PENILEVEL 500 MG HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Penilevel 500 mg Hard Capsules

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 any 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. See section 4.

Contents of the Package Leaflet

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

1. What is Penilevel and what is it used for

Penilevel contains phenoxymethylpenicillin as the active substance. Phenoxymethylpenicillin is used to treat certain infections caused by bacteria. It only works on specific strains of bacteria.

Penilevel is used to treat the following infections:

Adults

• Respiratory infections: Acute streptococcal pharyngitis (group A).
• Acute bacterial infections of the skin and its structures: Scarlet fever, ecthyma, furuncle, impetigo, erysipelas, and erysipeloid.
• Odontogenic infections: Dental abscesses with disseminated cellulitis.

Adolescents 12 years of age and older

• Respiratory infections: Acute streptococcal pharyngitis (group A).
• Bacterial infections of the skin and its structures: Scarlet fever, ecthyma, furuncle, impetigo, erysipelas, and cellulitis.
• Odontogenic infections: Dental abscesses with disseminated cellulitis.

2. What you need to know before you take Penilevel

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 impaired renal function, consult your doctor as a dose reduction may be necessary.

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

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

Other medications and Penilevel

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

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

• Methotrexate (medication for treating cancer and psoriasis): Penicillins can increase the risk of toxicity by reducing methotrexate excretion.
• Oral contraceptives (birth control pills): Penicillins can decrease the effectiveness of oral contraceptives, so additional contraceptive measures may be necessary (e.g., use of male condoms).
• Probenecid or Sulfinpyrazone (medications for treating gout).

Taking Penilevel with food, drinks, and alcohol

Penilevel can 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

The influence on driving or using machinery is nil or insignificant.

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 weight. Follow your doctor's or pharmacist's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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 sachets (Penilevel 250 mg sachets).

Swallow the capsules whole directly with a glass of water. The capsules should not be opened. Penilevel can 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.

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, 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 make up for forgotten doses.

If you stop taking Penilevel

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

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

4. Possible side effects

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

The most common side 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, flushing, and itching, hives (rash), skin inflammation (especially 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 the following side effects are common (stomach pain, nausea, vomiting, and diarrhea), discuss them with your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Penilevel

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 shown on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and other information

Composition of Penilevel

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

Appearance of the product and pack contents

Penilevel 500 mg hard capsules are available in packs of 20, 40, and 500 capsules, in PVDC/PVC-Aluminum blisters of 10 capsules.

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona, Spain.

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain.

Date of the last revision of this leaflet:October 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/