ERYTHROPED A 500 MG TABLETS - patient leaflet, side effects, dosage

Erythroped® A 500 mg tablets

(erythromycin ethylsuccinate)

Read all of this leaflet carefully before you start taking this medicine.

• – Please 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• – If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Erythroped A tablets are and what they are used for.

• 2. Before you take Erythroped A tablets.

• 3. How to take Erythroped A tablets.

• 4. Possible side effects.

• 5. How to store Erythroped A tablets.

• 6. Further Information.

• 1. What Erythroped A tablets are and what they are used for.

The name of your medicine is Erythroped A 500 mg tablets but will be referred to as Erythroped A tablets throughout this leaflet. Erythroped A tablets contain the active ingredient erythromycin ethylsuccinate, which belongs to a group of medicines called macrolide antibiotics.

Erythroped A tablets are used to prevent and treat infections such as:

• Throat and sinus infections
• Chest infections, such as bronchitis and pneumonia
• Ear infections
• Mouth and dental infections
• Eye infections
• Skin and tissue infections, such as acne
• Stomach and intestinal infections
• Prevention of infection following burns, operations or dental procedures
• Other infections, such as sexually transmitted diseases, bone infections or scarlet fever.

• 2. Before you take Erythroped A tablets Do not take Erythroped A tablets if you;

• have been told that you are allergic to erythromycin or any of the other ingredients of Erythroped A tablets
• are currently taking a medicine called

• – terfenadine or astemizole or mizolastine (widely taken for hayfever and allergies)

• – pimozide or amisulpride (for psychiatric conditions)

• – domperidone (for nausea (feeling sick) and vomiting (being sick)

• – ergotamine or dihydroergotamine (used to relieve migraine)

• – cisapride (used to treat acid reflux)

• simvastatin (used to lower cholesterol and triglycerides (types of fat) in the blood)
• tolterodine (used for treating overactive bladder with symptoms of urinary frequency, urgency, and leakage).
• have any liver problems or are taking any medicines which can cause liver problems
• suffer from a condition called myasthenia gravis which causes muscle weakness.

If any of these apply to you, or if you are not sure, tell your doctor.

Taking other medicines

Please tell your doctor if you are taking, or have recently taken any other medicines, including any medicines obtained without a prescription.

This is especially important if you are taking medicines called:

• astemizole, terfenadine or mizolastine (used to treat allergies such as hay fever)
• domperidone (used to treat nausea (feeling sick) and vomiting (being sick))
• pimozide (used to treat mental problems)
• clarithromycin (an antibiotic)
• cisapride (used to treat acid reflux)
• ergotamine or dihydroergotamine (used to relieve migraine)
• digoxin or disopyramide quinidine (used to treat heart problems)
• hexobarbitone or midazolam (used as sedatives)
• warfarin or acenocoumarol (used to thin the blood)
• valproate, carbamazepine or phenytoin (used to control epilepsy)
• theophylline (used to treat asthma and other breathing problems)
• ciclosporin or tacrolimus (used following organ transplants)
• bromocriptine (used to treat Parkinson’s di­sease)
• alfentanil, zopiclone or triazolam (used to help you sleep)
• rifabutin (used to treat tuberculosis (TB))
• lovastatin (used to control cholesterol levels)

If you or your child goes for any medical tests, tell your doctor that you are taking Erythroped A tablets, as this may interfere with some test results.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, or if you are breast-feeding please consult your doctor before taking this medicine

3. how to take erythroped a tablets

Always take Erythroped A tablets exactly as your doctor has told you.

You should check with your doctor if you are not sure.

The usual dose for adults and children over 8 years is: 2 g daily in divided doses i.e. two tablets twice a day, taken just before or with meals or food.

If you have a bad infection you may be told to take up to 4 g (8 tablets) daily.

Continue to take this medicine until the course is completed or until your doctor tells you to stop; do not stop taking your medicine, even if you feel better. If you stop the treatment too early your problem could come back.

If you take more Erythroped A tablets than you should

If you accidentally take more medicine in one day than your doctor has told you to, or if a child has taken some of the medicine by mistake, contact your doctor or go to your nearest hospital emergency department immediately.

An overdose of Erythroped A tablets could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythroped A tablets

If you forget to take a dose of your medicine, take it as soon as you remember. Do not take more medicine in one day than your doctor tells you to.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Erythroped A tablets can cause side effects, although not everybody gets them.

If you notice any of the following, stop taking Erythroped A tablets and contact your doctor immediately:

• difficulty breathing
• fainting
• swelling of the face, lips or throat
• skin rashes
• severe skin reactions including large fluid-filled

blisters, sores and ulcers

• ulcers in the mouth and throat.

As these may be signs of an allergic reaction. Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side effect is not known (cannot be estimated from the available data).

If you develop severe or prolonged diarrhoea during or after taking Erythroped A tablets, tell your doctor immediately.

Other side effects of Erythroped A tablets include:

• Feeling sick or being sick
• Stomach pains
• Reversible loss of hearing (usually with high

doses)

• Damage to the blood, kidneys or nervous systems.
• Yellowing of the skin and/or eyes, which are signs of liver problems including jaundice.
• Chest pain
• Dizziness
• Abnormal heart rhythm
• Vomiting and irritability in young children between the age of 1 month and 12 months
• Visual impairment/blurred vision (Mitochondrial optic neuropathy)

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store erythroped a tablets do not store above 25°c.

Store in the original package.

Protect from light and heat.

Do not use these tablets after the expiry date shown on the blister/label. The expiry date refers to the last day of that month.

If this medicine becomes discoloured or shows any other signs of deterioration, please contact your pharmacist who will advise you on what to do.

KEEP OUT THE SIGHT AND REACH OF CHILDREN

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• 6. Further Information
  
  What Erythroped A tablets contains

  Each film-coated tablet contains 500 mg of the active ingredient erythromycin.

What Erythroped A tablets look like and contents of the pack

Erythroped A are yellow film-coated tablets and are available in bottles of 100 tablets and blister packs of 30 or 100 tablets.

Product Licence Holder and Manufacturer

Procured from within the EU by the Product Licence holder Orifarm A/S, Energivej 15, 5260 Odense S, Denmark

Repacked by

Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic

Manufactured by

Aesica Queenborough Limited

Queenborouugh, Kent

ME11 5EL

United Kingdom

Erythroped A 500 mg tablets I POM

PL 46927/0070

Leaflet revision date: 16/10/2017

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