Trimoptin Tablets 100 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trimethoprim

Available from:

Athlone Laboratories Ltd

ATC code:

J01EA; J01EA01

INN (International Name):

Trimethoprim

Dosage:

100 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Trimethoprim and derivatives; trimethoprim

Authorization status:

Marketed

Authorization date:

2004-07-30

Patient Information leaflet

0011 CCRF21029
PATIENT INFORMATION LEAFLET
TRIMOPTIN
TABLETS 100MG
TRIMOPTIN
TABLETS 200MG
(Trimethoprim)
READ ALL OF THIS LEAFLET CAREFULLY 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 THESE 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 Trimoptin Tablets are and what they are used for
2.
What you need to know before you take Trimoptin Tablets
3.
How to take Trimoptin Tablets
4.
Possible side effects
5.
How to store Trimoptin Tablets
6.
Contents of the pack and other information
1.
WHAT TRIMOPTIN TABLETS ARE AND WHAT THEY ARE USED FOR
Trimoptin Tablets belong to a group of medicines known as
antibacterials and they contain
Trimethoprim as the antibiotic. They are used to treat infections in
your body, primarily urinary and
respiratory tract infections and for the prevention of recurrent
urinary tract infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMOPTIN TABLETS
DO NOT TAKE TRIMOPTIN TABLETS IF YOU:
•
are allergic to trimethoprim, or to any of the other ingredients
mentioned in Section 6
(consult your doctor if you think you might be)
•
suffer from severe kidney or liver impairment
•
suffer with fragile X chromosome (an inherited physical and
intellectual impairment)
•
suffer with porphyria (a disorder that may cause skin sensitivity to
the sun, pain attacks and
muscle weakness)
•
suffer from anaemia or other blood disorders
•
are pregnant
Trimethoprim is not suitable for babies less than 6 weeks old.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Trimoptin Tablets:
•
if you suffer from kidney or liver impairment or are having dialysis
treatment
•
if you are receiving long-term tre

Summary of Product characteristics

Health Products Regulatory Authority
15 June 2021
CRN009S1J
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trimoptin Tablets 100 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Trimethoprim 100 mg.
Also contains 10mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Flat, white, bevelled-edge tablets embossed ‘TR 100’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infections caused by trimethoprim-sensitive organisms
including urinary and respiratory tract infections and
prophylaxis of recurrent urinary tract infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Trimoptin 100mg tablets are not recommended for use in children under
12 years of age. Other suitable dosage forms are
available for this patient population.
1. Treatment of respiratory and urinary tract infections
Adults: 200mg twice daily for 7 – 10 days
The first dosage on the first day can be doubled.
Children
Over 12 years: same as adult dose
Not recommended for use in children under 12 years
2. Prophylaxis of recurrent urinary tract infection:
Adults: The usual dose is 100mg at night. An extra 100mg may be taken
in the morning if necessary.
Children
Over 12 years: same as adult dose
Not recommended for use in children under 12 years
3. Dosage in renal impairment
​
Creatinine Clearance (ml/sec)
​Plasma creatinine
(micromole/l)
​Dosage advised
​
Over 0.45
​Men <250
​Normal
Health Products Regulatory Authority
15 June 2021
CRN009S1J
Page 2 of 7
Women <175
​
0.25 - 0.45
​Men 250-600
Women 175-400
​Normal for 3 days then half dose
​
Under 0.25
​Men ˃600
Women >400
​Half the normal dose
Trimethoprim is removed by dialysis. However, it should not be
administered to dialysis patients unless plasma concentrations
can be estimated regularly.
Route of administration: Oral.
4.3 CONTRAINDICATIONS
Hypersensitivity to Trimethoprim or any of the excipients.
Severe hepatic insufficiency.
Severe renal insufficiency unless