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

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

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Package leaflet: Information for the user
Paracetamol/Diphenhydramine Hydrochloride 500mg/25mg Film-coated Tablets
Paracetamol/Diphenhydramine hydrochloride

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 have 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, pharmacist or nurse. 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.
The name of this medicine is Paracetamol/Diphenhydramine hydrochloride
500mg/25mg Film-coated Tablets.
In the rest of this leaflet Paracetamol/Diphenhydramine hydrochloride 500mg/25mg Filmcoated Tablets is called Paracetamol/Diphenhydramine hydrochloride.
What is in this leaflet:
1. What Paracetamol/Diphenhydramine hydrochloride is and what it is used for
2. What you need to know before you take Paracetamol/Diphenhydramine hydrochloride
3. How to take Paracetamol/Diphenhydramine hydrochloride
4. Possible side effects
5. How to store Paracetamol/Diphenhydramine hydrochloride
6. Contents of the pack and other information
1. What Paracetamol/Diphenhydramine hydrochloride is and what it is used for
Paracetamol/Diphenhydramine hydrochloride contains paracetamol which is an
analgesic (a pain killer which relieves aches and shivers) and antipyretic (it reduces
body temperature when you have a fever) and diphenhydramine hydrochloride, an
antihistamine that causes sleepiness or drowsiness making it useful when pain is
keeping you awake.
Paracetamol/Diphenhydramine hydrochloride 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.

2. What you need to know before you take Paracetamol/Diphenhydramine
hydrochloride
Do not take Paracetamol/Diphenhydramine hydrochloride:
• If you are allergic to paracetamol or diphenhydramine hydrochloride or to any of the
other ingredients of this medicine (listed in Section 6).
• With other products containing paracetamol.
• If you have a condition known as porphyria (too much of a pigment called porphyrin
which may discolour the urine).
• If you have glaucoma (increased pressure in your eye).
• If you suffer from asthma, do not use during an attack.
• With other medicines called antihistamines including those used on your skin or in
cough and cold medicines.
• If you are elderly and suffer from confusion.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol/Diphenhydramine
hydrochloride if you have:
• Liver or kidney problems, epilepsy, asthma, bronchitis or other breathing problems,
bowel obstruction, difficulty passing urine or have prostate problems, heart or circulation
problems, or myasthenia gravis (a disease with symptoms of muscle weakness and
fatigue).
• 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
• Glutathione deficiency
• Dehydration
• Chronic malnutrition
• Chronic alcoholism
• weight of less than 50kg
Children
Not recommended for children under 12 years except under medical advice.
Other medicines and Paracetamol/Diphenhydramine hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines
In particular tell your doctor or pharmacist if you are taking any of the following
medicines:
• You are taking metoclopramide or domperidone (used to treat nausea and vomiting) or
cholestyramine (used to treat high cholesterol) or warfarin (used to thin the blood).
• You are taking any other medicines particularly tablets to help you sleep or pain killers
or medicines for depression or anxiety, including venlafaxine, or tricyclic
antidepressants, or are taking or have taken in the last two weeks monoamine oxidase
inhibitors (MAOIs).
• You are taking metoprolol or atropine or medicines for stomach cramps or travel
sickness which may give you dry mouth or blurred vision.

• You are taking a medicine which can slow your heart beat (e.g. medicines used to treat
arrhythmias, some antibiotics, antimalarials or medicines used to treat psychological
conditions).
• You are taking a medicine which can decrease the level of potassium in your blood.
You should not take Paracetamol/Diphenhydramine hydrochloride at the same time as
other medicines containing antihistamines.
Paracetamol/Diphenhydramine hydrochloride with alcohol:
Alcohol should not be taken with Paracetamol/Diphenhydramine hydrochloride.
Pregnancy, breastfeeding 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:
Paracetamol/Diphenhydramine hydrochloride may cause drowsiness, dizziness, difficulty
concentrating or blurred vision which means that you should not drive or operate
machinery after taking the tablets.
3. How to take Paracetamol/Diphenhydramine hydrochloride
Always take this medicine exactly 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/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/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.
For Adolescents 12 years to 15 years: when taking Paracetamol/Diphenhydramine
hydrochloride at bedtime, you may take other tablets containing paracetamol during
the day but do not take do not take more than 3,000mg (including this product) in any
24 hours with at least 4 to 6 hours between doses.
Do not take Paracetamol/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 stated dose.
• If symptoms persist contact your doctor.
• Prolonged use except under medical supervision may be harmful.
If you take more Paracetamol/Diphenhydramine hydrochloride than you should
Immediate medical advice should be sought in the event of overdosage because of the
risk of irreversible liver damage.
If you forget to take Paracetamol/Diphenhydramine hydrochloride
Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Stop using this product and tell your doctor immediately if you experience any of the
following:
Common (may affect up to 1 in 10 people)
• fatigue.
• sedation, drowsiness, difficulty concentrating, unsteadiness, dizziness.
• dry mouth.
Very Rare (may affect up to 1 in 10,000 people)
• unexplained bruising or bleeding.
• allergic reactions such as skin rash or itching, sometimes with breathing problems or
swelling of the lips, tongue, throat or face.
• skin rash or peeling, swelling or mouth ulcers.
• previous breathing problems with aspirin or non-steroidal anti-inflammatories, and
you experience a similar reaction with this product.
• changes in blood tests that measure the function of your liver.
• cases of serious skin reactions.
Other side effects may include: confusion, restlessness, headache, seizure (fits),
tingling sensation in the skin, difficulty in making small movements, blurred vision,
raised or abnormal heart beat, thickening of phlegm, indigestion or upset stomach,
nausea, vomiting, muscle twitching, difficulty passing water.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme, Website: 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/Diphenhydramine hydrochloride
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) which is stated on the outer
carton and blister. The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.
6. Contents of the pack and other information
Each tablet contains: Paracetamol 500mg, Diphenhydramine hydrochloride 25mg.
The tablets also contain: maize starch, pregelatinised maize starch, povidone K30,
talc, stearic acid. The film coat contains: hypromellose, titanium dioxide (E171),
macrogol 400, indigo carmine (E132).
Paracetamol/Diphenhydramine hydrochloride are blue/light blue, capsule shaped,
film-coated tablets.
Paracetamol/Diphenhydramine hydrochloride 4, 10, 12, 20, 24 and 50 tablets in
blister strips. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Chanelle Medical
Loughrea
Co. Galway
Ireland
Manufacturer
Chanelle Medical,
Loughrea,
Co. Galway,
Ireland.
JSC Grindeks,
53 Krustpils street,
Riga,
LV-1057,
Latvia.
This leaflet was last revised in 10/2016

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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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