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Avopenin

Document: Avopenin film-coated tablet ENG PL change

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.


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

How to store Avopenin

6. Further information


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),


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 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:



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.


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 A/S, Energivej 15, 5260 Odense S, Denmark


Local representative

Orifarm Generics AB, Box 56048, 102 17 Stockholm, info@orifarm.com


Manufacturer

Remedica Ltd, P.O. Box 51706, CY-3508, Limassol, Cyprus


This leaflet was last approved in


17/05/2016