Patient leaflet - Sudafed Sinus Pressure & Pain 200 mg / 30 mg tablets

1. What Sudafed Sinus Pressure & Pain 200mg/ 30mg Tablets is and what it is used for

Sudafed Sinus Pressure & Pain 200mg/30mg Tablets contains two active substances: ibuprofen and pseudoephedrine hydrochloride.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inﬂammatory drugs (NSAIDs). NSAIDs provide relief by reducing pain and high temperature. Pseudoephedrine hydrochloride belongs to a group of active substances called vasoconstrictors which act on the blood vessels in the nose to relieve nasal congestion. Sudafed Sinus Pressure & Pain 200mg/30mg Tablets is used for the symptomatic treatment of nasal congestion in head colds together with headache and/or fever, in adults and adolescents aged 15 years and older. You should only take this combination product if you have a blocked nose with headache or fever. If you have only one of these symptoms you should talk to your pharmacist

of adverse reactions (see section “Other medicines and Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets” below) and 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. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. Bleeding of the gastrointestinal tract, ulcers and perforations

Sudden abdominal pain or rectal bleeding may occur with this medicine, due to inﬂammation of the colon (ischemic colitis). If you develop these gastro-intestinal symptoms, stop taking Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets and contact your doctor or seek medical attention immediately. See section 4.

If you develop a feverish generalised erythema associated with pustules, stop taking Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets and contact your doctor or seek medical attention immediately. See section 4. Heart attack and stroke

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.

Reduction of blood ﬂow to your optic nerve may occur with this medicine. If you develop sudden loss of vision, stop taking Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets and contact your doctor or seek medical attention immediately. See section 4.

If you are taking Sudafed Sinus Pressure & Pain 200mg/30mg Tablets 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). Skin reactions

Serious skin reactions have been reported in association with Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets treatment. You should stop taking this medicine 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

Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets may hide signs of infections such as fever and pain. It is therefore possible that this medicine 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.

Interference with blood test result

Pseudoephedrine has the potential to interfere with some diagnostic blood tests. You should tell your doctor that you are taking this medicine if you have a blood test. SINUS PRESSURE & PAIN 200mg/30mg Tablets

Ibuprofen

Pseudoephedrine hydrochloride or doctor about using either ibuprofen or pseudoephedrine by itself.

You must talk to a doctor if symptoms worsen, or if this medicine is required for more than 4 days (adults) or 3 days (adolescents), respectively.

2. What you need to know before you take Sudafed Sinus Pressure & Pain 200mg/30mg Tablets

Do not take Sudafed Sinus Pressure & Pain 200mg/30mg Tablets if you:

are allergic to ibuprofen or pseudoephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
are younger than 15 years
are in the third trimester of pregnancy (6 months or more pregnant)
are breast-feeding
have had an allergic reaction or shortness of breath, asthma, skin rash, itchy runny nose or facial and neck swelling (angioedema) or chest pain when previously taking acetylsalicylic acid or other NSAIDs including ibuprofen. Stop immediately Sudafed Sinus Pressure & Pain 200mg/30mg Tablets and contact immediately your doctor or medical emergencies if you notice any of these signs.
have an active or history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two different episodes of conﬁrmed ulcers or bleeding)
have a history of gastro-intestinal bleeding or perforation related to previous NSAID treatment
have severe liver failure or severe acute (sudden) or chronic (long-term) kidney disease or kidney failure
have severe heart failure
have severe heart or circulation problems (heart disease, high blood pressure (hypertension ), angina, fast heart rate), an overactive thyroid gland, diabetes, pheochromocytoma (a tumour of the adrenal gland)
have a history of heart attack (myocardial infarction)
have had a stroke or have previously been told you are at risk of having a stroke
have a history of seizures (ﬁts)
have unexplained disorders in the formation of blood components
have increased pressure in the eye (closed-angle glaucoma)
have difﬁculty in urinating related to prostate problems
have been diagnosed with Systemic Lupus Erythematosus (SLE), an illness affecting the immune system causing joint pain, skin changes and other problems
are taking:
- other nasal decongestants (vasoconstrictor drugs) administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline)
- methylphenidate, a medicine for ADHD (attention deﬁcit hyperactivity disorder)
- medicines for depression like non-selective Monoamine Oxidase Inhibitors (known as MAOIs e.g. iproniazid) or have taken them in the last 14 days Warnings and precautions

