Panadol NightPain tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Last ned Preparatomtale (SPC)
07-06-2018

Aktiv ingrediens:

Paracetamol; Diphenhydramine hydrochloride

Tilgjengelig fra:

Haleon UK Ltd

ATC-kode:

N02BE51

INN (International Name):

Paracetamol; Diphenhydramine hydrochloride

Dosering :

500mg ; 25mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04070100; GTIN: 5000347088254

Informasjon til brukeren

                                PHARMA CODE REF. NO. XXXX
PHARMA CODE REF. NO. XXXX
PHARMA CODE REF. NO. XXXX
PHARMA CODE REF. NO. XXXX
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use
Panadol NightPain carefully to get the best results from them.
• Keep this leaflet you may need to read it again.
• If you have any questions, or if there is anything you do not
understand,
ask your pharmacist.
IN THIS LEAFLET:
1. What Panadol NightPain does
2. Check before you take Panadol NightPain
3. How to take Panadol NightPain
4. Possible side effects
5. How to store Panadol NightPain
6. Further information
1. What Panadol NightPain does
PANADOL NIGHTPAIN IS USED FOR THE RELIEF OF BEDTIME PAIN. It is
suitable for pain
such as headache, migraine, backache, rheumatic and muscle pain,
neuralgia,
toothache or period pain.
The active ingredients are paracetamol and diphenhydramine
hydrochloride.
Paracetamol is a painkiller and diphenhydramine hydrochloride is an
antihistamine that causes sleepiness or drowsiness making it useful
when pain is
keeping you awake.
2. Check before you take Panadol NightPain
DO NOT TAKE PANADOL NIGHTPAIN:
• IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol,
diphenhydramine
hydrochloride or to any of the other ingredients (listed in Section 6)
• if you have PORPHYRIA (too much of the pigment called porphyrin
which
may discolour the urine)
• if you have taken another medicine containing PARACETAMOL IN THE
LAST 4 HOURS.
DO NOT TAKE WITH ANY OTHER ANTIHISTAMINE-CONTAINING PRODUCTS.
ASK YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE:
• if you have LIVER or KIDNEY DISEASE, including ALCOHOLIC LIVER
DISEASE
• if you have EPILEPSY, or SEIZURE DISORDERS
• if you have an OBSTRUCTION IN YOUR STOMACH OR GUT (for example,
because of an ulcer)
• if you experience DIFFICULTY PASSING URINE
• if you have narrow-angle GLAUCOMA (raised pressure in the eye)
• if you have an ENLARGED PROSTATE
• if you have MYASTHENIA GRAVIS
• 
                                
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Preparatomtale

                                OBJECT 1
PANADOL NIGHTPAIN
Summary of Product Characteristics Updated 23-Jun-2017 |
GlaxoSmithKline Consumer Healthcare
1. Name of the medicinal product
Panadol Night or Panadol NightPain
2. Qualitative and quantitative composition
Each tablet contains Paracetamol 500 mg and Diphenhydramine
hydrochloride 25 mg
Also contains lactose monohydrate.
3. Pharmaceutical form
Film-coated tablets
Blue film coated capsule shaped tablets embossed 'PM' on one face.
4. Clinical particulars
4.1 Therapeutic indications
For the short term treatment of bedtime pain, for example rheumatic
and muscle pain, backache,
neuralgia, toothache, migraine, headache and period pain which is
causing difficulty in getting to sleep.
4.2 Posology and method of administration
Oral administration only.
Do not exceed the stated dose or frequency of dosing
Adults (including the elderly) and children aged 16 years and over:
Two tablets to be taken 20 minutes before bedtime. Maximum daily dose:
Two tablets (1000 mg
paracetamol, 50 mg diphenhydramine hydrochloride) in 24 hours. Other
products containing paracetamol
may be taken for daytime pain relief but at a reduced maximum dose of
6 tablets in 24 hours. The dose
should not be repeated more frequently than every four hours.
Not recommended for children under 16 years of age except on medical
advice.
Patients should not take the tablets for more than 7 consecutive
nights without consulting their doctor.
4.3 Contraindications
Hypersensitivity to paracetamol, diphenhydramine hydrochloride or
other constituents. . Porphyria.
Antihistamines are contraindicated in premature infants or neonates
who have increased susceptibility to
antimuscarinic effects.
4.4 Special warnings and precautions for use
Antihistamines should be used with caution in conditions such as
epilepsy or seizure disorders, prostatic
hypertrophy, narrow-angle glaucoma, urinary retention, pyloroduodenal
obstruction, asthma, bronchitis,
chronic obstructive pulmonary disease (COPD) or myasthenia gravis.
Patients with renal or hepatic
impairme
                                
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