Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Xylometazoline hydrochloride, Dexpanthenol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Sudafed Plus is a medicine which is used to help clear the blocked up feeling in your nose and sinuses, and helps relieve congestion caused by sinusitis, colds and allergies (such as hay fever). The spray contains: ■ xylometazoline hydrochloride, which is a topical decongestant that relieves nasal and sinus congestion, and ■ dexpanthenol which is a derivative of the vitamin pantothenic acid, which promotes healing and protects the mucous membrane (lining) of the nose. This medicine is for use in adults and children aged 12 years and over.
Do not use this medicine:
■ if you have ever had a bad reaction (e.g. rash, swelling of the face and
throat, difficulty breathing) to any of the ingredients
■ if you are taking any other decongestant medicines, including other
xylometazoline products ■ if you have recently taken any other medicine containing any decongestant, including those with xylometazoline. This includes decongestant tablets, syrups and other nose sprays ■ if you have high blood pressure or heart disease ■ if you have an adrenal marrow tumour (phaeochromocytoma) ■ if you have diabetes ■ if you have an overactive thyroid gland ■ if you have closed angle glaucoma ■ if you are taking drugs to slow down the heart rate known as beta blockers ■ if you have a condition that causes the inside of the nose to become dry and irritated (rhinitis sicca) or any other long standing inflammation inside the nose ■ if you are taking, or have taken in the last two weeks, drugs for depression known as monoamine oxidase inhibitors (MAOIs) ■ if you have recently had brain surgery (neurosurgery) ■ if you have had your pituitary gland removed ■ for a child under 12 years old. If any of these apply to you, get advice from a pharmacist or doctor without using Sudafed Plus. Do not take with other decongestants While using Sudafed Plus, do not use any other decongestants, including anything containing xylometazoline. Do not use if you have recently taken any other medicine containing any decongestant, including those with xylometazoline. This includes decongestant tablets, syrups and other nose sprays.
Warnings and precautions
11507851-00 NEW
Talk to your pharmacist or doctor before using Sudafed Plus: ■ if you have elevated pressure inside the eye (glaucoma) ■ if you have long-term inflammation of the lining of the nose (chronic rhinitis) ■ if you have a metabolic disorder called porphyria ■ if you have an enlarged prostate. ■ if you have inadequate blood flow to the heart due to narrowing of the arteries (occlusive vascular disease). ■ if you have a rare heart condition that causes heart rhythm problems called long QT syndrome Stop using Sudafed Plus if any of the following occur after using it: ■ hallucinations (if you hear, see, smell, taste or feel things that seem real but are not) ■ restlessness ■ sleep disturbances.
Using the spray wrongly, or using too much, can cause side effects (see section 4, Possible side effects). Using the spray for too long or more often than recommended can cause rebound nasal congestion even after stopping treatment (see section 4, Possible side effects). Keep away from the eyes.
Other medicines and Sudafed Plus
Do not use if you are taking or have recently taken: ■ any other medicine containing any decongestant, including those with xylometazoline. This includes decongestant tablets, syrups and other nose sprays. Tell your pharmacist or doctor before using this nose spray if you are taking: ■ medicines for nasal congestion, including tablets, syrups or other nose sprays ■ medicines for high or low blood pressure ■ medicines for depression, specifically the antidepressants called
- tricyclic antidepressants e.g. amitriptyline
- monoamine oxidase inhibitors (MAOIs) e.g. moclobemide or have taken these medicines in the last two weeks ■ medicines for heart failure and irregular heartbeats (digoxin and other cardiac glycosides) ■ medicines for migraine (specifically ergotamine and methysergide) ■ medicines to suppress appetite and treat ADHD (amphetamine-like stimulants such as phentermine, dexamphetamine and lisdexamfetamine). Tell your pharmacist or doctor if you are taking, have recently taken or might take any other medicines.
If you are pregnant or breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine should not be used during pregnancy due to a lack of safety data in pregnant women. This medicine should not be used during breastfeeding since it is not known whether xylometazoline hydrochloride passes into breast milk.
Driving and using machines
This medicine is not expected to affect your ability to drive or use machines.
253
Project Name / Design Sudafed Plus Blocked Nose Spray Famar/10ml/GB/PIL/CRD 13471/11507851-00 NEW
Old Component / Item Code
Colours represented with a diagonal line have been modified to aid PDF approval.
Product / Eurocode / Mat. ID Code 90591500
Black
LITHO OFFSET
REPRESENTATION:
INSTRUCTION No changes or modifications allowed to approved artwork file without written consent from local Kenvue affiliate.