Undesirable effects may be minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects. Talk to your doctor or pharmacist before taking Sudafed Sinus Pressure & Pain 200mg/30mg Tablets if you: have asthma; use of this medicinal product can cause an

asthma attack
have a history of gastro-intestinal disorders such as hiatus hernia, gastro-intestinal bleeding, peptic or duodenal ulcer, previous stomach ulcer or other increased tendency to bleed
have or have ever had gastro-intestinal disease (ulcerative colitis or Crohn’s disease)
have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke or if you are a smoker
have had 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 liver or kidney problems
have diabetes because of potential diabetic nephropathy
have overactive thyroid gland (hyperthyroidism) or psychosis
have a blood clotting disorder
if you are pregnant or breastfeeding - please see heading "Pregnancy, breastfeeding and fertility" below
have an infection - please see heading "Infections" below
if you are dehydrated, as there is a risk of renal; impairment, especially in dehydrated adolescents and in elderly
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 treatment. Stop using Sudafed Sinus Pressure & Pain 200mg/30mg Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in 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 Sudafed Sinus Pressure & Pain 200mg/30mg Tablets 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)

Lowest effective dose

Do not take this product for anything other than its intended use and never take more than the recommended amount. Do not take for longer than the recommended length of treatment (4 days in adults or 3 days in adolescents).

Increased doses of pseudoephedrine can be toxic and continuous use may lead to taking more Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets than the recommended dose to get the desired effect, increasing the risk of overdosing. If you suddenly stop treatment, depression may occur.

The use with concomitant NSAIDs, including cyclo-oxygenase (COX)-2 speciﬁc inhibitors, increases risk

inform your anaesthetist.

Sudafed Sinus Pressure & Pain 200mg/30mg Tablets with alcohol

You should avoid alcohol intake during the 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. Pregnancy

Do not take this product 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 you 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, ibuprofen 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.

Breast-feeding

Do not take this medicine if you are breastfeeding, as it may harm your baby.

Fertility

Ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon stopping the medicine.

Driving and using machines

Sudafed Sinus Pressure & Pain 200mg/30mg Tablets could cause dizziness, hallucinations, unusual headache and visual or hearing disturbances and therefore might temporarily affect your ability to drive and use machines. If you experience any of these symptoms you should avoid driving or using machines.

Sudafed Sinus Pressure & Pain 200 mg/30 mg tablets contains sodium

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say "sodium free".

3. How to take Sudafed Sinus Pressure & Pain 200mg/ 30mg Tablets

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. Duration of Use

This medicine is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.

You must talk to a doctor if symptoms worsen, or if this medicine is required for more than 4 days (adults) or 3 days (adolescents), respectively.

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Children and adolescents

Sudafed Sinus Pressure & Pain 200mg/30mg Tablets must not be given to children below 15 years.

There is a risk of renal impairment in dehydrated adolescents.

Athletes

Pseudoephedrine hydrochloride can lead to positive results in doping tests.

Other medicines and Sudafed Sinus Pressure & Pain 200mg/30mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Sudafed Sinus Pressure & Pain 200mg/30mg Tablets may affect or be affected by some other medicines. For example:

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

Some other medicines may also affect or be affected by the treatment of Sudafed Sinus Pressure & Pain 200mg/30mg Tablets. Always seek the advice of a doctor before you use Sudafed Sinus Pressure & Pain 200mg/30mg Tablets with other medicines.

Sudafed Sinus Pressure & Pain 200mg/30mg Tablets must not be used in combination with:

other vasoconstrictor agents used as nasal decongestants, whether administered orally or nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine)
a medicine for ADHD (attention deﬁcit hyperactivity disorder) called methylphenidate
medicines for depression like non-selective Monoamine Oxidase Inhibitors (MAOIs, such as iproniazid). Also do not take this medicine if you have taken them within the last 14 days.

