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ERYTHROMYCIN TABLETS BP 250MG

Active substance(s): ERYTHROMYCIN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Rommix 250mg tablets
[Erythromycin]
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 or nurse.
• 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, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Rommix Tablets are and what they are used for
2. What you need to know before you take Rommix Tablets
3. How to take Rommix Tablets
4. Possible side effects
5. How to store Rommix Tablets
6. Contents of the pack and other information
1. What Rommix Tablets are and what they are used for
Erythromycin, the active ingredient in Rommix tablets, belongs to a group of medicines known as
antibiotics.
Rommix is used to treat bacterial infections causing infections o f the ear, nose, mouth, throat, gut
and chest. It can be used to treat skin infections including burns and to treat urinary infections and
sexually
transmitted infections. If may be used before or after operations to prevent infection.
2. W h a t y o u n e e d t o k n o w b efore you take Rommix Tablets
Do not take Rommix Tablets and tell your doctor if you:
• Are hypersensitive (allergic) to erythromycin or any of the other ingredients in this
medicine (See section 6. Contents of the pack and other information).
• Are taking Astemizole, Terfenadine or Mizolastine which are antihistamines and are
used to treat allergies (See section 2: Other medicines and Rommix Tablets)
• Are taking Cisapride for stomach problems (See section 2: Other medicines and Rommix
Tablets)
• Are taking Pimozide or Sertindole which are used to treat mental problems
• Are taking medicines know as ergot derivatives which are used to treat migraine and speed
up labour (e.g ergotamine, dihydroergotamine and methysergide)

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine if you:




Suffer from liver disease; your doctor may want to monitor your liver treatment
Have myasthenia gravis (muscle condition causing weakness) as Rommix Tablets may
aggravate your condition
Are already taking medication for a heart complaint as these may interfere with the heartbeat

(see section 2; Other medicines and Rommix Tablets)
• Are treating a young child with antibiotics and they are irritable or vomit when fed.
• Have previously experienced diarrhoea following the use of antibiotics
• Are pregnant and have been told that you have a sexually transmitted disease called
syphilis. In this case erythromycin may not be effective for preventing the transfer of this
infection to your baby. Consult your doctor before receiving erythromycin. Alternatively if
you were treated for early stages of syphilis during your pregnancy, and your child is under 1
year and is prescribed erythromycin, consult your doctor before giving erythromycin to your
child.
• Are taking colchicine (used for treatment of gout and arthritis) while also taking this
medicine as it may cause serious side effects
• Are taking 'statins' such as simvastatin or lovastatin (used to lower cholesterol) as serious
side effects may occur

Other medicines and Rommix Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

This is especially important if you are taking medicines from the following families:
-astemizole, terfenadine or mizolastine (used to treat allergies such as hayfever)
- pimozide (used to treat mental problems)
- ergotamine or dihydroergotamine (used to relieve migraine)
- cisapride (used to treat stomach problems)
-statins (used to lower cholesterol levels) e.g. simvaststin or lovastatin
- protease inhibitors (used to treat viral infections e.g. saquinavir)
-oral contraceptives.

This is also important if you are taking the following medicines:
-colchicine (used to treat gout and arthritis)
-cimetidine and omeprazole (used to treat acid reflux and other related conditions)
-clarithromycin, rifabutin or rifampacin (used to treat different types of bacterial infection)
-fluconazole, ketaconazole and itraconazole (used to treat fungal infections)
-digoxin, quinidine or disopyramide (used to treat heart problems)
-cilostazol used to treat peripheral circulation problems)

-hexobarbitone, Phenobarbital or midazolam (used as a sedative)
-warfarin or acenocoumarol (used to help thin the blood)
-valporate, carbamazepine or phenytoin (used to control epilepsy)
-theophylline (used to treat asthma and other breathing problems)
-ciclosporin or tacrolimus (used after organ transplants)
-bromocriptine (use to treat Parkinson’s disease)
-zopiclone or triazolam/alprazolam (used to help you sleep or relieve states of anxiety)
-alfentanil (used for pain relief)
-methylprednisolone (used to suppress the body’s immune system)
-St John’s Wort (a herbal medicine used to treat depression)
-verapamil (used to treat high blood pressure and chest pain)
-vinblastine (used to treat certain types of cancer)
-sildenafil (used to treat erectile dysfunction)

