Acyclovir 200/400/800 Stada

Acyclovir.

Each tablet contains: Acyclovir 200 mg, 400 mg or 800 mg.
Acyclovir 200/400/800 Stada is an antiviral drug.
Excipients/Inactive Ingredients: Microcrystalline cellulose, copolyvidon, magnesium stearate, sodium starch glycolate, colloidal anhydrous silica.

200-mg tablet: Herpes simplex virus infections, genital herpes of the skin and mucous membranes in particular (primary and frequently recurring genital herpes).
Recurrence prevention is indicated for adults with very severe forms of very frequently recurring genital herpes simplex virus infection.
400-mg tablet: Shingles (herpes zoster).
Prevention of severe cases of herpes simplex infection in severely immunocompromised adult patients exposed to an elevated risk of infection, for example following organ transplants.
800-mg tablet: Shingles (herpes zoster).

The instructions given as follows apply unless the doctor has prescribed Acyclovir 200/400/800 Stada otherwise.
Please comply with these and/or the doctor's instructions for effective and safe Acyclovir 200/400/800 Stada therapy.
How many tablets and how often should the patient take Acyclovir 200/400/800 Stada: Recommended dosage: Adults: 200-mg tablet: Herpes simplex virus infections: Take 1 tablet (200 mg of acyclovir) 5 times daily every 4 hours during the day.
Prophylaxis of severe forms and very frequently recurring genital herpes simplex virus infections: Immunocompetent patients take 1 tablet (200 mg of acyclovir) 4 times daily every 6 hours.
Some patients may achieve effective prophylaxis with 1 tablet (200 mg of acyclovir) 3 times daily every 8 hours or 1 tablet (200 mg of acyclovir) twice daily every 12 hours.
Immunocompromised patients take a prophylactic dosage of 1 tablet (200 mg of acyclovir) 4 times daily every 6 hours.
Severely immunocompromised patients, for example following organ transplants, may need 2 tablets (400 mg of acyclovir) 4 times daily every 6 hours.
400-mg tablet: Shingles (herpes zoster): Take 2 tablets (800 mg) of acyclovir 5 times daily every 4 hours during the day.
Prevention of herpes simplex virus infection in certain circumstances: One tablet (400 mg) of acyclovir can be taken 4 times daily every 6 hours for prevention of severe cases of herpes simplex infection in severely immunocompromised patients exposed to an elevated risk of infection, for example following organ transplants.
800-mg tablet: Shingles (herpes zoster): Take 1 tablet (800 mg) of acyclovir 5 times daily every 4 hours during the day.
Children: 200-mg tablet: For the treatment of herpes simplex virus infection, children over 2 years old receive the adult dosage and those under 2 half the adult dosage.
Patients with impaired kidney function: See Contraindications.
Patients with kidney function impairment, which is particularly prevalent in elderly patients, may need a lower acyclovir dose than indicated previously. If the patient should have kidney problems, the doctor will adjust the dosage to reflect the kidney function (see as follows).
200-mg tablet: See Table 1.

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400-mg tablet: See Table 2.

Click on icon to see table/diagram/image

800-mg tablet: See Table 3.

Click on icon to see table/diagram/image

How and when should the patient take Acyclovir 200/400/800 Stada: Swallow the tablets whole with a sufficient amount of liquid (eg a glass of water) after meals. An adequate fluid intake must be ensured during Acyclovir 200/400/800 Stada therapy, especially in patients with impaired kidney function.
Please note: For best response, Acyclovir 200/400/800 Stada therapy should be started as early as possible, ie as soon as the first signs or symptoms of infection appear.
Especially with recurrent herpes simplex virus infections, Acyclovir 200 Stada should be started on the first prodromes (eg itching, burning/discomfort, early vesicles).
For how long should the patient take Acyclovir 200/400/800 Stada: The doctor will determine for how long the patient should continue Acyclovir 200/400/800 Stada therapy.
200-mg tablet: In herpes simplex virus infections, Acyclovir 200 Stada therapy will usually be continued for 5 days, but the patient's clinical condition may call for longer treatment.
For prevention of herpes simplex virus infection in immunocompetent patients, the length of prophylaxis will depend on the severity and frequency of recurrences. However, prophylaxis should not be continued for longer than 6-12 months. The length of prophylaxis of herpes simplex virus infection in severely immunocompromised patients will depend on the severity of immunocompromise and be individualised by the treating doctor.
400-mg tablet: The duration of therapy of herpes zoster is 5-7 days. The length of prophylaxis of severe herpes simplex virus infection will depend on the severity of immunocompromise and will be determined by the treating doctor specifically for the patient.
800-mg tablet: The duration of therapy of herpes zoster is 5-7 days.
What should the patient do if he/she took less than the prescribed dose of Acyclovir 200/400/800 Stada or missed a dose: Continue therapy as prescribed (so do not take Acyclovir 200/400/800 Stada tablets more often or in larger doses). If the patient missed several doses, discuss with the doctor.
What should the patient bear in mind if he/she wishes to interrupt or stop Acyclovir 200/400/800 Stada early: Even as the well-being may improve appreciably, the patient should complete Acyclovir 200/400/800 Stada therapy as prescribed by the doctor so as not to jeopardise outcome. Should the patient be in doubt - because of side effects for example - discuss with the doctor before interrupting or stopping treatment.

