Product Description Recommended for colds in adults and adolescents over 15 years, in particular: – blocked nose, – clear nasal discharge, and – headaches and/or fever. How to Use For oral use. To be swallowed whole, with water. Dosage Suitable for adults and adolescents over 15 years. During the day: Take 1 rectangular tablet and repeat dose, if necessary, after 4 hours at the earliest. Do not take more than 3 tablets per day. For example – 1 tablet in the morning, 1 at midday (if necessary) and 1 with the evening meal (if necessary). During the evening, before bed: If necessary, take 1 round tablet. Do not take more than 3 tablets during the day, plus 1 at night, per 24-hour period. Frequency of Doses Leave at least 4 hours between doses. If you have serious kidney disease (or have suffered kidney failure), leave at least 8 hours between doses. If in doubt, consult your doctor or pharmacist. Length of Treatment Do not take this medicine for more than 4 days. If symptoms persist for more than 4 days, discontinue use and consult your doctor. Ingredients Active ingredients: Day tablet (rectangular): Paracetamol: 500 mg Pseudoephedrine hydrochloride: 30 mg Night tablet (round): Paracetamol: 500 mg Doxylamine hydrogen succinate: 7.5 mg Other ingredients: Rectangular day tablet: wheat starch, pre-gelatinised potato starch, sodium carboxymethyl starch (type A), lactose monohydrate, magnesium stearate Round night tablet: lactose monohydrate, sodium carboxymethyl starch (type A), corn and pre-gelatinised potato starch, talc, magnesium stearate Packaging This medicine is made as a coated tablet and sold in packs of 16 tablets. Precautions for Use Special Warnings Keep out of reach of children. Do not exceed the recommended dose or length of treatment. Heed all contra-indications. In case of overdose or accidental excessive dose, seek medical advice immediately. Contains paracetamol. Do not combine with other medicines containing paracetamol due to risk of exceeding maximum safe daily dose (see section titled "Dosage" above). While using this medicine, if you feel that your heart rate is accelerated, or experience palpitations, headache (including aggravated, pre-existing headache), nausea or behavioural changes, discontinue treatment and seek medical advice immediately. Consult your doctor prior to use if you have: – high blood pressure; – heart conditions, hyperthyroidism (overactive thyroid gland); – personality disorder; or – diabetes. Consult your doctor prior to use if you are currently taking: – a selective MAO-A inhibitor (e.g. moclobemide, toloxatone); or – a medicine containing a Claviceps purpurea alkaloid, e.g.: –– dopamine agonists (e.g. bromocriptine, cabergoline, lisuride or pergolide), such as anti-parkinson agents; or –– vasoconstrictors (e.g. ergotamine, dihydroergotamine, methylergometrine or methysergide), such as anti-migraine drugs; or – linezolid. Risks linked to excipients: Do not use if you are galactose-intolerant, or have a Lapp lactase deficiency or glucose or galactose malabsorption (these are rare hereditary disorders). This medicine may be used to treat coeliac disease. Wheat starch may contain gluten, but only in trace amounts. Therefore, this medicine is considered safe for coeliac disease sufferers. Precautions for Use If you experience purulent nasal discharge, your fever persists or your condition does not improve after 4 days, consult your doctor. This medicine contains paracetamol. Therefore, if you suffer from serious liver or kidney disease, you must consult your doctor prior to use. Use with caution if you are elderly or have a history of constipation, vertigo or urinary disorders. This medicine may cause drowsiness that can be aggravated by alcohol: it is preferable to start the treatment in the evening and to avoid alcoholic drinks or medicines containing alcohol throughout the course of treatment. If you have to be given an anaesthetic, discontinue treatment in advance and inform the anaesthetist. If in doubt, consult your doctor or pharmacist. Contra-indications Do NOT use: – if you are allergic to any of this medicine's ingredients; – if you are a child under 15; – if you have suffered a stroke; – if you have very high blood pressure, or unstable blood pressure due to treatment; – if you suffer from serious heart disease (e.g. coronary heart disease); – if you have certain types of glaucomas (increases in fluid pressure in the eye); – if you have difficulty passing urine (e.g. due to prostate problems); – if you have a history of convulsions (recent or non-recent); – (due to the presence of paracetamol) if you have serious liver or kidney disease; – if you are currently breast-feeding; – (due to the presence of wheat starch) if you are allergic to wheat; – in association with selective MAO-A inhibitors (due to the risk of paroxysmal hypertension and potentially fatal hyperthermia); – in association with other indirect-acting sympathomimetic drugs, e.g. vasoconstrictors designed to unblock the nose, administered orally or via the nose – such as phenylephrine (a.k.a. neosynephrine), pseudoephedrine, ephedrine and methylphenidate – due to the risk of vasoconstriction and/or elevated blood pressure; – in association with alpha-type sympathomimetic drugs, e.g. vasoconstrictors designed to unblock the nose, administered orally or via the nose – such as etilefrine, midodrine, naphazoline, oxymetazoline, phenylephrine (a.k.a. neosynephrine), synephrine, tetryzoline, tuaminoheptane, and tymazoline – due to the risk of vasoconstriction and/or elevated blood pressure; Association of two decongestants is inadvisable regardless of the method of administration (whether oral or nasal) – it is a dangerous misuse of drugs that serves no practical purpose. You should generally avoid using this medicine while pregnant unless recommended by your doctor. If in doubt, consult your doctor or pharmacist. If you are pregnant or breast-feeding: You are advised not to take this medicine during pregnancy. Since this medicine may be harmful to your baby's health, you are strongly advised not to use it while breast-feeding. If you are a professional sportsperson: This medicine contains an active principle (pseudoephedrine) that may be picked up by dope testing. If you drive or operate machinery: Due to the presence of doxylamine in the night tablet, be aware that use of this medicine may cause drowsiness or reduced alertness that may be aggravated by consumption of alcohol or use of medicines containing alcohol.
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