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are breast-feeding, you should ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Rommix Tablets may cause dizziness, if you are affected do not drive or operate machines.
Rommix Tablets contain Sunset E124 and E110
Rommix Tablets contain the colouring dispersed red lake which also contains sunset yellow (E124 and
E110), these can cause hypersensitivity (allergic reactions) this is more common in people allergic to
aspirin. Do not take Rommix Tablets is you are allergic to sunset yellow or dispersed red lake.
3. How to take Rommix Tablets
Always take Rommix Tablets exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed whole by mouth.
Adults and the Elderly:
The usual dose is 250mg every 6 hours one hour before meals. However, your doctor may suggest a
different dose. The dose may increase to 4000mg per day according to the severity of the condition.
Children:
Your doctor will determine the correct dose to use which depends on the age and weight of your child and
severity of the infection. The dose should be given 1 hour before meals. The usual dose is 3050mg/kg/day in divided doses given twice daily or every 6 hours. For more severe infections, this dose
may be doubled.

If you take more Rommix Tablets than you should
If you accidently take too many Rommix Tablets tell your doctor at once. If you can’t do this, go to the
nearest hospital casualty department. Take along any tablets that are left, the container and the label so the
hospital staff can easily tell what medicine you have taken.
If you forget to take Rommix Tablets
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not
take a double dose to make up for the forgotten dose.
If you stop taking Rommix Tablets
Even if your condition has improved it is important to complete the prescribed course of Rommix Tablets.
If you stop taking this medicine too soon, your infection may come back and could be more difficult to
treat.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you have sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) as
these may signs of an allergic reaction.
Serious side effects
If you develop any of the following side effects, contact your doctor immediately
• Chest pain or a fluttering heart beat (including palpitations)
• Severe stomach pain or diarrhoea which may be watery or bloody and high temperature
(fever), as these may be symptoms of a serious disorder (inflammation of the colon or
pancreatitis)
• Yellowing of the skin and the eyes which may indicate a liver disorder


Severe skin disorders, which is blistering and painful.

The following side effects have also been reported:
Less common:



Nausea (feeling sick), vomiting (being sick), stomach pain and discomfort which may occur
at higher dose levels
Liver problems which may have symptoms of jaundice (yellowing of the eyes and skin)



Rash which may be red or itchy

Rarely:

Other side effects
• Ringing in the ears (tinnitus)
• Super infections including colitis (with symptoms of severe diarrhea) and stomach pain
• Confusion, hallucinations (seeing or hearing things that aren’t really there), fits, vertigo
(feeling that the room is spinning) these may stop when the medication ceases
• Feeling generally unwell (malaise)
• Fever
• Inflammation of the kidneys (a condition known as interstitial nephritis)
• Low blood pressure.
• Increase in a particular type of white blood cells (eosinophilia)
• Reversible loss of hearing (usually associated with high doses or in patients with
kidney problems)
• Anorexia.
• Changes to the results of liver tests

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Rommix Tablets
Keep out the sight and reach of children.
Keep the tablets in a dry place away from direct light and below 25°C.
Do not use Rommix Tablets after the expiry date which is stated on the label. The expiry refers
to the last day of the month.
Do not use Rommix tablets if you notice visible signs of deterioration.
Medicines should not be disposed via waste water or household waste. Ask your pharmacist
how to dispose of medicine no longer required. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Rommix Tablets contain:
The tablets contain 250mg of the active substance Erythromycin BP/Ph. Eur
The other ingredients are
Maize starch,
Croscarmellose sodium,
Povidone, Purified Talc and
Magnesium Stearate.
Ingredients for Coating:
Hypromellose, Dispersed red lake 18152 (E110 and E124), polyethylene glycol 6000, Purified Talc,
Polysorbate 80 and methyacrylic acid – ethyl acylate Copolymer.
What Rommix Tablets look like and contents of the pack
Description: Reddish orange coloured, opaque enteric coated round tablet.
Contents of the pack: Blister pack with 14 tablets in a blister and 2 blisters in a carton.

Marketing Authorisation Holder

Co-Pharma Limited
Unit 4, Metro Centre,
Tolpits Lane, Watford, Herts,
WD18 9SS, UK
Manufacturer

Surepharm services Limited.
Unit 2H Bretby business Park,
Ashby Road East, A50 Bretby ,
Burton-on Trent. Staffs. DE15 0YZ
This leaflet was last amended in November 2015

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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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