253
St. 696, Zt. 696-1 Technical Code
WHITE
MANUFACTURING SITE
Reference
TECHNICAL DETAILS
Famar Madrid
Substrate
JJEXT_00505_V1 Date 24-04-2024
Plant
Stamping Area
Master Dieline
Perforation
Leaflet
Fold/Technical
Tamper Evident Label Area
296 x 210 mm
Bleed
Seal Area
Component
Text Limit
Varnish Free
Dimensions
Profile
Print Free
SMALLEST TEXT SIZE
Print & Varnish Free
Interstate-LightCondensed
AVE. TEXT SIZE
6.00 pt
LARGEST TEXT SIZE
9 pt
Coding (Silent Zone)
Braille Grid
FONTS USED
BlissPro-Bold BlissPro-ExtraBold BlissPro-Italic BlissPro-Regular Libertad-ExtraBold ZapfDingbatsITC
19.66 pt
2. Before you use Sudafed Plus
253
Always use this medicine exactly as described in this leaflet or as your pharmacist or doctor has told you. Check with your pharmacist or doctor if you are not sure. The recommended dose for adults and children 12 years and over is one spray into each nostril up to 3 times a day as necessary. The maximum daily dose is 3 doses in 24 hours. Do not give to children under 12 years of age. Do not use more than the stated dose. Do not use this medicine for more than 7 days. If you do not feel better after 7 days of treatment, talk to a doctor. After first opening, use the product within 3 months. If the bottle gets dropped with the cap off, check that the spray still squirts straight upwards when the bottle is held upright (see picture 1). If not, throw it away. If the spray is still working correctly, clean the nozzle thoroughly with an antiseptic wipe.
Method of administration
Sudafed Plus is intended for use in the nose. Follow the instructions and study the pictures below to ensure that you use Sudafed Plus correctly: First remove the protective cap from the sprayer. Before the first use, press the spray head 5 times away from the face, until a fine spray appears. If the spray has not been used for a long time the head should be pressed twice before use, away from the face. Insert the sprayer tip as upright as possible into one nostril and press the spray head once (picture 2). Gently inhale through the nose while spraying. If necessary, repeat this for the other nostril (up to 3 times a day as needed). After each use, wipe the sprayer tip with a paper tissue and place the protective cap back on the bottle. Do not share. For hygiene reasons and to avoid infections, each spray bottle should only be used by one person.
If you use more medicine than you should
If you use more of this medicine than you should or if you accidentally take in too much of it, contact your doctor or your nearest emergency department. Take this leaflet and pack with you. The following side effects might occur: ■ constricted or dilated eye pupils ■ fever, sweating, decreased body temperature ■ pale skin, blue skin or lips ■ nausea ■ drowsiness, convulsions, loss of consciousness ■ fast or slow heart rate, changes to heart rhythm, circulatory failure, cardiac arrest ■ high or low blood pressure ■ breathing problems ■ anxiety, agitation, hallucinations. If you notice any of these symptoms, seek medical help immediately.
If you forget to use the medicine
Possible side effects
Keep this medicine out of the sight and reach of children. After first opening of the container, the product should be used within 3 months. Do not use this medicine after the expiry date which is stated on the carton and label after 'EXP'. The expiry date refers to the last day of that month. Do not store above 250C. 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.
If you forget to use a dose, use the next dose when needed, but do not use more than 3 doses in 24 hours. Do not use a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon (may affect up to 1 in 100 people): ■ hypersensitivity reaction such as swelling of the skin and mucous membranes, skin rash, itching Rare (may affect up to 1 in 1,000 people): ■ palpitations (feeling your heartbeat), faster heartbeat, high blood pressure. Very rare (may affect up to 1 in 10,000 people): ■ nosebleeds. ■ restlessness, difficulty in sleeping ■ fatigue (drowsiness, sedation), headache ■ hallucinations (you hear, see, smell, taste or feel things that seem real but are not) ■ false belief of being under threat (paranoid delusions) ■ heart rhythm disorders ■ rebound nasal congestion (rhinitis medicamentosa), causing irritation and inflammation of the nose (especially after the spray is used frequently and/or for many days) ■ seizures. Frequency not known (cannot be estimated from the available data):
■ burning, irritation and dryness of the lining of the nose, sneezing ■ irritability, anxiety and excitability. ■ feeling sick (nausea)
■ reduced response to the spray especially after using it frequently
and/or for many days
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.
253
11507851-00 NEW
Contents of the pack and other information
What Sudafed Plus contains
■ The active substances are xylometazoline hydrochloride
and dexpanthenol. Each 1 ml of nasal spray contains 1 mg xylometazoline hydrochloride and 50 mg dexpanthenol. One spray contains 0.1 ml of nasal spray, containing 0.1 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol. ■ The other ingredients are potassium dihydrogen phosphate, disodium phosphate dodecahydrate and water for injections.
