50 mg / ml granules for oral solution, 100 mg / ml granules for oral suspension, 250 mg / ml granules for oral solution
What Phenoxymethylpenicillin EQL is and what it is used for
Phenoxymethylpenicillin EQL contains the active substance phenoxymethylpenicillin (which belongs to the antibiotic group penicillins ). This type of drug prevents the bacterium from building a normal cell wall. Without a functioning cell wall, the bacterium dies quickly.
Phenoxymethylpenicillin EQL is used in the treatment of sore throat, sinusitis, ear infection, pneumonia, a bacterial infection of the skin and soft tissues, Lyme disease, and tooth infection in children.
Phenoxymethylpenicillin potassium contained in Phenoxymethylpenicillin EQL 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.
What you need to know before using Phenoxymethylpenicillin EQL
Do not use Phenoxymethylpenicillin EQL
- if you / your child are allergic/allergic to phenoxymethylpenicillin, other penicillins, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking your Phenoxymenthylpencillin EQL:
- if you / your child has or has had allergic diseases or asthma
- if you / your child are hypersensitive to cephalosporins (another group of antibacterial drugs)
If you get a rash, fever, and/or facial swelling, stop treatment and consult a doctor.
Other medicines and Phenoxymethylpenicillin EQL
Tell your doctor or pharmacist if you / your child are taking, have recently taken, or might take any other medicines.
Phenoxymethylpenicillin EQL can affect or be affected by other drugs:
- certain medicines for tumors or disorders of the immune system (methotrexate)
- anti-gout medication (probenecid)
Phenoxymethylpenicillin EQL with food, drink, and alcohol
Phenoxymethylpenicillin EQL has the best effect if taken on an empty stomach, ie. at least 1 hour before or 2 hours after a meal. However, compliance may be better if Phenoxymethylpenicillin EQL is given with food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no known risks with the use of Phenoxymethylpenicillin EQL during pregnancy.
Breast-feeding
Phenoxymethylpenicillin potassium passes into breast milk but is unlikely to affect breastfed infants.
Driving and using machines
No or negligible effect on the ability to drive and use machines.
Phenoxymethylpenicillin EQL contains excipients
- Aspartame: This medicine contains aspartame:
50 mg / ml granules for oral solution: 5 mg aspartame / ml
100 mg / ml granules for oral suspension: 10 mg aspartame / ml
250 mg / ml granules for oral solution: 10 mg aspartame / ml
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
- Benzoate salt: This medicine contains benzoate
50 mg / ml granules for oral solution: 3.9 mg sodium benzoate / ml
100 mg / ml granules for oral suspension: 7.8 mg sodium benzoate / ml
250 mg / ml granules for oral solution: 1.5 mg sodium benzoate / ml
Benzoate may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).
- Benzyl alcohol: 250 mg/ml contains 0.0054 mg of benzyl alcohol per ml. Benzyl alcohol can cause allergic reactions.
- Sucrose: 50 and 100 mg / ml contain a maximum of 6.6 g per dose . This should be considered in patients with diabetes mellitus. If you / your child cannot tolerate certain sugars, you should consult your doctor before taking this medicine. May be harmful to teeth.
- Sodium: This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.
How to use Phenoxymethylpenicillin EQL
Use for children and adolescents
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by a doctor and is based on the type of infection you / your child has body weight, and age.
Phenoxymethylpenicillin EQL is a granulate before it is prepared at the pharmacy. Shake the bottle well before use to make sure that the solution/suspension is well mixed.
Use the 10 ml dose cup (50 mg / ml and 100 mg / ml) or the 5 ml dosing syringe (250 mg / ml) to measure dose one.
If you use more Phenoxymethylpenicillin EQL than you should
If you / your child has taken too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms of overdose include nausea, vomiting, diarrhea, altered level of consciousness, salt balance disorders, muscle twitching, seizures, unconsciousness ( coma ), severe anemia and jaundice, and kidney failure.
If you forget to use Phenoxymethylpenicillin EQL
Do not take a double dose to make up for a forgotten dose.
