Ibuprofen and Pseudoephedrine Hydrochloride Farmaldier 200 mg / 30 mg / 10 ml oral suspension – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Ibuprofen and Pseudoephedrine hydrochloride Farmalider 200 mg/ 30 mg/10 ml oral suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of oral suspension contains:

Ibuprofen………………………………….20 mg

Pseudoephedrine hydrochloride…………..3 mg

Excipients with known effect:

Glycerol (E-422)………………………….50 mg

Maltitol……………………………………500 mg

Sodium…………………………………….2.68 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral suspension.

A white color suspension with orange flavouring.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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 over 12 years of age.

4.2 Posology and method of administration

This combination product should be used when both, the decongestant action of Pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory and/or antipyretic action of Ibuprofen, are required. If one symptom (either nasal congestion or headache and/or fever) predominates, single-agent therapy is preferable.

Posology

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).

Adults, the elderly and adolescents over 12 years:

The usual recommended dose is depending on the severity of symptoms 10 ml to 20 ml every six to eight hours. Leave at least four hours between each dose and do not take more than 60 ml in 24 hours.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

The adult patient should consult a doctor if symptoms persist or worsen or if the product is required for more than 5 days.

Elderly:

No special dosage modifications are required, unless renal or hepatic function is impaired, in which case dosage should be assessed individually.

In elderly and patients with a history of ulcers, particularly if complicated by haemorrhage or perforation (see section 4.3), start with lowest dose possible as the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs.

The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients or patients taking other drugs that can increase the risk of gastrointestinal events (see below and section 4.5).

Paediatric population:

Ibuprofen and Pseudoephedrine hydrochloride Farmalider is contraindicated in children under the age of 12 (see section 4.3).

If in adolescents over 12 years this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Parents or carers should seek medical attention if the child’s condition deteriorates during treatment. Do not exceed the stated dose.

The maximum total daily dose of 60 ml (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride) should not be exceeded.

Method of administration

For oral administration only.

4.3 Contraindications

• Hypersensitivity to ibuprofen, pseudoephedrine or to any of the excipients listed in section 6.1.
• Use in children under 12 years of age.

• Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory

  Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticarial) in response to ibuprofen, aspirin or NSAIDs.

• During pregnancy (see section 4.6).
• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
• Cerebrovascular or other bleeding.
• Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Patients with phaeochromocytoma, closed angle glaucoma, diabetes or thyroid disease.
• Patients with history of haemorrhagic stroke.
• Patients suffering from heart disease, circulatory problems, prostatic hypertrophy, coronary artery disease, angina pectoris, tachycardia or haemorrhagic diathesis.
• Severe hypertension or uncontrolled hypertension.
• Patients taking other NSAIDs including cyclooxygenase-2 selective inhibitors, pain-relievers or decongestants.
• Patients receiving tricyclic antidepressants.
• Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4).
• Severe acute or chronic kidney disease/renal failure.
• History of seizures.
• Unexplained haematopoietic abnormalities.
• Disseminated lupus erythematosus.
• History of stroke or presence of risk factors for stroke.
• Concomitant use of monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5).
• Concomitant use of other vasoconstrictor drugs used as nasal decongestants, whether administered orally or nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine), and methylphenidate (see section 4.5).
• Risk of urinary retention associated with uretroprostatic disorders.

4.4 Special warnings and precautions for use

Concomitant use of Ibuprofen and Pseudoephedrine hydrochloride Farmalider with other NSAIDs containing cyclo-oxygenase (COX)-2 inhibitors should be avoided.

Undesirable effects may be reduced by using the minimum effective dose for the shortest duration necessary to control symptoms (see "Gastro-intestinal effects" and "Cardiovascular and cerebrovascular effects" below).

Special warnings related to pseudoephedrine hydrochloride:

• The dosage, the recommended maximum duration of treatment (5 days; in adolescents aged 12 years and above, 3 days) and the contraindications must be strictly adhered to (see section 4.8).
• Patients should be informed that treatment must be discontinued if they develop hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any neurological signs such as onset or worsening of headache.

Before using this product, patients should consult their doctor in case of:

• Hypertension, heart disease, hyperthyroidism, psychosis or diabetes.
• Concomitant administration of antimigraine agents, especially ergot alkaloid vasoconstrictors (because of the α-sympathomimetic activity of pseudoephedrine).
• Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8).
• Neurological symptoms such as seizures, hallucinations, behavioural disturbances, agitation and insomnia have been described after systemic administration of vasoconstrictors, especially during febrile episodes or on overdose. These symptoms have been more commonly reported in paediatric population.

