If you get any of the following side effects, see your doctor as soon as possible:

■    Effects on your heart: feeling faint and dizzy when standing up, change in blood pressure, fast or unusual heart beats, heart failure becoming worse

■    Effects on your brain and nervous system: feeling confused, feeling agitated, feeling disorientated (not knowing where you are), delusions and hearing or seeing things that are not there (hallucinations), difficulty sleeping, nightmares, feeling slightly hyperactive, numbness or tingling or pins and needles (particularly in the hands and feet), difficulty in co-ordinating movements, fits

■    Effects on your liver: hepatitis including changes in liver function that would be identified by a blood test, yellowing of the skin and the whites of your eyes (jaundice)

■ Effects on your hormones: change in sexual function and sex drive, breast swelling in men and women, production of breast milk, pain in the testicles, increased or decreased blood sugar levels, inappropriate secretion of the hormone ADH (antidiuretic hormone) that may make you pass water (urinate) more frequently.

Tell your doctor if you get any of these side effects:

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor

or pharmacist.

■    Effects on your ears: buzzing or ringing in the ears

■    Effects on your stomach and intestines: feeling or being sick, nasty taste in your mouth, dry mouth, constipation, diarrhoea

■    Effects on the skin: skin rashes, skin rash due to sunlight, swollen face, bleeding from the skin, swelling of the moist areas of the body such as the nose

■    Effects on your eyesight: blurred or double vision, changes in eyesight, glaucoma

■    General effects: headache, dizziness, tiredness, increased sweating, difficulty passing water, shaking.

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

Rasemont^ Package leaflet: Information for the user

Lofepramine Rosemont 70mg/5ml Oral Suspension

■    Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

■    Keep this leaflet. You may need to read it again.

■    If you have any further questions, ask your doctor or your pharmacist.

■    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

■    If any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

1.    What Lofepramine Rosemont is and what it is used for

2.    What you need to know before you take Lofepramine Rosemont

3.    How to take Lofepramine Rosemont

4.    Possible side effects

5.    How to store Lofepramine Rosemont

6.    Contents of the pack and other information

1. What Lofepramine Rosemont is and what it is used for

The name of your medicine is Lofepramine Rosemont 70mg/5ml Oral Suspension (called Lofepramine in this leaflet). This belongs to a group of medicines called tricyclic antidepressants.

Lofepramine alters the levels of chemicals in your brain to relieve the symptoms of depression.

Lofepramine can be used to treat the symptoms of depression.

2. What you need to know before you take Lofepramine Rosemont

5. How to store Lofepramine Rosemont

■    Keep this medicine out of the sight and reach of children.

■    Store between 4°C and 25°C. Store away from direct light.

■    Do not use this medicine after the expiry date which is stated on the label and carton after EXP: month year.

The expiry date refers to the last day of that month.

■    Do not use this medicine if you notice anything wrong with the medicine. Talk to your pharmacist.

■    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.

6. Contents of the pack and other information

What Lofepramine Rosemont contains

■    The active ingredient is lofepramine hydrochloride.

■    The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), sodium ascorbate (E301), sorbitol solution 70% non-crystallising (E420), liquid maltitol (E965), ethanol, colloidal silicon dioxide, cherry flavour and purified water.

What Lofepramine Rosemont looks like and contents of the pack

A white to pale yellow/orange suspension with a cherry odour.

It comes in a brown glass bottle holding 150ml of suspension.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

This leaflet was last revised in 11/2015

H8XD1RBJ1

Do not take Lofepramine and tell your doctor if:

■    you are allergic (hypersensitive) to lofepramine, other tricyclic antidepressants such as clomipramine and imipramine or any other ingredients in this liquid (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath

■    you are pregnant, likely to become pregnant or breast-feeding

■    you suffer from periods of increased and exaggerated unusual behaviour (mania)

■    you have liver or kidney disease

■    you have heart problems including unusual heart beats, heart block or if you have recently had a heart attack

■    you have untreated glaucoma (raised pressure of the fluid inside the eye)

■    you suffer from prostate problems and have problems passing urine

■    you suffer from chronic constipation

■    you are suffering from alcohol or drug poisoning

■    you are suffering from mental confusion (deliria)

■    you are taking MAOIs, amiodarone or terfenadine (see 'Other medicines and Lofepramine' section).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Lofepramine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lofepramine if:

■    you have epilepsy or you are experiencing withdrawal from alcohol or epileptic drugs

■    you have an enlarged prostate gland

■    you have increased pressure in your eye (known as narrow-angle glaucoma)

■    you have thyroid problems or you are taking medicine to treat a thyroid problem

■    you have a mental illness such as manic depression

■    you are having electroconvulsive therapy (ECT)

■    you have a problem with your blood called porphyria or other blood problems

■    you have tumour of the adrenal gland (phaeochromocytoma or neuroblastoma)

■    you have high blood pressure. Your doctor may want to check your blood pressure before starting you on treatment with lofepramine

■    you or members of your family have a history of irregular heart beats or other heart problems

■    you have been told by your doctor that you have low sodium or potassium levels.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lofepramine.

Continued overleaf

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