ERYTHROMYCIN 125 MG/5ML SUGAR FREE GRANULES FOR ORAL SUSPENSION

Active substance: ERYTHROMYCIN ETHYL SUCCINATE ESTER

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PATIENT INFORMATION LEAFLET
Primacine 125mg / 5ml Sugar Free Granules for Oral Suspension
Erythromycin ethyl succinate
Read all of this leaflet carefully before you start taking
this medicine.
- 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 gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Primacine is and what it is used for
2. Before you take Primacine
3. How to take Primacine
4. Possible side effects
5. How to store Primacine
6. Further information

Pregnancy and breast-feeding
As with all medicines, ask your doctor for advice before taking
Primacine if you are pregnant or if you are breast-feeding.
Important information about some ingredients of Primacine
Primacine contains sorbitol (E420). Tell your doctor before
taking this medicine if you have an intolerance to some sugars.

3. HOW TO TAKE PRIMACINE
The usual dose depends on the severity and nature of the infection;
your doctor will tell you what dose to take. Patients with kidney
problems must be given a reduced dose.
Shake Primacine well before use.
Taking Primacine with food and drink: Take Primacine before meals.
The usual dose is:
Adults, the elderly and children (over 8 years):
Two to four 5ml spoonfuls every 6 hours. Maximum daily dose:
up to 4g, your doctor will work out the maximum daily dose based
on the patient’s body weight.
For Acne vulgaris, the dose is two 5ml spoonfuls 3 times daily
before meals, for 1 to 4 weeks, and then reduced to twice daily
until improvement occurs.

1. WHAT PRIMACINE IS AND WHAT IT IS USED FOR
Primacine contains erythromycin ethyl succinate, which is
an antibiotic (macrolide group). It is used to treat or prevent
bacterial infections, including sexually transmitted diseases
and dental infections. It may be used to prevent whooping
cough, diphtheria or to treat certain skin infections
(Acne vulgaris).

2. BEFORE YOU TAKE PRIMACINE
Do not take Primacine if you:
• are allergic to erythromycin or any of the other ingredients
of Primacine (see Section 6 and end of Section 2)
• have ever reacted to any erythromycin-type antibiotic.
• have an intolerance to some sugars.
Before taking Primacine, consult your doctor if you:
• are pregnant, intending to become pregnant, or are
breast-feeding. Newborn babies treated with erythromycin
may develop a condition associated with severe vomiting
or irritability with feeding (infantile hypertrophic pyloric
stenosis, IHPS). If this occurs contact your doctor.

• have a history of or currently have liver disease.
• have kidney problems.
• have myasthenia gravis (a disease of the nerves causing
muscle weakness).
• are taking a urine test based on colour measurement, as
the results may be affected.
• develop unusual aches or pains in your muscles, which
go on for longer than expected.
Contact your doctor as soon as possible if you develop
watery and bloody stools during or up to 2 months after
treatment, with or without stomach cramps and fever (to rule
out the possibilty of pseudomembranous colitis).
Taking other medicines
DO NOT take Primacine if you are already taking the medicines:
• astemizole (for hives, rash, itching from an allergy,
or fever)
• terfenadine (for hayfever)
• cisapride (for heartburn)
• pimozide (for Tourette’s Syndrome)
• ergotamine or dihydroergotamine (for migraine)

Children aged 2 - 8 years:
Two 5ml spoonfuls every 6 hours or as advised by your doctor.
Maximum daily dose: up to 1.2ml per kg of body weight per
day in divided doses for standard infections and up to 2ml per
kg of body weight per day for severe infections, your doctor
will work this out.
Infants and babies up to 2 years:
One 5ml spoonful every 6 hours or as advised by your doctor.
An oral syringe may be used to measure this dose. Maximum
daily dose: up to 1.2ml per kg of body weight per day in divided
doses for standard infections and up to 2ml per kg of body weight
per day for severe infections, your doctor will work this out.
Your doctor may advise you to take your medicine differently,
so always follow your doctor’s advice and check with them
if you are not sure. Prolonged use of this antibiotic may result
in you becoming resistant to its action.
If you forget to take Primacine
Take the dose as soon as you remember, unless it is nearly time
for your next dose. Do not take a double dose to make up for
the missed dose.

