PACKAGE LEAFLET: INFORMATION FOR THE USER
Avopenin 800 mg film-coated tablets
Avopenin 1 g film-coated tablets
Phenoxymethylpenicillin potassium
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the 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 Avopenin is and what it is used for
2.
Before you take Avopenin
3.
How to take Avopenin
4.
Possible side effects
5.
How to store Avopenin
6.
Further information
1.
WHAT AVOPENIN IS AND WHAT IT IS USED FOR
The active substance in Avopenin, phenoxymethylpenicillin, is a penicillin (antibacterial
medicine) that prevents the bacteria from buildning a normal cell wall. Without cell walls, the
bacteria die fast.
Avopenin is used to treat tonsillitis, tooth infections, pneumonia, sinus infections, infections
in the ear (otitis), bacterial skin- and soft tissue infections (such as connective tissue infection
and Borrelia infection).
Avopenin can be given to adults, children and adolescents from the age of 12 years (or 40
kg),
2.
BEFORE YOU TAKE AVOPENIN
Do not use take Avopenin
if you are allergic (hypersensitive) to penicillin or any of the other ingredients of
Avopenin.
Take special care with Avopenin
if you are allergic (hypersensitive) to cephalosporins (another group of antibiotics)
contact your doctor for advice before using Avopenin
if you experience diarrhoea that last for a long time or is severe, contact your
doctor
If you experience sudden rash, fever and/or facial swelling, stop taking the medicine and
contact your doctor immediately.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Avopenin may affect or be affected by other medicines containing the following active
ingredients:
-
Methotrexate (for tumours and certain diseases in the immune system)
Probenecid (used to treat gout)
Oral contraceptives. Avopenin may have an impact on their efficacy.
Using Avopenin with food and drink
Avopenin has its best effect if it is taken on an empty stomach, or at least 1 hour before a
meal, or 2 hours after a meal.
Pregnancy and breast-feeding
There are no known risks when Avopenin is taken during pregnancy.
Ask your doctor for advice before taking Avopenin if you are pregnant.
Phenoxymethylpenicillin passes over into breastmilk, but it is not likely to have an effect on
nursing babies. Ask your doctor for advice before taking Avopenin if you are breast-feeding.
Driving and using machines
There are no known effects on the ability to drive or use machines.
3.
HOW TO USE AVOPENIN
Always use Avopenin exactly as your doctor has told you. The dose depends on the nature of
the infection and your bodyweight.
The usual dose is 1g to 2g 2-3 times daily. The length of the treatment period varies
depending on the type of infection.
Use in children
Avopenin could be used from the age of 12 years. There are other strengths and
pharmaceutical forms of phenoxymethylpenicillin available for children below 12 years of
age/below 40 kg
If you take more Avopenin than you should
If you have taken more Avopenin than you should, or if a child has been taking Avopenin by
accident, please contact your doctor or hospital to get an opinion of the risk and advice on
action to be taken.
If you forget to take Avopenin
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Avopenin
Do not stop taking Avopenin even if you feel better after a few days. It is important to
continue taking the medicine according to the instructions from your doctor. If you stop
taking Avopenin, some bacteria may survive, grow and muliply, and the infection may recur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Avopenin can cause side effects, although not everybody gets them.
Common ( affects 1 to 10 users in 100): Gastrointerstinal discomfort, mainly nausea or loose
stools, and skin rash.
Uncommon (affects 1 to 10 users in 1,000): Allergic reactions (hypersensitivity) with fever
and/or joint pain. Hives (urticaria), Temporary change in the blood (eosinofilia).
Rare (affects 1 to 10 users in 10,000): Severe allergic reaction (anaphylactic reaction)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.
5.
HOW TO STORE AVOPENIN
Keep out of the reach and sight of children. Do not store above 30°C.
Do not use Avopenin after the expiry date which is stated on the carton after EXP. The
expiry date refers to the last day of that 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.
FURTHER INFORMATION
What Avopenin contains
The active substance is phenoxymethylpenicillin potassium
The other ingredients are: Tablet core: magnesium stearate, povidone, tablet coating:
titanium dioxide (E171), hypromellose, macrogol.
What Avopenin looks like and contents of the pack
800 mg: White to offwhite, capsule-shaped film-coated tablets with a breakscore, embossed
P/0.8.
1 g: White to offwhite, capsule-shaped film-coated tablets with a breakscore, embossed P/1.0.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal
doses.
Pack sizes:
800 mg: Blister packs: 14, 20, 30, 40, 98 x 1 (single dose), and100 tablets.
1 g: Blister packs: 14, 20, 30, 40, 98 x 1 (single dose), and100 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pilum Pharma AB
Box 28
SE-257 21 Rydebäck
Manufacturer
Remedica Ltd, P.O. Box 51706, CY-3508, Limassol, Cyprus
This leaflet was last approved in
27/06/2012