As a result, it is advisable:

• to avoid administration of Ibuprofen and Pseudoephedrine hydrochloride

  Farmalider either in combination with medicines which can lower the epileptogenic threshold, such as terpene derivatives, clobutinol, atropine-like substances and local anaesthetics, or where there is a history of seizures.

• to adhere strictly to the recommended dosage in all cases and to inform the patients about the risks of overdose if Ibuprofen and Pseudoephedrine hydrochloride Farmalider is taken concomitantly with other medicines containing vasoconstrictors.

Patients with urethroprostatic disorders are more prone to develop symptoms like dysuria and urinary retention.

Elderly patients may be more sensitive to the effects on the central nervous system (CNS).

Precautions for use related to pseudoephedrine hydrochloride:

• In patients undergoing scheduled surgery in which volatile halogenated anaesthetics are to be used, it is preferable to discontinue treatment with Ibuprofen and Pseudoephedrine hydrochloride Farmalider several days before surgery in view of the risk of acute hypertension (see section 4.5).

• Athletes should be informed that treatment with pseudoephedrine

  hydrochloride can lead to positive results in doping tests.

Interference with serological testing

Pseudoephedrine has the potential to reduce iobenguane i-131 uptake in neuroendocrine tumors, thus interfering with scintigraphy.

Ischaemic colitis

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Ischaemic optic neuropathy

Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Cases of PRES and RCVS have been reported with the use of pseudoephedrine-containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3).

Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment.

Special warnings related to ibuprofen:

Bronchospasm may be precipitated in patients suffering from, or with a history of bronchial asthma or allergic disease. The product should not be taken in case of asthma without prior consultation with a doctor (see section 4.3).

Patients who have asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis have a higher risk of allergic reactions when taking acetylsalicylic acid and/or NSAIDs. Administration of Ibuprofen and Pseudoephedrine hydrochloride Farmalider may precipitate an acute asthma attack; particularly in some patients who are allergic to acetylsalicylic acid or an NSAID (see section 4.3).

There is a risk of renal failure in dehydrated adolescents.

Gastro-intestinal effects:

Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of gastrointestinal events.

The risk of gastro-intestinal bleeding, ulceration or perforation, which can be fatal, is higher with increasing NSAID doses, in patients with a history of ulcer (particularly if complicated with bleeding or perforation (see section 4.3) and in patients older than 60 years of age. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitant low-dose acetylsalicylic acid or other medicinal drug products likely to increase gastro-intestinal risk (see below and section 4.5).

Patients with a history of gastrointestinal toxicity, especially elderly patients, may present with unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment.

Particular caution is advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding such as oral corticosteroids, anticoagulants such as warfarin, SSRIs or antiplatelet agents such as acetylsalicylic acid (see section 4.5).

Treatment with Ibuprofen and Pseudoephedrine hydrochloride Farmalider should be discontinued immediately if gastro-intestinal bleeding or ulceration occurs.

NSAIDs should be given with care to patients with a history of gastro-intestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see section 4.8).

Through concomitant consumption of alcohol, active substance-related undesirable effects, particularly those that concern the gastrointestinal tract or the central nervous system, may be increased on use of NSAIDs.

Cardiovascular and cerebrovascular effects:

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low-dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

Caution is required in patients with a history of hypertension and/or heart failure as fluid retention, hypertension or oedema have been observed in association with previous NSAID therapy; advice from a doctor and/or pharmacist must be sought prior to starting treatment under these circumstances.

Cases of Kounis syndrome have been reported in patients treated with Ibuprofen and Pseudoephedrine hydrochloride Farmalider. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.

Severe cutaneous adverse reactions (SCARs)Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section 4.8). Most of these reactions occurred within the first month.

If signs and symptoms suggestive of these reactions appear ibuprofen should be discontinued withdrawn immediately and an alternative treatment considered (as appropriate).

Masking of symptoms of underlying infections

Ibuprofen and Pseudoephedrine hydrochloride Farmalider can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Ibuprofen and Pseudoephedrine hydrochloride Farmalider is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.

Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.

