Patient leaflet - Trimethoprim Dawa 200 mg tablets

1. What Trimethoprim tablets are and what they are used for

Trimethoprim tablets belong to a group of medicines known as antibacterials. They are used to kill a wide range of bacteria that cause infections in your body, primarily urinary and respiratory tract infections. This medicine can also be used for prevention of recurrent urinary tract infections.

2. What you need to know before you take Trimethoprim tablets

Do not take Trimethoprim tablets if you:

Ÿ are allergic (hypersensitive) to trimethoprim or to any of the other

ingredients of this medicine (see section 6)

Ÿ are pregnant (ﬁrst 3 months) or might be pregnant

Ÿ suﬀer from severe liver problems

Ÿ suﬀer from any blood disorders such as anaemia

Ÿ have ever developed a severe skin rash or skin peeling, blistering and/or

mouth sores after taking trimethoprim.

Trimethoprim should not be administered to premature babies or infants under 4 months of age.

The tablet form is NOT recommended for use in children under 6 years – the oral liquid form should be used.

Warnings and precautions

Talk to your doctor or pharmacist before taking Trimethoprim tablets if you: Ÿ are pregnant

Ÿ suﬀer from kidney problems/kidney disease or are having dialysis

treatment

Ÿ have a deﬁciency (are low) in folic acid (may cause anaemia) Ÿ are at greater risk of high levels of potassium in your blood

(hyperkalaemia), e.g. the elderly or those on higher doses Ÿ suﬀer from porphyria (a disorder that causes skin sensitivity to light, pain

attacks and muscle weakness)

Ÿ have a fructose intolerance or an intolerance to some sugars. You should let your doctor know and ask their advice if you suﬀer from or have ever had any of the above.

Serious skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with trimethoprim treatment. Stop taking trimethoprim and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Trimethoprim 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.

Your doctor may wish to do regular blood tests if you need long-term treatment or are prone to anaemia.

Children

This dosage form is not suitable for use in children younger than 6 years.

Other medicines and Trimethoprim tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even those not prescribed. Your medicine may interfere with other medicines that you are taking.

Take care with the following medicines:

Ÿ repaglinide, used to treat diabetes

Ÿ procainamide, to treat abnormal heart rhythm

Ÿ digoxin, to treat certain heart conditions

Ÿ potassium supplements

Ÿ medicines known as ACE inhibitors and angiotensin II antagonists, used to treat high blood pressure and certain heart conditions Ÿ heparin, used to treat and prevent blood clots

Ÿ diuretics, water tablets such as eplerenone, spironolactone, amiloride or triamterene

Ÿ rifampicin, antibiotic used to treat TB

Ÿ anticoagulants, to prevent clots from forming in the blood e.g. warfarin Ÿ phenytoin, to treat epilepsy

Ÿ pyrimethamine and dapsone, used to treat malaria

Ÿ immunosuppressant drugs - used in cancer treatment

(e.g. methotrexate) or to treat organ rejection after transplant (e.g. azathioprine or ciclosporin)

Ÿ bone marrow depressants.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should not be taken during the ﬁrst three months of pregnancy. Treatment with trimethoprim in the ﬁrst three months of pregnancy may increase the risk of miscarriage. Children born to mothers treated with trimethoprim during the ﬁrst trimester of pregnancy may have an increased risk of birth defects, in particular neural tube defects (where the spine and spinal cord do not form properly), oral clefts (where the lip and palate do not form properly) and defects aﬀecting the heart.

Driving and using machines

There is no evidence to suggest that Trimethoprim tablets aﬀect the ability to drive or operate machinery.

Trimethoprim tablets contain lactose

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

Trimethoprim tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

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. Trimethoprim tablets should be swallowed whole with a glass of water, but not chewed, at the same time each day.

The recommended dose is:

Adults and children over 12 years

Severe or sudden infections: usually your doctor will prescribe 200 mg taken twice daily.

Long-term treatment and prevention therapy: 100 mg at night.

Elderly

Dosage is dependent on kidney function.

Elderly patients with kidney problems will usually be prescribed a reduced dose.

Children aged 6 – 12 years

Severe or sudden infections: 100 mg twice daily.

