Fenoximetylpenicillin Eql Pharma
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fenoximetylpenicillin EQL Pharma 800 mg film-coated tablets
Fenoximetylpenicillin EQL Pharma 1 g film-coated tablets
Phenoxymethylpenicillin potassium
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet; you may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
In this leaflet:
1. What Fenoximetylpenicillin EQL Pharma is and what it is used for
2. What you need to know before you take Fenoximetylpenicillin EQL Pharma
3. How to take Fenoximetylpenicillin EQL Pharma
4. Possible side effects
5. How to store Fenoximetylpenicillin EQL Pharma
6. Contents of the pack and other information
1. WHAT FENOXIMETYLPENICILLIN EQL PHARMA IS AND WHAT IT IS USED FOR
The active ingredient in Fenoximetylpenicillin EQL Pharma, phenoxymethylpenicillin, is a penicillin (antibacterial drug) that prevents bacteria from building up a normal cell wall. Without a functioning cell wall the bacterium quickly dies.
Fenoximetylpenicillin EQL Pharma is used for tonsillitis, dental infection, pneumonia, sinusitis, ear infections, bacterial infections of the skin and subcutaneous tissue (like inflammation of the connective tissue, Lyme disease).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENOXIMETYLPENICILLIN EQL PHARMA
Do not take Fenoximetylpenicillin EQL Pharma
If you are allergic (hypersensitive) to penicillins or any of the other ingredients of Fenoximetylpenicillin EQL Pharma.
Warnings and precautions
If you are allergic to cephalosporins (another group of antibacterial drugs), consult your doctor before Fenoximetylpenicillin EQL Pharma is used.
If rash, fever and/or facial swelling rapidly develop, stop the treatment and contact your doctor.
Other medicines and Fenoximetylpenicillin EQL Pharma
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because certain medicines may affect or be affected by treatment with Fenoximetylpenicillin EQL Pharma, such as certain drugs against tumours and disorders of the immune system (methotrexate) or to treat gout (probenecid).
The effect of oral contraceptives may be affected by treatment with Fenoximetylpenicillin EQL Pharma.
Fenoximetylpenicillin EQL Pharma with food and drink
Fenoximetylpenicillin EQL Pharma is most effective if taken on an empty stomach, or at least 1 hour before or 2 hours after meals.
Pregnancy, breast-feeding and fertility
No known risks when used during pregnancy. Ask your doctor when using Fenoximetylpenicillin EQL Pharma during pregnancy.
Phenoxymethylpenicillin passes into breast milk, but is unlikely to affect nursing infants.
However, consult with your doctor at more than occasional use of Fenoximetylpenicillin EQL Pharma during lactation.
Driving and using machines
No known effect on the ability to drive or operate machinery.
3. HOW TO TAKE FENOXIMETYLPENICILLIN EQL PHARMA
Always take Fenoximetylpenicillin EQL Pharma exactly as your doctor has told you. The dose is determined by the doctor who adjusts it individually for you. The dose depends on the infection type and body weight. Ask your doctor or pharmacist if you are unsure.
Even if you feel better already after a few days, it is important that the entire Fenoximetylpenicillin EQL Pharma course of treatment is completed as prescribed.Otherwise, some bacteria may survive for some time, grow and cause the infection to recur.
If you take more Fenoximetylpenicillin EQL Pharma than you should
Always contact your doctor, hospital or Poisons Information Centre (phone 112) for assessment of risk and guidance.
If you forget to take Fenoximetylpenicillin EQL Pharma
Do not take a double dose to make up for a forgotten tablet.
4. POSSIBLE SIDE EFFECTS
Like all medicines Fenoximetylpenicillin EQL Pharma may cause side effects although not everybody gets them.
Common (more than 1 in 100 people affected): Abdominal discomfort, predominantly nausea or loose stools and rash.
Uncommon (less than 1 in 100 people affected):Hypersensitivity reactions with fever and/or joint pain. Hives, blood count changes (eosinophilia).
Rare (less than 1 in 1,000 people affected): Severe allergic reaction (anaphylaxis).
If you have prolonged or severe diarrhoea, you should contact your doctor.
Itching in the genital area may be caused by fungal overgrowth.
If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FENOXIMETYLPENICILLIN EQL PHARMA
Keep out of the reach and sight of children.
Store below 30°C.
The tablets are to be used before the expiry date printed on the package after Exp. Date. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fenoximetylpenicillin EQL Pharma contains
1 tablet contains:
The active ingredient is phenoxymethylpenicillin potassium 800 mg or 1 gram respectively.
Other ingredients are Povidone, Cellulose microcrystalline, Talc, Silica Colloidal anhydrous, Magnesium Stearate, Hypromellose, Macrogol, Titanium Dioxide (E171).
What Fenoximetylpenicillin EQL Pharma looks like and contents of the pack:
800 mg: White to off white, capsule shaped, 19.5 x 8.5 mm, film-coated tablets debossed with ‘7’ and ‘3’ on either side of the break line on one side and ‘F’ on other side.
1g: White to off white, capsule shaped, 21 x 9.5 mm, film-coated tablets debossed with ‘E’ and ‘86’ on either side of the break line on one side and plain on other side.
Pack size:
14, 20, 30, 40 and 100 tablets
Marketing Authorisation Holder:
EQL Pharma AB
Stortorget 1
222 23 Lund
Sweden
Manufacturer:
APL Swift Services Malta Ltd
HF26, Hal Far Industrial Estate
Hal Far Birzebbugia
BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
Sweden Fenoximetylpenicillin EQL Pharma
This leaflet was last revised in 2016-06-14