Distance between cutted line/middel of the spot = 51.6 mm spot = 12 x 2 centered in the margin of 14 mm le f 14 mm GB Benadryl Allergy Relief Plus Decon Caps 12s PIL MAH Update CRD 6738 t margin 23.06.2021 English 402428175_r0 N/A 1 Brochure/Leaet/Insert 145 x 250 mm Capsules are a medicine which are used to blood pressure). 364350C IM_Val-de-Reuil_Upper Normandy_France relieve the symptoms of hay fever and similar ■ If you have glaucoma (increased pressure allergic conditions. The capsules contain in the eye). CTE LITE 364350B Westrock Saint Pierre des Corps pseudoephedrine hydrochloride, which is a ■ If you have an overactive thyroid gland. 845 Oset Printing decongestant that relieves nasal and sinus ■ If you have severe kidney problems. 7996903 PAPER congestion and acrivastine which is an ■ If you are taking, or have taken in the last EMEA_2021_00024796_003 PC-0002778 antihistamine that helps relieve allergy two weeks, drugs for depression known symptoms such as sneezing, runny nose and as Monoamine Oxidase Inhibitors CAPSULES watery eyes. (MAOIs) or Reverse Inhibitors of Acrivastine 8mg & Pseudoephedrine 60mg Monoamine Oxidase 2 Before taking this (RIMAs). ■ This medicine is used to relieve the symptoms ■ If you are taking any cough or of hay fever and similar allergic conditions. cold medicines. PANTONE PANTONE medicine 356 C 287 C ■ This medicine is for use by adults and If any of these apply to you, get advice from children aged 12 - 65 years. This medicine is suitable for most adults under LITHO OFFSET LITHO OFFSET 65 years old and children aged 12 years and a doctor or pharmacist without taking ■ Do not take this medicine: REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. over. If you are in any doubt, talk to your doctor Benadryl Allergy Relief Plus Decongestant ■ There are some people who should not use Capsules. this medicine. See Section 2 to find out if or pharmacist. you are one of them Do not take this medicine… Talk to your doctor or pharmacist… ■ If you have ever had a bad reaction to any of ■ If you have kidney or severe liver problems. ■ If you have ever had a bad reaction to the ingredients. See Section 6 for the list ■ If you are being treated for a pseudoephedrine hydrochloride, of ingredients thyroid disorder. acrivastine or any of the ingredients (listed ■ Speak to your doctor: ■ If you have difficulty with passing water in Section 6), or to the antihistamine ■ If you suffer from any of the conditions and/or an enlarged prostate (which may triprolidine. mentioned in section 2. See Section 2 mean you need to pass water more often) ■ If you have high blood pressure or ■ If you are taking any other medicines. ■ If you have alcohol dependence. HelveticaNeueLTStd-MdCn Smallest Text Size heart disease. See Section 2 ■ If you have blocked arteries or veins HelveticaNeueLTStd-Roman 4.56pt ■ If you are taking beta blockers (used to ■ Follow the dosage instructions carefully. (occlusive vascular disease). Optima Ave. Text Size treat high blood pressure). See Section 3 ■ If you are taking any other medicines, Optima-Bold ■ If you are taking stimulants or appetite 9.0pt Now read this whole leaflet carefully before you including: Optima-BoldItalic suppressants or drugs used to treat Largest Text Size use this medicine. Keep the leaflet: you might ■ Antihypertensives (drugs to treat high Optima-Italic congestion and asthma need it again. blood pressure, such as guanethidine, Fonts used Fonts ZapfDingbatsITC 15.96pt 2021-06-23 15:54:48 (Sympathomimetic drugs). methyldopa, adrenergic neurone blockers ■ If you have diabetes. and beta blockers, debrisoquine, ■ If you have phaeochromocytoma (a rare 1 What the medicine is for bretylium and betanidine). Benadryl Allergy Relief Plus Decongestant tumour which affects your heart rate and turn over right margin 12 mm 12 mm 12 mm ■Sedatives or tranquillisers (used to treat due to inflammation of the colon (ischaemic anxiety or sleep disorders). colitis). See section 4. 3 How to take this medi- ■ Tricyclic antidepressants (used to treat ■ Sudden loss of vision. Reduction of blood cine mood disorders). flow to your optic nerve may occur with this 2 ■ Anticholinergic drugs (drugs used to treat medicine. See section 4. Check the table below to see how much medicine to take. cramps or spasms). ■ ■ Ketoconazole (an antifungal used to treat If you are pregnant or breast-feeding For oral use only. fungal infections). ■ If you are pregnant or breast-feeding, think Children under 12 years old ■ Erythromycin (an antibiotic used to treat you may be pregnant or are planning to bacterial infections). have a baby, ask your doctor or pharmacist This medicine is not recommended for children ■ Moclobemide (used to treat for advice before taking this medicine. aged under 12 years old. mood disorders). Special warnings about this medicine Adults and Children 12 - 65 years old ■ Cardiac glycosides (drugs used to control heart rhythms or contractions such ■ Benadryl Allergy Relief Plus Decongestant Age Dose as digoxin). Capsules may cause drowsiness Adults and children ■ ■ Ergot alkaloids (drugs used to treat and dizziness. 