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Home , Atenolol, Clomipramine, Guanethidine, Nefopam, Sotalol, Terfenadine

Package leaflet: Information for the patient Other medicines and Tell your doctor if you are taking, have recently Clomipramine 10 mg Capsules, Hard taken or might take any other medicines. Clomipramine 25 mg Capsules, Hard Some medicines may increase the side effects of Clomipramine 50 mg Capsules, Hard Clomipramine and may sometimes cause very clomipramine hydrochloride serious reactions. Do not take any other medicines whilst taking Clomipramine without first talking to Read all of this leaflet carefully before you your doctor, especially: start taking this medicine because it contains - medicines for depression, particularly MAOIs (see important information for you. section “Do not take” above) e.g. , - Keep this leaflet. You may need to read it again. , ; SSRIs e.g. (or - If you have any further questions, ask your have taken within the last 3 weeks), , doctor or pharmacist. , ; SNaRIs e.g. ; - This medicine has been prescribed for you only. and e.g. Do not pass it on to others. It may harm them, , dothiepin, even if their signs of illness are the same as yours. - , also known as ‘water tablets’, e.g. - If you get any side effects, talk to your doctor bendroflumethiazide, or pharmacist. This includes any possible side - anaesthetics, used for the temporary loss of effects not listed in this leaflet. See section 4. bodily sensation - e.g. What is in this leaflet - medicines for other mental health conditions 1. What Clomipramine is and what it is used for. such as schizophrenia or manic depression 2. What you need to know before you e.g. , , , , take Clomipramine. e.g. 3. How to take Clomipramine. - medicines for high blood pressure e.g. 4. Possible side effects. , betanidine, , or 5. How to store Clomipramine. alpha or 6. Contents of the pack and other information. - norepinephrine (noradrenaline), used to treat low blood pressure 1. What Clomipramine is and what it is used for - medicines to treat disorders, particularly Clomipramine is available as capsules in three those used to treat an abnormal heart rhythm, different strengths. e.g. , , epinephrine (), , , , Clomipramine belongs to a group of medicines and called tricyclic antidepressants. Clomipramine is - beta-blockers e.g. , believed to work by increasing the levels of two - anticoagulants (blood thinning tablets) e.g. warfarin naturally occurring chemicals within the , -  and similar pain killing non-steroidal anti- noradrenaline and 5-hydroxytryptamine (also inflammatory drugs (NSAIDs) called ). - medicines for Parkinson's Disease, e.g. levodopa, , entacapone or Clomipramine is used to treat depression - e.g. if you smoke or are using nicotine (especially if you also need to be sedated), replacement therapy obsessions and phobias (irrational fears). It is - , used to stop or fits e.g. also used along with other medications to treat such as , , . Cataplexy is a disorder which causes or muscle weakness and symptoms such as sagging - decongestants used for colds and flu such as jaw, drooping head and weakness at the knees. , Attacks of cataplexy are triggered by strong or emotions. Cataplexy often affects people who have - , used to treat stomach ulcers (a sleep disorder). or heartburn This medicine is for adults only. -  used to treat for ADHD - rifampicin, used to treat some infections 2. What you need to know before you including tuberculosis (TB) take Clomipramine - quinine, for cramp or malaria treatment - strong painkillers such as , , Do NOT take Clomipramine if you: or morphine related substances e.g. - are allergic to clomipramine or any of the other , ingredients of this medicine (listed in section 6) - drugs of abuse including Ecstasy - have ever had a rash or other allergic reaction to - or similar medicines (including eye drops) any other antidepressants - medicines containing oestrogens e.g. contraceptive - have had a heart attack within the last 3 months pill or hormone replacement therapy - have problems with your heart beat - medicines called protease inhibitors, used to - have any serious disease treat Human Immunodeficiency Virus (HIV) e.g. - have a mental health condition called ritonavir, indinavir - have (increased eye pressure) - terbinafine, used orally to treat skin, hair or nail - have difficulty in passing infections due to fungus - are taking, or within the last 3 weeks have taken - colestipol, cholestyramine, used to treat high medicines for depression called monoamine levels oxidase inhibitors (MAOI) - St. John’s wort (), - are taking medicines called selective, reversible a herbal product used to treat depression monoamine oxidase-A (MAO-A) inhibitors such and other conditions as moclobemide - disulfiram, used to help you stop