Patient leaflet - IBUPROFEN AND CAFFEINE SANOFI 400 MG / 100 MG FILM-COATED TABLETS
Package leaflet: Information for the user
Ibuprofen/Caffeine For use in adults
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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– 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.
What is in this leaflet
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1. What Ibuprofen and Caffeine Sanofi is and what it is used for
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2. What you need to know before you take Ibuprofen and Caffeine Sanofi
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3. How to take Ibuprofen and Caffeine Sanofi
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4. Possible side effects
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5. How to store Ibuprofen and Caffeine Sanofi
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6. Contents of the pack and other information
1. what ibuprofen and caffeine sanofi is and what it is used for
Ibuprofen and Caffeine Sanofi contains two active substances: ibuprofen and caffeine.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain.
Caffeine belongs to a group of medicines called stimulants.
Ibuprofen and Caffeine Sanofi is used for the short-term symptomatic treatment of acute moderate pain, such as dental pain or headache.
Ibuprofen and Caffeine Sanofi is indicated only for adults.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. what you need to know before you take ibuprofen and caffeine sanofi
Do not take Ibuprofen and Caffeine Sanofi:
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Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen and Caffeine Sanofi:
o if used for pain types other than dental pain or headache, the effect of Ibuprofen and Caffeine Sanofi may be different depending on the type of pain (e.g. a benefit has not been established for back or neck pain)
o if you have or have had asthma or allergic disease as shortness of breath may occur
o if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders, as an
increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria
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o if you have reduced renal function
o if you are taking medicines interacting with Ibuprofen and Caffeine Sanofi like corticosteroids, medicines for thinning the blood (such as warfarin), selective serotonin-reuptake inhibitors (medicines used for depression) or anti-platelet medicines (such as acetylsalicylic acid (e.g. ASS, Aspirin) (see section “Other medicines and Ibuprofen and Caffeine Sanofi”))
o if you have or have ever had bowel disease (ulcerative colitis or Crohn’s disease)
o if you have heart problems including heart failure, angina pectoris (chest pain), or if you have had a
heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
o if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
o if you have ever had a high blood pressure and/or heart failure
o particularly medical surveillance is required directly after major surgery
o if you suffer from coagulation disturbances
o if you have hereditary blood formation disorder (e.g. acute intermittent porphyria)
o if you have certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed connective tissue disease)
o if you have chicken pox (varicella), it is advisable to avoid use of Ibuprofen and Caffeine Sanofi o if you are suffering from hyperthyroidism (the risk of caffeine side effects might be increased) o if you are taking Ibuprofen containing medicines for a long time (regular check of your liver values, the kidney function, as well as of the blood count might be needed)
o if you have an infection – please see heading “Infections” below
Skin reactions
Serious skin reactions have been reported in association with Ibuprofen and Caffeine Sanofi treatment. You should stop taking Ibuprofen and Caffeine Sanofi and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.
Infections
Ibuprofen and Caffeine Sanofi may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen and Caffeine Sanofi may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
Contact your doctor immediately in case you experience:
o bright red faeces (stools/motions), black tarry stools, vomiting blood or coffee-grounds-like vomit o severe pain in upper stomach
Side effects may be minimised by using the minimum effective dose for the shortest period of time necessary to control symptoms. The elderly are at increased risk of side effects.
The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of adverse reactions (see section “Other medicines and Ibuprofen and Caffeine Sanofi”) and should be avoided.
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 (3 days).
Whilst taking Ibuprofen and Caffeine Sanofi, you should consult/inform your doctor or dentist before you undergo surgery.
In general terms, the habitual intake of painkillers, particularly on combination of several pain-relieving active substances, may lead to permanent renal damage with the risk of renal failure (analgesic nephropathy). This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore, it should be avoided.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained, and treatment should be discontinued.
Patients who report eye disorders during treatment with ibuprofen should discontinue therapy and ophthalmological examinations should be performed.
Other medicines and Ibuprofen and Caffeine Sanofi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ibuprofen and Caffeine Sanofi may affect or be affected by some other medicines. For example:
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– medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. acetylsalicylic acid (e.g. ASS, Aspirin), warfarin, ticlopidine)
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– 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 Ibuprofen and Caffeine Sanofi. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen and Caffeine Sanofi with other medicines.
In particular tell your doctor or pharmacist if you are taking:
| acetylsalicylic acid (e.g. ASS, Aspirin), or other NSAIDs (anti-inflammatories and pain-relieving medicines) | since this may increase the risk of gastrointestinal ulcers or bleeding |
| digoxin (for heart insufficiency) | since the effect of digoxin may be enhanced |
| glucocorticoids (medicines containing cortisone or cortisone-like substances) | since this may increase the risk of gastrointestinal ulcers or bleeding |
| anti-platelet medicines | since this may increase the risk of gastrointestinal bleeding |
| acetylsalicylic acid (e.g. ASS, Aspirin) (low dose) | since the blood-thinning effect may be impaired |
| medicines for thinning the blood (such as warfarin) | since ibuprofen may enhance the effects of these medicines |
| phenytoin (for epilepsy) | since the effect of phenytoin may be enhanced |
| selective serotonin reuptake inhibitors (medicines used for depression) | as these may increase the risk of gastrointestinal bleeding |
| lithium (a medicine for manic depressive illness and depression) | since the effect of lithium may be enhanced |
| probenecid and sulfinpyrazones (medicines for gout) | since the excretion of ibuprofen may be delayed |
| medicines for high blood pressure and water tablets | since ibuprofens may diminish the effects of these medicines and there could possibly be an increased risk for the kidney |
| potassium sparing diuretics | since this may lead to hyperkalaemia (high levels of potassium in the blood) |
| methotrexate (a medicine for cancer or rheumatism) | since the effect of methotrexate may be enhanced |
| tacrolimus and cyclosporine (immunosuppressive medicines) | since kidney damage may occur |
| zidovudine (a medicine for treating HIV/Aids) | since the use of Ibuprofen and Caffeine Sanofi may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs |
| sulfonylureas (antidiabetic medicines) | since disturbances of the blood glucose levels are possible |
| Quinolone antibiotics | since the risk for fits may be increased. Also the effect of caffeine might be increased. |
| CYP2C9 inhibitors (e.g. voriconazole and fluconazole): | Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the plasma concentrations to ibuprofen (CYP2C9 substrate). Reduction of the ibuprofen dose should be considered, especially if high doses (2400 mg/day) of ibuprofen are administered together with voriconazole or fluconazole. |
| Mifepristone | Since NSAIDs (as ibuprofen) can reduce the effect of mifepristone. |
| Ginkgo biloba (an herbal medicine) | since the risk of bleeding may be increased |
| Barbiturates, anti-histaminic and other medicines with sedative effect (to calm or make less anxious) | since caffeine may decrease sedative effect |
| Barbiturates and smoking | since they might lower the caffeine effects |
| Sympathomimetics, thyroxin and other medicines with tachycardic effect (medicines for, as an example, low blood pressure and for thyroid disorders) | since co-administration may increase the pulse accelerating effect of these medicines |
| Oral contraceptives, cimetidine, fluvoxamine and disulfiram (medicines taken for birth control, inhibition of stomach acid production, depression, and treatment of chronic alcoholism) | since they might increase the caffeine effects |
| Theophylline (a medicine used for the treatment of airway diseases) | since the effect of theophylline may be increased |
Ibuprofen and Caffeine Sanofi with food and drink and alcohol
Some side effects, such as those affecting the gastrointestinal and central nervous system can be more likely when alcohol is taken at the same time as Ibuprofen and Caffeine Sanofi. You should avoid consuming high amounts of caffeine containing products (e.g. coffee, tea, foods, other medicines and beverages) together with Ibuprofen and Caffeine Sanofi.
Pregnancy, breast-feeding 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.
Tell your doctor if you become pregnant during intake of Ibuprofen and Caffeine Sanofi. Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless the doctor advises otherwise.
