Aciclovir 400mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

即購入

ダウンロード 製品の特徴 (SPC)
11-04-2019
ダウンロード 公開評価報告書 (PAR)
20-04-2020

有効成分:

Aciclovir

から入手可能:

Almus Pharmaceuticals Ltd

ATCコード:

J05AB01

INN(国際名):

Aciclovir

投薬量:

400mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 05030201; GTIN: 05060057404119

情報リーフレット

                                PATIENT INFORMATION LEAFLET
ACICLOVIR 200MG, 400MG AND 800MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
pharmacist.
• This medicine has been prescribed only for you. Do not pass it
on to others. It may harm them, even if their symptoms are the
same as yours.
• If any of these side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET
1. What are Aciclovir Tablets and what are they used for
2. Before you take Aciclovir Tablets
3. How to take Aciclovir Tablets
4. Possible side effects
5. How to store Aciclovir Tablets
6. Further information
1. WHAT ARE ACICLOVIR TABLETS AND WHAT ARE
THEY USED FOR
The name of your medicine is Aciclovir Tablets. This belongs to
a group of medicines called antivirals.
Aciclovir Tablets can be used:
• to treat herpes and other viral infections caused by the herpes
virus (varicella zoster), such as shingles
• to prevent recurrent attacks of herpes simplex
• to help prevent those who have low immune systems from
getting herpes infections.
Aciclovir Tablets should not be used to treat herpes simplex virus
(HSV) infections in newborns and babies up to 3 months old or
severe HSV infections in children with low resistance to disease.
2. BEFORE YOU TAKE ACICLOVIR TABLETS
DO NOT TAKE ACICLOVIR TABLETS AND TELL YOUR DOCTOR IF:
• you are allergic (hypersensitive) to aciclovir, valaciclovir or
any
other ingredients in this medicine (see section 6: Further
Information). An allergic reaction can include a rash, itching or
shortness of breath.
Do not take this medicine if any of the above apply to you, talk
to your doctor or pharmacist before taking Aciclovir Tablets.
TAKE SPECIAL CARE WITH ACICLOVIR TABLETS
Before you take Aciclovir Tablets tell your doctor if:
• you are elderly
• you have kidney problems
• you are thirsty. You must make sure y
                                
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製品の特徴

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aciclovir 400 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg tablet contains 400 mg aciclovir.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round (diameter: 11.8 mm), biconvex, uncoated
tablets
debossed with ‘AR and 400’ separated with breakline on one side
and plain on
the other side. The tablet can be divided into equal doses
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aciclovir Tablets are indicated for the treatment of herpes simplex
virus
infections of the skin and mucous membranes including initial and
recurrent
genital herpes (excluding neonatal HSV and severe HSV infections in
immunocompromised children).
Aciclovir Tablets are indicated for the suppression (prevention of
recurrences)
of recurrent herpes simplex infections in immunocompetent patients.
Aciclovir Tablets are indicated for the prophylaxis of herpes simplex
infections in immunocompromised patients.
Aciclovir Tablets are indicated for the treatment of varicella
(chickenpox) and
herpes zoster (shingles) infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Dosage in adults _
_ _
Treatment of herpes simplex infections: 200 mg Aciclovir should be
taken five
times daily at approximately four hourly intervals omitting the night
time
dose. Treatment should continue for 5 days, but in severe initial
infections this
may have to be extended.
In severely immunocompromised patients (e.g. after marrow transplant)
or in
patients with impaired absorption from the gut the dose can be doubled
to 400
mg Aciclovir, or alternatively, intravenous dosing could be
considered.
Dosing should begin as early as possible after the start of an
infection; for
recurrent episodes this should preferably be during the prodromal
period or
when lesions first appear.
Suppression of herpes simplex infections in immunocompetent patients:
200
mg Aciclovir should be taken four times daily at approximately
six-hourly
intervals.
                                
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