Label: information for the user

Penilevel 500 mg hard capsules

Potassium phenoxymethylpenicillin

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Label content

1. What Penilevel is and for what it is used
2. What you need to know before starting to take Penilevel
3. How to take Penilevel
4. Possible adverse effects
5. Storage of Penilevel
6. Contents of the package and additional information

Penilevel contains phenoxymethylpenicillin as the active ingredient. Phenoxymethylpenicillin is used to treat some infections caused by bacteria.It only acts on specific strains of bacteria.

Penilevel is used to treat the following infections:

Adults

• Respiratory infections: Acute streptococcal pharyngitis (group A).
• Acute bacterial skin and structure infections: Scarlet fever, impetigo, furuncle, ecthyma, erysipelas, and erysipeloid.
• Dental infections: Abscesses with disseminated cellulitis.

Adolescents 12 years of age and older

• Respiratory infections: Acute streptococcal pharyngitis (group A).
• Bacterial skin and structure infections: Scarlet fever, impetigo, furuncle, ecthyma, erysipelas, and cellulitis.
• Dental infections: Abscesses with disseminated cellulitis.

Do not take Penilevel

If you are allergic to phenoxymethylpenicillin or any of the other components of this medication (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 suffered any hypersensitivity or allergic reaction to any penicillin or other beta-lactam antibiotics.

Penicillins can cause severe allergic reactions that can be fatal.

In the case of patients with renal impairment, consult your doctor as it may be necessary to reduce the dose.

Continuous and repeated use of antibiotics should be avoided as it may create resistance and the appearance of other infections.

Patients with renal insufficiency or on low-potassium diets should note that this medication contains 55 mg (1.4 mmol) of potassium per capsule.

Other medications and Penilevel

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist about any of the following medications:

• Metotrexate (cancer and psoriasis medication): Penicillins may increase the risk of toxicity by reducing the excretion of metotrexate.
• Oral contraceptives (birth control pill): Penicillins may reduce the effectiveness of oral contraceptives, so additional contraceptive measures may be necessary (e.g., use of male condoms).
• Probenecid or Sulfinpirazona (gout medications).

Taking Penilevel with food, drinks, and alcohol

Penilevel can be taken with or without food, although it is recommended 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The influence on driving or operating machinery is negligible or insignificant.

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 weight.Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended doseis:

Adults

Adolescents 12 years of age and older

Your doctor will determine the correct dose for your child:

Due to the size of the capsules, Penilevel 500 mg hard capsules should not be used in children under 12 years of age or in patients who cannot swallow the capsules whole. For children under 12 years of age, there is a presentation in packets (Penilevel 250 mg packets).

Swallow the capsules whole with a glass of water. Do not open the capsules. Penilevel can be taken with or without food, although it is recommended to take it on an empty stomach or 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 Toxicological Information Service, phone 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 compensate for the missed doses.

If you interrupt treatment with Penilevel

It is essential to continue taking Penilevel, unless your doctor tells you to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Penilevel may produce adverse effects, although not everyone will experience them.

The most frequent adverse effects are gastrointestinal and allergic reactions.

Stop taking the medication and ask your doctor immediately if you experience any of the following reactions:

• Allergic reaction accompanied by forced and rapid breathing, redness, and itching, hives (rashes), skin inflammation (especially lips, face, and tongue), chills, or fever,
• urticaria and skin reactions,
• shaking,
• acute and profuse diarrhea, usually accompanied by blood and mucus, stomach pain, and fever.

If the following adverse effects are frequent (stomach pain, nausea, vomiting, and diarrhea), report them to your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store below 25°C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the box and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Penilevel

• The active principle is potassium phenoxymethylpenicillin (penicillin V potassium), equivalent to 500 mg of phenoxymethylpenicillin.
• The other components are:Microcrystalline cellulose, talc, magnesium stearate, gelatin, titanium dioxide (E-171), indigotin (E-132), and quinoline yellow (E-104).

Appearance of the product and content of the packaging

Penilevel 500 mg hard capsules are presented in packaging with 20, 40, and 500 capsules, in a PVDC/PVC-Aluminum blister of 10 capsules.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona, Spain.

Responsible for manufacturing

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain.

Date of the last review of this leaflet:October 2018

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/