Erythromycin Tablets Bp 250mg
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INFORMATION FOR THE USER
Rommix 250mg tablets [Erythromycin]
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, healthcare provider 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 or pharmacist.
In this leaflet:
1. What are Rommix Tablets and what are they used for
2. Before you take Rommix Tablets
3. How to take Rommix Tablets
4. Possible side effects
5. How to store Rommix Tablets
6. Further information
1. What are Rommix Tablets and what are they 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 to 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. Before 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. Further information).
• Are taking any of the following medicine:
• Astemizole, Terfenadine or Mizolastine which are antihistamines and are used to treat allergies
• Cisapride for stomach problems
• Pimozide or Sertindole which are used to treat mental problems
• Amisulpride which is used to treat depression and mood disorders
• Simvastatin which is used to lower cholesterol (fat) levels
• Medicines know as ergot derivatives which are used to treat migraine and speed up labour (e.g ergotamine, di-hydroergotamine and methysergide)
• Tolterodine which is used to treat bladder disorders.
Take special care with Rommix Tablets
• T ell your doctor 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; Taking other medicines)
• 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines should not be taken at the same time as Rommix . These are listed under section 2 “Do not take”:
Tell your doctor if you are on the following medicines:
• Chloramphenicol, Clinamycin or Lincomycin used to treat infections
• Theophylline used to treat asthma
• Carbamazepine, Valporate, Phenytoin or Hexobarbital which are used to treat epilepsy
• Digoxin, Quinidine or Disopyramide used in heart conditions
• Warfarin and Acecumerol used to prevent blood clots
• Cimetidine used to treat stomach ulcers
• Lovastatin or Atorvastatin used to reduce cholesterol (fat) levels
• Buspirone used to treat anxiety disorders
• Clozapine or Quetiapine used to treat mental health problems
• Zopiclone or Midazolam or Triazolam used to treat insomnia (inability to sleep)
• Cabergoline or Bromocriptine used in Parkinson’s disease
• Cilostazol is used to treat intermittent claudication (circulation disorder)
• Eletriptan used to treat migraine
• Felodipine used to treat high blood pressure
• Rifabutin used to treat tuberculosis (TB)
• Sildenafil or Tadalafil used to treat erection problems
• Tacrolimus or Ciclosporin which suppress the immune system after an organ transplant
• Alfentanil used as an anesthetic
• Astemizole, Terfenedine or Mizolastine, Amisulpride, Pimozide and Sertindole as these medicines may cause a change in heart rhythm.
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.
Important information about some of the ingredients Rommix Tablets
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 30-50mg/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, Rommix Tablets 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)
Rarely:
• Rash which may be red or itchy
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.
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. Further 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