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PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE 500MG/25MG FILM-COATED TABLETS

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL

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Package leaflet: Information for the patient
Paracetamol and diphenhydramine hydrochloride 500 mg/25 mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse
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 after 7 days.
What is in this leaflet
1.
What Paracetamol and diphenhydramine hydrochloride is and what it is used for
2.
What you need to know before you take Paracetamol and diphenhydramine hydrochloride
3.
How to take use Paracetamol and diphenhydramine hydrochloride
4.
Possible side effects
5.
How to store Paracetamol and diphenhydramine hydrochloride
6.
Contents of the pack and other information

1.

What Paracetamol and diphenhydramine hydrochloride is and what it is used for

Paracetamol and diphenhydramine hydrochloride is used to provide fast and effective relief of the
fever, aches and pains associated with colds and flu, headaches, backache, rheumatic and muscle
pains, period pains and toothache which is causing difficulty in getting to sleep.
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.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

2.

What you need to know before you take Paracetamol and diphenhydramine hydrochloride

Do not take Paracetamol and diphenhydramine hydrochloride if you:
 are allergic to paracetamol or diphenhydramine or any of the other ingredients of this medicine
(listed in section 6)
 have porphyria (too much of the pigment called porphyrin which may discolour the urine)
 have glaucoma (raised pressure in the eye)
 have taken another medicine containing paracetamol in the last 4 hours
 are elderly and suffer from confusion.
Important:
This product contains Paracetamol. Do not take with any other paracetamol-containing products.
Never take more Paracetamol and diphenhydramine hydrochloride 500 mg/25 mg than recommended.
Higher doses than those recommended do not increase the pain-relieving effect, but may cause very
serious liver damage. The symptoms of liver damage normally do not appear until after a few days.
After an overdose, it is therefore very important to seek medical advice as soon as possible, even if
you feel well. Do not take with any other flu or cold products.
Do not take with any other antihistamine-containing products.
Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol and diphenhydramine hydrochloride














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 are an alcoholic
if you have an enlarged prostate
if you have myasthenia gravis
if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD)
if you have been told by your doctor that you have an intolerance to some sugars.
if you suffer from haemolytic anaemia (a reduction in red blood cells which can make the skin
pale yellow and cause weakness or breathlessness).
if you suffer from reduced glutathione levels.
if you are elderly as elderly people are more likely to experience possible side effects. Carers
should be aware that this medicine should not be given to elderly patients with confusion.
if you are malnourished, dehydrated or weigh less than 50 kg.

Taking a painkiller for headaches too often or for too long can make them worse
Tolerance may develop with continuous use.
Other medicines and Paracetamol and diphenhydramine hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This is particularly important if you have taken monoamine oxidase inhibitors (MAOis) in the last 2
weeks or tricyclic antidepressants (prescribed for depression); atropine; metoclopramide or
domperidone (for nausea or vomiting); colestyramine (to lower blood cholesterol); medicines for
stomach cramps (e.g. dicycloverine) or travel sickness (e.g. hyoscine); medicines to treat anxiety or to
help you sleep; medicines that make you drowsy or give you a dry mouth; or blood thinning drugs
(anticoagulants e.g. warfarin).
Paracetamol and diphenhydramine hydrochloride with alcohol
Do not drink alcohol while using Paracetamol and diphenhydramine hydrochloride.
Pregnancy and breast-feeding
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.
Do not take Paracetamol and diphenhydramine hydrochloride if you are pregnant or breast feeding.
Driving and using machines
Do not drive or operate machinery after taking Paracetamol and diphenhydramine hydrochloride.
Paracetamol and diphenhydramine hydrochloride is intended to produce sleepiness or drowsiness soon
after the dose is taken.
Paracetamol and diphenhydramine hydrochloride contains brilliant blue FCF (E133)
This may cause allergic reactions

3.

How to take Paracetamol and diphenhydramine hydrochloride

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
For bedtime use only.
Swallow Paracetamol and diphenhydramine hydrochloride with water.

Adults (including the elderly) and adolescents 16 years and over:
Take 2 tablets about 20 minutes before bedtime.
Do not take more than 2 tablets per night.
When taking Paracetamol and diphenhydramine hydrochloride at bedtime, you may take other tablets
containing paracetamol during the day but do not take more than 4,000 mg paracetamol (including this
product) in any 24 hours with at least 4 hours between doses.
Adolescents 12 years to 15 years:
Take 1 tablet about 20 minutes before bedtime.
Do not take more than 1 tablet per night.
When taking Paracetamol and diphenhydramine hydrochloride at bedtime, you may take other tablets
containing paracetamol during the day but do not take more than 3,000mg paracetamol (including this
product) in any 24 hours with at least 4 to 6 hours between doses.
Do not take Paracetamol and diphenhydramine hydrochloride for more than 7 consecutive nights
without consulting your doctor.
Do not take anything else containing paracetamol while taking this medicine.
Not recommended for children under 12 years except under medical advice.
Do not exceed the stated dose.
If symptoms persist contact your doctor.
Prolonged use except under medical supervision may be harmful.

If you take more Paracetamol and diphenhydramine hydrochloride than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because
too much paracetamol can cause delayed, serious liver damage.
Do not take Paracetamol and diphenhydramine hydrochloride for more than one week
If your bedtime pain carries on for more than one week, or if your headache becomes persistent, see
your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Older people are more prone to these side effects.
When using this product you may experience:
 drowsiness, dizziness, tiredness, blurred vision, or difficulty concentrating
 dry mouth.
Stop taking this medicine and tell your doctor immediately if you experience:
 allergic reactions which may be severe such as skin rash and itching sometimes with swelling of
the mouth or face or shortness of breath
 chest tightness or thickening of phlegm
 difficulty in passing urine, headaches
 skin rash or peeling or mouth ulcers
 upset Stomach
 breathing problems. These are more likely if you have experienced them before when taking other
painkillers (such as ibuprofen and aspirin)
 seizures or difficulty of muscle coordination
 changes in heart rhythm
 unexplained bruising or bleeding.

These reactions are rare.
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
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Paracetamol and diphenhydramine hydrochloride

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Blister packs: Store below 25C
Tablet containers: This medicine does not require any special storage conditions
Shelf life after first opening the container (plastic bottles only): 6 months
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Paracetamol and diphenhydramine hydrochloride contains



The active substances are paracetamol and diphenhydramine. Each film-coated tablet contains
500 mg of paracetamol and 25 mg of diphenhydramine.
The other ingredients are:
 Tablet core: microcrystalline cellulose, crospovidone type A, povidone K29-32, stearic
acid, silica colloidal anhydrous.
 Tablet coating: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), talc,
macrogol/PEG 3350, methacrylic acid-ethyl acrylate copolymer type A, brilliant blue FCF
(E133), indigo carmine (E132), sodium bicarbonate.

What Paracetamol and diphenhydramine hydrochloride looks like and contents of the pack
Paracetamol and diphenhydramine hydrochloride 500mg/25mg Film-coated Tablets are blue, capsule
shaped, film-coated tablets, 17.6 mm x 7.5 mm, engraved with “A163” on one side.
Pack sizes:
Blister packs: 8, 12, 16 or 24 tablets.
Tablet containers: 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78, Hafnarfjördur, 220, Iceland
Manufacturer

Balkanpharma - Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa, 2600, Bulgaria
This leaflet was last revised in 05/2017
PL 30306/0766

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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