What Sudafed Plus looks like and contents of the pack Sudafed Plus is a clear, colourless to slightly yellowish solution available in a 10 ml HDPE bottle with spray pump. The 10 ml of nasal spray solution is sufficient for 80 sprays. Marketing Authorisation Holder McNeil Products Limited, High Wycombe, Buckinghamshire, HP12 4EG, UK. Manufacturer Famar Health Care Services Madrid, S.A.U., Avda. Leganes, 62, Alcorcon, 28923, Madrid. This leaflet was last revised in April 2025 SUDAFED® is a registered trade mark. McNeil Products Limited 2025©
Frequently asked questions about Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray
How do I take Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray?
Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray comes as nasal spray containing 1mg / 50mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray?
The active substance in Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray is xylometazoline hydrochloride, dexpanthenol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: xylometazoline hydrochloride, dexpanthenol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
This product is indicated for adults and children 12 years and older:
- For the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis (vasomotor rhinitis), other upper respiratory tract allergies (see section 5.1).
4.2. Posology and method of administration
Posology
Adults and children 12 years and over:
One spray into each nostril up to 3 times a day, as necessary.
Maximum daily dose: 3 sprays in 24 hours.
The dosage depends on individual sensitivity and clinical efficacy.
Use for more than seven consecutive days is not recommended (See section 4.4). Do not exceed the recommended dose.
Children under 12 years:
Do not give to children under 12 years of age.
For hygienic reasons and to avoid infections, each spray bottle should only be used by the same person.
Method of administration: Nasal
First the protective cap should be removed from the sprayer.
Before the first use the spray head should be pressed five times away from the face until a fine spray appears. If the spray has not been used for a long period of time the head should be pressed two times away from the face before use.
The sprayer tip should be inserted as upright as possible into one nostril and the spray head should be pressed once. Patient should gently inhale through the nose while spraying. If necessary, the procedure should be repeated for the other nostril.
After each use, the sprayer tip should be wiped with a paper tissue and the cap placed back on the sprayer.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Contraindicated in children under 12 years of age.
Concomitant use of other sympathomimetic decongestants.
Cardiovascular disease including hypertension.
Phaeochromocytoma.
Diabetes Mellitus
Hyperthyroidism
Closed angle glaucoma.
Contraindicated in individuals who are taking beta blockers (see section 4.5).
Inflammation of the skin and/or mucosa of the nasal vestibule.
Contraindicated in individuals with dry inflammation of the nasal mucosa (rhinitis sicca).
Contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks (see section 4.5).
Contraindicated in individuals with a history of transsphenoidal hypophysectomy or other surgical interventions which expose the dura mater.
4.4. Special warnings and precautions for use
There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline.
This medicinal product may be used only after a careful assessment of the risks and benefits in cases of:
- increased intraocular pressure
- porphyria
- prostate hyperplasia.
Use during chronic rhinitis may only be carried out under medical supervision owing to the danger of the atrophy of the nasal mucosa.
Use with caution in occlusive vascular disease.
Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
This medicine is intended for short term use only. Prolonged treatment may lead to reactive hyperaemia of the nasal mucosa. This rebound effect may lead to nasal congestion or nasal obstruction during continued use or after discontinuation, resulting in repeated or even continuous use of the medicine by the patient (See section 4.8).
Keep away from the eyes.
In case of misuse or use of excessive amounts of the spray, the absorption of xylometazoline can cause systemic adverse effects (cardiovascular and neurological adverse effects) (see sections 4.8 and 4.9).
If any of the following occur, use of Sudafed Plus Blocked Nose Spray should be stopped:
- Hallucinations
- Restlessness
- Sleep disturbances
4.5. Interaction with other medicinal products and other forms of interaction
Xylometazoline hydrochloride
Due to low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is unlikely. No interaction studies have been performed. However, concomitant use with antihypertensive agents (e.g. methyldopa) should be avoided due to the potential effect of Xylometazoline to increase blood pressure.
Concomitant use with medicines which potentially increase blood pressure (e. g. doxapram, ergotamin, oxytocin, or tricyclic antidepressants) should be avoided as the vasopressor effect may be increased.
Concomitant use with sympathomimetics (e.g.: pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline) can lead to additive effects on the cardiovascular system and central nervous system.
MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis
Moclobemide: risk of hypertensive crisis
Antihypertensives (including adrenergic neurone blockers and beta-blockers). Sudafed Plus Blocked Nose Spray may block the hypotensive effects.
