TADA Nordic

Tablet 200 mg 
(White, round, biconvex tablet, marked VS 1 on one side (diameter 10 mm))

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 can harm them, even if they show signs of illness 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 STADA is and what it is used for 
2. What you need to know before using Aciclovir STADA 
3. How to use Aciclovir STADA 
4. Possible side effects 
5. How to store Aciclovir STADA 6. Contents of the pack 
and other information 

What Aciclovir STADA is and what it is used for

Aciclovir belongs to a group of medicines that are effective against viral infections.

Aciclovir Stada 200 mg is used

  • for the treatment of infections in the skin and mucous membranes caused by the herpes simplex virus in people with normal immune systems, especially where severe disease progression may be feared as primary genital herpes (excluding herpes simplex virus in newborns and in children with a weakened immune system with severe herpes simplex virus infection)
  • as a preventive treatment for severe forms of recurrent genital herpes – an infection in people with normal immune systems
  • as a preventive treatment for herpes simplex infection to patients undergoing bone marrow or organ transplants or to patients being treated for acute leukemia.

Aciclovir Stada 400 mg is used

  • as a preventive treatment for severe forms of recurrent genital herpes – infections in people with normal immune systems
  • for the treatment of shingles ( Varicella zoster – infections ) in the skin and mucous membranes of persons with normal immune systems and where a serious course of disease may be feared.

Aciclovir Stada 800 mg is used

  • for the treatment of shingles ( Varicella zoster – infections ) in the skin and mucous membranes of persons with normal immune systems and where a serious course of disease may be feared.

Aciclovir contained in Aciclovir Stada 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 use Aciclovir STADA

Do not take Aciclovir STADA

  • 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 Stada

  • if you have impaired kidney function or are older. The dose must be adjusted in such cases and you should also drink plenty of fluids during treatment (see also section 3. How to take Aciclovir Stada).
  • if you have a nerve disease

If you are being treated for genital herpes infection, you should refrain from sexual contact for as long as blisters and sores are visible due to the risk of infection.

Other medicines and Aciklovir STADA

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

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

  • interferon (used to treat multiple sclerosis ) the effect may be increased for any of the medicines.
  • zidovudine (a medicine used to treat AIDS ) may cause nerve problems ( neuropathy ), seizures, and drowsiness.
  • theophylline (used to treat asthma and other respiratory problems).
  • cimetidine (used to treat stomach ulcers ) and probenecid (used to treat gout ) as these increase the concentration of aciclovir.
  • mycophenolate mofetil (to suppress the immune system in transplant patients). Caution should be exercised if you are taking high doses of aciclovir, as blood levels of both medicines may increase.

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

Experience with use during pregnancy is limited. Talk to your doctor or pharmacist before taking Aciclovir Stada during pregnancy.

Breast-feeding

Aciclovir Stada passes into breast milk but the effect on the breastfeeding baby is unknown. Therefore, consult your doctor or pharmacist before taking Aciclovir Stada while breast-feeding.

Driving and using machines

It is not yet known whether aciclovir affects the ability to drive or use machines. Although aciclovir is unlikely to have such an effect due to its properties, fatigue, headaches, and effects on the nervous system have been temporarily reported.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 STADA contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Aciklovir STADA

Dose one is determined individually by the physician for each patient. Always take this medicine exactly as your doctor has told you. In some cases, the dose may differ from the recommended dosage. Consult a doctor if you are unsure.

The recommended dose is

Treatment of Herpes simplex infection is in people with normal immune systems

The usual dose is 1 tablet of 200 mg 5 times a day, ie every 4 hours during the waking part of the day for 5 days. In case of severe infection, long-term treatment may be necessary. The first dose should be taken as soon as symptoms appear.

Preventive treatment of severe forms of frequently recurrent genital herpes – infection s in patients with normal immune systems

The usual dose is 2 tablets of 200 mg or 1 tablet of 400 mg twice daily every 12 hours.

The length of treatment time depends on the condition and how frequent the infection is. In the case of long-term preventive treatment (after eg 6-12 months) in the case of recurrent genital herpes infection, the doctor may decide to end the treatment to see natural changes in the disease.

Preventive treatment of herpes simplex infection in patients undergoing bone marrow or organ transplants or being treated for acute leukemia

The usual dose is 1 tablet of 200 mg 4 times daily every 6 hours.

For people with very severe defenses of infection, the dose can be increased to 2 tablets of 200 mg 4 times daily. Preventive treatment with Aciclovir Stada 200 mg should be started at the same time as the start of the risk period, ie. when the immune system is weakened.