Please tell your doctor if you are taking or have recently
taken any other medicines, including those obtained without
a prescription. Primacine may interfere with other medicines
you may be taking. Especially, tell your doctor if you are
taking any of the following:
• Sleeping pills (e.g. triazolam, zopiclone, hexobarbitone)
• Medicines used to treat anxiety (e.g. diazepam, midazolam
or buspirone)
• Medicines used to prevent organ transplant rejection
(e.g. ciclosporin, tacrolimus)
• Heart drugs (e.g. quinidine, digoxin, disopyramide)
• Cholesterol-lowering drugs (especially lovastatin as your
muscles may be affected)
• Medicines used to treat epileptic seizures (e.g. sodium
valproate, carbamazepine, phenytoin)
• Medicines used to reduce pain (e.g. alfentanil)
• Medicines that prevent blood clotting (e.g. warfarin or
acenocoumarol)
• Medicines used to control dopamine levels in the brain
(e.g. bromocriptine)
• Theophylline (medicine that helps you breathe easier)

If you take more Primacine than you should
If you take too much Primacine, go immediately to your
nearest hospital casualty department, taking your medicine
bottle with you to show what you have taken.
If you stop taking Primacine
Remember to keep taking this medicine until your doctor tells
you to stop. Do not stop just because you feel better. If you
stop too early, your infection may return, or get worse.
If you have any further questions on the use of Primacine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Primacine can cause side effects, although
not everybody gets them.
STOP taking Primacine and contact your doctor immediately
if you experience a rare allergic reaction, as you may need
emergency treatment. Symptoms include:
• swelling of the face/and throat
• difficulty breathing
• a rash
• itching or skin reactions with blisters or peeling skin

Serious side effects: STOP taking Primacine and contact
your doctor immediately if you experience any of the following:
• irregular heartbeat
• chest pain
• liver effects (yellowing of skin and/or whites of your
eyes, abdominal discomfort and loss of appetite)
Common side effects include:
• mild skin rash with no peeling or blistering
• mild allergic skin reactions e.g. hives
• skin rashes with fever (skin red, itchy and patchy in
appearance)
• feeling or being sick
• loss of appetite
• diarrhoea, upset stomach and abdominal discomfort
• pseudomembranous colitis (bloody diarrhoea)
• fever
• general feeling of being unwell
• severe vomiting or irritability with feeding in new born
babies (see section “before taking Primacine”)

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LEAFLET POSITION GUIDE

Erythromycin
Ethyl Succinate
19

100 ml when reconstituted

TO THE PATIENT

Read the package leaflet before use.

Reconstituted suspension should be
stored at 2˚C-8˚C (in a refrigerator).
Do not freeze. Shake well before use.
Keep tightly closed and use within 14 days.

KEEP ALL MEDICINES OUT OF THE
REACH AND SIGHT OF CHILDREN.

Dosage: As directed by physician.

TO THE PHARMACIST

Erythromycin Ethyl Succinate granules
for oral suspension. Do not store
granules above 25˚C.
To reconstitute add 80 ml water and
shake the bottle vigorously. The resulting
100 ml of suspension contains 125 mg
of Erythromycin activity in each 5 ml.
PL 04917/0048
23LL
Pinewood Laboratories Ltd.,
POM
Clonmel, Ireland.

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BARCODE NUMBER MUST FACE OUTWARDS

55

Primacine

125 mg/5 ml Sugar Free
Granules for
Oral Suspension

For oral administration. Each 5 ml
of Primacine Suspension contains 125 mg
of Erythromycin activity. This product
also includes sorbitol (E420).