Cardiac glycosides: increased risk of arrhythmias.
Ergot alkaloids (ergotamine and methysergide): increased risk of ergotism.
Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.
Dexpanthenol
None known.
4.6. Fertility, pregnancy and lactation
Pregnancy
This medicine should not be used during pregnancy, as there is not sufficient data available concerning the use of xylometazoline hydrochloride by pregnant women.
Breast-feeding
This medicine should not be used during the lactation period since it is not known whether xylometazoline hydrochloride is excreted in the breast milk.
Fertility
There is no data on the influence of this medicine on fertility.
4.7. Effects on ability to drive and use machines
This product is not expected to adversely affect the ability to drive and use machines.
4.8. Undesirable effects
The following definitions apply to the incidence of the undesirable effects:
- 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)
Tabulated list of adverse reactions
Uncommon
Rare
Very rare
Not known
Immune system Disorders
hypersensitivity reaction (angioedema, skin rash, pruritus)
Psychiatric disorders, especially with prolonged and/or heavy use.
restlessness, insomnia, hallucinations and paranoid delusions.
irritability, anxiety, excitability
Nervous system Disorders
fatigue (drowsiness, sedation), headache, convulsions
Cardiac disorders, especially with prolonged and/or heavy use
palpitations, tachycardia, hypertension
arrhythmias
Respiratory, thoracic and mediastinal disorders
rebound congestion (rhinitis medicamentosa) - especially with prolonged and/or heavy use, nosebleed
Sneezing, burning, irritation and dryness of the nasal mucosa.
Gastrointestinal disorders
Nausea
General disorders and administration site conditions
Tolerance with diminished effect (especially with prolonged and/or heavy use.)
Reporting of suspected adverse reactions
Reporting of 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Xylometazoline hydrochloride
The clinical picture of intoxication with imidazole derivatives can be diverse, as phases of stimulation may alternate with periods of suppression of the central nervous system and cardiovascular system. An overdose results mainly in central nervous effects: convulsions and coma, bradycardia, apnoea, hypertension and also hypotension.
Symptoms of CNS stimulation are anxiety, agitation, hallucinations and convulsions.
Symptoms of CNS suppression are decreased body temperature, lethargy, drowsiness and coma.
The following additional symptoms may occur: miosis, mydriasis, diaphoresis, fever, pallor, cyanosis, nausea, tachycardia, bradycardia, cardiac arrhythmia, cardiac arrest, hypertension, shock-like hypotension, pulmonary oedema, respiratory disorders and apnoea.
In cases of severe overdose, intensive inpatient treatment is indicated. The administration of medicinal charcoal (absorbent), sodium sulphate (laxative) or gastric lavage (in the case of large quantities) should be performed immediately, as xylometazoline can be rapidly absorbed. In order to lower blood pressure, a non-selective alpha-adrenergic blocking agent can be given.
Vasopressor agents are contraindicated. If necessary, the following measures should be taken: fever reduction, anti-convulsive therapy and oxygen inhalation.
Dexpanthenol
Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. No measures are required in cases of overdose.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Xylometazoline hydrochloride, Dexpanthenol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- SNUP 0,5 mg/ml over the counter partial — not the same combinationXYLOMETAZOLINUM · eye / ear / nose
- SNUP 1mg/ml over the counter partial — not the same combinationXYLOMETAZOLINUM · eye / ear / nose
- VIBROCIL ACTILONG 1 mg/ml over the counter partial — not the same combinationXYLOMETAZOLINUM · eye / ear / nose
- RHINXYL HA 0,5 mg/ml over the counter partial — not the same combinationXYLOMETAZOLINUM · eye / ear / nose
- RHINXYL HA 1 mg/ml over the counter partial — not the same combinationXYLOMETAZOLINUM · eye / ear / nose
- BIXTONIM XYLO 0,5 mg/ml over the counter partial — not the same combinationXYLOMETAZOLINUM · eye / ear / nose
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- NasicXylometazolini hydrochloridum + Dexpanthenolum · eye / ear / nose
- Nasic KidsXylometazolini hydrochloridum + Dexpanthenolum · eye / ear / nose
- Xylodex 0,05% regeneracjaXylometazolini hydrochloridum + Dexpanthenolum · eye / ear / nose
- Xylometazolin + Dexpanthenol WZFXylometazolini hydrochloridum + Dexpanthenolum · eye / ear / nose
- Septanazal dla dorosłychXylometazolini hydrochloridum + Dexpanthenolum · eye / ear / nose
- Septanazal dla dzieciXylometazolini hydrochloridum + Dexpanthenolum · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.