1 capsule up to migraine such as ergotamine Caution should be used when driving or 12 - 65 years old 3 times a day and methysergide). operating machinery. If affected, do not ■ Do not give more than 3 doses in 24 hours. ■ Oxytocin (drug used to help contractions drive, cycle or operate machinery. ■ during childbirth). ■ Avoid alcoholic drink and do not drink If symptoms persist or get worse, stop use and If you are not sure about any of the medicines grapefruit juice while taking this medicine. talk to your doctor. you are taking, show the bottle or pack to your pharmacist. Some of the ingredients can cause Adults over 65 years problems If any of these bullet points apply to you now This medicine is not recommended for or in the past, talk to a doctor or ■ This product contains lactose. If you have adults aged over 65 years old. pharmacist. been told by your doctor that you have an If anyone has too much intolerance to some sugars, contact your If anyone has too much contact a doctor or If you experience the following, stop doctor before taking this medicine. your nearest Accident and Emergency taking this medicine immediately and ■ This medicine contains less than 1 mmol Department (Casualty) taking this leaflet and contact your doctor: sodium (23mg) per capsule, that is to say pack with you. essentially “sodium-free”. ■ A feverish generalised erythema (redness of If you forget to take the medicine skin) associated with pustules. See section 4. If you forget to take a dose, take the next ■ Sudden severe headaches, nausea, dose when needed provided that you only vomiting, confusion, fits, visual disturbances. take a maximum of 3 capsules in 24 hours. ■ Sudden abdominal pain or rectal bleeding Do not take a double dose. turn over t margin 14 mm f le 12 mm 12 mm le f 14 mm t margin nerve (ischaemic optic neuropathy). fects, you can help provide more information on 3 4 Possible side-effects the safety of this medicine. Like all medicines, Benadryl Allergy Relief Plus If you experience any of the following, stop taking this medicine and talk to your doctor: Decongestant Capsules can cause side-effects, although not everybody gets them. ■ Trouble passing water (especially in men with 5Storing this medicine prostate problems). Store below 25°C. If you experience the following, stop taking this Keep this medicine dry and store in its original packaging. medicine and seek immediate medical help: Other effects which may occur include: Keep this medicine out of the sight and reach ■ Reduced blood flow to the heart which can Very common (may affect more than 1 in of children. cause angina (discomfort or pain in the chest, 10 people) Do not use after the end of the month shown as neck, back, jaw, shoulders or arms), or heart ■ Headache or drowsiness. an expiry date on the packaging. attack. Common (may affect up to 1 in 10 people) ■ Stroke (weakness of the face, arms or legs, or ■ Difficulty sleeping, nervousness or dizziness. Do not throw away medicines via wastewater or speech problems). ■ Dry mouth or nausea. household waste. Ask your pharmacist how to ■ Sudden onset of fever, reddening of the skin, or Other effects which may occur but it is throw away medicines you no longer use. These many small pustules (possible symptoms of unknown how often: measures will help to protect the environment. Acute Generalized Exanthematous Pustulosis - ■ A fast or irregular heartbeat or an increased AGEP) may occur within the first 2 days of awareness of the heartbeat (palpitations). 6 Further information treatment with this medicine (See section 2). ■ Restlessness or sleep disturbances. What's in this medicine? ■ Sudden onset of severe headache, nausea, ■ Anxiety, irritability, feeling jittery or feelings of The active ingredients in Benadryl Allergy Relief vomiting, confusion, fits, visual disturbances. extreme happiness. Plus Decongestant Capsules are: 60 mg ■ Allergic reactions including skin rashes such as ■ High blood pressure. Pseudoephedrine hydrochloride and 8 mg hives (which may be severe and include ■ Vomiting. acrivastine in each capsule. blistering and peeling of the skin) and itching. ■ Pain when passing water. Other ingredients are: Lactose monohydrate, ■ Swelling of the face, lips, mouth, tongue or ■ Tingling or numbness of hands or feet (Pins throat which may cause difficulty in sodium starch glycollate, magnesium stearate, and needles). gelatin, titanium dioxide and patent blue V. swallowing or breathing. ■ A tremor or shakiness. ■ Hallucinations or paranoid delusions (seeing What the medicine looks like or hearing things that are not there, irrational Reporting of side-effects Benadryl Allergy Relief Plus Decongestant thoughts or feelings).