In particular tell your doctor or pharmacist if you are taking:

other nonsteroidal anti-inﬂammatory drugs (NSAIDs) including high dose acetylsalicylic acid and cyclo-oxygenase (COX)-2 selective inhibitors
medicines to treat heart arrhythmias (cardiac glycosides, e.g. digoxin)
medicine to treat epilepsy (e.g. phenytoin)
glucocorticoids, which are used for many conditions such as pain, swelling, allergy, asthma, rheumatism and skin problems
injectable heparin
some medicines for depression (e.g. lithium, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase A inhibitors (MAOIs))
medicines for the temporary suppression of your immune system e.g. methotrexate (for arthritis, psoriasis and some cancers), ciclosporin or tacrolimus (given after transplant surgery)
antidiabetic medicines (sulphonylureas)
medicines used to treat infections (e.g. quinolone antibiotics, trimethoprim)
medicines to help you pass water (water tablets e.g. potassium sparing diuretics)
medicines for gout (e.g. probenecid and sulﬁnpyrazones)
any anti migraine medicinal products (including ergot alkaloid derivatives medicinal products)
medicine for treating HIV/AIDS (zidovudine)
preparations containing Ginkgo biloba

Being given pseudoephedrine may cause a sudden increase in blood pressure around the time of your surgery. Discontinue treatment with Sudafed Sinus Pressure & Pain 200mg/30mg Tablets several days before surgery and

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). Dosage

The recommended dose is for adults and adolescents aged 15 years and older:

1 tablet every 6 hours, if necessary. For more severe symptoms, take 2 tablets every 6 hours, if necessary. Never exceed the maximum daily dose of 6 tablets per day (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride).

Method of administration:

The tablets are for oral use. They should be swallowed whole and without chewing with a large glass of water, preferably during meals.

Use in children and adolescents

Sudafed Sinus Pressure & Pain 200mg/30mg Tablets must not be given to children and adolescents below 15 years. If you take more Sudafed Sinus Pressure & Pain 200mg/30mg Tablets than you should

Stop treatment and consult your doctor immediately, even if you feel well.

If you have taken more Sudafed Sinus Pressure & Pain 200 mg/30 mg ﬁlm-coated Tablets 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.

The symptoms of overdose 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, low levels of potassium in your blood, cold body feeling, breathing problems and renal tubular acidosis (accumulation of acid in body) have been reported. 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.

Stop taking Sudafed Sinus Pressure & Pain 200mg/30mg Tablets and consult a doctor immediately if you experience:

Serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral
vasoconstriction syndrome (RCVS).
Symptoms include:
- sudden onset of severe headache
- nausea
- feeling sick
- confusion
- seizures
- vomiting
- visual disturbances
signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds
signs of colitis (inﬂammation of the colon) such as sudden stomach pains, blood in the faeces (stools/ motions), rectal bleeding and diarrhoea
signs of a serious allergic reaction 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

5. How to store Sudafed Sinus Pressure & Pain 200mg/ 30mg Tablets

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 or the blister after (EXP). The expiry date refers to the last day of the month.

Do not store above 30°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 Sudafed Sinus Pressure & Pain 200mg/30mg Tablets contains

The active substances are ibuprofen and pseudoephedrine hydrochloride. Each ﬁlm-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride
The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, maize starch, silica colloidal anhydrous, magnesium stearate.
Tablet coat: hypromellose, macrogol 400, talc, titanium dioxide (E171), iron oxide yellow (E 172)

What Sudafed Sinus Pressure & Pain 200mg/30mg Tablets looks like and contents of the pack

Sudafed Sinus Pressure & Pain 200mg/30mg Tablets are round, yellow ﬁlm-coated tablets.

Pack sizes: Available in packs of 12 or 24 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

McNeil Products Limited, High Wycombe,

Buckinghamshire, HP12 4EG, UK

Manufacturer

Dragenopharm Apotheker Puschl, GmbH, Gollstraße 1, 84529 Tittmoning, Germany

This leaﬂet was last revised in January 2025. SUDAFED® is a registered trade mark.

skin rashes can be preceded by fever and ﬂu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

Liver, kidney problems or difﬁculty urinating: Sudafed Sinus Pressure & Pain 200mg/30mg Tablets 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.
Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
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 at the initiation of treatment (acute generalised exanthematous pustulosis).

Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed.

