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IBUPROFEN EFFERVESCENT TABLETS 200MG

Active substance(s): IBUPROFEN

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PL16431/0090

PATIENT INFORMATION LEAFLET
SOLUBLE DENTOGEN IBUPROFEN EFFERVESCENT TABLETS
200 mg
Please read this leaflet carefully before you start to use this product. If you have any
questions, or if you are not sure about anything, ask your doctor or pharmacist.

Soluble Dentogen Ibuprofen Effervescent Tablets 200mg contain the following active
ingredient:
Ibuprofen 200mg.
In addition, they also contain the following inactive ingredients:
Sodium bicarbonate
Sodium carbonate (anhydrous)
Sodium cyclamate 1968
Sodium saccharin
Citric acid anhydrous
Docusate sodium
Polyethylene glycol powder 6000
Povidone
Orange mint flavour 611160E
IMS
Ibuprofen belongs to a class of medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs), which have both pain relieving and temperature reducing properties.
Soluble Dentogen Ibuprofen Effervescent Tablets 200mg are available in cartoned strip
packs containing 10, 12, 16, 24, 30, 36, 50, 56, 100 or 112 tablets.
MA Holder
Ayrton Saunders Ltd, 9Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire,
WA7 1NU
Manufacturer
Cupal Ltd, King Street, Blackburn, Lancashire, BB2 2DX, UK
Uses
For the relief of toothache pain and pain and swelling following minor oral surgery.

BEFORE USING SOLUBLE DENTOGEN IBUPROFEN
EFFERVESCENT TABLETS 200 MG
The following information should be read before using this medicine:
1. Do not use this medicine if you are sensitive (allergic) to ibuprofen or any of the

PL16431/0090

ingredients listed at the beginning of this leaflet
2. Make sure these tablets are suitable for you to use – ask your doctor or pharmacist
3. Do not take this medicine if you have ever had peptic ulcers or suffer from asthma
4. Do not take this medicine if you have liver, kidney or heart problems
5. Do not take this medicine if you are on a sodium restricted diet
6. Do not take this medicine if you are sensitive (allergic) to aspirin or other nonsteroidal anti-inflammatory (NSAIDs), such symptoms may be runny nose or
wheezing/breathing difficulties
7. Do not take this medicine if you are taking anticoagulants or thiazide diuretics – if in
doubt consult your doctor
8. Consult your doctor before taking Soluble Dentogen Ibuprofen Effervescent Tablets
200mg if you are currently taking aspirin or other NSAIDs
9. Do not take this medicine if you are pregnant or breastfeeding
10. Undesirable effects may be minimised by using the minimum effective dose for the
shortest possible duration
11. The elderly are at increased risk of the serious consequences of adverse reactions, if
you are worried, consult your doctor before taking Soluble Dentogen Ibuprofen
Effervescent Tablets 200mg
12. Each tablet contains 661mg of sodium and care should be taken if on a sodium
restricted diet.
13. If you suffer from any of the following at any time during your treatment
STOP TAKING the medicine and seek immediate medical help:
Pass blood in you faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee grounds
14. STOP TAKING the medicine and tell your doctor if you experience:
Indigestion or heartburn
Abdominal pain (pains in your stomach) or other abdominal stomach
symptoms
15. Do not take if you are taking aspirin at doses above 75mg daily. If you are on lowdose aspirin (up to 75mg daily) speak to your doctor, dentist or pharmacist before you
take Soluble Dentogen Ibuprofen Effervescent Tablets 200mg.
16. Soluble Dentogen Ibuprofen Effervescent Tablets 200mg belong to a group of
medicines which may impair fertility in women. This effect is reversible on stopping
the medicine. It is unlikely that Soluble Dentogen Ibuprofen Effervescent Tablets
200mg, used occasionally, will affect your chances of becoming pregnant, however,
tell your doctor before taking this medicine if you have problems becoming pregnant.
Warnings and Precautions
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly when used at high doses. Do not
exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking
Soluble Dentogen Ibuprofen Effervescent Tablets if you:
- have heart problems including heart failure, angina (chest pain), or if you have had a
heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of

