Patient Information Leaflet: Information for the User
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You might need to read it again.
Talk to your pharmacist for any other advice or information.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See Section 4.
You should not take the product for longer than 3 days. If symptoms persist or worsen, consult your doctor.
In This Leaflet
What Lexofen Plus tablets are and what they are used for
Before you take Lexofen Plus tablets
How to take Lexofen Plus tablets
Possible side effects
How to store Lexofen Plus tablets
Further information
1. What Lexofen Plus Tablets Are and What They Are Used For
Lexofen Plus tablets contain two active ingredients:
Ibuprofen
Paracetamol
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, reducing swelling, and lowering high temperatures.
Paracetamol is an analgesic which works in a different way from ibuprofen to relieve pain and fever.
Lexofen Plus tablets are used for the temporary relief of mild to moderate pain associated with:
Migraine
Headache
Backache
Period pain
Dental pain
Rheumatic and muscular pain
Pain of non-serious arthritis
Cold and flu symptoms
Sore throat
Fever
2. Before You Take Lexofen Plus Tablets
Do Not Take Lexofen Plus Tablets If You:
Are already taking any other paracetamol-containing products.
Are taking any other pain-relieving products including ibuprofen, high-dose aspirin (above 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclo-oxygenase-2 (COX-2) specific inhibitors.
Are allergic to ibuprofen, paracetamol, or any other ingredients in Lexofen Plus tablets.
Are allergic to aspirin or other NSAID painkillers.
Have or ever had an ulcer or bleeding in your stomach or duodenum (small bowel).
Have a blood clotting (coagulation) disorder.
Suffer from heart, liver, or kidney failure.
Are in the last 3 months of pregnancy.
Are under 12 years old.
Warnings and Precautions
Take special care and check with a doctor or pharmacist before taking Lexofen Plus tablets if you:
Have asthma or have suffered from asthma.
Have kidney, heart, liver, or bowel problems.
Have Systemic Lupus Erythematosus (SLE), a condition of the immune system affecting connective tissue resulting in joint pain, skin changes, and disorders of other organs.
Are in the first 6 months of pregnancy.
Are breastfeeding.
Are planning to become pregnant.
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.
Discuss your treatment with your doctor or pharmacist before taking Lexofen Plus tablets if you:
Have heart problems including heart failure or angina (chest pain).
Have had a heart attack.
Have had bypass surgery.
Have peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries).
Have had any kind of stroke (including mini-stroke or transient ischaemic attack "TIA").
Have high blood pressure.
Have diabetes.
Have high cholesterol.
Have a family history of heart disease or stroke.
Are a smoker.
Other Medicines and Lexofen Plus Tablets
Do Not Take Lexofen Plus Tablets With:
Other paracetamol-containing products.
Other NSAID-containing products such as aspirin or ibuprofen.
Special care is required as some medicines may interact with Lexofen Plus tablets, for example:
Corticosteroid tablets
Antibiotics (e.g. chloramphenicol or quinolones)
Anti-sickness medicines (e.g. metoclopramide, domperidone)
Heart stimulants (e.g. glycosides such as digoxin)
Medicines for high cholesterol (e.g. cholestyramine)
Diuretics (to help you pass water)
Medicines to suppress the immune system (e.g. methotrexate, ciclosporin, tacrolimus)
Medicines for mania or depression (e.g. lithium or SSRIs)
Mifepristone (for pregnancy termination)
HIV medicines (e.g. zidovudine)
Lexofen Plus tablets may affect or be affected by some other medicines.
For example:
Medicines that are anti-coagulants (blood thinners/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, angiotensin-II receptor antagonists such as losartan).
Some other medicines may also affect or be affected by Lexofen Plus tablets.
You should therefore always seek the advice of your doctor or pharmacist before using Lexofen Plus tablets with other medicines.
Taking Lexofen Plus Tablets With Food
To reduce the likelihood of side effects, take Lexofen Plus tablets with food.
Pregnancy and Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take if you are in the last 3 months of pregnancy.
Take special care if you are in the first 6 months of pregnancy.
Lexofen Plus tablets may make it more difficult to become pregnant.
If you are breastfeeding, ask your doctor before taking this medicine.
Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine.
You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
3. How to Take Lexofen Plus Tablets
For oral use and for short-term use only.
Only use the minimum effective dose for the shortest time necessary to relieve your symptoms.
You should not take Lexofen Plus tablets for longer than 3 days.
If your symptoms worsen or persist, consult your doctor.
Recommended Dose
The usual dose is:
One tablet three to four times a day.
Allow at least 6 hours between doses.
Lexofen Plus should be taken with food.
Do not take more than six tablets in any 24-hour period.
Not for use by children under 12 years.
If You Take More Lexofen Plus Tablets Than You Should
If you have taken more Lexofen Plus tablets than you should, or if a child has taken this medicine by accident, contact a doctor or nearest hospital immediately, even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
If You Forget to Take Lexofen Plus Tablets
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take it as soon as you remember it and then take the next dose at least 6 hours later.
4. Possible Side Effects
Like all medicines, Lexofen Plus tablets can cause side effects, although not everybody gets them.
STOP TAKING the medicine and tell your doctor if you experience:
Heartburn or indigestion.
Signs of intestinal bleeding (severe stomach pain, vomiting blood or liquid that looks like coffee granules, blood in the stools, black tarry stools).
Signs of inflammation of the brain lining such as stiff neck, headache, feeling or being sick, fever, or feeling disorientated.
Signs of a severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing, or worsening asthma).
Severe skin reaction known as DRESS syndrome (frequency not known). Symptoms include skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
Other Possible Side Effects
Common (occurs in less than 1 in 10 people)
Stomach pain or discomfort
Feeling or being sick
Diarrhoea
Higher levels of liver enzymes (shown in blood tests)
Uncommon (occurs in less than 1 in 100 people)
Headache
Dizziness
Wind
Constipation
Skin rashes
Swelling of the face
Reduction in red blood cell number
Increase in platelet (blood clotting cell) number
Very Rare (occurs in less than 1 in 10,000 people)
Reduction in blood cells (causing sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, bruising, and nose bleeds)
Visual disturbances
Ringing in the ears
Spinning sensation
Confusion
Depression
Hallucinations
Fatigue
Generally feeling unwell
Severe skin reactions such as blistering
High blood pressure
Water retention
Liver problems (causing yellowing of the skin and whites of the eyes)
Kidney problems (causing increased or decreased urination, swelling of the legs)
Heart failure (causing breathlessness and swelling)
Medicines such as Lexofen Plus tablets may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If you get any side effects, talk to your doctor, pharmacist, or nurse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to Store Lexofen Plus Tablets
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Store in a cool, dry place.
Keep away from direct sunlight.
Medicines should not be disposed of 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. Further Information
What Lexofen Plus Tablets Contain
Active Ingredients
Each uncoated tablet contains:
Ibuprofen 400 mg
Paracetamol 500 mg
Inactive Ingredients (Excipients)
Maize starch
Dibasic calcium phosphate
Sodium lauryl sulphate
Methyl hydroxybenzoate
Propyl hydroxybenzoate
Purified talc
Magnesium stearate
Sodium starch glycolate
Colloidal silicon dioxide
What Lexofen Plus Tablets Look Like
Off-white oval-shaped biconvex scored caplet printed with "LEXPLUS" on one side and "LUEX" on the other.
Marketing Authorization Holder
London United Exports Ltd.
38 Watford Way
London, UK
This leaflet was last updated in December 2019.
Manufactured for
LONDON UNITED EXPORTS LTD.
London, England
Website: www.luexhealthcare.com
Made in India