Pivmecillinam 200mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Pivmecillinam hydrochloride

Beszerezhető a:

Milpharm Ltd

ATC-kód:

J01CA08

INN (nemzetközi neve):

Pivmecillinam hydrochloride

Adagolás:

200mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 05010105; GTIN: 8901175025442

Betegtájékoztató

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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pivmecillinam hydrochloride is and what it is used for
2.
What you need to know before you take Pivmecillinam
hydrochloride
3.
How to take Pivmecillinam hydrochloride
4.
Possible side effects
5.
How to store Pivmecillinam hydrochloride
6.
Contents of the pack and other information
Pivmecillinam belongs to a group of medicines called penicillins. It
is a type of antibiotic.
Pivmecillinam works by killing germs (bacteria) that cause
infections.
Pivmecillinam hydrochloride is used to treat infections of the
bladder (cystitis) in adults.
Your doctor may have prescribed a different use or dosage than
stated in this information. Always follow your doctors instructions.
DO NOT TAKE PIVMECILLINAM HYDROCHLORIDE
Ÿ
If you are allergic to pivmecillinam or any of the other
ingredients of this medicine (listed in section 6).
Ÿ
If you are allergic to other antibiotics. Such antibiotics include
penicillin or cephalosporins.
Ÿ
If you have narrowing of the food pipe.
Ÿ
If you suffer from a condition which may reduce the amount of a
substance called carnitine in your body. Such conditions include
carnitine transporter defect, methylmalonic aciduria and
propionic acidaemia
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pivmecillinam
hydrochloride. The tablets must be taken with at least half a glass
of fluid to prevent that the tablets get stuck in your food pipe.
Before you take Pivmecillinam hydrochloride tell your doctor:
Ÿ
If you hav

Termékjellemzők

OBJECT 1
PIVMECILLINAM 200MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Oct-2015 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Pivmecillinam hydrochloride 200 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 200 mg of pivmecillinam
hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off-white, round shaped, biconvex, film coated tablets
debossed with 'F' on one side and '48' on
the other side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of adults with acute uncomplicated cystitis due to
mecillinam sensitive organisms.
4.2 Posology and method of administration
POSOLOGY
Adults: The usual dose is 200 mg two times daily for 7 days,
alternatively 200 mg 3 times daily for 5
days.
PAEDIATRIC POPULATION:
Pivmecillinam hydrochloride should not be used in children and
adolescents below 18 years because the
efficacy and safety have not yet been established.
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 Pivmecillinam hydrochloride
tablets.
HEPATIC IMPAIRMENT
Dosage adjustment is not necessary.
METHOD OF ADMINISTRATION
Route of administration is oral. The tablets must be taken with at
least half a glass of water, and
preferably taken with or immediately after a meal.
4.3 Contraindications
Pivmecillinam hydrochloride is contra-indicated in patients with:
• Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
• Hypersensitivity to penicillins and/or cephalosporins
• Any conditions resulting in impaired transit through the
oesophagus.
Genetic metabolism anomalies known to be leading to severe carnitine
deficiency such as carnitine
transporter defect, methylmalonic aciduria and propionic acidaemia.
4.4 Special warnings and precautions for use
Antibiotic-associated colitis has been reporte