Diphenhydramine 25mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Diphenhydramine hydrochloride

متاح من:

Crescent Pharma Ltd

ATC رمز:

R06AA02

INN (الاسم الدولي):

Diphenhydramine hydrochloride

جرعة:

25mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 03040100; GTIN: 5017123096259

نشرة المعلومات

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine contains the active substance diphenhydramine
hydrochloride which is an
antihistamine with sedative properties which induces drowsiness or
sedation. It works by
reducing the time needed to fall asleep and increases the depth and
quality of sleep.
This medicine is used to aid relief of temporary sleep disturbance
(difficulties sleeping) in
adults and children over 16 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE:
• if you are allergic to diphenhydramine hydrochloride or any of the
other ingredients of this
medicine (listed in section 6)
• if you have a peptic ulcer
• if you have a blockage between your stomach and small intestine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine:
• if you suffer from myasthenia gravis (abnormal muscle function)
• if you suffer from seizures or have epilepsy
• if you have asthma, bronchitis or Chronic Obstructive Pulmonary
Disease (COPD)
• if you have narrow angle glaucoma
• if you have enlarged prostate
• if you have difficulty urinating
• if you have moderate to severe liver or kidne

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diphenhydramine Hydrochloride Tablets 25 mg
Tesco Sleep Aid 25 mg Tablets
Lunox Sleep Aid 25 mg Tablets
Llodys Pharmacy Sleep Aid 25mg Tablets
Careway Sleep Aid 25mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diphenhydramine hydrochloride 25 mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, circular, normal convex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
An aid to the relief of temporary sleep disturbance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
Dosage instructions:
Two tablets to be taken 20 minutes before going to bed, or as directed
by a
physician.
Do not exceed the stated dose or frequency of dosing.
Children: Do not use in children under 16 years.
This medicinal product should not be used continuously for longer than
2
weeks without consulting a doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to diphenhydramine hydrochloride or to any of the
excipients.
Contraindicated for use in patients with the following conditions:
stenosing peptic
ulcer, pyloroduodenal obstruction.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Diphenhydramine should be used with caution in patients with
myasthenia
gravis, epilepsy or seizure disorders, prostatic hypertrophy, urinary
retention,
narrow-angle glaucoma, asthma, bronchitis and chronic obstructive
pulmonary
disease (COPD), moderate to severe hepatic impairment and moderate to
severe renal impairment.
Tolerance may develop with continuous use. Seek medical advice if
sleeplessness persists, as insomnia may be a symptom of a serious
underlying
medical illness.
This medicinal product should not be used continuously for longer than
2
weeks without consulting a doctor.
May increase the effects of alcohol, therefore alcohol should be
avoided.
Avoid use of other antihistamine-containing preparations, including
topical
antihistamines and cough and cold medicines.
Use with caution in the elderly, who are more likely to experience
side-effects.
Avo