Precautions for use related to ibuprofen:

• Elderly: the pharmacokinetics of ibuprofen is not modified by age, no dose adjustments is necessary in the older population. However, elderly patients should be carefully monitored as they are more sensitive to NSAID-related undesirable effects, particularly gastro-intestinal bleeding and perforation, which can be fatal.
• Caution and special monitoring is required when administering ibuprofen to patients with a history of gastro-intestinal disease (such as peptic ulcer, hiatus hernia or gastrointestinal bleeding).
• In the initial stages of treatment, careful monitoring of urine output and renal function is required in patients with heart failure, patients with chronically impaired renal or hepatic function, patients taking diuretics, patients who are hypovolaemic as a result of major surgery and, in particular, elderly patients. Renal function in these patients may be adversely influenced by treatment with NSAIDs.

• If visual disturbances occur during the course of treatment, a full

  ophthalmological examination should be carried out.

If symptoms persist or worsen, the patient should consult a doctor.

Warnings about excipients

This medicinal product contains glycerol, it may cause headache, stomach upset and diarrhoea.

This medicinal product contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

Pregnancy

Ibuprofen and Pseudoephedrine hydrochloride Farmalider is contraindicated during pregnancy (see section 4.3).

Ibuprofen:

From the 20th week of pregnancy onward, Ibuprofen and Pseudoephedrine hydrochloride Farmalider use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, Ibuprofen and Pseudoephedrine hydrochloride Farmalider should not be given unless clearly necessary. If Ibuprofen and Pseudoephedrine hydrochloride Farmalider is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to Ibuprofen and Pseudoephedrine hydrochloride Farmalider for several days from gestational week 20 onward. Ibuprofen and Pseudoephedrine hydrochloride Farmalider should be discontinued if oligohydramnios or ductus arteriosus constriction are found.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

• cardiopulmonary toxicity (with premature constriction/closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction (see above);

the mother and the neonate, at the end of pregnancy, to:

• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, Ibuprofen and Pseudoephedrine hydrochloride Farmalider is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3).

Pseudoephedrine hydrochloride:

Pseudoephedrine hydrochloride has been used extensively for many years without apparent negative consequences; however, there may be an increased risk in the early stages of gestation due to its vasoconstricting effects.

Breastfeeding

Although ibuprofen appears in breast milk in very low concentrations, significant amounts of pseudoephedrine are secreted into breast milk. The use of Ibuprofen and Pseudoephedrine hydrochloride Farmalider during lactation should, therefore, be avoided except under the supervision of a doctor when the benefit outweighs the risks.

Fertility

There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

4.7 Effects on ability to drive and use machines

Ibuprofen and Pseudoephedrine hydrochloride Farmalider has no known effects on the ability to drive and use machines.

However, since dizziness or hallucinations may appear in exceptional cases, owing to the presence of pseudoephedrine, anyone intending to drive should take this possibility into account.

4.8 Undesirable effects

The most commonly-observed adverse events related to ibuprofen are gastrointestinal in nature. In general, the risk of development of adverse events (in particular the risk of development of serious gastrointestinal complications) increases with increasing dose and with increasing duration of treatment administration.

Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of:

(a) Non-specific allergic reaction and anaphylaxis.

(b) Respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea.

(c) Assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke), (see section 4.4).

The following list of adverse effects relates to those experienced with ibuprofen and pseudoephedrine hydrochloride at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur. Patients should be informed that they should stop taking Ibuprofen and Pseudoephedrine hydrochloride Farmalider immediately and consult a doctor if they experience a serious adverse drug reaction.

Adverse reaction frequency is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

*Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9 Overdose

The clinical effects of this medication overdose are more likely to be due to pseudoephedrine hydrochloride than to ibuprofen. The effects are not always correlated with the dose taken because of the different inter-individual sensitivity with respect to the sympathomimetic properties.

Symptoms

The most frequent manifestations of ibuprofen overdose are abdominal pain, nausea, vomiting, lethargy, thirst, muscle weakness, drowsiness, blurred vision and dizziness. Other effects including headache, tinnitus, CNS depression, convulsions, hypotension, bradycardia, tachycardia, supraventricular and ventricular arrhythmias, and atrial fibrillation, may occur. Metabolic acidosis, coma, acute renal failure, hyperkalemia, apnoea (mainly in young children), respiratory depression, and respiratory failure have been reported rarely. Exacerbation of asthma is possible in asthmatics. In serious poisoning metabolic acidosis may occur.

Prolonged use at higher than recommended doses or overdose may result in renal tubular acidosis and hypokalaemia. Symptoms may include reduced level of consciousness and generalised weakness (see section 4.4 and section 4.8).

Symptoms and signs of pseudoephedrine overdose include irritability, insomnia, fever, sweating, anxiety, restlessness, tremor, convulsions, palpitations (sinus arrhythmia), hypertension, dry mouth, and difficulty in urination. Hallucinations have been reported (more likely in children).

Treatment

Treatment of overdose is supportive. Gastric lavage and activated charcoal may be of benefit within 1 hour of ingestion of a potentially toxic amount, and if necessary, correction of serum electrolytes.

Symptomatic and supportive treatment should be undertaken, particularly with regard to the cardiovascular and respiratory systems. For example, severe hypertension may need to be treated with an alpha-receptor blocking drug, whilst a beta-receptor blocking drug may be required to control cardiac arrhythmias. Convulsions may be controlled with intravenous diazepam, while chlorpromazine may be used to control marked excitement and hallucinations.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: pseudoephedrine combinations, ATC code: R01BA52.

Ibuprofen and Pseudoephedrine hydrochloride Farmalider is a medicine consisting of a combination of two active substances: ibuprofen and pseudoephedrine.

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta stimulant adrenergic stimulant activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which relieves nasal congestion.

Ibuprofen is an anti-inflammatory analgesic and antipyretic drug belonging to the group of non-steroidal anti-inflammatory drugs. In humans, it has been shown to be effective in reducing the symptoms (pain, fever and swelling) associated with inflammation and influenza. The therapeutic effects of the drug are the result of an inhibitory activity on the prostaglandin synthesis. Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

5.2 Pharmacokinetic properties

Ibuprofen:

Ibuprofen is rapidly absorbed from the gastrointestinal tract, and its plasma concentrations reach a maximum peak level about 2 hours after administration. Elimination half-life is approximately 2 hours.

Ibuprofen is metabolised in the liver into two major inactive metabolites and these together with unchanged ibuprofen are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete. Ibuprofen is extensively bound to plasma proteins.

Pseudoephedrine:

Pseudoephedrine is absorbed in the gastrointestinal tract and is largely excreted in the urine unchanged, together with small amounts of a hepatic metabolite.

It has an elimination half-life of several hours, which may be reduced by acidifying the urine.

5.3 Preclinical safety data

Only limited toxicity data are available with the drug combination ibuprofen and pseudoephedrine hydrochloride.

Based on different mechanisms of action of ibuprofen (non-steroidal anti-inflammatory) and pseudoephedrine hydrochloride (sympathomimetic), a compound-specific toxicity profile related to the pharmacodynamic activity of the mono-compounds was seen in non-clinical toxicity tests following overdosing (pseudoephedrine human data). Accordingly, there were different toxicological target organs, e.g. gastrointestinal lesions for ibuprofen and hemodynamic as well as CNS-effects for pseudoephedrine hydrochloride. Co-administration of ibuprofen and pseudoephedrine hydrochloride did not result in any clinically significant interaction. Therefore, no additive, synergistic and potentiating effects will be expected for the fixed-dose combination (FDC) ibuprofen/pseudoephedrine hydrochloride (200 mg/30 mg) in animals and men at equipotent doses. This is also supported by the absence of competitive metabolic pathways. There is no scientific evidence that the safety margins for the individual drugs will be different for the drug combination.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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), alpha-tocopherol (E307))

Purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

After the first opening the suspension is stable for 3 months.

6.4 Special precautions for storage

It does not require any special storage conditions.

6.5 Nature and contents of container

Amber-coloured PET bottles, of 150 and 200 ml, with child-resistant closure. It contains a 5 ml dosing syringe (graduated in milliliters). Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Disposal of the unused medicinal product and all materials that have been in contact with it should be carried out in accordance with local regulations.

7 MARKETING AUTHORISATION HOLDER

Farmalider, S.A.

C/ La Granja, nº1, 28108

Alcobendas (Madrid)

Spain

8 MARKETING AUTHORISATION NUMBER(S)

PL 35667/0020

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

03/03/2025

10 DATE OF REVISION OF THE TEXT

09/09/2026