SUN Pharmaceutical

Tablet 200 mg 
(White to off-white, capsule-shaped, biconvex, uncoated tablet marked “200” on one side and “ACV” on the other side.)

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

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Aciclovir SUN is and what it is used for

Aciclovir SUN contains aciclovir and belongs to a group of medicines that are effective against viral infections. It works by killing or stopping the growth of viruses.

Aciclovir SUN is used

  • for the treatment of shingles and chickenpox.
  • against infection are caused by herpes simplex virus in the skin or mucous membranes e.g. cold sores and genital herpes (excluding herpes simplex virus in newborns and in children with compromised immune systems with severe herpes simplex virus infection). It is also used to help prevent these infections from returning.
  • as a preventive treatment for herpes simplex infection in patients with compromised immune systems.

Aciclovir contained in Aciclovir SUN 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 SUN

Do not take Aciclovir SUN

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

If you are not sure, talk to your doctor or pharmacist before taking Aciclovir SUN.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Aciclovir SUN.

  • if you have kidney problems
  • if you are older than 65 years

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Aciclovir SUN.

While you are taking Aciclovir SUN, it is very important that you drink water regularly.

Children

Aciclovir tablets are mainly used to treat non-serious skin and mucous membrane infections caused by herpes simplex virus ( HSV ). Your child’s doctor may recommend aciclovir for infusion in the treatment of neonatal HSV and severe HSV infection if your child’s immune system is impaired.

Other medicines and Aciclovir SUN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, herbal medicines, or other natural products.

It is especially important to tell 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 (to suppress the immune system in transplant patients)

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.

Driving and using machines

Some side effects such as drowsiness or drowsiness and dizziness may impair your ability to concentrate and react. Avoid driving or using machines until you know how you are affected by Aciclovir SUN.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

How to take Aciclovir SUN

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

Your doctor will decide on a dose based on the cause of your treatment. Your doctor should discuss this with you.

How to take the medicine

  • Take this medicine by mouth.
  • Dissolve the tablet in a glass of water, stir, and drink.
  • The tablets can also be swallowed whole with water.
  • You should take Aciclovir SUN as soon as possible.

Treatment of chickenpox and shingles

  • The recommended dose is: 1 tablet of 800 mg or 2 tablets of 400 mg 5 times daily
  • You should have an interval of 4 hours between each dose
  • The treatment should last for 7 days.

Treatment of cold sores or genital herpes

  • The recommended dose is 200 mg 5 times daily
  • You should have an interval of 4 hours between each dose
  • The treatment should last for 5 days or until your doctor tells you to stop.

Helping to prevent HSV – infection you from returning after you have had them

  • The recommended dose is 200 mg 4 times daily
  • You should have an interval of 6 hours between each dose
  • You should take Aciclovir SUN until your doctor tells you to stop.

Preventive treatment for herpes simplex infections in patients with weakened immune systems

  • The recommended dose is 200 mg 4 times daily
  • You should have an interval of 6 hours between each dose
  • You should take Aciclovir SUN until your doctor tells you to stop.

Your doctor may adjust the dose of one of Aciclovir SUN:

  • if given to a child
  • if you are older than 65 years
  • if you have kidney problems. While you are taking Aciclovir SUN, it is very important that you drink water regularly throughout the day. This can help reduce the side effects that can affect the kidneys or nervous system

Talk to your doctor before taking Aciclovir SUN if any of the above apply to you.

If you take more Aciclovir SUN than you should

Aciclovir SUN is usually not harmful if you do not use too much for several days in a row. If you have taken too much Aciclovir SUN, talk to your doctor or pharmacist. Take the medicine pack with you.

4. Possible side effects

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

Serious side effects are

If you experience any of the following, stop taking Aciclovir SUN and contact your doctor or hospital immediately.

Severe allergic reactions (affects more than 1 user in 1,000):

  • redness, itchy rash
  • swelling of the lips, face, tongue or and other parts of the body
  • which causes breathing difficulties
  • collapse

Other side effects are

Common adverse s (occurring in more than 1 in 10):

  • headache
  • dizziness
  • feeling sick
  • diarrhea
  • stomach pains
  • rash
  • skin rash including photosensitivity (skin irritation in bright sunlight)
  • itching
  • excessive fatigue
  • unexplained high fever (high body temperature) and fainting, especially when standing up.

Less common side effects are (by less than 1 in 100):

  • hives
  • increased hair loss.

Rare side effects are (by less than 1 in 1000):

  • changed values ​​in laboratory tests performed on blood and urine
  • increased levels of liver enzyme.

Rare side effects are (by less than 1 in 10 000):

  • reduction in red blood cell count ( anemia )
  • the decrease in white blood cell count ( leukopenia )
  • reduction in the number of platelets, which helps the blood to clot ( thrombocytopenia )
  • feeling weak
  • anxiety or confusion
  • shaking or trembling
  • hallucinations
  • cramps
  • abnormally sleepy or drowsy
  • unsteady gait and inability to coordinate movements
  • speech difficulties
  • inability to think or judge clearly
  • unconsciousness ( coma )
  • paralysis of parts or the whole body
  • behavioral, speech, and eye movements disorders
  • neck stiffness and photosensitivity
  • inflammation of the liver
  • yellowing of the eyes and skin (signs of jaundice)
  • kidney problems with little or no urine
  • pain in the lower back (flank or kidney area).

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 SUN

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 and blister after EXP. 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 respectively.
  • The other ingredients are magnesium stearate, microcrystalline cellulose, sodium starch glycollate, pregelatinized starch, and anhydrous colloidal silica.

What the medicine looks like and the contents of the pack

White to off-white, capsule-shaped, biconvex, uncoated tablet marked “200”, “400” and “800” respectively on one side and “ACV” on the other side.

Pack sizes

Aciclovir SUN 200 mg: 25, 60 and 100 tablets

Aciclovir SUN 400 mg: 56, 60, 70 and 100 tablets

Aciclovir SUN 800 mg: 35, 60 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe BV Polarisavenue 87

2132 JH Hoofddorp Netherlands

Manufacturer

Therapy SA

124 Fabricii Street,

400 632 Cluj Napoca, Romania

Sun Pharmaceutical Industries Europe BV Polarisavenue 87

2132 JH Hoofddorp Netherlands

Muhammad Nadeem

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