Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Diphenhydramine hydrochloride
Haleon UK Ltd
N02BE51
Paracetamol; Diphenhydramine hydrochloride
500mg ; 25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5000347088254
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 • Les hele dokumentet
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 Les hele dokumentet