Intoxication is unlikely after an Acyclovir 200/400/800 Stada overdose. A single dose of 5 g of acyclovir produced no signs or symptoms of intoxication. However, no data are available for higher single (over) doses.
If overdose is suspected, should experience pronounced side effects or are in doubt, be sure to discuss with the doctor any concerns the patient may have.

When not to take Acyclovir 200/400/800 Stada: The patient must not take Acyclovir 200/400/800 Stada if he/she is hypersensitive to acyclovir or any other ingredient of Acyclovir 200/400/800 Stada.
If the kidney function is impaired or the urinary output is reduced to less than 100 ml of urine per 24 hours, the patient should not use Acyclovir 200/400 Stada for prevention because no data are available on the use of Acyclovir 200/400 Stada in these conditions.
What should the patient be aware of in case of pregnancy or breast-feeding: The treating doctor will have to carefully weigh expected benefits against potential risks in pregnant women in whom Acyclovir 200/400/800 Stada therapy proves necessary.
Acyclovir has been detected in breast milk following administration of acyclovir products. Breast-feeding is therefore discouraged while taking Acyclovir 200/400/800 Stada.
What should the patient be aware of if he/she is elderly: Elderly patients are more likely to have impaired kidney function than are younger people.
Elderly patients, therefore, are recommended to have their kidney function checked and to ensure an adequate fluid intake while taking Acyclovir 200/400/800 Stada tablets.
Also, the treating doctor may want to adjust the dosage (see Dosage & Administration).

What should the patient be aware of: See Contraindications and Dosage & Administration.

The treating doctor will have to carefully weigh expected benefits against potential risks in pregnant women in whom Acyclovir 200/400/800 Stada therapy proves necessary.
Acyclovir has been detected in breast milk following administration of acyclovir products. Breast-feeding is therefore discouraged while taking Acyclovir 200/400/800 Stada.

To date, Acyclovir 200/400/800 Stada has occasionally been associated with the following side effects: Skin rashes disappearing upon discontinuation of the medicinal product, gastro-intestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain.
There have also been occasional reports of neurological (affecting the nervous system) side effects, mainly dizziness, confusion, hallucinations and drowsiness.
These side effects disappeared upon discontinuation of the medicinal product and were typically seen in patients with impaired kidney function or other conditions pre-disposing to this sort of adverse reactions.
Moreover, there have been isolated reports of depersonalisation experiences disappearing upon discontinuation of the medicinal product. Transient convulsions and psychoses have been observed, especially with acyclovir administered by intravenous infusion to patients with complicated clinical courses.
There have been rare reports of transient laboratory adverse effects relating to liver and kidney function as well as the blood (bilirubin, liver enzyme, serum urea nitrogen and/or serum creatinine elevations, and/or slight reductions in haematological parameters). There have also been rare reports of headache, exhaustion, insomnia or fatigue.
The rare patient has experienced difficulty breathing. There have been occasional reports of diffuse loss of hair associated with the use of Acyclovir 200/400/800 Stada, but a causal relationship is unclear.
Should the patient experiences any adverse effects, please be sure to inform the doctor or pharmacist.

Other medicines known to interfere with the effects of Acyclovir 200/400/800 Stada: Probenecid (uricosuric drug for gout) reduces acyclovir excretion via the kidneys, which may increase acyclovir persistence in the body.
Please bear in mind that these interactions may also apply to recently used medicines.

Store below 25°C.

Antivirals

J05AB01 - aciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

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