If you stop using Phenoxymethylpenicillin EQL
Even if you feel better after just a few days, it is important to take the entire course of treatment with Phenoxymethylpenicillin EQL as prescribed by your doctor. Otherwise, some bacteria may survive, start growing and cause a new infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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)
- Nausea, diarrhea
- Rash
Uncommon (may affect up to 1 in 100 people)
- Fever
- Vomiting
- Stomatitis ( infection of the mouth)
- Inflammation of the tongue
- Digestive problems
- Joint pain
- Urticaria, swelling of the skin, red rash ( erythema multiforme or exfoliative dermatitis ). Exfoliative dermatitis is a serious skin condition (with symptoms such as reddening of the skin and peeling of the skin), consult a doctor or hospital.
- Hematopoiesis (high level of eosinophils )
Rare (may affect up to 1 in 1,000 people)
- Severe allergic reaction ( anaphylactic reaction ). Stop taking Phenoxymethylpenicillin EQL and consult a doctor or hospital.
Very rare (may affect up to 1 in 10,000 people)
- Changes in the blood picture: decrease in red blood cells ( hemolytic anemia ) which causes anemia – similar symptoms such as fatigue and fever. Decrease in leukocytes ( leukopenia ) which increases the tendency to get an infection. Dilation of platelets ( thrombocytopenia ). Decrease in white blood cells ( agranulocytosis ) which causes fever, and infectious symptoms such as the sore throat or urination problems. These conditions can be serious. Contact a doctor immediately if you get a fever.
- A positive result on the Coombs test (test for hemolytic syndromes).
How to store Phenoxymethylpenicillin EQL
Keep this medicine out of the sight and reach of children.
Phenoxymethylpenicillin EQL 50 mg / ml, oral solution
Phenoxymethylpenicillin EQL 100 mg / ml, oral suspension
Store the solution/suspension in a refrigerator (2 o C-8 o C).
It should be used within 14 days.
Phenoxymethylpenicillin EQL 250 mg / ml, oral solution
The solution is stored in a refrigerator (2 o C-8 o C).
It should be used within 20 days.
Do not use this medicine after the expiry date which is stated on the label after EXP. 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.
Contents of the package and other information
Content declaration
- The active substance is phenoxymethylpenicillin potassium. After reconstitution at the pharmacy contains 1 ml of:
- 50 mg / ml oral solution: 50 mg phenoxymethylpenicillin potassium
- 100 mg / ml oral suspension: 100 mg phenoxymethylpenicillin potassium
- 250 mg / ml oral solution: 250 mg phenoxymethylpenicillin potassium
- The other ingredients are
- Phenoxymethylpenicillin EQL 50 mg/ml granules for oral solution: aspartame E951, flavoring (orange, caramel), sodium benzoate E211, sodium citrate E331, sucrose, povidone, propylene glycol E1520
- Phenoxymethylpenicillin EQL 100 mg / ml granules for oral suspension: aspartame E951, flavoring (lemon, cocoa), sodium benzoate E211, sodium citrate E331, sucrose, titanium dioxide E171, povidone, propylene glycol E1520
- Phenoxymethylpenicillin EQL 250 mg/ml granules for oral solution: aspartame E951, flavoring (grapefruit, apricot), sodium benzoate E211, sodium citrate E331, sucrose, povidone, propylene glycol E1520, benzyl alcohol E1519
What the medicine looks like and the contents of the pack
Granules for oral suspension and oral solution: White to off-white granules.
Prepared suspension / solution:
Phenoxymethylpenicillin EQL 50 mg / ml granules for oral solution: Clear solution.
Phenoxymethylpenicillin EQL 100 mg/ml granules for oral suspension: Homogeneous white to off-white suspension.
Phenoxymethylpenicillin EQL 250 mg / ml granules for oral solution: Clear solution.
Pack sizes
Phenoxymethylpenicillin EQL 50 and 100 mg / ml granules for oral solution / suspension: 60, 125 and 200 ml with a 10 ml dose cup.
Phenoxymethylpenicillin EQL 250 mg/ml granules for oral solution: 20 and 40 ml with a 5 ml dosing syringe.
Marketing Authorization Holder and Manufacturer
EQL Pharma AB
Stortorget 1
222 23 Lund
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Phenoxymethylpenicillin EQL
Latvia: Phenoxymethylpenicillin EQL Pharma