Penilevel 250 mg powder for oral solution
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Penilevel 250 mg powder for oral solution
Phenoxymethylpenicillin potassium
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Package leaflet
- What Penilevel is and what it is used for
- What you need to know before taking Penilevel
- How to take Penilevel
- Possible side effects
- Storage of Penilevel
- Contents of the pack and other information
1. What Penilevel is and what it is used for
Penilevel contains phenoxymethylpenicillin as the active substance. Phenoxymethylpenicillin is used to treat certain infections caused by bacteria. It only acts against specific strains of bacteria.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste. |
Penilevel is used for the treatment of the following infections:
Adults
- Respiratory tract infections: Acute streptococcal pharyngotonsillitis (group A).
- Acute bacterial skin and skin structure infections: Scarlet fever, ecthyma, furuncle, impetigo, erysipelas, and erysipeloid.
- Odontogenic infections: Dental abscesses with disseminated cellulitis.
Pediatric population one year of age and older (infants, children, and adolescents)
- Respiratory tract infections: Acute streptococcal pharyngotonsillitis (group A).
- Bacterial skin and skin structure infections: Scarlet fever, ecthyma, furuncle, impetigo, erysipelas, and cellulitis.
- Odontogenic infections: Dental abscesses with disseminated cellulitis.
2. What you need to know before taking Penilevel
Do not take Penilevel
If you are allergic to phenoxymethylpenicillin or to any of the other ingredients of this medicine (see section 6) or to other beta-lactam antibiotics (penicillins or cephalosporins).
Warnings and precautions
Consult your doctor before starting to take Penilevel, especially if you have previously experienced any hypersensitivity or allergic reaction to penicillins or other beta-lactam antibiotics.
Penicillins may cause severe allergic reactions, which can be life-threatening.
In patients with impaired renal function, consult your doctor, as dose reduction may be necessary.
Repeated and prolonged use of antibiotics should be avoided, as this may lead to the development of resistance and the emergence of other infections.
Patients with renal insufficiency or on low-potassium diets should be aware that this medicine contains 27.8 mg (0.711 mmol) of potassium per sachet.
This medicine contains 30 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to metabolize it properly.
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 1.389 g of sucrose per sachet.
Other medicines and Penilevel
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor or pharmacist about any of the following medicines:
- Methotrexate (a medicine used to treat cancer and psoriasis): Penicillins may increase the risk of toxicity by reducing methotrexate excretion.
- Oral contraceptives (birth control pills): Penicillins may reduce the effectiveness of oral contraceptives, so additional contraceptive measures (e.g., use of male condoms) may be necessary.
- Probenecid or sulfinpyrazone (medicines used to treat gout).
Taking Penilevel with food, drinks and alcohol
Penilevel may be taken with or without food, although it is preferable to take it on an empty stomach or 1 hour before or 2 hours after meals.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The effect on the ability to drive or use machinery is none or negligible.
3. How to take Penilevel
Your doctor will explain exactly how much Penilevel you should take, how often, and for how long. This will depend on the type of infection you have, its severity, and your body weight. Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults
Indication |
Dosage |
Duration of treatment |
|
Acute streptococcal pharyngotonsillitis (group A) |
500 mg every 12 hours |
10 days |
|
Acute bacterial skin infections and their structures |
Scarlet fever |
500 mg every 12 hours |
10 days |
Impetigo |
125–500 mg every 6 hours |
10 days |
|
Furuncle |
125–500 mg every 6 hours |
10 days |
|
Impetigo |
125–500 mg every 6 hours |
10 days |
|
Erysipelas |
250–500 mg every 6 hours |
5 days |
|
Erysipeloid |
500 mg every 6 hours |
7–10 days |
|
Odontogenic infections |
Dental abscesses with disseminated cellulitis |
1,000 mg (initial dose) |
3–7 days |
Pediatric population aged one year and older (infants, children, and adolescents)
The physician will determine the appropriate dose for your child:
Indication | Pediatric population weight | Dosage | Duration of treatment | |
Acute streptococcal pharyngotonsillitis (group A) | < 27 kg ≥ 27 kg | 250 mg every 12 hours 500 mg every 12 hours | 10 days | |
Acute bacterial skin and skin structure infections | Scarlet fever | < 27 kg ≥ 27 kg | 250 mg every 12 hours 500 mg every 12 hours | 10 days |
Ecthyma | 25–50 mg/kg/day (maximum dose: 3 g/day) every 6 hours | 10 days | ||
Furuncle | 25–50 mg/kg/day (maximum dose: 3 g/day) every 6 hours | 10 days | ||
Impetigo | 25–50 mg/kg/day (maximum dose: 3 g/day) every 6 hours | 10 days | ||
Erysipelas | 25–50 mg/kg/day (maximum dose: 3 g/day) every 6 hours | 5 days | ||
Cellulitis | 25–50 mg/kg/day (maximum dose: 3 g/day) every 6 hours | 5 days | ||
Odontogenic infections | Dental abscesses with disseminated cellulitis | 25–50 mg/kg/day (maximum dose: 3 g/day) every 6 hours | 5–7 days |
If the patient and dosage regimen require it, Penilevel 500 mg hard capsules are available for administration to adults and adolescents aged 12 years and older.
Cut the sachet at the top using scissors, pour the contents of one sachet into about 20 ml of water, and shake until completely dissolved; then take immediately.
Penilevel may be taken with or without food, although it is preferable to take it on an empty stomach, 1 hour before or 2 hours after meals.
If you take more Penilevel than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.
If you forget to take Penilevel
If you forget to take a daily dose, take the next dose as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Penilevel
It is important to continue taking Penilevel unless your doctor tells you to stop the treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Penilevel can cause adverse effects, although not everybody will experience them.
The most frequently occurring adverse effects are gastrointestinal and allergic reactions.
Stop taking the medicine and consult your doctor immediately if you experience any of the following reactions:
- Allergic reaction accompanied by labored and rapid breathing, redness and itching, hives (wheals), skin swelling (especially of the lips, face and tongue), chills or fever,
- Urticaria and skin reactions,
- Tremors,
- Acute and profuse diarrhea, usually accompanied by blood and mucus, stomach pain and fever.
If you experience any of the following adverse effects frequently (stomach pain, nausea, vomiting and diarrhea), discuss them with your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Penilevel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Penilevel
- The active substance is potassium phenoxymethylpenicillin (potassium penicillin V), equivalent to 250 mg of phenoxymethylpenicillin.
- The other components are: Sucrose, sodium saccharin, banana flavouring, and aspartame (E-951).
Appearance of the medicine and contents of the pack
Penilevel 250 mg powder for oral solution is available in cartons containing 20 or 40 sachets, depending on the pack size.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228
08020 Barcelona, Spain.
Manufacturer
LABORATORIOS ERN, S.A.
Gorgs Lladó, 188
08210 Barberà del Vallès, Barcelona, Spain.
Date of the most recent review of this leaflet: February 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/