Buspirone 5mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Buspirone hydrochloride

Dostopno od:

Viatris UK Healthcare Ltd

Koda artikla:

N05BE01

INN (mednarodno ime):

Buspirone hydrochloride

Odmerek:

5mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04010200; GTIN: 5016695002309

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BUSPIRONE HYDROCHLORIDE 5 MG TABLETS
(buspirone hydrochloride)
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 Buspirone is and what it is used for.
2. What you need to know before you take Buspirone.
3. How to take Buspirone.
4. Possible side effects.
5. How to store Buspirone.
6. Contents of the pack and other information.
1. WHAT BUSPIRONE IS AND WHAT IT IS USED FOR
Buspirone contains the active ingredient buspirone hydrochloride.
Buspirone belongs to a
group of medicines called azapirones, used to treat anxiety. These
medicines work on the
central nervous system, altering levels of chemicals in the brain
which can help make you feel
less anxious. It should only be taken for a short time to relieve
anxiety.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUSPIRONE
DO NOT TAKE BUSPIRONE:

if you are allergic to buspirone hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)

if you have severe liver or kidney problems

if you have consumed high quantities of alcohol, hypnotics, pain
killers or antipsychotic
drugs (for mental illness) in the last few days

if you have epilepsy (suffer from fits)
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Buspirone:

if you have been prescribed a benzodiazepine e.g. nitrazepam,
temazepam or another
common sedative or hypnotic medicine (which may make you feel sleepy).
You should
be gradually withdrawn from these medicines before taking Buspirone

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buspirone Hydrochloride 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: buspirone hydrochloride 5 mg
Excipient with known effect:
Each tablet also contains 55.7 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Buspirone Hydrochloride 5 mg Tablets are white, round, bevelled edge
tablets,
embossed “BR 5” on one side, “G” on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Buspirone hydrochloride tablets are indicated for short-term use in
cases of anxiety
and to relieve the symptoms of anxiety with or without accompanying
depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be individualised for each patient
_Adults and older people_: Initially, a dose of 5 mg two to three
times daily is
given. After several weeks, to allow for a lag period, this may be
increased in
increments of 5 mg at 2 to 3 day intervals according to the
therapeutic
response. After dosage titration, the usual daily dose is 15 to 30 mg
per day in
divided doses. The maximum recommended daily dosage should not exceed
60 mg per day.
Food increases the bioavailability of buspirone.
If buspirone is administered with a potent CYP3A4 inhibitor, the
initial dose
should be lowered and only increased gradually after medical
evaluation (see
section 4.5).
Grapefruit juice increases the plasma concentrations of buspirone.
Patients
taking buspirone should avoid consuming large quantities of grapefruit
juice
(see section 4.5).
_Renal impairment _
After a single administration to patients with mild to moderate renal
insufficiency (creatinine clearance 20-49 ml/min/1.72 m
2
) a slight increase in
the buspirone blood levels was seen, without increase of the half-life
time. In
these patients buspirone should be administered with caution and a low
dosage, two-times daily, is advised. The response and the symptoms of
the
patients should be evaluated carefully, befo