800 mg and 1 g film-coated tablets 
phenoxymethylpenicillin potassium

Read all of this leaflet carefully before you start taking this medicine.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Avopenin is and what it is used for 
2. What you need to know before you use Avopenin 
3. How to use Avopenin 
4. Possible side effects 
5. How to store Avopenin 
6. Contents of the packaging and other information 

1. What Avopenin is and what it is used for

The active substance in Avopenin, phenoxymethylpenicillin, is penicillin(antibacterial drug) that prevents the bacterium from building a normal cell wall. Without a functioning cell wall, the bacterium dies quickly.

Avopenin is used for sore throat, tooth infection, pneumonia, sinusitis, ear infections, bacterial infections of the skin, and soft tissues (such as inflammation of the connective tissue, and Borrelia infection ).

The phenoxymethylpenicillin potassium contained in Avopenin 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

2. What you need to know before you use Avopenin

Do not use Avopenin

  • if you are allergic to phenoxymethylpenicillin potassium or other penicillins or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Avopenin:

  • If you are allergic (hypersensitive) to cephalosporins (another group of antibacterial drugs), consult your doctor before using Avopenin.

In case of sudden rash, fever and/or swelling of the face, treatment should be stopped and a doctor should be consulted immediately.

Other medicines and Avopenin

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

Avopenin may affect or be affected by other medicines that contain the following active ingredients:

  • Methotrexate (for tumors and disorders of the immune system)
  • Probenecid (for gout )

Avopenin with food, drink and alcohol

Avopenin has the best effect if taken on an empty stomach, or at least 1 hour before or 2 hours after a meal.

Pregnancy, breastfeeding and fertility

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.

No known risks when used during pregnancy.


Talk to your doctor before using Avopenin if you are pregnant.

Phenoxymethylpenicillin passes into breast milk but is unlikely to affect breastfed infants. However, talk to your doctor before using Avopenin if you are breast-feeding.

Driving and using machines

No known effect on the ability to drive or use machines.

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.

3. How to use Avopenin

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor who adapts it individually for you. The size of the dose depends on the type of infection and body weight.

Use for children and adolescents

Avopenin can be used in children over 12 years of age.

The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.

There are other strengths and pharmaceuticals of phenoxymethylpenicillin for children under 12 years / under 40 kg.

If you forget to use Avopenin

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

If you stop using Avopenin

Even if you feel better after just a few days, it is important that the entire Avopenin regimen is completed as prescribed. Otherwise, some bacteria may survive for a while, grow and cause a recurrence of infection.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Stomach upset, mainly nausea or loose stools and skin rash.

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

Allergic reaction (hypersensitivity) with fever and/or joint pain. Hives, a temporary change in blood count ( eosinophilia ).

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

Severe allergic reaction ( anaphylactic reaction ).

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

Itching.

In the case of prolonged or severe diarrhea, you should consult a doctor.

Itching in the abdomen can be caused by a fungal infection.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

Läkemedelsverket 
Box 26 
751 03 Uppsala

www.lakemedelsverket.se

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 Avopenin

Keep this medicine out of the sight and reach of children. Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. date. The expiration date is the last day of the specified 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. Contents of the packaging and other information

Content declaration

  • The active substance is phenoxymethylpenicillin potassium.
  • The other ingredients are Tablet core: magnesium stearate, povidone. Film coating: titanium dioxide (E171), hypromellose, macrogol.

What the medicine looks like and contents of the pack

800 mg: White to bone-colored capsule-shaped film-coated tablets, marked with a scoreline and P / 0.8. 
1 g: White to bone-colored capsule-shaped film-coated tablets, marked with a scoreline and P / 1.0.


Pack sizes : 800 mg: Blister packs: 14, 20, 30, 40, 98 x 1 (single dose) and 100 tablets 
1 g: Blister packs: 14, 20, 30, 40, 98 x 1 (single dose) and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

Remedica Ltd,

 PO Box 51706,

CY-3508,

 Limassol,

Cyprus

Local representative

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

Muhammad Nadeem

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