TRIMETHOPRIM DAWA 100 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - TRIMETHOPRIM DAWA 100 MG TABLETS

Trimethoprim DAWA 100mg and 200mg Tablets

(trimethoprim)

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.
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.
1. What Trimethoprim Tablets are and what they are used for
2. What you need to know before you take Trimethoprim Tablets
3. How to take Trimethoprim Tablets
4. Possible side effects
5. How to store Trimethoprim Tablets
6. Contents of the pack and further information

1. What Trimethoprim Tablets are and what they are used for Trimethoprim is a type of antibacterial medicine which works by killing bacteria.

Trimethoprim tablets may be used to treat urinary infections and respiratory tract infections and for long-term prevention of recurrent urinary tract infections.

2. what you need to know before you take trimethoprim tablets

Do not take Trimethoprim Tablets:

if you are allergic to Trimethoprim or any of the other ingredients of this medicine (listed in section 6)
if you have a severe blood disorder
if you are pregnant
if you have severe liver disease
Trimethoprim Tablets should not be given to premature babies or babies during the first 4 months of life.

If you are not sure whether any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Trimethoprim Tablets if you have:

kidney disease or undergo dialysis treatment
deficiency of folic acid (may caused anaemia)
suffer from porphyria (a disorder that causes skin sensitivity to light, pain attacks and muscle weakness).

Trimethoprim Tablets can increase potassium blood levels. Patients at risk of increased potassium blood levels include those with kidney problems, poorly controlled diabetes, or those on certain medicines or potassium supplements. The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache. Your doctor may perform blood tests to monitor your potassium blood levels.

There is only a slight difference between an effective dose of Trimethoprim Tablets and an overdose. Therefore, if you get symptoms such as nausea (feeling sick), vomiting (being sick), stomach pain and diarrhoea, stop taking Trimethoprim Tablets and immediately contact your doctor (see also section 4 ‚Possible side effects‘).

Trimethoprim Tablets can cause a serious decrease in bone marrow function leading to a decrease in certain white blood cells (agranulocytosis), a decrease in red blood cells and pigment (aplastic anaemia) and/or a low blood platelet count (thrombocytopenia). You should have regular blood tests to monitor any changes.

If you develop symptoms such as fever, inflammation of the mouth, sore throat, prolonged bleeding, bruising or skin problems, stop taking this medicine and contact your doctor immediately. These could be signs that you have a serious blood problem and your doctor may want you to have blood tests straight away (see also section 4 ‚Possible side effects‘).

Children and adolescents

Trimethoprim tablets are not recommended for children under the age of 6 years. Other more suitable formulations should be checked for their availablity.

Other medicines and Trimethoprim Tablets

Tell your doctor or pharmacist Trimethoprim if you are taking, have recently taken or might take any other medicines including medicines obtained without prescription.

Taking another medicine whilst you are taking Trimethoprim Tablets can affect how they or the other medicine works.

When Trimethoprim Tablets are taken together with any of the following medicines, side effects due to Trimethoprim toxicity are more likely and these can be serious and life-threatening. Tell your doctor if you are taking any of the following:

antibiotics such as rifampicin
anticoagulants to prevent your blood clotting such as warfarin
digoxin (to treat heart conditions)
phenytoin (to treat epilepsy)
pyrimethamine or Dapsone (to treat malaria)
bone marrow depressants and immunosuppressant drugs – used in cancer treatment (e.g. methotrexate, mercaptopurine) or to treat organ rejection after transplant (e.g. azathioprine or ciclosporin)
potassium supplements and potassium sparing diuretics such as amiloride, triamterene, spironolactone and eplenerone
medicines known as ACE inhibitors and angiotensin II antagonists (used to treat high blood pressure and certain heart conditions)
heparin (used to treat and prevent blood clots)
repaglinide (to treat diabetes)
diuretics (water tablets such as bendroflumethiazide, hydrochlorothiazide)
procainamide, to treat abnormal heart rhythm.

Check with your doctor before taking any such medicine while you are taking trimethoprim.

Trimethoprim Tablets with food and drink

Trimethoprim Tablets may be taken with or without food.

Pregnancy and breast-feeding

Trimethoprim should not be administered to pregnant women, premature infants or infants during the first few weeks of life.

Breast-feeding

If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Taking this medicine should not affect your ability to drive or operate machinery, however, if you think you are affected you should not drive or operate machinery until you feel better.

Trimethoprim Tablets contain lasctose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take trimethoprim tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many Trimethoprim Tablets to take and for how long you should take them.

Trimethoprim Tablets should be swallowed whole with a glass of water.

Treatment should continue for a period of between three days (e.g. uncomplicated bacterial cystitis in women) and two weeks according to the nature and severity of infection. The first dose can be doubled.

