Selexid 200mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Pivmecillinam hydrochloride

متاح من:

Dowelhurst Ltd

ATC رمز:

J01CA08

INN (الاسم الدولي):

Pivmecillinam hydrochloride

جرعة:

200mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 05010105

نشرة المعلومات

OTHER MEDICINES AND SELEXID
Tell your doctor or pharmacist if you are taking, have recently taken
or might
take any other medicines. This includes any medicines which you have
bought without a prescription.
You must tell your doctor or pharmacist if you are taking any of the
following
medicines:
*
Methotrexate: for arthritis or psoriasis. You may need to take a
different
dose of methotrexate.
*
Probenecid: for gout. This may increase the effect of Selexid.
*
Valproic acid or valproate: for epilepsy.
*
Any other antibiotic: for treating an infection such as erythromycin
or
tetracycline. This may have an effect on how Selexid works in your
body.
SELEXID WITH FOOD AND DRINK
Selexid should be taken during or after a meal. Tablets must be
swallowed
whole with at least half a glass of fluid, while sitting or standing
(see section
3 ‘How to take Selexid’).
It is important to take your medicine with plenty of fluid. This will
stop you
getting mouth ulcers or ulcers in your food pipe. Please read section
4 of this
leaflet so you can spot any signs this may be happening to you.
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.
Tell your doctor if you become pregnant while taking this medicine.
DRIVING AND USING MACHINES
Usually your medicine may have very little effect on your ability to
drive or
use machines. Check with your doctor if you feel any side effect that
may
stop you from driving or using machines.
HOW TO TAKE SELEXID
Always take this medicine exactly as your doctor or pharmacist has
told you.
Check with your doctor or pharmacist if you are not sure.
HOW MUCH SELEXID TO TAKE
Your doctor will tell you how many tablets to take, or give to your
child. Your
doctor will tell you how many times each day to take your medicine.
You should take the medicine at equally spaced times in the day.
Remember to always swallow the tablets whole during or immediately
after a
meal an

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Selexid
200 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pivmecillinam hydrochloride 200 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
A white circular film-coated convex tablet embossed with an Assyrian
lion on
one side and 137 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Selexid is indicated for the treatment of infections due to mecillinam
sensitive
organisms (see section 5.1), including:
•
urinary tract infections
•
salmonellosis
Preliminary experience in a small number of patients suggests that
Selexid
tablets may be a useful alternative antibiotic in the treatment of
acute typhoid
fever and in some carriers of salmonellae when antibiotic treatment is
considered essential.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND CHILDREN WEIGHING MORE THAN 40 KG:
Urinary tract infections:
•
Acute uncomplicated cystitis: 72 hour course of 2 tablets immediately
followed by 1 tablet 3 times daily to a total of 10 tablets.
•
Chronic or recurrent bacteriuria: 2 tablets three to four times daily.
Salmonellosis:
•
Enteric fever: 1.2-2.4 g daily for 14 days.
•
Salmonella carriers: 1.2-2.4 g daily for 2-4 weeks.
CHILDREN WEIGHING LESS THAN 40 KG:
•
Urinary tract infections: 20-40 mg/kg body weight, daily, in 3 to 4
divided
doses.
•
Salmonellosis: 30-60 mg/kg body weight, daily, in 3 to 4 divided
doses.
DOSAGE IN THE ELDERLY:
Renal excretion of mecillinam is delayed in the elderly, but
significant
accumulation of the drug is not likely at the recommended adult dosage
of
Selexid tablets.
Method of administration
Route of administration is oral. The tablets must be taken with at
least half a
glass of fluid, and preferably taken with or immediately after a meal.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipient