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What you need to know before you take Metoclopramide Hydrochloride 5mg/5ml Oral Solution

Do not take Metoclopramide if: ■ you are allergic (hypersensitive) to metoclopramide, procaine or procainamide or any other ingredients in this liquid (listed in section 6 below). The signs of an allergic reaction can include a rash, itching or shortness of breath ■ you have bleeding, blockage or a tear in your stomach or gut ■ you have had an operation on your stomach or gut in the last three or four days ■ you have or may have a rare tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma) ■ you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine ■ you have epilepsy. Metoclopramide may increase the risk of you having a ‑t (seizure) ■ you have Parkinson’s disease ■ you are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic agonists (see below “Other medicines and Metoclopramide”) ■ you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 de‑ciency. Do not give Metoclopramide to a child less than 1 year of age (see below “Children and adolescents”). Do not take Metoclopramide if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Metoclopramide. Warnings and precautions Talk to your doctor or pharmacist before taking Metoclopramide if: ■ you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems ■ you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium ■ you are using other medicines known to affect the way your heart beats ■ you have any neurological (brain) problems ■ you have liver or kidney problems. The dose may be reduced (see section 3) ■ you have an inherited blood disorder known as porphyria ■ you have a history of allergies including asthma. If vomiting persists, even when you are taking this medicine, you should talk to your doctor. Tests whilst taking Metoclopramide ■ Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methaemoglobinemia), the treatment should be immediately and permanently stopped. ■ Metoclopramide may interfere with a hormone test (Gonadorelin test). Tell your doctor you are taking Metoclopramide if you need to take this test. You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose. Do not exceed 3 months treatment because of the risk of involuntary muscle spasms. Children and adolescents Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This medicine must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see above “Do not take Metoclopramide if”). If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking metoclopramide. Other medicines and Metoclopramide Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because metoclopramide can affect the way some other medicines work. Also, some medicines can affect the way metoclopramide works. In particular tell your doctor if you are taking any of the following: ■ medicines used to treat Parkinson’s disease and other related conditions, such as apomorphine, levodopa, pergolide and bromocriptine (see above “Do not take Metoclopramide if”) ■ tetrabenazine, a medicine used to treat movement disorders ■ anticholinergics, used to relieve stomach cramps or spasms ■ painkillers such as paracetamol or aspirin or stronger painkillers containing ‘opioids’, such as codeine and other similar medicines. These may also be used for drug addiction ■ medicines known as sedatives that have a calming effect on you and may make you feel drowsy or lethargic ■ any medicines for mental health problems, such as schizophrenia and other related conditions, including medicines known as phenothiazines (for example promazines or tri­uoperazine) ■ ­uoxetine and paroxetine, used to treat depression ■ other medicines used to treat depression or anxiety including medicines known as serotonergic drugs (SSRIs, for example citalopram, sertraline) and benzodiazepines (e.g. diazepam, temazepam), especially if they have a sedative effect ■ barbiturates, used to treat epilepsy, such as phenobarbital ■ digoxin, used to treat heart failure ■ mexiletine, or other medicines used to treat unusual heart rhythms ■ clonidine, normally used to treat high blood pressure ■ antihistamines such as chlorphenamine that have a sedative effect ■ ciclosporin, a medicine used during organ transplant to avoid the organ rejection ■ suxamethonium or mivacurium, used to relax the muscles when having anaesthetic ■ atovaquone, used to treat pneumonia. Taking Metoclopramide with alcohol Do not drink alcohol whilst taking metoclopramide. This is because alcohol will make you drowsy and taking metoclopramide with it may make you even more drowsy. Also, it may make your blood alcohol levels higher than normal. Pregnancy, breast-feeding and fertility If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine. If necessary, Metoclopramide may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine. Metoclopramide is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby. Driving and using machines Metoclopramide may make you drowsy, feel dizzy and can cause movement disorders or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after taking Metoclopramide. This may affect your vision and also interfere with your ability to drive and use machines. Metoclopramide Oral Solution contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sorbitol (E420) and propylene glycol (E1520): ■ parahydroxybenzoates. These may cause allergic reactions (possibly delayed). ■ sorbitol (a type of sugar). This medicine contains 227.3mg sorbitol in each 5ml. Sorbitol is a source of fructose. If your doctor has told you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. ■ propylene glycol. This medicine contains 259.3mg propylene glycol in each 5ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you are pregnant, breast-feeding or suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine ■ sodium. This medicine contains less than 1mmol sodium in each 5ml, that is to say essentially ‘sodium-free’.