney problems; if you have kidney problems, it is essential to drink plenty of water while being treated with Aciclovir.

If you have any other questions about using this medication, ask your doctor.

If you take more Aciclovir Teva than you should

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 medication and the amount ingested.

The 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 missed doses. Take the next dose at the usual time.

4. Possible Side Effects

Like all medications, this medication can 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 Teva and consult your doctor immediately.

The 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:

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

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

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

• itchy skin 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)

• reduction in the number of red blood cells in the blood (anemia),
• reduction in the number of white blood cells in the blood (leukopenia),
• reduction in the number of platelets in the blood (thrombocytopenia),
• feeling weak,
• feeling agitated or confused,
• agitation or tremors,
• hallucinations (seeing or hearing things that are not there),
• seizures,
• unusual sleepiness or drowsiness,
• unsteadiness when walking and lack of coordination,
• difficulty speaking,
• inability to think or judge clearly,
• loss of consciousness (coma),
• paralysis of part or all of the body,
• behavioral, speech, and eye movement disorders,
• stiffness of the neck and sensitivity to light,
• inflammation of the liver (hepatitis),
• yellowing of the skin and eyes (jaundice),
• kidney problems where little or no urine is passed,
• pain in the lower back, kidney area of the back, or just above the hip (kidney pain).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them 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 medication.

5. Storage of Aciclovir Teva

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

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging and label after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Aciclovir Teva

• The active ingredient is aciclovir.Each tablet contains800 mg of aciclovir.
• The other ingredients are: povidone K 30 (E1202), sodium carboxymethyl starch (type A) (derived from potato starch) (E468), microcrystalline cellulose (E460), and magnesium stearate (E470b).

Appearance of the Product and Contents of the Pack

Aciclovir Teva 800 mg tablets are presented as white, elongated, biconvex tablets, scored on one face.

They are available in packs of 30 or 35 tablets, packaged in aluminum/PVC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

Netherlands

Manufacturer

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this package leaflet:February 2023

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82578/P_82578.html.