• Medicines used to treat migraine (e.g. ergotamine)
• Antihistamines (e.g. cetirizine)
• Cardiac glycosides (e.g. digitoxin for heart failure or
abnormal heartbeat)
• Methylprednisolone (to treat sickle cell anaemia, a rare
blood disorder where red blood cells are affected)
• Cimetidine or Omeprazole (to treat stomach ulcers)
• Rifabutin (to treat tuberculosis)
• Sildenafil (used to treat erection problems in men or
pulmonary arterial hypertension)
• Vinblastine (used to treat certain kinds of cancer)
• Antifungals e.g. fluconazole, itraconazole
• St. John’s wort (used to treat mild depression)
• Contraceptive pill
• Other antibiotics
• Ritonavir (used to treat HIV)
• Verapamil (used to treat high blood pressure)
• Cilostazol (used to treat pain in leg when walking)
• Medications causing specific changes to your ECG (heart
trace) (prolongation of the QT interval)
• Colchicine (used to treat gout)

Very rarely, the following effects have been reported:
• irregular heartbeat or palpitations
• reversible deafness
• reinfection following prolonged or repeated doses
• transient confusion, fits and vertigo
• hallucinations
• low blood pressure
• inflammation of the kidneys which may result in kidney
failure
• pancreatitis - inflammation of the pancreas causing
abdominal pain, feeling or being sick.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE PRIMACINE
Keep out of the reach and sight of children. Do not use your
medicine after the expiry date which is stated on the label.
Once the granules are reconstituted by your doctor or
pharmacist, store medicine at 2˚C-8˚C (in a refrigerator), keep
the cap tightly closed, and use within 14 days. Do not freeze.
Take unused medicines to your pharmacist for safe disposal.

For oral administration. Each 5 ml
of Primacine Suspension contains 125 mg
of Erythromycin activity. This product
also includes sorbitol (E420).

Primacine
PRIMACINE
#125 MG/
#5 ML SUGAR
FREE

125 mg/5 ml Sugar Free
Granules for
Oral Suspension
Erythromycin
Ethyl Succinate

100 ml when reconstituted

TO THE PATIENT

Read the package leaflet before use.

Reconstituted suspension should be
stored at 2˚C-8˚C (in a refrigerator).
Do not freeze. Shake well before use.
Keep tightly closed and use within 14 days.

KEEP ALL MEDICINES OUT OF THE
REACH AND SIGHT OF CHILDREN.

Dosage: As directed by physician.

TO THE PHARMACIST

Erythromycin Ethyl Succinate granules
for oral suspension. Do not store
granules above 25˚C.
To reconstitute add 80 ml water and
shake the bottle vigorously. The resulting
100 ml of suspension contains 125 mg
of Erythromycin activity in each 5 ml.
PL 04917/0048
23LL
Pinewood Laboratories Ltd., POM
Clonmel, Ireland.

6. FURTHER INFORMATION
Primacine contains:
• the active substance: erythromycin ethyl succinate; each
5ml of the oral suspension contains erythromycin 125mg.
• the other ingredients: carmellose sodium, colloidal
anhydrous silica, riboflavin-5-sodium phosphate, orange
flavour (containing traces of propylene glycol), glyceryl
monostearate, anhydrous disodium hydrogen phosphate
and sorbitol (E420) (see end of Section 2: ‘Important
information’).
What Primacine looks like and contents of the pack
Primacine comes as granules for preparation by your
pharmacist. Once reconstituted it is a yellow liquid. It is
available in 100 ml amber glass or white plastic bottles, and
is also available in strengths of 250mg or 500mg per 5ml.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel,
Co. Tipperary, Ireland.
PL04917/0048
This leaflet was last updated in 04/2011.

PRIMACINE 125 MG/5 ML
SUGAR FREE
PRIMACINE #125 MG/#5 ML
SUGAR FREE

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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