Adults and children over 12 years: 200mg twice daily.
Children 6–12 years: 100mg twice daily.
Children under 6 years of age: Not recommended; a more suitable dosage form should be used this age group.
Elderly: Dosage is dependent upon kidney function.

Long-term treatment and prophylactic therapy:

Adults and children over 12 years: 100mg at night.
Children 6–12 years: 50mg at night. Where a single daily dose is required, dosage at bedtime may maximize urinary concentrations. The approximate dosage in children is 2mg trimethoprim per kg body weight per day.
Elderly: Dosage is dependent upon kidney function.

If you suffer from impaired kidney function, your doctor may prescribe a reduced dose of trimethoprim.

If you take more Trimethoprim Tablets than you should

If you take more Trimethoprim Tablets than you are supposed to, contact your doctor or nearest hospital accident and emergency department immediately. Take this leaflet and any Trimethoprim Tablets you have left with you.

PHARMACODE

At too high a dose Trimethoprim Tablets can be seriously toxic, even fatal. Early symptoms of overdose (which appear on average after 3 hours but can take longer) may include nausea, vomiting, stomach pain, bloody diarrhoea and low blood pressure.

If you forget to take Trimethoprim Tablets

If you forget to take a dose take another as soon as you remember. If it is almost time for your next dose do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet. Do not take Trimethoprim Tablets with a shorter interval than prescribed by your doctor.

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

4. possible side effects

Like all medicines Trimethoprim Tablets can cause side effects, although not everybody gets them.

Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

STOP taking this medicine and contact your doctor or go to your nearest hospital casualty department IMMEDIATELY if you notice any of the following symptoms:

difficulty breathing, swelling of the face, lips, tongue or throat
chest pain, shock, fainting or collapse
blistering/peeling of the skin, skin eruptions/lesions, deep swelling of the skin (angioedema)
pancreatitis (signs may include a sudden, severe upper abdominal pain) jaundice (yellowing of the skin or whites of the eyes).

Tell your doctor or pharmacist if you notice any of the following side effects:

Very Common (may affect more than 1 in 10 people)

hyperkalaemia (particularly in the elderly and in HIV patients) which is high levels of potassium in the blood (may result in abnormal heart rhythm).
headache
skin rashes, hives, thrush
nausea, diarrhoea, vomiting.
anaemia (may cause you to feel tired and look pale), sore throats or mouth ulcers (due to a decrease in white blood cells)
abnormal bleeding due to low platelet count
allergic reactions
allergic inflammation of blood vessels
constipation, severe watery/bloody diarrhoea
cough
agitation, abnormal behaviour
aseptic meningitis can occur in some patients. This may show as a combination of symptoms such as headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light
kidney problems (signs may include painful urination or blood in the urine)
dizziness, tiredness
convulsions, involuntary movements, pins and needles, shakiness, tremors
ringing in the ears, vertigo
eye redness and pain
increased sensitivity of the skin to the sun
low blood sugar, low levels of sodium in the blood (may cause nausea, tiredness, muscle cramping)
anorexia
sore tongue
depression, anxiety, sleeping difficulties and nightmares, confusion, hallucinations
jaundice (yellowing of the skin or whites of the eyes), elevation of serum transaminases, (an indication of liver damage), elevation of bilirubin levels
joint and muscle ache
shortness of breath, wheezing, nosebleeds
lupus erythematosus (an auto-immune disorder)
purple discolorations of the skin
fever.

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 MHRAYellow 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.

5. how to store trimethoprim tablets

Do not take Trimethoprim Tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not take Trimethoprim Tablets if you notice that they are showing signs of deterioration such as discolouration.

This medicinal product does not require any special storage condition.

Medicines should not be disposed of 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. contents of the pack and further information

What Trimethoprim Tablets contains

The active ingredient in this medicine is trimethoprim.

Each tablet contains either 100 mg or 200 mg of trimethoprim.

The other ingredients are: lactose monohydrate, sodium starch glycollate, microcrystalline cellulose, povidone K30, magnesium stearate and purified water.

What Trimethoprim Tablets looks like and contents of the pack For 100mg tablets:

White coloured, round, flat bevelled edge (8.10 mm) tablets embossed with ‚Rx‘ on one side & ‚100‘ on other side.

For 200mg tablets:

White coloured, round, flat bevelled edge (10.10 mm) tablets embossed with ‚Rx‘ on one side & ‚200‘ on other side.

Trimethoprim Tablets are available in blister packs of 6, 10, 14, 28 & 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited

5, Sandridge Close,

Harrow, Middlesex,

HA1 1XD,

United Kingdom

Manufacturer

Drugsrus Limited