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

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 low-dose 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

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, beta-blockers 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 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

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