Orion Pharma

Tablet 200 mg 
(White, round, biconvex tablet 9 mm in diameter, marked with “200” 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 information, 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.

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

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

Aciclovir belongs to a group of medicines that are effective against viral infections. They work by stopping the growth of viruses.

Aciclovir Orion can be used for:

  • treatment or as a preventive treatment of skin and mucous membranes caused by herpes simplex viruses, such as cold sores and genital herpes.
  • treatment of chickenpox (Varicella infections ) and shingles ( Herpes zoster infections )
  • to prevent infection caused by herpes simplex, herpes zoster, and cytomegalovirus( CMV ) in people whose immune systems are weakened.

Aciclovir contained in Aciclovir Orion may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 use Aciclovir Orion

Do not use Aciclovir Orion

Do not take Aciclovir Orion :

  • if you are allergic to aciclovir or 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 Orion

  • you are over 65 years old
  • if you have impaired kidney function to avoid dehydration, it is important that you drink plenty of water while taking Aciclovir Orion tablets, especially if you are elderly or taking high doses of Aciclovir Orion. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Aciclovir Orion.

Other medicines and Aciclovir Orion

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

The effect of certain medicines may be affected by, or affect the effect of Aciclovir Orion if taken at the same time as Aciclovir Orion.

It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:

  • probenecid (used for gout )
  • cimetidine (used to inhibit acid secretion in the stomach)
  • mycophenolate mofetil (used to prevent organ rejection after transplantation).

Pregnancy, breastfeeding, and fertility

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

Possible effects of aciclovir on the ability to drive and use machines have not been studied. Some side effects such as dizziness, drowsiness, or drowsiness may impair your ability to concentrate and react. Avoid driving or using machines until you know how you are affected by Aciclovir Orion.

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.

3. How to use Aciclovir Orion

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

The dose you should take depends on what you are taking Aciclovir Orion for.

Your doctor may need to adjust the dose of one of Aciclovir Orion if:

  • it is given to a child
  • you are older
  • you have kidney problems
  • your immune system is not working properly or if you have an infection you.

The recommended dose for adults is:

Treatment of Herpes simplex infections:

1 tablet of 200 mg 5 times daily (every 4 hours) for 5 days. Treatment should be started as early as possible. In case of severe infection, a longer treatment period may be needed.

Preventive treatment of Herpes simplex infections:

1 tablet of 200 mg 4 times daily (every 6 hours) or 1 tablet of 400 mg twice daily (every 12 hours)

Treatment of chickenpox and shingles:

1 tablet of 800 mg 5 times daily, for 7 days.

Elderly and patients with renal impairment

For patients with renal impairment or elderly patients with renal impairment, the daily dose should be reduced by prolonging the interval between doses. For the elderly, it is especially important to drink plenty of fluids during treatment with Aciclovir Orion.

Use for children and adolescents

Treatment of herpes simplex infections:

Children from 3 months to 2 years: 100 mg 5 times daily (every 4 hours) for 5 days.

Children over 2 years: 1 tablet of 200 mg 5 times daily (every 4 hours) for 5 days.

Preventive treatment of Herpes simplex infection in children with weakened immune systems:

Children from 3 months to 2 years: 100 mg 4 times daily, approximately every 6 hours).

Children over 2 years: 200 mg 4 times daily, approximately every 6 hours).

Treatment of chickenpox:

> 6 years 1 tablet of 800 mg aciclovir 4 times daily
2- 6 years 1 tablet of 400 mg aciclovir 4 times daily
<2 years 1 tablet of 200 mg aciclovir 4 times daily

The treatment time is 5 days. Dosage one can be calculated more accurately as follows: 20 mg aciclovir/kg body weight (do not exceed 800 mg aciclovir per individual dose ) aciclovir 4 times daily. A liquid formulation of aciclovir may be more suitable for young children.

If you forget to use Aciclovir Orion

If you forget to take a tablet, you should take the forgotten tablet as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

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 Orion and contact your doctor immediately if you get any of the following symptoms:

Severe allergic reaction (anaphylactic and / or angioedema ) (affects less than 1 in 1,000 people):

May cause symptoms such as:

  • sudden onset of hives
  • swelling of the face, lips, tongue, or other parts of the body
  • shortness of breath, wheezing, or difficulty breathing
  • collapse.

Other possible side effects:

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

  • headache, dizziness
  • nausea, abdominal pain, diarrhea
  • itching, rash (including skin irritation when exposed to strong sunlight, photosensitivity )
  • fatigue, fever.

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

  • skin rash that itches and resembles hives
  • hair loss

Rare side effects are (may affect up to 1 in 1000):

  • increase in urea and creatinine
  • increase in liver values ​​( bilirubin liver enzymes)
  • difficulty breathing ( dyspnoea )

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

  • decreased number of red blood cells ( anemia )
  • decreased white blood cell count ( leukopenia )
  • decreased platelet count, cells that help the blood clot ( thrombocytopenia )
  • anxiety, confusion
  • shaking or trembling
  • unsteady gait and inability to coordinate movements, speech difficulties, hallucinations (seeing or hearing things that do not exist), inability to think clearly and poorly, tenderness, seizures, abnormally sleepy or drowsy, encephalopathy (a type of brain disorder), unconsciousness ( coma ).
  • inflammation of the liver, which can cause jaundice (yellowing of the skin and whites of the eyes)
  • pain in the lower back, at the level of the kidneys, or just above the hip (kidney pain that may be associated with kidney failure ).

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly via

Läkemedelsverket 
Box 26 
751 03 Uppsala

By reporting side effects, you can help increase drug safety information.

5. How to store Aciclovir Orion

Do not store above 30 ° C.

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 or 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. One tablet contains 200 mg, 400 mg, or 800 mg aciclovir.
  • The other ingredients are microcrystalline cellulose, povidone, sodium starch glycolate (type A), and magnesium stearate.

What the medicine looks like and the contents of the pack

200 mg: White, round, biconvex tablet with a diameter of 9 mm, marked with “200” on one side.

400 mg: White, round, biconvex tablet with a diameter of 11 mm.

800 mg: White, oblong, biconvex tablet with a scoreline on one side, 19.3 mm long and 10.5 mm wide.

The breaker is not for dividing the tablet into equal doses but only for easier swallowing.

Aciclovir Orion is available as:

Aluminum / PVC blister.

200 mg: 25 tablets

400 mg: 56 and 70 tablets

800 mg: 35 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionvägen 1

FI-02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Sollentuna, medinfo@orionpharma.com 

Manufacturer

Orion Corporation Orion Pharma

Orionvägen 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Pharmaceutical Works Polpharma SA

19, Pelplinska Street

83-200 Starogard Gdanski

Poland

Muhammad Nadeem

Leave a Reply