Long-term treatment and prevention therapy: 50 mg at night. The usual dose is around 2 mg/kg body weight of the child per day.

Children under 6

This tablet form of Trimethoprim is not recommended for use in children under 6 years.

Your doctor has carefully chosen the correct dosage for you, taking into account the severity of your condition, your age and any other particular reasons special to you. Instructions on how many tablets to take and when to take them will be printed on the dispensing label on the pack. Never change the dose of your medicine without talking to your doctor ﬁrst.

If you take more Trimethoprim tablets than you should

If you forget to take Trimethoprim tablets

If you forget to take a dose of your medicine at the correct time, take it as soon as you remember, then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Trimethoprim tablets

Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking this medicine, your condition may reoccur or get worse. If you experience symptoms on stopping treatment, contact 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, this medicine can cause side eﬀects, although not everybody gets them.

Rare, serious allergic reactions have occurred known as anaphylactic or anaphylactoid reactions.

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

Ÿ diﬃculty breathing

Ÿ swelling of the face, lips, tongue and throat

Ÿ chest pain

Ÿ shock, fainting or collapse

Ÿ blistering/peeling of the skin

Ÿ pancreatitis (signs may include a sudden, severe upper abdominal pain) Ÿ skin eruptions/lesions

Ÿ deep swelling of the skin (angioedema)

Ÿ jaundice (yellowing of the skin or whites of the eyes)

Ÿ elevation of serum transaminases (an indication of liver damage) Ÿ elevation of bilirubin levels

Ÿ reddish patches on the trunk, often with central blisters, skin peeling,

ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and ﬂu-like symptoms (Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)) Ÿ widespread rash, high body temperature and enlarged lymph nodes

(DRESS syndrome or drug hypersensitivity syndrome).

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

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

Ÿ hyperkalaemia (particularly in the elderly and in HIV patients) which is

high levels of potassium in the blood (may result in abnormal heart rhythm).

Common (may aﬀect up to 1 in 10 people)

Ÿ headache

Ÿ skin rashes, hives

Ÿ thrush

Ÿ nausea, diarrhoea, vomiting.

Very rare (may aﬀect up to 1 in 10,000 people)

Ÿ constipation, severe watery/bloody diarrhoea, sore tongue and mouth Ÿ cough, shortness of breath, wheezing, nosebleeds

Ÿ 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 Ÿ kidney problems (signs may include painful urination or blood in the

urine)

Ÿ dizziness, tiredness, convulsions, ringing in the ears, vertigo, involuntary

movements, pins and needles, shakiness, tremors

Ÿ eye redness and pain

Ÿ increased sensitivity of the skin to the sun

Ÿ low blood sugar, low levels of sodium in the blood (may cause nausea,

tiredness, muscle cramping), anorexia

Ÿ depression, anxiety, sleeping diﬃculties and nightmares, confusion,

hallucinations, agitation, abnormal behaviour

Ÿ joint and muscle ache

Ÿ lupus erythematosus (an auto-immune disorder)

Ÿ purple discolourations of the skin, reduction in number of blood cells,

anaemia

Ÿ hypersensitivity, anaphylaxis, anaphylactoid reaction drug fever, allergic

vasculitis

Ÿ sore throat.

Not known (frequency cannot be estimated from the available data) Ÿ pruritus (itching)

Ÿ elevation of serum creatinine and blood urea nitrogen levels Ÿ gastrointestinal disturbances.

If any side eﬀects get serious, or if you notice any side eﬀects not listed in this leaﬂet, please tell your doctor or pharmacist.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow 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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use this medicine if you notice signs of deterioration such as discolouration.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Trimethoprim tablets contain

Ÿ The active substance is trimethoprim. Each tablet contains either

100 mg or 200 mg of trimethoprim.

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

What Trimethoprim tablets look like and contents of the pack

Trimethoprim DAWA 100mg Tablets are approximately 8.10 mm, white, round, ﬂat, bevelled edged tablets embossed with 'Rx' on one side and '100' on the other side.

Trimethoprim DAWA 200mg Tablets are approximately 10.10 mm, white, round, ﬂat, bevelled edged tablets embossed with 'Rx' on one side and '200' on the other side.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited,