Pregabalin Medical Valley 50 mg Kapsel, hård

Country: Շվեդիա

language: շվեդերեն

source: Läkemedelsverket (Medical Products Agency)

active_ingredient:

pregabalin

MAH:

Medical Valley Invest AB

ATC_code:

N02BF02

INN:

pregabalin

dosage:

50 mg

pharmaceutical_form:

Kapsel, hård

composition:

laktosmonohydrat Hjälpämne; pregabalin 50 mg Aktiv substans

prescription_type:

Receptbelagt

leaflet_short:

Förpacknings: Blister, 100 kapslar (Al); Blister, 100 x 1 kapslar (endos) (Al); Blister, 14 kapslar (Al); Blister, 21 kapslar (Al); Blister, 56 kapslar (Al); Blister, 84 kapslar (Al); Blister, 14 kapslar (plast/Al); Blister, 21 kapslar (plast/Al); Blister, 56 kapslar (plast/Al); Blister, 84 kapslar (plast/Al); Blister, 100 kapslar (plast/Al); Blister, 100 x 1 kapslar (endos) (plast/Al)

authorization_status:

Godkänd

authorization_date:

2016-03-31

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
PREGABALIN MEDICAL VALLEY 25 MG HARD CAPSULES,
PREGABALIN MEDICAL VALLEY 50 MG HARD CAPSULES,
PREGABALIN MEDICAL VALLEY 75 MG HARD CAPSULES,
PREGABALIN MEDICAL VALLEY 100 MG HARD CAPSULES,
PREGABALIN MEDICAL VALLEY 150 MG HARD CAPSULES, PREGABALIN MEDICAL VALLEY 200 MG HARD CAPSULES,
PREGABALIN MEDICAL VALLEY 225 MG HARD CAPSULES
PREGABALIN MEDICAL VALLEY 300 MG HARD CAPSULES,
PREGABALIN
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 further questions, ask your doctor or your 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
belongs to a group of medicines used to treat
epilepsy, neuropathic pain and
Generalised Anxiety Disorder (GAD) in adults.
PERIPHERAL AND CENTRAL NEUROPATHIC PAIN:
is used to treat long lasting pain caused
by damage to the nerves. A variety of diseases can cause peripheral
neuropathic pain, such as
diabetes or shingles. Pain sensations may be described as hot,
burning, throbbing, shooting, stabbing,
sharp, cramping, aching, tingling, numbness, pins and needles.
Peripheral and central neuropathic
pain may also be associated with mood changes, sleep disturbance,
fatigue (tiredness), and can have
an impact on physical and social functioning and overall quality of
life.
EPILEPSY:
is used to treat a

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pregabalin Medical Valley 25 mg hard capsules
Pregabalin Medical Valley 50 mg hard capsules
Pregabalin Medical Valley 75 mg hard capsules
Pregabalin Medical Valley 100 mg hard capsules
Pregabalin Medical Valley 150 mg hard capsules
Pregabalin Medical Valley 200 mg hard capsules
Pregabalin Medical Valley 225 mg hard capsules
Pregabalin Medical Valley 300 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg hard capsules:
Each hard capsule contains 25 mg of pregabalin.
Excipients: Each capsule contains 65 mg of lactose monohydrate
50 mg hard capsules:
Each hard capsule contains 50 mg of pregabalin.
Excipients: Each capsule contains 130 mg of lactose monohydrate
75 mg hard capsules:
Each hard capsule contains 75 mg of pregabalin.
Excipients: Each capsule contains 8.30 mg of lactose monohydrate
100 mg hard capsules:
Each hard capsule contains 100 mg of pregabalin.
Excipients: Each capsule contains 11 mg of lactose monohydrate
150 mg hard capsules:
Each hard capsule contains 150 mg of pregabalin.
Excipients: Each capsule contains 16.50 mg of lactose monohydrate
200 mg hard capsules:
Each hard capsule contains 200 mg of pregabalin.
Excipients: Each capsule contains 22 mg of lactose monohydrate
225 mg hard capsules:
Each hard capsule contains 225 mg of pregabalin.
Excipients: Each capsule contains 24.7 mg of lactose monohydrate
300 mg hard capsules:
Each hard capsule contains 300 mg of pregabalin.
Excipients: Each capsule contains 33 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3
3.
PHARMACEUTICAL FORM
25 mg hard capsules:
Hard capsules with white cap and white body, with approximate size of
14 mm.
50 mg hard capsules:
Hard capsules with pink cap and pink body, with approximate size of 16
mm.
75 mg hard capsules:
Hard capsules with wh