drinking - altretamine, used to treat cancer If you are unsure if any of the above applies to you, - , used in the treatment of multiple please talk to your doctor or pharmacist. sclerosis and spinal damage Warnings and precautions - pentamidine, an antibiotic used to treat pneumonia Talk to your doctor or pharmacist before taking - levacetylmethadol, used to treat addiction to Clomipramine if you: drugs such as . - have ever had suicidal thoughts - / (used to treat opioid - suffer from epilepsy (fits) overdose). These medicines may interact - have had a head injury or have suffered with Clomipramine and you may experience brain damage symptoms such as involuntary, rhythmic - are going to have electric therapy (ECT) contractions of muscles, including the muscles - have other problems with your heart that control movement of the eye, agitation, - have been told you have a low level of , , excessive sweating, , in your blood (hypokalaemia). The doctor will need exaggeration of reflexes, increased muscle to treat this before you start taking clomipramine tension, body temperature above 38°C. Contact - have disease your doctor when experiencing such symptoms. - suffer from schizophrenia or other mental Clomipramine with food, drink and alcohol health conditions Take care when eating grapefruit, or drinking - have a blood disorder grapefruit juice or cranberry juice as this may - have an overactive thyroid gland increase your chance of experiencing side effects. - have had severe for a long time Be careful when drinking alcohol - it may affect you - have a tumour (cancer) of the adrenal gland (such more than usual. as phaeochromocytoma or neuroblastoma) - liver disease Pregnancy and breast-feeding - have low blood pressure Clomipramine should not be taken if you are - wear contact lenses pregnant unless your doctor has told you to do so. - are elderly Clomipramine may harm your unborn child. - The use of Buprenorphine together with Clomipramine can lead to , a Clomipramine may reach your baby through potentially life-threatening condition (see “Other the . Therefore, you should not take medicines and Clomipramine”). Clomipramine if you are breast-feeding. Thoughts of and worsening of your If you are pregnant or breast-feeding, think you depression or anxiety disorder: may be pregnant or are planning to have a baby, If you are depressed and/or have anxiety disorders ask your doctor or pharmacist for advice before you can sometimes have thoughts of harming or taking this medicine. killing yourself. These may be increased when first Driving and using machines starting antidepressants, since these medicines all If you feel dizzy, tired, have blurred vision, have take time to work, usually about two weeks but difficulty concentrating, or have other effects such sometimes longer. as confusion, disorientation or your depression You may be more likely to think like this: gets worse when you start to take Clomipramine - If you have previously had thoughts about killing do not drive or work with machinery until these or harming yourself. effects have worn off. - If you are a young adult. Information from clinical Alcohol and other medicines may make these trials has shown an increased risk of suicidal side effects worse (see ‘Other medicines behaviour in young adults (less than 25 years old) and Clomipramine’) with mental health conditions who were treated with an . The medicine can affect your ability to drive as it may make you sleepy or dizzy. If you have thoughts of harming or killing yourself • Do not drive while taking this medicine until you at any time, contact your doctor or go to a know how it affects you. hospital straight away. You may find it helpful • It is an offence to drive if this medicine affects to tell a relative or close friend that you are your ability to drive. depressed or have an anxiety disorder, and ask • However, you would not be committing an them to read this leaflet. You might ask them to offence if: tell you if they think your depression or anxiety is 0 The medicine has been prescribed to treat a getting worse, or if they are worried about changes medical or dental problem and in your behaviour. 