PL16431/0090

feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’
or transient ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
There is a risk of kidney damage in dehydrated adolescents (age range 12 to 18)
Other medicines and Soluble Dentogen Ibuprofen Effervescent Tablets
Soluble Dentogen Ibuprofen Effervescent Tablets may be affected by some other
medicines. For example:
-medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine)
-medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of Soluble Dentogen
Ibuprofen Effervescent Tablets. You should therefore always seek the advice of your
doctor or pharmacist before you use with other medicines.
DIRECTIONS FOR USE
For oral administration
Dosage Instructions
Adults, the elderly and children over 12 years:
Initial dose: One or two tablets to be taken. The initial dose may be followed by further
doses of one or two tablets every four hours. Maximum daily dose – 6 tablets in 24
hours. To be taken preferably with food.
This product is intended for short-term use only. You should take the lowest dose for the
shortest time necessary to relieve symptoms.
Adults aged 18 or over:
You should not take Soluble Dentogen Ibuprofen Effervescent Tablets 200mg for
longer than 10 days. If symptoms persist or worsen consult your doctor, who may
instruct you to continue taking the medicine.
Adolescents (age range 12 to 18)
If this medicine is required for more than 3 days, or if symptoms worsen a doctor should
be consulted
Children:
Not recommended for children under 12 years.
Directions
The tablets must be dissolved in half a glass of water (100 ml). The tablets dissolve more

PL16431/0090

quickly in warm water, or if stirred.
In the event of accidental or deliberate overdose, seek immediate medical attention from
your doctor or local hospital casualty department.
If you forget to take a dose, do not worry, take the next dose at the right time. Do not
double-up on a dose to make up for the one you’ve missed.
SIDE EFFECTS
Like all medicines, your medicine can cause side effects, although not everybody gets
them.
The following side effects are very rare (less than 1 in 10,000 people), but if you
experience any of the following serious effects then STOP taking the medicine
immediately and contact your doctor or pharmacist:

Peptic (stomach) ulceration or perforation. Symptoms could include abdominal pain,
vomiting blood or liquid with what looks like coffee grounds, blood in the faeces
(stools/motions) or passing black tarry stools

Meningitis (inflammation of the brain lining) has occurred in patients with certain
auto-immune diseases (such as lupus or connective tissue disease).Symptoms could
include stiff neck, headache, feeling or being sick, fever or feeling disoriented.

Severe allergic reactions. Symptoms could include fainting, faster heart rate,
swelling of the face, tongue and throat

Worsening of asthma and wheezing or difficulty breathing
Between 1 in 100 and 1 in 1,000 people may experience the following uncommon side
effects:

Allergic reactions such as hives, skin rashes and itching (or SLE)

Abdominal (stomach) pain, indigestion, heartburn and feeling sick

Headache
Between 1 in 1000 and 1 in 10,000 people may experience the following rare side effects:

Diarrhoea, wind, constipation or being sick
Less than 1 in 10,000 people may experience the following very rare side effects:

Worsening of colitis (inflammation of the bowel)

Worsening of Crohn’s disease

Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore
throat, mild mouth ulcers, flu-like symptoms, severe exhaustion or weakness, easy
bruising, or bleeding from the skin or nose

Visual disturbance, and dizziness

Liver problems. Symptoms could include yellowing of the skin or the whites of the
eyes

Kidney problems. Symptoms could include swelling of the ankles

Severe skin reactions. Symptoms could include blistering and peeling
Other side effects which have been reported with this type of medicine:

Heart failure

High blood pressure

Swelling

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Medicines such as this product may be associated with a small increased risk of heart
attack or stroke. Any risk is more likely with high doses and prolonged treatment.
If any of the side effects get serious, or your notice any side effect not listed in the leaflet,
please tell your doctor or pharmacist
STORAGE
This product has a two year shelf life, its expiry date is given on the foil and carton.
Do not use Soluble Dentogen Ibuprofen Effervescent Tablets 200mg after the expiry date
shown on the carton.
Soluble Dentogen Ibuprofen Effervescent Tablets 200mg should be stored in a cool dry
place out of the reach of children.
Date of leaflet revision: February 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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