Sandoz AS

Tablet 200 mg 
(White, round tablet with a scoreline on one side.)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Aciclovir Sandoz is and what it is used for 
2. What you need to know before taking Aciclovir Sandoz 
3. How to take Aciclovir Sandoz 
4. Possible side effects 
5. How to store Aciclovir Sandoz 
6. Contents of the packaging and other information 

What Aciclovir Sandoz is and what it is used for

Aciclovir Sandoz inhibits the spread of the herpes virus.

Aciclovir Sandoz is used to treating severe infections of the skin and mucous membranes caused by the herpes simplex virus or as a long-term treatment to prevent outbreaks of recurrent herpes simplex infections of the genital skin and mucous membranes.

Aciclovir Sandoz is also used to treat chickenpox and to treat shingles ( herpes zoster).

Aciclovir Sandoz is used to preventing infection caused by cytomegalovirus ( CMV ) after bone marrow transplantation.

Aciclovir contained in Aciclovir Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Aciclovir Sandoz

Do not take Aciclovir Sandoz

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Aciclovir Sandoz if you have impaired kidney function.

For the elderly, people with renal impairment, and people receiving high doses of acyclovir, it is important to drink plenty of fluids during treatment.

Taking other medicines 

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Talk to your doctor before using Aciclovir Sandoz if you are being treated with any of the following medicines:

  • Lithium (for depression)
  • Theophylline (for asthma )
  • Cimetidine (used to inhibit acid secretion in the stomach)
  • Mycophenolate mofetil (used to inhibit the activity of the immune system in organ transplants and connective tissue diseases, among others)
  • Probenecid (used for gout )

Taking Aciclovir Sandoz with food and drink

Aciclovir Sandoz can be taken with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Always consult your doctor if you are taking Aciclovir Sandoz more than temporarily during pregnancy.

Breast-feeding

Aciclovir Sandoz passes into breast milk but the effect on the breastfed baby is unlikely. However, consult a physician when using Aciclovir Sandoz during breast-feeding.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Aciclovir Sandoz contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Aciclovir Sandoz

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you depending on your illness.

The tablets can be divided into equal parts.

If you forget to take Aciclovir Sandoz

Do not take a double dose to make up for a forgotten dose. If you forget to take a tablet, you should take the forgotten tablet as soon as possible. Then continue to take the tablets as directed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Aciclovir Sandoz and contact your doctor immediately if you get any of the following symptoms ( angioedema ):

  • Swelling of the face, tongue, or throat
  • Difficulty swallowing
  • Hives and difficulty breathing

The above side effect is rare (may affect up to 1 in 1,000 people)

Other side effects that may occur are:

Common (may affect up to 1 in 10 people): Skin rash (including sensitivity to sunlight), itching, nausea, stomach vomiting, abdominal pain, diarrhea, extreme fatigue/exhaustion, fever, headache, dizziness.

Uncommon (may affect up to 1 in 100 people): Hives, diffuse hair loss.

Rare (may affect up to 1 in 1,000 people): Hypersensitivity reaction with fever, rash, swelling and sometimes drop in blood pressure, fluid retention, shortness of breath, mild renal impairment, transient increase in liver values ​​, and transient increase in bilirubin (bile dye) in the blood.

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

Acute renal failure, renal pain (renal pain may be associated with renal failure ), inflammation of the liver, jaundice, fatigue/sleep disturbances, confusion, agitation/irritability, impaired coordination of movements, tremors, speech difficulties, brain, coma, psychotic symptoms, hallucinations, convulsions and the effect on the formation of blood cell count is mainly in patients with renal impairment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aciclovir Sandoz

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. The expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is aciclovir 200 mg, 400 mg, and 800 mg per tablet respectively.

The other ingredients are lactose monohydrate (35 mg, 70 mg, and 140 mg respectively), microcrystalline cellulose, sodium starch glycolate, crospovidone, and magnesium stearate.

What the medicine looks like and the contents of the pack

200 mg tablet: White, round tablet with a scoreline on one side.

400 mg tablet: A white, biconvex, round tablet with a scoreline on one side.

800 mg tablet: A white, biconvex, oblong tablet with a scoreline on both sides

200 mg tablets: blisters of 25 and 100 tablets

200 mg tablets: plastic jar with 25 and 100 tablets

400 mg tablets: blister of 50 tablets

400 mg tablets: blister of 70 tablets

400 mg tablets: plastic jar with 70 tablets

800 mg tablets: blister of 35 tablets

800 mg tablets: a plastic jar of 35 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Muhammad Nadeem

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