0 You have taken it according to the instructions given by the prescriber or in the information Information for families, and caregivers provided with the medicine and You should monitor whether your depressed patient 0 It was not affecting your ability to drive safely shows signs of behavioural changes such as unusual anxiety, restlessness, sleeping problems, irritability, Talk to your doctor or pharmacist if you are not aggressiveness, over-excitedness or other unusual sure whether it is safe for you to drive while taking changes in behaviour, worsening of depression or this medicine. thinking about suicide. You should report any such Clomipramine capsules contains lactose symptoms to the patient’s doctor, especially if they If you have been told by your doctor that you have are severe, start suddenly, or were not part of the an intolerance to some sugars, contact your doctor patient’s presenting symptoms before. You should before taking this medicinal product. evaluate the emergence of such symptoms on a day-day basis, especially during anti- Clomipramine 10 mg capsules contain Sunset treatment and when the dose is increased yellow (E110) or decreased, since changes may be abrupt. This may cause allergic reactions. Symptoms such as these may be associated 3. How to take Clomipramine with an increased risk for suicidal thinking and behaviour and indicate a need for very close Always take this medicine exactly as your doctor or monitoring and possibly changes in medication. pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Tell your doctor, dentist or hospital staff you are taking Clomipramine if you are to have surgery If you have low blood potassium (hypokalaemia) your (including dental procedures), as the dose of doctor will treat this before you can start treatment. Clomipramine may need to be reduced or stopped before you have an anaesthetic. The recommended dose is: • For depression a starting dose of 10 mg which While you are taking Clomipramine, especially if can be increased to find a dose that works for you take this medicine for a long time your doctor you. This is normally 30 - 150 mg daily or up to a may want to monitor you by doing blood tests and maximum of 250 mg daily for severe conditions. other tests to check your heart and liver function. • For obsessions and phobias a starting dose of You should also have regular dental check-ups, as 25 mg which can be increased to 100 - 150 mg daily. Clomipramine may cause dryness of the mouth • For cataplexy a starting dose of 10 mg which can which can increase the chance of tooth decay. be increased to a maximum of 75 mg daily.

Description Clomipramine Hydrochloride 50 mg,25 mg,10 mg 28 Date: 16 Nov 2020 Time: 19:26

Component Type Leaflet Pharma Code 876 No. of colours 1 Page Count 1/2 400000588, 400000590 Affiliate Item Code 2228379 SAP No. 400000589, 400556466 Colours Black 400556465, 400556464 Superceded Affiliate Item Code 894225 Vendor Job No. 559758 Non-Print TrackWise PR No. 2228379 Trackwise Proof No. 5 Colours MA No. PL 04569/0229-31 Client Market Equate CMYK Packing Site/Printer NA Keyline/Drawing No. NA with Supplier Code LT1378AI Barcode Info NA Main Font Myriad Pro Body Text Size 9 pt 3D Render ID NA Dimensions 170 x 580 mm Min Text Size used 9 pt Sign-offs

v3/July 2017 Elderly patients often need a lower dose because • yawning they are more likely to experience side effects. The • feeling confused or aggressive maximum dose for elderly patients is 75 mg daily. • feeling disorientated or agitated • sleep disturbances Your doctor will tell you about this. • nightmares Do not stop taking Clomipramine suddenly • worsening of existing depression because this may cause withdrawal side effects. If • impaired memory or concentration the decision is made by your doctor to discontinue • increased sensitivity of the skin to sunlight treatment, the dose you receive will be cut down • rash, hives or itching gradually to prevent the development of withdrawal • breast enlargement, spontaneous flow of milk symptoms. You may get these side effects if you from the breast stop taking Clomipramine suddenly: feeling or • women may not be able to orgasm being sick, stomach ache, diarrhoea, , • minor changes to your electrocardiogram (ECG) difficulty sleeping, nervousness or anxiety. may show up if your heart is tested • numbness or tingling in the arms and legs Use in children and adolescents (0 to 17 years): • movement disorder Clomipramine is not recommended in children • changes in liver function tests and adolescents. • changes to sense of taste Method of administration • ringing in the ears (). Swallow your Clomipramine capsules whole with a Uncommon (may affect up to 1 in 100 people) drink of water. • clumsiness and lack of coordination, affecting The medicine may be taken as one dose at night, balance and walking, limb or eye movements or split into several smaller doses and taken • increased blood pressure throughout the day. Your doctor will tell you what • irregular heartbeats. to do. Rare (may affect up to 1 in 1,000 people) Duration of treatment • vaginal bleeding. Treatment is often long-term. Once an effective Very rare (may affect up to 1 in 10,000 people) dose is reached, you should continue to take this • fluid retention or generalised swelling medicine until your doctor tells you to stop. • If you take more Clomipramine than you should • swelling of the lungs which can cause flu-like Your heart and nervous system will be affected. effects such as coughing, chest tightness, chills Contact your doctor or nearest hospital emergency wheezing and difficulty breathing. department immediately. Take the container and • unexplained or easily bruising under the skin or any remaining capsules with you. increased bleeding if you are cut or injured (due to low levels in your blood) You may have the following signs of illness: • blue or purplish spots on the skin (ecchymosis) drowsiness, stupor (when you are unable to • bleeding in the skin causing purple patches move but still conscious) coma (unconscious), • abnormal reading of the electrical activity of the (uncoordinated muscle movement), brain (as seen in an electroencephalogram) restlessness, agitation, enhanced reflexes, muscle stiffness, irregular muscle contractions, twisting Not known (frequency cannot be estimated from and writhing movements of the hands and feet, the available data) convulsions (fits). You may also have signs of • feeling of inner restlessness and a compelling need to be in constant motion so-called “Serotonin Syndrome” (very high blood • repetitive, involuntary movements pressure, very high , muscle twitching, • inability to ejaculate or a delay in ejaculation confusion and coma). Other signs include: rapid • increase in prolactin (a hormone) level in or irregular heartbeat, sudden () the blood. and in very rare cases heart attack, fever, being sick, abnormally dilated pupil, sweating, low An increased risk of bone fractures has been blood pressure or a severe drop in blood pressure, observed in patients taking this type of medicine. , blue skin, and a decrease or absence of urine production. If you are elderly you may be more likely to suffer from agitation and postural . Mental If you forget to take Clomipramine disorders such as confusion, disorientation and If you miss a dose, take the next dose at the usual hallucinations (seeing or hearing things that are time. Then go on as before. DO NOT take a double not there) are also more likely, especially at night, dose to make up for a forgotten dose. and especially if you have Parkinson’s disease. These side effects should disappear a few days If you stop taking Clomipramine after you stop taking Clomipramine. Speak to your doctor first before stopping this medicine. Your doctor will tell you how to Reporting of side effects gradually reduce your medication. This will help If you get any side effects, talk to your doctor or avoid unwanted side effects such as feeling sick, pharmacist. This includes any possible side effects being sick, stomach pain, diarrhoea, sleeplessness, not listed in this leaflet. headache, feeling nervous or anxious. You can also report side effects directly via the If you have any further questions on the use of this Yellow Card Scheme, website: medicine, ask your doctor or pharmacist. www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on 4. Possible side effects the safety of this medicine. Like all medicines, this medicine can cause side 5. How to store Clomipramine effects, although not everybody gets them. Store Clomipramine capsules below 25°C in a Some side effects can be serious dry place. Stop taking Clomipramine and tell your doctor immediately or go to your nearest hospital Keep this medicine out of the sight and reach emergency department if you notice the following: of children. Common (may affect up to 1 in 10 people) Do not use this medicine after the expiry date, • changes in your mood or behaviour such as which is stated on the pack or bottle. The expiry feeling unusually happy, excited (delirious), date refers to the last day of that month. irritable, confused, seeing or hearing things that aren’t there (hallucinations) or changes in your If your doctor tells you to stop taking perception of reality (depersonalisation). Clomipramine please take any unused medicine • difficulty or inability to pass urine back to your pharmacist to be destroyed. Do not throw away any medicines via wastewater or Uncommon (may affect up to 1 in 100 people) household waste. Ask your pharmacist how to • convulsions (fits) throw away medicines you no longer use. These measures will help protect the environment. Very rare (may affect up to 1 in 10,000 people) • rash, changes in blood pressure, swelling of the 6. Contents of the pack and other information hands, face, tongue, neck or throat and increased fluid in tissues, an increased heart rate, difficulty What Clomipramine contains breathing and collapse. These may all be the The active substance is clomipramine signs of a severe allergic reaction hydrochloride. Each 10 mg capsule contains 10 mg • a high temperature and sweating with rigid clomipramine hydrochloride. Each 25 mg capsule muscles and confusion or agitation, or if you contains 25 mg clomipramine