The active substances, ibuprofen and caffeine, pass into the breast milk. Irritability and poor sleeping pattern have been reported in breast-fed infants. Ibuprofen and Caffeine Sanofi should only be used by breastfeeding mothers if clearly needed.
The medicine belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.
Driving and using machines
For short-term use and at normal dose this medicine has no or negligible influence on the ability to drive and use machines. People who, nevertheless, suffer from side effects such as dizziness, tiredness or visual disturbances should not drive or operate machines. This applies to a greater extent in combination with alcohol.
Ibuprofen and Caffeine contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‚sodium-free‘.
3. how to take ibuprofen and caffeine sanofi
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.
The recommended dose is:
Adults :
Initial dose: take 1 film-coated tablet (400 mg ibuprofen and 100 mg caffeine). If necessary, take an additional dose (1 film-coated tablet) but do not exceed a total dose of 3 film-coated tablets (1200 mg ibuprofen and 300 mg caffeine) in any 24 hour period. The dosing interval should not be below 6 hours. Talk to the doctor or pharmacist if you feel that the effect of this medicine is greater or less than you expected.
For mild pain conditions or when treatment duration exceeds 3 days, Ibuprofen and Caffeine Sanofi is not recommended.
Not intended for use in children and adolescents below the age of 18 years because no data are available. Oral use.
Swallow the film-coated tablets whole with a glass of water.
It is recommended that patients with sensitive stomach take Ibuprofen and Caffeine Sanofi with food.
For short-term use only.
Treatment duration should not exceed 3 days.
Consult your doctor if symptoms worsen or in case you still have pain after 3 days.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
If you take more Ibuprofen and Caffeine Sanofi than you should
If you have taken more Ibuprofen and Caffeine Sanofi than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.
The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), gastrointestinal bleeding, increased heartbeat, headache, ringing in the ears, shaking, restlessness, confusion, shaky eye movement, or more rarely diarrhoea. In addition, at high doses, vertigo, blurred vision, low blood pressure, agitation, coma, raised blood potassium levels, acute renal failure, liver damage, respiratory depression, cyanosis and exacerbation of asthma in asthmatics, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
If you forget to take Ibuprofen and Caffeine Sanofi
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may suffer from one of the known side effects of NSAIDs (see below). If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly people using this medicine are at increased risk of developing problems associated with side effects.
With regard to the following side effects, it must be considered that they are largely dependent on the dose and that they vary from patient to patient.
STOP TAKING Ibuprofen and caffeine immediately and consult a doctor if you experience one of the following conditions, which may be possible signs of severe adverse events:
- severe stomach trouble
- vomiting of blood or coffee-grounds-like vomit
- black tarry stool or blood in the urine
- allergic reactions such as skin rash, itching
- difficult breathing and/or swelling in face or throat
- lassitude combined with loss of appetite
- abnormal fatigue combined with reduced urine excretion
- swelling of face, feet or legs
- chest pain
- visual disturbances
Other side effects
Common (may affect up to 1 in 10 people)
- heartburn, abdominal pain, feeling sick and indigestion, nausea, vomiting, wind (flatulence), diarrhoea, constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases
- dizziness, sleeplessness, headache
Uncommon (may affect up to 1 in 100 people)
- stomach or intestinal ulcers, sometimes with bleeding and perforation especially in elderly patients, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), black tarry stools, coffee grounds like vomit, worsening of colitis and Crohn's disease. In particular, the risk of developing gastrointestinal bleeding depends on the dose level and duration of treatment.
