Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Diphenhydramine Hydrochloride 25 mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Diphenhydramine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for ; Diphenhydramine Hydrochloride Tablets contain the active substance diphenhydramine hydrochloride which is an antihistamine with sedative properties which induces drowsiness or sedation. It works by reducing the time needed o fall asleep and increases the depth and quality of sleep. Diphenhydramine hydrochloride is used to aid relief of emporary sleep disturbance (difficulties sleeping) in adults and children over 16 years of age.
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Diphenhydramine Hydrochloride Tablets Do not take Diphenhydramine Hydrochloride Tablets:
- tricyclic antidepressants (e.g. imipramine, amitriptyline). Diphenhydramine Hydrochloride Tablets with alcohol Do not drink alcohol if you are taking this medicine. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine. Driving and using machines: This medicine causes drowsiness and sedation and may also cause dizziness, blurred vision, disturbance in attention and
slower reaction times. Do not drive or operate machinery while you are affected in this way.
Diphenhydramine Hydrochloride Tablets contain lactose This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking 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
What you need to know before you take it
e Diphenhydramine Hydrochloride Tablets
- venlafaxine used to treat depression
- antimuscarinics which relax smooth muscles and are used
3. How to take Diphenhydramine Hydrochloride Tablets
for example in Parkinsons Disease, irritable bowel
How to take it
Diphenhydramine Hydrochloride Tablets
¢ if you have a blockage between your stomach and small intestine.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with
Warnings and precautions
your doctor or pharmacist if you are not sure.
Talk to your doctor or pharmacist before taking Diphenhydramine Hydrochloride Tablets
he recommended dose is: Adults and children over 16 years:
¢ if you suffer from myasthenia gravis (abnonnal muscle function) ¢ if you suffer from seizures or have epilepsy
25mg strength tablets: Take two tablets 20 minutes before going to bed. 50mg strength tablets: Take one tablet 20 minutes before
¢ if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD)
going to bed. Do not exceed the stated dose. Do not continue to take it for
- if you have narrow angle glaucoma ¢ if you have an enlarged prostate
longer than 2 weeks without consulting a doctor. Use in children:
- if you have difficulty urinating
Do not use in children under 16 years of age.
- if you have moderate to severe liver or kidney problems
- if you are elderly, particularly if you also suffer from confusion.
This medicine is for oral use. Swallow the tablets whole
with water.
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o not use this medicine after the expiry date which is stated on the label, carton or blister after "EXP".
If you take too much of this medicine it is likely to result in
The expiry date refers to the last day of that month.
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effects similar to those listed below in section 4 Possible Side Effects. Other effects may include dilated pupils, fever,
This medicinal product does not require any special a:
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flushing, agitation, shaking, movement disorder, seeing or hearing things that are not real or ECG changes. A large overdose may cause abnormal muscle breakdown which can lead to kidney problems, fits, delirtum, loss of contact with es .
Do not throw away any medicines via wastewater or household waste. Ask vour pharmacist how to throw ousenore waste. yourP . away medicines you no longer use. These measures will help
Talk to your doctor or pharmacist if you take too many tablets.
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If you have any further questions on the use of this medicine ask your doctor or pharmacist.
What Diphenhydramine Hydrochloride Tablets contains
reality, irregular heartbeat, coma or cardiovascular collapse.
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The active substance is diphenhydramine hydrochloride. Each tablet contains either 25 mg or 50 mg diphenhydramine hydrochloride. The other ingredients are Lactose monohydrate, Maize Starch and Magnesium Stearate.
; _. . .. ; Like all medicines, this medicine can cause side effects, although not everybody gets them. . If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as these may be signs of an allergic reaction:
What Diphenhydramine Hydrochloride Tablets looks like land contents of the pack ; Diphenhydramine Hydrochloride 25 mg Tablet are white, circular, normal convex tablets marked with '25' on one side & plain on the reverse. . Diphenhydramine Hydrochloride 50 mg Tablets are white, circular, biconvex tablets with embossed '50' on one side &
¢ difficulty breathing or shortness of breath, swelling of the face, mouth or throat ° rash, hives (itchy, raised red weals).
If you notice any of the following effects tell your doctor
plain on other side.
straightaway:
° fever, chills, sore throat, infections. These may be signs of} | Diphenhydramine Hydrochloride Tablets are available in
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a blood disorder
- faster heartbeat, irregular heartbeat
cartons containing blister packs of Aluminium-PVC/PVDC foil of 12's, 16's and 20's along with a leaflet inside.
- fits, difficulty making or controlling movements.
Not all pack sizes may be marketed.
Tell your doctor, pharmacist or nurse if you suffer from any of the following other effects:
Marketing Authorization Holder Flamingo Pharma (UK) Ltd. 1" Floor, Kirkland House,
Common effects (may affect up to 1 in 10 people): ¢ sedation, drowsiness, dizziness, unsteadiness, disturbance
11-15 Peterborough Road, Harrow, Middlesex,
in attention
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2AX, United Kingdom.
