Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
The Boots Company Plc
n/a
Not applicable
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 04070100; GTIN: 5045095151133
Package leaflet: Information for the user Max Strength Sinus Pressure & Pain Relief Day & Night Capsules (Caffeine, Paracetamol, Phenylephrine) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. What is in this leaflet 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. What this medicine is and what it is used for This medicine contains: • paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever • phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily. The Day capsules also contain: • caffeine which helps to increase the pain relief from paracetamol and makes you more alert. The Day capsules are used for the relief of the symptoms of sinus pain and congestion, including relief of aches and pains, headache, fatigue (tiredness) and drowsiness, nasal congestion (blocked nose) and feverishness (high temperature). The Night capsules are used for the relief of the symptoms of colds and flu, including aches and pains, sore throat, headache, nasal congestion (blocked nose) and feverishness (high temperature). 2. What you need to know before you take this medicine B Do not take this medicine if you: • are allergic to paracetamol, caffeine, phenylephrine or any of the other ingredients • hav Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paramed Max Strength Sinus Relief Day & Night Capsules, hard Boots Max Strength Sinus Pressure & Pain Relief Day & Night Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DAY CAPSULE ACTIVE INGREDIENT MG/CAPSULE Paracetamol 500 Caffeine 25 Phenylephrine Hydrochloride 6.1 NIGHT CAPSULE ACTIVE INGREDIENT MG/CAPSULE Paracetamol 500 Phenylephrine Hydrochloride 6.1 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Red/blue (Day) and dark blue/light blue (Night) hard gelatin capsules containing the drug products, which are off-white powders. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DAY CAPSULE For the relief of symptoms associated with the pain and congestion of sinusitis, including relief of aches and pains, headache, fatigue and drowsiness, nasal congestion and lowering of temperature. NIGHT CAPSULE For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Swallow whole with water. Do not chew. Each blister contains 6 red/blue Day capsules and 2 dark blue/light blue Night capsules. For all indications: Adults, the elderly and Children over 16 years 2 red/blue capsules every 4 to 6 hours during the day as required, followed by 2 dark blue/ light blue capsules at bedtime. Leave at least 4 to 6 hours between doses. Do not take more than 8 capsules (4 doses) in any 24 hours. Dosage should not be continued for longer than 3 days without consulting a doctor. Not recommended for children under 16 years of age. Note: Does not contain a sleep aid. 4.3 CONTRAINDICATIONS PARACETAMOL Hypersensitivity to paracetamol or any of the other constituents. CAFFEINE (DAY CAPSULE ONLY): Should be given with care to patients with a history of peptic ulcer. PHENYLEPHRINE HYDROCHLORIDE Severe coronary heart disease and cardiovascular Διαβάστε το πλήρες έγγραφο