- agitation, feeling your heartbeat, irritability or tiredness
- visual disturbances, psychotic reactions
- allergic reactions, such as skin rashes, itching and asthma attacks. You must stop taking Ibuprofen and Caffeine Sanofi and inform your doctor at once
Rare (may affect up to 1 in 1,000 people)
- tinnitus (ringing in the ears), loss of hearing
- kidney damage (papillary necrosis), elevated uric acid concentrations in the blood, elevated urea concentrations in the blood
Very rare (may affect up to 1 in 10,000 people)
- swelling (oedema), high blood pressure (hypertension) and cardiac failure have been reported in association with NSAID treatment
- inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small and
large intestines (intestinal, diaphragm-like strictures)
- passing less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that my lead to acute kidney failure. If one of the above mentioned symptoms occur or if you have a general miserable feeling, stop taking Ibuprofen and Caffeine Sanofi and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure
- problems in the blood cell production – first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you must stop the therapy immediately and consult a doctor. Any self-treatment with pain killers or medicinal products that reduce fever (antipyretic medicine) mustn’t be done
- depression
- Ibuprofen and Caffeine Sanofi may hide signs and symptoms of infections (such as fever and pain), worsening of infections (including respiratory or skin/soft tissue infections) or complications of infections (including chicken pox). If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay
- high blood pressure, heart failure, heart attack, vasculitis
- liver dysfunction (first signs could be discoloration of the skin), liver damage, especially during long-term treatment, liver failure, acute inflammation of the liver (acute hepatitis)
- the symptoms of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be affected. Contact a doctor at once, if these occur
- severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia), serious infections of the skin and soft-tissue complications have occurred during chicken pox (varicella) infection
- severe general hypersensitivity reactions (signs may be a serious allergic reaction which causes swelling of the face or throat, difficulty in breathing, faster heartbeat, drop in blood pressure, anaphylactic shock (serious allergic reaction which causes difficulty in breathing or dizziness)
Not known (frequency cannot be estimated from the available data)
- shaking
- faster heartbeat
- a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
- a red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen and Caffeine Sanofi if you develop these symptoms and seek medical attention immediately. See also section 2.
- skin becomes sensitive to light
5. how to store ibuprofen and caffeine sanofi
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 and the blister.
The expiry date refers to the last day of that month.
Do not store above 25°C.
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 to protect the environment.
6. contents of the pack and other information
What Ibuprofen and Caffeine Sanofi contains
The active substances are ibuprofen and caffeine.
Each film-coated tablet contains 400 mg ibuprofen and 100 mg caffeine.
The other ingredients are:
Tablet Core:
Cellulose, microcrystalline
Croscarmellose sodium
Silica colloidal, anhydrous
Magnesium stearate
Film-coating:
Hydroxymethylcellulose
Hydroxypropylcellulose
Macrogol 6000
Talc
Titanium dioxide (E171)
What Ibuprofen and Caffeine Sanofi looks like and contents of the pack
Ibuprofen and Caffeine Sanofi is a white, oblong shape film-coated tablet of 17.8 mm x 8.6 mm size.
Ibuprofen and Caffeine Sanofi is available in blisters.
Packs of 6, 10, 12, 15, 18, 20 and 24 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom
Tel: 0800 035 2525
Email:
Manufacturer
Delpharm Reims, 10 rue du Colonel Charbonneaux, 51100 Reims, France
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Ibuprofen / Coffein Sanofi 400 mg/100 mg Filmtabletten
Bulgaria: Nospalgin 400 mg/100 mg film-coated tablets (HomnaaruH 400 mg/100 mg $uaMupaHu rnao.ieTKH)
Czech Republic: Ibalgin Plus 400 mg/100 mg potahovane tablety
Cyprus: Buscofem Extra 400 mg/100 mg sniKaZu^^sva p.s Zsnio u^svio dioKia
Greece: Buscofem Extra 400 mg/100 mg sniKaXup.p.eva p.s Zsnio u^svio oioKia
Spain: Dolalgial Ibuprofeno/Cafeina 400mg /100mg comprimidos recubiertos con peHcula
Hungary: Algoflex Duo 400 mg/100 mg filmtabletta
Italy: BUSCOACTFOKUS 400 mg + 100 mg compresse rivestite con film
Poland: IBU-SPA 400 mg + 100 mg tabletki powlekane
Portugal: Ibuprofeno + Cafeina Aspegic
Romania: Ibalgin DUO 400 mg/100 mg comprimate filmate
Slovakia: Ibalgin Plus 400 mg/100 mg filmom obalene tablety
United Kingdom: Ibuprofen and Caffeine Sanofi 400 mg/100 mg Film-coated tablets
This leaflet was last revised in 04/2021.
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