Patient leaflet - Ibuprofen and Pseudoephedrine Hydrochloride Farmaldier 200 mg / 30 mg / 10 ml oral suspension

1. What Ibuprofen and Pseudoephedrine hydrochloride Farmalider is and what it is used for

Ibuprofen and Pseudoephedrine hydrochloride Farmalider contains Ibuprofen and Pseudoephedrine hydrochloride.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling and high temperature. Pseudoephedrine belongs to a group of drugs called vasoconstrictors, which act on the blood vessels in the nose to relieve nasal congestion.

Ibuprofen and Pseudoephedrine hydrochloride Farmalider is indicated for the relief of symptoms of cold and flu with associated pain, fever, congestion and blocked nose.

Ibuprofen and Pseudoephedrine hydrochloride Farmalider is indicated in adults and adolescents of 12 years and older.

You should only take this combination product if you have a blocked nose with pain or fever. If you have only one of these symptoms you should talk to your pharmacist or doctor about using mono preparations alone.

You must talk to your doctor if you do not feel better or if you feel worse after:

5 days if you are an adult.
3 days when you are an adolescent of 12 years and older.

2. What you need to know before you use Ibuprofen and Pseudoephedrine hydrochloride Farmalider

Do not take Ibuprofen and Pseudoephedrine hydrochloride Farmalider if:

you are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6).
you are less than 12 years old.
you are pregnant.
you have or have ever had an allergic reaction or wheezing after taking other anti-inflammatory pain killers (NSAIDs).
you have or have ever had a stomach ulcer or other gastric complaint.
you have previously had gastrointestinal bleeding related to taking NSAIDs.
you suffer from heart problems, diabetes, a condition called phaeochromocytoma (a tumour which causes increased blood pressure, palpitations, increased heart rate and headaches), glaucoma, prostate enlargement, severe liver problems.
you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure.
you have a history of heart attack (myocardial infarction).
you have very high blood pressure (severe hypertension) or hypertension not controlled by your medication.
you have had a stroke or have been told that you are at risk of having a stroke.
you have a history of seizures.
you have or have ever had unexplained blood clotting problems.
you are using other medicines such as blood thinners, corticosteroids, anti-blood clotting agents, lithium, antidepressants (or have taken them in the last 14 days) and an anti-cancer medicine called methotrexate.

Warnings and precautions

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

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen and Pseudoephedrine hydrochloride Farmalider if:

you are taking:
- other NSAID painkillers
- antimigraine medicines
- other medicines such as blood thinners or corticosteroids
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”).
you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
you are diagnosed with psychosis.
you have Systemic Lupus Erythematosus (SLE), a condition to the immune system affecting connective tissue resulting in joint pains, skin changes and disorder of other organs.
you have had seizures or changes in behaviour when you have used medicines containing the same active substances before.
you are older and have urinary disorders.
you have surgery scheduled.
you are an athlete, as this pseudoephedrine present in this medicine can lead to positive results in doping tests.
you are scheduled to have blood tests.
you have asthma or have suffered from asthma.
you have a history of ulcer or bleeding in your stomach.
you have skin reactions when you have used medicines containing the same active substances before.
you have an infection - please see heading “Infections” below.

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.

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. Stop immediately Ibuprofen and Pseudoephedrine hydrochloride Farmalider and contact immediately your doctor or medical emergencies if you notice any of these signs.

Sudden abdominal pain or rectal bleeding may occur with Ibuprofen and Pseudoephedrine hydrochloride Farmalider, due to inflammation of the colon (ischemic colitis). If you develop these gastro-intestinal symptoms, stop taking Ibuprofen and Pseudoephedrine hydrochloride Farmalider and contact your doctor or seek medical attention immediately. See section 4.

Reduction of blood flow to your optic nerve may occur with Ibuprofen and Pseudoephedrine hydrochloride Farmalider. If you develop sudden loss of vision, stop taking Ibuprofen and Pseudoephedrine hydrochloride Farmalider and contact your doctor or seek medical attention immediately. See section

4.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using Ibuprofen and Pseudoephedrine hydrochloride Farmalider immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms).

Infections

Ibuprofen and Pseudoephedrine hydrochloride Farmalider may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen and Pseudoephedrine hydrochloride Farmalider 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.

Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with Ibuprofen and Pseudoephedrine hydrochloride Farmalider treatment. Stop using Ibuprofen and Pseudoephedrine hydrochloride Farmalider and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Interference with analytical tests

If you are going to have any diagnostic tests (including blood tests, urine, skin tests that use allergens, etc.), tell the doctor that you are taking this medicine, as it may alter the results.

Pseudoephedrine may interfere with some blood tests used for diagnosis. You should tell your doctor that you are taking this medicine if you should have a blood test.

Children

Ibuprofen and Pseudoephedrine hydrochloride Farmalider is contraindicated in children under 12 years of age.

