Tabumol: detailed information

Package leaflet: Information for the user

Tabumol 200 mg/500 mg film-coated tablets

Ibuprofen/paracetamol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more advice or information, contact your pharmacist.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

What Tabumol is and what it is used for
What you need to know before taking Tabumol
How to take Tabumol
Possible side effects
How to store Tabumol
Contents of the pack and other information

1. What Tabumol is and what it is used for

Tabumol contains two active substances (which make the medicine work). These are ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, swelling and lowering high temperatures.
Paracetamol is an analgesic that acts differently from ibuprofen to provide relief from pain and fever. This medicine is particularly suitable for pain requiring stronger analgesia than ibuprofen or paracetamol alone.
Tabumol is used for the short-term relief of mild to moderate pain associated with migraine, headache, backache, menstrual pain, toothache, rheumatic and muscular pain, non-severe arthritic pain, influenza and cold symptoms, sore throat and fever.
Tabumol is indicated for adults aged 18 years and over.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before taking Tabumol

Do not take Tabumol:

if you are already taking other medicines containing paracetamol
if you are taking other pain-relief medicines including ibuprofen, acetylsalicylic acid at high doses (over 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs), including specific cyclooxygenase-2 (COX-2) inhibitors
if you are allergic to ibuprofen, paracetamol, or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to acetylsalicylic acid or to other NSAID painkillers
if you have or have previously had a stomach or duodenal ulcer (small intestine) or bleeding
if you have a blood clotting disorder
if you suffer from heart, liver, or kidney failure
if you are in the last 3 months of pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before taking Tabumol:

if you are elderly
if you have asthma or have previously suffered from asthma
if you have problems with your kidneys, heart, liver, or intestines
if you have an infection – see section "Infections" below
if you have systemic lupus erythematosus (SLE) – an autoimmune condition affecting connective tissue and causing joint pain, skin changes, and disorders of other organs – or mixed connective tissue disease
if you have gastrointestinal disorders or chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease)
if you are in the first six months of pregnancy or if you are breastfeeding
if you are planning a pregnancy

Pain-relieving anti-inflammatory medicines such as 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.

Infections
Tabumol may mask symptoms of infection such as fever and pain. Therefore, Tabumol could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.

Skin reactions
Serious skin reactions have been reported in association with treatment with Tabumol. You must stop taking Tabumol and seek immediate medical help if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

You should discuss treatment with your doctor or pharmacist before taking Tabumol if you have:

heart problems including heart attack, angina (chest pain), or a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or TIA, transient ischemic attack);
high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Other medicines and Tabumol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Tabumol with:

other medicines containing paracetamol
other medicines containing NSAIDs such as acetylsalicylic acid, ibuprofen.

Special caution is required because some medicines may interact with Tabumol:

corticosteroid tablets
antibiotics (e.g., chloramphenicol or quinolones)
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (metabolic acidosis with high anion gap) requiring urgent treatment, which may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used
anti-nausea medicines (e.g., metoclopramide, domperidone)
cardiac stimulants (e.g., glycosides)
medicines for high cholesterol (e.g., cholestyramine)
diuretics (to help you urinate)
medicines for suppression of the immune system (e.g., methotrexate, cyclosporine, tacrolimus)
medicines for mania or depression (e.g., lithium or SSRIs)
mifepristone (for termination of pregnancy)
HIV medicines (e.g., zidovudine)

Tabumol may affect or be affected by other medicines.
For example:

medicines that are anticoagulants (i.e., substances that thin the blood/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Other medicines may also affect or be affected by treatment with Tabumol.
Therefore, always consult your doctor or pharmacist before using Tabumol with other medicines.

Tabumol with food
To reduce the likelihood of side effects, take Tabumol with food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take Tabumol during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It could affect your or your baby's tendency to bleed and delay or prolong labour beyond the expected time. You should not take Tabumol during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is needed during this period or when trying to conceive, the lowest effective dose for the shortest possible time should be used. From week 20 of pregnancy, Tabumol may cause kidney problems in the fetus if taken for more than a few days, thereby reducing levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Ibuprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible upon discontinuation of the medicine. Inform your doctor if you are planning a pregnancy or have difficulty becoming pregnant.

Driving and using machines
Tabumol may cause dizziness, impaired concentration, and drowsiness.
If you experience any of these effects, do not drive and do not operate tools or machinery.

3. How to take Tabumol

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults: the recommended dose is 1 tablet with water and food, up to 3 times a day.
Leave at least 6 hours between doses.
If one tablet does not control symptoms, a maximum of 2 tablets may be taken up to 3 times
a day.
Do not take more than 6 tablets within 24 hours (equivalent to 1200 mg of ibuprofen and 3000 mg of
paracetamol per day).
Use in children and adolescents
Not recommended for use in children and adolescents under 18 years of age.
For oral use and for short-term use only.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. Do not
take Tabumol for more than 3 days. If you have an infection, consult your doctor immediately if
symptoms (e.g. fever and pain) persist or worsen (see section 2).
If you take more Tabumol than you should
If you have taken more Tabumol than you should, or if children have accidentally ingested Tabumol, contact
a doctor or the nearest hospital immediately for advice on the risk and actions to take.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood),
headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses,
drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in
children), weakness and dizziness, blood in the urine, feeling cold, and breathing difficulties have been reported.
Seek immediate medical attention if you have taken too much of this medicine, even if you feel well, because
excess paracetamol can cause severe and delayed liver damage.
If you forget to take Tabumol
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, and then take the next dose at least 6 hours later.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP TAKING the medicine and inform your doctor if you experience:

stomach burning, indigestion
signs of intestinal bleeding (severe stomach pain, vomiting blood or material that looks like coffee grounds, blood in the stool/faeces, black stools)
signs of inflammation of the lining of the brain such as: stiff neck, headache, feeling sick or vomiting, fever or feeling confused
signs of a severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing, worsening of asthma)
severe skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).

Other side effects:
Common (may affect up to 1 in 10 people):

stomach ache or stomach discomfort, feeling sick and vomiting, diarrhoea
elevated liver enzymes (shown by blood tests)

Uncommon (may affect up to 1 in 100 people)

headache and dizziness, wind and constipation, skin rashes, swelling of the face
reduction in red blood cells and increased platelets (blood clotting cells)

Very rare (may affect up to 1 in 10,000 people)

reduction in blood cells (causing sore throat, mouth ulcers, flu-like symptoms, severe tiredness, unexplained bleeding, bruising and nosebleeds)
visual disturbances, ringing in the ears, sensation of spinning
confusion, depression, hallucinations
fatigue, general feeling of being unwell
high blood pressure, fluid 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, swelling)

Not known (frequency cannot be estimated from the available data)

a red, scaly rash with lumps under the skin and blisters mainly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If you develop these symptoms, stop using Tabumol and seek immediate medical help. See also section 2.

Medicines like Tabumol may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke (see section 2).
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tabumol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tabumol contains

The active substances are paracetamol and ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.
The other components are:
Tablet core: maize starch, crospovidone (Type A) (E1202), anhydrous colloidal silica (E551), povidone K-30 (E1201), pregelatinized maize starch, talc (E553b), stearic acid (50).
Coating: polyvinyl alcohol (E1203), talc (E553b), macrogol 3350 (E1521), titanium dioxide (E171).

Description of the appearance of Tabumol and package contents
Tabumol tablets are white to almost white, capsule-shaped, film-coated tablets, measuring 19.7 mm x 9.2 mm.
They are available in blisters in carton boxes containing 16 or 20 film-coated tablets.
They are also available in blisters in carton boxes containing 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA),
Italy

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
41004 Larisa,
Greece
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Tabumol