Common (may affect up to 1 in 10 people)

indigestion, stomach discomfort or pain, nausea, vomiting, ﬂatulence, diarrhoea, constipation, minor gastrointestinal blood loss in rare cases leading to anaemia
insomnia, dry mouth

Uncommon (may affect up to 1 in 100 people)

hypersensitivity reactions with nettle rash, itching and asthma attacks (with drop in blood pressure)
central nervous disturbances such as headache, dizziness, difﬁculty in sleeping, agitation, irritability or tiredness
visual disturbances
stomach or intestinal ulcers, sometimes with bleeding and perforation, gastritis, swelling of the mouth lining with ulceration (ulcerative stomatitis), worsening of colitis and Crohn's disease
various skin rashes

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

tinnitus (ringing in the ears)
restlessness, tremor
worsening of asthma or hypersensitivity reaction with shortness of breath
kidney-tissue damage (papillary necrosis), increased uric acid concentrations in the blood

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

worsening of infectious inﬂammations (e.g. necrotizing fasciitis), aseptic meningitis (stiffness of the neck, headache, nausea, vomiting, fever or disorientation) in patients with preexisting autoimmune diseases (Systemic Lupus Erythematosus (SLE), mixed connective tissue disease)
problems in blood cell production (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) that might make you bruise more easily or make you more susceptible to infections
severe allergic reactions
psychotic reactions and depression
high blood pressure, irregular heartbeat, heart failure, heart attack
rash, pruritus (itching skin)
inﬂammation of the oesophagus (oesophagitis) and the pancreas (pancreatitis), intestinal diaphragm-like strictures
liver dysfunction, liver damage, especially in long-term
therapy, liver failure, acute liver inﬂammation (hepatitis)
severe skin reactions including skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), loss of hair (alopecia), severe skin infections and soft-tissue complications in a chicken pox infection (varicella zoster infection)
increase in serum creatinine, oedemas (especially in patients with arterial hypertension or renal insufﬁciency), nephrotic syndrome, interstitial nephritis, acute renal insufﬁciency

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

abnormal behaviour
stroke, ﬁts, headache
chest pain, fast heartbeat, irregular heartbeat
chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome. In that case contact your doctor immediately.
thirst, nausea, vomiting
nettle rash, itching, excessive sweating
euphoric mood, hallucination, nervousness, anxiety
sleepiness
reddening of the skin, blisters or rash
pain, discomfort or difﬁculty passing urine, inability to pass urine
high blood pressure
angioedema (difﬁculty in breathing, skin rash, swelling of the face, hands or feet)
reduced blood ﬂow to the optic nerve (ischaemic optic neuropathy)
inﬂammation of the colon due to insufﬁcient blood supply (ischaemic colitis)
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).
skin becomes sensitive to light
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 (Acute Generalized Exanthematous Pustulosis - AGEP) may occur at the initiation of treatment or within the ﬁrst 2 days of treatment with this medicine.

Stop using Sudafed Sinus Pressure & Pain 200mg/30mg Tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. See section 2. Medicines such as Sudafed Sinus Pressure & Pain 200mg/30mg Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

Prescription needed?	No, but it is sold only in pharmacies (P)
Active substances	Pseudoephedrine, Ibuprofen
Strength	200 mg / 30 mg
Pharmaceutical form	Yellow, round, film-coated tablets. Diameter: approx. 11 mm, height: approx. 5 mm.
Excipients	Microcrystalline cellulose, Calcium hydrogen phosphate anhydrous, Croscarmellose sodium, Maize starch, Silica, colloidal anhydrous, Magnesium stearate, Hypromellose, Macrogol 400, Talc, Titanium dioxide (E171), Iron oxide yellow (E 172)
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	48 months.
Storage	Do not store above 30°C.
Drug group (ATC)	Cough and cold preparations; other cold preparations M Musculo-skeletal system drugs M01 Antiinflammatory and antirheumatic products M01A Antiinflammatory and antirheumatic products, non-steroids M01AE Propionic acid derivatives, antiinflammatory and antirheumatic products M01AE51 ibuprofen, combinations
Marketing authorisation	PL 15513/0396 (first authorised 15 June 2017)
Marketing authorisation holder	McNeil Products Limited

Sudafed Sinus Pressure & Pain 200 mg / 30 mg tablets – patient leaflet, side effects, dosage