Treatment of shingles ( Varicella zoster – infections )

The usual dose is 1 tablet of 800 mg or 2 tablets of 400 mg 5 times a day, about every 4 hours during the waking part of the day. Treatment should be started within 48 hours after the onset of symptoms and should last for 7 days. If the doctor deems it necessary, the treatment time can be extended.

Patients with renal impairment

Caution is advised when aciclovir is given to patients with renal impairment.

Herpes simplex infection is

For patients with severe renal impairment ( creatinine – clearance <10 / ml/min) a dose adjustment of 200 mg 2 times daily, every 12 hours.

Treatment of shingles ( Varicella zoster – infections )

The dose should be reduced to 2 tablets of 400 mg or 1 tablet of 800 mg 3 times daily approximately every 8 hours for patients with moderate renal impairment ( creatinine clearance between 10-25 ml/min). If renal function is severely impaired ( creatinine clearance <10 ml/min), a dose of 2 tablets of 400 mg or 1 tablet of 800 mg every 12 hours is recommended.

Elderly Patients

In principle, no dose adjustment is required for elderly patients. Only in case of impaired renal function can the doctor decide that the dose needs to be adjusted.

Method of administration

Swallow the tablets with a glass of water or some other liquid.

For the elderly and people with impaired kidney function, it is important to drink plenty of fluids during treatment. It is also very important to drink plenty of fluids for people taking high doses of aciclovir.

Use for children and adolescents

For children over 2 years of age, the same dose as for adults can be used. The tablets are not suitable for younger children (under 2 years).

There are no dosing data for the treatment of shingles in children.

If you forget to take Aciclovir STADA

If you have recently forgotten to take your tablet, take the forgotten tablet as soon as possible. If it has been a long time, you must skip the missed dose. Wait until it is time for the next dose and then continue to take the tablets as prescribed.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Aciclovir STADA

Your doctor has decided how long you should take aciclovir. Do not end treatment in advance without talking to your doctor first.

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. The side effects usually disappear when the treatment is stopped. Below is a list of possible side effects.

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

  • confusion
  • hallucinations
  • headache, dizziness, drowsiness
  • The above-mentioned commonly reversible side effects are most often seen in patients with renal impairment or in patients with a predisposition to these side effects, but the connection with the treatment is unclear.
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • itching,
  • skin rash (incl. photosensitivity)
  • fatigue,
  • fever
  • fatigue.

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

  • insomnia
  • hives,
  • diffuse hair loss (connection with the treatment is unclear).

Rare (may affect up to 1 in 1,000 people):

  • severe allergic reaction ( anaphylaxis )
  • difficulty breathing ( dyspnoea )
  • transient increase in bilirubin and liver enzymes
  • angioedema
  • increases in urea and creatinine levels in the blood.

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

  • altered blood levels ( anemia , leukopenia, thrombocytopenia )
  • the feeling of alienation (disappears after treatment), restlessness, psychotic symptoms
  • tremors, coordination difficulties, speech difficulties, seizures, brain disease ( encephalopathy ), decreased level of consciousness down to coma
  • The above-mentioned commonly reversible side effects are most often seen in patients with renal impairment or in patients with a predisposition to these side effects, but the connection with the treatment is unclear.
  • acute renal failure, renal pain.

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 Aciklovir STADA

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 after “EXP.”.

Do not store above 25 ° C.

If you store the medicine in this way, you can use the product until the expiry date.

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.

Each tablet contains 200 mg, 400 mg, or 800 mg of aciclovir.

The other ingredients are microcrystalline cellulose, sodium starch glycolate, copolyvidone, magnesium stearate, colloidal anhydrous silica.

What the medicine looks like and the contents of the pack

Aciclovir Stada 200 mg: White, round, biconvex tablet.

Aciclovir Stada 400 mg: White, round biconvex tablet.

Aciclovir Stada 800 mg: White, oblong tablet with a score on both sides.

Pack sizes

Aciclovir Stada 200 mg: 25, 50, 100 and 500 tablets

Aciclovir Stada 400 mg: 30, 50, 56, 60, 70 and 500 tablets.

Aciclovir Stada 800 mg: 35, 50 and 500 tablets.

Blister pack

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18,

61 118 Bad Vilbel

Germany

Other manufacturers

Centrafarm Services BV

New Donk 9

4879 AC Etten-Leur

Netherlands

LAMP San Prospero SpA

Via Della Pace 25 / A

41030 San Prospero, Modena

Italy

Sanico NV

Veedijk 59

2300 Turnhout

Belgium

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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