Patient Information Leaflet

Aciclovir pensa pharma 200 mg Tablets EFG

Read 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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

Aciclovirpensa pharmacontains an active ingredient called aciclovir. It belongs to a group of medicines known as antivirals. It is used in the treatment of infections caused by viruses.

Aciclovirpensa pharmais indicated for:

•Treatment of chickenpox and shingles.

•Treatment of cold sores, genital herpes, and other herpes simplex infections.

•For the detection of recurrent infections.

• For the detection of these problems in immunocompromised patients, patients with inadequate immune system function

Do not take Aciclovirpensa pharma:

• 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 pensa pharma if the above applies to you. If you are unsure, speak to your doctor or pharmacist before taking Aciclovir pensa pharma.

Warnings and precautionspensa pharma

Consult your doctor or pharmacist before starting to takeAciclovir pensa pharma:

•if your kidney function is impaired,

•if you are an elderly person.

Consult your doctor or pharmacistif you have any doubts related to the taking of Aciclovir pensa pharma.

It is important to drink a sufficient amount of liquid while taking Aciclovir pensa pharma.

Other medicines and Aciclovir pensa pharma

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

Particularly, 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 used recently or might have to use any other medicine.

Pregnancy, breastfeeding and fertility

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

Driving and operating machinery

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 your ability is affected.

Aciclovir pensa pharma contains sodium

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

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

Administration of this medication:

•Take this medication orally.

•Swallow the tablet whole with a little water.

•You can take this medication with or without food.

•Start taking Aciclovirpensa pharmaas soon as possible.

Your doctor will indicate the duration and dosage of your treatment with this medication. There is also another dosage of 800 mg available in the market.

Treatment of chickenpox and shingles:

•The usual dosage is 800 mg, 5 times a day.

•You must leave a 4-hour gap between doses (excluding the nighttime dose).

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

•You must take Aciclovirpensa pharmafor 7 days.

Treatment of cold sores and genital herpes:

•The usual dosage is 200 mg, 5 times a day.

•You must leave a 4-hour gap between doses (excluding the nighttime dose).

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

•You must take Aciclovirpensa pharmafor 5 days or more if your doctor advises you to.

In the detection of recurrent infections:

•The usual dosage is 200 mg, 4 times a day

•You must leave a 6-hour gap between doses

In the detection of these problems in immunocompromised patients, patients with inadequate immune system function:

•The usual dosage is 200 mg, 4 times a day

•You must leave a 6-hour gap between doses.

Your doctor may adjust the dosage of Aciclovir pensa pharma if:

•you are a child,

•you are an elderly person,

•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 doubts about the use of this medication, ask your doctor

If you take more Aciclovir pensa pharma than you should:

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.

The symptoms of an overdose include gastrointestinal effects, such as nausea or vomiting, and central nervous system effects, such as confusion.

If you forgot to take Aciclovir pensa pharma:

If you forget to take Aciclovirpensa pharma, take it as soon as you remember. However, if it is almost time for your next dose, omit the missed dose.

Do not take a double dose to compensate for the missed dose. Take the next dose at the usual time.

Like all medicines, this medicine 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 pensa pharma and consult your doctor immediately.

The symptoms may include:

• hives, itching, or urticaria 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,

•nausea or feeling sick,

•diarrhea,

•stomach pain,

•eruption,

•skin eruptions caused by sunlight (photosensitivity),

•pruritus,

•fatigue,

•unexplained fever (high temperature) and dizziness, especially when standing.

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

•pruritic skin eruption.

•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 (leucopenia),

•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),

•convulsions,

•unusual sleepiness or somnolence,

•instability when walking and lack of coordination,

•difficulty speaking,

•inability to think or judge clearly,

•unconsciousness (coma),

•paralysis of part or all of the body,

•behavioral, speech, and movement disorders or eye movements,

•neck stiffness and light sensitivity,

•inflammation of the liver (hepatitis),

•yellowing of the skin and eyes (jaundice),

•renal problems where little or no urine is passed,

•lower back pain, renal area pain, or pain just above the hip (renal 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 through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of

this medicine.

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

Do not store at a temperature above 30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Aciclovir pensa pharma

• The active ingredient is aciclovir.Each tablet contains200 mg of aciclovir
• The other components are: povidone K 30(E1202), carboxymethylstarch sodium (type A) (derived from potato starch) (E468), microcrystalline cellulose (E460) and magnesium stearate (E470b).

Appearance of the product and content of the packaging

Aciclovir pensa pharma is presented in white, round, biconvex tablets, marked on one face with “200”.

They are presented in packaging of 25 or 30 tablets conditioned in Aluminio/PVC blister

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

Last review date of this leaflet: February 2023

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