hydrochloride. experience jerky muscle movements which Each 50 mg capsule contains 50 mg clomipramine you can’t control. These may be the symptoms hydrochloride. of a serious condition known as neuroleptic The other ingredients are lactose monohydrate malignant syndrome (see section 2 ‘Clomipramine contains lactose’), • low numbers of white blood cells, leading to maize starch dried, purified talc, silica, colloidal frequent infections, such as fever, chills, sore anhydrous and stearate. The shell of throat or mouth ulcers each strength of capsule also contains gelatin, iron • changes to your eyesight that may be due to high oxide red (E172) and titanium dioxide (E171). The pressure in the eye (known as glaucoma) 10 mg capsule shell also contains Sunset yellow • very high fever or heatstroke (E110) (see section 2 ‘Clomipramine contains • disease of the liver (known as ), this Sunset yellow’) and Quinoline yellow (E104). may result in . You may feel sick, be sick, The 25 mg capsule shell also contains iron oxide generally feel unwell, lose your appetite, have a yellow (E172) and erythrosine (E127). The 50 mg fever, yellowing of the skin or whites of the eyes, capsule shell also contains Indigo carmine (E132). light coloured stools and dark-coloured urine The printing ink for the 10 mg capsule contains • problems with how your heart beats. You may shellac, iron oxide black (E172), propylene glycol have shortness of breath, irregular heart beat and and ammonium hydroxide. The printing ink for fainting (especially if you have low potassium the 25 mg and 50 mg capsule contains shellac, levels in your blood) titanium dioxide (E171), propylene glycol, • a lower than normal level of sodium in the blood, ammonium hydroxide and simeticone. which may make you feel weak and confused with aching of muscles. This may be due to What Clomipramine looks like and contents of inappropriate ADH secretion, a hormone that the pack: causes the body to retain water and dilute the Clomipramine 10 mg capsules are red and yellow blood, reducing the amount of sodium. hard gelatin capsules marked ‘G CI10’. Clomipramine 25 mg capsules are red and orange Not known (frequency cannot be estimated from hard gelatin capsules marked ‘G CI25’. the available data) Clomipramine 50 mg capsules are red and blue • thoughts of suicide or self-harm (see section 2 for hard gelatin capsules marked ‘G CI50’. more information) • breakdown of muscle, causing muscle pain, The capsules are available in blisters or plastic weakness or tenderness accompanied by dark containers of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, urine (rhabdomyolysis) 60, 84, 90, 100, 112, 120, 168 and 180 capsules. Not • serotonin syndrome (caused by an increase in all pack sizes may be marketed. naturally occurring messenger, serotonin, in the Marketing Authorisation Holder: brain; symptoms include agitation, confusion, Mylan, Potters Bar, Hertfordshire, EN6 1TL, diarrhoea, high temperature, increased blood United Kingdom. pressure, excessive sweating and rapid heartbeat) Manufacturer: Other side effects that you may experience Generics [UK] Limited, Potters Bar, Hertfordshire, Very common (may affect more than 1 in 10 people) EN6 1TL, United Kingdom. • increase in appetite, weight gain Gerard Laboratories, 35/36 Baldoyle Industrial • , , feeling sick (), Estate, Grange Road, Dublin 13, Ireland. constipation, dry mouth, increased sweating • shaking (particularly the hands), problems with This leaflet was last revised in: your eye sight including blurred vision, feeling November 2020 tired or sleepy • problems with either your sex drive or getting or maintaining an erection • muscle twitching, restlessness • changes in the amount of sugar in the blood • changes to the amount of urine you produce or frequency of . Common (may affect up to 1 in 10 people) • reduced appetite • stomach problems • being sick • diarrhoea • fast heart rate, which you may feel as a racing or thumping in the chest (), light- headedness when standing up (due to low blood pressure) • increased anxiety • hot flushes • enlarged pupils LT1378AI • problems with your speech 2228379

Description Clomipramine Hydrochloride 50 mg,25 mg,10 mg 28 Date: 16 Nov 2020 Time: 19:26

Component Type Leaflet Pharma Code 876 No. of colours 1 Page Count 2/2 400000588, 400000590 Affiliate Item Code 2228379 SAP No. 400000589, 400556466 Colours Black 400556465, 400556464 Superceded Affiliate Item Code 894225 Vendor Job No. 559758 Non-Print TrackWise PR No. 2228379 Trackwise Proof No. 5 Colours MA No. PL 04569/0229-31 Client Market United Kingdom Equate CMYK Packing Site/Printer NA Keyline/Drawing No. NA with Supplier Code LT1378AI Barcode Info NA Main Font Myriad Pro Body Text Size 9 pt 3D Render ID NA Dimensions 170 x 580 mm Min Text Size used 9 pt Sign-offs

v3/July 2017