Other medicines and Ibuprofen and Pseudoephedrine hydrochloride Farmalider

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

Do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:

acetylsalicylic acid
other NSAIDs
other pain relievers or medicines that reduce fever
if you have been treated with monoamine oxidase inhibitors in the last 2 weeks (used for treatment of Parkinson's disease or for depression)
other vasoconstricting agents used as nasal decongestants (e.g. phenylpropanolamine, phenylephrine and ephedrine given orally and nasally).

Ibuprofen and Pseudoephedrine hydrochloride Farmalider may also affect or 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).
Water tablets (diuretics).
Corticosteroids.
Any medicines for depression such as:
- Selective serotonin reuptake inhibitors (SSRIs) such as paroxetine and fluoxetine.
- Lithium.
- tricyclics such as amitriptyline.
- monoamine oxidase inhibitors (MAOIs) such as phenelzine.
- other indirectly acting agents such as methylphenidate.
Digoxin (for heart failure).
Methotrexate (for arthritis, psoriasis or some cancers).
Tacrolimus (for transplant and eczema).
Ciclosporin (for transplant, arthritis or psoriasis).
Antibiotics called Quinolones (such as Ciprofloxacin) and ones used for skin and pneumonia (such as linezolid).
Zidovudine (used to treat HIV infection).
Decongestants or appetite suppressants.
Digitalis (used for heart arrhythmias).
Phenytoin (used to treat seizures).
Probenecid and sulfinpyrazone (used to treat gout).
Medicines for diabetes.
Antibiotics called Aminoglycosides.
Mifepristone.
Injectable heparin or preparations containing Ginkgo biloba, as they could increase the risk of bleeding.
Antacids.

Other medicines may also affect or be affected by treatment with Ibuprofen and Pseudoephedrine hydrochloride Farmalider. Therefore, you should always consult your doctor or pharmacist before using Ibuprofen and Pseudoephedrine hydrochloride Farmalider with other medicines.

Acute hypertension may occur in the perioperative period due to the administration of pseudoephedrine. Therefore, discontinue treatment with Ibuprofen and Pseudoephedrine hydrochloride Farmalider several days prior to surgery and report to your anesthesiologist.

Ibuprofen and Pseudoephedrine hydrochloride Farmalider with alcohol

Avoid drinking alcohol during treatment.

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.

Do not take Ibuprofen and Pseudoephedrine hydrochloride Farmalider 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 Ibuprofen and Pseudoephedrine hydrochloride Farmalider 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, Ibuprofen and Pseudoephedrine hydrochloride Farmalider 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.

Ibuprofen and Pseudoephedrine hydrochloride Farmalider should not be used while breastfeeding unless otherwise specified by your doctor.

Ibuprofen and Pseudoephedrine hydrochloride Farmalider contains ibuprofen, which belongs to the group of medicines (NSAIDs) that can impair fertility in women. This effect is reversible upon discontinuation of treatment.

Athletes

Pseudoephedrine hydrochloride may give positive results in doping controls.

Driving and using machines

This medicine is unlikely to affect your ability to drive or to operate machinery. However, dizziness or hallucinations may appear in exceptional cases, so please take this into account when driving.

Ibuprofen and Pseudoephedrine hydrochloride Farmalider contains

This medicinal product may cause headache, stomach upset and diarrhoea because it contains glycerol. This medicinal product contains maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains 26.8 mg (1.17 mmol) sodium per dose (10 ml). To be taken into consideration by patients on a controlled sodium diet.

3. How to take Ibuprofen and Pseudoephedrine hydrochloride Farmalider

Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

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).

The recommended dose is:

Adults and adolescents aged 12 years and above: Depending on the severity of the symptoms 10 ml to 20 ml every six to eight hours. Never exceed the maximum daily dose of 60 ml.

Do not take more than the stated dose.
The medicine should be used for shortest time possible and at the lowest dose to relieve your symptoms.
Do not give to children under 12 years of age.
Doses should usually be given every 6 to 8 hours as required. Leave at least 4 hours between doses.

Before measuring the dose shake the bottle well until the sediment in the bottle is completely dispersed; a measuring oral syringe is provided to ensure accuracy.

Use in children and adolescents

Ibuprofen and Pseudoephedrine hydrochloride Farmalider is contraindicated in children under 12 years.

If you take more Ibuprofen and Pseudoephedrine hydrochloride Farmalider than you should If you have taken more Ibuprofen and Pseudoephedrine hydrochloride Farmalider than you should, or if children have been taken medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken. Always take any remaining medicine, the container and the label with you, so that the medicine can be identified.

The symptoms of overdose can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. Also agitation, somnolence, disorientation or coma may occur. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, low levels of potassium in your blood, cold body feeling, and breathing problems have been reported. Furthermore, there may be low blood pressure and reduced breathing.

