Minotrim 10mg/Ml Oral Suspension
Minotrim 10 mg/ml Oral Suspension leaflet 13-Jun-2016 14:45 87B/L/k/5
Leaflet Size 148 x 315 mm
CHEM1DEX PHARMA
87B/L/k/5
Read all of this leaflet carefully before you start using 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
Minotrim suspension contains trimethoprim which is an antibiotic.
It is effective against bacteria that cause infections such as:
• urinary tract infections
• chest infections.
Do NOT take Minotrim suspension if you:
• are allergic to trimethoprim or to any of the other ingredients (see Section 6)
• are pregnant or planning to become pregnant
• have a blood disorder
• have severe kidney problems.
If any of the above apply to you, speak to your doctor or pharmacist.
Take special care with Minotrim suspension
Before taking the suspension, tell your doctor if you:
• have been told you may have folic acid deficiency
• have kidney problems
• have high concentration of potassium ions in the blood
• are elderly
• are breast-feeding.
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, and herbal preparations.
Some medicines may be affected by Minotrim or they may affect how well Minotrim will work.
Tell your doctor or pharmacist if you are taking:
• anticonvulsants for epilepsy or related conditions, particularly phenytoin
• diuretics (water tablets), e.g. bendroflumethiazide
• medicines likely to increase the amount of potassium in your blood (e.g. ACE-inhibitors such as lisinopril)
• digoxin, a medicine used to treat certain heart conditions
• medicines that thin the blood (e.g. warfarin)
• ciclosporin, a medicine used to suppress the immune system
• folate antagonists (e.g. methotrexate used to treat arthritis or cancer))
• oestrogen-containing contraceptives. Ask your doctor or pharmacist about alternative contraception
• medicines likely to depress bone marrow (e.g. azathioprine, mercaptopurine)
• procainamide, a medicine used to treat certain heart conditions
• repaglinide, a medicine used to treat diabetes
• dapsone, a medicine used to treat skin infections.
• pyrimethamine, a medicine used to prevent malaria.
• lamivudine, a medicine used to treat HIV.
• oral typhoid vaccine, a medicine used to protect against typhoid fever.
Blood monitoring may be carried out if taking these drugs with Minotrim.
Pregnancy and breast-feeding
DO NOT take Minotrim if you are pregnant as it may affect your unborn baby.
Minotrim can pass into breast milk, therefore care should be taken if breast-feeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Minotrim is unlikely to affect your ability to use machinery or to drive.
Important information about some of the ingredients of Minotrim Suspension:
• sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sorbitol may have a mild laxative effect and can cause an upset stomach and diarrhoea. Each 5 ml of Minotrim Suspension contains 2.04 g of sorbitol.
Calorific value 2.6 kcal/g sorbitol.
• methyl hydroxy benzoate
This may cause allergic reactions (possibly delayed).
Always take Minotrim suspension exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure.
• Take the suspension by mouth.
• Shake the bottle gently before taking the medicine. It is important to shake up any sediment but do not shake it too hard - it may harm the suspension and produce even more sediment.
Doses to treat infections Adult: the usual dose is 20 ml twice a day (every 12 hours)
Children:
• 6 to 12 years: 10 ml twice a day
• 6 months to 5 years: 5 ml twice a day
• 6 weeks to 5 months: 2.5ml twice a day. Treatment will normally be given for 7 days, but not for more than 2 weeks.
Doses to prevent urinary infections
Adults: 10 ml at night
Children:
• 6 to 12 years: 5 ml at night
• 6 months to 5 years: 2.5 ml at night.
Dialysis patients
Trimethoprim is removed by dialysis. Blood tests may be carried out to check your blood levels before and after dialysis.
Elderly
Your doctor may prescribe a lower dose. You will be advised by your doctor.
Taking Minotrim long term
If you are taking this for long periods, blood tests may be carried out. The doctor may also prescribe an additional drug, folic acid, for you to take.
If you take more than you should
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the bottle and any remaining suspension with you so that people can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking
Do not stop just because you feel better. If you stop too soon, the infection may come back.
Keep taking the suspension until the prescribed course is finished.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Tell your doctor if you get any of the following side effects:
• muscle pain or muscle weakness
• nausea, vomiting or an upset stomach These symptoms are generally mild and disappear if you stop taking the medicine
• reactions to the sun. Skin may become red, painful and swollen - do not sunbathe, use a sun bed, or expose your skin to UV light.
Some people may get an increased amount of potassium in their blood (especially the elderly or those with kidney problems). You cannot feel or see this but your doctor may test your blood for this side effect.
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 directly 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.
• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the bottle label and on the carton. The expiry date refers to the last day of that month.
• Store below 25°C.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
Like all medicines, Minotrim suspension can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the suspension and seek medical help immediately if you have any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin.
Seek immediate medical attention if you have any of the following symptoms:
• eye pain, redness, or sensitivity to bright light, blurred vision, floaters (dots that move across the field of vision)
• sudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash
• unusual bleeding or bruising or fever, sore throat, mouth ulcers; repeated infections or infections that will not go away. This may be due to changes in your blood. Blood tests may be carried out to check for this
• yellowing of the skin or whites of the eyes caused by liver or blood problems.
What Minotrim Suspension contains
• The active ingredient is trimethoprim (10 mg per ml).
• The other ingredients are:
sorbitol (E420), methyl hydroxybenzoate (E218), carmellose, microcrystalline cellulose -carboxymethylcellulose sodium, ammonium glycyrrhizinate, anise oil and purified water. (See end of Section 2 for further information on sorbitol and methyl hydroxybenzoate).
What Minotrim Suspension looks like and contents of the pack
Minotrim suspension is a white liquid with an aniseed aroma.
It is available in plastic bottles of 25 ml and 100 ml. Not all pack sizes may be marketed
Marketing Authorisation Holder
Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB.
Manufacturer
MediFill UK Ltd, 59 Third Avenue, Deeside Industrial Park, Deeside, Flintshire, CH5 2LA.
This leaflet was last revised in
June 2016
'Chemidex' is a registered trade mark.
87B/L/k/5