¢ dry mouth ° fatigue Other effects:
Manufacturers re Pharma (UK) Limited
- palpitations (feeling your heartbeat)
- headache, tingling or numbness (pins and needles) ° depression, sleep disturbances
38 Springfield Way, Anlaby, Hull, HU10 6RJ, United Kingdom
- confusion, excitation e.g. increased energy, restlessness,
nervousness (the elderly are more likely to experience these
[This leaflet was last revised in 06/2020.
effects) ¢ difficulty urinating or inability to pass urine
- thicker bronchial mucus
- blurred vision
- feeling or being sick, stomach problems
- muscle twitching Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Possible side effects
syndrome and incontinence e.g. procyclidine,
5. How to store Diphenhydramine Hydrochloride Tablets
trihexyphenidyl, atropine, oxybutinin, fesoterodine
How to store it
Diphenhydramine Hydrochloride OE Cay
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Keep this medicine out of the sight and reach of children.
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Customer/ Livery : FPL – UK
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Frequently asked questions about Diphenhydramine Hydrochloride 25 mg Tablets
How do I take Diphenhydramine Hydrochloride 25 mg Tablets?
Diphenhydramine Hydrochloride 25 mg Tablets comes as tablet containing 25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Diphenhydramine Hydrochloride 25 mg Tablets?
The active substance in Diphenhydramine Hydrochloride 25 mg Tablets is diphenhydramine hydrochloride.
Are there equivalent medicines to Diphenhydramine Hydrochloride 25 mg Tablets?
Medicines with the same active substance, strength and form include: Boots Sleepeaze 25mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Diphenhydramine Hydrochloride 25 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Diphenhydramine Hydrochloride 25 mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: diphenhydramine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
An aid to the relief of temporary sleep disturbance.
4.2. Posology and method of administration
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.
Method of administration
For oral administration.
4.3. Contraindications
Diphenhydramine is contraindicated for patients known to be hypersensitive to the drug or to any of the excipients listed in section 6.1.
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.
Avoid use in elderly patients with confusion.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Diphenhydramine may potentiate the sedative effects of alcohol and other CNS depressants (e.g. tranquillizers, hypnotics and anxiolytics).
Monoamine oxidase inhibitors (MAOIs) prolong and intensify the anticholinergic effects of diphenhydramine. The product should be used with caution with MAOIs or within 2 weeks of stopping an MAOI.
As diphenhydramine has some antimuscarinic activity, the effects of some anticholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated therefore medical advice should be sought before taking diphenhydramine with such medicines.
Diphenhydramine is an inhibitor of the cytochrome p450 isoenzyme CYP2D6.
Therefore, there may be a potential for interaction with drugs which are primarily metabolised by CYP2D6, such as metoprolol and venlafaxine.
Diphenhydramine should not be used in patients receiving any of the above drugs unless directed by a doctor.
4.6. Fertility, pregnancy and lactation
Pregnancy
Diphenhydramine crosses the placenta. Because animal reproduction studies are not always predictive of human response and since there is inadequate experience with use of diphenhydramine in pregnant women, the potential risk for humans is unknown. Use of sedating antihistamines during the third trimester may result in reactions in the newborn or premature neonates. This drug is not recommended during pregnancy. Consult a doctor before use.
Breastfeeding
Diphenhydramine has been detected in breast milk, but the effect of this on breastfed infants is unknown. Diphenhydramine is not recommended for use during breastfeeding. Consult a doctor before use.
Fertility
There are no available data on the effect of diphenhydramine on fertility.
4.7. Effects on ability to drive and use machines
Diphenhydramine is a hypnotic and will produce drowsiness or sedation soon after the dose has been taken. It may also cause dizziness, blurred vision, cognitive and psychomotor impairment. These can seriously affect the patient's ability to drive and use machines. If affected, do not drive or operate machinery.
4.8. Undesirable effects
Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trials and which are considered to be common (occurring in >1/100 to <1/10) or very common (occurring in >1/10) are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post-marketing use is unknown, but these reactions are likely to be uncommon (occurring in >1/1000 to <1/100), or rare (occurring in <1/1000).
Blood and lymphatic system disorders:
Unknown: agranulocytosis
Immune system disorders:
Unknown: hypersensitivity reactions including rash, urticaria, dyspnoea and angioedema
Psychiatric disorders:
Unknown: confusion, paradoxical excitation (e.g. increased energy, restlessness, nervousness), depression, sleep disturbances
* The elderly are more prone to confusion and paradoxical excitation.
Nervous system disorders:
Common: sedation, drowsiness, disturbance in attention, unsteadiness, dizziness
Unknown: convulsions, headache, paraesthesia, dyskinesias
Eye disorders:
Unknown: blurred vision
Cardiac disorders:
Unknown: tachycardia, palpitations, arrhythmias
Respiratory, thoracic and mediastinal disorders:
Unknown: thickening of bronchial secretions
Gastrointestinal disorders:
Common: dry mouth
Unknown: gastrointestinal disturbance including nausea, vomiting
Musculoskeletal and connective tissue disorders:
Unknown: muscle twitching
Renal and urinary disorders:
Unknown: urinary difficulty, urinary retention
General disorders and administration site conditions:
Common: fatigue
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdose is likely to result in effects similar to those listed under adverse reactions.
Additional symptoms may include mydriasis, fever, flushing, agitation, tremor, dystonic reactions, hallucinations and ECG changes. Large overdose may cause rhabdomyolysis, convulsions, delirium, toxic psychosis, arrhythmias, coma and cardiovascular collapse.
Treatment should be supportive and directed towards specific symptoms. Convulsions and marked CNS stimulation should be treated with parenteral diazepam.
💬 Ask about this leaflet
Ask anything about Diphenhydramine Hydrochloride 25 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.