Patient leaflet - Ibuprofen/paracetamol Interdos 200 mg/500 mg capsules, soft

1. What this medicine is and what it is used for

This medicine contains two active ingredients (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, reducing swelling and lowering high temperatures. Paracetamol is an analgesic (pain killer) which works in a different way from ibuprofen to relieve pain and fever.

This medicine is 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 arthritus, cold and flu symptoms, sore throat and fever.

2. Before you take this medicine

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region(angioedema), chest pain have been reported with ibuprofen. Immediately stop taking this medicine and contact your docto ror medical emergencies if you notice any of these signs.

Do not take this medice if you

are already taking any other paracetamol containing product
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 this medicine
are allergic to aspirin or other NSAID painkillers
have or ever had an ulcer or bleeding in your stomach or duodenum (small bowel)
have blood clotting (coagulation) disorder
suffer from heart, liver or kidney failure
are in the last 3 months of pregnancy
are under 18 years old

Take special care and check with a doctor or pharmacist before taking this medicine if you:

are elderly
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 disorder of other organs – or other mixed connective tissue disease
have gastrointestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease)
are in the first 6 months of pregnancy or are breastfeeding
are planning to become pregnant
have an infection – please see heading “Infections” below

Infections

This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infections, 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.

Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome,toxic epidermalnecrolysis, drug reaction with eosinophiliaand systemicsymptoms (DRESS), acute generalised exanthematous pustulosis(AGEP) have been reported in association with ibuprofen treatment. Stop using this medicine and seek medical attention immediately, if you notice any of the symptoms related to these serious skin reactions described in section 4. Anti-inflammatory/pain-killer medicines suc has ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses.

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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 or 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.

During treatment with Ibuprofen/Paracetamol Interdos, tell your doctor straight away if:

If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin.

Symptoms of metabolic acidosis may include serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick(nausea) and being sick (vomiting).

Taking this medicine with other medicines

Do not take this medicine with

other paracetamol containing products
other NSAID containing products such as aspirin, ibuprofen.

Some other medicines may also affect or be affected by the treatment of this medicine.

You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.

For example:

corticosteroid tablets
antibiotics (e.g. chloramphenicol or quinolones)
flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called high anion gap metabolic acidosis) that must have urgent treatment
anti sickness medicines (e.g. metoclopramide, domperidone)
anti-coagulant medicines (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
heart stimulants (e.g. glycosides)
medicines for high cholesterol (e.g. cholestyramine)
diuretics (to help you pass water)
medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan).
medicines to suppress the immune system (e.g. methotrexate, ciclosporine, tacrolimus)
medicines for mania or depression (e.g. lithium or SSRI’s)
mifepristone (for pregnancy termination)
HIV medicines (e.g. zidovudine)
Isoniazid (tuberculosis treatment),due to increased risk of liver damage with paracetamol overdose

Taking this medicine with food

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

if you are taking this medicine for longer than the recommended time or at higher than recommended doses you are at risk of serious harm. These include serious harm to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not take this medicine if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take this medicine during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant,the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, this medicine can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring. Take special care if you are in the first 6 months of pregnancy.

This medicine may make it more difficult to become pregnant. Ibuprofen belongs to a group of medicines which may impair fertility in women. This 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.

Important information about some of the ingredients in this medicine

This medicine contains propylene glycol

This medicine contains 16 mg propylene glycol in each capsule.

This medicine contains sorbitol

This medicine contains 60 mg sorbitol in each capsule.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.

This medicine contains potassium hydroxide

This medicine contains 35 mg potassium hydroxide in each capsule.

To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

3. How to take this medicine

For oral use and for short term use only. 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).

You should not take this medicine for longer than 3 days.

If your symptoms worsen or persist, consult your doctor.

One capsule to be taken with water and food, up to three times a day. Leave at least 6 hours between doses.

If one capsule does not control symptoms, then a maximum of 2 capsules may be taken up to three times a day.

Do not take more than six capsules in within 24 hours (equivalent to 1200 mg ibuprofen and 3000 mg paracetamol a day).

Not for use by children under 18 years.

If you have taken more of this medicine 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), headache, ringing in the ears, confusion and shaky eye movement. At high doses, 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. Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take this medicine

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, this medicine can cause side effects, although not everybody gets them.

STOP TAKING this medicine and tell your doctor if you experience:

heartburn, indigestion
signs of intestinal bleeding (severe stomach pain, vomiting blood or liquid with what looks like coffee granules, blood in the stools/motions, 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, difficult breathing, worsening of asthma).
severe skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
signs of hypersensitivity and skin reactions such as reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
a red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanies by fever at the initiation of treatment (acute generalised exanthematous pustulosis) (frequency not known). See also section 2

Other possible side effects

Tell your doctor or pharmacist if you get any of the following side effects or any side effects not listed.

Common: may affect up to 1 in 10 people:

stomach pain or discomfort, feeling or being sick, diarrhoea
higher levels of liver enzymes (shown in blood tests)
excessive sweating

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 number or increase in platelets (blood clotting cells) number.

Very Rare: may affect up to 1 in 10,000 people:

very rare cases of serious skin reactions have been reported
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, swelling)

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

a serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)
skin becomes sensitive to light

Medicines such as Ibuprofen/Paracetamol Interdos may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. (See section 2).

Tell your doctor or pharmacist if you notice any of the following:

chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
liver, kidney problems or difficulty urinating.

This medicine, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store this medicine

Keep this medicene out of the sight and reach of children. Store below 25°C.

Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicinesyou no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What this medicine contains

The active substances are ibuprofen and paracetamol. Each capsule contains 200 mg of ibuprofen and 500 mg of paracetamol
The other ingredients are macrogol 400, propylene glycol (E1520), potassium hydroxide. Capsule shell mass: gelatin, glycerol (E420), sorbitol liquid, partially dehydrated, titanium dioxide (E171), ferric oxide red (in light brown opaque shell mass) (E172), ferric oxide yellow (in light brown opaque mass) (E172).

What this medicine looks like and contents of the pack

Ibuprofen/Paracetamol Interdos are white, opaque and light brown opaque colored oval shaped soft gelatin capsules, containing off white to white colored suspension.

They are available in blister packs containing 6, 10, 12, or 16 capsules. Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Interdos Pharma B.V.

Burgemeester Lemmensstraat 352

6163 JT Geleen

The Netherlands

Manufacturer:

PharmaMatch B.V.

Van Boshuizenstraat 12 Unit 2.3

1083 BA Amsterdam