If you forget to take Ibuprofen and Pseudoephedrine hydrochloride Farmalider If you forget to take a dose, take the next dose as soon as you remember unless it is time for the next one. Do not take a double dose to make up for a forgotten dose.

If you are worried, or not sure of when or how to use this medicine, ask your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop using Ibuprofen and Pseudoephedrine hydrochloride Farmalider and seek medical attention immediately if you notice any of the following symptoms:

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].
Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear

Stop using Ibuprofen and Pseudoephedrine hydrochloride Farmalider immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

severe headache with a sudden onset
feeling sick
vomiting
confusion
seizures changes in vision

Serious side effects

Whilst taking Ibuprofen and Pseudoephedrine hydrochloride, if you develop any of the following symptoms you should contact your doctor immediately:

serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) (not known)
If you observe stiff neck, headache, nausea, vomiting, fever or disorientation (aseptic meningitis);
(very rare, may affect up to 1 in 10,000 people)
Changes in the blood clotting capacity of the blood, increasing risk of bleeding (thrombocytopenia);
(very rare, may affect up to 1 in 10,000 people)
Unexplained wheezing, shortness of breath, skin rash (which may be severe and include blistering or peeling of the skin), swelling of mouth or tongue, mouth ulcers, itching or bruising, light headedness, racing heart or fluid retention, e.g. swollen ankles). All these may be the results of anaphylactic shock and severe allergic reactions. (very rare, may affect up to 1 in 10,000 people)
Stroke (not known)
Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
(rare, may affect up to 1 in 1,000 people)
Severe skin infections and /or blistering, peeling off of the skin (erythema multiforme, toxic epidermal necrolysis); (very rare, may affect up to 1 in 10,000 people)

These are very serious side effects. You may need immediate medical attention.

Other side effects

If any of the following side effects occur, contact your doctor as soon as possible:

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

Inflammation of stomach or intestine, sometimes with blood loss leading to anaemia
Indigestion, stomachache, loss of appetite
Feeling & being sick
Diarrhoea, wind or constipation

Uncommon (may affect up to 1 in 100 people):

Hives: swelling of face/lips/mouth/tongue or throat which may cause difficulty in swallowing or breathing
Skin rashes
Asthma attack
Headache, dizziness, sleeplessness, agitation, irritability or tiredness
Difficulty in seeing
Stomach or intestinal ulcers
Worsening of colitis and Crohn's disease.
Dry mouth, thirst, nausea, vomiting

Rare (may affect up to 1 in 1,000 people):

Nervousness, anxiety, restlessness, tremor, hallucinations
Ringing in your ears
Worsening of asthma
Kidney problems
Fits irregular and rapid heart beats
Rash, itching, hives, excessive sweating, skin redness

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

Worsening of infectious inflammations
Disorders of the blood such as anaemia
Allergic reactions with signs such as face swelling, difficulty in breathing, rapid heart betas, drop in blood pressure
Depression
Swelling (oedema), high blood pressure, feeling your heartbeat, heart attack
Inflammation of the throat due to reflux (oesophagitis)
Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
Yellowing of the eye and/or skin, which may be a sign of liver problems, inflammation of the liver
(hepatitis)
Hair loss, severe condition of the skin-red blotches (erythema multiforme)

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

Liver, kidney problems or difficulty urinating
Abnormal behaviour
Difficulties passing urine
Inflammation of the colon due to insufficient blood supply (ischemic colitis)
Reduced blood flow to the optic nerve (Ischaemic optic neuropathy)
A severe skin reaction known as DRESS syndrom 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 Pseudoephedrine hydrochloride Farmalider if you develop these symptoms and seek medical attention immediately. See also section
2.
Skin becomes sensitive to light.

<Product Name>, 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. Website: 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 Ibuprofen and Pseudoephedrine hydrochloride Farmalider

Keep this medicine out of the sight and reach of children.

It does not require any special storage conditions. Do not use this medicine after 3 months after first opening.

Do not use this medicine after the expiry date which is stated on the bottle after Exp. 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 medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen and Pseudoephedrine hydrochloride Farmalider contains

The active substances are Ibuprofen (20 mg/ml) and Pseudoephedrine hydrochloride (3 mg/ml).

The other ingredients (excipients) are: sodium benzoate, anhydrous citric acid, sodium citrate, saccharin sodium, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E-422), thaumatin (E-957), orange flavour (contains butylated hydroxyanisole (E-320) and alpha-tocopherol (E307)) and purified water.

What Ibuprofen and Pseudoephedrine hydrochloride Farmalider looks like and contents of the pack

Suspension of white color with orange flavor.

It is presented in 150 and 200 ml bottles. It contains a 5 ml dosing syringe (graduated in milliliters).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Farmalider, S.A.

C/ La Granja, nº1, 28108

Alcobendas (Madrid)

España

Manufacturer